[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guidance finalizes the draft guidance entitled ``Use of Electronic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