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1. Purpose of policy

This policy reaffirms the University’s commitment to the protection of the rights and welfare of human subjects research. The University requires all human subjects research to be conducted in conformance and compliance with all applicable federal, state and other regulations, and with the terms of the Federalwide Assurance (FWA) on file with the U.S. Department of Health and Human Services (DHHS), Office for Human Research Protections (OHRP). The policy supports the University's mission to pursue excellence to enable discovery, and promote creativity and research.

2. Stakeholders most impacted by the policy

All faculty, staff and other employees, students, volunteers or other individuals conducting research under the aegis of WMU, on WMU premises, using WMU’s property or facilities, and WMU’s Institutional Review Board (IRB).

3. Key Definitions 

The key definitions are “research” and “human subject” as defined by the federal agencies administering the regulations related to the protections of human research subjects. 

• 3.1. Research:  For purposes of this policy, the University adheres to the definitions of research as provided by DHHS under 45 CFR 46.102(d) and the Food and Drug Administration (FDA) under 21 CFR 50.3(c), 21 CFR 56.102(c).
• 3.2. Human Subject:  The University adheres to the definitions of human subject as provided by DHHS under 45 CFR 102(f) and the FDA under 21 CFR 50.3(g), 21 CFR 56.102(e).  *
• 3.3. Principal Investigator (PI) is a university employee with an eligible appointment who is responsible for conduct of a research, training, or service project. The PI is the primary researcher who must personally participate in the project and will be responsible for the funded or unfunded project, directing the research, and reporting directly to WMU IRB, sponsor, or others as required.
• 3.4 Serious Adverse Event (SAE): Any adverse event that results in death; is life-threatening (places the subject at immediate risk of death from the event as it occurred); results in inpatient hospitalization or prolongation of existing hospitalization; results in a persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; or based upon appropriate medical judgment, may jeopardize the subject’s health and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

*Note:    The terms “subject” and “participant” are used interchangeably in this document and have the same definition throughout the materials and guidance for the Western ��һ�鶹��Ƭ�� University’s Human Subject Research Protection Program (HRPP).

4. Full Policy DETAILS 

Without exception, all human subject research conducted at or by Western ��һ�鶹��Ƭ�� University must receive prior approval of University’s Institutional Review Board (IRB).

4.1. The following outlines the roles, authorities, and responsibilities for the Human Subject Research Protection Program at Western ��һ�鶹��Ƭ�� University.

• 4.1.1. Institutional Official (IO):   The Institutional Official is the signatory for the Federalwide Assurance and assures that human subject research to which the FWA applies is conducted in accordance with the terms of the assurance. Overall Program direction is a shared responsibility among the IO, Associate Director Research Compliance, and the IRB.   The IO has the responsibility and authority for:
• 4.1.1.1. Establishing and maintaining Institutional Review Boards (IRBs) and other review bodies to review and oversee human subjects research and to ensure the protection of research participants.
• 4.1.1.2. Resource planning and ensuring alignment of Program goals with the institution’s mission while providing continuous HRPP improvement initiatives including periodic review of the program’s scope and resources dedicated to its implementation. 
• 4.1.1.3. Communicating the importance of the rights and well-being of human research subjects across Western ��һ�鶹��Ƭ�� University, and advising senior administrative officials of HRPP issues as necessary.
• 4.1.1.4. Assuming the obligations of the Federal Wide Assurance on behalf of Western ��һ�鶹��Ƭ�� University
• 4.1.1.5. Supporting implementation of Program decisions and taking administrative actions to facilitate compliance
• 4.1.1.6. Adopting and enforcing written policies and procedures governing the conduct of human subjects research designed to promote institutional and individual compliance with applicable legal and ethical standards.
• 4.1.1.7. Allocating and distributing resources as necessary to ensure the Program’s overall effectiveness.
• 4.1.1.8. Appointing individuals to the IRB and ensuring that these individuals are protected from coercion or undue influence while serving in this capacity.
• 4.1.1.9. Appointing a Chair and Vice-Chair to provide leadership to the IRB
• 4.1.1.10. Ensuring the Chair, Vice-Chair, and Associate Director Research Compliance have the proper authority and resources to meet his/her responsibilities to the HRPP.
• 4.1.1.11. Serving as a point of contact for HHS, OHRP, FDA and other federal agencies sponsoring and overseeing human subject research and providing required HRPP reports to these agencies

• 4.1.2. Institutional Review Board (IRB):   The WMU IRB is a standing committee composed pursuant to specific criteria as required by and described in the federal regulations. Board membership will meet applicable regulatory standards.   Members will appropriately represent the varying perspectives of subjects, investigators, and the community at large. IRB members will not participate in the approval of projects in which they are involved or otherwise have a conflicting interest.

• The IRB is responsible for the following oversight functions:
• 4.1.2.1. Determine what activities constitute human participant research.
• 4.1.2.2. Review, approve, disapprove or require modifications in all research activities covered by this policy prior to the commencement of the research.
• 4.1.2.3. Require that information given to participants as part of informed consent is in accordance with appropriate laws, regulations, and international standards. The IRB may require that additional information be given to the participants when, in the IRB's judgment, the information would meaningfully add to the protection of the rights and welfare of participants.
• 4.1.2.4. Require documentation of informed consent or waive documentation in accordance with federal and ��һ�鶹��Ƭ�� state laws and regulations. When research activities are being proposed to be conducted in other states and/or countries by WMU faculty, staff, and/or students, the research activities will be approved in compliance with the regulations for those specific research locations.
• 4.1.2.5. Notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
• 4.1.2.6. Conduct ongoing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year and have authority to observe or have a third party observe the consent process and the research.
• 4.1.2.7. Suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to participants. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, appropriate institutional official and the department or agency head.
• 4.1.2.8. Solicit advice from external consultants as needed to ensure appropriate expertise on the boards and represent the views of particular subject populations.
• 4.1.2.9. Provide guidance and oversight for the human participant protection program and compliance with applicable laws, regulations, and policies.
• Note: Proposals approved by the IRB may be subject to further appropriate review and approval by officials of the Institution. However, no individual or official of the university may approve a human subject research project (i.e., authorize it to proceed) that has not been reviewed and approved by the WMU IRB. The IRB’s decision-making must be independent from coercion or undue influence.

• 4.1.3. Principal Investigator (PI): Primary responsibility for research with human subjects is vested in the principal investigator conducting a study. This includes responsibility to comply with the laws, regulations, and institutional policies that regulate research. Others engaged in the conduct of the research such as co-investigators and research staff share this responsibility.

• 4.1.3.1. The following are eligible to serve as PI:
• 4.1.3.1.1. Tenured/tenure track faculty
• 4.1.3.1.2. Faculty specialists
• 4.1.3.1.3. Full time professional staff on permanent appointment with WMU that have appropriate credentials (less than full time permanent appointments are at the discretion of the WMU IRB)
• 4.1.3.1.4. Research Scientist (at the discretion of the WMU IRB)
• 4.1.3.1.5. Emeritus Faculty (with department appointment and at the discretion of the WMU IRB
• 4.1.3.2. The following are not eligible to serve as PI:
• 4.1.3.2.1. Students may not serve as the principal investigator on a human research study.
• 4.1.3.2.2. Part-time faculty, adjuncts, research associates, visiting professors, and visiting scholars are not eligible to serve as the principal investigator; however, they may serve as a Co-Investigator on a human research study.
• 4.1.3.3. Principal Investigators who conduct human subject research have the following responsibilities:
• 4.1.3.3.1. Obtain IRB approval prior to conducting any activities involving human subject research
• 4.1.3.3.2. Ensure that all personnel involved in human subject research are listed on the applicable IRB protocol prior to implementing the project.
• 4.1.3.3.3. Ensure all personnel listed on the protocol have completed the IRB required training prior to working on the research study.
• 4.1.3.3.4. Train all personnel working on the study to the approved protocol and the conduct of activities described in the protocol and the elements of confidentiality and privacy of data collected.
• 4.1.3.3.5. Promote the principles of the Belmont Report (respect for persons, beneficence, and justice).
• 4.1.3.3.6. Assure research does not expose subjects to unreasonable risk of harm (whether physical, psychological, social, legal or economic in nature).  The probability and magnitude of possible harm must be reasonable in relation to the anticipated direct or indirect benefits of participation in any research project.
• 4.1.3.3.7. Identify and minimize risks without undermining legitimate research objectives.
• 4.1.3.3.8. Ensure protocols are renewed prior to expiration for study when continuing beyond the one year approval date.
• 4.1.3.3.9. Submit all changes to the protocol to IRB for approval prior to implementation.
• 4.1.3.3.10 Assure research performed by students is supervised to ensure that the students are qualified to conduct the research and to safeguard subject rights and welfare.

4.2. Human subject research protection program will consist of: 

• 4.2.1. Procedures, guidelines, and practices to ensure all WMU research is conducted in compliance with federal, state, and local laws and regulations and University policies related to the use of humans in research. 
• 4.2.2. Documentation necessary to demonstrate compliance with laws and regulations governing the use of humans in research.
• 4.2.3. Defined process(es) for the timely review of submitted requests for human subject research protocols.
• 4.2.4. Process for post approval monitoring to assure human subjects research is being conducted as approved by the WMU IRB.
• 4.2.5. A process for record keeping and auditing (internal and external).

4.3. Training in human subject research protection

All individuals working on a human subject research project must complete an IRB approved course on the protections of humans in research.

4.4. Implementation 

To carry out this policy Western ��һ�鶹��Ƭ�� University will maintain an IRB with appropriate membership to provide for adequate reviews and adopt operating procedures to implement this policy. These procedures shall serve as the governing procedures for the conduct and review of all human subject research conducted under this policy.

The WMU IRB is a social and behavioral IRB; research involving FDA regulated or biomedical project will require review by an external IRB. The University may rely upon an external IRB for review and approval of research if (a) the University’s Institutional Official, identified in its FWA, approves use of the external IRB and (b) the external IRB meets federal standards, as determined by the responsible official. A copy of the approved protocol and approval letter must be on file with the WMU IRB.

No official of the university or affiliate shall take any action intended to influence or coerce an IRB, or any of its members, to approve specific research.

• 4.4.1. Communication: Research proposals/protocols must be communicated in writing, on the appropriate forms, to the IRB.  The IRB has final authority regarding approval of human subjects research.  Following the proposal/protocol review, the IRB will inform the investigator in writing of its determination.
• 4.4.2. Exceptions: University officials may independently review any research protocol and if they deem necessary may disapprove the implementation of a research protocol even if it has been approved by the IRB. However, University official or officials may not approve the implementation of any human subject research protocol in lieu of IRB approval, nor may they override IRB decisions disapproving a research protocol.

5. Accountability 

Infractions of federal regulations or University policies and procedures for human subject research may result in suspension or termination of the research. The IRB will investigate and determine the necessary corrective action with regard to any infraction of this policy. 

Issues of non-compliance may include additional consequences required by other University policies and governing federal agency that provides oversight for human subject research (e.g., OHRP, FDA, etc.).

Study-related serious, unanticipated adverse events – as defined by the study protocol – that are unexpected in terms of nature, severity, or frequency, given a) the research procedures that are described in the protocol-related documents and b) the characteristics of the subject population being studied, must be reported to the IRB within 24 hours with a written follow up within 5 business days.

All other adverse events that may be related, but that are not serious, should be reported within 5 days.

Protocol deviations and other non-compliance should be reported within 5 days of the event.

Additional consequences for non-compliance include possible individual disciplinary procedures for failure to follow applicable University policies and requirements.

6. Related procedures and guidelines 

Human Subject Research Standard Operating Procedures

IRB Common Practices

Training in Human Subject Research Protections

ClinicalTrials.gov Registration Procedure

Required Training for Human Subjects Researchers Procedure

Agency-required training (NIH, NIS, IRB, IACUC)

7. Additional Information 

NA

8. Faqs

See web page for frequently asked questions.