University of Southern California (USC) Health Sciences Institutional Review Board (HSIRB) Public Meeting Minutes / HSIRB 1 and 2
The list above is not complete: earlier USC Health Sciences Institutional Review Board (HSIRB) Public Meeting Minutes can be retrieved by selecting the link with the earliest date(s) from the entries above and from that set of minutes, selecting the link to the previous meeting.
What follows are examples of IRB minutes previously disclosed to the public by the Office for Human Research Protection or in the course of civil litigation. Generally speaking, these are high quality examples of what's supposed to be documented in IRB minutes in terms of study protocol, personnel, substantive discussion of proposed research, and resolution of controverted issues. They are unrepresentative to the extent that they are extracts focused on the initial review of specific studies. Generally speaking IRB meeting minutes also include correspondence, consent forms, protocols approved by expedited review and continuing review,
including annual review and re-approval of studies and compliance and oversight actions as necessary. We hope to add more representative examples to this collection in the future.
Effects of a Single Dose of Dextroamphetamine in Attention Deficit Hyperactivity Disorder: A Functional Magnetic Resonance Study.Available from http://www.hhs.gov/ohrp/panels/jreview01/min102803.pdf
Effects of a Single Dose of Dextroamphetamine in Attention Deficit Hyperactivity Disorder: A Functional Magnetic Resonance Study.Available from http://www.hhs.gov/ohrp/panels/jreview01/min110403.pdf
Effects of a Single Dose of Dextroamphetamine in Attention Deficit Hyperactivity Disorder: A Functional Magnetic Resonance Study.Available from http://www.hhs.gov/ohrp/panels/jreview01/min012704.pdf
Alcohol, Sleep and Circadian Rhythms in Young Humans, Study 2 – Effects of Evening Ingestion of Alcohol on Sleep, Circadian Phase, and Performance as a Function of Parental History of Alcohol Abuse/Dependence.Available from http://www.hhs.gov/ohrp/children/407-01pnl/rihreview.pdf
A Multicenter, Randomized Dose Response Study of the Safety, Clinical and Immune Responses of Dryvax Administered to Children 2 to 5 Years of Age.Available from http://www.hhs.gov/ohrp/dpanel/uclairb.pdf
A Multicenter, Randomized Dose Response Study of the Safety, Clinical and Immune Responses of Dryvax Administered to Children 2 to 5 Years of Age.Available from http://www.hhs.gov/ohrp/dpanel/min716.pdf
A Multicenter, Randomized Dose Response Study of the Safety, Clinical and Immune Responses of Dryvax Administered to Children 2 to 5 Years of Age.Available from http://www.hhs.gov/ohrp/dpanel/min730.pdf
Sleep Mechanisms in Children: Role of Metabolism.Available from http://www.hhs.gov/ohrp/panels/407-03pnl/irbdel.pdf
Prevention of GVHD by Deletion in vitro of Donor T-Cells with Monoclonal Antibody and Complement.Available from http://www.sskrplaw.com/gene/wright/d1_6.pdf. (Courtesy of SSKR & P, Attorneys At Law.
The following are examples of IRB minutes of the Great Lakes College of Clinical Medicine IRB. On 2000-03-09, based on objectionable conditions observed during inspection, FDA suspended the IRB's authority to approve new studies or enroll new subjects in research subject to FDA regulation. IRB inspection revealed deficiencies in IRB meeting minutes including failure to identify studies under discussion, failure to document required changes, failure to document that required changes were incorporated into protocols and informed consents prior to initiation of research, failure to document IRB determination of significant or non-significant risk status in device studies, and poor documentation practices in general. (1) While the IRB meeting minutes that follow are not the meeting minutes described in the FDA warning letter of 2000-03-09 to Great Lakes College of Clinical Medicine IRB, they may provide a basis of comparison.
Research involving human subjects funded by the federal government must comply with 45 CFR 46, The Common Rule; human studies testing products subject to FDA regulation must comply with 21 CFR 50, 54, 56, 312, and 812.
In simple terms, 45 CFR 46 requires that:
Minutes of IRB meetings must be kept in sufficient detail to record the following information: attendance at each meeting; actions taken by the IRB; the vote on actions taken (including the number of members voting for, against, and abstaining); the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution. (2)
Relevant OHRP guidance and regulation:
For proposed research subject to FDA regulation, 21 CFR 56.115(a)[2] requires that:
Minutes of IRB meetings which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution. (3)
While it might seem like a simple matter for IRBs to create and maintain meeting minutes as required by FDA and OHRP, available evidence seems to indicate IRBs often fail to do so. A recent survey of 52 FDA warning letters issued to IRBs between 1997 and 2004 identified 47 warning letters citing IRB failure to prepare and maintain adequate documentation of IRB activities. (4) Conspicuous failure to document IRB activity has also figured in the handful of situations in which OHRP suspended Federal Wide Assurances or Multiple Policy Assurances at major academic research institutions. (5)
Maryland Code, Title 13 – Miscellaneous Health Care Program, Subtitle 20 – Human Subject Research, provides members of the public with the opportunity to examine meeting minutes from institutional review boards in that state.
§ 13-2003. Institutional review board minutes.
(a) Availability. – An institutional review board shall make the final minutes of a meeting available for inspection within 30 days of receipt of a request for the minutes from any person.
(b) Redaction of confidential or privileged information. – Prior to making the minutes of a meeting available for inspection under subsection (a) of this section, an institutional review board may redact confidential or privileged information.
(c) Minutes not public records. – The minutes of a meeting of an institutional review board are not public records under Title 10, Subtitle 6 of the State Government Article.
[2002, ch. 552.]Source: Maryland Code Online (Michie-Lexis) accessed on 2004-01-09 from http://198.187.128.12/maryland/lpext.dll?f=templates&fn=fs-main.htm&2.0
Information and contacts for requests to examine meeting minutes of Johns Hopkins University institutional review boards: Johns Hopkins University Organization Policy on Maryland State Law Requirements: Maryland House Bill No. 917 (Hubbard Act) (Policy No. SL1). 2005-05-31. Available from http://irb.jhmi.edu/Policies/SL1.html
University of Maryland Institutional Review Board / Home Page. Available from http://www.umresearch.umd.edu/IRB/index.htm
Format for NIH IRB Meeting Minutes. National Institutes of Health. Available from http://www.nihtraining.com/ohsrsite/info/minutes.html
NCQA IRB Meeting Checklist. Available from http://www1.va.gov/resdev/programs/pride/training/docs/ACE-irb-minutes.doc
Hellman S, Cassel C, Stock C, Wood A, Zapol W. Report of Johns Hopkins University External Review Committee. 2001-08-01. [NB IRB work load.] Available from http://www.hopkinsmedicine.org/external.pdf
Notes
1. Masiello SA. FDA Warning Letter to Great Lakes College of Clinical Medicine Institutional Review Board and L. Terry Chappell, M.D. 2000-03-09, p.12. Available from http://www.circare.org/foia2/fda_glccm20000309.pdf
2. IRB Guidebook. Ch. 1, Institutional Administration.
Office for Human Research Protections. Accessed 2005-03-09 from http://www.hhs.gov/ohrp/irb/irb_chapter1.htm#c5
3. 21 CFR 56.115(a)[2] IRB Records. Applicable FDA regulations are conveniently linked on the CIRCARE web site at http://www.circare.org/info5.htm
4. Bramstedt KA, Kassimatis K. A study of warning letters issued to institutional review boards by the United States Food and Drug Administration. Clin Invest Med. 2004;27(6):316-23. Available from http://www.cma.ca/multimedia/staticContent/HTML/N0/l2/cim/vol-27/issue-6/pdf/pg316.pdf. Accessibility verified on 2006-06-22.
An alphabetized list of FDA warning letters issued to IRBs is available on the CIRCARE web site at http://www.circare.org/FOIA/irblast.htm
5. Steinbrook R. Protecting Research Subjects — The Crisis at Johns Hopkins. N Engl J Med. 2002;346:716-720, Table 1, Suspensions of Federally Supported Research
for a list of institutions. Available from http://content.nejm.org/cgi/content/full/346/9/716. Accessibility verified on 2005-03-09.
FDA suspensions of IRB authority:
Last Updated: 2006-06-23
If you find the information on this page helpful, please support CIRCARE with a tax-deductible contribution today. Because CIRCARE doesn't accept funds from pharmaceutical or medical device manufacturers, we depend on contributions from individuals like you to help us advocate for meaningful protection of human subjects in research. Donating on-line with PayPal is quick and easy. Find out more on our Support page.
All material on this site © CIRCARE Incorporated (2002- ) or as indicated. Single copies can be downloaded for personal education. Adobe® Reader :: ::
