Draft Guidance for Industry, Clinical Investigators, and Institutional Review Boards-Use of an Electronic Informed Consent in Clinical Investigations-Questions and Answers; Availability, 12497-12498 [2015-05301]

Download as PDF Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices 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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to https:// www.regulations.gov.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INFORMATION: mstockstill on DSK4VPTVN1PROD with NOTICES I. Background FDA is announcing the availability of a draft guidance for industry, clinical investigators, and institutional review boards entitled ‘‘Use of Electronic Informed Consent in Clinical Investigations: Questions and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 VerDate Sep<11>2014 18:04 Mar 06, 2015 Jkt 235001 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. PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 12497 III. Comments Interested persons may submit either electronic comments regarding this document to https://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 https:// www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the document at https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm; https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm; https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm; or https://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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Draft Guidance for Industry, Clinical Investigators, and Institutional Review Boards—Use of an Electronic Informed Consent in Clinical Investigations— Questions and Answers; Availability Office for Human Research Protections, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice. AGENCY: In this issue of the Federal Register, the Food and Drug Administration (FDA) is announcing the availability of draft guidance for industry, clinical investigators, and institutional review boards entitled ‘‘Use of Electronic Informed Consent in Clinical Investigations—Questions and Answers.’’ The draft 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 SUMMARY: E:\FR\FM\09MRN1.SGM 09MRN1 mstockstill on DSK4VPTVN1PROD with NOTICES 12498 Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices biological products, medical devices, and combinations thereof. To enhance human subject protection and reduce regulatory burden, the Department of Health and Human Services Office for Human Research Protections (OHRP) and FDA have been actively working to harmonize the agencies’ regulatory requirements and guidance for human subject research, and the FDA draft guidance document was developed as a part of these efforts. Although the document is issued by FDA and is drafted as guidance that would apply to FDA-regulated clinical investigations, OHRP is considering whether to adopt the positions and recommendations proposed in this guidance for research regulated under the HHS protection of human subjects regulations, 45 CFR part 46, and to issue a joint OHRP and FDA guidance document on this topic when the final guidance document is developed. OHRP asks for public comment about whether a joint guidance document would be useful for the regulated community. In particular, OHRP is interested in public comment regarding whether FDA’s draft guidance would be appropriate for all research regulated under 45 CFR part 46, including research studies other than clinical investigations or clinical trials, such as social and behavioral research studies. If different guidance should apply to social and behavioral research, or other non-FDA-regulated studies, OHRP asks that the public comments address how the guidance should differ from the proposed guidance for FDA-regulated clinical investigations. OHRP specifically welcomes feedback regarding when it might or might not be appropriate, for studies other than clinical trials, for OHRP to recommend that researchers verify that the person signing the informed consent form is the subject participating in the research. OHRP and FDA will consider these comments in deciding whether to issue a joint OHRP/FDA guidance document on this topic when the final guidance document is developed. DATES: May 7, 2015. ADDRESSES: You may submit comments identified by docket ID number HHS– OPHS–2015–0002 by one of the following methods: Federal eRulemaking Portal: https:// www.regulations.gov. Enter the above docket ID number in the Enter Keyword or ID field and click on ‘‘Search.’’ On the next page, click the ‘‘Submit a Comment’’ action and follow the instructions. Mail/Hand delivery/Courier [For paper, disk, or CD–ROM submissions] VerDate Sep<11>2014 18:04 Mar 06, 2015 Jkt 235001 to: Irene Stith-Coleman, Ph.D., Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Comments received, including any personal information, will be posted without change to https:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Irene Stith-Coleman, Office for Human Research Protections, Department of Health and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852; phone 240–453–6900; email Irene.Stith-Coleman@hhs.gov. Dated: March 3, 2015. Jerry Menikoff, Director, Office for Human Research Protections. Dated: March 3, 2015. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–05305 Filed 3–6–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–0647] Complexities in Personalized Medicine: Harmonizing Companion Diagnostics Across a Class of Targeted Therapies; Public Workshop AGENCY: Food and Drug Administration, HHS. Notice of public workshop. [FR Doc. 2015–05301 Filed 3–6–15; 8:45 am] ACTION: BILLING CODE 4150–36–P The Food and Drug Administration (FDA), in co-sponsorship with the American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO), is announcing a public workshop entitled ‘‘Complexities in Personalized Medicine: Harmonizing Companion Diagnostics Across a Class of Targeted Therapies.’’ The objective of the workshop is to facilitate an in-depth discussion of harmonization of companion diagnostic devices across a class of targeted therapies. The workshop aims to foster collaborations in the clinical cancer research community; provide a deeper understanding of anticancer drug and device development related to personalized medicine; provide a unique perspective of personalized medicine; and help incorporate emerging scientific findings to harmonize companion diagnostics across a class of targeted therapies. Date and Time: The public workshop will be held on March 24, 2015, from 8:30 a.m. to 4:30 p.m. Location: The public workshop will be held at the Mayflower Hotel, Grand Ballroom, 1127 Connecticut Ave. NW., Washington, DC 20036, 202–347–3000. Contact Persons: Kaitlyn Antonelli, American Society of Clinical Oncology, 2318 Mill Rd., suite 800, Alexandria, VA 22314, 571–483–1606, Kaitlyn.Antonelli@asco.org; Pamela Bradley, Center for Devices and Radiological Health, Office of In Vitro Diagnostics and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 240–731–3734, Pamela.Bradley@fda.hhs.gov; and Rasika Kalamegham, American Association for Cancer Research, 1425 K DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome Research Institute; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Special Emphasis Panel Loan Repayment Program. Date: April 30, 2015. Time: 1:00 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Human Genome Research Institute, 3rd Floor Conference Room, 5635 Fishers Lane, Rockville, MD, (Telephone Conference Call). Contact Person: Keith McKenney, Ph.D., Scientific Review Officer, National Human Genome Research Institute, 5635 Fishers Lane, Suite 4076, Bethesda, MD 20814, 301– 594–4280, mckenneyk@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.172, Human Genome Research, National Institutes of Health, HHS) PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 E:\FR\FM\09MRN1.SGM 09MRN1

Agencies

[Federal Register Volume 80, Number 45 (Monday, March 9, 2015)]
[Notices]
[Pages 12497-12498]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-05301]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


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

AGENCY: Office for Human Research Protections, Office of the Assistant 
Secretary for Health, Office of the Secretary, Department of Health and 
Human Services.

ACTION: Notice.

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

SUMMARY: In this issue of the Federal Register, the Food and Drug 
Administration (FDA) is announcing the availability of draft guidance 
for industry, clinical investigators, and institutional review boards 
entitled ``Use of Electronic Informed Consent in Clinical 
Investigations--Questions and Answers.'' The draft 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

[[Page 12498]]

biological products, medical devices, and combinations thereof.
    To enhance human subject protection and reduce regulatory burden, 
the Department of Health and Human Services Office for Human Research 
Protections (OHRP) and FDA have been actively working to harmonize the 
agencies' regulatory requirements and guidance for human subject 
research, and the FDA draft guidance document was developed as a part 
of these efforts. Although the document is issued by FDA and is drafted 
as guidance that would apply to FDA-regulated clinical investigations, 
OHRP is considering whether to adopt the positions and recommendations 
proposed in this guidance for research regulated under the HHS 
protection of human subjects regulations, 45 CFR part 46, and to issue 
a joint OHRP and FDA guidance document on this topic when the final 
guidance document is developed. OHRP asks for public comment about 
whether a joint guidance document would be useful for the regulated 
community. In particular, OHRP is interested in public comment 
regarding whether FDA's draft guidance would be appropriate for all 
research regulated under 45 CFR part 46, including research studies 
other than clinical investigations or clinical trials, such as social 
and behavioral research studies. If different guidance should apply to 
social and behavioral research, or other non-FDA-regulated studies, 
OHRP asks that the public comments address how the guidance should 
differ from the proposed guidance for FDA-regulated clinical 
investigations.
    OHRP specifically welcomes feedback regarding when it might or 
might not be appropriate, for studies other than clinical trials, for 
OHRP to recommend that researchers verify that the person signing the 
informed consent form is the subject participating in the research.
    OHRP and FDA will consider these comments in deciding whether to 
issue a joint OHRP/FDA guidance document on this topic when the final 
guidance document is developed.

DATES: May 7, 2015.

ADDRESSES: You may submit comments identified by docket ID number HHS-
OPHS-2015-0002 by one of the following methods:
    Federal eRulemaking Portal: https://www.regulations.gov. Enter the 
above docket ID number in the Enter Keyword or ID field and click on 
``Search.'' On the next page, click the ``Submit a Comment'' action and 
follow the instructions.
    Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions] 
to: Irene Stith-Coleman, Ph.D., Office for Human Research Protections, 
1101 Wootton Parkway, Suite 200, Rockville, MD 20852.
    Comments received, including any personal information, will be 
posted without change to https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Irene Stith-Coleman, Office for Human 
Research Protections, Department of Health and Human Services, 1101 
Wootton Parkway, Suite 200, Rockville, MD 20852; phone 240-453-6900; 
email Irene.Stith-Coleman@hhs.gov.

    Dated: March 3, 2015.
Jerry Menikoff,
Director, Office for Human Research Protections.
[FR Doc. 2015-05301 Filed 3-6-15; 8:45 am]
 BILLING CODE 4150-36-P
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