
[Federal Register Volume 82, Number 141 (Tuesday, July 25, 2017)]
[Notices]
[Pages 34535-34536]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15539]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-3235]


Institutional Review Board Waiver or Alteration of Informed 
Consent for Clinical Investigations Involving No More Than Minimal Risk 
to Human Subjects; Guidance for Sponsors, Investigators, and 
Institutional Review Boards; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the availability of a guidance for sponsors, investigators, 
and institutional review boards (IRBs) entitled ``IRB Waiver or 
Alteration of Informed Consent for Clinical Investigations Involving No 
More Than Minimal Risk to Human Subjects.'' This guidance informs 
sponsors, investigators, IRBs, and other interested parties that FDA 
does not intend to object to an IRB waiving or altering informed 
consent requirements, as described in the guidance, for certain minimal 
risk clinical investigations. In addition, this guidance explains that 
FDA does not intend to object to a sponsor initiating, or an 
investigator conducting, a minimal risk clinical investigation for 
which an IRB waives or alters the informed consent requirements as 
described in the guidance.

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: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2017-D-3235 for ``IRB Waiver or Alteration of Informed Consent for 
Clinical Investigations Involving No More Than Minimal Risk to Human 
Subjects; Guidance for Sponsors, Investigators, and Institutional 
Review Boards.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the office of Dockets 
Management Staff 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

[[Page 34536]]

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 https://www.regulations.gov. Submit both copies to the Dockets Management 
Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance to the 
Office of Good Clinical Practice, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 32, Rm. 5169, Silver Spring, MD 20993. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Janet Norden, Office of Good Clinical 
Practice, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993, 301-796-1127.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a guidance for sponsors, 
investigators and IRBs entitled ``IRB Waiver or Alteration of Informed 
Consent for Clinical Investigations Involving No More Than Minimal Risk 
to Human Subjects.'' We are issuing this guidance consistent with our 
good guidance practices (GGP) regulation (Sec.  10.115 (21 CFR 
10.115)). We are implementing this guidance without prior public 
comment because we have determined that prior public participation is 
not feasible or appropriate (Sec.  10.115(g)(2)). We made this 
determination because this guidance presents a less burdensome policy 
that is consistent with the public health. FDA believes this guidance 
will facilitate the conduct of certain minimal risk clinical 
investigations that are important to addressing significant public 
health needs without compromising the rights, safety, or welfare of 
human subjects. Although this guidance is immediately in effect, it 
remains subject to comment in accordance with FDA's GGP regulation. FDA 
will consider all comments received and will revise this guidance when 
appropriate.
    On December 13, 2016, the 21st Century Cures Act (Cures Act) (Pub. 
L. 114-255) was signed into law. Title III, section 3024 of the Cures 
Act amended sections 520(g)(3) and 505(i)(4) of the Federal Food, Drug, 
and Cosmetic Act (the FD&C Act) to provide authority for FDA to permit 
an exception from informed consent requirements when the proposed 
clinical testing poses no more than minimal risk to the human subject 
and includes appropriate safeguards to protect the rights, safety, and 
welfare of the human subject. This statutory amendment became effective 
on December 13, 2016.
    Currently, FDA's regulations governing the protection of human 
subjects (21 CFR parts 50 and 56) allow exception from the general 
requirements for informed consent only in life-threatening situations 
when certain conditions are met (21 CFR 50.23) or when the requirements 
for emergency research are met (21 CFR 50.24), but do not include an 
exception from informed consent for minimal risk clinical 
investigations. In light of the Cures Act amendment to the FD&C Act 
described previously, FDA intends to revise its informed consent 
regulations to add a waiver or alteration for minimal risk clinical 
investigations, under appropriate human subject protection safeguards, 
to the two existing exceptions from informed consent.
    This guidance informs sponsors, investigators, and IRBs that until 
FDA issues these regulations, we do not intend to object to an IRB 
approving a consent procedure that does not include, or that alters, 
some or all of the elements of informed consent set forth in 21 CFR 
50.25, or waiving the requirements to obtain informed consent as 
described in the guidance. In addition, we do not intend to object to a 
sponsor initiating, or an investigator conducting, a minimal risk 
clinical investigation for which an IRB waives or alters the informed 
consent requirements as described in the guidance. We believe that this 
guidance will facilitate investigators' ability to conduct studies that 
may contribute substantially to the development of products to diagnose 
or treat diseases or conditions, or address unmet medical needs, 
without compromising the rights, safety, or welfare of human subjects.
    The guidance represents the current thinking of FDA on this topic. 
It does not establish any rights for any person and is not binding on 
FDA or the public. You can use an alternative approach if it satisfies 
the requirements of the applicable statutes and regulations. This is 
not a significant regulatory action subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This 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 referenced in this guidance that are related 
to IRB recordkeeping requirements under 21 CFR part 56 have been 
approved under OMB control numbers 0910-0755 and 0910-0130.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/RegulatoryInformation/Guidances/default.htm, 
http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm219433.htm, or https://www.regulations.gov. Use the FDA Web site listed in the previous 
sentence to find the most current version of the guidance.

    Dated: July 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-15539 Filed 7-24-17; 8:45 am]
 BILLING CODE 4164-01-P


