Institutional Review Board for Health Sciences Research (IRB-HSR)

Getting Started

Reliance on the IRB-HSR to serve as the Single IRB (sIRB) of record

Overview

The University of Virginia IRB-HSR may act as the single IRB of record, allowing other institutions to cede review to the UVA IRB. If UVA may not serve as the sIRB, the UVA IRB-HSR is available for consultation to assist researchers in choosing a Single IRB. UVA IRB-HSR may only engage in a Reliance Agreement for expedited and full board studies with no more than 10 relying sites. Reliance Agreements for sIRB review are ONLY used to cede the IRB review of projects. All institutionally required ancillary reviews must still be obtained locally, and it is up to the relying site(s) to identify these reviews (e.g., Conflict of Interest, Institutional Biosafety, IND/IDE Support, Radiation Safety, etc.) Oversight of these ancillary reviews still require local review and approval regardless of ceding IRB review. Local relying sites will be responsible to collect and provide the UVA IRB with any local ancillary reviews.

It is the responsibility of the UVA study team to evaluate the study to determine if the work to be done by personnel at an outside institution, meets the criteria for being engaged in Human Subject Research or a clinical investigation of a test article. The IRB-HSR staff is available to help make this determination if the answer is not clear.

The UVa PI takes on several additional responsibilities when serving as the overall PI of a multisite study. It is important that you review Reviewing and Relying Site Responsibilities. The UVA study team must ensure they have the resources to accomplish these responsibilities. The UVA study team may take on these responsibilities or contract them out to a Data Coordinating Center (DCC). The UVA SOM Clinical Trials Office may serve as the Data Coordinating Center. For more information, contact the SOM-CTO.

Definitions

IRB of Record: A reviewing IRB (non-UVA IRB) that assumes IRB responsibilities for another institution/site.

IRB Reliance Agreement: A formal, written agreement in which the reviewing IRB agrees to serve as the IRB of Record for a Relying institution/site. The signed agreement permits a single IRB to review human subject research activities for more than one site.

Multicenter/site research study: Human subject research conducted according to a single protocol but at more than one site, and therefore, carried out by more than one principal investigator. Multisite research refers to research that is conducted at both UVA and non-UVA locations. Multisite studies do NOT include studies involving multiple UVA locations that fall under the purview of the UVA IRB-HSR.

Relying Institution/Participating/Site: A relying institution/site is the site that has entered into an IRB Reliance Agreement with another site’s IRB to serve as the IRB of Record.

Lead Site/Study Team: site that (usually) receives the grant or contract from the funding source and then establishes sub-awards or subcontracts with the participating sites. The lead PI is the PI responsible for overall management and coordination of the study across all participating sites.

Engagement of Organization in Non-Exempt Human Subject Research: An organization is considered engaged in human subject research when its employees or agents, for the purposes the research project obtain:

  1. Data about the subjects of the research through intervention or interaction with them;
  2. Identifiable private information about the subjects of the research;
  3. Informed consent of human subjects for the research; OR
  4. A direct federal award to conduct human subject research, even when all activities involving human subjects are carried out by subcontractors (i.e. employees or agents of another organization). HHS Guidance: Engagement in Human Subjects Research.

Engaged in Research: An institution becomes "engaged" in human subjects research when its employees or agents (all individuals performing institutionally designated activities or exercising institutionally delegated authority or responsibility) (i) intervene or interact with living individuals for research purposes; or (ii) obtain individually identifiable private information for research purposes [45 CFR 46.102( d), (f)]. Solicitation of consent by participating site staff would be considered engagement.

Federal-wide Assurance (FWA): A formal written, binding commitment that is submitted to a federal agency in which an institution promises to comply with applicable regulations governing research with human subjects and stipulates the procedures through which compliance will be achieved [45 CFR 46.103]. Since December 31, 2005, the Office for Human Research Protections (OHRP) only recognizes Federal-wide Assurances.

Investigator: A person responsible for the conduct of research at a site. If research is conducted by a team of individuals at a research site, the investigator is the responsible leader of the team and may be called the principal investigator [GCP E6 1.34].

Sponsor: The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization that takes responsibility for and initiates a clinical investigation. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator [21 CFR 312.3(b)].

Data Coordinating Center (DCC): a site that is responsible for the collection, verification and storage of data collected from all sites involved in a multi-site trial.

Sponsor-Investigator: An individual (usually the study Principal Investigator) who both initiates and conducts a clinical investigation, and under whose immediate direction the investigational product is administered or dispensed. The term does not include any person other than an individual investigator. The requirements applicable to a sponsor-investigator under FDA subpart [21 CFR 312 Subpart D] mean that sponsor investigators must follow the regulations for both an investigator and a sponsor [21 CFR 312.3(b)].

Local Research Context: Information provided to the IRB of record by a local context reviewer, consultant, or a participating site's IRB regarding the participating site's local community, geographical area, institution, and/or other factors that may influence the conduct of the proposed research, including local laws, regulations, customs, and practices.

Grant Proposal Instructions:

As of March 2017, the National Institutes of Health (NIH) requires the use of a single Institutional Review Board for non-exempt human subjects research protocols funded by the NIH that are carried out at more than one site in the United States. Additional information regarding this policy may be found HERE.

For NIH-funded research, you may obtain a Letter of Support from the UVA IRB-HSR to include in the NIH grant submission. This should be requested by email to SIRB@virginia.edu: Subject heading: Letter of Support Request for NIH Grant Submission.
Your request should include the following information. The IRB-HSR cannot write the letter without this information.

For additional information: See Section D “NIH Grant Application/Contract Proposal Preparation” of the NIH FAQ Single IRB Policy and Multi-site Research and (for specific details) Section 3.2 of the PHS Human Subjects and Clinical Trials Information Form Application Guide.

NIH expects the following New information in grant applications for multi-site research:

SUBMISSION INSTRUCTIONS:

  1. The UVA study team may wish to preliminarily contact the Principal Investigators (PI’s) at other sites to determine if there is interest in a Reliance Agreement, which would enable the UVa IRB-HSR to serve as the sIRB of Record for the Relying site. Getting a sense from the site PI’s as to their interest may be helpful for your planning. If a Letter of Support is needed from the IRB-HSR to send to relying sites, please send a request to SIRB@virginia.edu

  2. If a UVA study team is creating a NEW multisite study in Protocol Builder, if not already considered, the study team will need to write the protocol using a template designed to work for all participating sites. Include a reference to a Data Coordinating Center if one is being utilized for the study. A protocol template will NOT be provided through Protocol Builder. Possible templates may be found HERE.

  3. The UVA study team will submit the study to the UVa IRB-HSR for review and approval per usual practice. See Protocol Submission Process.

  4. Once the protocol is approved by the UVA IRB-HSR, the UVA study team or the UVA Data Coordinating Center (DCC) is ready to send the required documents to the Relying site and can confirm the Relying site’s agreement to rely on the UVA IRB-HSR as the sIRB of record.

  5. Submit the following documents to the Relying site:

    o - Interest Letter to Potential Relying Sites (if applicable)
    o - IRB-HSR approved protocol and consent(s)/Assent(s), additional consents as applicable
    o - IRB Reliance Agreement Request Form: UVA IRB-HSR to serve as the IRB of Record which includes the
        Relying Site Local Context Template
        Note: The sections of the consent that Relying Sites are permitted to edit are as follows: - Institutional letterhead (if applicable)
        - Local study staff & contact information
        - Local HIPAA language (if applicable)
        - Local compensation for injury language (if the procedures have the potential to cause physical harm)
        - Local data storage and/or retention requirements
        - Local compensation (if applicable)

      The following completed documents will be submitted to SIRB@virginia.edu:

    • If revisions are required to the Reliance Agreement Request form or consent/assent documents, a draft of the document(s) will be emailed to the UVA study team or DCC with a request for revisions.
    • Following final review by the IRB-HSR, the UVA study team or the DCC will receive the following documents by email:
    • o IRB Reliance Agreement signed by both the Relying site Institutional official and the UVa Institutional Official (VP for Research) if SMART IRB is not viable
      OR
      o IRB-HSR Cede letter
      o Assurance/approval notice indicating a modification to add the Relying site
      o Approved site-specific consent/assents for the Relying site.
      NOTE: It is the responsibility of the DCC or the UVA study team to send the consent/assent documents back to the Relying site.

    HIPAA Privacy Board

    The Privacy Rule

    When the UVA IRB will serve as the Privacy Board for the relying sites that are covered entities, the protected health information (PHI) will not be shared among relying institutions unless there is:

    1. appropriate authorization to use and disclose such information for the purpose of the research [as outlined in the informed consent], or
    2. an appropriate waiver of HIPAA authorization has been granted by the UVA IRB in accordance with the HIPAA Privacy rule, or
    3. the information constitutes a limited data set pursuant to a Data Use Agreement as those terms are defined in HIPAA.

    HIPPA Authorization Language

    HIPAA authorization language will be incorporated into the informed consent document. The relying sites are responsible for providing the UVA IRB their entity language as part of the Reliance Agreement Request form local context submission. The relying sites also have the opportunity to use the UVA HIPAA consent language if they so choose. The UVA IRB will ensure the appropriate authorization language is incorporated into the informed consent document for use at the relying site.

    Waivers and Alterations of Authorization

    The UVA IRB will review requests for waiver or alteration of authorization to the extent it is compliant with the local UVA HIPAA policies and procedures. The UVA IRB will notify all affected relying sites of the rationale for the waiver so that the relying sites can accomplish accounting of disclosures.

    Breach Notifications

    Relying sites are responsibility for investigating and reporting to appropriate authorities, including privacy officers, breaches of PHI in accordance with institutional policies. Relying sites must promptly notify the UVA IRB of any PHI breaches that occur as well as to any individuals or offices required by local institutional policy (e.g. their local privacy officer). The UVA IRB will evaluate the breach as a potential unanticipated problem. Reporting will occur according to the UVA reporting procedures for unanticipated problems. Any data breach will be reported per the UVA Information Security Incident Reporting Policy. The data breach will be reported to the study team or DCC if the report meets the criteria of an Unanticipated Problem.

    Continuations

    1. Continuation reviews will be completed by the UVA IRB as per usual practice
    2. Either the UVA study team or the DCC responsible for obtaining information from each Relying site will submit ONE comprehensive Protocol Status Report to the IRB-HSR. The UVA site is responsible for obtaining the information from each relying site so the IRB-HSR can review a comprehensive report regarding study progress, enrollment numbers, reportable events, new information, and any problems that have occurred.
    3. If a relying site does not provide the UVA study team with the required information before the continuing review is submitted to the UVA IRB, the UVA study team should report this absence of this information as part of the continuing review and notify the relying site study team of lapse in approval for their site and any applicable corrective active plans.
    4. The UVA IRB-HSR will conduct continuing reviews in accordance with applicable federal regulations, the local context provided by each of the relying sites and the UVA IRB SOP's.
    5. In the event any continuing review information is submitted to the UVA site from a relying site after UVA IRB-HSR approval for the study expires or the study expires before the UVA IRB-HSR can reapprove the study, the UVA IRB-HSR will notify the relying sites of the expiration.
    6. The UVA IRB is responsible for reviewing all relevant information on the Protocol Status Report until the research is closed.
    7. Upon approval, the UVA site or DCC is responsible for providing all currently approved documents along with the assurance to the relying sites. If the UVA IRB-HSR determines that it cannot reapprove the study, the IRB-HSR will notify the UVA site and relevant relying sites of its determination and the reasons for the determination.

    Modifications/Personnel Changes:

    1. Modification review will be completed by the UVA IRB as per usual practice.
    2. Modifications are submitted to the UVA IRB-HSR by either the main site or the DCC.
    3. The UVA IRB-HSR will review the study modification in accordance with applicable federal regulations, the local context provided by the relying sites and the UVA SOP's.
    4. The UVA site will report changes in personnel and potential conflicts of interest as they change/occur to the DCC for submission to the UVA IRB or to the UVA IRB directly.
    5. If a study is closed to enrollment, the UVA IRB will notify the study team or DCC whether a revised consent form or an addendum be used.
    6. If a Consent Short Form is required for a potential subject that speaks a language other than English or Spanish, see the information located on Consent Short forms for non-English Speaking Subjects.

    Advertisements:

    Subjects Enrolled as Minors who Reach the Age of Majority

    If a subject is enrolled while a minor, and they have now or will reach the age of majority, you may use the following two forms as a template to obtain consent of the subject. Age of Majority: Cover Letter Template and Age of Majority Consent.

    Unanticipated Problems, Serious or Continuing Non-Compliance, Deviations, Terminations, Subject Complaints or Research Misconduct

    All unanticipated problems, deviations, suspensions, terminations, noncompliance, subject complaints, from any relying site should be reported to the UVA IRB-HSR. The UVA IRB-HSR will review and notify
    The UVA study team will report the following to the UVA IRB as per usual practice:
    - Unanticipated problems including adverse events
    - Injuries to subjects,
    - Protocol deviations/violations
    - Changes initiated without approval from the IRB of Record to eliminate apparent immediate hazards to subjects
    - Complaints
    - Non-compliance that does not rise to the level of serious or continuing.

    Resources

    Questions? Contact:
    Eileen Sembrowich
    Associate Director IRB-HSR
    434-243-6542
    ecs3b@virginia.edu

    or

    Joanna Faulconer
    Compliance Coordinator IRB-HSR
    434-982-1855
    jld6p@virginia.edu