Human Research Protection

Definition of Key Personnel

The principal investigator (PI) and the instructions share responsibility for ensuring that PIs, co-investigators, and all other personnel (referred to as the "research team members") involved in the conduct of human subjects research fulfill basic educational requirements in compliance with all applicable laws, regulations and institutional policies see Policy IV.03 HRP Training-Researchers.

The University of Cincinnati defines 'research team members' as persons who have direct contact with subjects2, contribute to the research in a substantive way, have contact with subjects' identifiable data or biological samples (e.g., tissue, blood, urine, plasma, saliva), or use subjects' personal information.

Biomedical research example: a nurse who ordinarily works in the clinical context but becomes involved in a research protocol obtaining informed consents and drawing bloods for research would be considered a research team member. A lab technician, narrowly involved on the project, working only with de-identified data would not be research team member. On the other hand, a biostatistician working with identifiable data would be considered a member of the research team.

Social and Behavioral Sciences example: an instructor who ordinarily teaches in the classroom but becomes involved in a research protocol by obtaining informed consents and administering surveys for research would be considered a research team member.  The same teacher who only distributes packets for children to take home and then sets out a box for students to use when returning the forms for the PI to pick up would not be considered a research team member.  A statistician working with identifiable data would be considered a member of the research team.

Because of the variability in research situations, it is impossible for the University of Cincinnati to define precisely every category3 of employee who could be considered to be a member of the research team. Some interpretation by PIs will be needed. The PI is expected to make a good faith effort to meet the spirit of this requirement by assuring that all members of the research team receive education to their role in the project (see the IRB educational requirements at Policy IV.03 HRP Training-Researchers).

For additional information to help you in determining who constitutes your research team and would therefore need to fulfill the educational requirements please refer to the OHRP "Guidance on Engagement of Institutions in Human Subject Research" by accessing the following link:  http://www.hhs.gov/ohrp/policy/engage08.html.

1The information provided here is only intended to assist with the definition of the 'research team member', and is not intended to address issues associated with mentorship or authorship.

2There will be some exceptions. For example, there will be individuals whose primary contact with the subject is in the context of clinical care but who might play a minimal role in the research. An example of this would be a nurse or phlebotomist drawing blood for a clinical purpose and taking an extra sample at the same time for someone else's research project. In this case, provided that someone other than the nurse or phlebotomist administered informed consent and that the nurse/phlebotomist would not be playing any further role in the research, s/he would not be considered a research team member, and no educational requirement would apply.

3Employees who may compose your research team could include research coordinators, nurses, recruiters, dieticians, laboratory technicians, data entry/analysis persons etc.  The employees would need to meet the educational requirement outlined by the University of Cincinnati.

 
Additional Examples:

Mary Smith has a business of doing transcription of whatever dictation / tapes she is paid to do, whether they are doctor office visit dictation, student class notes dictation, or research focus group tapes.  Her usual job is not research related.  She is NOT key personnel, does NOT need to be listed, or have CITI training.

Mary Smith’s job in the Psychology Department is to transcribe tapes from the department’s research studies.  She only does research related dictation, for any studies in the department.  Her job is completely research-related.  She IS key personnel, DOES need to be listed, and have CITI training.

Mary Smith is a student at UC.  The PI knows she is able to do transcription and has asked her to do the transcription for this research study.  She IS key personnel, DOES need to be listed, and have CITI training.