[Federal Register Volume 80, Number 45 (Monday, March 9, 2015)]
[Notices]
[Pages 12497-12498]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Draft Guidance for Industry, Clinical Investigators, and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Administration (FDA) is announcing the availability of draft guidance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 The draft guidance provides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research, and the FDA draft guidance document was developed as a part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regarding whether FDA's draft guidance would be appropriate for all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]
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