As initial training, all researchers, staff and others involved in the design and conduct of research involving human subjects, regardless of the source of funding, if any, (collectively “Key Personnel”), IRB administrative staff and IRB members must complete the following modules of the applicable “Basic” course unless equivalent training, approved under section C below, has been successfully completed:
- “Introduction” (review Belmont report)
- “History and Ethical Principles” under either biomedical modules or social and behavioral modules
- “Informed Consent” under either biomedical modules or social and behavioral modules
- “Basic Institutional Review Board Regulations and Review Process” under the biomedical modules
- “Conflicts of Interest in Research involving Human Subjects” under biomedical modules
- At least 9 other modules of the participant’s choosing. (For IRB members and staff one of these nine modules must be the IRB member module.)
Each module takes approximately 15-20 minutes to complete. Therefore the training requirement will take up to 3 1/2 to 4 1/2 hours to complete.
A passing score of 90% or better is required to complete the course. Participants are expected to go back and repeat the quizzes if a low score is received on any particular module. If an answer is wrong, the correct answer is provided and participants can go back and re-take the quiz.
Institutional Officials (DMH Facility Directors at facilities where human subjects research is conducted and persons approving studies in this capacity for Central Office, Commissioner's Designee, RFMH Managing Director and Deputy Managing Director, and, if applicable, their designees) are required to complete at least the first five modules listed above.