80 FR 12497 - Draft Guidance for Industry, Clinical Investigators, and Institutional Review Boards-Use of an Electronic Informed Consent in Clinical Investigations-Questions and Answers; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 80, Issue 45 (March 9, 2015)

Page Range		12497-12498
FR Document		2015-05301

In this issue of the Federal Register, the Food and Drug Administration (FDA) is announcing the availability of draft guidance for industry, clinical investigators, and institutional review boards entitled ``Use of Electronic Informed Consent in Clinical Investigations--Questions and Answers.'' The draft guidance provides recommendations for clinical investigators, sponsors, and institutional review boards (IRBs) on the use of electronic media and processes to obtain informed consent for FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof. To enhance human subject protection and reduce regulatory burden, the Department of Health and Human Services Office for Human Research Protections (OHRP) and FDA have been actively working to harmonize the agencies' regulatory requirements and guidance for human subject research, and the FDA draft guidance document was developed as a part of these efforts. Although the document is issued by FDA and is drafted as guidance that would apply to FDA-regulated clinical investigations, OHRP is considering whether to adopt the positions and recommendations proposed in this guidance for research regulated under the HHS protection of human subjects regulations, 45 CFR part 46, and to issue a joint OHRP and FDA guidance document on this topic when the final guidance document is developed. OHRP asks for public comment about whether a joint guidance document would be useful for the regulated community. In particular, OHRP is interested in public comment regarding whether FDA's draft guidance would be appropriate for all research regulated under 45 CFR part 46, including research studies other than clinical investigations or clinical trials, such as social and behavioral research studies. If different guidance should apply to social and behavioral research, or other non-FDA-regulated studies, OHRP asks that the public comments address how the guidance should differ from the proposed guidance for FDA-regulated clinical investigations. OHRP specifically welcomes feedback regarding when it might or might not be appropriate, for studies other than clinical trials, for OHRP to recommend that researchers verify that the person signing the informed consent form is the subject participating in the research. OHRP and FDA will consider these comments in deciding whether to issue a joint OHRP/FDA guidance document on this topic when the final guidance document is developed.

Federal Register, Volume 80 Issue 45 (Monday, March 9, 2015)

[Federal Register Volume 80, Number 45 (Monday, March 9, 2015)]
[Notices]
[Pages 12497-12498]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-05301]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Draft Guidance for Industry, Clinical Investigators, and 
Institutional Review Boards--Use of an Electronic Informed Consent in 
Clinical Investigations--Questions and Answers; Availability

AGENCY: Office for Human Research Protections, Office of the Assistant 
Secretary for Health, Office of the Secretary, Department of Health and 
Human Services.

ACTION: Notice.

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SUMMARY: In this issue of the Federal Register, the Food and Drug 
Administration (FDA) is announcing the availability of draft guidance 
for industry, clinical investigators, and institutional review boards 
entitled ``Use of Electronic Informed Consent in Clinical 
Investigations--Questions and Answers.'' The draft guidance provides 
recommendations for clinical investigators, sponsors, and institutional 
review boards (IRBs) on the use of electronic media and processes to 
obtain informed consent for FDA-regulated clinical investigations of 
medical products, including human drug and

[[Page 12498]]

biological products, medical devices, and combinations thereof.
    To enhance human subject protection and reduce regulatory burden, 
the Department of Health and Human Services Office for Human Research 
Protections (OHRP) and FDA have been actively working to harmonize the 
agencies' regulatory requirements and guidance for human subject 
research, and the FDA draft guidance document was developed as a part 
of these efforts. Although the document is issued by FDA and is drafted 
as guidance that would apply to FDA-regulated clinical investigations, 
OHRP is considering whether to adopt the positions and recommendations 
proposed in this guidance for research regulated under the HHS 
protection of human subjects regulations, 45 CFR part 46, and to issue 
a joint OHRP and FDA guidance document on this topic when the final 
guidance document is developed. OHRP asks for public comment about 
whether a joint guidance document would be useful for the regulated 
community. In particular, OHRP is interested in public comment 
regarding whether FDA's draft guidance would be appropriate for all 
research regulated under 45 CFR part 46, including research studies 
other than clinical investigations or clinical trials, such as social 
and behavioral research studies. If different guidance should apply to 
social and behavioral research, or other non-FDA-regulated studies, 
OHRP asks that the public comments address how the guidance should 
differ from the proposed guidance for FDA-regulated clinical 
investigations.
    OHRP specifically welcomes feedback regarding when it might or 
might not be appropriate, for studies other than clinical trials, for 
OHRP to recommend that researchers verify that the person signing the 
informed consent form is the subject participating in the research.
    OHRP and FDA will consider these comments in deciding whether to 
issue a joint OHRP/FDA guidance document on this topic when the final 
guidance document is developed.

DATES: May 7, 2015.

ADDRESSES: You may submit comments identified by docket ID number HHS-
OPHS-2015-0002 by one of the following methods:
    Federal eRulemaking Portal: http://www.regulations.gov. Enter the 
above docket ID number in the Enter Keyword or ID field and click on 
``Search.'' On the next page, click the ``Submit a Comment'' action and 
follow the instructions.
    Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions] 
to: Irene Stith-Coleman, Ph.D., Office for Human Research Protections, 
1101 Wootton Parkway, Suite 200, Rockville, MD 20852.
    Comments received, including any personal information, will be 
posted without change to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Irene Stith-Coleman, Office for Human 
Research Protections, Department of Health and Human Services, 1101 
Wootton Parkway, Suite 200, Rockville, MD 20852; phone 240-453-6900; 
email [email protected].

    Dated: March 3, 2015.
Jerry Menikoff,
Director, Office for Human Research Protections.
[FR Doc. 2015-05301 Filed 3-6-15; 8:45 am]
 BILLING CODE 4150-36-P

Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices 12497

Ave., Bldg. 32, Rm. 5103, Silver Spring, may be followed when using an III. Comments
MD 20993–0002; or the Office of electronic informed consent (eIC) to Interested persons may submit either
Communication, Outreach and help (1) ensure protection of the rights, electronic comments regarding this
Development, Center for Biologics safety, and welfare of human subjects; document to http://www.regulations.gov
Evaluation and Research, Food and (2) ensure the subject’s comprehension or written comments to the Division of
Drug Administration, 10903 New of the information presented during the Dockets Management (see ADDRESSES). It
Hampshire Ave., Bldg. 71, Rm. 3128, eIC process; (3) ensure that appropriate is only necessary to send one set of
Silver Spring, MD 20993–0002; or the documentation of consent is obtained comments. Identify comments with the
Division of Small Manufacturers, when electronic media and processes docket number found in brackets in the
International, and Consumer Assistance, are used to obtain informed consent; heading of this document. Received
Center for Devices and Radiological and (4) ensure the quality and integrity comments may be seen in the Division
Health, Food and Drug Administration, of eIC data included in FDA application of Dockets Management between 9 a.m.
10903 New Hampshire Ave., Bldg. 66, submissions or made available to FDA and 4 p.m., Monday through Friday, and
Rm. 4613, Silver Spring, MD 20993– during inspections. will be posted to the docket at http://
0002. Send one self-addressed adhesive To enhance human subject protection www.regulations.gov.
label to assist that office in processing
and reduce regulatory burden, the
your requests. See the SUPPLEMENTARY IV. Electronic Access
Department of Health and Human
INFORMATION section for electronic Persons with access to the Internet
Services, Office for Human Research
access to the draft guidance document. may obtain the document at http://
Protections, and FDA have been actively
Submit electronic comments on the www.fda.gov/Drugs/Guidance
working to harmonize the Agencies’
draft guidance to http:// ComplianceRegulatoryInformation/
regulatory requirements and guidance
www.regulations.gov. Submit written Guidances/default.htm; http://
for human subject research. This
comments to the Division of Dockets www.fda.gov/BiologicsBloodVaccines/
Management (HFA–305), Food and Drug guidance document was developed as a
part of these efforts. GuidanceComplianceRegulatory
Administration, 5630 Fishers Lane, Rm. Information/Guidances/default.htm;
1061, Rockville, MD 20852. This draft guidance is being issued
http://www.fda.gov/MedicalDevices/
FOR FURTHER INFORMATION CONTACT: consistent with FDA’s good guidance
DeviceRegulationandGuidance/
Cheryl Grandinetti, Center for Drug practices regulation (21 CFR 10.115). GuidanceDocuments/default.htm; or
Evaluation and Research, Food and The draft guidance, when finalized, will http://www.regulations.gov.
Drug Administration, 10903 New represent the Agency’s current thinking
on the use of eIC in investigational Dated: March 3, 2015.
Hampshire Ave., Bldg. 51, Rm. 6316,
studies. It does not create or confer any Leslie Kux,
Silver Spring, MD 20993–0002, 301–
796–2500; Patrick McNeilly, Office of rights for or on any person and does not Associate Commissioner for Policy.
the Commissioner, Food and Drug operate to bind FDA or the public. An [FR Doc. 2015–05377 Filed 3–6–15; 8:45 am]
Administration, 10903 New Hampshire alternative approach may be used if BILLING CODE 4164–01–P
Ave., Bldg. 32, Rm. 5103, Silver Spring, such approach satisfies the
MD 20993, 301–796–8340; Stephen requirements of the applicable statutes
Ripley, Center for Biologics Evaluation and regulations. DEPARTMENT OF HEALTH AND
and Research, Food and Drug HUMAN SERVICES
II. The Paperwork Reduction Act of
Administration, 10903 New Hampshire 1995 Draft Guidance for Industry, Clinical
Ave., Bldg. 71, Rm. 7301, Silver Spring,
Investigators, and Institutional Review
MD 20993–0002, 1–800–835–4709 or This draft guidance refers to
Boards—Use of an Electronic Informed
301–827–6210; or Irfan Khan, Center for previously approved collections of
Consent in Clinical Investigations—
Devices and Radiological Health, Food information found in FDA regulations.
Questions and Answers; Availability
and Drug Administration, 10903 New These collections of information are
Hampshire Ave., Bldg. 66, Rm. 3459, subject to review by the Office of AGENCY: Office for Human Research
Silver Spring, MD 20993, 1–800–638– Management and Budget (OMB) under Protections, Office of the Assistant
2041 or 301–796–7100. the Paperwork Reduction Act of 1995 Secretary for Health, Office of the
SUPPLEMENTARY INFORMATION: (44 U.S.C. 3501–3520). The collections Secretary, Department of Health and
of information in 21 CFR part 11 related Human Services.
I. Background to electronic records; electronic ACTION: Notice.
FDA is announcing the availability of signatures have been approved under
a draft guidance for industry, clinical OMB control number 0910–0303; 21 SUMMARY: In this issue of the Federal
investigators, and institutional review CFR parts 50 and 56 related to Register, the Food and Drug
boards entitled ‘‘Use of Electronic protection of human subjects; IRBs have Administration (FDA) is announcing the
Informed Consent in Clinical been approved under OMB control availability of draft guidance for
Investigations: Questions and Answers.’’ number 0910–0755; 21 CFR 56.115 industry, clinical investigators, and
This guidance provides related to IRB recordkeeping institutional review boards entitled
recommendations for clinical requirements, which include the ‘‘Use of Electronic Informed Consent in
investigators, study sponsors, and IRBs requirements for records related to Clinical Investigations—Questions and
mstockstill on DSK4VPTVN1PROD with NOTICES

on the use of electronic media and informed consent, have been approved Answers.’’ The draft guidance provides
processes to obtain informed consent for under OMB control number 0910–0130; recommendations for clinical
FDA-regulated clinical investigations of the collections of information in 21 CFR investigators, sponsors, and institutional
medical products, including human part 312 have been approved under review boards (IRBs) on the use of
drug and biological products, medical OMB control number 0910–0014; and electronic media and processes to obtain
devices, and combinations thereof. In the collections of information in 21 CFR informed consent for FDA-regulated
particular, the guidance provides part 812 have been approved under clinical investigations of medical
recommendations on procedures that OMB control number 0910–0078. products, including human drug and

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Document Created: 2015-12-18 12:05:52
Document Modified: 2015-12-18 12:05:52

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.
Dates		May 7, 2015.
Contact		Irene Stith-Coleman, Office for Human Research Protections, Department of Health and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852; phone 240-453-6900; email [email protected]
FR Citation		80 FR 12497