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 Certification (HRPP/IRB Certification) is required for PIs and any individuals engaged in human research overseen by MSU.

HRPP/IRB Certification 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.

Alternate training can be accepted in four ways:

MSU individuals who previously completed MSU IRB training (i.e. MSU IRB Initial Tutorial or CITI Renewal) will automatically have the previous MSU IRB training accepted as an alternate to the “Ethical and Regulatory Considerations” module and will only be required to complete the “Overview of Human Research Protection at MSU” module.
MSU individuals who previously completed a non-MSU human subject protection course may request acceptance of alternate training in lieu of completion of the “Ethical and Regulatory Considerations” module. If approved, the individual will only be required to complete the “Overview of Human Research Protection at MSU” module.
Non-MSU individuals (e.g. individuals affiliated with another institution) 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.
Alternate arrangements for training can be made when an individual is unable to complete the online modules.

Requests for acceptance of alternate training are submitted to an HRPP manager or designee. The HRPP manager may accept the training as alternate. Such acceptance must be documented within the HRPP training system.

Transition to New MSU HRPP/IRB Certification Training Requirements
Individuals who previously completed MSU Institutional Review Board required training (i.e. MSU IRB Initial Tutorial or CITI Renewal) will maintain the expiration date assigned as part of that training completion and they will need to complete the MSU HRPP/IRB Certification prior to that expiration date.

Continuing Requirement for HRPP Training
PIs are 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.

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
PIs are responsible for ensuring that individuals engaged in their research project obtain and maintain relevant and appropriate training, including the protection of human subjects in research. Individuals who do not complete the required HRPP/IRB Certification should not be engaged in research studies involving human subjects until the training has been completed.

Educational Activities
To supplement required HRPP training, the HRPP and the Office of Regulatory Affairs (ORA) 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, 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. The Office of Regulatory Affairs 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 and typically includes an optional advanced session specifically on human research subject protection.

Workshops
Workshops for departments are scheduled on an ad hoc basis for labs, departments, or colleges. Typically, workshops cover the history of 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.

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