Protecting Research and Research Participants

Sponsors of a clinical trial should be forthright in responding to requests for information about financial or other interests of investigators that may create a conflict or appearance of a conflict in conducting research.

Investigators should disclose to participants that they are compensated for conducting clinical trials. Payments to investigators and research institutions should not be contingent on the research outcome.

Sponsors should not reward investigators or research institutions that obtain data, recruit or enroll research participants without adhering to the IRB-approved protocol establishing acceptable risks to research participants.

Investigators and sponsors should support a reviewing IRB's determination that an interest of an investigator or research institution presents a conflict of interest, and its recommendation for dealing with the conflict, whether the interest is

1. Disqualifying,
2. Is one of the risks that should be disclosed to research participants during the informed consent process, or
3. Is an interest that can be managed by the IRB through research process and oversight.

Protecting The Contributions Of Investigators And Sponsors Requires Fairness And Foresight

1. Investigators conducting clinical trials for marketing and approval cannot be compensated by sponsors with equity interests.
2. Subject to arrangements for protecting participants from conflicts of interest in the conduct of a research protocol, individual scientists should be allowed to hold equity interests, directly or indirectly, in companies that sponsor or invest in research protocols. These interests should be fully disclosed to the IRB.
3. Sponsors should be forthcoming in disclosing results that are of material significance for the health and health care of individuals.
4. Subject to the rights of research participants to be free of unwanted publicity or interference, consents, authorizations and rights in research data shall be designed to assure investigators and sponsors the maximum value of their contributions for future research and analysis.