1360 Human Research Protection
This policy applies to all personnel who conduct research involving human subjects under the purview of the Yale University designated IRB1 (Yale IRB or an external IRB authorized by the Yale Human Research Protection program (HRPP) to provide review of research on behalf of Yale), and to the members and staff supporting the Yale University Institutional Review Boards.
The University fosters a research environment that promotes respect for the rights and welfare of human subjects in research. In the review and conduct of research involving human subjects, actions by the University will be guided by the principles of respect for persons, beneficence, and justice as set forth in the Belmont Report (Ethical Principles and Guidelines for the Protection of Human Subjects of Research) and other applicable guidelines and human research standards. The actions of the University will also conform to applicable federal, state, and local laws and regulations.
The University maintains an integrated human research protection program (HRPP) under the oversight of the Associate Vice President for Research Administration to ensure the protection of human subjects who participate in research projects conducted under the auspices of the University. 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.
- Provide timely and high-quality education, review, and oversight of human research projects.
- Facilitate best practices in the conduct of human subjects research.
University personnel involved in human research are required to prospectively submit research protocols to the University Human Research Protection Office for submission for review by the relevant Institutional Review Board (IRB). Human research protocols cannot commence without IRB approval or exemption determination by the IRB or experienced HRPP/IRB staff.
The University recognizes that the protection of human subjects participating in research transcends traditional department jurisdictions and is not the sole responsibility of the IRB. The University therefore includes comprehensive regulatory, compliance, quality, education, and IRB reliance functions managed by the HRPP office, as well as, investigator and departmental oversight responsibilities to allow for an integrated program for research subject protection initiatives as they relate to the individual and the unit’s core function in supporting the research enterprise.
Reason for the Policy
- To ensure that the rights and welfare of human research participants are protected in all research conducted under the auspices of Yale University.
- To define the review, approval and oversight responsibilities and authority of the University Institutional Review Boards (IRBs), the Human Subjects Protection Administrator (HPA) and the Institutional Official (IO) for the ethical conduct of research involving human subjects which the University has included in its human research protection program.
- To describe the Yale University Human Research Protection Program (HRPP).
Institutional Review Board
An autonomous committee established in accordance with applicable regulations to protect the rights and welfare of human research subjects.
The Yale University Human Research Protection Program (HRPP) involves the cooperative interaction of offices and individuals within the University which are involved in research involving human subjects.
The Associate Vice President for Research Administration is the Institutional Official (IO) responsible for oversight of the HRPP and the human subjects research the University engages in. The responsibilities of the IO include:
- Fostering, supporting, and maintaining an organizational culture that supports the ethical conduct of research involving human subjects and compliance with applicable regulatory and other requirements.
- Serving as the signatory authority and ensuring compliance with the terms of the University’s Federal-wide Assurance filed with the Office of Human Research Protections.
- Ensuring that the HRPP and IRBs have the resources and support necessary to fulfill their mission and responsibilities. Such resources include, but are not limited to:
- Staffing commensurate with the size and complexity of the research program.
- Appropriate office space, meeting space, equipment, materials, and technology.
- Resources for the production, maintenance, and secure storage of HRPP and IRB records.
- Resources for overseeing the conduct of research, including audits and investigations.
- Access to legal counsel.
- Access to consulting reviewers as needed to ensure that the IRB has the appropriate expertise to review the research before it.
- Training in human research protections and other relevant subject matter for researchers, IRB members, and staff to support the review and conduct of human research in accordance with ethical standards and applicable regulations and requirements.
- Appointing members of the IRBs
- Ensuring that the IRB functions independently by, among other mechanisms, being directly accessible to the IRB Chairs and members if they experience undue influence or if they have concerns about how the IRB is functioning.
- Oversight of the IRBs
- Determining when reliance upon an external IRB is acceptable and appropriate.
- Oversight over the conduct of research under the auspices of the University
- Taking action as necessary to ensure the protection of human subjects, the integrity of research and the HRPP, the autonomy and authority of the IRBs, the proper conduct of research, and to ensure compliance with regulatory and other requirements. This includes the authority to suspend, terminate, or disapprove research, to sanction or restrict research privileges, and to disallow or restrict the use of research data. Such actions will be reported to the HRPP and IRB when appropriate (e.g., so that the HRPP and IRB may take any necessary actions to ensure the protection of human subjects).
The IO ensures that the IRBs retain autonomy and remain free from undue influence. Attempts to unduly influence HRPP or IRB members or staff to obtain a particular result, decision, or action by the HRPP or IRB are not tolerated at Yale. The Institutional Official must be informed of any allegation of undue influence on the HRPP, IRB, or its staff. Reports of potential undue influence will be thoroughly investigated by an appropriate person or persons assigned by the IO and, if determined valid, corrective actions will be taken by the University to manage the situation and prevent additional occurrences.
In the performance of these duties, the IO has the authority to delegate responsibilities to others while maintaining primary responsibility for the program.
The Institutional Official and the HRPP shall adopt operating procedures to implement this policy. These procedures shall serve as the governing procedures for the conduct and review of human research conducted under the auspices of Yale University.
The Human Protections Administrator (HPA) is responsible for oversight and day-to-day management of the HRPP. The HPA ensures that IRB policies, procedures and practices are compliant with applicable laws, regulations, guidelines, and other human research standards. The HPA provides guidance to the IRBs and ensures consistency across the University IRBs.
The University maintains Institutional Review Boards (IRBs) which are charged with the review and continuing oversight of research involving human subjects, in accordance with University policies and applicable laws, regulations, and other human research standards. The IRBs have the authority to:
- Determine when activities do not require IRB review.
- Determine when research qualifies for exempt status, and to conduct limited IRB review when applicable.
- Approve, require modifications to secure approval, or disapprove human subject research activities, including exempt research under 45 CFR 46.104 of the revised Common Rule for which limited IRB review is a condition of exemption.
- Require that informed consent be obtained and documented in accordance with regulatory and policy requirements unless the IRB determines that the criteria for the waiver or alteration of such requirements have been satisfied and approves the waiver or alteration. 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.
- Conduct continuing review of research at intervals appropriate to the degree of risk of the research, but not less than once per year unless continuing review is not required under applicable regulation and/or policy.
- 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, this authority extends to exempt research.
- Observe, or have a third party observe, the consent process.
- Observe, or have a third party observe, the conduct of the research; and
- In consultation with the HPA and IO, determine whether data or specimens gathered without IRB approval or in association with serious or continuing noncompliance may be published or used for research purposes.
- Oversee the conduct of human subjects research that qualifies for exempt status and to take action as needed to ensure the protection of human subjects and the integrity of the research.
All IRB-approved research studies are subject to ongoing review. 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 University IRBs have jurisdiction over all human subject research conducted under the auspices of Yale, regardless of funding source or performance site, unless the University has agreed to rely upon an external IRB for the IRB review and oversight of a protocol or determines that the University is not engaged in the research. Research under the auspices of Yale includes research:
- Conducted at or using any property or facility of the University.
- Conducted by or under the direction of any employee or agent of the University (including students) in connection with their University position or responsibilities.
- Involving the use of the University’s non-public information to identify, contact, or study human subjects.
No research involving human subjects may be conducted without IRB approval and no research may commence until all required Institutional approvals (including IRB) are obtained. Exempt research is subject to review for determination of exemption status. At Yale, exemptions are determined by IRB members and, when appropriate, experienced HRPP/IRB staff.
Other institutional bodies may review any human subjects research protocol and may have the right to disapprove or terminate approval of a research protocol that has been approved by the IRB of record. However, no one at the University may approve the implementation of human subjects research that has been disapproved or not yet been approved by the IRB, nor may anyone override an IRB suspension or termination of IRB approval.
University faculty, staff, fellows, students, and trainees involved in the design, conduct or analysis of human research are responsible for ensuring adequate subject protection. Investigators must submit human research protocols to the IRB for approval or other determination pursuant to IRB procedures prior to commencing the research.
Investigators shall maintain IRB approval for the lifespan of the project and shall submit continuing review materials to the IRB as necessary to maintain the approval. Research staff shall adhere to the approved protocol except when nonadherence is necessary to eliminate apparent immediate hazards to the subject(s), such deviations must be promptly reported to the IRB in accordance with the IRB’s procedures.
Other offices or committees that oversee University research are responsible for considering the rights and welfare of human subjects participating in Yale studies when developing and carrying out their core functions supporting the research, including their own compliance responsibilities. These entities are responsible for integrating their core business processes and/or responsibilities into the University’s human subject protection program. Coordination and communication among components is ensured through periodic meetings. Review functions are coordinated through a comprehensive ancillary review process to ensure that all necessary reviews and approvals are in place before research commences.
The HRPP will conduct oversight and supporting activities to ensure that all individuals involved in the conduct of human research understand their responsibilities and adhere to University policies related to the conduct of human research. The HRPP is also responsible for the development and maintenance of systems and processes to facilitate human research record keeping and reporting requirements.
- 45 CFR 46 (2018 Common Rule)
- 21 CFR 56 (FDA – Institutional Review Boards)
- The Belmont Report
- Yale University Human Research Protection Program (HRPP) Policy and Standard Operating Procedure Manual
- AAHRPP Element I.1.B - The organization delegates responsibility for the HRPP to an official with sufficient standing, authority, and independence to ensure implementation and maintenance of the program
- AAHRPP Element I.1.C – The organization has and follows written policies and procedures that allow the Institutional Review Board or Ethics Committee to function independently of other organizational entities in protecting research participants