Stony Brook University Office of Research Services
Office of Research Compliance : IRB Update : June 2010

In this update:


I. AAHRPP Site Visit Update: Done!
II. Educational tidbits, strengthened during our site visit preparation
III. Webinar on Overcoming Barriers to Recruitment and Retention of Minority Populations...Interested?

I. AAHRPP Site Visit Update: Done!

I know you are all wondering who was lucky enough to be chosen by the Association for the Accreditation of Human Research Protection Program (AAHRPP) to be interviewed at our site visit last week. Well, wonder no more. Here are the names of the dedicated professionals who did a stellar job representing the high quality of our human research protection program. Next time you see one of these folks, please feel free to pat them on the back for a job incredibly well done:

Jonathan Buscaglia, Sharon Nachman, Luis Gruberg, Patricia Coyle, Henry Woo, Leonie Huddy, Shanthy Sridhar, Marijean Buhse, Andrzej Kudelka, Marie Marino, Bob Marmo, Betsy Baron, Michael Wade, Omar Gould (BNL), Leigh Gentilcore, Ivar Strand, Lydia Chabza,Clinton Rubin, Peter Stephens, Nancy Daneau, Margaret Parker, Margaret Mcgovern, Todd Rosengart, Annie Laurie Shroyer, Patricia Pugliani, Ruth Tenzler, Laura Bertolotti, Joan Kavanaugh, Erin Infanzon, Denise Ferraro, Patricia Hentschel, Jeannene Strianse, Wayne Patterson, Harold Carlson, Michael Pearl, Robert Parker, Lauren Krupp, Gene-Jack Wang (BNL), Hal Skopicki, Marie Gelato, Abdool Samad, Laura Wessels, Mary O'Neill, Arthur Samuel, Susan Brennan, Darcy Mallon (BNL), Susan Blum, Ronnie McKinnon, Mark Sedler, Gregory Garra, Christopher Cutler.

THANKS TO EACH AND EVERY ONE OF YOU. We will receive the formal determination of our accreditation status following the AAHRPP Council Meeting in September:

II. Educational tidbits, strengthened during our site visit preparation

  1. It's AAHRPP, not AA-IRBs
    The accreditation process doesn't assess our IRBs. It assesses our human research protection program (HRPP). Look at the names of the people above above and see all the different facets of our program they represent. Maintaining a quality HRPP is a shared responsibility…made up of many components that interact with each other … IRB, Office of Research Compliance (ORC), Department Chairs, Investigators, Study Coordinators, Sponsored Programs, Legal Counsel, Office of Clinical Trials, GCRC, Pharmacy, Institutional COI Committee, BNL. If you are reading this e-mail, you are also part of the program.

    How do all these components communicate? Many ways…some examples:

    • Through the IRB application process (IRBNet allows for electronic access, and sends regular reports to many components of the program to ‘do their HRPP thing’, i.e., study team, sponsored programs, BNL, University Hospital components-Pharmacy-IT-Pathology-finance, GCRC , OCT)
    • Through the Grant process (checks and balances to ensure compliance across the grant, the IRB submission, the institutional requirements etc.)
    • Through the ORC: Representation on the COI committee, the GCRC Advisory Committee, communication with Sponsored Programs, BNL, etc.
    • IRB Minutes get disseminated to Institutional Officials, Pharmacy, BNL.
  1. We operate under many Federal Regulations:
    • OHRP (DHHS) –ALL non-exempt research: 45 CFR- 46 Subpart A
      And additional Subparts for specific protection of Pregnant Women, Fetuses, Prisoners, Minors
    • FDA (DHHS)-for research involving drugs, biologics, devices
    • DOE: (for DOE-funded studies, all BNL)
    • DOD: (for DOD-funded Studies—Navy, Army, Air Force)
    • ICH-Good Clinical Practice: For clinical trials from sponsors that require it.


  2. We operate under SBU’s Standard Operating Procedures:
    http://www.stonybrook.edu/research/orc/humans/HSG.shtml


  3. Conflict of Interest can be financial…covered by university financial disclosures to the IRB and to the Institutional COI committee and can also be non-financial (what might affect your objectivity in doing the research? e.g., relationships, desire for tenure, nobel prize). This type of COI is not governed by a policy or process, but expects that you are aware of it, and act ethically accordingly.


  4. Privacy vs. Confidentiality
    We know about confidentiality. We maintain subject confidentiality by coding, keeping data in a secured limited access location, etc.

    We also know about the Privacy Law, HIPAA, governing the ability of an individual to control access to their (private) identifiable health data.

    But privacy is also about how you interact with, or recruit the subject. How are you approaching people for participation? Are you protecting their right to privacy? You should pay attention to this concept in drafting your protocol, and in subsequently answering questions in the IRB application.


  5. Risk is the magnitude and likelihood of harm (physical, psychological, breach of confidentiality etc.)
    So…Let's say one of the side effects that can happen in a study is that the subject may have an allergic reaction to the study medication. The allergic reaction is a harm. But it doesn’t tell you the risk. What is the probability of the allergic reaction (common, rare etc) and what is the magnitude of the reaction (a minor skin rash? anaphylactic shock)? Both pieces of information provide the RISK of that harm.


  6. What are you required to report to the IRB once your study is approved? UNANTICIPATED PROBLEMS (UPs). NOT ADVERSE EVENTS . UNANTICIPATED PROBLEMS (UPs) are:
    • unexpected,
    • related to the research, and
    • increase risk to the subject or others

Go here for a full discussion, per our SOPs: https://web.stonybrook.edu/research/humans-sop/Shared%20Documents/Section08.aspx

  1. CONSENT IS A PROCESS, NOT A FORM.
    For more on this amazingly important concept, go to our SOPs: https://web.stonybrook.edu/research/humans-sop/Shared%20Documents/Section05.aspx

III. Webinar on Overcoming Barriers to Recruitment and Retention of Minority Populations

If you are interested, let me know (jmatuk@notes.cc.sunysb.edu)...Location to be determined.

Strengthen your knowledge of the history and future of minority participation in research... Register now!
Distrust, Race, and Research: Overcoming Barriers to Recruitment and Retention of Minority Populations is a 90-minute webinar to be held on Wednesday, July 14, 2010, at 1:00 PM ET. 

During this webinar, you'll learn about...

  • The National Bioethics Research Infrastructure Initiative: Building Trust Between Minorities and Researchers;
  • Selected cases of research abuse involving racial and ethnic minority populations;
  • Background and context of the U.S. Public Health Service Syphilis Study at Tuskegee, the subsequent presidential apology, and NIH supported research initiatives designed to repair the damage caused by this study;
  • Preliminary data from a qualitative study of investigators, as well as survey data from institutional review board (IRB) members, IRB staff, and researchers; and
  • A new conceptual model of the research continuum that serves as a viable framework for designing, implementing, and evaluating measures that aim to overcome barriers to minority recruitment.

Faculty:

Stephen B. Thomas, PhD
Inaugural Philip Hallen Professor of Community Health and Social Justice,
Associate Dean for Diversity
Graduate School of Public Health
University of Pittsburgh

 

Sandra Crouse Quinn, PhD
Associate Dean for Student Affairs and Education,
Director of the Peace Corps Master’s International Program,
Associate Professor
Graduate School of Public Health
University of Pittsburgh