PEERRS: Human Subjects Research Protections Course Details

The PEERRS Human Subjects Research Protections (HSP) course defines human subjects research, identifies the federal regulations that govern the research activity, explains why compliance with the regulations is important, and provides information on the common methods used to apply these regulations, including: risk evaluation, study population considerations, informed consent, and IRB review processes.

HSP Course Requirements

Who should take this course?

University of Michigan faculty, students, or staff working on a U-M human research study in which they will interact with the human participants and/or the participants’ identifiable data (i.e., are engaged on the project) are required to complete the PEERRS HSP course or submit proof of an acceptable equivalent. Typically, engaged personnel are listed on the U-M IRB application (HUM) in the following roles:

Principal Investigator (PI)
Co-Investigator
Faculty Advisor
Study Coordinator
Research Staff
Biostatistician (when working with identifiable data)

Non-UM investigators collaborating as engaged personnel on a U-M human research study, if their organization does not have their own institutional HSP training.
Note: the Common Rule<< indicates that training requirements for cooperative (i.e., “multi-site”)<< human research studies are overseen by the investigator’s local IRB. Non-UM investigators who elect to take the U-M course must first request access to PEERRS.
U-M students may be asked to take the PEERRS HSP course for educational purposes, either as part of an academic class or as a pre-requisite for broader school- or college-based responsible conduct of research and scholarship (RCRS) education.

ADA version available upon request

The PEERRS Human Subjects Research Protections course contains visual / interactive elements that may be difficult to use with a screen reader. If you need an alternative option due to visual impairment or other ADA-compliance reasons, email [email protected].

Already completed CITI HSP training?

Apply for a PEERRS training waiver (i.e., course credit) instead of duplicating training.

How much time will it take?

Expect to spend 2 – 4 hours completing the course. The course has five modules with a scored assessment at the end of the course. To receive certification for the course, you must review all of the course pages and pass the assessment with a score of 85%.

Do I need to renew certification in this course?

Certifications are required every three years if you are actively working on a U-M human research study. The My LINC system sends two automated notification emails, one 30 days prior to course expiration and one on the expiration date. These are notifications of expiration only – the PEERRS group expects you to determine whether or not you need to renew certification based on the current status of your research project(s). Certification is renewable by re-taking the PEERRS Human Subject Research Protections course.

If you completed the course for academic or RCRS purposes, you do not need to renew the certification.

Course Outline

The PEERRS Human Subjects Research Protections course is based on the following CITI modules:

PEERRS Human Subjects Protections Topics

Ethics and Regulatory Overview
- Definitions
- Belmont Principles
- Federal Regulations (Common Rule)
Study Team Considerations – Risks To and Safeguards for Subjects
- Types of Risk
- Vulnerable Populations
- Subject Privacy and Data Confidentiality
- Conflicts of Interest
Informed Consent Process
- Requirements
- Considerations
- Consent and Documentation Waivers
IRB Oversight
- IRB Role
- Review Requirements
- Review Types
- Incident Reporting
- Amendments
- Continuing Review
- Investigator and Study Team Responsibilities

Based on CITI Human Subjects Protections Modules

History and Ethics of Human Subjects Research (ID: 498)
History and Ethical Principles – Social-Behavioral-Educational (SBE) (ID: 490)
Basic Institutional Review Board (IRB) Regulations and Review Process (ID: 2)
Defining Research with Human Subjects – SBE (ID: 502)
Assessing Risk – SBE (ID: 503)
Privacy and Confidentiality -SBE (ID: 505)
Research and HIPAA Privacy Protections (ID: 14)
Populations in Research Requiring Additional Considerations and/or Protections (ID: 16680)
Conflicts of Interest in Human Subjects Research (ID: 17464)
Informed Consent (ID: 3, SBE – ID: 504)
International Studies / Research (ID: 971, SBE – ID: 509)
Unanticipated Problems and Reporting Requirements in Social and Behavioral Research (ID: 14928)
Recognizing and Reporting Unanticipated Problems Involving Risks to Subjects or Others in Biomedical Research (ID: 14777)

FAQs

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.

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:

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.
Request PEERRS access. See the PEERRS Access Request Form for instructions.
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:

For PEERRS credit in:	Complete the following CITI modules:
Human Subjects Protections – Biomedical focus	History & Ethical Principles (ID: 498)Basic IRB Regulations and Review Process (ID: 2)Informed Consent (ID: 3)Populations in Research Requiring Additional Considerations and/or Protections (ID: 16680)
Human Subjects Protections – Social-Behavioral focus	History & Ethical Principles (ID: 490)Defining Research with Human Subjects (ID: 491)The Regulations (ID: 502)Assessing Risk (ID: 503)Informed Consent (ID: 504)Privacy and Confidentiality (ID: 505)

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.

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.

Who at U-M	When	Where
Office of Research and Sponsored Projects (ORSP)	Prior to processing new awards and incremental funding (existing awards)	eResearch Proposal Approval Form (PAF), Award (AWD), and Award Modification (AWD-MOD)
Institutional Review Boards (IRBs)	Prior to approving human subjects studies	eResearch IRB application (HUM) or IRB amendment (AME)
Export Controls Office (ECO)	Prior to approving research activity using controlled technology or data	eResearch Technology Control Plan (TCP) or TCP amendment
Research Security Information Oversight (RISO)	When processing new sponsored awards that reference controlled unclassified information (CUI) regulations	eResearch Proposal Approval Form (PAF), Award (AWD), and Award Modification (AWD-MOD)

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.

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.

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.

How to Register for a PEERRS Course

My LINC document providing step-by-step instructions to register for and launch a PEERRS eLearning course.

Questions?

For technical assistance using My LINC to register for a course, locate and open a course, or navigate through the PEERRS Human Subjects Research Protections course, contact the ITS Service Center at 734-764-4357.

For questions regarding course content or training requirements, contact your U-M IRB Office.

For questions regarding the PEERRS program or PEERRS access, contact the U-M PEERRS group at [email protected].