Faculty Handbook

32. Faculty Research

32.5. Investigator's Responsibilities

1. Investigators must receive education on the ethical conduct of human research and provide documentation of such education at the time that their proposed research is submitted to the Board. Information about on-line and other sources of education is available from the Institutional Review Board Office or the web site: https://www.citiprogram.org/

2. Investigators must be qualified to perform the proposed research and must obtain Board approval before beginning the research.

3. Investigators must disclose all conflicts of interest and must develop a management plan for any conflicts relevant to the proposed research.

4. Investigators must obtain informed consent in the manner approved by the Board.

5. Investigators must keep records of numbers of subjects studied and any adverse reactions.

6. Investigators must monitor subjects for and immediately (within 3 calendar days) report adverse reactions, injuries, breaches in confidentiality or detrimental effects to the Board.  If an adverse reaction occurs, the research should be discontinued until the Institutional Review Board has been informed and has given approval to continue the research.

7. Investigators must report any proposed changes in the experimental protocol to the Board and obtain re-approval before instituting the changes in the experimental design.