A Principal Investigator may be the primary expert in knowing the scientific background and procedures of a protocol; however, there are also regulatory and ethical issues to be aware of.

These domains are the expertise and the primary perspective provided by Regulatory Knowledge and Support, and may have operational implications that pertain to inclusion/exclusion criteria, identification and recruitment of human subjects, the consent process and document, and study monitoring.

Data and safety monitoring plans help outline processes that promote safe study conduct.

Consultation for developing and drafting Data Safety and Monitoring Plans (DSMP), establishing and operating Data and Safety Monitoring Boards (DSMB), and assistance with accessing and modified DSMP templates are available.

In 2001 the National Institutes of Health formally implemented a Research Subject Advocacy (RSA) program through its network of general clinical research centers. 

The RSA program at Ohio State exists for all studies that utilize the services of the Clinical Research Center. Research Subject Advocates are also available upon request for consultation or to serve in such capacity at the discretion of either an Ohio State IRB, the study sponsor, or the Principal Investigator of a study.

The Senate Advisory Committee for Human Research Protection recommends the use of an independent party (e.g. RSA) during the process of consent for high-risk studies.

Contact April Green with any questions.

The Institutional Review Board (IRB) review process is often times perceived as the primary rate-limiting step to conducting clinical and translational research. Regulatory Knowledge and Support consultation may be able to shorten the time to approval with its experience and particular regulatory and ethics perspective.

Clinical research coordinators and investigators can request a consult for BUCK-IRB submission training and associated concerns.

This service is complementary to the assistance provided by the University’s Office of Responsible Research Practices (ORRP) and to the University’s overall Human Research Protection Program.

The overall objective of an ethics consultation is to enhance the quality of the project for IRB and/or sponsor submission. Ethics consultation is encouraged in the early stages of protocol development.

Ethics consultations are focused on but not limited to study design, selection of subjects, recruitment, informed consent, and safety monitoring. The overall objective is to enhance the quality of the project for IRB and/or sponsor submission.