Statement of Practice: PEERRS Certification Requirements

Current certification demonstrating a basic level of human subjects’ protection education is required for certain study team roles before IRBMED Approval or Exempt determination; these roles include:

• Principal Investigator (PI)
• Co-Investigator (Co-I)
• Faculty Advisor
• Study Coordinator/Project Manager
• Research Staff ¹

IMPORTANT: The Michigan Medicine Compliance Office requires any study team member who will be requesting access to medical records to complete PEERRS certification, regardless of the individual’s role in eResearch.

This certification requirement applies to the above study team roles for the following application types:

• New applications (HUMs)
• Amendments (AMEs) adding new staff

Completion of PEERRS is strongly recommended for all individuals participating as a member of a study team. However, Research Staff may be exempted from the certification requirement only if the PI indicates within eResearch that the individual is not required to complete certification.

Acceptable U-M Program for Education and Evaluation in Responsible Research and Scholarship (PEERRS) certifications include:

• “Human Subjects Research Protections” module

Or

•  Human subjects requirement waiver as requested and processed by PEERRS staff, per https://research-compliance.umich.edu/request-peerrs-human-subjects-certification-waiver

It is the responsibility of the PI to enforce appropriate human subjects protection education for other study team roles. IRBMED strongly encourages that all listed study team members maintain current PEERRS certification or equivalent training, particularly those who interact with human subjects and/or obtain identifiable data.

This recommendation is particularly applicable to study team members who obtain:

• Research data through either intervention or interaction with subjects
• Identifiable private information about the subjects

OR

• Informed consent/assent from the subjects

This recommendation does not extend to persons not engaged in human subjects research. Persons not expected to complete certification include, for example, individuals working with either coded specimen examples in the lab or working with deidentified data.

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¹ Research Staff are required to complete certification of IRBMED practice; PIs, Co-Is, Faculty Advisors, and Study Coordinators/Project Managers are required to complete certification under institutional policy.

1. UM Human Research Protection Program (HRPP) Operations Manual (OM), Part 13, Section I https://research-compliance.umich.edu/files/hrppoperationsmanualpdf#page=141
2. PEERRS Home Page https://research-compliance.umich.edu/peerrs-portal/
3. IRBMED Frequently Asked Questions, “What is PEERRS …?” https://research.medicine.umich.edu/our-units/institutional-review-boards-irbmed/frequently-asked-questions-faq