80 FR 12496 - Use of an Electronic Informed Consent in Clinical Investigations: Questions and Answers; Draft Guidance for Industry, Clinical Investigators, and Institutional Review Boards; Availability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

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry, clinical investigators, and institutional review boards entitled ``Use of Electronic Informed Consent in Clinical Investigations: Questions and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Questions and Answers; Draft Guidance for Industry, Clinical 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

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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announcing the availability of a draft guidance for industry, clinical 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 8, 2015.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