Data from annual audits of the Institutional Review Board and questions from learners of prior Institutional Review Board series suggest that gaps in knowledge persist, which lead to a decreased quality in the review of human subject research. These gaps include the difficulty in balancing the risks and benefits to subjects of research, the potential for limited interaction between the research community and those who provide research oversight, and the potential for learners to overlook important aspects of specific human subject research projects. This activity is designed to address that gap in quality by providing standardized education with the aim of achieving the highest quality in conduct and oversight of human subject research and encouraging collaboration between the research community and learners.
Regulatory and ethical responsibilities for conducting and reviewing human subject research will be presented to learners, and learners are expected to turn this information into applicable knowledge to be used when reviewing human subject research projects. Through the quality of reviews and the number of questions received by the HRPP from reviewers, it will be assessed whether or not learners turned the information into knowledge. Also, audits by MCW’s Corporate Compliance, audits by the FDA, and audits by AAHRPP will help determine how well learners grasped the concepts.
Learners will be instructed of the differences between clinical and research activities as well as the regulatory and institutional oversight requirements for type of each activity. With this information, learners should be able to properly distinguish between clinical activities and research activities, which will aid them in understanding and carrying out their responsibilities for oversight of each activity. The comprehension of this objective will be assessed through review of the documentation provided by learners for each activity and the discussions that arise throughout the activity.
Learners will be provided with various resources that aid in the interpretation of policies and regulations and the application of ethical principles to human research subject protections. It is hoped that learners will use these resources to assist them in review of human subject research projects. Through discussions and feedback in surveys for this activity, the degree to which learners utilize these resources to carry out their responsibilities will be assessed.
Researchers and clinicians who serve as Institutional Review Board members.
Participants who engage in this educational intervention will be able to:
- Incorporate regulatory and ethical responsibilities into conducting and reviewing human subject research
- Differentiate between clinical and research activities as well as the regulatory and institutional oversight requirements for type of each activity
- Interpret policies and regulations and apply ethical principles to human research subject protections
Mary Eapen, MRCPI, MS, MBBS
Professor, Department of Medicine/Division of Hematology and Oncology
In accordance with the ACCME® Standards for Commercial Support Six, all in control of content must disclose any relevant financial relationships. The following in control of content had no relevant financial relationships to disclose.
- Mary Eapen, MD
- Sara Griffin
In accordance with the ACCME® Standards for Commercial Support Six, all in control of content must disclose any relevant financial relationships. These relationships were reviewed via the MCW conflict of interest resolution process and resolved.
The Medical College of Wisconsin is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians
Designation of Credit Statement
The Medical College of Wisconsin designates this live activity for a maximum of 2.0 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity
Hours of Participation for Allied Health Professionals
The Medical College of Wisconsin designates this activity for up to 2.0 hours of participation for continuing education for allied health professionals.
- 2.00 AMA PRA Category 1 Credit(s)™AMA PRA Category 1 Credit(s)™
- 2.00 Hours of ParticipationHours of Participation credit.