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Responsible Research: A Systems Approach to Protecting Research Participants
discussed in Chapter 2), possibly complemented by appropriate accreditation standards, could help to avoid or manage such conflicts.
For this reason, disclosure is the cornerstone of financial conflict of interest guidelines and regulations (AAMC, 2001; AAU, 2001; DHHS, 2001a; NBAC, 2001b; NHRPAC, 2001; 42 CFR 50, subpart F; 21 CFR54). Investigators should understand their obligation to disclose potential financial conflicts of interest to the institution, as required by federal regulations.8 The Public Health Service and National Science Foundation require that investigators disclose payments of $10,000 or more and more than 5 percent ownership in any single entity, while FDA requires investigators to report, among other things, payments of $25,000 beyond the cost of research and equity interests valued at more than $50,000 in sponsor companies. Research organizations, and particularly Research ERBs, should be apprised of the potential conflicts of interest of researchers, their staff, spouses, and dependents, before research is approved. As discussed in Chapter 3, conflicts relevant to research with human participants should be communicated to the Research ERB as a component of the protocol review.
At the conclusion of a research study, investigators should have sufficient control of data and publication to ensure that objective information is shared with the public (Blumenthal, 2001; Bodenheimer, 2001; Davidoff et al., 2001;Yamada, 2001). Sponsor input that limits investigator control over research design and data can create a serious conflict that can be precluded by the institution’s role in the approval of contractual agreements.
Payments to the investigator conditioned on particular research results should not be allowed, and payments to investigators for participant enrollment should be allowed only under limited circumstances, according to the American Association of Medical Colleges (2001). Likewise, the American Medical Association states in its ethical code that “offering or accepting payment for referring patients to research studies (finder’s fees) is unethical” (Council on Ethical and Judicial Affairs, AMA, 2000). Some associations, advisory groups, and government agencies have further declared that investigators and staff responsible for the informed consent process, patient selection, monitoring, management, or data analysis should have no financial stake in a trial (ASGT, 2000; DHHS, 2001a; NHRPAC, 2001). This committee agrees that finder’s fees constitute a serious conflict of interest and should not be allowed for anyone directly responsible for enrolling participants and that individuals who have been identified as having a conflict of interest should not be allowed to carry out functions that could be compromised by their conflicting interest. Further consideration is given in Chapter 6 to financial conflict of interest issues.