OHRP Guidance on IRB Approval of Research with Conditions

OHRP has posted on its website a finalized guidance document entitled, “Guidance on IRB Approval of Research with Conditions.” The guidance document provides OHRP’s first formal guidance on this topic. The guidance document finalizes the draft guidance that was made available for public comment through a notice in the Federal Register on November 6, 2009 (74 FR 57486). The public comments submitted on our draft document were very helpful to us as we finalized this guidance document, and we thank those of you who took the time to provide us with your feedback. The finalized guidance document is available on the OHRP website at http://www.hhs.gov/ohrp/policy/conditionalapproval2010.html or URLs http://www.hhs.gov/ohrp/policy/conditionalapproval2010.pdf.

OHRP Guidance on IRB Continuing Review of Research

OHRP has posted on its website a finalized guidance document entitled, “Guidance on IRB Continuing Review of Research.” The guidance document supersedes OHRP’s January 15, 2007 guidance entitled “Guidance on Continuing Review.” The guidance document finalizes the draft guidance that was made available for public comment through a notice in the Federal Register on November 6, 2009 (74 FR 57487). The public comments submitted on our draft document were very helpful to us as we finalized this guidance document, and we thank those of you who took the time to provide us with your feedback. The finalized guidance document is available on the OHRP website at http://www.hhs.gov/ohrp/policy/continuingreview2010.html or http://www.hhs.gov/ohrp/policy/continuingreview2010.pdf.

OHRP News – Clarification of “noninvasive” in expedited review category 3

OHRP has posted a new item of correspondence on its view about the meaning of “noninvasive” as the term is used in expedited review category 3, which is the expedited review category that applies to the prospective collection of biological specimens for research purposes by noninvasive means. OHRP’s statement can be viewed at http://www.hhs.gov/ohrp/policy/correspond/. Specifically, that statement clarifies that OHRP agrees with the Food and Drug Administration’s position that for purposes of expedited review category 3.

OHRP Issues New Guidance of the Withdrawal of Subjects from Research

OHRP has posted on its website a finalized guidance document entitled, “Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues.” The guidance document provides OHRP’s first formal guidance on this topic and finalizes the draft guidance entitled, “Guidance on Important Consideration for When Participation of Human Subjects in Research is Discontinued,” that was made available for public comment through a notice in the Federal Register on December 1, 2008 (73 FR 72804).

CLICK HERE to read the newly issued guidance.

OHRP Videos on YouTube

OHRP is pleased to announce the availability for the first time of educational videos on the HHS YouTube channel. The videos are accessible through the OHRP playlist at http://www.youtube.com/user/USGOVHHS#g/c/5965CB14C2506914 and include “Research Use of Human Biological Specimens and Other Private Information” and “Reviewing and Reporting Unanticipated Problems and Adverse Events,” (both of which premiered and are still available also in RealPlayer format), in addition to two new videos “Institutional Review Board (IRB) Membership” and “General Informed Consent Requirements Parts I (Research Investigator)and II (Research Subject).”

OHRP Educational Videos

OHRP is pleased to announce the availability of two educational videos developed by the Division of Education and Development that provide information on topics regarding the Department of Health and Human Services (HHS) regulations for the protection of human subjects of research described at 45 CFR part 46.

One video discusses research use of human biological specimens and other private information; it can be accessed at: http://videocast.nih.gov/ram/ohrp_kaneshiro.ram.

The second video discusses reviewing and reporting unanticipated problems and adverse events; it can be assessed at: http://videocast.nih.gov/ram/ohrp_carome.ram.

(If a hyperlink does not work because the URL wraps to next line, paste the entire URL into your browser to access the video.)

OHRP Information – Student Subject Pools

Student Subject Pools and Use of Penalties for Students Who Fail to Show up for Scheduled Research Appointments (January 8, 2010)

OHRP has posted its January 8, 2010 letter to a commercial company, which provides a web-based system for managing student subject pools, in the belief that others may find the content to be useful. This letter clarifies that imposing penalty credits on students who fail to show up for scheduled appointments with investigators without cancelling by a specified deadline violates the requirement of Department of Health and Human Services (HHS) regulations at 45 CFR part 46.116(a)(8). Such penalties may not be implemented for non-exempt human subjects research conducted or supported by HHS or for non-federally supported research to which an OHRP-approved Federalwide Assurance (FWA) applies. OHRP’s determination in this matter applies to any system used for managing student subject pools, not just the commercial web-based system referenced in OHRP’s letter.

While the Federal Policy for the Protection of Human Subjects (also known as the Common Rule) has language identical to the provision under HHS regulations at 45 CFR 46.116(a)(8) prohibiting imposition of any penalty if an individual refuses to participate in research and most other federal departments and agencies accept the FWA for the research that they conduct or support, OHRP does not interpret or enforce the human subjects protection regulations for any other federal department or agency. Therefore, OHRP’s determination regarding the use of penalties as a component of student subject pool management systems does not necessarily extend to research conducted or supported by other federal departments and agencies. OHRP recommends that, for research conducted by a federal department or agency other than HHS, institutions using the student subject pool management system referenced in our letter (or similar systems) consult with that department or agency regarding the acceptability of imposing penalties on students.

Finally, OHRP’s letter describes some acceptable alternative approaches for encouraging students to show up for scheduled appointments with investigators without imposing penalties on students who fail to show up.

The links below provide the full text of OHRP’s January 8, 2010 letter. OHRP welcomes comments on the content of this memorandum. Comments on this or other topics may be submitted to OHRP by email at ohrp@hhs.gov. Please include the phrase “January 8, 2010 letter regarding student subject pools” in the subject field. Alternatively, comments may be submitted to:

Office for Human Research Protections
1101 Wootton Parkway, Suite 200
Rockville, MD 20852

Comments received, including any personal information provided, will be made available to the public upon request.

Letter – HTML PDF