80 FR 12496 - Use of an Electronic Informed Consent in Clinical Investigations: Questions and Answers; Draft Guidance for Industry, Clinical Investigators, and Institutional Review Boards; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

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

Page Range		12496-12497
FR Document		2015-05377

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry, clinical investigators, and institutional review boards entitled ``Use of Electronic Informed Consent in Clinical Investigations: Questions and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.'' The 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.

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

[Federal Register Volume 80, Number 45 (Monday, March 9, 2015)]
[Notices]
[Pages 12496-12497]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-05377]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-0390]

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Questions and Answers; Draft Guidance for Industry, Clinical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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or the Agency) 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announcing the availability of a draft guidance for industry, clinical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.'' The 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.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 8, 2015.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD
20993; or Office of Good Clinical Practice, Office of Special Medical
Programs, Office of the Commissioner, Food and Drug Administration,
10903 New Hampshire

[[Page 12497]]

Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002; or the Office
of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or
the Division of Small Manufacturers, International, and Consumer
Assistance, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver
Spring, MD 20993-0002. 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 http://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:

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 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.

III. Comments

Interested persons may submit either electronic comments regarding
this document to http://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 http://www.regulations.gov.

IV. Electronic Access

Persons with access to the Internet may obtain the document at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm; http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm; http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm; or http://www.regulations.gov.

Dated: March 3, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05377 Filed 3-6-15; 8:45 am]
BILLING CODE 4164-01-P

12496 Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices

time. Persons who do not file an Microbiology and Infectious Diseases (Catalogue of Federal Domestic Assistance
advance request for a presentation, but Research, National Institutes of Health, HHS) Program Nos. 93.847, Diabetes,
desire to make an oral statement, may Dated: March 3, 2015. Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
announce it at the time of the public David Clary, Research; 93.849, Kidney Diseases, Urology
comment period. Public participation Program Analyst, Office of Federal Advisory and Hematology Research, National Institutes
and ability to comment will be limited Committee Policy. of Health, HHS)
to space and time as it permits. [FR Doc. 2015–05309 Filed 3–6–15; 8:45 am] Dated: March 3, 2015.
The logistical challenges of BILLING CODE 4140–01–P David Clary,
scheduling this meeting delayed an
Program Analyst, Office of Federal Advisory
earlier publication of this notice.
Committee Policy.
FOR FURTHER INFORMATION CONTACT: DEPARTMENT OF HEALTH AND
[FR Doc. 2015–05308 Filed 3–6–15; 8:45 am]
Anyone requiring information regarding HUMAN SERVICES
BILLING CODE 4140–01P
the ACCV should contact Annie Herzog,
National Institutes of Health
DICP, HSB, HRSA, Room 11C–26, 5600
Fishers Lane, Rockville, Maryland National Institute of Diabetes and DEPARTMENT OF HEALTH AND
20857, telephone (301) 443–6593, or Digestive and Kidney Diseases; Notice HUMAN SERVICES
email: aherzog@hrsa.gov. of Closed Meetings
Food and Drug Administration
Jackie Painter, Pursuant to section 10(d) of the
Director, Division of the Executive Secretariat. [Docket No. FDA–2015–D–0390]
Federal Advisory Committee Act, as
[FR Doc. 2015–05200 Filed 3–6–15; 8:45 am] amended (5 U.S.C. App.), notice is Use of an Electronic Informed Consent
BILLING CODE 4165–15–P hereby given of the following meetings. in Clinical Investigations: Questions
The meetings will be closed to the
and Answers; Draft Guidance for
public in accordance with the
Industry, Clinical Investigators, and
DEPARTMENT OF HEALTH AND provisions set forth in sections
Institutional Review Boards;
HUMAN SERVICES 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
Availability
as amended. The grant applications and
National Institutes of Health the discussions could disclose AGENCY: Food and Drug Administration,
confidential trade secrets or commercial HHS.
National Institute of Allergy and
property such as patentable material, ACTION: Notice.
Infectious Diseases; Notice of Closed
and personal information concerning
Meeting SUMMARY: The Food and Drug
individuals associated with the grant
applications, the disclosure of which Administration (FDA or the Agency) is
Pursuant to section 10(d) of the
would constitute a clearly unwarranted announcing the availability of a draft
Federal Advisory Committee Act, as
invasion of personal privacy. guidance for industry, clinical
amended (5 U.S.C. App.), notice is
investigators, and institutional review
hereby given of the following meeting. Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
boards entitled ‘‘Use of Electronic
The meeting will be closed to the Informed Consent in Clinical
public in accordance with the Special Emphasis Panel; Time-Sensitive
Obesity Meeting. Investigations: Questions and Answers.’’
provisions set forth in sections The guidance provides
Date: March 26, 2015.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Time: 1:00 p.m. to 3:00 p.m. recommendations for clinical
as amended. The grant applications and Agenda: To review and evaluate grant investigators, sponsors, and institutional
the discussions could disclose applications. review boards (IRBs) on the use of
confidential trade secrets or commercial Place: National Institutes of Health, Two electronic media and processes to obtain
property such as patentable material, Democracy Plaza, 6707 Democracy informed consent for FDA-regulated
and personal information concerning Boulevard, Bethesda, MD 20892, (Telephone
Conference Call).
clinical investigations of medical
individuals associated with the grant products, including human drug and
applications, the disclosure of which Contact Person: Michele L. Barnard, Ph.D.,
Scientific Review Officer, Review Branch, biological products, medical devices,
would constitute a clearly unwarranted and combinations thereof.
DEA, NIDDK, National Institutes of Health,
invasion of personal privacy. Room 753, 6707 Democracy Boulevard, DATES: Although you can comment on
Name of Committee: National Institute of Bethesda, MD 20892–2542, (301) 594–8898, any guidance at any time (see 21 CFR
Allergy and Infectious Diseases Special barnardm@extra.niddk.nih.gov. 10.115(g)(5)), to ensure that the Agency
Emphasis Panel; ‘‘NIAID Resource-Related Name of Committee: National Institute of considers your comment on this draft
Research Projects (R24): Fecal Microbiome Diabetes and Digestive and Kidney Diseases
Transplant National Registry’’.
guidance before it begins work on the
Special Emphasis Panel; NIDDK—Planning final version of the guidance, submit
Date: April 2, 2015. Grant in Chronic Kidney Disease (U34).
Time: 1:00 p.m. to 3:00 p.m. Date: April 8, 2015.
either electronic or written comments
Agenda: To review and evaluate grant Time: 1:00 p.m. to 2:30 p.m. on the draft guidance by May 8, 2015.
applications. Agenda: To review and evaluate grant ADDRESSES: Submit written requests for
Place: National Institutes of Health, Room applications. single copies of the draft guidance to the
3G61, 5601 Fishers Lane, Rockville, MD Place: National Institutes of Health, Two Division of Drug Information, Center for
20892, (Telephone Conference Call). Democracy Plaza, 6707 Democracy
mstockstill on DSK4VPTVN1PROD with NOTICES

Drug Evaluation and Research, Food
Contact Person: Travis J. Taylor, Ph.D., Boulevard, Bethesda, MD 20892, (Telephone
Scientific Review Program, DEA/NIAID/NIH/
and Drug Administration, 10001 New
Conference Call). Hampshire Ave., Hillandale Building,
DHHS, 5601 Fishers Lane, Rockville, MD Contact Person: Najma Begum, Ph.D.,
20892, 240–669–5082, Travis.Taylor@ Scientific Review Officer, Review Branch,
4th Floor, Silver Spring, MD 20993; or
nih.gov. DEA, NIDDK, National Institutes of Health, Office of Good Clinical Practice, Office
(Catalogue of Federal Domestic Assistance Room 749, 6707 Democracy Boulevard, of Special Medical Programs, Office of
Program Nos. 93.855, Allergy, Immunology, Bethesda, MD 20892–5452, (301) 594–8894, the Commissioner, Food and Drug
and Transplantation Research; 93.856, begumn@niddk.nih.gov. Administration, 10903 New Hampshire

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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 12:05:24
Document Modified: 2015-12-18 12:05:24

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		Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 8, 2015.
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.
FR Citation		80 FR 12496

80 FR 12496 - Use of an Electronic Informed Consent in Clinical Investigations: Questions and Answers; Draft Guidance for Industry, Clinical Investigators, and Institutional Review Boards; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration