Update (03/31/2014)
The full version of The Research Clinic is now available at
http://ori.hhs.gov/TheResearchClinic
Office of Research Integrity (ORI) and the Office for Human Research Protections (OHRP) will release a web-based, interactive training video entitled The Research Clinic. The video aims to educate clinical and social researchers and their staffs on the importance of appropriately protecting research subjects and avoiding research misconduct. The Research Clinic is expected to be released on March 28th and will be available free of charge on the ORI website and the OHRP website.
Each year, research institutions report to OHRP up to 400 incidents of serious non-compliance with the regulations for protecting research subjects. These incidents include enrolling ineligible subjects who may be harmed by research interventions, failing to obtain or appropriately document informed consent, and conducting research without IRB review and approval.
The Research Clinic allows the viewer to assume the role of one of four characters and determines the outcome of the storyline by selecting decision-making choices for each “playable” character. The four characters include a clinical research coordinator (CRC), a principal investigator (PI), an IRB Chair, and a research assistant. The CRC is an overworked nurse who works for a PI who routinely violates IRB protocol. The PI is a caring oncologist who must strike a balance between doing what he thinks is best for his patients and doing what is best for his research. New to the job, the IRB Chair must make changes to the IRB while dealing with resistive hospital administrators and PIs. Finally, a young research assistant is part of a social science study and encounters difficulty with obtaining informed consent and following research protocols.
In 2011, ORI released a similar product on biomedical research entitled The Lab: Avoiding Research Misconduct (http://ori.hhs.gov/TheLab). Since its release, The Lab has been viewed over 50,000 times and has been integrated in the research training programs at many universities and research institutions. ORI and OHRP anticipates The Research Clinic to have the same success with research hospitals and other clinical research organizations.
