Draft Guidance for Industry, Clinical Investigators, and Institutional Review Boards-Use of an Electronic Informed Consent in Clinical Investigations-Questions and Answers; Availability, 12497-12498 [2015-05301]
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Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993–0002; or the Office of
Communication, Outreach and
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0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Cheryl Grandinetti, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6316,
Silver Spring, MD 20993–0002, 301–
796–2500; Patrick McNeilly, Office of
the Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993, 301–796–8340; Stephen
Ripley, Center for Biologics Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 7301, Silver Spring,
MD 20993–0002, 1–800–835–4709 or
301–827–6210; or Irfan Khan, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3459,
Silver Spring, MD 20993, 1–800–638–
2041 or 301–796–7100.
SUPPLEMENTARY INFORMATION:
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I. Background
FDA is announcing the availability of
a draft guidance for industry, clinical
investigators, and institutional review
boards entitled ‘‘Use of Electronic
Informed Consent in Clinical
Investigations: Questions and Answers.’’
This guidance provides
recommendations for clinical
investigators, study sponsors, and 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. In
particular, the guidance provides
recommendations on procedures that
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18:04 Mar 06, 2015
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may be followed when using an
electronic informed consent (eIC) to
help (1) ensure protection of the rights,
safety, and welfare of human subjects;
(2) ensure the subject’s comprehension
of the information presented during the
eIC process; (3) ensure that appropriate
documentation of consent is obtained
when electronic media and processes
are used to obtain informed consent;
and (4) ensure the quality and integrity
of eIC data included in FDA application
submissions or made available to FDA
during inspections.
To enhance human subject protection
and reduce regulatory burden, the
Department of Health and Human
Services, Office for Human Research
Protections, and FDA have been actively
working to harmonize the Agencies’
regulatory requirements and guidance
for human subject research. This
guidance document was developed as a
part of these efforts.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on the use of eIC in investigational
studies. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. The Paperwork Reduction Act of
1995
This draft 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 in 21 CFR part 11 related
to electronic records; electronic
signatures have been approved under
OMB control number 0910–0303; 21
CFR parts 50 and 56 related to
protection of human subjects; IRBs have
been approved under OMB control
number 0910–0755; 21 CFR 56.115
related to IRB recordkeeping
requirements, which include the
requirements for records related to
informed consent, have been approved
under OMB control number 0910–0130;
the collections of information in 21 CFR
part 312 have been approved under
OMB control number 0910–0014; and
the collections of information in 21 CFR
part 812 have been approved under
OMB control number 0910–0078.
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III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm; https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm;
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm; or
https://www.regulations.gov.
Dated: March 3, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–05377 Filed 3–6–15; 8:45 am]
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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
Office for Human Research
Protections, Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
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
SUMMARY:
E:\FR\FM\09MRN1.SGM
09MRN1
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12498
Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices
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: https://
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]
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18:04 Mar 06, 2015
Jkt 235001
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 https://
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
Irene.Stith-Coleman@hhs.gov.
Dated: March 3, 2015.
Jerry Menikoff,
Director, Office for Human Research
Protections.
Dated: March 3, 2015.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–05305 Filed 3–6–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0647]
Complexities in Personalized
Medicine: Harmonizing Companion
Diagnostics Across a Class of
Targeted Therapies; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop.
[FR Doc. 2015–05301 Filed 3–6–15; 8:45 am]
ACTION:
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The Food and Drug Administration
(FDA), in co-sponsorship with the
American Association for Cancer
Research (AACR) and the American
Society of Clinical Oncology (ASCO), is
announcing a public workshop entitled
‘‘Complexities in Personalized
Medicine: Harmonizing Companion
Diagnostics Across a Class of Targeted
Therapies.’’ The objective of the
workshop is to facilitate an in-depth
discussion of harmonization of
companion diagnostic devices across a
class of targeted therapies. The
workshop aims to foster collaborations
in the clinical cancer research
community; provide a deeper
understanding of anticancer drug and
device development related to
personalized medicine; provide a
unique perspective of personalized
medicine; and help incorporate
emerging scientific findings to
harmonize companion diagnostics
across a class of targeted therapies.
Date and Time: The public workshop
will be held on March 24, 2015, from
8:30 a.m. to 4:30 p.m.
Location: The public workshop will
be held at the Mayflower Hotel, Grand
Ballroom, 1127 Connecticut Ave. NW.,
Washington, DC 20036, 202–347–3000.
Contact Persons: Kaitlyn Antonelli,
American Society of Clinical Oncology,
2318 Mill Rd., suite 800, Alexandria,
VA 22314, 571–483–1606,
Kaitlyn.Antonelli@asco.org; Pamela
Bradley, Center for Devices and
Radiological Health, Office of In Vitro
Diagnostics and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD
20993–0002, 240–731–3734,
Pamela.Bradley@fda.hhs.gov; and
Rasika Kalamegham, American
Association for Cancer Research, 1425 K
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Human Genome Research
Institute; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Human
Genome Research Institute Special Emphasis
Panel Loan Repayment Program.
Date: April 30, 2015.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Human Genome Research
Institute, 3rd Floor Conference Room, 5635
Fishers Lane, Rockville, MD, (Telephone
Conference Call).
Contact Person: Keith McKenney, Ph.D.,
Scientific Review Officer, National Human
Genome Research Institute, 5635 Fishers
Lane, Suite 4076, Bethesda, MD 20814, 301–
594–4280, mckenneyk@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.172, Human Genome
Research, National Institutes of Health, HHS)
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Agencies
[Federal Register Volume 80, Number 45 (Monday, March 9, 2015)]
[Notices]
[Pages 12497-12498]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-05301]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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 https://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 Irene.Stith-Coleman@hhs.gov.
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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