82 FR 43459 - Protection of Human Subjects
CONSUMER PRODUCT SAFETY COMMISSION Federal Register Volume 82, Issue 179 (September 18, 2017)
Federal Register Volume 82, Issue 179 (September 18, 2017)
| Page Range | 43459-43470 | |
| FR Document | 2017-19737 |
[Federal Register Volume 82, Number 179 (Monday, September 18, 2017)] [Rules and Regulations] [Pages 43459-43470] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-19737] ======================================================================= ----------------------------------------------------------------------- CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Part 1028 Protection of Human Subjects AGENCY: Consumer Product Safety Commission. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: On January 19, 2017, the Federal departments and agencies that are subject to the Federal Policy for the Protection of Human Subjects (referred to as the Common Rule) published a final rule amending the Common Rule. The Consumer Product Safety Commission (CPSC or Commission) adopts the Common Rule. DATES: The rule is effective on January 19, 2018. The compliance date for this rule, except for Sec. 1028.114(b) (cooperative research), is January 19, 2018. The compliance date for Sec. 1028.114(b) (cooperative research) is January 20, 2020. FOR FURTHER INFORMATION CONTACT: Alice Thaler, Associate Executive Director for Health Sciences, Consumer Product Safety Commission, 5 Research Place, Rockville, MD 20850: 301-987-2240, or by email to: [email protected]. SUPPLEMENTARY INFORMATION: On June 18, 1991, the U.S. Department of Health and Human Services (HHS) issued a rule setting forth the Common Rule requirements for the protection of human subjects. (56 FR 28003). The HHS regulations are codified at 45 CFR part 46. At that time, 15 other agencies, including CPSC, joined HHS in adopting a uniform set of rules for the protection of human subjects, identical to subpart A of 45 CFR part 46. The Common Rule is codified in CPSC's regulations at 16 CFR part 1028. The basic provisions of the Common Rule include, among other things, requirements related to the review of human subjects research by an institutional review board, obtaining and documenting informed consent of human subjects, and submitting written assurance of institutional compliance with the Common Rule. On September 8, 2015 (80 FR 53933), HHS, on behalf of many of the same agencies that were signatories to the original Common Rule, proposed revisions to the Common Rule to modernize and strengthen the rule. Although CPSC was not a signatory to the Common Rule NPR, CPSC proposed to amend the Commission's regulations at 16 CFR part 1028, to cross-reference the HHS regulations in 45 CFR part 46, subpart A. 80 FR 57548 (Sept. 24, 2015). In addition, CPSC directed that any comments on the proposed Common Rule be sent to the HHS docket for the proceeding at HHS-OPHS-2015-0008. On January 19, 2017, HHS issued a final rule on the Common Rule, which, among other things, establishes new requirements regarding the information that must be given to prospective research subjects as part of the informed consent process. 82 FR 7149. HHS also reviewed and addressed more than 2,100 comments. Although CPSC instructed that any comment on the Common Rule be submitted in the HHS docket, 22 comments were submitted, instead, to the CPSC docket. CPSC reviewed the comments and determined that all of the substantive issues were addressed in the Common Rule final rule. Because CPSC's current regulations on the protection of human subjects, codified at 16 CFR part 1028, follow the [[Page 43460]] HHS regulations in 45 CFR part 46, subpart A, CPSC proposed to adopt the amended regulatory text provided in the Common Rule final rule by providing a cross-reference to the HHS regulations in 45 CFR part 46, subpart A, rather than restating the text of HHS's regulation in CPSC's rule. However, at the direction of the Office of the Federal Register, for the final rule, CPSC is codifying the text of the revised Common Rule in CPSC's regulations at 16 CFR part 1028. CPSC's final rule is substantively identical to the HHS regulations in 45 CFR part 46, subpart A. Accordingly, CPSC now adopts the final Common Rule. The effective date of the Common Rule is January 19, 2018, with a compliance date of January 19, 2018, except for the section on cooperative research (Sec. 1028.114), which has a compliance date of January 20, 2020. List of Subjects in 16 CFR Part 1028 Human research subjects, Reporting and recordkeeping requirements, Research. For the reasons stated in the preamble, the Consumer Product Safety Commission amends Title 16 of the Code of Federal Regulations by revising part 1028 to read as follows: PART 1028--PROTECTION OF HUMAN SUBJECTS Sec. 1028.101 To what does this policy apply? 1028.102 Definitions for purposes of this policy. 1028.103 Assuring compliance with this policy--research conducted or supported by any Federal department or agency. 1028.104 Exempt research. 1028.105 [Reserved] 1028.106 [Reserved] 1028.107 IRB membership. 1028.108 IRB functions and operations. 1028.109 IRB review of research. 1028.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. 1028.111 Criteria for IRB approval of research. 1028.112 Review by institution. 1028.113 Suspension or termination of IRB approval of research. 1028.114 Cooperative research. 1028.115 IRB records. 1028.116 General requirements for informed consent. 1028.117 Documentation of informed consent. 1028.118 Applications and proposals lacking definite plans for involvement of human subjects. 1028.119 Research undertaken without the intention of involving human subjects. 1028.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal department or agency. 1028.121 [Reserved] 1028.122 Use of Federal funds. 1028.123 Early termination of research support: Evaluation of applications and proposals. 1028.124 Conditions. Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b). Sec. 1028.101 To what does this policy apply? (a) Except as detailed in Sec. 1028.104, this policy applies to all research involving human subjects conducted, supported, or otherwise subject to regulation by any Federal department or agency that takes appropriate administrative action to make the policy applicable to such research. This includes research conducted by Federal civilian employees or military personnel, except that each department or agency head may adopt such procedural modifications as may be appropriate from an administrative standpoint. It also includes research conducted, supported, or otherwise subject to regulation by the Federal Government outside the United States. Institutions that are engaged in research described in this paragraph and institutional review boards (IRBs) reviewing research that is subject to this policy must comply with this policy. (b) [Reserved] (c) Department or agency heads retain final judgment as to whether a particular activity is covered by this policy and this judgment shall be exercised consistent with the ethical principles of the Belmont Report.\1\ --------------------------------------------------------------------------- \1\ The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research--Belmont Report. Washington, DC: U.S. Department of Health and Human Services. 1979. --------------------------------------------------------------------------- (d) Department or agency heads may require that specific research activities or classes of research activities conducted, supported, or otherwise subject to regulation by the Federal department or agency but not otherwise covered by this policy comply with some or all of the requirements of this policy. (e) Compliance with this policy requires compliance with pertinent federal laws or regulations that provide additional protections for human subjects. (f) This policy does not affect any state or local laws or regulations (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe) that may otherwise be applicable and that provide additional protections for human subjects. (g) This policy does not affect any foreign laws or regulations that may otherwise be applicable and that provide additional protections to human subjects of research. (h) When research covered by this policy takes place in foreign countries, procedures normally followed in the foreign countries to protect human subjects may differ from those set forth in this policy. In these circumstances, if a department or agency head determines that the procedures prescribed by the institution afford protections that are at least equivalent to those provided in this policy, the department or agency head may approve the substitution of the foreign procedures in lieu of the procedural requirements provided in this policy. Except when otherwise required by statute, Executive Order, or the department or agency head, notices of these actions as they occur will be published in the Federal Register or will be otherwise published as provided in department or agency procedures. (i) Unless otherwise required by law, department or agency heads may waive the applicability of some or all of the provisions of this policy to specific research activities or classes of research activities otherwise covered by this policy, provided the alternative procedures to be followed are consistent with the principles of the Belmont Report.\2\ Except when otherwise required by statute or Executive Order, the department or agency head shall forward advance notices of these actions to the Office for Human Research Protections, Department of Health and Human Services (HHS), or any successor office, or to the equivalent office within the appropriate Federal department or agency, and shall also publish them in the Federal Register or in such other manner as provided in department or agency procedures. The waiver notice must include a statement that identifies the conditions under which the waiver will be applied and a justification as to why the waiver is appropriate for the research, including how the decision is consistent with the principles of the Belmont Report. --------------------------------------------------------------------------- \2\ Id. --------------------------------------------------------------------------- (j) Federal guidance on the requirements of this policy shall be issued only after consultation, for the purpose of harmonization (to the extent appropriate), with other Federal departments and agencies that have adopted this policy, unless such consultation is not feasible. (k) [Reserved] (l) Compliance dates and transition provisions: (1) For purposes of this section, the pre-2018 Requirements means this [[Page 43461]] subpart as published in the 2016 edition of the Code of Federal Regulations. (2) For purposes of this section, the 2018 Requirements means the Federal Policy for the Protection of Human Subjects requirements contained in this subpart. The compliance date for Sec. 1028.114(b) (cooperative research) of the 2018 Requirements is January 20, 2020. (3) Research initially approved by an IRB, for which such review was waived pursuant to Sec. 1028.101(i), or for which a determination was made that the research was exempt before January 19, 2018, shall comply with the pre-2018 Requirements, except that an institution engaged in such research on or after January 19, 2018, may instead comply with the 2018 Requirements if the institution determines that such ongoing research will comply with the 2018 Requirements and an IRB documents such determination. (4) Research initially approved by an IRB, for which such review was waived pursuant to Sec. 1028.101(i), or for which a determination was made that the research was exempt on or after January 19, 2018, shall comply with the 2018 Requirements. (m) Severability: Any provision of this part held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, shall be construed so as to continue to give maximum effect to the provision permitted by law, unless such holding shall be one of utter invalidity or unenforceability, in which event the provision shall be severable from this part and shall not affect the remainder thereof or the application of the provision to other persons not similarly situated or to other dissimilar circumstances. Sec. 1028.102 Definitions for purposes of this policy. (a) Certification means the official notification by the institution to the supporting Federal department or agency component, in accordance with the requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved assurance. (b) Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. (c) Department or agency head means the head of any Federal department or agency, for example, the Secretary of HHS, and any other officer or employee of any Federal department or agency to whom the authority provided by these regulations to the department or agency head has been delegated. (d) Federal department or agency refers to a federal department or agency (the department or agency itself rather than its bureaus, offices or divisions) that takes appropriate administrative action to make this policy applicable to the research involving human subjects it conducts, supports, or otherwise regulates (e.g., the U.S. Department of Health and Human Services, the U.S. Department of Defense, or the Central Intelligence Agency). (e)(1) Human subject means a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. (2) Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. (3) Interaction includes communication or interpersonal contact between investigator and subject. (4) Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record). (5) Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information. (6) An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen. (7) Federal departments or agencies implementing this policy shall: (i) Upon consultation with appropriate experts (including experts in data matching and re-identification), reexamine the meaning of ``identifiable private information,'' as defined in paragraph (e)(5) of this section, and ``identifiable biospecimen,'' as defined in paragraph (e)(6) of this section. This reexamination shall take place within 1 year and regularly thereafter (at least every 4 years). This process will be conducted by collaboration among the Federal departments and agencies implementing this policy. If appropriate and permitted by law, such Federal departments and agencies may alter the interpretation of these terms, including through the use of guidance. (ii) Upon consultation with appropriate experts, assess whether there are analytic technologies or techniques that should be considered by investigators to generate ``identifiable private information,'' as defined in paragraph (e)(5) of this section, or an ``identifiable biospecimen,'' as defined in paragraph (e)(6) of this section. This assessment shall take place within 1 year and regularly thereafter (at least every 4 years). This process will be conducted by collaboration among the Federal departments and agencies implementing this policy. Any such technologies or techniques will be included on a list of technologies or techniques that produce identifiable private information or identifiable biospecimens. This list will be published in the Federal Register after notice and an opportunity for public comment. The Secretary, HHS, shall maintain the list on a publicly accessible Web site. (f) Institution means any public or private entity, or department or agency (including federal, state, and other agencies). (g) IRB means an institutional review board established in accord with and for the purposes expressed in this policy. (h) IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements. (i) Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research. If there is no applicable law addressing this issue, legally authorized representative means an individual recognized by institutional policy as acceptable for providing consent in the nonresearch context on behalf of the prospective subject to the subject's participation in the procedure(s) involved in the research. (j) Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily [[Page 43462]] life or during the performance of routine physical or psychological examinations or tests. (k) Public health authority means an agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate. (l) Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. For purposes of this part, the following activities are deemed not to be research: (1) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected. (2) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters). (3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes. (4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions. (m) Written, or in writing, for purposes of this part, refers to writing on a tangible medium (e.g., paper) or in an electronic format. Sec. 1028.103 Assuring compliance with this policy--research conducted or supported by any Federal department or agency. (a) Each institution engaged in research that is covered by this policy, with the exception of research eligible for exemption under Sec. 1028.104, and that is conducted or supported by a Federal department or agency, shall provide written assurance satisfactory to the department or agency head that it will comply with the requirements of this policy. In lieu of requiring submission of an assurance, individual department or agency heads shall accept the existence of a current assurance, appropriate for the research in question, on file with the Office for Human Research Protections, HHS, or any successor office, and approved for Federal-wide use by that office. When the existence of an HHS-approved assurance is accepted in lieu of requiring submission of an assurance, reports (except certification) required by this policy to be made to department and agency heads shall also be made to the Office for Human Research Protections, HHS, or any successor office. Federal departments and agencies will conduct or support research covered by this policy only if the institution has provided an assurance that it will comply with the requirements of this policy, as provided in this section, and only if the institution has certified to the department or agency head that the research has been reviewed and approved by an IRB (if such certification is required by paragraph (d) of this section). (b) The assurance shall be executed by an individual authorized to act for the institution and to assume on behalf of the institution the obligations imposed by this policy and shall be filed in such form and manner as the department or agency head prescribes. (c) The department or agency head may limit the period during which any assurance shall remain effective or otherwise condition or restrict the assurance. (d) Certification is required when the research is supported by a Federal department or agency and not otherwise waived under Sec. 1028.101(i) or exempted under Sec. 1028.104. For such research, institutions shall certify that each proposed research study covered by the assurance and this section has been reviewed and approved by the IRB. Such certification must be submitted as prescribed by the Federal department or agency component supporting the research. Under no condition shall research covered by this section be initiated prior to receipt of the certification that the research has been reviewed and approved by the IRB. (e) For nonexempt research involving human subjects covered by this policy (or exempt research for which limited IRB review takes place pursuant to Sec. 1028.104(d)(2)(iii), (d)(3)(i)(C), or (d)(7) or (8)) that takes place at an institution in which IRB oversight is conducted by an IRB that is not operated by the institution, the institution and the organization operating the IRB shall document the institution's reliance on the IRB for oversight of the research and the responsibilities that each entity will undertake to ensure compliance with the requirements of this policy (e.g., in a written agreement between the institution and the IRB, by implementation of an institution-wide policy directive providing the allocation of responsibilities between the institution and an IRB that is not affiliated with the institution, or as set forth in a research protocol). (Approved by the Office of Management and Budget under Control Number 0990-0260) Sec. 1028.104 Exempt research. (a) Unless otherwise required by law or by department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the categories in paragraph (d) of this section are exempt from the requirements of this policy, except that such activities must comply with the requirements of this section and as specified in each category. (b) Use of the exemption categories for research subject to the requirements of 45 CFR part 46, subparts B, C, and D: Application of the exemption categories to research subject to the requirements of 45 CFR part 46, subparts B, C, and D, is as follows: (1) Subpart B. Each of the exemptions at this section may be applied to research subject to subpart B if the conditions of the exemption are met. (2) Subpart C. The exemptions at this section do not apply to research subject to subpart C, except for research aimed at involving a broader subject population that only incidentally includes prisoners. (3) Subpart D. The exemptions at paragraphs (d)(1) and (d)(4) through (8) of this section may be applied to [[Page 43463]] research subject to subpart D if the conditions of the exemption are met. Paragraphs (d)(2)(i) and (ii) of this section only may apply to research subject to subpart D involving educational tests or the observation of public behavior when the investigator(s) do not participate in the activities being observed. Paragraph (d)(2)(iii) of this section may not be applied to research subject to subpart D. (c) [Reserved.] (d) Except as described in paragraph (a) of this section, the following categories of human subjects research are exempt from this policy: (1) Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. (2) Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met: (i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; (ii) Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or (iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by Sec. 1028.111(a)(7). (3)(i) Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met: (A) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; (B) Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or (C) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by Sec. 1028.111(a)(7). (ii) For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else. (iii) If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research. (4) Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met: (i) The identifiable private information or identifiable biospecimens are publicly available; (ii) Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects; (iii) The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of ``health care operations'' or ``research'' as those terms are defined at 45 CFR 164.501 or for ``public health activities and purposes'' as described under 45 CFR 164.512(b); or (iv) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq. (5) Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended. (i) Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this [[Page 43464]] provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects. (ii) [Reserved] (6) Taste and food quality evaluation and consumer acceptance studies: (i) If wholesome foods without additives are consumed, or (ii) If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture. (7) Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by Sec. 1028.111(a)(8). (8) Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met: (i) Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with Sec. 1028.116(a)(1) through (4), (a)(6), and (d); (ii) Documentation of informed consent or waiver of documentation of consent was obtained in accordance with Sec. 1028.117; (iii) An IRB conducts a limited IRB review and makes the determination required by Sec. 1028.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and (iv) The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results. (Approved by the Office of Management and Budget under Control Number 0990-0260) Sec. 1028.105 [Reserved.] Sec. 1028.106 [Reserved] Sec. 1028.107 IRB membership. (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members (professional competence), and the diversity of its members, including race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. The IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments (including policies and resources) and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a category of subjects that is vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these categories of subjects. (b) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. (c) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution. (d) No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. (e) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB. Sec. 1028.108 IRB functions and operations. (a) In order to fulfill the requirements of this policy each IRB shall: (1) Have access to meeting space and sufficient staff to support the IRB's review and recordkeeping duties; (2) Prepare and maintain a current list of the IRB members identified by name; earned degrees; representative capacity; indications of experience such as board certifications or licenses sufficient to describe each member's chief anticipated contributions to IRB deliberations; and any employment or other relationship between each member and the institution, for example, full-time employee, part- time employee, member of governing panel or board, stockholder, paid or unpaid consultant; (3) Establish and follow written procedures for: (i) Conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the institution; (ii) Determining which projects require review more often than annually and which projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review; and (iii) Ensuring prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that investigators will conduct the research activity in accordance with the terms of the IRB approval until any proposed changes have been reviewed and approved by the IRB, except when necessary to eliminate apparent immediate hazards to the subject. (4) Establish and follow written procedures for ensuring prompt reporting to the IRB; appropriate institutional officials; the department or agency head; and the Office for Human Research Protections, HHS, or any successor office, or the equivalent office within the appropriate Federal department or agency of (i) Any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this policy or the requirements or determinations of the IRB; and (ii) Any suspension or termination of IRB approval. (b) Except when an expedited review procedure is used (as described in Sec. 1028.110), an IRB must review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting. (Approved by the Office of Management and Budget under Control Number 0990-0260) [[Page 43465]] Sec. 1028.109 IRB review of research. (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy, including exempt research activities under Sec. 1028.104 for which limited IRB review is a condition of exemption (under Sec. 1028.104(d)(2)(iii), (d)(3)(i)(C), or (d)(7) or (8)). (b) An IRB shall require that information given to subjects (or legally authorized representatives, when appropriate) as part of informed consent is in accordance with Sec. 1028.116. The IRB may require that information, in addition to that specifically mentioned in Sec. 1028.116, be given to the subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights and welfare of subjects. (c) An IRB shall require documentation of informed consent or may waive documentation in accordance with Sec. 1028.117. (d) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing. (e) An IRB shall conduct continuing review of research requiring review by the convened IRB at intervals appropriate to the degree of risk, not less than once per year, except as described in paragraph (f) of this section. (f)(1) Unless an IRB determines otherwise, continuing review of research is not required in the following circumstances: (i) Research eligible for expedited review in accordance with Sec. 1028.110; (ii) Research reviewed by the IRB in accordance with the limited IRB review described in Sec. 1028.104(d)(2)(iii), (d)(3)(i)(C), or (d)(7) or (8); (iii) Research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study: (A) Data analysis, including analysis of identifiable private information or identifiable biospecimens, or (B) Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care. (2) [Reserved.] (g) An IRB shall have authority to observe or have a third party observe the consent process and the research. (Approved by the Office of Management and Budget under Control Number 0990-0260) Sec. 1028.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. (a) The Secretary of HHS has established, and published as a Notice in the Federal Register, a list of categories of research that may be reviewed by the IRB through an expedited review procedure. The Secretary will evaluate the list at least every 8 years and amend it, as appropriate, after consultation with other Federal departments and agencies and after publication in the Federal Register for public comment. A copy of the list is available from the Office for Human Research Protections, HHS, or any successor office. (b)(1) An IRB may use the expedited review procedure to review the following: (i) Some or all of the research appearing on the list described in paragraph (a) of this section, unless the reviewer determines that the study involves more than minimal risk; (ii) Minor changes in previously approved research during the period for which approval is authorized; or (iii) Research for which limited IRB review is a condition of exemption under Sec. 1028.104(d)(2)(iii), (d)(3)(i)(C), and (d)(7) and (8). (2) Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the nonexpedited procedure set forth in Sec. 1028.108(b). (c) Each IRB that uses an expedited review procedure shall adopt a method for keeping all members advised of research proposals that have been approved under the procedure. (d) The department or agency head may restrict, suspend, terminate, or choose not to authorize an institution's or IRB's use of the expedited review procedure. Sec. 1028.111 Criteria for IRB approval of research. (a) In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied: (1) Risks to subjects are minimized: (i) By using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes. (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility. (3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted. The IRB should be particularly cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons. (4) Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by, Sec. 1028.116. (5) Informed consent will be appropriately documented or appropriately waived in accordance with Sec. 1028.117. (6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. (7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. (i) The Secretary of HHS will, after consultation with the Office of Management and Budget's privacy office and other Federal departments and agencies that have adopted this policy, issue guidance to assist IRBs in assessing what provisions are adequate to protect the privacy of subjects and to maintain the confidentiality of data. (ii) [Reserved.] [[Page 43466]] (8) For purposes of conducting the limited IRB review required by Sec. 1028.104(d)(7)), the IRB need not make the determinations at paragraphs (a)(1) through (7) of this section, and shall make the following determinations: (i) Broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained in accordance with the requirements of Sec. 1028.116(a)(1)- (4), (a)(6), and (d); (ii) Broad consent is appropriately documented or waiver of documentation is appropriate, in accordance with Sec. 1028.117; and (iii) If there is a change made for research purposes in the way the identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects. Sec. 1028.112 Review by institution. Research covered by this policy that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. However, those officials may not approve the research if it has not been approved by an IRB. Sec. 1028.113 Suspension or termination of IRB approval of research. An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, appropriate institutional officials, and the department or agency head. Sec. 1028.114 Cooperative research. (a) Cooperative research projects are those projects covered by this policy that involve more than one institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy. (b)(1) Any institution located in the United States that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States. The reviewing IRB will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the Federal department or agency supporting the research. (2) The following research is not subject to this provision: (i) Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe); or (ii) Research for which any Federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context. (c) For research not subject to paragraph (b) of this section, an institution participating in a cooperative project may enter into a joint review arrangement, rely on the review of another IRB, or make similar arrangements for avoiding duplication of effort. Sec. 1028.115 IRB Records. (a) An institution, or when appropriate an IRB, shall prepare and maintain adequate documentation of IRB activities, including the following: (1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent forms, progress reports submitted by investigators, and reports of injuries to subjects. (2) Minutes of IRB meetings, which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution. (3) Records of continuing review activities, including the rationale for conducting continuing review of research that otherwise would not require continuing review as described in Sec. 1028.109(f)(1). (4) Copies of all correspondence between the IRB and the investigators. (5) A list of IRB members in the same detail as described in Sec. 1028.108(a)(2). (6) Written procedures for the IRB in the same detail as described in Sec. 1028.108(a)(3) and (4). (7) Statements of significant new findings provided to subjects, as required by Sec. 1028.116(c)(5). (8) The rationale for an expedited reviewer's determination under Sec. 1028.110(b)(1)(i) that research appearing on the expedited review list described in Sec. 1028.110(a) is more than minimal risk. (9) Documentation specifying the responsibilities that an institution and an organization operating an IRB each will undertake to ensure compliance with the requirements of this policy, as described in Sec. 1028.103(e). (b) The records required by this policy shall be retained for at least 3 years, and records relating to research that is conducted shall be retained for at least 3 years after completion of the research. The institution or IRB may maintain the records in printed form, or electronically. All records shall be accessible for inspection and copying by authorized representatives of the Federal department or agency at reasonable times and in a reasonable manner. Sec. 1028.116 General requirements for informed consent. (a) General. General requirements for informed consent, whether written or oral, are set forth in this paragraph and apply to consent obtained in accordance with the requirements set forth in paragraphs (b) through (d) of this section. Broad consent may be obtained in lieu of informed consent obtained in accordance with paragraphs (b) and (c) of this section only with respect to the storage, maintenance, and secondary research uses of identifiable private information and identifiable biospecimens. Waiver or alteration of consent in research involving public benefit and service programs conducted by or subject to the approval of state or local officials is described in paragraph (e) of this section. General waiver or alteration of informed consent is described in paragraph (f) of this section. Except as provided elsewhere in this policy: (1) Before involving a human subject in research covered by this policy, an investigator shall obtain the legally effective informed consent of the subject or the subject's legally authorized representative. (2) An investigator shall seek informed consent only under circumstances that provide the prospective subject or the legally authorized representative sufficient opportunity to discuss and consider [[Page 43467]] whether or not to participate and that minimize the possibility of coercion or undue influence. (3) The information that is given to the subject or the legally authorized representative shall be in language understandable to the subject or the legally authorized representative. (4) The prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information. (5) Except for broad consent obtained in accordance with paragraph (d) of this section: (i) Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension. (ii) Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject's or legally authorized representative's understanding of the reasons why one might or might not want to participate. (6) No informed consent may include any exculpatory language through which the subject or the legally authorized representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence. (b) Basic elements of informed consent. Except as provided in paragraph (d), (e), or (f) of this section, in seeking informed consent the following information shall be provided to each subject or the legally authorized representative: (1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures that are experimental; (2) A description of any reasonably foreseeable risks or discomforts to the subject; (3) A description of any benefits to the subject or to others that may reasonably be expected from the research; (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained; (6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained; (7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled; and (9) One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens: (i) A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or (ii) A statement that the subject's information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies. (c) Additional elements of informed consent. Except as provided in paragraphs (d), (e), or (f) of this section, one or more of the following elements of information, when appropriate, shall also be provided to each subject or the legally authorized representative: (1) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable; (2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's or the legally authorized representative's consent; (3) Any additional costs to the subject that may result from participation in the research; (4) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject; (5) A statement that significant new findings developed during the course of the research that may relate to the subject's willingness to continue participation will be provided to the subject; (6) The approximate number of subjects involved in the study; (7) A statement that the subject's biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit; (8) A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and (9) For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen). (d) Elements of broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens. Broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens (collected for either research studies other than the proposed research or nonresearch purposes) is permitted as an alternative to the informed consent requirements in paragraphs (b) and (c) of this paragraph. If the subject or the legally authorized representative is asked to provide broad consent, the following shall be provided to each subject or the subject's legally authorized representative: (1) The information required in paragraphs (b)(2), (3), (5), and (8) and, when appropriate, (c)(7) and (9) of this section; (2) A general description of the types of research that may be conducted with the identifiable private information or identifiable biospecimens. This description must include sufficient information such that a reasonable person would expect that the broad consent would permit the types of research conducted; (3) A description of the identifiable private information or identifiable biospecimens that might be used in [[Page 43468]] research, whether sharing of identifiable private information or identifiable biospecimens might occur, and the types of institutions or researchers that might conduct research with the identifiable private information or identifiable biospecimens; (4) A description of the period of time that the identifiable private information or identifiable biospecimens may be stored and maintained (which period of time could be indefinite), and a description of the period of time that the identifiable private information or identifiable biospecimens may be used for research purposes (which period of time could be indefinite); (5) Unless the subject or legally authorized representative will be provided details about specific research studies, a statement that they will not be informed of the details of any specific research studies that might be conducted using the subject's identifiable private information or identifiable biospecimens, including the purposes of the research, and that they might have chosen not to consent to some of those specific research studies; (6) Unless it is known that clinically relevant research results, including individual research results, will be disclosed to the subject in all circumstances, a statement that such results may not be disclosed to the subject; and (7) An explanation of whom to contact for answers to questions about the subject's rights and about storage and use of the subject's identifiable private information or identifiable biospecimens, and whom to contact in the event of a research-related harm. (e) Waiver or alteration of consent in research involving public benefit and service programs conducted by or subject to the approval of state or local officials--(1) Waiver. An IRB may waive the requirement to obtain informed consent for research under paragraphs (a), (b), and (c) of this section, provided the IRB satisfies the requirements of paragraph (e)(3) of this section. If an individual was asked to provide broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens in accordance with the requirements at paragraph (d) of this section, and refused to consent, an IRB cannot waive consent for the storage, maintenance, or secondary research use of the identifiable private information or identifiable biospecimens. (2) Alteration. An IRB may approve a consent procedure that omits some, or alters some or all, of the elements of informed consent set forth in paragraphs (b) and (c) of this section provided the IRB satisfies the requirements of paragraph (e)(3) of this section. An IRB may not omit or alter any of the requirements described in paragraph (a) of this section. If a broad consent procedure is used, an IRB may not omit or alter any of the elements required under paragraph (d) of this section. (3) Requirements for waiver and alteration. In order for an IRB to waive or alter consent as described in this subsection, the IRB must find and document that: (i) The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (A) Public benefit or service programs; (B) Procedures for obtaining benefits or services under those programs; (C) Possible changes in or alternatives to those programs or procedures; or (D) Possible changes in methods or levels of payment for benefits or services under those programs; and (ii) The research could not practicably be carried out without the waiver or alteration. (f) General waiver or alteration of consent--(1) Waiver. An IRB may waive the requirement to obtain informed consent for research under paragraphs (a), (b), and (c) of this section, provided the IRB satisfies the requirements of paragraph (f)(3) of this section. If an individual was asked to provide broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens in accordance with the requirements at paragraph (d) of this section, and refused to consent, an IRB cannot waive consent for the storage, maintenance, or secondary research use of the identifiable private information or identifiable biospecimens. (2) Alteration. An IRB may approve a consent procedure that omits some, or alters some or all, of the elements of informed consent set forth in paragraphs (b) and (c) of this section provided the IRB satisfies the requirements of paragraph (f)(3) of this section. An IRB may not omit or alter any of the requirements described in paragraph (a) of this section. If a broad consent procedure is used, an IRB may not omit or alter any of the elements required under paragraph (d) of this section. (3) Requirements for waiver and alteration. In order for an IRB to waive or alter consent as described in this subsection, the IRB must find and document that: (i) The research involves no more than minimal risk to the subjects; (ii) The research could not practicably be carried out without the requested waiver or alteration; (iii) If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format; (iv) The waiver or alteration will not adversely affect the rights and welfare of the subjects; and (v) Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation. (g) Screening, recruiting, or determining eligibility. An IRB may approve a research proposal in which an investigator will obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective subjects without the informed consent of the prospective subject or the subject's legally authorized representative, if either of the following conditions are met: (1) The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, or (2) The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens. (h) Posting of clinical trial consent form. (1) For each clinical trial conducted or supported by a Federal department or agency, one IRB-approved informed consent form used to enroll subjects must be posted by the awardee or the Federal department or agency component conducting the trial on a publicly available Federal Web site that will be established as a repository for such informed consent forms. (2) If the Federal department or agency supporting or conducting the clinical trial determines that certain information should not be made publicly available on a Federal Web site (e.g. confidential commercial information), such Federal department or agency may permit or require redactions to the information posted. (3) The informed consent form must be posted on the Federal Web site after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol. (i) Preemption. The informed consent requirements in this policy are not intended to preempt any applicable Federal, state, or local laws (including [[Page 43469]] tribal laws passed by the official governing body of an American Indian or Alaska Native tribe) that require additional information to be disclosed in order for informed consent to be legally effective. (j) Emergency medical care. Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under applicable Federal, state, or local law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe). (Approved by the Office of Management and Budget under Control Number 0990-0260) Sec. 1028.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written informed consent form approved by the IRB and signed (including in an electronic format) by the subject or the subject's legally authorized representative. A written copy shall be given to the person signing the informed consent form. (b) Except as provided in paragraph (c) of this section, the informed consent form may be either of the following: (1) A written informed consent form that meets the requirements of Sec. 1028.116. The investigator shall give either the subject or the subject's legally authorized representative adequate opportunity to read the informed consent form before it is signed; alternatively, this form may be read to the subject or the subject's legally authorized representative. (2) A short form written informed consent form stating that the elements of informed consent required by Sec. 1028.116 have been presented orally to the subject or the subject's legally authorized representative, and that the key information required by Sec. 1028.116(a)(5)(i) was presented first to the subject, before other information, if any, was provided. The IRB shall approve a written summary of what is to be said to the subject or the legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Only the short form itself is to be signed by the subject or the subject's legally authorized representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the subject's legally authorized representative, in addition to a copy of the short form. (c)(1) An IRB may waive the requirement for the investigator to obtain a signed informed consent form for some or all subjects if it finds any of the following: (i) That the only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; (ii) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; or (iii) If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained. (2) In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects or legally authorized representatives with a written statement regarding the research. Sec. 1028.118 Applications and proposals lacking definite plans for involvement of human subjects. Certain types of applications for grants, cooperative agreements, or contracts are submitted to Federal departments or agencies with the knowledge that subjects may be involved within the period of support, but definite plans would not normally be set forth in the application or proposal. These include activities such as institutional type grants when selection of specific projects is the institution's responsibility; research training grants in which the activities involving subjects remain to be selected; and projects in which human subjects' involvement will depend upon completion of instruments, prior animal studies, or purification of compounds. Except for research waived under Sec. 1028.101(i) or exempted under Sec. 1028.104, no human subjects may be involved in any project supported by these awards until the project has been reviewed and approved by the IRB, as provided in this policy, and certification submitted, by the institution, to the Federal department or agency component supporting the research. Sec. 1028.119 Research undertaken without the intention of involving human subjects. Except for research waived under Sec. 1028.101(i) or exempted under Sec. 1028.104, in the event research is undertaken without the intention of involving human subjects, but it is later proposed to involve human subjects in the research, the research shall first be reviewed and approved by an IRB, as provided in this policy, a certification submitted by the institution to the Federal department or agency component supporting the research, and final approval given to the proposed change by the Federal department or agency component. Sec. 1028.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal department or agency. (a) The department or agency head will evaluate all applications and proposals involving human subjects submitted to the Federal department or agency through such officers and employees of the Federal department or agency and such experts and consultants as the department or agency head determines to be appropriate. This evaluation will take into consideration the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. (b) On the basis of this evaluation, the department or agency head may approve or disapprove the application or proposal, or enter into negotiations to develop an approvable one. Sec. 1028.121 [Reserved] Sec. 1028.122 Use of Federal funds. Federal funds administered by a Federal department or agency may not be expended for research involving human subjects unless the requirements of this policy have been satisfied. Sec. 1028.123 Early termination of research support: Evaluation of applications and proposals. (a) The department or agency head may require that Federal department or agency support for any project be terminated or suspended in the manner prescribed in applicable program requirements, when the department or agency head finds an institution has materially failed to comply with the terms of this policy. (b) In making decisions about supporting or approving applications or [[Page 43470]] proposals covered by this policy the department or agency head may take into account, in addition to all other eligibility requirements and program criteria, factors such as whether the applicant has been subject to a termination or suspension under paragraph (a) of this section and whether the applicant or the person or persons who would direct or has/have directed the scientific and technical aspects of an activity has/have, in the judgment of the department or agency head, materially failed to discharge responsibility for the protection of the rights and welfare of human subjects (whether or not the research was subject to federal regulation). Sec. 1028.124 Conditions With respect to any research project or any class of research projects the department or agency head of either the conducting or the supporting Federal department or agency may impose additional conditions prior to or at the time of approval when in the judgment of the department or agency head additional conditions are necessary for the protection of human subjects. Alberta E. Mills, Acting Secretary, Consumer Product Safety Commission. [FR Doc. 2017-19737 Filed 9-15-17; 8:45 am] BILLING CODE 6355-01-P
![Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Rules and Regulations 43459
(e) Reason appropriate. If sending information directly 2018. The compliance date for
This AD was prompted by a determination to the certification office, send it to ATTN: § 1028.114(b) (cooperative research) is
that a certain task in the aircraft maintenance Program Manager, Continuing Operational January 20, 2020.
manual (AMM) will not accomplish the Safety, FAA, New York ACO Branch, 1600
Stewart Avenue, Suite 410, Westbury, NY FOR FURTHER INFORMATION CONTACT:
intent of a candidate certification
11590; telephone 516–228–7300; fax 516– Alice Thaler, Associate Executive
maintenance requirement (CCMR). This
CCMR task tests the pitch feel (PF) and 794–5531. Before using any approved AMOC, Director for Health Sciences, Consumer
rudder travel limiter actuator (RTLA) back-up notify your appropriate principal inspector, Product Safety Commission, 5 Research
modules in the flight control unit (FCU) to or lacking a principal inspector, the manager Place, Rockville, MD 20850: 301–987–
detect dormant failures. We are issuing this of the local flight standards district office/ 2240, or by email to: athaler@cpsc.gov.
AD to detect and correct a dormant failure of certificate holding district office. The AMOC
approval letter must specifically reference SUPPLEMENTARY INFORMATION: On June
both FCU back-up modules. This condition, 18, 1991, the U.S. Department of Health
in combination with other failures in the this AD.
(2) Contacting the Manufacturer: For any and Human Services (HHS) issued a
FCU, may result in the inability to maintain
the minimum control requirements for the PF requirement in this AD to obtain corrective rule setting forth the Common Rule
and RTLA, which could create hazardous actions from a manufacturer, the action must requirements for the protection of
flight control inputs during flight. be accomplished using a method approved human subjects. (56 FR 28003). The
by the Manager, New York ACO Branch, HHS regulations are codified at 45 CFR
(f) Compliance FAA; or TCCA; or Bombardier, Inc.’s TCCA
part 46. At that time, 15 other agencies,
Comply with this AD within the DAO. If approved by the DAO, the approval
must include the DAO-authorized signature. including CPSC, joined HHS in
compliance times specified, unless already adopting a uniform set of rules for the
done. (j) Related Information protection of human subjects, identical
(g) FCU Operational Test (1) Refer to Mandatory Continuing to subpart A of 45 CFR part 46. The
(1) For airplanes with an FCU that has Airworthiness Information (MCAI) Canadian Common Rule is codified in CPSC’s
accumulated 3,000 total flight hours or more Airworthiness Directive CF–2015–06R1, regulations at 16 CFR part 1028. The
as of the effective date of this AD: Within 15 dated April 22, 2015, for related information. basic provisions of the Common Rule
months or 700 flight hours, whichever occurs This MCAI may be found in the AD docket
include, among other things,
first, after the effective date of this AD, do an on the Internet at http://www.regulations.gov
by searching for and locating Docket No. requirements related to the review of
operational test of the FCU back-up modules, human subjects research by an
in accordance with a method approved by FAA–2016–8177.
(2) For more information about this AD, institutional review board, obtaining
the Manager, New York ACO Branch, FAA.
(2) For airplanes with an FCU that has contact Assata Dessaline, Aerospace and documenting informed consent of
accumulated less than 3,000 total flight hours Engineer, Avionics and Services Section, human subjects, and submitting written
as of the effective date of this AD, and on FAA, New York ACO Branch, 1600 Stewart assurance of institutional compliance
which an operational test has been Avenue, Suite 410, Westbury, NY 11590; with the Common Rule.
accomplished as specified in AMM task 27– telephone 516–228–7301; fax 516–794–5531. On September 8, 2015 (80 FR 53933),
61–05–710–801: Within 15 months or 700 (k) Material Incorporated by Reference HHS, on behalf of many of the same
flight hours, whichever occurs first, after the agencies that were signatories to the
None.
effective date of this AD, do an operational original Common Rule, proposed
test of the FCU back-up modules, in Issued in Renton, Washington, on revisions to the Common Rule to
accordance with a method approved by the September 7, 2017.
Manager, New York ACO Branch, FAA.
modernize and strengthen the rule.
Jeffrey E. Duven, Although CPSC was not a signatory to
(3) For airplanes with an FCU that has Director, System Oversight Division, Aircraft
accumulated less than 3,000 total flight hours the Common Rule NPR, CPSC proposed
Certification Service. to amend the Commission’s regulations
as of the effective date of this AD, and on
which an operational test has not been [FR Doc. 2017–19658 Filed 9–15–17; 8:45 am] at 16 CFR part 1028, to cross-reference
accomplished as specified in AMM task 27– BILLING CODE 4910–13–P the HHS regulations in 45 CFR part 46,
61–05–710–801: Before the FCU accumulates subpart A. 80 FR 57548 (Sept. 24, 2015).
3,000 total flight hours or within 30 days In addition, CPSC directed that any
after the effective date of this AD, whichever CONSUMER PRODUCT SAFETY comments on the proposed Common
occurs later, perform an operational test of COMMISSION
the FCU back-up modules, in accordance
Rule be sent to the HHS docket for the
with a method approved by the Manager, proceeding at HHS–OPHS–2015–0008.
16 CFR Part 1028 On January 19, 2017, HHS issued a
New York ACO Branch, FAA.
final rule on the Common Rule, which,
(h) Corrective Action Protection of Human Subjects among other things, establishes new
If any FCU fails any operational test AGENCY: Consumer Product Safety requirements regarding the information
required by this AD: Before further flight, Commission. that must be given to prospective
repair using a method approved by the research subjects as part of the informed
Manager, New York ACO Branch, FAA; or ACTION: Final rule.
consent process. 82 FR 7149. HHS also
Transport Canada Civil Aviation (TCCA); or SUMMARY: On January 19, 2017, the
Bombardier, Inc.’s TCCA Design Approval reviewed and addressed more than
Organization (DAO).
Federal departments and agencies that 2,100 comments. Although CPSC
are subject to the Federal Policy for the instructed that any comment on the
(i) Other FAA AD Provisions Protection of Human Subjects (referred Common Rule be submitted in the HHS
The following provisions also apply to this to as the Common Rule) published a docket, 22 comments were submitted,
AD: final rule amending the Common Rule. instead, to the CPSC docket. CPSC
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(1) Alternative Methods of Compliance The Consumer Product Safety reviewed the comments and determined
(AMOCs): The Manager, New York ACO Commission (CPSC or Commission) that all of the substantive issues were
Branch, FAA, has the authority to approve adopts the Common Rule.
AMOCs for this AD, if requested using the addressed in the Common Rule final
procedures found in 14 CFR 39.19. In DATES: The rule is effective on January rule.
accordance with 14 CFR 39.19, send your 19, 2018. The compliance date for this Because CPSC’s current regulations
request to your principal inspector or local rule, except for § 1028.114(b) on the protection of human subjects,
Flight Standards District Office, as (cooperative research), is January 19, codified at 16 CFR part 1028, follow the
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![43460 Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Rules and Regulations
HHS regulations in 45 CFR part 46, to be conducted or supported by a otherwise be applicable and that
subpart A, CPSC proposed to adopt the Federal department or agency. provide additional protections to human
amended regulatory text provided in the 1028.121 [Reserved] subjects of research.
1028.122 Use of Federal funds.
Common Rule final rule by providing a 1028.123 Early termination of research
(h) When research covered by this
cross-reference to the HHS regulations support: Evaluation of applications and policy takes place in foreign countries,
in 45 CFR part 46, subpart A, rather proposals. procedures normally followed in the
than restating the text of HHS’s 1028.124 Conditions. foreign countries to protect human
regulation in CPSC’s rule. However, at Authority: 5 U.S.C. 301; 42 U.S.C. 300v– subjects may differ from those set forth
the direction of the Office of the Federal 1(b). in this policy. In these circumstances, if
Register, for the final rule, CPSC is a department or agency head determines
codifying the text of the revised § 1028.101 To what does this policy apply? that the procedures prescribed by the
Common Rule in CPSC’s regulations at (a) Except as detailed in § 1028.104, institution afford protections that are at
16 CFR part 1028. CPSC’s final rule is this policy applies to all research least equivalent to those provided in
substantively identical to the HHS involving human subjects conducted, this policy, the department or agency
regulations in 45 CFR part 46, subpart supported, or otherwise subject to head may approve the substitution of
A. Accordingly, CPSC now adopts the regulation by any Federal department or the foreign procedures in lieu of the
final Common Rule. The effective date agency that takes appropriate procedural requirements provided in
of the Common Rule is January 19, administrative action to make the policy this policy. Except when otherwise
2018, with a compliance date of January applicable to such research. This required by statute, Executive Order, or
19, 2018, except for the section on includes research conducted by Federal the department or agency head, notices
cooperative research (§ 1028.114), civilian employees or military of these actions as they occur will be
which has a compliance date of January personnel, except that each department published in the Federal Register or
20, 2020. or agency head may adopt such will be otherwise published as provided
procedural modifications as may be in department or agency procedures.
List of Subjects in 16 CFR Part 1028 appropriate from an administrative (i) Unless otherwise required by law,
Human research subjects, Reporting standpoint. It also includes research department or agency heads may waive
and recordkeeping requirements, conducted, supported, or otherwise the applicability of some or all of the
Research. subject to regulation by the Federal provisions of this policy to specific
For the reasons stated in the Government outside the United States. research activities or classes of research
Institutions that are engaged in research activities otherwise covered by this
preamble, the Consumer Product Safety
described in this paragraph and policy, provided the alternative
Commission amends Title 16 of the
institutional review boards (IRBs) procedures to be followed are consistent
Code of Federal Regulations by revising
reviewing research that is subject to this with the principles of the Belmont
part 1028 to read as follows:
policy must comply with this policy. Report.2 Except when otherwise
PART 1028—PROTECTION OF HUMAN (b) [Reserved] required by statute or Executive Order,
(c) Department or agency heads retain
SUBJECTS the department or agency head shall
final judgment as to whether a
forward advance notices of these actions
Sec. particular activity is covered by this
to the Office for Human Research
1028.101 To what does this policy apply? policy and this judgment shall be
1028.102 Definitions for purposes of this Protections, Department of Health and
exercised consistent with the ethical
policy. Human Services (HHS), or any
principles of the Belmont Report.1
1028.103 Assuring compliance with this (d) Department or agency heads may successor office, or to the equivalent
policy—research conducted or supported require that specific research activities office within the appropriate Federal
by any Federal department or agency. or classes of research activities department or agency, and shall also
1028.104 Exempt research. publish them in the Federal Register or
1028.105 [Reserved]
conducted, supported, or otherwise
subject to regulation by the Federal in such other manner as provided in
1028.106 [Reserved] department or agency procedures. The
1028.107 IRB membership. department or agency but not otherwise
covered by this policy comply with waiver notice must include a statement
1028.108 IRB functions and operations.
1028.109 IRB review of research. some or all of the requirements of this that identifies the conditions under
1028.110 Expedited review procedures for policy. which the waiver will be applied and a
certain kinds of research involving no (e) Compliance with this policy justification as to why the waiver is
more than minimal risk, and for minor requires compliance with pertinent appropriate for the research, including
changes in approved research. federal laws or regulations that provide how the decision is consistent with the
1028.111 Criteria for IRB approval of additional protections for human principles of the Belmont Report.
research. (j) Federal guidance on the
subjects.
1028.112 Review by institution. requirements of this policy shall be
(f) This policy does not affect any
1028.113 Suspension or termination of IRB
approval of research. state or local laws or regulations issued only after consultation, for the
1028.114 Cooperative research. (including tribal law passed by the purpose of harmonization (to the extent
1028.115 IRB records. official governing body of an American appropriate), with other Federal
1028.116 General requirements for Indian or Alaska Native tribe) that may departments and agencies that have
informed consent. otherwise be applicable and that adopted this policy, unless such
1028.117 Documentation of informed provide additional protections for consultation is not feasible.
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consent. human subjects. (k) [Reserved]
1028.118 Applications and proposals (g) This policy does not affect any (l) Compliance dates and transition
lacking definite plans for involvement of foreign laws or regulations that may provisions:
human subjects.
1028.119 Research undertaken without the
(1) For purposes of this section, the
1 The National Commission for the Protection of
intention of involving human subjects. pre-2018 Requirements means this
Human Subjects of Biomedical and Behavioral
1028.120 Evaluation and disposition of Research—Belmont Report. Washington, DC: U.S.
applications and proposals for research Department of Health and Human Services. 1979. 2 Id.
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research subject to subpart D if the and information collection and at least (iii) The research involves only
conditions of the exemption are met. one of the following criteria is met: information collection and analysis
Paragraphs (d)(2)(i) and (ii) of this (A) The information obtained is involving the investigator’s use of
section only may apply to research recorded by the investigator in such a identifiable health information when
subject to subpart D involving manner that the identity of the human that use is regulated under 45 CFR parts
educational tests or the observation of subjects cannot readily be ascertained, 160 and 164, subparts A and E, for the
public behavior when the investigator(s) directly or through identifiers linked to purposes of ‘‘health care operations’’ or
do not participate in the activities being the subjects; ‘‘research’’ as those terms are defined at
observed. Paragraph (d)(2)(iii) of this (B) Any disclosure of the human 45 CFR 164.501 or for ‘‘public health
section may not be applied to research subjects’ responses outside the research activities and purposes’’ as described
subject to subpart D. would not reasonably place the subjects under 45 CFR 164.512(b); or
(c) [Reserved.] at risk of criminal or civil liability or be (iv) The research is conducted by, or
(d) Except as described in paragraph damaging to the subjects’ financial on behalf of, a Federal department or
(a) of this section, the following standing, employability, educational agency using government-generated or
categories of human subjects research advancement, or reputation; or government-collected information
are exempt from this policy: (C) The information obtained is obtained for nonresearch activities, if
recorded by the investigator in such a the research generates identifiable
(1) Research, conducted in established
manner that the identity of the human private information that is or will be
or commonly accepted educational
subjects can readily be ascertained, maintained on information technology
settings, that specifically involves
directly or through identifiers linked to that is subject to and in compliance
normal educational practices that are
the subjects, and an IRB conducts a with section 208(b) of the E-Government
not likely to adversely impact students’
limited IRB review to make the Act of 2002, 44 U.S.C. 3501 note, if all
opportunity to learn required
determination required by of the identifiable private information
educational content or the assessment of
§ 1028.111(a)(7). collected, used, or generated as part of
educators who provide instruction. This (ii) For the purpose of this provision,
includes most research on regular and the activity will be maintained in
benign behavioral interventions are brief systems of records subject to the Privacy
special education instructional in duration, harmless, painless, not
strategies, and research on the Act of 1974, 5 U.S.C. 552a, and, if
physically invasive, not likely to have a applicable, the information used in the
effectiveness of or the comparison significant adverse lasting impact on the research was collected subject to the
among instructional techniques, subjects, and the investigator has no Paperwork Reduction Act of 1995, 44
curricula, or classroom management reason to think the subjects will find the U.S.C. 3501 et seq.
methods. interventions offensive or embarrassing. (5) Research and demonstration
(2) Research that only includes Provided all such criteria are met, projects that are conducted or supported
interactions involving educational tests examples of such benign behavioral by a Federal department or agency, or
(cognitive, diagnostic, aptitude, interventions would include having the otherwise subject to the approval of
achievement), survey procedures, subjects play an online game, having department or agency heads (or the
interview procedures, or observation of them solve puzzles under various noise approval of the heads of bureaus or
public behavior (including visual or conditions, or having them decide how other subordinate agencies that have
auditory recording) if at least one of the to allocate a nominal amount of been delegated authority to conduct the
following criteria is met: received cash between themselves and research and demonstration projects),
(i) The information obtained is someone else. and that are designed to study, evaluate,
recorded by the investigator in such a (iii) If the research involves deceiving improve, or otherwise examine public
manner that the identity of the human the subjects regarding the nature or benefit or service programs, including
subjects cannot readily be ascertained, purposes of the research, this exemption procedures for obtaining benefits or
directly or through identifiers linked to is not applicable unless the subject services under those programs, possible
the subjects; authorizes the deception through a changes in or alternatives to those
(ii) Any disclosure of the human prospective agreement to participate in programs or procedures, or possible
subjects’ responses outside the research research in circumstances in which the changes in methods or levels of
would not reasonably place the subjects subject is informed that he or she will payment for benefits or services under
at risk of criminal or civil liability or be be unaware of or misled regarding the those programs. Such projects include,
damaging to the subjects’ financial nature or purposes of the research. but are not limited to, internal studies
standing, employability, educational (4) Secondary research for which by Federal employees, and studies
advancement, or reputation; or consent is not required: Secondary under contracts or consulting
(iii) The information obtained is research uses of identifiable private arrangements, cooperative agreements,
recorded by the investigator in such a information or identifiable or grants. Exempt projects also include
manner that the identity of the human biospecimens, if at least one of the waivers of otherwise mandatory
subjects can readily be ascertained, following criteria is met: requirements using authorities such as
directly or through identifiers linked to (i) The identifiable private sections 1115 and 1115A of the Social
the subjects, and an IRB conducts a information or identifiable Security Act, as amended.
limited IRB review to make the biospecimens are publicly available; (i) Each Federal department or agency
determination required by (ii) Information, which may include conducting or supporting the research
§ 1028.111(a)(7). information about biospecimens, is and demonstration projects must
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(3)(i) Research involving benign recorded by the investigator in such a establish, on a publicly accessible
behavioral interventions in conjunction manner that the identity of the human Federal Web site or in such other
with the collection of information from subjects cannot readily be ascertained manner as the department or agency
an adult subject through verbal or directly or through identifiers linked to head may determine, a list of the
written responses (including data entry) the subjects, the investigator does not research and demonstration projects
or audiovisual recording if the subject contact the subjects, and the investigator that the Federal department or agency
prospectively agrees to the intervention will not re-identify subjects; conducts or supports under this
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provision. The research or § 1028.105 [Reserved.] (2) Prepare and maintain a current list
demonstration project must be of the IRB members identified by name;
§ 1028.106 [Reserved]
published on this list prior to earned degrees; representative capacity;
commencing the research involving § 1028.107 IRB membership. indications of experience such as board
human subjects. (a) Each IRB shall have at least five certifications or licenses sufficient to
(ii) [Reserved] members, with varying backgrounds to describe each member’s chief
promote complete and adequate review anticipated contributions to IRB
(6) Taste and food quality evaluation deliberations; and any employment or
of research activities commonly
and consumer acceptance studies: other relationship between each
conducted by the institution. The IRB
(i) If wholesome foods without shall be sufficiently qualified through member and the institution, for
additives are consumed, or the experience and expertise of its example, full-time employee, part-time
(ii) If a food is consumed that contains members (professional competence), employee, member of governing panel
a food ingredient at or below the level and the diversity of its members, or board, stockholder, paid or unpaid
and for a use found to be safe, or including race, gender, and cultural consultant;
agricultural chemical or environmental backgrounds and sensitivity to such (3) Establish and follow written
contaminant at or below the level found issues as community attitudes, to procedures for:
to be safe, by the Food and Drug promote respect for its advice and (i) Conducting its initial and
Administration or approved by the counsel in safeguarding the rights and continuing review of research and for
Environmental Protection Agency or the welfare of human subjects. The IRB reporting its findings and actions to the
Food Safety and Inspection Service of shall be able to ascertain the investigator and the institution;
the U.S. Department of Agriculture. acceptability of proposed research in (ii) Determining which projects
terms of institutional commitments require review more often than annually
(7) Storage or maintenance for (including policies and resources) and and which projects need verification
secondary research for which broad regulations, applicable law, and from sources other than the
consent is required: Storage or standards of professional conduct and investigators that no material changes
maintenance of identifiable private practice. The IRB shall therefore include have occurred since previous IRB
information or identifiable persons knowledgeable in these areas. If review; and
biospecimens for potential secondary an IRB regularly reviews research that
research use if an IRB conducts a (iii) Ensuring prompt reporting to the
involves a category of subjects that is
limited IRB review and makes the IRB of proposed changes in a research
vulnerable to coercion or undue
determinations required by activity, and for ensuring that
influence, such as children, prisoners,
§ 1028.111(a)(8). investigators will conduct the research
individuals with impaired decision-
activity in accordance with the terms of
(8) Secondary research for which making capacity, or economically or
the IRB approval until any proposed
broad consent is required: Research educationally disadvantaged persons,
changes have been reviewed and
involving the use of identifiable private consideration shall be given to the
approved by the IRB, except when
information or identifiable inclusion of one or more individuals
necessary to eliminate apparent
biospecimens for secondary research who are knowledgeable about and
immediate hazards to the subject.
use, if the following criteria are met: experienced in working with these
categories of subjects. (4) Establish and follow written
(i) Broad consent for the storage, (b) Each IRB shall include at least one procedures for ensuring prompt
maintenance, and secondary research member whose primary concerns are in reporting to the IRB; appropriate
use of the identifiable private scientific areas and at least one member institutional officials; the department or
information or identifiable whose primary concerns are in agency head; and the Office for Human
biospecimens was obtained in nonscientific areas. Research Protections, HHS, or any
accordance with § 1028.116(a)(1) (c) Each IRB shall include at least one successor office, or the equivalent office
through (4), (a)(6), and (d); member who is not otherwise affiliated within the appropriate Federal
(ii) Documentation of informed with the institution and who is not part department or agency of
consent or waiver of documentation of of the immediate family of a person who (i) Any unanticipated problems
consent was obtained in accordance is affiliated with the institution. involving risks to subjects or others or
with § 1028.117; (d) No IRB may have a member any serious or continuing
participate in the IRB’s initial or noncompliance with this policy or the
(iii) An IRB conducts a limited IRB requirements or determinations of the
continuing review of any project in
review and makes the determination IRB; and (ii) Any suspension or
which the member has a conflicting
required by § 1028.111(a)(7) and makes termination of IRB approval.
interest, except to provide information
the determination that the research to be
requested by the IRB. (b) Except when an expedited review
conducted is within the scope of the (e) An IRB may, in its discretion, procedure is used (as described in
broad consent referenced in paragraph invite individuals with competence in § 1028.110), an IRB must review
(d)(8)(i) of this section; and special areas to assist in the review of proposed research at convened meetings
(iv) The investigator does not include issues that require expertise beyond or at which a majority of the members of
returning individual research results to in addition to that available on the IRB. the IRB are present, including at least
subjects as part of the study plan. This These individuals may not vote with the one member whose primary concerns
provision does not prevent an IRB. are in nonscientific areas. In order for
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investigator from abiding by any legal the research to be approved, it shall
requirements to return individual § 1028.108 IRB functions and operations.
receive the approval of a majority of
research results. (a) In order to fulfill the requirements those members present at the meeting.
of this policy each IRB shall:
(Approved by the Office of Management (1) Have access to meeting space and (Approved by the Office of Management
and Budget under Control Number sufficient staff to support the IRB’s and Budget under Control Number
0990–0260) review and recordkeeping duties; 0990–0260)
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§ 1028.109 IRB review of research. (g) An IRB shall have authority to determine that all of the following
(a) An IRB shall review and have observe or have a third party observe the requirements are satisfied:
authority to approve, require consent process and the research. (1) Risks to subjects are minimized:
modifications in (to secure approval), or (Approved by the Office of Management (i) By using procedures that are
disapprove all research activities and Budget under Control Number consistent with sound research design
covered by this policy, including 0990–0260) and that do not unnecessarily expose
exempt research activities under subjects to risk, and
§ 1028.104 for which limited IRB review § 1028.110 Expedited review procedures (ii) Whenever appropriate, by using
is a condition of exemption (under for certain kinds of research involving no procedures already being performed on
more than minimal risk, and for minor the subjects for diagnostic or treatment
§ 1028.104(d)(2)(iii), (d)(3)(i)(C), or
changes in approved research. purposes.
(d)(7) or (8)).
(a) The Secretary of HHS has (2) Risks to subjects are reasonable in
(b) An IRB shall require that
established, and published as a Notice relation to anticipated benefits, if any, to
information given to subjects (or legally
in the Federal Register, a list of subjects, and the importance of the
authorized representatives, when
categories of research that may be knowledge that may reasonably be
appropriate) as part of informed consent
reviewed by the IRB through an expected to result. In evaluating risks
is in accordance with § 1028.116. The
expedited review procedure. The and benefits, the IRB should consider
IRB may require that information, in
Secretary will evaluate the list at least only those risks and benefits that may
addition to that specifically mentioned
every 8 years and amend it, as result from the research (as
in § 1028.116, be given to the subjects
appropriate, after consultation with distinguished from risks and benefits of
when in the IRB’s judgment the
other Federal departments and agencies therapies subjects would receive even if
information would meaningfully add to
and after publication in the Federal not participating in the research). The
the protection of the rights and welfare
Register for public comment. A copy of IRB should not consider possible long-
of subjects.
the list is available from the Office for range effects of applying knowledge
(c) An IRB shall require Human Research Protections, HHS, or
documentation of informed consent or gained in the research (e.g., the possible
any successor office. effects of the research on public policy)
may waive documentation in (b)(1) An IRB may use the expedited
accordance with § 1028.117. as among those research risks that fall
review procedure to review the within the purview of its responsibility.
(d) An IRB shall notify investigators following:
and the institution in writing of its (3) Selection of subjects is equitable.
(i) Some or all of the research In making this assessment the IRB
decision to approve or disapprove the appearing on the list described in
proposed research activity, or of should take into account the purposes of
paragraph (a) of this section, unless the the research and the setting in which
modifications required to secure IRB reviewer determines that the study
approval of the research activity. If the the research will be conducted. The IRB
involves more than minimal risk; should be particularly cognizant of the
IRB decides to disapprove a research (ii) Minor changes in previously
activity, it shall include in its written special problems of research that
approved research during the period for involves a category of subjects who are
notification a statement of the reasons which approval is authorized; or
for its decision and give the investigator vulnerable to coercion or undue
(iii) Research for which limited IRB influence, such as children, prisoners,
an opportunity to respond in person or review is a condition of exemption
in writing. individuals with impaired decision-
under § 1028.104(d)(2)(iii), (d)(3)(i)(C), making capacity, or economically or
(e) An IRB shall conduct continuing and (d)(7) and (8). educationally disadvantaged persons.
review of research requiring review by (2) Under an expedited review
(4) Informed consent will be sought
the convened IRB at intervals procedure, the review may be carried
from each prospective subject or the
appropriate to the degree of risk, not out by the IRB chairperson or by one or
subject’s legally authorized
less than once per year, except as more experienced reviewers designated
representative, in accordance with, and
described in paragraph (f) of this by the chairperson from among
to the extent required by, § 1028.116.
section. members of the IRB. In reviewing the
(5) Informed consent will be
(f)(1) Unless an IRB determines research, the reviewers may exercise all
appropriately documented or
otherwise, continuing review of of the authorities of the IRB except that
appropriately waived in accordance
research is not required in the following the reviewers may not disapprove the
with § 1028.117.
circumstances: research. A research activity may be
(6) When appropriate, the research
(i) Research eligible for expedited disapproved only after review in
plan makes adequate provision for
review in accordance with § 1028.110; accordance with the nonexpedited
monitoring the data collected to ensure
(ii) Research reviewed by the IRB in procedure set forth in § 1028.108(b).
(c) Each IRB that uses an expedited the safety of subjects.
accordance with the limited IRB review (7) When appropriate, there are
described in § 1028.104(d)(2)(iii), review procedure shall adopt a method
for keeping all members advised of adequate provisions to protect the
(d)(3)(i)(C), or (d)(7) or (8); privacy of subjects and to maintain the
(iii) Research that has progressed to research proposals that have been
approved under the procedure. confidentiality of data.
the point that it involves only one or (i) The Secretary of HHS will, after
both of the following, which are part of (d) The department or agency head
may restrict, suspend, terminate, or consultation with the Office of
the IRB-approved study: Management and Budget’s privacy office
choose not to authorize an institution’s
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(A) Data analysis, including analysis and other Federal departments and
or IRB’s use of the expedited review
of identifiable private information or agencies that have adopted this policy,
procedure.
identifiable biospecimens, or issue guidance to assist IRBs in
(B) Accessing follow-up clinical data § 1028.111 Criteria for IRB approval of assessing what provisions are adequate
from procedures that subjects would research. to protect the privacy of subjects and to
undergo as part of clinical care. (a) In order to approve research maintain the confidentiality of data.
(2) [Reserved.] covered by this policy the IRB shall (ii) [Reserved.]
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![Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Rules and Regulations 43469
tribal laws passed by the official representative, in addition to a copy of submitted, by the institution, to the
governing body of an American Indian the short form. Federal department or agency
or Alaska Native tribe) that require (c)(1) An IRB may waive the component supporting the research.
additional information to be disclosed requirement for the investigator to
in order for informed consent to be obtain a signed informed consent form § 1028.119 Research undertaken without
the intention of involving human subjects.
legally effective. for some or all subjects if it finds any
(j) Emergency medical care. Nothing of the following: Except for research waived under
in this policy is intended to limit the (i) That the only record linking the § 1028.101(i) or exempted under
authority of a physician to provide subject and the research would be the § 1028.104, in the event research is
emergency medical care, to the extent informed consent form and the undertaken without the intention of
the physician is permitted to do so principal risk would be potential harm involving human subjects, but it is later
under applicable Federal, state, or local resulting from a breach of proposed to involve human subjects in
law (including tribal law passed by the confidentiality. Each subject (or legally the research, the research shall first be
official governing body of an American authorized representative) will be asked reviewed and approved by an IRB, as
Indian or Alaska Native tribe). whether the subject wants provided in this policy, a certification
documentation linking the subject with submitted by the institution to the
(Approved by the Office of Management the research, and the subject’s wishes Federal department or agency
and Budget under Control Number will govern; component supporting the research, and
0990–0260) (ii) That the research presents no final approval given to the proposed
§ 1028.117 Documentation of informed more than minimal risk of harm to change by the Federal department or
consent. subjects and involves no procedures for agency component.
(a) Except as provided in paragraph which written consent is normally
§ 1028.120 Evaluation and disposition of
(c) of this section, informed consent required outside of the research context; applications and proposals for research to
shall be documented by the use of a or be conducted or supported by a Federal
written informed consent form (iii) If the subjects or legally department or agency.
approved by the IRB and signed authorized representatives are members
(a) The department or agency head
(including in an electronic format) by of a distinct cultural group or
will evaluate all applications and
the subject or the subject’s legally community in which signing forms is
proposals involving human subjects
authorized representative. A written not the norm, that the research presents
submitted to the Federal department or
copy shall be given to the person no more than minimal risk of harm to
agency through such officers and
signing the informed consent form. subjects and provided there is an
employees of the Federal department or
appropriate alternative mechanism for
(b) Except as provided in paragraph agency and such experts and
documenting that informed consent was
(c) of this section, the informed consent consultants as the department or agency
obtained.
form may be either of the following: head determines to be appropriate. This
(2) In cases in which the
(1) A written informed consent form evaluation will take into consideration
documentation requirement is waived,
that meets the requirements of the risks to the subjects, the adequacy of
the IRB may require the investigator to
§ 1028.116. The investigator shall give protection against these risks, the
provide subjects or legally authorized
either the subject or the subject’s legally potential benefits of the research to the
representatives with a written statement
authorized representative adequate subjects and others, and the importance
regarding the research.
opportunity to read the informed of the knowledge gained or to be gained.
consent form before it is signed; § 1028.118 Applications and proposals (b) On the basis of this evaluation, the
alternatively, this form may be read to lacking definite plans for involvement of department or agency head may approve
the subject or the subject’s legally human subjects. or disapprove the application or
authorized representative. Certain types of applications for proposal, or enter into negotiations to
(2) A short form written informed grants, cooperative agreements, or develop an approvable one.
consent form stating that the elements of contracts are submitted to Federal
informed consent required by departments or agencies with the § 1028.121 [Reserved]
§ 1028.116 have been presented orally to knowledge that subjects may be § 1028.122 Use of Federal funds.
the subject or the subject’s legally involved within the period of support, Federal funds administered by a
authorized representative, and that the but definite plans would not normally Federal department or agency may not
key information required by be set forth in the application or be expended for research involving
§ 1028.116(a)(5)(i) was presented first to proposal. These include activities such human subjects unless the requirements
the subject, before other information, if as institutional type grants when of this policy have been satisfied.
any, was provided. The IRB shall selection of specific projects is the
approve a written summary of what is institution’s responsibility; research § 1028.123 Early termination of research
to be said to the subject or the legally training grants in which the activities support: Evaluation of applications and
authorized representative. When this involving subjects remain to be selected; proposals.
method is used, there shall be a witness and projects in which human subjects’ (a) The department or agency head
to the oral presentation. Only the short involvement will depend upon may require that Federal department or
form itself is to be signed by the subject completion of instruments, prior animal agency support for any project be
or the subject’s legally authorized studies, or purification of compounds. terminated or suspended in the manner
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representative. However, the witness Except for research waived under prescribed in applicable program
shall sign both the short form and a § 1028.101(i) or exempted under requirements, when the department or
copy of the summary, and the person § 1028.104, no human subjects may be agency head finds an institution has
actually obtaining consent shall sign a involved in any project supported by materially failed to comply with the
copy of the summary. A copy of the these awards until the project has been terms of this policy.
summary shall be given to the subject or reviewed and approved by the IRB, as (b) In making decisions about
the subject’s legally authorized provided in this policy, and certification supporting or approving applications or
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![43470 Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Rules and Regulations
proposals covered by this policy the in response to the direction of section Safety Specification for Infant Bouncer
department or agency head may take 104(b) of the CPSIA. Additionally, the Seats (ASTM F2167), as a mandatory
into account, in addition to all other Commission is finalizing an amendment consumer product safety rule with
eligibility requirements and program to its regulations regarding third party several modifications to the content,
criteria, factors such as whether the conformity assessment bodies to include format, and placement of warning labels
applicant has been subject to a safety standard for bouncer seats in the and instructions, to strengthen the
termination or suspension under list of notice of requirements (NORs) standard.
paragraph (a) of this section and issued by the Commission. In this document, the Commission is
whether the applicant or the person or DATES: This rule will become effective issuing a mandatory consumer product
persons who would direct or has/have March 19, 2018. The incorporation by safety standard for bouncer seats. As
directed the scientific and technical reference of the publication listed in required by section 104(b)(1)(A), the
aspects of an activity has/have, in the this rule is approved by the Director of Commission consulted with
judgment of the department or agency the Federal Register as of March 19, manufacturers, retailers, trade
head, materially failed to discharge 2018. organizations, laboratories, consumer
responsibility for the protection of the advocacy groups, consultants, and the
FOR FURTHER INFORMATION CONTACT:
rights and welfare of human subjects public to develop this rule, largely
(whether or not the research was subject Keysha Walker, Compliance Officer,
through the ASTM process. Based on
to federal regulation). U.S. Consumer Product Safety
revisions to the voluntary standard
Commission, 4330 East West Highway,
since the NPR published, the final rule
§ 1028.124 Conditions Bethesda, MD 20814; telephone: 301–
incorporates by reference the most
With respect to any research project 504–6820; email: kwalker@cpsc.gov.
recent voluntary standard for infant
or any class of research projects the SUPPLEMENTARY INFORMATION: bouncer seats, developed by ASTM
department or agency head of either the International, ASTM F2167–17, with
I. Background and Statutory Authority
conducting or the supporting Federal two modifications related to warning
department or agency may impose The CPSIA was enacted on August 14,
2008. Section 104(b) of the CPSIA label content and placement. These
additional conditions prior to or at the modifications strengthen the standard
time of approval when in the judgment requires the Commission to: (1) Examine
and assess the effectiveness of voluntary by requiring a more stringent warning to
of the department or agency head caregivers to use the restraints, even if
additional conditions are necessary for consumer product safety standards for
durable infant or toddler products, in an infant falls asleep in the bouncer,
the protection of human subjects. and requires the fall hazard warning to
consultation with representatives of
Alberta E. Mills, consumer groups, juvenile product be placed on the upper seat back of the
Acting Secretary, Consumer Product Safety manufacturers, and independent child bouncer seat, to ensure that caregivers
Commission.
product engineers and experts; and (2) read and heed the warning. The
[FR Doc. 2017–19737 Filed 9–15–17; 8:45 am] promulgate consumer product safety Commission’s more stringent
BILLING CODE 6355–01–P standards for durable infant and toddler requirements are intended to further
products. Standards issued under reduce the risk of injury to infants that
section 104 are to be ‘‘substantially the fall from, and with, bouncer seats,
CONSUMER PRODUCT SAFETY same as’’ the applicable voluntary especially bouncer seats that are placed
COMMISSION standards or more stringent than the on an elevated surface.
Additionally, the final rule amends
16 CFR Parts 1112 and 1229 voluntary standard, if the Commission
the list of NORs issued by the
determines that more stringent
[Docket No. CPSC–2015–0028] Commission in 16 CFR part 1112 to
requirements would further reduce the
include the standard for infant bouncer
risk of injury associated with the
Safety Standard for Infant Bouncer seats. Under section 14 of the CPSA, the
product.
Seats The term ‘‘durable infant or toddler Commission promulgated 16 CFR part
product’’ is defined in section 104(f)(1) 1112 to establish requirements for
AGENCY: Consumer Product Safety accreditation of third party conformity
Commission. of the CPSIA as ‘‘a durable product
intended for use, or that may be assessment bodies (or testing
ACTION: Final rule. laboratories) to test for conformity with
reasonably expected to be used, by
SUMMARY: The Danny Keysar Child children under the age of 5 years,’’ and a children’s product safety rule.
Product Safety Notification Act, section the statute specifies twelve categories of Amending part 1112 adds an NOR for
104 of the Consumer Product Safety products that are included in the the infant bouncer seat standard to the
Improvement Act of 2008 (CPSIA), definition, including walkers, carriers list of children’s product safety rules.
requires the United States Consumer and various types of children’s chairs. II. Product Description
Product Safety Commission When issuing a regulation governing
(Commission or CPSC) to promulgate product registration under section 104, A. Definition of ‘‘Bouncer Seats’’
consumer product safety standards for the Commission determined that an Section 1.2 of ASTM F2167–17
durable infant or toddler products. ‘‘infant bouncer’’ falls within the defines an ‘‘infant bouncer seat’’ as: ‘‘a
These standards are to be ‘‘substantially definition of a ‘‘durable infant or toddler freestanding product intended to
the same as’’ applicable voluntary product.’’ 74 FR 68668 (Dec. 29, 2009); support an occupant in a reclined
standards or more stringent than the 16 CFR 1130.2(a)(15). position to facilitate bouncing by the
sradovich on DSKBBY8HB2PROD with RULES
voluntary standard, if the Commission On October 19, 2015, the Commission occupant, with the aid of a caregiver or
determines that more stringent issued a notice of proposed rulemaking by other means.’’ Additionally, section
requirements would further reduce the (NPR) for infant bouncer seats. 80 FR 1.2 states that infant bouncer seats are
risk of injury associated with the 63168. The NPR proposed to intended for ‘‘infants who have not
product. The Commission is issuing this incorporate by reference the 2015 developed the ability to sit up
final rule establishing a safety standard version of the voluntary standard, unassisted (approximately 0 to 6 months
for infant bouncer seats (bouncer seats) ASTM F2167 Standard Consumer of age).’’
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Document Created: 2017-09-16 00:52:40
Document Modified: 2017-09-16 00:52:40
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | The rule is effective on January 19, 2018. The compliance date for this rule, except for Sec. 1028.114(b) (cooperative research), is January 19, 2018. The compliance date for Sec. 1028.114(b) (cooperative research) is January 20, 2020. | |
| Contact | Alice Thaler, Associate Executive Director for Health Sciences, Consumer Product Safety Commission, 5 Research Place, Rockville, MD 20850: 301-987-2240, or by email to: [email protected] | |
| FR Citation | 82 FR 43459 | |
| CFR Associated | Human Research Subjects; Reporting and Recordkeeping Requirements and Research |
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