PEERRS: Human Subjects Research Protections Course Details

Other U-M offices may check PEERRS certification status as part of audit or misconduct investigations, including: University Audits, the Office of Research Compliance Review (ORCR), and the OVPR Research Integrity program.  School/colleges may check student and trainee certification status if utilizing PEERRS courses as a part of their unit-based Responsible Conduct of Research curriculum. 

Yes. It is not a requirement to hold PEERRS certification prior to sumbmitting a research transaction (e.g., PAF, HUM, TCP) for review by a U-M central office (e.g., ORSP, IRB Offices).  However, the required training must be completed before that transaction can be awarded or approved.

Yes, if you are engaged (i.e., interacting with the participants and/or their identifiable data) on a U-M human research study you may need to complete the PEERRS Human Subjects Research Protections (HSP) course or show proof of equivalent training.

  At U-M, HSP training is tracked only for those non-UM investigators who qualify to be listed on the IRB application; otherwise training requirements and oversight are handled by the investigator's local IRB.

If you have completed an equivalent human subjects protections training course (e.g., CITI) at your institution within the past three years, submit the training certificate to PEERRS to obtain a training waiver.  See Request a PEERRS Human Subjects Training Waiver for instructions.  

If you have not completed an equivalent training course:

1. Establish a U-M Friend Account using your current email address at:   https://friend.weblogin.umich.edu/friend/.  This email address will be your Login ID for PEERRS/My LINC.
2. Request PEERRS access.  See the PEERRS Access Request Form for instructions.
3. Upon confirmation that PEERRS access has been granted, select the Human Subjects Research Protections course from the PEERRS Portal and log into My LINC to complete the course.

For your PEERRS credit to display in the U-M IRB application (HUM), the email address used as your U-M Friend Account Login ID and the email address associated with you in the IRB application must be the same.

Yes, but only for human subjects protections regulatory training.  One commonly accepted equivalent is the basic or refresher courses for either biomedical or social-behavioral human subjects protections from the Collaborative Institutional Training Initiative (CITI).

The equivalent training must have been completed within the past 3 years and cover content similar to PEERRS content.  Certifications from CITI must include the following, at a minimum:

U-M may accept another (non-CITI) course as a human subjects protections training equivalent upon ad-hoc review.  

To request a waiver for equivalent training, submit a certificate showing the course completion date and a list of course topics through the Request a PEERRS Human Subjects Certification Waiver form.

No.  Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical research that involves human participants in research.  A sponsor (e.g., National Institutes of Health) may require that research involving a clinical trial and/or utilizing an FDA-approved protocol follow the International Conference on Harmonization (ICH) Good Clinical Practice guidelines, including ICH-GCP training for investigators.  The biomedical version of GCP focuses on FDA requirements and the application of the informed consent processes for clinical research.  The social-behavioral version of GCP training focuses on the informed consent process for clinical research.

GCP training is not offered through PEERRS.  For U-M GCP training options, see:  HRPP Education Resources.

Human Subjects Protections (HSP) training focuses on the U.S. Common Rule regulations and requirements, including the ethical principles associated with protecting the human particpants in research and the codified protection methods such as Institutional Review Board (IRB) oversight and criteria for an appropriate informed consent process.  HSP training is required by federal sponsors for human subjects research, including research that qualifies for an IRB exemption.

No.  If within the past 3 years you've completed a CITI human subjects protections basic course (biomedical or social-behavioral) or a CITI human subjects refresher course, you should submit a training waiver request to obtain credit for the U-M course.  As part of the waiver request, upload a copy of the CITI completion report that lists the course modules and the completion date for each. 

Provide the sponsor/institution with copy of the PEERRS HSP course outline comparing U-M course content to CITI's content to see if that satisfies their requirement.