Who is considered study personnel on a protocol involving human subjects?
The following information is intended to help researchers determine who is to be included on a protocol involving human subjects. This information is also related to the mandatory training requirement that the University of Massachusetts Amherst has for involvement in human subjects protection.
A person listed as study personnel in the IRB application is an individual who is interacting and/or intervening with human subjects or handles the personally identifiable data of a human subject.
Study personnel that are involved in the informed consent process should also be included on the IRB study personnel list.
All study personnel listed in the IRB application must complete the CITI human subjects protection training. This training is required for all researchers. Every 5 years a refresher course will be required in order to be considered in good standing and have research protocols processed through e-Protocol. Investigators must take either:
Group 1 -Biomedical Research (Researchers collaborating with Baystate should complete all modules to be certified for Baystate Collaborative Studies.);
Group 2 - Social and Behavioral and Educational Research;
Refresher Course for either Group 1 or Group 2.
Addition of new study personnel to an IRB approved protocol will only be approved if the proposed study personnel have completed the required CITI training. Please note that funding agencies may have their own definition of study personnel as it applies to grant or other funding applications.