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HRPP Manual Section 11-1-A

Education: Investigators and Research Staff

Principal investigators (PI) and any individual engaged in human research overseen by Michigan State University (MSU) must complete and maintain current Human Research Protection training.

The PI is responsible for:

  • Ensuring that all individuals have appropriate training prior to engaging in research and/or clinical investigations with human subjects.

  • Evaluating the knowledge and skills of all researchers involved in conducting research and/or clinical investigations with human subjects on studies for which they are responsible.

  • Providing documentation of such training, upon request, to the MSU Human Research Protection Program (HRPP); training records may be reviewed by the MSU HRPP at any time.

Requirement for Human Research Protection Training

Completion of the MSU Human Research Protection training or an approved alternate training is required for PIs and any individuals engaged in human research overseen by MSU.

Prior to January 5, 2026, Human Research Protection training can be achieved through the completion of online training module(s) available at the MSU Human Research Protection Program (HRPP) website. The online training modules include:

  • “Overview of Human Research Protection at MSU:” MSU-specific requirements for human research protection

  • “Ethical and Regulatory Considerations:” ethical and regulatory topics such as risks and benefits, selection of subjects, informed consent, protecting privacy, etc.

Completion of both the “Overview of Human Research Protection at MSU” and “Ethical and Regulatory Considerations” modules is required unless alternate training is accepted.

On or after January 5, 2026, Human Research Protection training can be achieved through completion of CITI online training modules for Biomedical Human Research Protection or Social/Behavioral/Education Human Research Protection. The CITI online training modules include:

Biomedical Researchers

  • History of Ethics of Human Subjects Research

  • Basic Institutional Review Board (IRB) Regulations and Review Process

  • Informed Consent

  • Social and Behavioral Research (SBR) for Biomedical Researchers

  • Populations in Research Requiring Additional Considerations and/or Protections

  • Avoiding Group Harms - U.S. Research Perspectives

  • Recognizing and Reporting Unanticipated Problems Involving Risks to Subjects or Others in Biomedical Research

  • Conflicts of Interest in Human Subjects Research

Social/Behavioral/Educational Researchers

  • History and Ethical Principles

  • Defining Research with Human Subjects

  • The Federal Regulations

  • Assessing Risk

  • Informed Consent

  • Privacy and Confidentiality

  • Unanticipated Problems and Reporting Requirements in Social and Behavioral Research

  • Conflicts of Interest in Human Subjects Research

Individuals may choose to complete either the CITI training for Biomedical Researchers or Social/Behavioral/Educational Researchers.

Alternate training can be accepted:

  • Non-MSU individuals (individuals affiliated with another institution), excluding Henry Ford Health employees, may submit a request to accept a completion record for another institution’s human subject protection course as an alternate to both the “Ethical and Regulatory Considerations” module and the “Overview of Human Research Protection at MSU” module or the MSU required CITI training modules.

  • Henry Ford Health (HFH) human research protection training requirements for HFH employed individuals are deemed equivalent and do not need to be submitted for alternate training acceptance.

  • Alternate arrangements for training can be made when an individual is unable to complete the online modules.

Requests for acceptance of alternate training are reviewed by an HRPP manager or HRPP staff designated by the HRPP manager. The HRPP manager or HRPP staff may accept the training as alternate. Such acceptance must be documented.

Transition to CITI Training Requirements

Individuals who previously completed MSU Human Research Protection training (i.e. Legacy HRPP Training  “Overview of Human Research Protection at MSU” and “Ethical and Regulatory Considerations”) will be required to complete the CITI human research protection training for Biomedical Researchers or Social/Behavioral/Education Researchers by January 4, 2027.  

Continuing Requirement for HRPP Training

Individuals will be required to complete a refresher CITI course that includes conflict of interest every four years.

PIs are also responsible for ensuring that individuals engaged in their research project maintain relevant and appropriate training, including the protection of human subjects in research. PIs are expected to evaluate the training needs of individuals engaged in their human research project and to provide continuing training as appropriate to the individual’s role and responsibilities.

The HRPP will provide targeted human research protection training information to researchers as needed.

Additional Training

Supplemental HRPP training may be required, initially or as a continuing requirement, by the HRPP when appropriate (e.g. research involves vulnerable populations, based on results of a post approval monitoring visit).

When applicable, individuals (e.g., investigators, research staff) may be required to complete other appropriate training (e.g., radiation, chemical, or biological safety, animal use, occupational health). The specific training requirements are determined by the appropriate MSU offices based on the nature and scope of the specific research activity, e.g., use of biological materials, hazardous or controlled chemicals.

Individuals are encouraged to participate in additional educational opportunities provided by the HRPP, other MSU offices, and external organizations.

Failure to Fulfill Requirements

It is the responsibility of each individual to maintain up to date human research protection training when engaged in research with human subjects. Because an individual may be engaged in multiple studies with different PIs with different study statuses (engaged or not engaged in human research), an individual’s expired human research protection training will not be considered noncompliance under HRPP Manual 9-2 “Noncompliance.” However, individuals who do not complete the required human research protection training should not be engaged in research studies involving human subjects until the training has been completed.

PIs are responsible for ensuring that individuals engaged in their research project obtain and maintain relevant, appropriate, and up to date training, including the protection of human subjects in research. Failure to provide oversight over a study team’s training may be considered noncompliance under HRPP Manual 9-2 “Noncompliance.”

Educational Activities

To supplement required HRPP training, the HRPP and the Office of Research Regulatory Support (ORRS) offers a range of educational activities for investigators, research staff, and graduate students. Education activities focus on both the basics of human subjects’ protections and emerging issues or ongoing concerns. The campus community is informed of changes in federal and state regulations and university policies through multiple mechanisms, such as updates to the HRPP website, memos to deans, chairs, and directors, updates to the Council of Research Deans, and emails to investigators with active protocols. Continuing education encompasses many activities.

Orientations

Orientations occur each fall for new chairs, directors, faculty, and graduate students. ORRS typically provides information on human subject protection requirements. Departments wishing to provide a more in-depth orientation for graduate students may request orientations specific to their discipline.

Research Administration Series

A research administration certificate series is offered through MSU Human Resources for MSU employees. The series includes a basic required session on compliance which includes human research subject protection.

Workshops

Workshops for departments are scheduled on an ad hoc basis for labs, departments, or colleges. Typically, workshops cover the regulations related to human subjects’ protections and the basic issues researchers need to consider when conducting research with human subjects. From time to time, workshops on specialized topics are also offered. In particular, workshops on special topics may be offered when policies and procedures change that significantly affect investigators, or based on an educational needs assessment.

HRPP Conferences

HRPP conferences may be organized to bring experts to campus to discuss emerging issues related to the protection of human subjects. The audience typically includes IRB members, HRPP staff, and investigators. The HRPP may partner with other institutions to provide conference opportunities.

HRPP Email

HRPP emails are sent to keep PIs apprised of changes in HRPP policy and in new resources available. The HRPP Director will determine the audience and frequency of dissemination.

HRPP Website

The HRPP website provides news items and updates related to MSU and other human subject research protection requirements.

CREST

The Clinical Research Education Series and Training (CREST) sessions are reoccurring meetings designed to be an opportunity for study coordinators, clinical research administrators and all people who provide clinical research support to come and share questions/concerns and obtain information from the HRPP.

TEACH

Teaching Education and Compliance Help (TEACH) is a collaborative, educational initiative designed to assist the PIs and their research team with regulatory compliance. TEACH sessions are provided by the HRPP’s Compliance Analysts.

The HRPP should be contacted to schedule a seminar or workshop or to offer input at (517) 355-2180 or irb@msu.edu.

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 4-21-2005. Revision 1 approved by VP Research & Graduate Studies on 2-1-2006. Revision 2 approved by VP Research & Graduate Studies on 7-5-2006. Revision 3 approved by VP Research & Graduate Studies on 7-22-2011. Revision 4 approved by VP Research & Graduate Studies on 5-14-2015. Revision 5 approved by Assistant VP Regulatory Affairs on 11-23-2015. Revision 6 approved by Senior VP for Research and Innovation on 1-18-2019. Revision 7 approved by Associate VP Research Regulatory Support on 11-8-2025.

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