MSU HRPP Manual Section 4-12

Engagement

Individuals who engage in human research activities and who act on behalf of Michigan State University (MSU), exercise institutional authority or responsibility, or perform institutionally (MSU) designated activities are subject to MSU Human Research Protection Program (HRPP) policies and procedures as outlined in MSU HRPP Manual Section 4-1, Applicability, which includes the requirement to obtain MSU IRB review and approval, an MSU IRB exempt determination, or to submit an application to the MSU HRPP to request reliance upon an external (non-MSU) IRB. Individuals who engage in human research activities who are not acting on behalf of the institution, are not exercising institutional authority or responsibility, and are not performing MSU designated activities are not subject to MSU HRPP policies and procedures unless they are individuals conducting research at entities that have a formal written agreement with MSU for review and approval of their human subject research. See HRPP Manual Section 4-1, Applicability. Individuals can include faculty, staff, students, contractors, and volunteers, among others, regardless of whether the individual is receiving compensation. Engagement is not based on the location of the research, but whether an individual is acting on behalf of MSU, exercising institutional authority or responsibility, or performing institutionally (MSU) designated activities.

The MSU HRPP typically applies the U.S. Office for Human Research Protections (OHRP) Guidance document, Engagement of Institutions in Human Subjects Research (2008), to activities that have been determined to be research involving human subjects that are not exempt under the Revised Common Rule protection of human research subject regulations at 45 CFR 46.104 or are not exempt based on MSU HRPP requirements. http://www.hhs.gov/ohrp/policy/engage08.html.

In general, MSU is considered engaged in a particular non-exempt human subject research project when its employees or agents for the purposes of the research project obtain:

  • data about the subjects of the research through intervention or interaction with them;

  • identifiable private information about the subjects of the research; or

  • the informed consent of human subjects for the research.

MSU would also be considered engaged in research with human subjects when it receives an award through a grant, contract, or cooperative agreement directly from HHS or another federal agency that has adopted the Revised Common Rule for non-exempt human subjects research (i.e. awardee institutions), even where all activities involving human subjects are carried out by employees or agents of another (non-MSU) institution.

Though OHRP guidance refers specifically to non-exempt research, the HRPP also typically applies the OHRP guidance to exempt research to determine whether a submission to the MSU HRPP is required.

Engagement Scenarios

The following section clarifies scenarios when an individual is subject to MSU HRPP policies and procedures. This applies to exempt and non-exempt human research. When an individual is not subject to MSU HRPP policies and procedures, that individual must follow the requirements of the non-MSU institution that is conducting the human research activity, including completing training and obtaining the appropriate approvals/permissions. If there are any questions on whether the HRPP policies and procedures as outlined in HRPP Manual 4-1, Applicability apply, contact the MSU HRPP. The MSU HRPP may consult with the MSU Office of General Counsel as needed.

Students

An MSU student who assists or volunteers at another university, school or institution and engages in human subjects research to gain experience that is not part of a degree program, is not acting on behalf of MSU, is not exercising institutional authority or responsibility, and is not performing MSU designated activities is therefore not typically subject to MSU HRPP policies and procedures.

An MSU student who is employed with another institution and engages in human research as an employee of that institution, even when enrolled as a student at MSU, is not acting on behalf of MSU, is not exercising institutional authority or responsibility, and is not performing institutional designated activities is therefore not typically subject to MSU HRPP policies and procedures. The student would be acting on behalf of the employing institution.

Students who are engaging in human subject research to satisfy a requirement for an MSU course, degree or certification would be performing institutionally designated activities and would be subject to the MSU HRPP policies and procedures as outlined in MSU HRPP Manual Section 4-1, Applicability.

Medical Students and Residents

MSU medical students enrolled as MSU students and/or residents in MSU-sponsored residencies are subject to the MSU HRPP policies and procedures as outlined in MSU HRPP Manual Section 4-1, Applicability, including the requirement  to obtain MSU IRB review and approval, an MSU IRB exempt determination, or to submit an application to the MSU HRPP to request reliance upon an external (non-MSU) IRB, when engaged in human subject research activities to satisfy a requirement for a MSU course, degree or certification This applies regardless of where the human subject research activities take place (e.g. College of Osteopathic Medicine learning sites, College of Human Medicine statewide campus locations).

Residents in other organization’s sponsored residency would be acting on behalf of that organization and would not be acting on behalf of MSU, not exercising institutional authority or responsibility and not performing MSU designated activities.

Employees who are Students

MSU employees who are also students at another university or school and who become engaged in human research activities to satisfy the degree requirements of the other university or school, but who are not acting on behalf of MSU, are not exercising institutional authority or responsibility, and are not performing MSU designated activities are not typically subject to the MSU HRPP policies and procedures as outlined in MSU HRPP Manual Section 4-1, Applicability.

Faculty Performing Outside Work for Pay

When a faculty member is engaged in Outside Work for Pay as permitted by the “Outside Work for Pay” University policy, the faculty member is acting in their individual capacities and not on behalf of MSU and would not typically be subject to the MSU HRPP policies and procedures as outlined in MSU HRPP Manual 4-1, Applicability. The Outside Work for Pay policies do not permit use of University services or employees unless specific criteria are met, including reimbursement in full for the fair market value for their use. As such, if the activity the individual is engaging in as part Outside Work for Pay requires IRB review and approval, an external or independent (commercial) IRB would typically need to be used.

No Pay Faculty

Some faculty appointments are no pay appointments, including adjunct or clinical appointments and non-pre-fixed no pay appointments. Individuals who are appointed in this manner are not MSU employees and are not typically subject to the MSU HRPP policies and procedures as outlined in MSU HRPP Manual Section 4-1, Applicability. If the individual wants to conduct the research on behalf of MSU, the individual would need to obtain approval from their department or college, and would be subject to the MSU HRPP policies and procedures as outlined in MSU HRPP Manual Section 4-1, Applicability, including HRPP Manual 4-9, Designation as Principal Investigator. If human research is done as part of MSU designated activities (e.g. MSU has asked or paid the individual to perform the research), the individual would be subject to the MSU HRPP policies and procedures as outlined in MSU HRPP Manual 4-1, Applicability.

Partial or Contract Faculty Appointments

Some faculty appointments are minimal in nature (e.g. 5%, 10%) or the individual may be contracted by the university to perform administrative, clinical, or other duties. The following scenarios describe when that individual is considered to be engaged in MSU human research.

  • If human research is done as part of MSU designated activities (e.g., MSU has asked or paid the individual to perform the research), the individual would be subject to the MSU HRPP policies and procedures as outlined in MSU HRPP Manual 4-1, Applicability.

  • For sponsored research, if MSU is receiving a direct award for the human research, then the human research is being performed as part of MSU designated activities and the individual would be subject to the MSU HRPP policies and procedures as outlined in MSU HRPP Manual 4-1, Applicability.

  • For sponsored research, if another entity is receiving a direct award for the human research and a subcontract or subaward is not being issued to MSU to perform the work, then the research is not considered to be conducted on behalf of MSU or as an MSU designated activity. The individual would not be subject to the MSU HRPP policies and procedures. However, for the activity to be considered not to be conducted on behalf of MSU or as an MSU designated activity, no other MSU employee could engage in the activity on behalf of MSU, and MSU students could not engage in the activity to satisfy a requirement for a MSU degree or program.

  • For activities that are not sponsored, if the individual indicates that they are conducting the research on behalf of MSU, the individual would be subject to the MSU HRPP policies and procedures as outlined in MSU HRPP Manual 4-1, Applicability.

Consultation with legal counsel and others (e.g. College, Department) may be required to determine whether the individual is engaged on behalf of MSU or is performing MSU designated activities.

Personnel Involved in Activities Regulated by the U.S. Food and Drug Administration

For activities regulated by the U.S. Food and Drug Administration (FDA), the MSU HRPP also applies the FDA’s Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs: Frequently Asked Questions – Statement of Investigator (1572) to evaluate the involvement of non-MSU personnel in the research study.

Approved By

Vice President for Research and Innovation on 12-2-2021.

This policy and procedure supersedes those previously drafted.

Related HRPP Manual Sections