Relying on Commercial IRBs
Requesting Reliance on a Commercial IRB
UNC allows investigators to utilize a commercial IRB for industry-sponsored, multi-center, clinical research studies for which one of the following approved commercial IRBs have been appointed as the commercial IRB by the Sponsor or CRO and the commercial IRB has already approved the study.
Please review the IRB-specific annotated site submission application prior to completing your commercial IRB registration application.
Please note: ALL registration applications must include a UNC Coversheet. The coversheet identifies UNC as the submitter and serves as a reminder to the commercial IRB to review your submission under the terms of the UNC Master Service Agreement.
The annotated forms above provide you with UNC-specific responses for each commercial IRB. If you have questions about the reliance process please call Celeste Cantrell (919-966-3113).
The use of a commercial IRB is optional; you may wish to rely on an external IRB for some studies (e.g., Phase III) but not others (e.g., Phase I or II) or may choose to work with some commercial IRBs but not others.
Step 1: Submit the Clinical Trials Agreement (CTA), model consent form and current version of the protocol to the Office Industry Contracting prior to submitting your study in IRBIS. The Office of Industry Contracting (OIC) Contract Manager needs to ensure that the subject injury language in the Sponsor/CRO-provided draft consent form is consistent with the language in the Clinical Trial Agreement (CTA).
If you are an investigator from an affiliate institution (e.g., Rex, High Point Regional), please follow your local process for finalization of COI and subject injury consent form language.
Step 2: Submit an IRB application via IRBIS. An abbreviated application will capture information related to institutional responsibilities and IT data security requirements.
To generate the abbreviated version of the IRB application:
- Respond “yes” to Screening question #6.
- Respond “yes” to Multi-site Study Information, second part of question #2 (Are you requesting that UNC-CH rely on an external IRB for continuing review and approval of this study?).
- Select “Independent/Central IRB already designated for this study by Sponsor/CRO” in response to 5.A.1. and select the designated commercial IRB from the drop menu.
- Complete the remainder of the application. For more information about submitting a request to rely on a commercial IRB, please click here.
Step 3: Following a review of your application, the IRB will email you a Permission to Register letter. Follow the instructions outlined in the letter. The letter will also include stipulations for any outstanding institutional requirements that must be satisfied prior to finalizing reliance on the commercial IRB. Information about registering with the individual commercial IRBs can be found below.
Step 4: Once you have completed all of the requirements outlined in the Permission to Register letter and have registered with the commercial IRB, you should respond to the IRB by responding to stipulations and providing any outstanding documents (e.g., IDS, RSC approval letters). Include a copy of the commercial IRB approval letter (approving UNC as a study site) and a copy of the current commercial IRB-approved consent document(s). **Please review the consent document(s) for accuracy prior to submission to the UNC IRB
Step 5: The IRB will review your responses and if no outstanding institutional approvals have been identified and COI and injury language are acceptable, the UNC IRB will email you an “official” reliance letter, permitting research to begin. If applicable, the UNC IRB will grant a limited waiver of HIPAA, allowing you to review medical records for the purpose of identifying and contacting potential eligible subjects.
Step 6: Research may begin. Although UNC has agreed to defer oversight of your study to the commercial IRB, you still have institutional responsibilities. These are outlined in the reliance letter and are further defined below:
|Inform the UNC-CH IRB about any actions by the external IRB affecting their approval to conduct the study, including suspension or termination of approval.||The UNC IRB has both internal and external (i.e., FDA, OHRP) reporting obligations for certain events (e.g., unanticipated problems involving risks to subjects or others (UPIRSOS)).|
|Report all determinations of UPIRSO, Serious Noncompliance or Continuing Noncompliance involving UNC subjects or researchers, and Suspension or Termination of IRB approval of research within 7 calendar days of notification by the reviewing IRB. You may submit a copy of the report you submitted to the external IRB; this should be done via the IRBIS UP reporting pathway.|
|Submit a modification to the UNC-CH IRB (via IRBIS) if/when new personnel are added to the study team or the study is modified in such a way that additional institutional approvals are required (e.g., radiation safety, biosafety).||UNC maintains responsibility for ensuring that all researchers have completed ethics training, conflict of interest disclosures and for obtaining institutional approvals (e.g., radiation safety). The IRB application serves as the conduit for identifying these activities.|
|Submit a copy of the external IRB approval letter and current approved consent document to the UNC-CH IRB (via IRBIS) when the study is renewed; you will continue to receive reminder notices from the UNC-CH IRB for renewal, and should provide the external approval and consent documents within 30 days of receipt.||The UNC IRB maintains a record of human subjects research (HSR) studies conducted at UNC and its affiliate sites. In order to maintain accurate information, following continuing review and approval (i.e., annual renewal) by the commercial IRB, you must provide a copy of the current approval letter. Also, you must provide a copy of the current approved consent document(s) so that the UNC IRB can confirm that the UNC-approved subject injury and COI language has not been altered.|
|Maintain compliance with all other UNC-CH policies (e.g., data security, Investigational Drug Service [IDS], conflict of interest (COI)).||As with all studies, compliance with all institutional policies remains your responsibility.|
Please be aware that when relying on a commercial IRB, the UNC IRB does not approve or serve as a repository for your approved documents. All modifications, with the exceptions of those described in the table above, should be submitted to the commercial IRB only. This includes requests for single subject exceptions.
If you have questions about this process, please call Celeste Cantrell (919-966-3113).
The following UNC-specific documents have been created for your use. The letter templates are informational only.
The UNC Coversheet should be included with ALL commercial IRB registration applications.
- UNC Coversheet-Quorum (submit to Quorum IRB ONLY) – version 4/3/2017
- UNC Coversheet (submit to ALL other commercial IRBs) – version 4/3/2017
The annotated applications (provided above) identify when the following information should be provided to the commercial IRB as part of your site registration application.