Announcements for 2012
(November 27, 2012) 2013 Update to the International Compilation of Human Research Standards - Now Available
The International Compilation of Human Research Standards is a listing of over 1,000 laws, regulations, and guidelines on human subjects protections in 104 countries and from several international organizations. The Compilation is designed for use by IRBs, researchers, sponsors, and others. Many of the listings embed hyperlinks to the source document.
The 2013 edition is now available, and can be accessed in both Word and PDF formats: http://www.hhs.gov/ohrp/international/index.html One new country is featured in the 2013 Edition: Ecuador.
As in the past, the new edition updates the human research standards based on information provided by in-country experts.
(November 13, 2012) Effects of Superstorm Sandy on IRB Operations
The effects of Superstorm Sandy have been devastating to a number of geographic areas, most notably including (but not limited to) New Jersey, New York, Delaware, and Connecticut. The Office for Human Research Protections (OHRP) understands that, as a result, some human subjects protections programs at institutions in affected areas are unable to function and may be unable to do so for some time.
Oversight of Research
Some affected institutions have asked OHRP how they should handle IRB oversight of research. One option is to refer review to another IRB that is not affected by the storm. However, where IRB records are not available to send to another IRB, it may not be possible or practical to prevent the expiration of IRB approval. Nor may it be feasible to notify investigators that research for which IRB approval has expired must be suspended. Of course, any such research that is determined to be in the best interest of the subjects may continue after IRB approval has expired.
OHRP encourages reasonable attempts to suspend or refer research to another IRB. However, if circumstances prohibit such efforts, OHRP will use available flexibility in any decision making about affected institutions that fail either to conduct continuing review in time or to suspend expired research. This flexibility will continue for as long as storm devastation prevents the IRB from either conducting continuing review or temporarily referring that responsibility to another IRB.
Research Subject Interventions
OHRP has also been asked about subjects receiving research interventions if the facility where they would normally receive those interventions is unable to provide that service. Subjects may receive those interventions temporarily at other facilities that are able to provide them. OHRP anticipates that the majority of institutions to which research subjects are temporarily referred will not be “engaged” in the research according to OHRP’s 2008 “Guidance on Engagement of Institutions in Human Subjects Research” (see http://www.hhs.gov/ohrp/policy/engage08.pdf). For example, non-engaged scenario B.(3) describes institutions not initially selected as research sites whose employees or agents administer study interventions on a one-time or short-term basis. These institutions are not required to obtain an FWA or to secure IRB review and approval in order to provide the research interventions. Even when such facilities are considered engaged in the research, subjects should continue to receive investigational treatments if that is in the best interests of subjects.
Reporting to OHRP
We also have been asked whether circumstances related to Superstorm Sandy represent events that must be reported to OHRP. In general, disruptions of human subjects protections programs by this storm do not constitute unanticipated problems involving risks to subjects or others, serious or continuing noncompliance, or suspension or termination of IRB approval. Therefore, these events need not be reported to OHRP as such.
OHRP wishes the best to those in the affected areas. If we may provide guidance or any other assistance, please contact OHRP at 1-866-447-4777 or firstname.lastname@example.org and reference “Sandy 12” in the message or subject line.
The Office for Human Research Protections (OHRP) would like to announce four new members who have been invited to join the Secretary's Advisory Committee on Human Research Protections (SACHRP). The invited members are:
- Chair Designate: Jeffrey R. Botkin, M.D., M.P.H., Professor of Pediatrics and Medical Ethics, Associate Vice President for Research, University of Utah. Term: October 15, 2012 - October 15, 2016;
- Thomas Eissenberg, Ph.D., Professor, Department of Psychology and Institute for Drug and Alcohol Studies; Director, Clinical Behavioral Pharmacology Laboratory, Virginia Commonwealth University. Term: October 9, 2012 - October 9, 2016;
- Owen Garrick, M.D., M.B.A., President and CEO, Bridge Clinical Research, Inc. Term: October 15, 2012 - October 15, 2016; and,
- Pilar Ossorio, J.D., Ph.D., Associate Professor of Law and Bioethics, University of Wisconsin-Madison. Term: October 15, 2012 - October 15, 2016.
OHRP would like to thank all applicants, and notes that the current Federal Register Notice soliciting nominations for SACHRP 2013 vacancies closes October 9, 2012. Please see http://www.gpo.gov/fdsys/pkg/FR-2012-09-07/html/2012-22103.htm or http://www.gpo.gov/fdsys/pkg/FR-2012-09-07/pdf/2012-22103.pdf.
(August 3, 2012) OHRP Archives Guidance Document on IRB Knowledge of Local Research Context
OHRP has moved the guidance entitled “IRB Knowledge of Local Research Context” to its archive of guidance documents no longer in effect. That guidance was last updated in 2000, and, due to developments over the intervening years, much of the information in the guidance is now outdated or inaccurate. OHRP plans to develop new guidance that will address the issues discussed in the now-archived July 21, 2000 guidance.
If you have specific questions regarding the issues discussed in the archived guidance, please contact OHRP by phone at (866) 447-4777 (toll-free within the U.S.) or (240) 453-6900, or by e-mail at email@example.com.
All archived OHRP documents may be accessed on the OHRP Web site at: http://www.hhs.gov/ohrp/archive/
(June 12, 2012) OHRP Announces the Availability of a Draft Guidance Document on Transferring a Previously-Approved Research Project to a New IRB or Institution
On June 12, 2012, the Office for Human Research Protections (OHRP) announced in the Federal Register the availability of a draft guidance document entitled, “Considerations in Transferring a Previously-Approved Research Project to a New IRB or Research Institution” and is seeking comment on the draft guidance.
The draft guidance document, when finalized, will represent OHRP’s current thinking on this topic and OHRP’s first formal guidance on this topic. The guidance would apply to non-exempt human subjects research conducted or supported by HHS. OHRP will consider comments received before issuing the final guidance document.
The draft document is intended primarily for institutional review boards (IRBs), institutions, and investigators that are responsible for the review, conduct, or oversight of human subjects research conducted or supported by HHS. It presents common scenarios for transfer of a previously-approved research project to another institutional review board (IRB) or to a new engaged research institution, and outlines the administrative actions to be considered by IRBs, engaged institution(s), and investigators. In particular, the guidance addresses the following questions:
- What is the regulatory background for research project transfer?
- What actions may apply when the research project remains at the same institution, but responsibility for IRB review is transferred either from an internal to an external IRB, or from an external IRB to another external IRB ?
- What actions may apply when the research project remains at the same institution, but responsibility for IRB review is transferred from one internal to another internal IRB?
- What actions may apply when the research project is transferred to a new engaged institution?
To enhance human subject protections and reduce regulatory burden, OHRP and the Food and Drug Administration (FDA) have been actively working to harmonize the agencies' regulatory requirements and guidance for human subject research.
FDA has simultaneously published in the same issue of the Federal Register notice of the availability of a draft guidance document entitled “Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors, Considerations When Transferring Clinical Investigation Oversight to Another Institutional Review Board” that is similar to OHRP’s draft document.
The Federal Register notice of availability, the draft guidance document, and instructions for how to submit comments can be accessed on the OHRP website at http://www.hhs.gov/ohrp/newsroom/rfc/drafttransfer.html.
The Federal Register’s notice of availability of FDA’s draft guidance document can be accessed at: http://www.gpo.gov/fdsys/pkg/FR-2012-06-12/html/2012-14295.htm, or http://www.gpo.gov/fdsys/pkg/FR-2012-06-12/pdf/2012-14295.pdf.