82 FR 34535 - Institutional Review Board Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects; Guidance for Sponsors, Investigators, and Institutional Review Boards; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 141 (July 25, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 141 (July 25, 2017)
| Page Range | 34535-34536 | |
| FR Document | 2017-15539 |
[Federal Register Volume 82, Number 141 (Tuesday, July 25, 2017)] [Notices] [Pages 34535-34536] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-15539] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-3235] Institutional Review Board Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects; Guidance for Sponsors, Investigators, and Institutional Review Boards; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for sponsors, investigators, and institutional review boards (IRBs) entitled ``IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects.'' This guidance informs sponsors, investigators, IRBs, and other interested parties that FDA does not intend to object to an IRB waiving or altering informed consent requirements, as described in the guidance, for certain minimal risk clinical investigations. In addition, this guidance explains that FDA does not intend to object to a sponsor initiating, or an investigator conducting, a minimal risk clinical investigation for which an IRB waives or alters the informed consent requirements as described in the guidance. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2017-D-3235 for ``IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects; Guidance for Sponsors, Investigators, and Institutional Review Boards.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the office of Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The [[Page 34536]] Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the guidance to the Office of Good Clinical Practice, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5169, Silver Spring, MD 20993. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Janet Norden, Office of Good Clinical Practice, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-1127. SUPPLEMENTARY INFORMATION: I. Background We are announcing the availability of a guidance for sponsors, investigators and IRBs entitled ``IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects.'' We are issuing this guidance consistent with our good guidance practices (GGP) regulation (Sec. 10.115 (21 CFR 10.115)). We are implementing this guidance without prior public comment because we have determined that prior public participation is not feasible or appropriate (Sec. 10.115(g)(2)). We made this determination because this guidance presents a less burdensome policy that is consistent with the public health. FDA believes this guidance will facilitate the conduct of certain minimal risk clinical investigations that are important to addressing significant public health needs without compromising the rights, safety, or welfare of human subjects. Although this guidance is immediately in effect, it remains subject to comment in accordance with FDA's GGP regulation. FDA will consider all comments received and will revise this guidance when appropriate. On December 13, 2016, the 21st Century Cures Act (Cures Act) (Pub. L. 114-255) was signed into law. Title III, section 3024 of the Cures Act amended sections 520(g)(3) and 505(i)(4) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to provide authority for FDA to permit an exception from informed consent requirements when the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject. This statutory amendment became effective on December 13, 2016. Currently, FDA's regulations governing the protection of human subjects (21 CFR parts 50 and 56) allow exception from the general requirements for informed consent only in life-threatening situations when certain conditions are met (21 CFR 50.23) or when the requirements for emergency research are met (21 CFR 50.24), but do not include an exception from informed consent for minimal risk clinical investigations. In light of the Cures Act amendment to the FD&C Act described previously, FDA intends to revise its informed consent regulations to add a waiver or alteration for minimal risk clinical investigations, under appropriate human subject protection safeguards, to the two existing exceptions from informed consent. This guidance informs sponsors, investigators, and IRBs that until FDA issues these regulations, we do not intend to object to an IRB approving a consent procedure that does not include, or that alters, some or all of the elements of informed consent set forth in 21 CFR 50.25, or waiving the requirements to obtain informed consent as described in the guidance. In addition, we do not intend to object to a sponsor initiating, or an investigator conducting, a minimal risk clinical investigation for which an IRB waives or alters the informed consent requirements as described in the guidance. We believe that this guidance will facilitate investigators' ability to conduct studies that may contribute substantially to the development of products to diagnose or treat diseases or conditions, or address unmet medical needs, without compromising the rights, safety, or welfare of human subjects. The guidance represents the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This is not a significant regulatory action subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information referenced in this guidance that are related to IRB recordkeeping requirements under 21 CFR part 56 have been approved under OMB control numbers 0910-0755 and 0910-0130. III. Electronic Access Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/RegulatoryInformation/Guidances/default.htm, http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm219433.htm, or https://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the guidance. Dated: July 11, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-15539 Filed 7-24-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 141 / Tuesday, July 25, 2017 / Notices 34535
received, go to https:// IV. Electronic Access instructions for submitting comments.
www.regulations.gov/ and insert the Persons with access to the Internet Comments submitted electronically,
docket number, found in brackets in the may obtain the guidance at either including attachments, to https://
heading of this document, into the https://www.fda.gov/AnimalVeterinary/ www.regulations.gov will be posted to
‘‘Search’’ box and follow the prompts GuidanceComplianceEnforcement/ the docket unchanged. Because your
and/or go to the Dockets Management GuidanceforIndustry/default.htm or comment will be made public, you are
Staff, 5630 Fishers Lane, Rm. 1061, https://www.regulations.gov. solely responsible for ensuring that your
Rockville, MD 20852. comment does not include any
Submit written requests for single Dated: July 19, 2017. confidential information that you or a
copies of the guidance to the Policy and Anna K. Abram, third party may not wish to be posted,
Regulations Staff (HFV–6), Center for Deputy Commissioner for Policy, Planning, such as medical information, your or
Veterinary Medicine, Food and Drug Legislation, and Analysis. anyone else’s Social Security number, or
Administration, 7519 Standish Pl., [FR Doc. 2017–15536 Filed 7–24–17; 8:45 am] confidential business information, such
Rockville, MD 20855. Send one self- BILLING CODE 4164–01–P as a manufacturing process. Please note
addressed adhesive label to assist that that if you include your name, contact
office in processing your requests. See information, or other information that
the SUPPLEMENTARY INFORMATION section DEPARTMENT OF HEALTH AND identifies you in the body of your
for electronic access to the guidance HUMAN SERVICES comments, that information will be
document. posted on https://www.regulations.gov.
Food and Drug Administration • If you want to submit a comment
FOR FURTHER INFORMATION CONTACT: with confidential information that you
[Docket No. FDA–2017–D–3235]
Diane Heinz, Center for Veterinary do not wish to be made available to the
Medicine (HFV–6), Food and Drug Institutional Review Board Waiver or public, submit the comment as a
Administration, 7519 Standish Pl., Alteration of Informed Consent for written/paper submission and in the
Rockville, MD 20855, 240–402–5692, Clinical Investigations Involving No manner detailed (see ‘‘Written/Paper
diane.heinz@fda.hhs.gov. More Than Minimal Risk to Human Submissions’’ and ‘‘Instructions’’).
SUPPLEMENTARY INFORMATION: Subjects; Guidance for Sponsors,
Written/Paper Submissions
I. Background Investigators, and Institutional Review
Boards; Availability Submit written/paper submissions as
In the Federal Register of November follows:
2, 2016 (81 FR 76360), FDA published AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for
the notice of availability for a draft HHS. written/paper submissions): Dockets
revised guidance entitled ‘‘Animal Drug ACTION: Notice of availability. Management Staff (HFA–305), Food and
User Fees and Fee Waivers and Drug Administration, 5630 Fishers
Reductions’’ giving interested persons SUMMARY: The Food and Drug Lane, rm. 1061, Rockville, MD 20852.
until January 3, 2017, to comment on Administration (FDA, the Agency, or • For written/paper comments
the draft revised guidance. FDA we) is announcing the availability of a submitted to the Dockets Management
received no comments on the draft guidance for sponsors, investigators, Staff, FDA will post your comment, as
revised guidance. The guidance and institutional review boards (IRBs) well as any attachments, except for
announced in this notice finalizes the entitled ‘‘IRB Waiver or Alteration of information submitted, marked and
draft guidance dated November 2016. Informed Consent for Clinical identified, as confidential, if submitted
Investigations Involving No More Than as detailed in ‘‘Instructions.’’
II. Significance of Guidance Minimal Risk to Human Subjects.’’ This Instructions: All submissions received
This level 1 guidance is being issued guidance informs sponsors, must include the Docket No. FDA–
consistent with FDA’s good guidance investigators, IRBs, and other interested 2017–D–3235 for ‘‘IRB Waiver or
practices regulation (21 CFR 10.115). parties that FDA does not intend to Alteration of Informed Consent for
The guidance represents the current object to an IRB waiving or altering Clinical Investigations Involving No
thinking of FDA on Animal Drug User informed consent requirements, as More Than Minimal Risk to Human
Fees and Fee Waivers and Reductions. described in the guidance, for certain Subjects; Guidance for Sponsors,
It does not establish any rights for any minimal risk clinical investigations. In Investigators, and Institutional Review
person and is not binding on FDA or the addition, this guidance explains that Boards.’’ Received comments will be
public. You can use an alternative FDA does not intend to object to a placed in the docket and, except for
approach if it satisfies the requirements sponsor initiating, or an investigator those submitted as ‘‘Confidential
of the applicable statutes and conducting, a minimal risk clinical Submissions,’’ publicly viewable at
regulations. This guidance is not subject investigation for which an IRB waives or https://www.regulations.gov or at the
to Executive Order 12866. alters the informed consent office of Dockets Management Staff
requirements as described in the between 9 a.m. and 4 p.m., Monday
III. Paperwork Reduction Act of 1995 guidance. through Friday.
This revised guidance refers to DATES: Submit either electronic or • Confidential Submissions—To
previously approved collections of written comments on Agency guidances submit a comment with confidential
information that are subject to review by at any time. information that you do not wish to be
the Office of Management and Budget made publicly available, submit your
mstockstill on DSK30JT082PROD with NOTICES
ADDRESSES: You may submit comments
(OMB) under the Paperwork Reduction as follows: comments only as a written/paper
Act of 1995 (44 U.S.C. 3501–3520). The submission. You should submit two
collections of information referred to in Electronic Submissions copies total. One copy will include the
the guidance entitled ‘‘Animal Drug Submit electronic comments in the information you claim to be confidential
User Fees and Fee Waivers and following way: with a heading or cover note that states
Reductions’’ have been approved under • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
OMB control number 0910–540. https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
VerDate Sep<11>2014 19:30 Jul 24, 2017 Jkt 241001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\25JYN1.SGM 25JYN1](https://thefederalregister.org/doc/82_FR_34676/page/1.svg)
![34536 Federal Register / Vol. 82, No. 141 / Tuesday, July 25, 2017 / Notices
Agency will review this copy, including appropriate (§ 10.115(g)(2)). We made guidance. We believe that this guidance
the claimed confidential information, in this determination because this will facilitate investigators’ ability to
its consideration of comments. The guidance presents a less burdensome conduct studies that may contribute
second copy, which will have the policy that is consistent with the public substantially to the development of
claimed confidential information health. FDA believes this guidance will products to diagnose or treat diseases or
redacted/blacked out, will be available facilitate the conduct of certain minimal conditions, or address unmet medical
for public viewing and posted on risk clinical investigations that are needs, without compromising the rights,
https://www.regulations.gov. Submit important to addressing significant safety, or welfare of human subjects.
both copies to the Dockets Management public health needs without
Staff. If you do not wish your name and compromising the rights, safety, or The guidance represents the current
contact information to be made publicly welfare of human subjects. Although thinking of FDA on this topic. It does
available, you can provide this this guidance is immediately in effect, it not establish any rights for any person
information on the cover sheet and not remains subject to comment in and is not binding on FDA or the public.
in the body of your comments and you accordance with FDA’s GGP regulation. You can use an alternative approach if
must identify this information as FDA will consider all comments it satisfies the requirements of the
‘‘confidential.’’ Any information marked received and will revise this guidance applicable statutes and regulations. This
as ‘‘confidential’’ will not be disclosed when appropriate. is not a significant regulatory action
except in accordance with 21 CFR 10.20 On December 13, 2016, the 21st subject to Executive Order 12866.
and other applicable disclosure law. For Century Cures Act (Cures Act) (Pub. L.
114–255) was signed into law. Title III, II. Paperwork Reduction Act of 1995
more information about FDA’s posting
of comments to public dockets, see 80 section 3024 of the Cures Act amended
This guidance refers to previously
FR 56469, September 18, 2015, or access sections 520(g)(3) and 505(i)(4) of the
Federal Food, Drug, and Cosmetic Act approved collections of information
the information at: https://www.gpo.gov/ found in FDA regulations. These
fdsys/pkg/FR-2015-09-18/pdf/2015- (the FD&C Act) to provide authority for
FDA to permit an exception from collections of information are subject to
23389.pdf. review by the Office of Management and
Docket: For access to the docket to informed consent requirements when
the proposed clinical testing poses no Budget (OMB) under the Paperwork
read background documents or the
more than minimal risk to the human Reduction Act of 1995 (44 U.S.C. 3501–
electronic and written/paper comments
received, go to https:// subject and includes appropriate 3520). The collections of information
www.regulations.gov and insert the safeguards to protect the rights, safety, referenced in this guidance that are
docket number, found in brackets in the and welfare of the human subject. This related to IRB recordkeeping
heading of this document, into the statutory amendment became effective requirements under 21 CFR part 56 have
‘‘Search’’ box and follow the prompts on December 13, 2016. been approved under OMB control
and/or go to the Dockets Management Currently, FDA’s regulations numbers 0910–0755 and 0910–0130.
Staff, 5630 Fishers Lane, Rm. 1061, governing the protection of human
subjects (21 CFR parts 50 and 56) allow III. Electronic Access
Rockville, MD 20852.
Submit written requests for single exception from the general requirements
Persons with access to the Internet
copies of the guidance to the Office of for informed consent only in life-
threatening situations when certain may obtain the guidance at either http://
Good Clinical Practice, Food and Drug www.fda.gov/RegulatoryInformation/
Administration, 10903 New Hampshire conditions are met (21 CFR 50.23) or
when the requirements for emergency Guidances/default.htm, http://
Ave., Bldg. 32, Rm. 5169, Silver Spring, www.fda.gov/ScienceResearch/Special
MD 20993. Send one self-addressed research are met (21 CFR 50.24), but do
not include an exception from informed Topics/RunningClinicalTrials/
adhesive label to assist that office in GuidancesInformationSheetsandNotices
processing your requests. See the consent for minimal risk clinical
investigations. In light of the Cures Act /ucm219433.htm, or https://
SUPPLEMENTARY INFORMATION section for
amendment to the FD&C Act described www.regulations.gov. Use the FDA Web
electronic access to the guidance
previously, FDA intends to revise its site listed in the previous sentence to
document.
informed consent regulations to add a find the most current version of the
FOR FURTHER INFORMATION CONTACT: waiver or alteration for minimal risk guidance.
Janet Norden, Office of Good Clinical clinical investigations, under
Practice, Food and Drug Administration, Dated: July 11, 2017.
appropriate human subject protection
10903 New Hampshire Ave., Silver safeguards, to the two existing Anna K. Abram,
Spring, MD 20993, 301–796–1127. exceptions from informed consent. Deputy Commissioner for Policy, Planning,
SUPPLEMENTARY INFORMATION: This guidance informs sponsors, Legislation, and Analysis.
investigators, and IRBs that until FDA [FR Doc. 2017–15539 Filed 7–24–17; 8:45 am]
I. Background issues these regulations, we do not BILLING CODE 4164–01–P
We are announcing the availability of intend to object to an IRB approving a
a guidance for sponsors, investigators consent procedure that does not
and IRBs entitled ‘‘IRB Waiver or include, or that alters, some or all of the
Alteration of Informed Consent for elements of informed consent set forth
Clinical Investigations Involving No in 21 CFR 50.25, or waiving the
More Than Minimal Risk to Human requirements to obtain informed
mstockstill on DSK30JT082PROD with NOTICES
Subjects.’’ We are issuing this guidance consent as described in the guidance. In
consistent with our good guidance addition, we do not intend to object to
practices (GGP) regulation (§ 10.115 (21 a sponsor initiating, or an investigator
CFR 10.115)). We are implementing this conducting, a minimal risk clinical
guidance without prior public comment investigation for which an IRB waives or
because we have determined that prior alters the informed consent
public participation is not feasible or requirements as described in the
VerDate Sep<11>2014 19:30 Jul 24, 2017 Jkt 241001 PO 00000 Frm 00065 Fmt 4703 Sfmt 9990 E:\FR\FM\25JYN1.SGM 25JYN1](https://thefederalregister.org/doc/82_FR_34676/page/2.svg)
Document Created: 2018-10-24 11:22:37
Document Modified: 2018-10-24 11:22:37
| 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 | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on Agency guidances at any time. | |
| Contact | Janet Norden, Office of Good Clinical Practice, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-1127. | |
| FR Citation | 82 FR 34535 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR