Chapter 4 Institutional Review Board (IRB) Roles and Authorities

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1 Chapter 4 Institutional Review Board (IRB) Roles and Authorities HSS Institutional Review Board Guidance An Institutional Review Board (IRB) is an appropriately constituted group that has been formally designated to review and monitor research involving human subjects. Any IRB designated by HSS derives its institutional authority from, and is ultimately accountable to the Board of Directors (or Trustees). IRB members are appointed by the Surgeon in Chief of the Hospital. The President and Chief Executive Officer (CEO) of HSS serves as the Human Subject Signatory Official under the Institutional Federalwide Assurance for Protection of Human Subjects. In compliance with DHHS regulations at 45 CFR (b)(2), it is the responsibility of the Human Subject Signatory Official to ensure that IRB operated by HSS is provided with sufficient resources, meeting space and staff to support the IRB s review and recordkeeping responsibilities. In accordance with the Common Rule, DHHS regulations, and FDA regulations, an IRB designated by HSS has authority and responsibility for approving, requiring modification in (to secure approval), or disapproving human subject research. The IRB also has the authority to suspend or terminate research for continued noncompliance with the Common Rule, DHHS regulations, and FDA regulations, or its own findings, determinations, and requirements. No official or committee of HSS may permit the conduct of human subject research that has not been approved by an IRB designated by HSS. I. Subject Protections under Federal Regulations. Federal regulations at 45 CFR Part 46 require that institutions engaging in human subject research supported by the Department of Health and Human Services (DHHS) devise mechanisms for the protection of human subjects. The regulations require that each institution conducting human subject research file a written Assurance of protection for human subjects and designate one or more Institutional Review Boards (IRBs) to review its human subject research. (These and other applicable regulations are provided in Appendix IV.) The filing of the Institutional Assurance and the registration of IRBs of HSS are the responsibility of the designated Human Subject Signatory Official. HSS s IRB operates under a Federalwide Assurance approved by the DHHS Office for Human Research Protections (OHRP). No component of HSS may operate an IRB without authorization from the designated Human Subject Signatory Official and designation under HSS s FWA. HSS s IRB must comply with the requirements of all relevant regulatory agencies including the DHHS Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA). Copies of any reports or correspondence to or from such Page 1 of 6

2 agencies must be provided by the IRB to HSS s Human Subject Signatory Official, Legal Counsel, and Compliance Officer. II. Oversight of HSS s IRB(s). The Human Subject Signatory Official is responsible for oversight of regulatory compliance for all human subject research activities conducted under the auspices of HSS. Such oversight will be accomplished in coordination with, and with input from, the Compliance Officer, and (as warranted) in consultation with Legal Counsel. The Human Subject Signatory Official may designate one or more Institutional Review Boards (IRBs) to review HSS s human subject research. Designated IRBs must be listed in HSS s OHRP-approved FWA. (Note: Hereinafter, the IRB shall refer to any IRB formally designated under HSSal FWA.) The IRB must report any serious unanticipated problem involving risks to subjects or others to the Human Subject Signatory Official, Legal Counsel, and the Compliance Officer. The Human Subject Signatory Official may establish additional reporting or communication relationships between the IRB and other officials or other committees, including the Board of Directors (or Trustees), as deemed appropriate. The Human Subject Signatory Official is responsible for compliance oversight and review of HSS s systemic protections for human subjects. This oversight and review may involve auditing of IRB files, subject records, investigator research files, or regulatory materials maintained by investigators and their staff. The review and oversight responsibilities for human subject research activities include, but are not limited to, the following. Day-to-day responsibility for these activities may be delegated as deemed appropriate by the Signatory Official. A. Conducting compliance monitoring and auditing site visits to periodically review IRB and Principal Investigator documentation and determine compliance level with assurances, OHRP and FDA requirements. B. Preparing reports to the Board of Directors (or Trustees) as appropriate. If warranted, the Human Subject Signatory Official and/or the Compliance Officer has the authority to require corrective action or to forward any matter to the Board of Directors (or Trustees) should a component of HSS fail to take appropriate corrective action to address any confirmed compliance deficiencies. C. Reviewing Institutional policies, IRB and Research Investigator manuals and educational materials periodically to determine if they are maintained and updated appropriately. Page 2 of 6

3 D. Participating in regulatory inquiries and/or correspondence with regulatory authorities concerning protection of human research subjects. III. Purpose and Mission of the IRB. The IRB s primary responsibility is to protect the rights and welfare of participants involved in human subject research. In doing so, the IRB monitors human subject research to determine that it is conducted ethically, and in compliance with applicable Federal regulations, applicable State law, HSS s Assurance, and Institutional policies and procedures for protecting human subjects. The IRB fulfills these responsibilities by conducting prospective and continuing review of human subject research, including review of the protocol and grant applications or proposals (for Federally-supported research), the informed consent process, procedures used to enroll subjects, and any adverse events or unanticipated problems reported to the IRB. Prospective review and approval of research or changes to previously approved research ensures that research is not initiated without IRB review and approval. In communications to investigators, the IRB will make investigators aware of the requirement to submit protocol changes to the IRB for review and approval before initiation of such changes except where necessary to eliminate apparent immediate hazards to the subject. The practice of medicine and applied clinical research must coexist and work to improve the techniques of each other. The Mission of the IRB includes making available to all children research that is therapeutic and constructive for them, and allowing children to contribute to the advancement of medicine. In doing so, the IRB will demonstrate compliance with the Belmont Report, applicable Federal Regulations, and International Conference on Harmonisation Good Clinical Practice Guidelines (ICH GCPs). IV. Scope of the IRB s Authority. As indicated above, an IRB designated by HSS has authority and responsibility for approving, requiring modification in (to secure approval), or disapproving human subject research. The IRB also has the authority to suspend or terminate research for continued noncompliance with the Common Rule, DHHS regulations, and FDA regulations, or its own findings, determinations, and requirements. No official or committee of HSS may permit the conduct of human subject research that has not been approved by an IRB designated by HSS. Research that has been approved by an IRB designated by HSS remains subject to any additional review deemed appropriate by HSS s President or Board of Directors (or Trustees). HSS retains the authority to prohibit conduct of research within its facilities or by its employees or agents that HSS deems not to be in its best interests (e.g., research that is not consistent with the mission of HSS; research that would require skills or resources that are not readily available; or research that might result in unacceptable fiscal or reputational risks). Page 3 of 6

4 A. Requirement for Prospective Review and Approval. All human subject research conducted at HSS or any of its component or by any employee or agent of HSS must be prospectively reviewed and approved by the IRB. No human subject research may be initiated or continued at HSS or any of its component or by any employee or agent of HSS without prospective approval of the IRB. B. Adding a New Site to an Existing Approved Protocol. Any component of HSS or investigator desiring to add a new site to an existing IRB-approved protocol must submit the request with all required materials to the IRB. C. Power to Take Action. The IRB is empowered to take any action necessary to protect the rights and welfare of human subjects participating in research at HSS. The IRB has the authority to approve, require modifications in, or disapprove the respective institution s human subject research. D. Power to Suspend or Terminate Enrollment. The IRB may suspend or terminate the enrollment and/or ongoing involvement of human subjects in research as it determines necessary for the protection of those subjects, especially in instances of serious or continuing noncompliance. The IRB has the authority to observe and/or monitor the respective institution s human subject research to whatever extent it considers necessary to protect human subjects and assure compliance with applicable laws and regulations. E. Cases of Serious or Continuing Noncompliance. In cases of serious or continuing noncompliance, the IRB may: (i) disqualify an investigator from conducting a particular research project or research altogether at HSS; (ii) require education and training in the ethics and regulations of human subject research; or (iii) any other reasonable measure deemed appropriate to protect the rights and welfare of research subjects. F. Access to Regulatory Correspondence. All persons conducting research within any component of HSS, and all persons acting as employees or agents of HSS regardless of location, must promptly provide the IRB with copies of any reports, audit findings, or correspondence to or from any regulatory agency (such as OHRP or FDA) that bear upon the protection of human subjects in research in which they are involved. The IRB will review such correspondence to determine if action is needed to protect human subjects. The IRB will notify HSS s Legal Counsel and Compliance Officer of any such reports. G. Access to Institutional Officials. The IRB or any IRB member may bring any matter directly to the attention of the Human Subject Signatory Official, Compliance Officer, or Legal Counsel when warranted. Page 4 of 6

5 H. Review of Non-Institutional Research. Research that is not conducted either (i) by an employee or agent of HSS, or (ii) at a component of HSS is not considered research at HSS. The IRB may accept responsibility for review and oversight of such non-institutional research only with the written agreement of the Human Subject Signatory Official, and in accordance with applicable regulatory requirements. Any such arrangement must also be accompanied by a written agreement specifying the responsibilities of the non-institutional investigator and/or non-institutional institution, and of HSS and its IRB. I. Review of Research Under a Non-Institutional Assurance. The IRB may be designated for review of research under another institution s (non-wholly owned or controlled by HSS) Assurance only with the written agreement of the Human Subject Signatory Official and in accordance with applicable regulatory requirements. Any such designation must be accompanied by a written agreement specifying the responsibilities of HSS and its IRB under the other institution s Assurance. The IRB has no authority over, or responsibility for, research conducted at other institutions in the absence of such a written agreement. V. Appeal of IRB Determinations. A. No Overrule Permitted. No committee or official of HSS may set aside or overrule a determination by the IRB to disapprove or require modifications in HSS s human subject research. No committee or official of HSS may permit the conduct of human subject research that has not been approved by an IRB officially designated by HSS. B. Notice to Investigator of Disapproval. The IRB must provide the research investigator with a written statement of its reasons for disapproving or requiring modifications in proposed research and must give the investigator an opportunity to respond in person or in writing. C. Investigator Response and Appeal. The IRB will evaluate the investigator s response in reaching its final determination. VI. VII. Human Subject Protection Education Program. HSS is required under its OHRPapproved FWA to have a plan to provide education about human subject protections for research investigators and IRB members and staff (see Chapter 22). Relationship of the IRB to IND/IDE Sponsors. Unless specifically required by an Investigational New Drug Application (IND) or Investigational Device Exemption (IDE) sponsor or by the IRB, no written notifications of IRB decisions will be provided to IND/IDE Sponsors by the IRB. The Principal Investigator serves as the communications link between the IRB and the Sponsor for this purpose. For FDA regulated test articles, such linkage is agreed to by the Sponsor and principal Investigators when they sign the FDA Form 1572, Statement of Investigator. Page 5 of 6

6 VIII. IRB Review Fees. The Human Subject Signatory Official may authorize the IRB to collect reasonable fees for initial review and continuing review of sponsored research. The Signatory Official will review the fee schedule periodically to determine if the fee is market-based and adequate when considering the time and resources consumed in performing such reviews. IX. Privacy Board Functions and Determinations. The IRB may be designated to serve as the Privacy Board as required by HIPAA, 45 CFR , , (i). Functions include review and determinations of requests for Waiver or Alteration of Authorization to use or disclose Protected Health Information in Research. Please refer to HSS s separate policies and procedures on research privacy under HIPAA. Page 6 of 6