Yale IRB
Institutional Review Board

Yale University
School of Medicine
47 College Street
P.O. Box 208010
New Haven, CT
06510 USA

Ph: 203-785-4688
Fx: 203- 785-2847

Yale School of Medicine.

Roles and Responsibilities

Many different individuals and organizations play a role in the protection of human research subjects. Human subjects protection is the responsibility of all individuals and organizations involved in the research and does not fall to one individual or organization. It is important that potential RAs become familiar with the different roles and responsibilities listed below.

Principal Investigator (PI)

Definition:
Full-time Yale University faculty member with primary responsibility for the protection of human subjects and conduct of the research. The PI is ultimately responsible for those acting on her/his behalf even if any of the PI's responsibilities are delegated to members of the research team.

  1. Oversees the research process and is responsible for the conduct of the investigators and research staff at all study sites. Ensures compliance with research protocols, and applicable federal, state, and local laws and regulations, Yale University policies, and IRB policies and procedures.
  2. Responsible for the safety and welfare of subjects. Ensures compliance with the protocol's data and safety monitoring plan and reports adverse events to the cognizant IRB, study sponsor, and appropriate federal agencies.
  3. Ensures that informed consent is appropriately obtained from all subjects and that subjects are treated with respect and dignity.
  4. Completes all required human subjects protection training, and if applicable, HIPAA training, and ensures that investigators and key study personnel complete required training.
  5. Reviews all cognizant IRB policies and procedures as part of the required initial training for conducting human subjects research. Routinely reviews the cognizant IRB website for new or revised IRB policies and procedures.
  6. Reviews scientific literature to ensure that protocol interventions are consistent with current research data and do not place subjects at unnecessary risk.
  7. Is responsible for the adequacy of all submissions to the IRB including protocol applications, amendments, and adverse event reports.
  8. Ensures the timely continuing review of protocols and the submission of all reapproval applications before the protocol's expiration date. Reports protocol expirations promptly to the cognizant IRB.
  9. Submits proposed changes to the research in the form of protocol amendments to the cognizant IRB before the changes are implemented, except when such changes must be implemented immediately to ensure the health and wellbeing of research subjects.
  10. Responsible for the protection of subjects' privacy and confidentiality according to applicable HIPAA policies, Yale policies, and IRB policies and procedures.
  11. Maintains all study-related documentation in accordance with Yale policies, IRB policies, and federal regulations.

Study Coordinator/Research Staff/Nurse

Definition:
Individuals working on a research project under the supervision and direction of a Principal Investigator (PI).

  1. Performs research-related interventions in accordance with the IRB-approved study protocol.
  2. When requested, obtains appropriate informed consent from all subjects and treats subjects with respect and dignity.
  3. Completes all required human subjects protection training, and, if applicable, HIPAA training.
  4. Complies with the IRB-approved research protocols, applicable federal, state, and local laws and regulations, Yale policies, RA policies, and IRB policies and procedures.
  5. Complies with the protocol's data and safety monitoring plan and reports adverse events to the PI, cognizant IRB, study sponsor, and appropriate federal agencies.
  6. May act as an intermediary between the PI and the IRB, Office of Grant and Contract Administration, and study sponsor.
  7. Protects subjects' privacy and confidentiality according to applicable HIPAA policies, Yale policies, and IRB policies and procedures.
  8. Maintains all study-related documentation in accordance with Yale policies, IRB policies, and federal regulations.

Signatory Official

Definition:
The Signatory Official must be a senior official who has the authority to commit the entire organization named in the FWA, as well as all of the components listed in the FWA, to a legally binding agreement.  The SO must also have the authority to assure compliance of the organization and all of its components to the Terms of the FWA. Generally, this is someone at the level of President, Chief Executive Officer (CEO), or Vice President of a company, or at the level of President, Provost, Chancellor, Vice President, or Dean of an academic institution, unless another official has been specifically delegated with this authority. Typically, the Signatory Official is not a department chair, division director, or another official who only has authority over a portion of the organization. (DHHS, OHRP, "Step-by-Step Instructions for Filing a Federalwide Assurance for Institutions Within the United States")

  1. Allocates necessary resources to the human subjects protections program to ensure its success.
  2. Completes all training requirements for the protection of human subjects, and, if applicable, HIPAA.
    3. September 7, 2005gular communication regarding the status of the human subjects protections program and, as necessary, individual studies.

Human Protections Administrator

Definition:
An individual capable, both in experience and available resources, of overseeing and managing the day-to-day operations of the organization's human subjects protection program. The HPA serves as th e primary contact for OHRP regarding human subjects protection issues for the organization. The HPA exercises operational responsibility for the organization's program for protecting human subjects in research. The HPA should have comprehensive knowledge of all aspects of the organization's system of protections for human subjects, 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. (DHHS, OHRP, "Step-by-Step Instructions for Filing a Federalwide Assurance for Institutions Within the United States "

  1. Responsible for maintaining RA's Federalwide Assurance (FWA) and for ensuring compliance with its Terms.
  2. Responsible for compliance with the RA's policies and procedures, federal regulations, and state and local laws relative to the conduct of human subjects research studies.
  3. Provides guidance regarding the interpretation of regulations, laws, and policies to the organization's researchers, staff, and administrators.
  4. Develops and implements the RA's human subjects protections policies and procedures.
  5. Completes all required human subjects protection training requirements and, if applicable, HIPAA training, and ensures that investigators and key study personnel complete required training.
  6. Responsible for providing opportunities for human subjects protection training to investigators, key study personnel, the Signatory Official, and all RA staff who participate in the human subjects protections program.
  7. Performs quality assurance monitoring of research protocols and investigates matters of non-compliance. Implements corrective action as needed in accordance with RA policies and IRB policies and procedures.
  8. Monitors federal regulatory websites and other research-related resources so as to stay current with regulatory changes in human subjects protections guidelines and policies. Communicates pertinent information to staff in a timely manner.
  9. Maintains all study-related documentation in accordance with Yale policies, IRB policies, and federal regulations.

Institutional Review Board

Definition:
A federally mandated committee charged with responsibility to review proposed research in order to ensure that the rights of human subjects are protected and that risk of harm to subjects is minimized. An IRB is considered the "IRB of record" when it assumes IRB responsibilities for another organization and is designated to do so by (1) an OHRP- approved Federalwide Assurance (FWA) and (2) an IRB Authorization Agreement (IAA) signed by the organization and by Yale.

  1. With the IRB staff, responsible for ensuring compliance with the Terms of Yale's Federalwide Assurance (FWA).
  2. Ensures compliance with Yale policies and procedures, federal regulations, and state and local laws relative to the review of human subjects research studies.
  3. Reviews all research activities involving human subjects and documents its findings regarding ethical considerations, scientific merit, and adherence to federal regulations and IRB policies and procedures.
  4. Reviews research activities to ensure that:
    1. Risks to subjects are minimized;
    2. Risks to subjects are reasonable in relation to anticipated benefits;
    3. Selection of subjects is equitable;
    4. Informed consent is obtained or appropriately waived from all prospective subjects and documented;
    5. The research protocol includes a plan for data and safety monitoring;
    6. Subjects' privacy and confidentiality are protected; and
    7. Appropriate additional safeguards are incorporated for any vulnerable subjects.
  5. Reviews research protocols and has the authority to
    1. Approve;
    2. Require modifications to secure approval;
    3. Disapprove; and
    4. Terminate or suspend.
  6. Conducts continuing reviews of approved research. Reviews proposed amendments, adverse events, protocol deviations, and matters of non-compliance.
  7. Has the authority to:
    1. Require research progress reports;
    2. Audit and/or monitor the research and researchers for adherence to the federal regulations, RA policies and IRB policies and procedures; and
    3. Report suspensions, terminations, and non-compliance to IRB officials, Yale officials, RA officials, and the federal government.
  8. IRB members complete all training requirements and stay informed of current research-related and regulatory developments.

Institutional Review Board Staff

Definition:
Administrative and professional staff that support and facilitate the IRB process.

  1. With the IRB, responsible for ensuring compliance with the Terms of Yale's Federalwide Assurance (FWA).
  2. Ensure compliance with Yale policies and procedures, federal regulations, and state and local laws relative to the review of human subjects research studies.
  3. Provide guidance regarding the interpretation of regulations, laws, and policies to researchers, staff, and Yale administrators.
  4. Develop and implement Yale's human subjects protection policies and procedures.
  5. Perform quality assurance monitoring of research protocols and investigates matters of non-compliance. Implement corrective action(s) as needed in accordance with federal regulations, Yale policies, and IRB policies and procedures.
  6. Provide human subjects protection training for investigators, key study personnel, IRB members, and IRB staff.
  7. Complete all training requirements and stays informed of current research-related and regulatory developments.
  8. Monitor federal regulatory websites and other research-related resources to stay current with regulatory changes in human subjects protection guidelines and policies. Communicates pertinent information to other IRB staff, IRB members, and investigators in a timely manner.
  9. Maintain IRB study-related documentation in accordance with Yale policies, IRB policies, and federal regulations.

HIPAA Privacy Board

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

  1. Reviews and has the authority to approve or deny requests for waiver of subject authorization.
  2. The Privacy Board members complete all training requirements and stay informed of current regulatory developments.

References: Vanderbilt Medical Center IRB Roles and Responsibilities.

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