NHGRI Institutional Review Board
The National Human Genome Research Institute (NHGRI) Institutional Review Board (IRB) is responsible for protecting the rights and welfare of the human subjects of research conducted by intramural investigators at NHGRI.
All intramural research protocols involving human subjects must be submitted for review by the NHGRI IRB. These Web pages contain the instructions, forms and relevant links for submitting a research protocol to the IRB.
IRB News and Updates
August 7, 2013
From: Deputy Director for Intramural Research, NIH
To: All NIH Clinical and Basic Research Investigators
Subject: AAHRPP Accreditation
This memorandum is to inform you that the NIH Human Research Protection Program (HRPP) has applied for accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) [aahrpp.org]. This memorandum outlines the time frame for accreditation and, more importantly, your vital roles in the accreditation process.
This is the first step in a process that will take several months, during which time comments will be received back from AAHRPP and NIH will respond. NIH will then submit the AAHRPP Step 2 Application, which will include the final HRPP Standard Operating Procedures (SOPs), IRB minutes, and a list of active protocols with the Principal Investigators' names. Within 90 days after receiving the Step 2 application, AAHRPP will schedule an NIH site visit, anticipated in December 2013. The purpose of the site visit is to evaluate whether NIH is complying with its SOPs. At the site visit, an AAHRPP team will interview the Principal Investigators of randomly-selected protocols. They will also conduct interviews with other selected NIH HRPP and Institute and Center personnel, including Clinical Directors; IRB Chairs, IRB members and IRB administrative staff; OHSRP staff; other investigators; research support staff; nurses; clinical monitors; protocol navigators; pharmacists; ethicists, etc. AAHRPP will send a draft site visit report within 30 days, and NIH will have up to 30 days to provide a response to the report. The final AAHRPP site visit report and recommendations will be reviewed by the AAHRPP Council on Accreditation in March 2014.
The application for accreditation includes 42 new HRPP SOPs as well as numerous supporting documents that describe the way we do business at the NIH to protect human subjects. Much of this will be familiar and has been developed with significant input from the intramural community. A list of the SOPs is attached, by topic. They are posted on the Office of Human Subjects Research Protections (OHSRP) website at https://federation.nih.gov/ohsr/nih/pnp.php, under HRPP, Policies and Procedures.
Our challenge now is to implement all SOPs by October 1, 2013. Also, everyone must become well prepared for the site visit. OHSRP staff will provide training and education sessions about the SOPs. Additionally, each IC Clinical Director has appointed an IC AAHRPP Contact [federation.nih.gov] to assist in preparation for the AAHRPP site visit and to answer questions regarding accreditation activities. IRB Chairs and IRB office staff can also answer questions regarding the SOPs.
I am asking for your help and cooperation in achieving accreditation that will validate the excellence of the NIH HRPP. Please work with your colleagues and OHSRP to familiarize yourself with the HRPP policies and the accreditation process. If you have any questions about accreditation, or need any assistance with the SOPs or aspects of the site visit, please call OHSRP at 301-402-3444.
October 14, 2010
The emerging availability of affordable "next generation" whole exome- and whole genome sequencing (WES and WGS, respectively), has prompted questions about whether there are ethically-relevant distinctions between "traditional" targeted genetic research (e.g., candidate gene approaches) and WES/WGS research; and, if so, what implications this will have for human subject protections. While WES/WGS does not raise novel ethical concerns, the issues associated with traditional genetic research will be amplified by the sheer magnitude of information generated by WES/WGS. Ethical concerns that had been rare or theoretical are now becoming more prevalent and more complex, particularly related to return of incidental findings, which are much more likely to be identified; informed consent; and privacy.
Starting in late 2009, the NHGRI IRP began seeing a marked increase in the number of research protocols that proposed to utilize WES/WGS technology, with considerable variability in the way that the proposed research anticipated and addressed these emerging ethical issues. We are aware that investigators in other ICs have begun to utilize this technology as well. Because of the diversity of research that will propose to incorporate next generation sequencing, different approaches are indicated for different protocols. Generally, however, we believe that the significant differences between traditional genetic research and WES/WGS require a consistent baseline level of ethical review to ensure that investigators have adequately considered the novel aspects of their proposed WES/WGS research.
The NHGRI Bioethics Core has developed a draft document, Points to Consider in the Transition Toward Whole-Genome Sequencing in Human Subjects Research that we hope will be useful for both investigators and IRBs.
10 Center Drive, CRC
Building 10 CRC, Room 6-3340
Bethesda, MD 20892-1611
Phone: (301) 496-1906
Fax: (301) 480-3015
Sara Hull, Ph.D.
Director, NHGRI Bioethics Core
IRB Vice-Chair and Administrator
Phone: (301) 435-8712
Ben Berkman, J.D., M.P.H.
Deputy Director, NHGRI Bioethics Core
Phone: (301) 496-1531
Fabio Candotti, M.D.
Phone: (301) 435-2944
To view the files on this page, you will need Adobe Acrobat Reader.
To view the files on this page, you will need MS Word. A copy of the latest version of Word Viewer can be downloaded for free.
Top of page
Last Updated: August 26, 2013