Human Research Protection Program

HITECH Act

Roles & Responsibilities

Institutional Signatory Official (IO)

The Institutional Signatory Official is a senior official who has the authority to commit Yale to the legally binding FWA terms and conditions. The IO has the authority to require compliance of the organization and all of its components to the terms of the FWA.

Responsibilities of the Institutional Official

  • Be cognizant of and understand the federal regulations pertaining to and the responsibilities of all components of the HRPP including the Organization, the IRBs, Sponsored Research, and investigators and research staff in protecting human research participants.
  • Appoint IRB Chairs and members.
  • Ensure that necessary resources are allocated to the human research protection program to assure its success.
  • Report all incidents, as required by Yale’s Federalwide Assurance, deemed to be serous or continuing noncompliance to the appropriate federal authorities.
  • Complete all training requirements for the protection of human research participants, and for HIPAA.
  • Receive regular communication regarding the status of the human research protection program and, as necessary, individual studies.
  • Meet regularly with IRB Chairs and senior HRPP leadership

Director, Human Research Protection Program (HRPP)

An individual capable, both in experience and available resources, of overseeing the organization's human research protection program. The Director serves as the primary contact for OHRP regarding human research protection issues for the organization. The Director has responsibility for the organization's distributed program for protecting human participants in research. The Director should have comprehensive knowledge of all aspects of the organization's system of protections for research participants, as well as be familiar with the organization's commitments under the FWA, and play a key role in ensuring that the organization fulfills its responsibilities under the FWA. 

Responsibilities of the Director, HRPP

  • Maintain Yale's Federalwide Assurance (FWA) and ensure compliance with its terms, as well as Yale policies and procedures, federal regulations, and state and local laws relative to the conduct of human research studies.
  • Provide guidance regarding the interpretation of regulations, laws, and policies to the organization's IRBs, researchers, staff, and administrators.
  • Develop and implement Yale human research protection policies and procedures.
  • Oversee and coordinate HRPP activities across the various offices and staff that have roles in protecting research participants.
  • Complete all required human research protection training and HIPAA training.
  • Ensure that human research protection training is available and completed by investigators, key study personnel, the Institutional Signatory Official, and all Yale staff who participate in the human subjects protection program.
  • Oversee the quality assurance monitoring of the HRPP, including research protocols and investigation of matters of non-compliance. Ensure implementation of corrective action, as needed, in accordance with Yale policies and IRB policies and procedures.
  • Maintain current knowledge of human research protection guidance and regulations as they evolve. Stay current on emerging issues. Monitor federal regulatory websites and other research-related resources so as to stay current with regulatory changes in human research protections guidelines and policies. Communicate pertinent information to staff in a timely manner.

Institutional Review Board (IRB)

A federally mandated committee charged with responsibility to review proposed research in order to ensure that the rights of research participants are protected and that risk of harm to participants is minimized.

Responsibilities of the Institutional Review Board

  • Review all research activities involving human participants and document its findings regarding ethical considerations, scientific merit, and adherence to federal regulations and IRB policies and procedures.
  • Responsible for ensuring compliance with the terms of the Institution’s Federalwide Assurance (FWA) as well as Yale policies and procedures, federal regulations, and state and local laws related to the review of human research.
  • Review research activities to ensure that:
    • Risks to subjects are minimized;
    • Risks to subjects are reasonable in relation to anticipated benefits;
    • Selection of subjects is equitable;
    • Informed consent is obtained or appropriately waived from all prospective subjects and documented;
    • The research protocol includes a plan for data and safety monitoring;
    • Subjects' privacy and confidentiality are protected; and
    • Appropriate additional safeguards are incorporated for any vulnerable subjects.
  • Review research protocols with the authority to:
    • Approve;
    • Require modifications to secure approval;
    • Disapprove; and
    • Terminate or suspend.
  • Conduct continuing reviews of approved research. Review proposed amendments, adverse events, protocol deviations, and matters of non-compliance.
  • Determine if and when it will:
    • Require research progress reports;
    • Audit and/or monitor the research and researchers for adherence to the federal regulations and policies and IRB policies and procedures; and
    • Report suspensions, terminations, and non-compliance to IRB officials, Yale officials, and the federal government.

IRB Chair & Vice Chair

In conjunction with the Associate Vice President for Research Administration, the Office of the Provost, the Office of the General Counsel, appropriate Yale Deans’ Offices, other University IRB Chairs, Vice Chairs and others, the IRB Chair promotes a culture consistent with the objectives of Yale’s Human Research Protection Program (HRPP), with special emphasis on the respect for and protection of individuals participating in research at the University. In promoting such a culture, the Chair and Vice Chair are directly responsible for overseeing the protection of research participants by ensuring the proper review, approval, disapproval or determination of exemption from further review of research protocol submissions to the IRB.

Responsibilities of the Institutional Review Board Chair and Vice Chair

  • Preside over meetings of the fully convened IRB and ensure that the IRB carries out its duly authorized responsibilities as required by federal regulations, ethical principles, state laws and University policy.

  • Review and approve protocol submissions that qualify for expedited review pursuant to federal regulations, ethical principles, state laws and University policies, or delegate such authority to a qualified and experienced IRB member to conduct such review and approval.
  • Ensure that membership of the IRB is recruited, appointed and oriented such that the IRB is duly qualified to fulfill its obligations to review, require modifications to, approve (or disapprove) research protocols that represent the breadth of research submitted to the IRB by Yale researchers.
  • Serve as a liason between the HRPP and the University research community to promote communication and understanding of the concerns of the IRB, the research community and other HRPP partners.
  • Ensure that reports related to safety, noncompliance, unanticipated problems in research and adverse events are reviewed, attended to and reported pursuant to federal regulations, state laws and University policy.
  • Respond to local and federal investigations relating to protocols and actions, as required.
  • In conjunction with the Associate Vice Provost for Research Administration, the Offices of the Provost, General Counsel, the Yale Deans and others as appropriate, develop and revise HRPP and IRB policies, procedures and guidelines to stay current with societal thinking, regulatory changes and national best practice standards.

Institutional Review Board Manager & Staff

Administrative and professional staff that support and facilitate the IRB processes.

Responsibilities of the Institutional Review Board Staff

  • Provide guidance regarding the interpretation of regulations, laws, and policies to researchers, staff, and Yale administrators.
  • Ensure compliance with the terms of Yale's Federalwide Assurance (FWA) as well as with Yale policies and procedures, federal regulations, and state and local laws related to the review of human research.
  • Participate in the development and subsequent implementation of Yale's human research protection policies and procedures.
  • Perform quality assurance monitoring of research protocols and investigate matters of non-compliance. Implement corrective action(s) as needed in accordance with federal regulations, Yale policies, and IRB policies and procedures.
  • Provide human research protection training for investigators, key study personnel, IRB members, and IRB staff.
  • Complete all training requirements and stay informed of current research-related and regulatory developments.
  • Monitor federal regulatory websites and other research-related resources to stay current with regulatory changes in human research protection guidelines and policies. Communicate pertinent information to other IRB staff, IRB members, and investigators in a timely manner.
  • Maintain IRB study-related documentation in accordance with Yale policies, IRB policies, and federal regulations

Compliance Manager

The Compliance Manager serves as the primary contact for compliance issues involving human subjects research at Yale University.  The Compliance Manager is responsible for the continued development and implementation of a post-IRB approval monitoring program of research studies involving human subjects, as well as other quality improvement activities.

Responsibilities of the Compliance Manager

  • Conduct reviews in response to allegations and findings of noncompliance with Human Research Protection Program (HRPP) and sponsor requirements.
  • Conduct systematic reviews that evaluate researchers’ and their study team’s compliance with approved protocols, federal regulations and guidance regarding the protection of human subjects, and relevant University and HRPP/IRB policies relating to the protection of subjects participating in research. 
  • Review protocol review processes performed by the Yale Institutional Review Boards (IRBs) to ensure compliance with federal regulations and guidance and University and HRPP/IRB policies and procedures regarding the human subject protection programs and protocol tracking integrity.
  • Compile reports on audit/monitoring findings. Recommend corrective actions to researchers and the IRBs as required. Report findings when appropriate to the IRB Leadership, the Associate Vice President for Research Administration (the Institutional Official), the University Research Compliance Officer, the Office of the General Counsel, the University’s Chief Privacy Officer and other University compliance offices and authorities.
  • Receive and handle compliance issues and complaints, and may refer such items, as appropriate, to the University Research Compliance Officer, Yale Medical Group, appropriate Deans’ offices and other Yale University offices for investigation and resolution.
  • In conjunction with other HRPP leadership, develop and implement written policies and procedures that foster and enhance compliance in research involving human subjects.
  • Generate reports requested by federal agencies. Assist representatives from sponsors and federal agencies conducting audits of Yale human research activities.
  • Develop and conduct seminars and lectures, distributing literature, and other programs to educate and facilitate compliance of Yale’s human research activities.
  • Notify the HRPP and research community of important research ethics and human subject protection issues as they arise. Monitor changes in federal regulations and state laws and assess their impact on research compliance. Provide guidance to operations staff and IRB members on federal regulations and state laws as required.
  • Serve as a compliance resource to the research community and other internal interested parties.

Education and Community Outreach Manager

The Education and Community Outreach Manager is responsible for the development, implementation and oversight of human subject protection programs to ensure that research personnel, IRB members and staff and other persons charged with the protection of research participants receive and maintain the training and education necessary to fulfill their obligations in the research enterprise. In addition, the Education and Community Outreach Manager works with Yale researchers whose studies include collaborations with external organizations or individuals, to ensure appropriate IRB approvals, and to provide support to community agencies for whom Yale serves as IRB of record as they develop their research infrastructure.

Responsibilities of the Education and Community Outreach Manager

  • Manage the HRPP’s comprehensive human subject protection training curriculum.   Manage, develop, plan and/or coordinate appropriate human subjects protection education programs, workshops and conferences, on a regular basis, that complement and enhance the core human subjects protection curriculum.  Ensure that appropriate courses are offered to the Research Community by either presenting the information directly or arranging for guest speakers and lecturers who are qualified to conduct the course offering.  Conduct ad hoc training programs as required.
  • Develop, with input from IRB Chairs and HRPP Leadership members, a comprehensive IRB member orientation and training program.  With a Chair, or the Chair’s designee, conduct new IRB member orientation for incoming members of the Human Investigation Committee.  Manage the new member orientation program to ensure that new members are conversant in the area of federal regulations and guidance regarding the protection of human subjects and relevant University and IRB policies relating to the protection of subjects participating in research. 
  • Responsible for working with institutional officials and IRB administrators in developing formal collaborative agreements with IRBs external to Yale, so that Yale may rely on these external IRBs for research project approval and/or whereby the external institution may rely on the HIC approval in lieu of their conducting their own IRB review and approval.  Responsible for recommending formal approval of these collaborative agreements to the HRPP Director and the University Institutional Official.
  • Responsible for formally recommending to the HRPP Director and University Institutional Official approval of requests made by prospective research affiliate organizations to rely on the HIC as their IRB of record as required by the Department of Health and Human Services Federal Wide Assurance (FWA). or Collaborating Investigator requirements.   Facilitates discussions with research investigators, program directors and high ranking
  • Responsible for formally recommending to the IRB Chair approval of requests made by prospective Independent Investigators to rely on the HIC as their IRB of record as required by the Department of Health and Human Services.
  • Responsible for interfacing directly with community representatives, agencies, organizations and support groups on behalf of the HRPP, the University and investigators to provide education about the risks and benefits of participating in human subject research. 

Billing and Affiliate Agreements

The Institutional Review Board Billing (IRB) and Affiliate Agreements Manager role is to ensure the maximum recovery of IRB fees related to Industry Sponsored Clinical Trial Agreements (CTA), as well as monitor and track existing IRB Authorization Agreements (IAA), and Research Affiliates. The IRB Billing and Affiliate Agreements Manager functions as a primary resource and educator on IRB review fees communicating with clinical departments, Grant and Contract Administration (GCA) staff, to ensure contracts contain proper language set forth by Yale University Office of Research Administration Official.

Responsibilities of the Billing and Affiliate Agreements Manager

  • Develop, implement, and amend University Policy & Procedure relating to IRB review fees.
  • Monitor and review Industry Sponsored CTAs to optimize reimbursement and safeguard billing compliance with university, government, & third party regulations and payer requirements.
  • Advise and/or propose recommendations to the Human Research Protection Program’s (HRPP) Director of improvements to maximize reimbursements.
  • Design, modify and maintain revenue accounting system to provide a record of IRB revenue.
  • Generate weekly account summary report ensuring accuracy of financial information.
  • Analyze and interpret data; identify trends or deviations from standards and assess impact of trends, explain or resolve variances.
  • Invoice Industry Sponsors in accordance to the terms and conditions set forth in the Clinical Trial Agreement.
  • Regularly review account receivable and aging history reports.
  • Communicate with Industry Sponsors to resolve billing discrepancies.
  • Identify delinquent accounts and prepare final review and disposition of problem accounts.
  • Review Human Investigation Committee (HIC) protocol to certify proper coding is utilized by Regulatory Analyst to accurately reflect the correct action in the submission type or submission qualifier type to ensure Industry Sponsor is appropriately invoiced.
  • Perform quality assurance; audit active HIC protocols to ensure all Industry Sponsor CTA are being invoiced.
  • Serve as a resource for IRB billing and review fees; providing information, assistance and training to faculty, staff.

Informatics Manager  

The Informatics Manager is the principal liaison for the development, maintenance, and analysis of information pertaining to not only the Human Research Protection Program at Yale University, but also the research community at Yale in general. To this end, the Informatics Manager oversees the proper functioning of the current electronic submission system (Coeus), the creation of a new electronic submission system, all HRPP-related websites, reporting conducted within the auspices of the HRPP, as well as supervises administrators dedicated to these goals.

Responsibilities of the Informatics Manager

  • Development and implementation of a new robust electronic submission system for the Yale IRBs and affiliated research communities.
  • Analysis of reporting information concerning past and present interactions between the Yale Human Research Protection Program (HRPP) and the research community, including (but not limited to) submission turnaround time, review periods, researcher profile metrics, and comparison data between the various IRBs at Yale and abroad.
  • Oversight of the current Coeus electronic submission system, including serving as the primary liaison between the HRPP and Yale Information Technology Services (ITS), as well as consulting groups hired for enhancement and continuing maintenance purposes for the system.
  • Enhancement of the current HRPP and Coeus websites, including the development of a new, Drupal-based compilation site that will house both existing pages and provide a more sophisticated method for information gathering and interactive training for the Yale research community and beyond.
  • Supervision of administrative staff (both full-time HRPP staff and student employees) tasked with providing assistance on the items listed above, as well as additional Informatics-related duties.

HIPAA Privacy Board

A committee formed within a HIPAA covered entity to review requests to waive authorization for access to PHI (protected health information) for research purposes.

Responsibilities of the HIPAA Privacy Board

  • Review and approve or deny requests for waiver of participant authorization.
  • Complete all training requirements and stay informed of current regulatory developments.

Scientific and Safety Review and other Research Oversight Committees and their responsibilities

Review by specific scientific or safety oversight committees may be necessary before submitting a protocol to the IRB. The need for this review is dependent on specific protocol attributes which may include children as subjects, area of research, resource utilization and/or exposure to radioactive agents or interventions for research purposes.

Oversight committees that must review the protocol prior to its being submitted to the IRB

  • Institutional Biosafety Committee (IBC): Reviews the scientific and safety aspects of research involving gene transfers, human pathogen and other biologic agents.

  • Magnetic Resonance Research Center Protocol Review Committee (MRRC): Reviews and approves all human research protocols that will make use of the facilities of the MRRC. The Committee evaluates each proposed study for the level of supervision that must be available, based primarily on risk stratification.

  • Pediatric Protocol Review Committee (PPRC): Reviews the scientific aspects of all research at the Yale School of Medicine that involves children, with the exception of Pediatric Oncology, which is reviewed by the Yale Cancer Center’s Protocol Review Committee.

  • Protocol Review Committee (PRC): Reviews the scientific aspects of all oncology research to be conducted at Yale, regardless of department.

  • Psychology Subject Pool Committee: Oversees the process for ensuring that research proposals intending to recruit introductory psychology students meet education standards set for the course.
  • Radiation Safety Committee: Reviews, on the basis of safety, and approves or denies, consistent with the limitations of the regulations and the license, all requests for authorization to use radioactive material within the institution.
  • Yale Diagnostic Clinical Research Committee: All research studies utilizing Diagnostic Imaging hospital/affiliated facilities imaging equipment or research studies requesting a Diagnostic Radiology clinical research coordinator must be reviewed and approved by the YDR Clinical Research Committee.
  • Yale New Haven Hospital Radioactive Drug Research Committee: Oversees the use of radioactive materials to be used in human participants, prepared at the Yale Medical Center, which require neither an Investigational New Drug (IND) nor Food and Drug Administration (FDA) approval.
  • Yale Center for Clinical Investigation (YCCI): The YCCI participates in the review of research that is fully or partially supported with YCCI funds. The scientific aspects of research supported by the YCCI may be reviewed by the YCCI’s Science and Safety Committee (SSC).
  • Other HRPP Partners With Oversight Responsibilities
    • IRB Leadership: Provides oversight and guidance to the IRBs. Reviews and approves institution-wide IRB policies, and, if applicable, Good Clinical Practice Guidelines as adopted by the Food and Drug Administration (FDA) for the conduct of human research.
    • Committee on Conflict of Interest and Conflict of Commitment: Collaborates with the Yale IRBs in the review of protocol-specific conflict of interest disclosures and ensures that conflicts are either reduced, managed or eliminated.
    • Office of the General Counsel: Interprets regulations related to the protection of human research participants and advises and guides Yale personnel in the protection of research participants.

 

Last Updated 3/5/2013