Frequently Asked Questions About Single IRB Review

A single IRB (sIRB) is the IRB of record that oversees all clinical trial sites participating in a multi-site study. 

Common Rule Cooperative Research Provision

Common Rule Cooperative Research Provision applies to all studies that are:

• Federally funded cooperative research projects receiving initial IRB approval on or after January 20, 2020.
• Involve non-exempt human subjects research, and
• They Involve multiple sites conducting research with human subjects (regardless if each institution is not carrying out the same human subject research activities).

Exceptions to the Common Rule

The Common Rule Cooperative Research Provision does not apply to studies that are:

• International sites, or
• Tribal nation sites, or
• Studies that received initial IRB approval prior to January 20, 2020.

NIH sIRB Policy

The NIH policy applies to all studies that are:

• Funded through grants, cooperative agreements, contracts, or the NIH Intramural Research Program, and
• Involve non-exempt human subjects research, and
• Involve multiple sites, all of which are conducting the same human subjects research protocol.

The NIH policy does not apply to studies that are:

• Funded to foreign awardees and/or conducted at foreign sites, or
• Funded through career development, research training or fellowship awards, or
• Where review by the proposed sIRB would be prohibited by a federal, tribal, or state law, regulation, or policy, or
• Collaborative projects in which multiple sites are involved, but different sites may complete different parts of the study. Some other networks, companies and foundations may also require sIRB review.

MUSC has created a Reliance Intake Form. You must submit your request for reliance using this form before making any commitment in your grant application that MUSC is willing to serve as the sIRB. MUSC IRB is required to review and approve your request before providing you with a letter of support and additional instructions for your grant application.

Once you have received confirmation from MUSC IRB, the next steps are available on the MUSC IRB Reliance website.

Once you have completed the Reliance Intake Form, and you have been notified that MUSC IRB agrees to enter into a reliance agreement, you will be provided a letter of support.

The grant application should include a plan describing the use of a sIRB. The plan should identify the IRB that will serve as the sIRB and should address any requests for exceptions from the policy. For NIH studies, see the NIH sIRB plan instructions for further details on what needs to be included.

The grant application should also include letters of support from the MUSC IRB and each of the sites that will rely on the sIRB. Each site participating in the study must document its agreement with the IRB review arrangement in a letter of support. This letter is not the same as the formal IRB reliance agreements that may need to be established after the grant is awarded. See the section above for more information about the letters of support.

The grant should also outline a budget that includes IRB fees that will be charged as direct costs. Depending on the sIRB that is selected for your study, there could be fees involved. This should include a description of the resources (personnel, budget) you will need to manage IRB communications. You should anticipate that studies with more than a handful of sites will require significant additional staffing resources to manage the complex communications and document management associated with the use of a sIRB and with IRB-related coordination across sites. This role is being called the “IRB Liaison” at many other institutions nationwide. It is typically a staff member on the research team at the lead site.

The NIH policy requires that a “communication plan” be included in your grant application/proposal. The applicant/offeror is expected to submit a communication plan describing the use of an sIRB that will be selected to serve as the IRB of record for all study sites.

An IAA is always needed when the MUSC IRB agrees to serve as IRB of record for external personnel or collaborators affiliated with an institution with its own IRB. An IAA is also needed when the MUSC IRB agrees to rely on an outside organization. The MUSC IRB office will facilitate development and processing of IAAs when needed.

Preparing an IRB application involving reliance and multisite research issues can take additional time. Study teams are advised to plan accordingly and consult with the IRB reliance Manager when preparing the IRB application.

SmartIRB is an agreement between over 700 participating institutions to enable reliance on a study by study basis. The agreement assists in streamlining IRB review and oversight of multisite studies and supports small and large studies, regardless of funding. Investigators from participating institutions can use the SMART IRB online reliance system to request reliance arrangements for their studies. Investigators interested in using SmartIRB should submit a Reliance Intake Form to the MUSC IRB to begin the reliance process as an MUSC abbreviated application is still required via eIRB.

Note: SmartIRB does not take the place of an eIRB submission to the MUSC IRB. SmartIRB is only a platform to streamline the reliance agreement process. Local IRB and institutional requirements must still be met and an abbreviated eIRB application is still required.

Yes. The Medical University of South Carolina (MUSC) offers the use of the commercial IRBs for multi-site corporate-sponsored clinical trials to all departments as long as the following criteria are met:

• The external IRB is currently registered with OHRP/FDA
• For commercial IRBs: the commercial IRB is AAHRPP-accredited
• For non-commercial IRBs: the IRB is AAHRPP-accredited or determined as part of the administrative review to meet MUSC standards
• The external IRB is located within the U.S. (MUSC IRB reserves the right to withhold any new research study from being sent to an external IRB)

An MUSC external application is still required via eIRB to document local context requirement and the reliance arrangement. Many commercial IRBs are members of SMART IRB and can be used via the SmartIRB platform.

The policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program. It does not apply to career development, research training or fellowship awards.

This policy applies to domestic awardees and participating domestic sites. Foreign sites participating in NIH-funded, multi-site studies will not be expected to follow this policy.

The policy applies to all competing grant applications (new, renewal, revision, or resubmission) with receipt dates on or after January 25, 2018. Ongoing, non-competing awards will not be expected to comply with this policy until the grantee submits a competing renewal application. For contracts, the policy applies to all solicitations issued on or after January 25, 2018. For the intramural program, the policy applies to intramural multi-site studies submitted for initial review after January 25, 2108. See the NIH single IRB policy (PDF) for more information.

Yes! MUSC has created a Reliance Intake Form that must be submitted and reviewed. You must submit your request before making any commitment that MUSC will rely on an external IRB. The MUSC IRB will review your reliance request to determine whether we are willing to enter into a reliance agreement. Once you have received confirmation of our willingness to enter into a reliance arrangement, you will be asked to submit an abbreviated application via eIRB. Even though another IRB has taken responsibility for the review of your research under the criteria required by the applicable federal regulations and/or HIPAA, there are still pieces of review that must occur at MUSC (local context review, ancillary review, etc.). The IRB also requests copies of the consent document, protocol, and IRB approval letter from the IRB of Record for documentation purposes.

Yes! MUSC has created a Reliance Intake Form that must be submitted and reviewed. You must submit your request before making any commitment that MUSC will rely on an external IRB. The MUSC IRB will review your reliance request to determine whether we are willing to enter into a reliance agreement. Once you have received confirmation of our willingness to enter into a reliance arrangement, you will be asked to submit an abbreviated application via eIRB. Even though another IRB has taken responsibility for the review of your research under the criteria required by the applicable federal regulations and/or HIPAA, there are still pieces of review that must occur at MUSC (local context review, ancillary review, etc). The IRB also requests copies of the consent document, protocol, and IRB approval letter from the IRB of Record for documentation purposes.

You, as PI, will need to make sure that all study personnel receive appropriate training and are qualified to perform their duties, and that the study is conducted in accordance with the sIRB approved protocol and IRB policies. These requirements are outlined in the HRPP 9.5 Relying on an External IRB (PDF).

Keep in mind that if you rely on another IRB, you as the MUSC PI still retain considerable responsibility. In summary, you must:

1. Ensure all members of your study team are appropriately qualified and have met standards for eligibility to conduct research, including completion of human subjects training and conflict of interest disclosure.

2. Comply with the determinations and requirements of the Reviewing IRB, which includes conducting the research in accordance with the reviewing IRB's policies and procedures, the IRB approved documents and conditions of approval, and any applicable laws and regulations.

3. Ensure that the Reviewing Site PI has provided approval letter for the MUSC site before initiation of the research activities at MUSC.

4. Maintain appropriate copies of all approvals, and other correspondence documenting the review and approval of the research as required by the regulations.

5. Once the MUSC IRB has acknowledged your request for reliance and the external IRB has approved your study, there are still some things you are required to continue to submit to the MUSC IRB. Please submit amendments and/or updates to the MUSC IRB via eIRB for the following:

I. MUSC study personnel changes when adding or removing study team members from the study application

II. Changes which require revision to the HIPAA authorization

III. Changes to conflict of interest

IV. Changes are made which affect local context / institutional policy / state law requirements

V. The reviewing IRB has approved a change to the study procedures or recruitment and is modified in such a way that additional institutional approvals are required from one of the following:

i. Conflict of Interest Committee

ii. Protocol Review Committee

iii. Radiation Safety Committee

iv. Institutional Biosafety Committee

v. Other ancillary committees that require re-review

VI. The recruitment activities that were described in the initial application that require compliance with MUSC HRPP policies:

i. Students, trainees, and employees;

ii. Persons with impaired decision-making capacity

iii. Children as subjects;

iv. Prisoners as subjects.

6. Status Updates must continue to be submitted to the MUSC IRB via eIRB for the following:

I. Status Update with the IRB of Record's Continuing Review attached.

II. Closure Report after the IRB of record closes the study.

7. Report promptly to the Reviewing IRB any proposed changes in the research. No changes should be initiated in the research (including changes in the consent document) without prior Reviewing IRB review and approval, except where necessary to eliminate apparent immediate hazards to the participants.

8. Report to the Reviewing IRB any unanticipated problems involving risks to participants or others; non-compliance or any complaints from a subject or other person regarding the research according to the Reviewing IRB’s reporting policy.

9. Report to the Reviewing IRB protocol deviations according to the Reviewing IRB's reporting policy.

10. Report to the Reviewing IRB as well as the MUSC IRB any complaints from a subject or other person regarding the research.

Yes, the MUSC IRB charges a fee of $1000.00 for the processing of industry-sponsored protocols submitted to an external IRB for review.

The MUSC IRB does not charge a fee to rely however the lead IRB will most likely charge a fee to the grant or Lead study team for the review of the MUSC site.

The reviewing IRB will provide a template Informed consent form that has been reviewed and approved by the Reviewing IRB with certain sections allowed to be edited and/or completed with local information. This is the consent version that should be used here at MUSC.

MUSC generally requires that informed consent templates include the following local context information:

• Local HIPAA language
• Local information on payment,
• Local cost language
• Subject injury language either required by contract or local requirements
• Medical record information template language
• Any state law required language relevant to the study

The local context form provided by the External site will assist in determining what local language should be included. The Reliance manager at the IRB will also review the template consent and protocol and provide the local language to include. If you have any questions about language in the consent document, contact the IRB reliance manager.

Yes, after receiving the approved study documents from the Lead site, submit a study status update for MUSC via eIRB at the time of the continuing review.

Any breach of confidentiality or data breach that takes place at MUSC should be reported to the MUSC IRB via eIRB as well as the Reviewing IRB. All other unanticipated problems should be reported to the reviewing IRB.

Generally, Amendments/modifications need to be submitted to the MUSC IRB 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, conflict of interest)

All other amendments should be submitted directly to the reviewing IRB. The reliance agreement governing the study will determine the exact reporting structure for amendments.

It depends. If the study is a network or consortium funded study, the network will often name the IRB of Record. For NIH funded studies, the lead PI may request his/her institution to be the IRB of Record and for studies subject to the Common Rule cooperative research provision the reviewing IRB will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution (subject to the acceptance of the Federal department or agency supporting the research). All requests should be submitted using the Reliance Intake Form.

Yes, sIRB fees may increase or decrease due to future rate adjustments. It is always best to check for the most up to date fees.

When serving as the lead PI and MUSC is the IRB of Record, you are responsible for contacting the IRB Reliance Manager at MUSC as soon as possible so that the reliance process can begin with the relying site IRBs. The MUSC IRB Reliance Manager will aid in gathering appropriate local context information and can provide assistance to you in submitting the appropriate information via eIRB. You are responsible for submitting all study-related materials based upon HRPP policies and procedures, just as you would if you were conducting a single site research project at MUSC. In addition, amendments adding relying sites will need to be submitted so that the relying sites receive the appropriate consent forms and documentation.

You are responsible for communicating approvals to the participating site PIs, as well as providing the approved study materials (application, protocol, site consent form, approval letter, etc.). You are also responsible for submitting any study related reports from relying sites to the MUSC IRB for review and approval. Essentially, you are submitting all sites’ study reports, revisions for local context, amendments, continuing reviews, reports of non-compliance, and adverse events as you would if you were conducting the study only at MUSC. The key difference is that you are now reporting for every site to MUSC’s IRB.

These requirements are outlined in the HRPP 9.4 MUSC as Single IRB of Record (PDF) as well as in the sIRB PI responsibilities.

At continuing review, you will submit a continuing review application, along with all continuing review documents per IRB Policy for ALL SITES approved by the MUSC IRB.

Report the event to the MUSC IRB as soon as possible but within the 10 day required reporting window per MUSC policy. The IRB Reliance Manager will facilitate review of this submission. As Lead PI, you are agreeing to be responsible for reporting these events in accordance with the MUSC IRB policies and procedures.

For more information, see the eIRB documentation on how to submit a reportable event for a relying site (PDF).

You, as the Lead PI will need to obtain the study documents from the local site and submit these materials as a Remote Site Document (RSD) to the MUSC IRB via eIRB. Please consider whether the participating site’s revisions may also affect the other sites and make revisions, as necessary.

For more information, see the eIRB documentation on how to submit an amendment for a relying site (PDF).

Submit an amendment to the MUSC eIRB with any applicable revised documents. Once the main amendment is approved for the protocol and amendment, you, the Lead PI, will then need to submit an RSD for each site on the study to update the consent form at that site.

Submit an RSD to add the site. The MUSC reliance Manager will assist in obtaining the local context information for the site.

For more information, see the eIRB documentation on how to add an RSD (PDF).