Guidelines for Monitoring the Involvement of Trainees in Research Affected by Conflicts of Interest
These guidelines will generally be followed by monitors who are appointed by the BUMC or CRC Review Committees on Research Conflicts of Interest. The committees may, in any specific decision, modify or amplify the responsibilities of monitors and individuals with a conflict of interest as appropriate to the case.
The committee may appoint a member of the committee, or request the appointment of another faculty member to monitor any situation in which trainees (postdoctoral fellows or students) are involved in research that could be affected by a conflict of interest.
The monitor should be a faculty member who is not participating in the research study and who is not a subordinate of the conflicted investigator. Furthermore, the monitor is an individual whom the trainee(s) would feel comfortable coming to and who is not in a position to oversee the student’s work or to take any adverse actions against the student. The monitor’s role is to be an advocate for the trainee’s interests.
The monitor will be responsible, unless otherwise indicated by the committee, for:
- initiating contact with the trainee
- if possible, speaking with the trainee; otherwise using email
- confirming that the trainee has received a colleague disclosure letter
- offering the trainee an opportunity to meet, answer any questions, and speak about any concerns, at any time
- providing the trainee with his/her contact information, in writing
- informing the trainee that s/he will initiate contact again with the trainee in one year’s time, and that s/he will be available at any time to address any concerns
In addition, if the trainee is a degree candidate, the monitor will, generally, be responsible for working with the dissertation committee chair and addressing the conflict situation.
Individual with a Conflict of Interest
The individual with the conflict of interest will be expected to provide the trainee monitor with all necessary contacts and related information.
The minimum frequency of monitoring contacts will be recommended by the committee as warranted by the circumstances.
The monitor will report to the committee after initial contact, any other significant contact, and any visits with a student’s dissertation committee. These events will be reported on by email messages to the compliance manager, who will place the item on the next meeting agenda for verbal report.
If any concerns arise, these should be brought to the attention of the committee. Concerns could include, for example,
- trainee’s concern that s/he feels that bias is negatively affecting his/her academic program due to the conflict of interest
- the monitor’s assessment that the academic program or independence of the trainee appears to have been compromised by the effects of the conflict of interest, and the reasons for that assessment