National Cancer Institute; Amended Notice of Meeting, 512 [2014-30883]

Download as PDF 512 Federal Register / Vol. 80, No. 3 / Tuesday, January 6, 2015 / Notices Request for Comments NIH encourages the public to provide comments on any aspect of the draft policy outlined below. Comments should be submitted electronically by January 29, 2015, to the Office of Clinical Research and Bioethics Policy, Office of Science Policy, NIH, via email at SingleIRBpolicy@mail.nih.gov; mail to 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892; or fax at 301–496– 9839. Submitted comments are considered public information; private or confidential information should not be submitted. Comments may be posted along with the submitter’s name and affiliation on the OCRBP Web site after the public comment period closes. Draft NIH Policy on the Use of a Single Institutional Review Board for MultiSite Research tkelley on DSK3SPTVN1PROD with NOTICES Purpose. The purpose of this Policy is to increase the use of single Institutional Review Boards (IRB) for multi-site studies funded by the National Institutes of Health (NIH). Its goal is to enhance and streamline the process of IRB review and reduce inefficiencies so that research can proceed efficiently without compromising ethical principles and protections. Scope. NIH generally expects all domestic sites of multi-site NIH-funded studies to use a single IRB of record. The Policy applies to all domestic sites participating in NIH conducted or supported multi-site studies, whether supported through grants, contracts, or the NIH intramural program. While foreign sites in multi-site studies will not be expected to follow this Policy, they may elect to do so. Responsibilities. All sites participating in a multi-site study will be expected to rely on a single IRB to carry out the functions that are required for institutional compliance with IRB review set forth in the HHS regulations for the Protection of Human Subjects. The single IRB will be the IRB of record for the other participating sites. The single IRB will be accountable for compliance with regulatory requirements for IRBs specified under the HHS regulations at 45 CFR part 46, such as providing initial and continuing review of the research.12 All the use of a single IRB could lead to increased liability and diminished accountability for participating sites, and decreased consideration of local context. See https://www.gpo.gov/fdsys/pkg/ FR–2011–07–26/html/2011–18792.htm 12 On March 5, 2009, OHRP published an ANPRM requesting public comments on whether OHRP should pursue rulemaking to hold institutional review boards and institutions or organizations operating them directly accountable for compliance with the provisions of 45 CFR part 46 that relate VerDate Sep<11>2014 19:38 Jan 05, 2015 Jkt 235001 participating sites will be responsible for meeting other regulatory obligations, such as obtaining informed consent, overseeing the implementation of approved protocols, and, reporting unanticipated problems and adverse events to the single IRB of record. Agreements between the single IRB of record and other participating sites will be needed in accordance with 45 CFR part 46. IRB Authorization Agreements will document the delegation of responsibilities of IRB review to the designated IRB of record and that IRB site’s acceptance of the responsibilities. The agreement will set forth the specific responsibilities of each participating site. Participating sites will then rely on the IRB of record to satisfy the regulatory requirements relevant to the IRB review. The awardee or lead site for an NIH-funded, multi-site study will be responsible for maintaining authorization agreements and should be prepared to provide copies of the authorization agreements and other necessary documentation to the NIH funding Institute or Center upon request. As necessary, mechanisms should be established to enable the single IRB of record to consider local context issues during its deliberations. A duplicate IRB review at a participating site would be counter to the intent and goal of the Policy, but the Policy does not prohibit any participating site from carrying out its own IRB review. If this approach is taken, the participating site should expect to bear the cost of the additional review. Identification of the IRB that will serve as the single IRB of record will be the responsibility of the extramural applicant or offerer, or the intramural principal investigator. The funding NIH Institute or Center has final decisional authority for approving the selected single IRB. Use of the designated single IRB will be a term and condition of award. If the agreed-upon single IRB is a fee-based IRB, these costs will be included in the Notice of Award as a direct cost. Compliance with this Policy will be a term and condition in the Notice of Award and a contract requirement in the Contract Award. Exceptions. Exceptions to the expectation to use a single IRB may be to IRB responsibilities. In the ANPRM, OHRP identified: Responsibilities that may be unique to IRBs and the institutions operating them; responsibilities that may be unique to institutions engaged in human subjects research; and, responsibilities that may be fulfilled by either IRBs/ IORGs or institutions engaged in human subjects research. See https://www.gpo.gov/fdsys/pkg/FR– 2009–03–05/pdf/E9–4628.pdf. PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 made with appropriate justification. Exceptions will be allowed only if the designated single IRB is unable to meet the needs of specific populations or where local IRB review is required by federal, tribal, or state laws or regulations.13 Effective Date. The Policy applies to all new grant applications (Type 1 and 2) and contract proposals with receipt dates after [date to be determined]. It will also apply to intramural multi-site studies submitted for initial review after that date.14 Dated: December 24, 2014. Lawrence Tabak, Principal Deputy Director, [FR Doc. 2014–30964 Filed 1–5–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Cancer Institute Special Emphasis Panel, January 29, 2015 10:30 a.m. to January 30, 2015, 04:00 p.m., National Cancer Institute Shady Grove, 9609 Medical Center Drive, Rockville, MD 20850 which was published in the Federal Register on November 26, 2014, 79FR70537. The meeting notice is amended to change the date and start time to be held on January 29, 2015 at 10:00 a.m. The meeting is closed to the public. Dated: December 30, 2014. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2014–30883 Filed 1–5–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as 13 For example, FDA-regulated research involving a device is required to have local IRB review under 21 U.S.C. 360j(g)(3)(A)). 14 When a final policy is issued, NIH will also provide more specific procedural guidance to facilitate implementation. E:\FR\FM\06JAN1.SGM 06JAN1

Agencies

[Federal Register Volume 80, Number 3 (Tuesday, January 6, 2015)]
[Notices]
[Page 512]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-30883]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Cancer Institute; Amended Notice of Meeting

    Notice is hereby given of a change in the meeting of the National 
Cancer Institute Special Emphasis Panel, January 29, 2015 10:30 a.m. to 
January 30, 2015, 04:00 p.m., National Cancer Institute Shady Grove, 
9609 Medical Center Drive, Rockville, MD 20850 which was published in 
the Federal Register on November 26, 2014, 79FR70537.
    The meeting notice is amended to change the date and start time to 
be held on January 29, 2015 at 10:00 a.m. The meeting is closed to the 
public.

    Dated: December 30, 2014.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2014-30883 Filed 1-5-15; 8:45 am]
BILLING CODE 4140-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.