80 FR 12497 - Draft Guidance for Industry, Clinical Investigators, and Institutional Review Boards-Use of an Electronic Informed Consent in Clinical Investigations-Questions and Answers;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

In this issue of the Federal Register, the Food and Drug Administration (FDA) is announcing the availability of draft guidance for industry, clinical investigators, and institutional review boards entitled ``Use of Electronic Informed Consent in Clinical Investigations--Questions and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 The draft guidance provides recommendations for clinical investigators, sponsors, and institutional review boards (IRBs) on the use of electronic media and processes to obtain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working to harmonize the agencies' regulatory requirements and guidance for human subject research, and the FDA draft guidance document was developed as a part of these efforts.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 In particular, OHRP is interested in public comment regarding whether FDA's draft guidance would be appropriate for all research regulated under 45 CFR part 46, including research studies other than clinical investigations or clinical trials, such as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, 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