[Federal Register Volume 81, Number 241 (Thursday, December 15, 2016)]
[Notices]
[Pages 90855-90857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-30146]



[[Page 90855]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Use of Electronic Informed Consent--Questions and Answers; 
Guidance for Institutional Review Boards, Investigators, and Sponsors; 
Availability

AGENCY: Food and Drug Administration and Office for Human Research 
Protections, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) and the Office for 
Human Research Protections (OHRP), Department of Health and Human 
Services (HHS), are announcing the availability of a guidance entitled 
``Use of Electronic Informed Consent--Questions and Answers.'' The 
guidance is intended for institutional review boards (IRBs), 
investigators, and sponsors engaged in or responsible for oversight of 
human subject research under HHS and/or FDA regulations. The guidance 
provides recommendations on the use of electronic systems and processes 
that may employ multiple electronic media to obtain informed consent 
for both HHS-regulated human subject research and FDA-regulated 
clinical investigations of medical products, including human drug and 
biological products, medical devices, and combinations thereof. This 
guidance finalizes the draft guidance entitled ``Use of Electronic 
Informed Consent in Clinical Investigations--Questions and Answers'' 
issued in March 2015.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-D-0390 for ``Use of Electronic Informed Consent--Questions and 
Answers; Guidance for Institutional Review Boards, Investigators, and 
Sponsors; Availability.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    See section III of the SUPPLEMENTARY INFORMATION section for 
submitting written requests for single copies of this guidance and for 
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Cheryl Grandinetti, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 3348, Silver Spring, MD 20993-0002, 301-
796-2500; Nicole Wolanski, Office of Good Clinical Practice, Office of 
Special Medical Programs, Office of Medical Products and Tobacco, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5108, 
Silver Spring, MD 20993, 301 796-6570; 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, 
240-402-7911; 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; or Irene 
Stith-Coleman, Office for Human Research Protections, 1101 Wootton 
Pkwy., suite 200, Rockville, MD 20852, 240-453-6900.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA and OHRP are announcing the availability of a guidance entitled 
``Use of Electronic Informed Consent--Questions and Answers.'' The 
guidance is intended for IRBs, investigators, and sponsors responsible 
for oversight of human subject research under HHS and/or FDA 
regulations. The guidance provides recommendations on the use of 
electronic systems and processes that

[[Page 90856]]

may employ multiple electronic media to obtain informed consent for 
both HHS-regulated human subject research and 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) 
facilitate the subject's comprehension of the information presented 
during the eIC process; (3) ensure that appropriate documentation of 
consent is obtained when electronic systems and processes that may 
employ multiple electronic media are used to obtain informed consent; 
and (4) ensure the quality and integrity of eIC data included in FDA 
applications and made available to FDA during inspections.
    In the Federal Register of March 9, 2015 (80 FR 12496), FDA 
announced the availability of a draft guidance entitled ``Use of 
Electronic Informed Consent in Clinical Investigations--Questions and 
Answers.'' FDA received a number of comments on the draft guidance. In 
response to these comments, this guidance provides further 
clarification on: (1) How to present information in the eIC to the 
subject; (2) how and where to conduct the eIC process; (3) how and when 
questions from subjects should be answered; (4) steps that may be taken 
to facilitate the subject's understanding; (5) how to convey additional 
information to the subject during the course of the research; (6) how 
to use electronic signatures to document eIC; (7) how to verify the 
identity of the subjects who will be electronically signing the 
informed consent; (8) how to use electronic informed consent for 
pediatric studies; (9) how to provide copies of the eIC to the subject; 
(10) steps that may be taken to ensure privacy, security, and 
confidentiality of the eIC information; (11) how to obtain Health 
Insurance Portability and Accountability Act authorizations for 
research electronically; (12) what eIC materials the investigator 
should submit to the IRB; (13) what the IRB's responsibilities are in 
the eIC process; (14) the eIC documentation required for FDA submission 
with applications; (15) steps to ensure that eIC materials are archived 
appropriately for FDA-regulated clinical investigations; and (16) what 
eIC materials or documents FDA will require during an inspection.
    In addition, in the Federal Register of March 9, 2015 (80 FR 
12497), OHRP asked for public comment on whether OHRP should adopt the 
positions and recommendations proposed in the draft guidance for 
research regulated under the HHS protection of human subjects 
regulations, 45 CFR part 46, and whether OHRP and FDA should issue a 
joint guidance on this topic. In response to these comments, the final 
guidance was developed in collaboration with FDA and OHRP and is issued 
as a joint final guidance.
    To enhance human subject protection and reduce regulatory burden, 
OHRP and FDA have been actively working to harmonize the Agencies' 
regulatory requirements and guidance for human subject research. This 
guidance was developed as a part of these efforts. OHRP and FDA believe 
that it will be helpful to the regulated community to issue a joint 
guidance, which will clearly demonstrate the Agencies' collaborative 
approach to the topic of electronic informed consent.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA and OHRP on the use of electronic informed 
consent. It does not establish any rights for any person and is not 
binding on OHRP, FDA, or the public. You can use an alternative 
approach if it satisfies the requirements of the applicable statutes 
and regulations.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information. 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 and electronic signatures 
have been approved under OMB control number 0910-0303; the collections 
of information in 21 CFR parts 50 and 56 related to protection of human 
subjects and to IRBs have been approved under OMB control number 0910-
0755; the collections of information in 21 CFR 56.115 related to IRB 
recordkeeping requirements, which include 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. The collections of information related to 
the protection of human subjects under 45 CFR part 46 and to IRB 
recordkeeping under 45 CFR 46.115 have been approved under OMB control 
number 0990-0260.

III. Addresses for Written Requests

    Submit written requests for single copies of this guidance and for 
electronic access to the guidance document to one of the following 
Centers.

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              Center                          Address                 Telephone            Other information
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Division of Drug Information,       10001 New Hampshire Ave.,   .....................  .........................
 Center for Drug Evaluation and      Hillandale Building, 4th
 Research, Food and Drug             Floor, Silver Spring, MD
 Administration.                     20993-0002.
Office of Good Clinical Practice,   10903 New Hampshire Ave.,   .....................  .........................
 Office of Special Medical           Bldg. 32, rm. 5103,
 Programs, Office of Medical         Silver Spring, MD 20993-
 Products and Tobacco, Food and      0002.
 Drug Administration.
Office for Human Research           1101 Wootton Pkwy., suite   .....................  .........................
 Protections.                        200, Rockville, MD 20852.
Center for Biologics Evaluation     10903 New Hampshire Ave.,   240-7911-402.........  .........................
 and Research, Food and Drug         Bldg. 71, rm. 7301,
 Administration.                     Silver Spring, MD 20993-
                                     0002.
Center for Devices and              10903 New Hampshire Ave.,   1-800-638-2041 or 301- Send one self-addressed
 Radiological Health, Food and       Bldg. 66, rm. 4621,         796-7100.              adhesive label to assist
 Drug Administration.                Silver Spring, MD 20993.                           that office in
                                                                                        processing your
                                                                                        requests.
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IV. Electronic Access

    Persons with access to the Internet may obtain the guidance 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, http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm219433.htm, http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances/default.htm, http://www.hhs.gov/ohrp/newsroom/rfc/index.html, or http://www.regulations.gov.

Leslie Kux,
Assistant Commissioner for Policy, Food and Drug Administration.
Karen B. DeSalvo,
Acting Assistant Secretary for Health, Department of Health and Human 
Services.
[FR Doc. 2016-30146 Filed 12-14-16; 8:45 am]
 BILLING CODE 4164-01-P