§10.09
Human Subjects Conflict of Interest

 


Links updated 05/11

  1. General
  2. Human Subjects Research
  3. Summary of Forms

A.  GENERAL

In the protection of human subjects at Lawrence Berkeley National Laboratory (LBNL), “conflict of interest in research” refers to situations in which financial or other personal considerations may compromise, or have the appearance of compromising, a researcher’s professional judgment in conducting or reporting research so as to adversely affect the rights and welfare of subjects. Additionally, a conflict of interest in research depends on the situation, and not on the actions or character of an individual investigator.

The U.S. Department of Health and Human Services, from which LBNL holds its approval to conduct research involving human subjects, has issued Financial Relationships and Interests in Research Involving Human Subjects:  Guidance for Human Subjects Protection which can be found at: http://www.hhs.gov/ohrp/policy/fguid.pdf.

B. HUMAN SUBJECTS RESEARCH

At LBNL, all protocol applications for research involving human subjects must be submitted to and approved by the LBNL Human Subjects Committee (HSC), which is the LBNL Institutional Review Board. The Human and Animal Regulatory Committees (HARC) Office provides support for HSC.

For all protocol applications submitted to HSC (except exemptions or “not human use” determinations for pre-existing tissue), the Protocol Lead Investigator must:

Review and Approval of the Disclosure of Financial Interest Form
When there is a positive disclosure, the HARC Office will forward the protocol application and disclosure forms to RIIO for COI review. Should RIIO need additional information, RIIO will contact the individuals filing the disclosure. RIIO will inform the HARC Office, the individual filing the disclosure, and the Protocol Lead Investigator of the outcome. The Human Subjects Committee will proceed with its review while RIIO is completing the COI review, but final approval of the human subjects research protocol, amendment, or renewal will be withheld until RIIO has completed its review.

C.  SUMMARY OF FORMS

Printed . The official or current version is located in the online LBNL Requirements and Policies Manual.
Printed or electronically transmitted copies are not official. Users are responsible for working with the latest approved revision.

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