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. 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 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 policy describes the roles, responsibilities, and coordination among the MSU offices and units for the protection of human subjects in research. While this policy 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 assure 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 Institutional Review Board (IRB) review and approval; others may require other institutional approvals. The communications and additional requirements described in this policy 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.

Institutional Review Boards (IRB)

Michigan State University (MSU) has established Institutional Review Boards (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 Sections 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 Regulatory Affairs (ORA). 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 assistant vice president for the ORA (AVP ORA) 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.

Office of Regulatory Affairs (ORA)

ORA is organized under ORI and provides administrative oversight of the HRPP, the Animal Care Program, the Environmental Health and Safety Program, the Conflict of Interest office, Office of Export Controls and Trade Sanctions, and the Institutional Stem Cell Research Committee. These units report to the AVP ORA. ORA facilitates research review processes in accordance with federal regulations to protect the rights and welfare of research subjects, to protect public health and safety, and to assure the proper execution of research.

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

Human Research Protection Program (HRPP)

The HRPP office is organized under ORA. The HRPP includes the offices of the IRB 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 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., Registrar’s Office) 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 is also notified of requests to use external (non-MSU) IRBs, Single IRB requests, waived PI requests that involve individuals who are not employed by MSU, and may be notified for study specific questions.

Institutional Review Board (IRB) Office

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

Compliance

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.

Compliance office staff are notified when an IRB submission involves 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 Section 5-2-B HRPP Staff: Compliance Office.

Environmental Health and Safety (EHS)

EHS is organized under ORA and promotes and establishes programs in health and safety, protection of the environment, and regulatory compliance. Committees within EHS include Radiation Safety Committee (RSC), Institutional Biological Safety Committee (IBC), and the Chemical Hygiene Committee (CHC). 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 RSC reviews, approves, and continually monitors the use of radioactivity on campus.  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. EHS also includes areas such as occupational health and safety, hazardous waste, environmental compliance, and controlled substances.

Individuals from EHS are notified when an IRB submission involves 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).

Conflict of Interest (COI)

The COI office is organized under ORA and facilitates the COI processes. The Conflict Resolution Committee (CRC) reviews and manages disclosures of COI. The Faculty Conflict of Interest Officer (FCOIO) assists with implementation of the Faculty COI policy and is available to answer questions about conflict of interest, including questions about COI as it relates to the protection of human subjects. The FCOIO is notified when an IRB submission involves disclosure of a conflict of interest or a financial entity.

HRPP staff communicate with the COI office and/or FCOIO regarding conflict of interest disclosures, review, and management.  The IRB chair communicates with the FCOIO regarding advice, consultation, and notification of IRB determinations of conflict of interest that 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 FCOIO works with the CRC which is responsible for developing and enforcing 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) 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 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.

Sponsored Programs Administration (SPA) and Business CONNECT (BC)

Sponsored Programs Administration (SPA) reports to ORI and the Vice President for Finance and Treasurer and includes the Office of Sponsored Programs (OSP) and Contract and Grant Administration (CGA). OSP manages financial and contractual aspects of submitting proposals to non-industrial external sponsors and reviews, negotiates, and accepts the terms of awards. CGA manages awards after they are made to the university. Any non-industry agreement that involves financial transactions and obligations between MSU and other parties must be reviewed by OSP. CGA is responsible for the administration of awards (industrial and non-industrial) according to sponsor's and MSU regulations.

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.

Investigators are required to disclose through SPA’s online system whether the proposal includes human subject research. Communication between the IRB and OSP or BC includes the review of 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 readable consent language).
• 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.
• The IRB reviews the final consent form for approval.

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 or determined exempt, 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 IRB approval to SPA.

Individuals within BC are notified when an IRB submission involves an industry sponsored clinical trial. Individuals within OSP are notified when an IRB submission involves a non-industry sponsored clinical trial.

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 when the protocol indicates that data will be shared with another institution.

MSU Office of the General Counsel (OGC)

Generally, the 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 ORA and the HRPP and is contacted when legal questions arise.

The legal counsel assigned to ORA and 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.

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.

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).

Clinical and Translational Sciences Institute (CTSI)

The CTSI is organized under ORI and assists researchers with the development, implementation, management, and completion of industry and government-funded clinical research (i.e., 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 in all its diverse dimensions. 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 IRB approval 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 the Registrar

The Office of the Registrar is an academic service unit, whose core functions include academic records and transcripts; certificates and diplomas; classroom and event scheduling; degree certification; enrollment and registration; grade collection and recording; fee classification; student athlete and veterans’ certification; and transfer credit processing.

Individuals within the Office of the Registrar are 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 subject of the research, or any other individual. When reporting as required by HRPP Manual 4-8, Reporting Policy, any incident that may also involve research misconduct is report 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.

Institutional Reliance Partners

MSU has entered into institution-wide agreements that permit reliance on an MSU IRB. Designated individual(s) from certain institutional reliance partners are 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.

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 ORA, IO) if needed to determine whether the request may be fulfilled.

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.

Related HRPP Manual Sections

• 4-4, Institutional Official
• 4-8, Reporting Policy