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 HRPP exempt determination, or an acknowledgement of reliance upon an external (non-MSU) IRB from the MSU HRPP. 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:

have a key role in designing the research or substantially contributing to the conception of the research;
use, study, or analyze for research purposes coded data when the key is maintained by other MSU individuals who will collaborate on other activities related to the conduct of the research, such as the study, interpretation, or analysis of the data, or authorship of presentations or manuscripts related to the research;
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 U.S. Health and Human Services (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. MSU may also be considered engaged in research with human subjects when it receives an award directly from a non-federal source (such as non-profit organizations, foundations, private or commercial businesses, state agencies, etc.).

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/determinations. 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. Investigators may be asked to submit a new study submission including the HRP-514 – Template – Engagement through the MSU IRB online system. The MSU HRPP may consult with the MSU Office of General Counsel as needed.

Students and Medical Students

Not engaged scenarios:

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, including MSU medical students, who are engaging in human subject research being conducted at or by a non-MSU location or non-MSU investigator when they are being added as research staff, without the research being modified for the purposes of the student (e.g., additional survey questions, additional experiments, new or modified objectives), would not be exercising institutional authority or responsibility, or performing institutional designated activities, and would therefore not typically be subject to MSU HRPP policies and procedures. This could apply even if the student is engaged in the research to satisfy the requirement for an MSU course, degree or certification. See also scenarios 2 and 3 below for other examples when this would not apply.

Engaged scenarios:

Students, including MSU medical 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, unless the above scenario 3 applies. This also 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).
Students who are engaging in human subject research when the research is student-driven (e.g., designed by the student for the purposes of undergraduate research or for a thesis or dissertation), but the research takes place at a non-MSU location, 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.”
Students who are engaging in human subject research that is being conducted at or by a non-MSU location or non-MSU investigator and the research will be modified (e.g., additional survey questions, additional experiments, new or modified objectives) for the purposes of the student (e.g., for the student’s thesis), 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.”

Residents

Residents in MSU operated residencies are subject to the MSU HRPP policies and procedures as outlined in MSU HRPP Manual Section 4-1 “Applicability.” 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 or operated 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 Activities as permitted by the MSU Board of Trustees (BOT) 414: Conflict of Interest and Conflict of Commitment Identification and Disclosure policy, the faculty member is acting in their individual capacity 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 BOT 414: Conflict of Interest and Conflict of Commitment Identification and Disclosure policy does 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 Activities 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.”

Individuals with no pay faculty appointments who are Henry Ford Health employed lead PI’s on federal awards or subawards submitted through the Henry Ford Health + Michigan State University Health Sciences would be performing the human research as part of MSU designated activities and would be subject to the MSU HRPP policies and procedures. See HRPP Manual 1-7 “Henry Ford Health and Michigan State University Partnership and MSU HRPP Requirements.”

Visiting Scholars

Individuals who are visiting scholars 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,” while they are a visiting scholar. When the individual returns to their home institution, if they are still involved in the conduct of the research, they would be engaged on behalf of their home institution.

Consultants or Contractors

Individuals hired by MSU through a contract or professional service contract if the contract encompasses the specific research project 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.”

Individuals hired by MSU through a contract or professional service contract if the contract encompasses research, but does not identify specific activities (e.g., an individual hired by a department to support their research activities), would be performing institutionally designated activities if the department has directed the individual to work on an identified research activity as part of the contract.

Individuals hired by MSU through a contract or professional service contract for a specific activity that does not encompass research would not be performing institutionally designated activities and would not typically be subject to the MSU HRPP policies and procedures as outlined in MSU HRPP Manual Section 4-1 “Applicability.”

Temporary or On-call Status

Individuals with a temporary or on-call status who are paid by MSU and whose work encompasses human research 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.”

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.

This policy and procedure supersedes those previously drafted.

Approved By: Vice President for Research and Innovation on 12-2-2021. Revision 1 approved by Associate VP Research Regulatory Support on 12-5-2025.

Human Research Protection Program Office of Research Regulatory Support