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.