Human Research Protection Policy

Purpose: 
To describe the human research protections program at Pacific Northwest University of Health Sciences (PNWU). 

Scope: 
This policy applies to all agents, offices, departments, and affiliate sites of PNWU. 

Policy:  
3.1 PNWU fosters a research environment that promotes the respect for the rights and welfare of individuals recruited for, or participating in, research conducted by or under the auspices of PNWU. In the review and conduct of research, actions by PNWU will be guided by the principles (i.e., respect for persons, beneficence, and justice) set forth in the Ethical Principles and Guidelines for the Protection of Human Subjects of Research (often referred to as the Belmont Report).  The actions of PNWU will also conform to all applicable federal, state, and local laws and regulations. 

3.2 In order to fulfill this mission, PNWU has established a human research protections program (HRPP). The mission of the HRPP is to: 

• Safeguard and promote the health and welfare of human research subjects by ensuring that their rights, safety and well-being are protected;  
• Provide guidance and support to the research community in the conduct of research with human subjects; 
• Assist the research community in ensuring compliance with relevant regulations; 
• To provide timely and high- quality education, review and monitoring of human research projects; and  
• To facilitate excellence in human subjects research. 

3.3 PNWU will designate an Institutional Official (IO) who has overall responsibility for PNWU’s HRPP. The IO is appointed by the PNWU President. The duties of the Institutional Official are as follows: 

• Fostering, supporting and maintaining an organizational culture that supports the ethical conduct of all research involving human subjects and the adherence to regulations and organizational policies; 
• Oversight of the Institutional Review Board (IRB); 
• Ensuring that the IRB functions independently by, among other mechanisms, being directly accessible to the IRB Chair(s) and members if they experience undue influence or if they have concerns about the function of the IRB; 
• Oversight of the Institutional Review Board (IRB); 
• Oversight over the conduct of research conducted by all PNWU investigators; 
• Ensuring the IRB members are appropriately knowledgeable to review research in accordance with ethical standards and applicable regulations; 
• Ensuring that all investigators are appropriately knowledgeable to conduct research in accordance with ethical standards and applicable regulations;  
• Oversight of the development and implementation of an educational plan for IRB members, staff and investigators; 
• Ensuring compliance with institutional policies and all applicable regulations for the protection of human subjects; 
• Serving as the signatory authority and ensuring compliance with the terms of the Federalwide Assurance to the Office of Human Research Protections; and  
• Providing support to the human research protections program, by ensuring that the HRPP has the sufficient staff and resources to fulfill its mission and obligations. 

In the performance of these duties, the Institutional Official has the authority to delegate such activities as may be necessary in order to fulfill these duties. 

3.4 To conduct its responsibility effectively, PNWU maintains an Institutional Review Board (IRB) to review research protocols involving human subjects.  The IRB is an autonomous administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of PNWU. The IRB has the following authority: 

• To approve, require modifications to secure approval, or disapprove all research activities overseen and conducted under the auspices of PNWU, regardless of location of the research activities;  
• To require that informed consent be obtained and documented in accordance with regulatory requirements unless the criteria for the waiver or alteration of such requirements has been satisfied and approved by the IRB.  The IRB may require that information, in addition to that specifically mentioned in the regulations, be given to the subjects when in the IRB’s judgment the information would meaningfully add to the protection of the rights and welfare of subjects; 
• To conduct continuing review of research at intervals appropriate to the degree of risk of the research; 
• To suspend or terminate approval of research not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to subjects;  
• To observe, or have a third party observe, the consent process;  
• To observe, or have a third party observe, the conduct of the research; and  
• To determine whether data or information gathered without IRB approval or in association with serious noncompliance may be published or used for research purposes. 

3.5 All IRB-approved non-exempt research studies are subject to ongoing review, which must be conducted at least once annually by the IRB.  If approval by the IRB lapses, all research activity must stop unless it is determined to be in the best interest of already enrolled subjects to continue participating in the research. The investigator can petition the IRB to continue an individual subject’s research intervention/interaction during a period of lapsed IRB approval if the investigator believes there is a safety concern or ethical issue such that it is in the best interests of the individual participant to do so. 

3.6 The IRB has jurisdiction over all human subject research conducted under the auspices of PNWU, regardless of funding source or performance site. Research under the auspices of the institution includes research: 

• Conducted at this organization;  
• Conducted by or under the direction of any employee or agent of this organization (including students) in connection with his or her organization responsibilities;  
• Conducted by or under the direction of any employee or agent (including students) of this organization using any property or facility of this organization; or  
• Involving the use of this organization’s non-public information to identify, contact, or study human subjects. 

3.7 No non-exempt research involving human subjects may be conducted without IRB approval and no research may commence until all required Institutional approvals (including IRB) are obtained.

3.8 Exempt research is subject to review for determination of exemption status. At PNWU exempt studies are reviewed and granted by appropriately qualified members of the Institutional Review Board. Exempt research undergoes an annual check-in procedure that assists the IRB in determining if the exempt research is ongoing or if changes have been made to the research since the initial submission. Exempt study reviews are assigned to members on a rotating basis.  

3.9 PNWU may review any human subjects research protocol and has the right to disapprove or terminate approval of a research protocol that has been approved by the IRB.  However, no one at PNWU shall approve the implementation of human subjects research that has not been approved by the IRB nor may anyone override a decision of the IRB.   

3.10 All institutional and non-institutional performance sites for PNWU, domestic or foreign, will be obligated by this policy to conform to ethical principles which are at least equivalent to those of this institution or as may be determined by the Department of Health and Human Services (DHHS) Secretary. 

3.11 The Institutional Official and the IRB shall adopt operating procedures to implement this policy.  These procedures shall serve as the governing procedures for the conduct and review of all human research conducted under the auspices of PNWU  

Related documents: 
Code of Federal Regulations, Title 45, Public Welfare, Department oOf Health aAnd Human Services Part 46, Protection of Human Subjects, Revised Common Rule, Effective January 21, 2019 https://www.hhs.gov/ohrp/regulations-and-policy/index.html 

PNWU Standard Operating Procedure 124 Review and Approval of Studies 

Policy Resources

• Policy Development and Approval Training
• Establishing and Creating University Policies and Procedures (Policy)
• Policy Development & Approval Procedure
• Policy Development & Approval Diagram
• Policy Justification Form
• Policy Template (password protected)
• Procedure Resources (password protected)
• PNWU Alumni Association Bylaws
• COM Bylaws
• PNWU Bylaws

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For assistance with policies and procedures contact:

Lori Fulton
lfulton@pnwu.edu