1) Formal Coursework on Research Responsibility and Ethics (RRE)
In 6 weeks of the fall term each year beginning in September, the Program in Biomedical Sciences (PIBS) conducts a mini-course on RRE under the direction of Kate Barald, Ph.D. The course is comprised of a series of meetings in which issues in responsibility and ethics are discussed in large and small group meetings. The course utilizes podcasts, panel discussions, and debates conducted by faculty moderators that also discuss case studies as examples of ethic violations. This course is mandatory for all graduate students and post-doctoral trainees at the University of Michigan and is repeated for these trainees every 4 years. This course specifically covers the following areas:
- Fraud, Fabrication, and Plagiarism
- Data Storage and Ownership
- Peer review
- Conflict of Interest
- Human Subjects Research, Informed consent, and IRBs
- Research in the Global Workplace
- Dual use issues
- Animal use and Care
A number of resources are used for this course, including Responsible Conduct of Research by AE Shamoo & David B Resnik (Oxford University Press) and Teaching the Responsible Conduct of Research Through Case Study Approach by SG Korenman and AC Shipp, Eds. Upon completion the trainee is awarded a certificate and the Program documents completion of the training.
2) Online Tutorials and Testing- The Office of Vice President for Research (OVPR) has been enhancing its training opportunities in the responsible conduct of research with the development of a web-based curriculum for faculty, staff, post-doctoral trainees, and students. This initiative is called the Program for the Education and Evaluation in Responsible Research and Scholarship (PEERRS). This web-based foundational instruction and certification program provides a customized curriculum of required, recommended or optional modules for each user according to that individual's research role. This effort was initiated on June 1, 2003 and has continued to expand and is now a requirement for all NIH-funded researchers including T32 or F series fellowship trainees. This is a Campus-wide initiative and covers conflicts and associated potential problems in the research setting and has been approved by the NIH to be qualified as a training vehicle specifically for T32 recipients. It discusses the fundamental responsibilities of authors, issues related to multi-author publications, and the varying publication norms and practices that exist among academic disciplines. The PEERS program is outlined below
Modules Covered in PEERRS
1) Foundations of responsible research conduct (publication/authorship, intellectual property,
conflict of interest, signatures, plagiarism, misconduct reporting)
2) Research Administration (U-M procedures/forms, PI responsibilities, pre- and post-award
activities, federal regulations, important contacts)
3) Conflict of Interest (definitions and recognizing potential conflicts, responsibilities toward
students/colleagues, consulting and conflict of commitment, sponsored project and technology transfer issues)
4) Human Research (basic module covering definition of human subjects research, why is human subjects research regulated, regulatory and ethical responsibilities of the PI, IRB, and University). The basic Human Research module is offered as three tracks, depending on the type of research the PEERRS user is involved in, and which roughly correspond to the three types of IRBs on the UM campus. The three tracks are:
◦ biomedical sciences
◦ health sciences
◦ social and behavioral sciences
5) Animal Research (principles and regulations for animal care and use, regulatory and ethical
obligations of investigators, reporting requirements, obtaining approval)
Plans for Instruction:
Each module consists of 20-30 web pages containing the core material, short case studies with questions, and pop-ups with additional information to provide greater depth and elaboration. At the end of each module a compiled list of module resources is provided.
Certification- PEERRS certification (valid for three years) is based on passing a short test associated with each topic with a score of 80% or better. The Human Subjects modules require a score of 100% to pass.