Members of the public who wish to respond to the following questions, should have sent their comments by September 30, 2000 to the addresses below.

1. For each group listed below, what types of financial interests are associated with human subjects research funded or regulated by HHS agencies?

   Clinical investigators (including sponsor/investigators)

   IRB members and staff

   Awardee institutions

2. Is there empirical evidence that informing research participants about financial relationships or financial conflict of interest of the investigator, the institution, or the IRB:

   Can cause or prevent real or perceived harm (physical or psychological) to human research subjects?

   Can compromise the objectivity of the associated research?

   Can adversely or positively affect participation in the trial?

   Can enhance the informed consent process by more fully informing potential participants?

   Can be understood by and is meaningful to the potential research participant?

3. If information about financial interests is disclosed to potential participants in clinical trials, what information should be disclosed and at what level of detail?

   Should potential participants be told of all of the financial interests of investigators, IRB members, or institutions, or only those financial interests which constitute a financial conflict of interest or might constitute a financial conflict of interest?

   Should potential participants be told what protections are in place and are working to ensure that financial conflicts are managed, reduced, or eliminated to promote objectivity and enhance human subject protection in the trial?

   Are the financial limits set forth in current PHS regulations covering awardee institutions still appropriate for clinical researchers?

   What are appropriate levels of reportable financial relationships for IRB members and institutions?

4. If information about financial interests is disclosed to potential participants, when and how should information about financial conflict of interest be provided to them?

   If information about financial interests/conflict of interest involving institutions, IRBs, and investigators should be provided, what is the optimal point in the process for disclosure?

   Should information be provided by the institution, the research investigator, the IRB, or a third party?

   Should disclosure information and institutional policy be provided in the informed consent document or in an entirely separate document?

5. What are appropriate roles for the institution, the IRB, the clinical investigator (including sponsor/investigators), and perhaps other entities in dealing with financial interests or financial conflict of interest?

   What are the responsibilities and obligations of each entity?

   How should each entity relate to the other entities?

   Should disclosed information on which determinations are made (including deliberations) be shared with the other entities? If so, what information should be shared and how and when should the disclosures be conducted?

   What confidentiality protections are/should be in place to safeguard the privacy and confidentiality of the investigator, IRB member, and institution?

6. Other than those at the Federal level, what protections exist to ensure that the financial conflicts are managed, reduced, or eliminated to promote objectivity in the trial and to enhance human subjects protection?

Comments should have been addressed to

Stuart Nightingale, M.D.
Office of the Assistant Secretary for Planning and Evaluation
Hubert H. Humphrey Bldg., Room 447D
200 Independence Ave., S.W.
Washington, D.C. 20201

For more information, please contact coi@osaspe.dhhs.gov

Conference
Top of Page | Agenda | Background Materials | Comments Received | Conference Front Page

Conference Sponsor's Web Sites
U.S. Department of Health and Human Services (HHS) - Office of the Secretary
Assistant Secretary for Planning and Evaluation (ASPE)
National Institutes of Health (NIH)
Centers for Disease Control and Prevention (CDC)
Food and Drug Administration (FDA)

Back to OHRP Home Page

Questions/suggestions about this web page?  Webmaster
Updated July 16, 2001