MSU HRPP Manual Section 3-1

MSU Human Research Protection Program Plan

The Michigan State University (MSU) Human Research Protection Program’s (HRPP) primary mission is the protection of individuals who are the subjects of research. MSU is committed to following the ethical standards described in the Belmont Report, and all applicable federal, state, and local regulations and university policies and procedures related to human research protection. The HRPP at MSU sets forth the structure, policies, and procedures to implement this mission and commitment. The processes of education, review, and monitoring described in the HRPP serve to ensure the safe and ethical conduct of human research.

While the HRPP office provides the primary oversight and coordination for the protection of human subjects in research, it is not the only MSU office that is involved in the protection of human subjects in research. This responsibility is broader and is shared and distributed with other MSU offices and units. Each of these offices or units plays an important role in the protection of human subjects. Integration between such components is essential for the protection of human subjects in the research. This document describes the roles, responsibilities, and coordination among the MSU offices and units for the protection of human subjects in research. While this document focuses on the communications related to human subject protection, the units also communicate closely on other areas related to research (e.g., execution of a contract or grant, other regulatory compliance areas such as biosafety).

Communications between the MSU offices and units may occur on a protocol specific basis or may be of a programmatic nature. When issues arise on a specific research study, meetings may be scheduled as needed between the units. Additional meetings may be scheduled on an as needed basis between the units to discuss issues or communication strategies that are programmatic in nature.

Communication between the MSU units related to human research protection also helps to assure that all institutional approvals will be in place before the research is initiated. However, it is the responsibility of the principal investigator (PI) to ensure that all appropriate institutional approvals, including those related to human subject protection, are in place prior to initiation of the research. Some research studies may only require HRPP or Institutional Review Board (IRB) approval or determination; others may require other institutional approvals. The communications and additional requirements described in this document between the HRPP and other university offices and units provide steps and communication mechanisms to facilitate and assist the PI to assure that all appropriate institutional approvals are in place before the initiation of the research. Other units not described in this document may also be notified and/or assigned as an ancillary reviewer in the MSU IRB online system as appropriate.

MSU Committees, Offices, and Units

The following sections describe the collaboration between the HRPP and committees, offices, and units within MSU.

Institutional Review Boards (IRB)

MSU has established IRBs under its Federal Wide Assurance #00004556. For more information about the IRBs structure and function, see the MSU HRPP Manual sections including but not limited to 4-2 “Authority of IRBs,” 4-5 “Responsibilities of the IRBs,” and 5-3 “IRB Membership.”

Office of Research and Innovation (ORI)

The Vice President of the Office for Research and Innovation (ORI) has been designated as the Institutional Official (IO) for MSU; see HRPP Manual 4-4 “Institutional Official,” for a full description of the role and responsibilities of the IO for the protection of human subjects. Organizationally, the HRPP office reports to ORI through the Office of Research Regulatory Support (ORRS). Other units involved in the protection of human subjects also report to ORI including the Office of Sponsored Programs and MSU Technologies.

Coordination with the IO occurs as needed for the protection of human subjects. Meetings with the IO and staff from the HRPP and with the associate vice president for the ORRS (AVP ORRS) occur as well. The ORI regular staff meetings attended by senior ORI staff and the heads of ORI units facilitate communication between the units in the ORI.

The ORI Director of Research and Technology and Compliance may be notified when an IRB submission involves the use of generative Artificial Intelligence or other technology.

Office of Research Regulatory Support (ORRS)

ORRS is organized under ORI and includes the following units: the Animal Care Programs, Conflict Disclosures and Management, Environmental Health and Safety, Export Controls and Trade Sanctions, the HRPP, the Institutional Stem Cell Research Committee, Research Security, and administrative and technical staff. ORRS facilitates research review processes in accordance with federal, state, and local regulations, and university policies to protect the rights and welfare of research subjects, to protect public health and safety, and to assure the objectivity and integrity of research.

Senior staff meetings with ORRS unit heads facilitate communication between the units in ORRS. The AVP ORRS also meets regularly with the director of the HRPP. Staff from units within ORRS also communicate directly with each other regarding human subject protection as described below and as needed.

The ORRS Administrative Business Manager and/or financial analysts may be notified when an IRB submission involves HRPP IRB fees. See HRPP Manual 5-8 “IRB Fees” for more information.

Human Research Protection Program (HRPP)

The HRPP office is organized under ORRS. The HRPP includes the offices of the IRB, IRB Reliance, and Compliance. The HRPP encompasses not only the IRB requirements for the protection of human subjects, but other additional areas of human research regulatory oversight that are broader than the IRB requirements (e.g., U.S. Food and Drug Administration regulations, interactions with Pharmacy, clinical research billing compliance) that provide protections for human subjects. The HRPP staff within the HRPP units meet regularly. The HRPP director, HRPP managers, and IRB chairs meet regularly.

The HRPP office uses an online software system for the submission and review of human research studies. The MSU IRB online system is the Click™ Research Compliance System. Click allows for the submission and review of new studies, modifications, continuing review including renewed approval and closure, and reports of new information. Click also permits the assignment of offices and individuals involved in the protection of human subjects as ancillary reviewers or permits designation of individual(s) to view the study through the guest list. Such access allows the individual(s) to view the study submission, clarifications, and comments viewable by the principal investigator associated with the study. Click includes system generated notifications (e.g., continuing review reminders, notification of approvals, clarifications requested, reviewer assignments). Access to Click requires multi-factor authentication through the university’s log in system.

HRPP staff notifies other offices and individuals involved in the protection of human subjects when research studies require input from various offices. Notifications are typically provided through assignment as an ancillary reviewer in the MSU IRB online system. Some notifications are sent manually. For example, the Compliance office coordinates and works with other units (e.g., MSU Health Care, Inc.) to accomplish its role in post approval monitoring and non-IRB regulatory oversight (e.g., Compliance office will provide coordination when an IRB submission involves protected health information). The HRPP director may also be notified through ancillary review assignment when an IRB submission involves additional requirements such as use of external (non-MSU) IRBs, university reporting protocols, and may be notified for study specific questions.

IRB Office

The IRB office facilitates the IRB review processes in accordance with federal, state, and local regulations, university policies, and ethical standards related to human research protection. Designated IRB staff may be notified through ancillary review assignment when an IRB submission involves additional requirements such as federal agency specific requirements, genomic data sharing, raffle, waived PI requests, or Association for the Accreditation of Human Research Protection Programs (AAHRPP) review. For more information about the IRB staff structure and function, see the MSU HRPP Manual section including but not limited to 5-2-C “HRPP Staff: IRB Office.”

IRB Reliance Office

The IRB Reliance office facilitates the IRB reliance process in accordance with federal, state, and local regulations, university policies, and ethical standards related to human research protection. The IRB Reliance office manages the processing of IRB submissions that involve IRB reliance, individual investigator agreements, and engagement. The IRB Reliance office leads communications with MSU researchers, MSU units, Henry Ford Health, IRBs at other academic institutions, hospitals, clinics, and others to facilitate IRB reliance and collaborative research studies. IRB Reliance office staff may be notified through ancillary review assignment when an IRB submission involves additional requirements such as a certificate of confidentiality, data management and sharing requirements, Single IRB, engagement, reliance, and individual investigator agreements.

Compliance Office

The Compliance office encompasses post approval monitoring activities, education, and non-IRB regulatory oversight (e.g., FDA requirements, protected health information, clinical research billing compliance, clinicaltrials.gov, Common Rule clinical trials, International Conference on Harmonisation Good Clinical Practice (ICH GCP), student educational records, research conducted in elementary and/or secondary public schools, data protection regulations). The Compliance office provides resources to the research community and others involved in patient care activities during research studies to ensure proper billing of health care services and items according to federal, state, and local regulations. Post approval monitoring conducted by the Compliance office serves to educate researchers and to assure that the research study is being conducted in accordance with federal, state, and local regulations, university policies, and ethical standards related to human research protection.

Compliance office staff are notified through ancillary review assignment when an IRB submission involves additional requirements such as non-IRB regulatory oversight described above. For more information about the Compliance office staff structure and function, see the MSU HRPP Manual section including but not limited to “5-2-B HRPP Staff: Compliance Office.”

Environmental Health and Safety (EHS)

EHS is organized under ORRS and promotes and establishes programs in health and safety, protection of the environment, and regulatory compliance. Committees within EHS include the Chemical Hygiene Committee (CHC), Institutional Biosafety Committee (IBC), and the Radiation Safety Committee (RSC). The CHC reviews and monitors the effectiveness of MSU’s Chemical Hygiene Plan and key areas of compliance such as training and use of controlled or hazardous materials. The IBC is a regulatory required committee that approves the use of recombinant DNA and provides guidance on the use of infectious agents. The MSU Biosafety Officer oversees the transport of these materials and provides training on use of infectious agents. The RSC reviews, approves, and continually monitors the use of radioactivity on campus. EHS also includes areas such as occupational health and safety, hazardous waste, environmental compliance, and controlled substances.

Individuals from EHS are notified through ancillary review assignment when an IRB submission involves areas such as the use of biological materials, gene therapy, radioactive materials, radiation producing machines, use of contrast agents, or controlled substances. The respective office then communicates with the IRB and/or the investigator as needed (e.g., training needs, appropriate review).

Export Controls and Trade Sanctions (ECTS)

The Office of Export Controls and Trade Sanctions (ECTS) is organized under ORRS and provides best practices advice and hands-on assistance to the MSU community for compliance with the U.S. Export Control Regulations. ECTS supports MSU faculty, students, and staff with export compliance matters.

ECTS staff are notified through the ancillary review process when an IRB submission involves areas such as involvement of Office of Foreign Assets Control embargoed country(ies).

Research Security

To comply with the research security requirements outlined in the Presidential Memorandum on United States Government-Supported Research and Development National Security Policy (NSPM-33) and other applicable regulations, a research security committee has been formed at Michigan State University. This committee will provide recommendations to the Vice President for Research and Innovation for implementing a Research Security Program.

Conflict Disclosures and Management (CDM)

The CDM office is organized under ORRS and facilitates the conflict of interest (COI) processes. The Conflict Resolution Committee (CRC) reviews and manages disclosures of COI. The CDM office assists with implementation of the Board of Trustees 414: Conflict of Interest and Conflict of Commitment Identification and Disclosure policy and is available to answer questions about conflict of interest, including questions about COI as it relates to the protection of human subjects. CDM staff are notified when an IRB submission involves disclosure of a conflict of interest.

HRPP staff communicate with the CDM office regarding conflict of interest disclosures, review, and management. The HRPP director and/or IRB chair communicates with CDM office regarding advice, consultation, and notification of conflict of interest disclosure that may affect the rights and welfare of subjects. These may include but are not limited to instances of conflict of interest of IRB members, IRB consultants, investigators, students, sponsors, or administrators. The CDM office works with the CRC which is responsible for developing and approving a management plan and informing the IRB of their decisions. The IRB has the authority to approve the research, to require modifications that incorporate the CRC management plan and/or additional IRB determined modifications, or to not approve the research. The CRC may not approve the research if it has not been approved by the IRB. See HRPP Manual 10-1 “Conflict of Interest,” for more information.

Animal Care Program

The Institutional Animal Care and Use Committee (IACUC) is part of the Animal Care Program and is organized under ORRS and reviews, approves and oversees all MSU programs involving the care and use of all live animal activities to ensure compliance with standards and regulatory requirements. The IACUC administrator is notified when an IRB submission involves animals.

Institutional Stem Cell Research Committee

The Institutional Stem Cell Research Committee is organized under ORRS and oversees certain kinds of human stem cell research conducted by MSU faculty, staff, and students. The Institutional Stem Cell Research Committee administrator is notified when an IRB submission involves human embryos or human stem cells.

Office of Sponsored Programs (OSP)

The Office of Sponsored Programs (OSP) reports to ORI. OSP manages financial and contractual aspects of submitting proposals to non-industrial external sponsors and reviews, negotiates, and accepts the terms of awards. Any non-industry agreement that involves financial transactions and obligations between MSU and other parties must be reviewed by OSP.

Funds awarded to MSU investigators for human subject research will not be made available by OSP until the research is approved by an MSU IRB, determined exempt by the MSU HRPP, or an MSU HRPP reliance acknowledgement letter is issued, with limited exceptions. See HRPP Manual 1-3 “Use of Institutional Authorization Agreements” and 8-4 “45 CFR 46.118 Designation.” When a research study is externally funded, HRPP staff sends a notice of the HRPP or IRB approval or determination to OSP.

Business CONNECT (BC)

Business CONNECT (BC) reports to ORI and manages financial and contractual aspects of submitting proposals to industrial external sponsors. Any industry agreement that involves financial transactions and obligations between MSU and other parties must be reviewed by BC. Individuals within BC are notified when an IRB submission involves an industry sponsored clinical trial.

Investigators are required to disclose through the Research Administration online system, Kuali Research, whether the proposal includes human subject research. Communication between the HRPP and OSP or BC includes the review of negotiated funding or contract agreements to assure inclusion of AAHRPP funding or contract agreement language as needed. This process includes:

The contract negotiator evaluates whether the AAHRPP required language has been included in the agreement and negotiates with the sponsor to include AAHRPP required language.
The contract negotiator completes a worksheet to document their review.
The HRPP staff and the contract negotiator communicate as needed to address any questions or comments (e.g., how to translate contract language to easily understandable consent language). This may also involve the MSU Office of the General Counsel.
The contract negotiator provides the completed worksheet to the HRPP staff.
The HRPP staff verifies that the agreement includes the required AAHRPP language and that the consent and agreement are congruent.
The HRPP staff communicates and works with the contract negotiator if there is any question of whether the agreement includes the necessary AAHRPP language or if the agreement and consent are congruent and may involve MSU legal counsel as needed.
For studies reviewed by an MSU IRB, the IRB reviews the final consent form for approval.
For studies reviewed by an External IRB, any required consent changes are provided to the reviewing IRB by the study team or IRB reliance office.

The HRPP director, HRPP managers, OSP staff, and BC staff typically meet quarterly.

Contract and Grant Administration (CGA)

Contract and Grant Administration (CGA) reports to the Senior Vice President and Chief Financial Officer. CGA manages awards after they are made to the university. CGA is responsible for the administration of awards (industrial and non-industrial) according to sponsor's and MSU regulations.

If reporting is required by HRPP Manual 4-8 “Reporting Policy” and involves externally sponsored research, the HRPP communicates with CGA to obtain the appropriate external sponsor contacts.

MSU Technologies

MSU Technologies is organized under ORI and is responsible for managing MSU’s intellectual property. MSU Technologies executes Material Transfer Agreements (transfer of materials from MSU to another entity or to MSU from another entity), facilitates data use agreements, reviews and manages invention disclosures and the patent process, and handles confidential disclosure agreements. This office is also responsible for licensing MSU technology.

Individual(s) within MSU Technologies may be notified through ancillary review when the protocol indicates that data will be shared with another institution.

MSU Office of the General Counsel (OGC)

Generally, the MSU Office of the General Counsel (OGC) must review in advance all contracts and agreements that could bind MSU or involve potential legal liabilities. Legal counsel from the OGC is assigned to ORRS and the HRPP and are contacted when legal questions arise.

Legal counsel assigned to the HRPP meets regularly with the HRPP and is also contacted on an as needed basis. Legal counsel may be contacted on protocol specific questions or on broader legal issues (e.g., state law, EU GDPR) and may be notified through the MSU IRB online system.

Clinical and Translational Sciences Institute (CTSI)

The CTSI assists researchers with the development, implementation, management, and completion of industry and government-funded clinical research (e.g., clinical trials, investigator-initiated research, etc.) conducted through MSU and its community partners, to expedite the research administration process, and to facilitate research compliance. CTSI also manages MSU’s use of ResearchMatch. Individual(s) within the CTSI are notified when an IRB submission involves ResearchMatch.

Graduate School

The Graduate School serves as an advocate for graduate education to the university and beyond and to enhance the quality of graduate education at MSU. The Graduate School offers resources such as the lectures and information on the Responsible Conduct of Research.

Graduate students who conducted human subject research for their thesis / dissertation must provide a copy of their MSU IRB approval letter, MSU exempt determination letter, or MSU HRPP reliance acknowledgement letter to the Graduate School with their form for final submission of their thesis / dissertation. Designated Graduate School staff are assigned as ancillary reviewers through the MSU IRB online system when an IRB submission involves a dissertation or thesis.

Office of Accreditation, Assessment, Curriculum, and Compliance

The Office of Accreditation, Assessment, Curriculum, and Compliance (AACC) is an academic unit within the Office of the Provost that leads essential work in accreditation and compliance, facilitating campus-wide assessment processes, and supports continuous improvement in curriculum development and design. This unit includes the Family Educational Rights and Privacy Act (FERPA) Compliance Officer who ensures that the University fulfills its obligations under FERPA. The FERPA Compliance Officer manages FERPA record requests, the record amendment process, consults with University partners to ensure their processes are FERPA compliant, and implements FERPA training for students, faculty, and staff. The FERPA Compliance Officer and the Compliance Office staff typically meet weekly.

The FERPA Compliance Officer is notified when an IRB submission involves MSU student educational records where their input is needed.

Research Integrity Officer (RIO)

The RIO reports to the President and administers the MSU Faculty Handbook Procedures Concerning Allegations of Misconduct in Research and Creative Activities. They provide the procedures for investigation and evaluation of alleged or apparent misconduct.

Any case of research misconduct or serious or continuing noncompliance with government regulations pertaining to research and/or university policy can be reported to the RIO as an allegation of misconduct. These allegations can be presented to the RIO by the chair of the IRB, any member of the IRB, HRPP staff, human research participant, or any other individual. When reporting as required by HRPP Manual 4-8 “Reporting Policy,” any incident that may also involve research misconduct is reported to the RIO. Such reporting may also occur at the beginning of the incident investigation.

The RIO may be provided with access to MSU IRB records when necessary for the RIO to fulfill their responsibilities under the MSU Faculty Handbook Procedures Concerning Allegations of Misconduct in Research and Creative Activities.

Office of Audit, Risk, and Compliance

The Office of Audit, Risk, and Compliance performs independent internal audits, conducts the university risk assessment process, and oversees the institutional compliance program. The Office of Audit, Risk, and Compliance may request information from the HRPP to perform their duties.

Departments and Colleges

Departments, Colleges, and other academic units share in the oversight responsibility for the human research conducted by individuals within their units. While the PI is responsible for the oversight of the study (see HRPP Manual 4-6 “Responsibilities of Investigators” and 4-9 “Designation as Principal Investigator”), Departments, Colleges, and other academic units also share in the responsibility to assure that individuals in their units are conducting research in compliance with human subject protection requirements and other institutional requirements.

Leadership in units with responsibilities for oversight of human research study(ies) may be provided or request access to materials submitted to the HRPP and/or materials provided to the researchers by the HRPP to fulfill their oversight responsibilities. For example, this may occur when required by the College, if a study that would otherwise qualify as exempt may be likely to have a significant adverse lasting impact on subjects or may be likely that a reasonable person would find the interaction offensive, or by request. Any questions about such requests are provided to the HRPP director and/or HRPP manager, who may consult with others (e.g., IRB chairs, legal counsel, AVP ORRS, IO) if needed to determine whether the request may be fulfilled.

External (Non-MSU) Committees, Offices, and Units

The following sections describe the collaboration between the HRPP and committees, offices, and units external to MSU.

MSU Health Care, Inc. (MSU HCI)

MSU established MSU Health Care, Inc., (MSU HCI) a non-profit corporation created to be the clinical enterprise of MSU’s College of Human Medicine, College of Nursing, and College of Osteopathic Medicine. In addition to clinical services, research may occur in MSU HCI clinics or facilities, use MSU HCI equipment, or may involve protected health information obtained from MSU HCI.

The MSU HCI Compliance Officer is notified when an IRB submission involves obtaining protected health information from MSU HCI as the covered entity or when research will be conducted using MSU HCI space, personnel, or resources.

The Pharmacy is organized under MSU HCI and offers clinical services to the MSU community. In addition to clinical services, investigational articles may be stored separately from standard inventory by the MSU HCI Pharmacy. The MSU HCI Pharmacy is available to provide information to investigators on the requirements for proper investigational drug and devices storage and control. When an IRB submission involves use of the MSU HCI Pharmacy, the MSU HCI Pharmacy will be notified through the MSU IRB online system.

MSU HCI Imaging Services provides a variety of diagnostic radiology services. An individual within MSU HCI Imaging Services is notified when an IRB submission involves equipment from MSU HCI Imaging Services (e.g., MRI, fMRI, CT, PET), Spartan Imaging, or Izzo Family Medical Center Imaging.

Institutional Reliance Partners

MSU has entered into institution-wide agreements that permit reliance on an MSU IRB, although use of SMART IRB is preferred. Designated individual(s) from certain institutional reliance partners may be notified when an IRB submission involves their institution. This may be performed through the MSU IRB online system or through other communication mechanisms such as email.

See HRPP Manual 1-3 “Use of Institutional Authorization Agreements” and 1-4 “Reliance on External Independent (Commercial) Institutional Review Boards” for more information.

Henry Ford Health Institutional Review Board

In 2021, a long-term partnership agreement was signed between Henry Ford Health (HFH) and MSU and a key feature of the agreement included fostering innovative, groundbreaking research. The HFH IRB and MSU HRPP collaborate in an HFH-MSU IRB Workgroup to provide optimal guidance and information about human research protection requirements for studies that involve both HFH and MSU. This group meets weekly to continue to align and streamline institutional processes and address project specific reliance questions.

Designated individual(s) from HFH IRB may be notified when an IRB submission involves HFH. This may be performed through the MSU IRB online system or through other communication mechanisms such as email. See HRPP Manual 1-7 “Henry Ford Health and Michigan State University Partnership and MSU HRPP Requirements” for more information.

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 4-21-05. Revision 1 approved by VP Research & Graduate Studies on 3-9-08. Revision 2 approved by VP Research & Graduate Studies on 5-6-2008. Revision 3 approved by the VP Research & Graduate Studies on 7-21-2011. Revision 4 approved by the VP Research & Graduate Studies on 12-14-2011. Revision 5 approved by the VP Research & Graduate Studies on 6-5-2015. Revision 6 approved by Assistant VP Regulatory Affairs on 12-10-2015. Revision 7 approved by Assistant VP Regulatory Affairs on 6-27-2018. Revision 8 approved by Assistant VP Regulatory Affairs on 11-27-2021. Revision 9 approved by Associate VP Research Regulatory Support on 11-9-2025. Revision 10 approved by Associate VP Research Regulatory Support on 12-8-2025.

Human Research Protection Program Office of Research Regulatory Support