As of June 2011, the requirement for completion of Investigator Disclosure Forms was extended to any member of the study staff responsible for the design, conduct, or reporting of the research.
Any individuals who conduct the following activities:
- Designing or directing research
- Serving as the principal investigator, co-investigator, or sub-investigator
- Enrolling research subjects (including obtaining human subjects' informed consent, if applicable)
- Making decisions related to eligibility to research subjects' enrollment in research
- Analyzing or reporting research data
- Submitting manuscripts concerning the research for publication as a primary author or co-author
- In addition to the above, if the protocol is funded under a grant on which there are other individuals listed as key personnel or as other significant contributors, those individuals must also submit a disclosure form, as must all other individuals who you have determined to play any role in conducting the research such that they reasonably could be expected to influence its outcome.