Announcements for 2010
(December 1, 2010)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 The guidance document finalizes the draft guidance that was made available for public comment through a notice in the Federal Register on November 6, 2009 (74 FR 57487).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. The Federal Register notice announcing the availability of this new guidance document can be found at http://edocket.access.gpo.gov/2010/2010-30198.htm or http://edocket.access.gpo.gov/2010/pdf/2010-30198.pdf.
(December 1, 2010)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 The guidance document finalizes the draft guidance that was made available for public comment through a notice in the Federal Register on November 6, 2009 (74 FR 57486).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. The Federal Register notice announcing the availability of this new guidance document can be found at http://edocket.access.gpo.gov/2010/2010-30201.htm or http://edocket.access.gpo.gov/2010/pdf/2010-30201.pdf.
(October 14, 2010)Revised Frequently Asked Question Regarding Engagement in Research
In the FWA frequently asked questions (FAQs), at http://www.hhs.gov/ohrp/assurances/assurances/index.html, OHRP has revised the answer to Question #4: When is an institution considered to be "engaged in research"? The revisions include:
Adding obtaining informed consent as an activity that can make an institution engaged;
Removing the statement that pertained to awardee institutions bearing the ultimate responsibility for protecting human subjects, even when all human subjects activities are carried out by other institutions; and
Correcting the link at the end of the FAQ to link to the current guidance document.
This FAQ was revised to be consistent with OHRP's October 16, 2008 guidance document on the Engagement of Institutions in Human Subjects Research. Specifically, consistent with OHRP's 2008 engagement guidance document, the FAQ was modified to clarify that an institution is generally considered to be engaged in human subjects research when its employees or agents obtain the informed consent of human subjects. OHRP also removed the statement in the FAQ that pertained to awardee institutions bearing the ultimate responsibility for protecting subjects involved in the research conducted under the award, even when all human subjects activities are carried out by other institutions. OHRP removed this statement to be consistent with OHRP's 2008 engagement guidance, which reflects OHRP's broader goal of directing communication about noncompliance to the institution or IRB most directly involved in any regulatory noncompliance with 45 CFR part 46 as appropriate. For an example of the application of this concept, see OHRP's recent determination letter at http://www.hhs.gov/ohrp/detrm_letrs/YR10/sep10b.pdf.
The revised FAQ answer is:
When is an institution considered to be "engaged in research"?
In general, an institution is considered to be engaged in human subjects research when its employees or agents:
(1) obtain data about living individuals for research purposes through intervention or interaction with them,
(2) obtain individually identifiable private information for research purposes (45 CFR 46.102(d),(f)) http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.102; or
(3) obtain the informed consent of human subjects.
Employees and agents, including students, are individuals performing institutionally designated activities and acting on behalf of the institution or exercising institutional authority or responsibility.
In general, an institution is considered to be engaged in human subjects research whenever it receives a direct HHS award to support such research, even if all of the human subjects activities will be performed by agents or employees of another institution. In general, simply informing potential subjects about a research study is not considered engagement in research. Also, providing written information about a research study, including how to contact the investigators for information and enrollment, and seeking and obtaining prospective subjects' permission for investigators to contact them are not considered engagement in research. However, seeking or obtaining informed consent from a research participant is considered engagement in research.
For details, please see OHRP guidance on this topic at; http://www.hhs.gov/ohrp/policy/engage08.html specifically, Section (B)(4).
(October 4, 2010)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, the following procedures are considered noninvasive:
* Vaginal swabs that do not go beyond the cervical os;
* Rectal swabs that do not go beyond the rectum; and
* Nasal swabs that do not go beyond the nares.
(September 23, 2010)Comments Requested on Proposed Revisions in FWA Documents
OHRP is announcing the availability of the draft revised Federalwide Assurance (FWA) form and Terms of Assurance, and is seeking comment on these draft documents. OHRP is proposing several changes to simplify and shorten the FWA form and Terms of Assurance. Institutions engaged in non-exempt human subjects research conducted or supported the Department of Health and Human Services must hold an OHRP-approved FWA. The draft revised FWA form and Terms of Assurance, when finalized, will supersede the current FWA documents available on the OHRP website at http://www.hhs.gov/ohrp/assurances/assurances/index.htm. The current FWA form has been approved by the Office of Management and Budget for use through May 31, 2011. Links to the draft revised FWA documents and the Federal Register notice announcing the availability of these draft documents can be found on OHRP's website at http://www.hhs.gov/ohrp/newsroom/rfc/com0910rev.html. Instructions for submitting comments are provided on the OHRP website. The Federal Register notice of availability describes key changes in the draft revised FWA documents in comparison to the current FWA documents.
(September 21, 2010)Guidance on 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). 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 v http://www.hhs.gov/ohrp/policy/subjectwithdrawal.html or http://www.hhs.gov/ohrp/policy/subjectwithdrawal.pdf. The Federal Register notice announcing the availability of this new guidance document can be found at http://edocket.access.gpo.gov/2010/2010-23517.htm or http://edocket.access.gpo.gov/2010/pdf/2010-23517.pdf.
(September 3, 2010)Determinations related to allegations regarding dexamethasone use in pregnant women
The Office for Human Research Protections (OHRP) posted on its website OHRP's September 2, 2010 letter of determination along with a U.S. Food and Drug Administration (FDA) memorandum. OHRP received allegations concerning activities conducted by Dr. Maria New at Weill Cornell Medical College and Mount Sinai School of Medicine involving the use of dexamethasone in pregnant women at risk of carrying a female fetus with congenital adrenal hyperplasia.
During OHRP’s review, OHRP had numerous discussions with staff at FDA, and determined that the allegations raised by the complainants are unproven and did not find any evidence that Dr. Maria New violated the Department of Health and Human Services (HHS) regulations for the protection of human research subjects (45 CFR Part 46).
(July 14, 2010)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)."
(June 30, 2010)Agenda & Registration for the OHRP Research Community Forum in Cleveland, Ohio on September 16, 2010
Register NOW for the OHRP Research Community Forum entitled "Building Harmony: Enhancing Human Subject Protections through Coordinated Regulatory Oversight" sponsored by University Hospitals and Case Western Reserve University in Cleveland, Ohio on September 16, 2010.
(May 10, 2010)OHRP Posts Correspondence Regarding Use of Central IRB in Multi-site Research
OHRP has posted on its website OHRP's April 30, 2010 response to a medical center regarding the use of a central IRB, as well as the incoming letter to OHRP. We have chosen to make these letters available since they address an issue that may be of interest to others (see http://www.hhs.gov/ohrp/policy/protocol/cirb20100430.html).
The OHRP letter clarifies that OHRP fully agrees with the Food and Drug Administration's position on the benefits of relying on a single central IRB for multi-center research. In addition, OHRP's letter clarifies that the advance notice of proposed rulemaking on IRB accountability that OHRP issued on March 5, 2009, was proposed to address this issue. Even in the absence of new regulation, the OHRP response also notes that OHRP is taking steps to address institutions' concerns about relying on an IRB external to the institution.
(May 6, 2010)Save-the-Date for the Upcoming OHRP Research Community Forum in Cleveland, OH on September 16, 2010
Save-the-Date for an upcoming OHRP Research Community Forum entitled, "Building Harmony: Enhancing Human Subject Protections Through Coordinated Regulatory Oversight," sponsored by University Hospitals and Case Western Reserve University at Severance Hall, in Cleveland, Ohio on September 16, 2010.
(March 29, 2010)OHRP Posts Revised Set of Frequently Asked Questions and Answers) on IRB Registration
OHRP posted on its website a revised set of Frequently Asked Questions and Answers (FAQs) on Institutional Review Board (IRB) Registration.
These revised FAQs include guidance on the Department of Health and Human Services IRB requirements found in subpart E of 45 CFR 46 that were adopted on July 14, 2009. The use of the word "must" in OHRP guidance means that something is required under HHS regulations at 45 CFR part 46. The use of the word "should" in OHRP guidance means that something is recommended or suggested, but not required. The revised OHRP IRB Registration FAQs can be accessed at: http://answers.hhs.gov/ohrp/categories/1565
(March 16, 2010)Availability of 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://www.youtube.com/watch?v=yp5GzAmXlPM&list=SP5965CB14C2506914&index=6. The second video discusses reviewing and reporting unanticipated problems and adverse events; it can be assessed at: http://www.youtube.com/watch?v=hsUS0k3Ie_g&list=SP5965CB14C2506914&index=8
Each video is approximately 20-25 minutes in length. An institution may reproduce or share these materials for educational purposes and may wish to consider incorporating the materials in their training programs.
OHRP anticipates the release of additional educational videos in the future on a variety of topics including IRB membership, general informed consent requirements, IRB records, and complex issues with research involving vulnerable populations. Additional information on OHRP's educational videos can be found at: http://www.hhs.gov/ohrp/education/index.html.
(February 24, 2010)Research Grant Opportunity
The Department of Health and Human Services has published a Funding Opportunity Announcement (FOA) titled “Research on Integrity in Collaborative Research (R21)”, with the Office for Human Research Protections (OHRP) listed as one of the participating organizations, along with the Office of Research Integrity (ORI) and the National Institutes of Health (NIH). In part, the purpose of this program is described as follows:
“Applications must address the influence of collaborative interactions and/or activities on research integrity in at least one of the following areas that are of particular interest to the ORI and NIH: the clarification of community norms and standards, the effectiveness of self-regulation, the societal, organizational, group, or individual factors that affect integrity in research, both positively and negatively, or the impacts of non-adherence to accepted codes of conduct.”
While OHRP is not participating in funding the opportunities described in the FOA, OHRP supports the importance of this program and the potential for research activities that could shed light on the operation of human research protection programs and how they could be improved. OHRP notes that research activity proposals addressing the areas of particular interest in this program could include investigations of various aspects of collaborative activities related to or including the protection of human subjects in research. OHRP hopes that high quality research proposals of this kind will be submitted for consideration. The opening date is March 7, 2010 (the earliest date an application may be submitted to Grants.gov), the Letters of Intent receipt date is also March 7, 2010, and the Application due date is April 7, 2010. Interested parties should review the announcement, which is available at http://grants.nih.gov/grants/guide/rfa-files/RFA-RR-10-001.html.
(January 29, 2010)FDA Guidance Regarding IRB Continuing Review
The following notice is being sent on behalf of the Food and Drug Administration (FDA):
On January 13, the FDA announced in the Federal Register the availability of a draft guidance entitled, "Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Continuing Review After Clinical Investigation Approval." (http://edocket.access.gpo.gov/2010/2010-426.htm, or http://edocket.access.gpo.gov/2010/pdf/2010-426.pdf)
The draft guidance is intended to assist institutional review boards (IRBs) in carrying out their continuing review responsibility by providing recommendations regarding the criteria, process, and frequency of continuing review to assure the protection of the rights and welfare of subjects in clinical investigations. The draft guidance should also help clinical investigators and sponsors better understand their responsibilities related to continuing review.
Persons with access to the Internet may obtain the document at http://www.regulations.gov, or at http://www.fda.gov/
ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances/default.htm. (If hyperlink does not work because address wraps to next line, copy and paste entire URL in your browser's address window to reach the document.)
Written or electronic comments on the draft guidance should be submitted by March 15, 2010.
(January 11, 2010)Student Pools and Use of Penalties
OHRP has posted on its website a 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 (see http://www.hhs.gov/ohrp/policy/protocol/ohrp20100108.html). 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.
(January 5, 2010)OHRP Archives Two Guidance Documents on Multicenter Clinical Trials
OHRP has moved two guidance documents to its archive of guidance documents no longer in effect. The two documents are “Local IRB Review of Multicenter Clinical Trials” and “Local Institutional Review Board (IRB) Review of Multicenter Clinical Trials Sponsored by the Division of Aids (DAIDS) National Institute of Allergy and Infectious Diseases (NIAID).”
These documents have been archived because OHRP's policy regarding local IRB review has changed and they no longer represent OHRP's policy. OHRP policy continues to be that a reviewing IRB should have knowledge of the local context for studies it reviews, but that review by a local IRB is not favored over review by a non-local IRB.
All archived OHRP documents may be accessed on the OHRP Web site at: http://www.hhs.gov/ohrp/archive/.