Office of the Vice President forResearch and Innovation

Protocols are required to ensure researchers design studies that align with regulatory requirements, state laws, and institutional policy. VCU’s main protocol template (HRP-503) was developed to help the researchers plan any type of study.  Any questions that are not applicable should be marked as “N/A”. The comprehensive list of questions contained within the new template allows the Human Subjects Office to better determine, at an early stage, whether the protocol should be classified as exempt or should be routed for expedited or full committee review.  If a researcher has a standalone protocol that addresses all elements of the HRP-508, they are not required to also submit the HRP-508.

External protocols, such as industry or consortium protocols, often need the supplemental HRP-508 to document VCU-specific information.  If the separate protocol includes all elements of the HRP-503, including the VCU-specific information, no additional documentation is required.

The protocol reviewed by VCU IRB must be clear about the roles of VCU personnel in the research activities and engagement in human research activities.  This includes certain interactions with research participants and access to/collection of private, identifiable data for research purposes.  VCU is considered to be engaged in human research when receiving direct federal awards, including when human research activities occur through a collaborative site.  When making determinations related to engagement, the IRB applies the HRP-311 - WORKSHEET - Engagement determination. 

If you would like to discuss VCU IRB acting as the IRB of record for your multi-site study, please email IRBreliance@vcu.edu to set up an appointment with the VCU IRB reliance specialist. 

You will be asked to submit your study in VIRBs.

The study will be reviewed and, if appropriate, approved at the VCU site. After initial approval is in place, the other sites will be added via the modification process.   Include the documents in the mod application:

• A completed Basic Site Information Form (HRP-811) for each site that will rely on VCU's IRB.
• Site-specific informed consent form(s) and HIPAA authorization(s), if applicable.
• The VCU PI must send HRP-103p to the PI at the relying institution.
• The IRB reliance specialist will work with the VCU IRB analyst and PI to facilitate all the necessary IRB agreements.

For all studies where VCU relies on an external IRB, you must submit an IRB Reliance Application via VIRBs and an application must be submitted to the external IRB (IRB of Record).

For the VIRBs Reliance Application:

• Create a standard new study application in VIRBs.
  
• Under Basic Study Information, Q. 5, check: YES.  This will open branching. Answer the remaining questions.
• Even though an external IRB will be the IRB of record, you must still upload the following documents to your VIRBs Reliance Application:
  • Study protocol (HRP-503, HRP-503A or HRP-508).
    • HRP-508 is a supplement to a separate sponsor protocol.
      • If utilized, both the separate protocol and HRP-508 must be uploaded.

• • Consent and assent forms
    • Must include all elements of consent as listed under the revised common rule, including, a key information section
    • Must include VCU-approved injury language for greater than minimal risk studies
    • When compensation is being provided by VCU (not external sponsor), must include template language indicating collection of social security number (SSN). Template language found in the HRP-502 - TEMPLATE CONSENT DOCUMENT
    • Must include mandatory reporting language, if applicable
    • Where VCU is responsible for contributing data to an NIH genomic data repository, must include a disclosure of that sharing
    • Must include contact information

• • Separate HIPAA form, if not incorporated into the consent form
    • It is strongly preferred that the VCU HIPAA language is used.
    • If the VCU HIPAA form is not used, the HIPAA language must include an “expiration date or event;” and cannot include language “this authorization does not expire”
    • The form must also include all the required elements of a research HIPAA, per HRP-330.

• • Site-specific recruitment materials
    • Generic recruitment materials that will be used by all sites do not require VCU review

• • Study approval letter from the IRB of record, if available
    • Your study may have an overarching IRB study approval letter as well as an IRB site approval letter. If so, both letters should be uploaded.
      
      
  • PI’s curriculum vitae and current CITI certificate
    
  • Memo from OSP verifying injury clause language in the consent, if an industry-sponsored study (PDF of final version)
  • For studies that rely on another academic institution or health system (not a commercial IRB), upload the IRB of record’s preferred local context form
• Confirm all institutional requirements outside of IRB review are met. To assist researchers in identifying when other institutional requirements may apply to their study, please see HRP-309 Ancillary Review Matrix.

When relying on a commercial IRB, such as Advarra or WCG, you will also submit the external IRB application via the commercial IRB’s system (e.g. CIRBI or Connexus, respectively). 

It is preferred that your reliance application is reviewed by the VCU reliance analyst before the study is approved by the external IRB, to ensure the consent form includes all the required VCU language. Some researchers find it time efficient to start the VCU and external applications simultaneously, but delay submitting to the external until after the initial VCU review. The reliance analyst will ensure the final consent includes all the required VCU language.

Cede Letter. Once the VCU application is approved for local considerations, the IRB Analyst will send a Cede Letter (HRP-857) via VIRBs.

When relying on an institutional IRB (for example an academic or health system IRB), the lead PI will likely submit the application to the IRB of record. For these studies, the VCU IRB reliance specialist will work closely with the PI and the external IRB to execute the necessary IRB agreements. SMART IRB, IREX are some of the external web-based portals that may be used to facilitate this process.

The VCU reliance application must be accepted and the external IRB must approve the study before study activities may begin at this site.

Responsibilities with the external IRB

When your study is approved by an external IRB, you are responsible for following all of the policies of the reviewing IRB. These responsibilities may be outlined in the reliance agreement or the approval letter, but typically will include:

• Adhering to the study procedures approved by the reviewing IRB
• Submitting any changes for approval prior to implementation (amendments), including changes in study personnel
• Reporting all unanticipated problems and noncompliance within deadlines established by the reviewing IRB
• Reporting any changes in financial relationships that may be perceived as a COI
• Cooperating with any post-approval monitoring requests

Responsibilities with the VCU IRB

Even though your study is approved by an external IRB, you still have some responsibilities with the VCU IRB as listed in HRP-103. These include:

• Submit the following as amendments to your VCU submission:
  • PI and personnel changes to VCU for approval prior to submitting to the reviewing IRB (required because most reliance agreements require VCU to verify personnel qualifications and training)
  • Changes to HIPAA pathways
  • Changes to the consent form
  • Addition of drugs or devices
  • Change in research funding

• Submit a report on your VCU submission when:
  • The reviewing IRB determined that an unanticipated problem occurred at the VCU site
  • The reviewing IRB determined that noncompliance occurred at the VCU site
  • The sponsor has made an SAE report to the FDA.
• Close the study with the VCU IRB when the reviewing IRB closes the VCU site.