SMART IRB AND YOU
October 2019 Issue
Did you know there is a special code name available to you? Upon hearing it, it makes the IRB smile, cuts through administrative red tape, and draws a friendly welcome with open doors at other institutions who use the same special code name.
Do you need to include external investigators from other institutions in your study, including non-BU Medical Campus students being added for academic credit? Do you want to participate in a study or clinical trial being conducted at other institutions or sites that is under another IRB? Do you want to be a participating site in an NIH-funded study which requires a single IRB?
If any of the above scenarios apply to you, then this Feature Article will enable you and your research staff to self-navigate in the complex world of “reliance agreements” using the special code name: “SMART IRB.”
This article is an update of two previous CR TIMES articles, When Ceding Review:
Adding BMC or BUMC as a Site through an External IRB, March 2018 Issue; and The Complexities of “Simplification” – Using a Single IRB to Review for Multiple Sites, October 2017 Issue.
A “reliance agreement,” also known as an “IRB Authorization Agreement (IAA)” is a document which formally spells out who will be the IRB of Record for a study, and who will be the participating Relying Site. Institutional officials from both the IRB of Record and the Relying Site will sign off on the reliance agreement to confirm that the Relying Site agrees to cede IRB review of its institution’s research activities over to the IRB of Record for the study. The reliance agreement also lists the responsibilities of the IRB of Record and of the Relying Site.
Traditionally, each institution used its own reliance/IAA template when serving as the IRB of record. These agreements could range from a simple one-page form to a complicated legal document requiring time-consuming review negotiations between the attorneys of the IRB of record and of the Relying Site before arriving at an agreement acceptable to both parties. In addition, it can be time-consuming to hunt down the details of the Relying Site which are needed for the agreement (for instance, Federalwide Assurance Number, IRB contact name, phone, and email address).
This is where SMART IRB comes into play.
SMART IRB is a national group of Institutions who have met established standards for joining the group and who have all pre-signed one master SMART IRB reliance agreement to participate in research studies with one another. The list of participating institutions and their details can be viewed at www.smartirb.org (currently there are 633). Boston Medical Center and Boston University Medical Campus are SMART IRB members. (Just to clarify, SMART IRB is not an IRB; it’s a mechanism for IRBs to communicate with one another.)
The “SMART” is an acronym for “Streamlined Multisite Accelerated Resources for Trials. It was developed to help institutions meet the challenge of implementing multi-site reliance agreements under the “NIH Single IRB Review Policy” effective January 25, 2018, but it can be used for any non-Exempt study with as few as two sites regardless of funding. Although the SMART IRB reliance agreement can also be used for Exempt studies, many institutions continue to not enter into reliance agreements for Exempt studies, which was the standard institutional policy for traditional reliance agreements prior to the inception of SMART IRB.
The SMART IRB system provides a platform which allows the SMART IRB member institutions to communicate directly with each other to set up a reliance arrangement for a specific study. Although there is a paper SMART IRB “Acknowledgement Form” available for use, more and more SMART IRB member institutions will only initiate and accept online SMART IRB reliance requests to enable them to manage and track all their SMART IRB reliances in one central place in the SMART IRB system.
The master SMART IRB reliance agreement can replace any other traditional reliance agreement templates which the IRB of Record may have for the study if the IRB of Record is a SMART IRB member. By agreeing to review the study under the master SMART IRB reliance agreement with Relying Sites who are also SMART IRB members, the IRB of Record can then save substantial time and effort as compared to attempting to execute a traditional reliance agreement template, which may necessitate site-specific legal review and negotiations with each individual Relying Site. It is natural, then, for the IRB of Record to prefer collaborating with Relying Sites who are SMART IRB members whenever possible.
How Do I Use SMART IRB to participate in a study being reviewed by another IRB?
Answer these step-by-step questions and follow the instructions:
Will I be “engaged in research” (interacting directly with subjects for the purpose of collecting research data; and/or accessing individually identifiable data for research purposes)?
If the answer is NO (for example, analyzing de-identified data, developing study design and tools, manuscript preparation, or consulting), then your research activities will not require IRB oversight or an IRB submission. No further action or SMART IRB is needed.
If the answer is YES, then your research activities will require IRB oversight--proceed with Question 2:
Has the other IRB already approved the study?
If the answer is YES, identify the IRB of Record. Typically, the IRB of Record will be the IRB of the Lead Principal Investigator’s home institution, but not always. If this is a multi-center industry-sponsored trial, or if this is a NIH-funded multi-center study, the preferred IRB of Record could be a Commercial IRB. Once you confirm the IRB of Record, proceed with Question 3.
If the answer is NO, then consult with the Lead Principal Investigator to determine when the study will be submitted to their IRB; and when a reliance agreement will need to be executed for your Relying Site. It has been our IRB’s experience that when there are urgent deadlines for the Lead Principal Investigator related to Just-In-Time funding, that reliance agreements may need to be executed simultaneously with when the Lead Principal Investigator is waiting for initial approval from the IRB of Record for the study. Proceed with Question 4 as soon as you know the identity of the IRB of Record.
Is this a multi-center industry-sponsored study involving an IND or IDE held by the sponsor and in which the sponsor uses a Commercial IRB as the IRB of Record?
If the answer is YES, then proceed with PROCEDURE FOR PREPARING COMMERCIAL IRB SUBMISSIONS THROUGH SMART IRB FOR MULTI-CENTERED INDUSTRY-SPONSORED SUBMISSIONS WHERE THE INDUSTRY SPONSOR HOLDS THE IND OR IDE.
If the answer is NO, then proceed with Question 4.
Is this an NIH federally funded study requiring a single IRB?
If the answer is YES, then proceed with submitting a cede application in INSPIR. In the Review Path section 4.1, please check off: BMC/BU Medical Campus (the Relying Institution) cedes IRB review to another institution (the Reviewing Institution) under an Authorization Agreement. The IRB will soon release detailed instructions for these studies similar to the instructions for IND/IDE studies linked to the above Question 3.
If the answer is NO, then proceed with Question 5.
- Is the IRB of Record a SMART IRB member? (Look up the IRB of record at www.smartirb.org; then click the link to Participating Institutions.) Whether the answer is YES or NO, proceed with Question 6.
- Will you be recruiting and consenting subjects at BMC or BU Medical Campus?
If the answer is NO, then you can proceed with “Creating Your INSPIR Cede Application”
- If the answer is YES, then proceed with Question (7).
- Is the IRB of Record both a SMART IRB member and has AAHRPP accreditation? (Look up the IRB of record at http://www.aahrpp.org/learn/find-an-accredited-organization)
If the answer is NO, then send an email to firstname.lastname@example.org to confirm whether it will agree to cede review to the IRB of record for the study that is either not a SMART IRB member or does not have AAHRPP accreditation. Give the name of the IRB of Record, and a description of the study activities and how you will be engaged in research.
If the answer is YES, then you can proceed with “Creating Your INSPIR Cede Application.”
How Do I Use SMART IRB As a Lead Principal Investigator?
Answer these step-by-step questions and follow the instructions:
- Are you adding external investigators who are “engaged in research” (interacting directly with subjects for the purpose of collecting research data; and/or accessing individually identifiable data for research purposes)? Or, is an external investigator receiving the funding, but requesting that our IRB serve as the IRB of record to oversee the research activities?
If the answer is NO (for example, the external investigators are analyzing de-identified data, developing study design and tools, assisting with manuscript preparation), then their research activities will not require IRB oversight or an IRB submission. In Section 9.0 of your INSPIR application, “Study Site Information”, select the first option, “Single site research – conducted by BMC/BU Medical Campus investigator(s).” No SMART IRB action is needed.
If the answer is YES, then proceed with Question 2.
- Has the BMC/BU Medical Campus IRB agreed to perform review for external sites/investigators?
If the answer is NO, then here is a very important point to consider in the planning stages of your multi-site study: You will need to find an IRB of Record. Not all IRBs (including our BMC/BU Medical Campus IRB) will have the resources to take on the responsibilities of being the IRB of Record for a multi-site study. For instance, the IRB may not have sufficient staffing and technical or funding support to accommodate the extra workload involved with reviewing and approving multi-site consents, amendments, and renewals PLUS tracking all the variations in the participating institutions’ site-specific policies and state laws regarding research. Or, the IRB may not have reviewers with expertise in the study’s subject matter. Instead, a Commercial IRB can be used as the IRB of Record; or perhaps an IRB from one of the participating institutions would be willing to serve as the IRB of Record for all of the sites, including the Lead Principal Investigator’s home institution (Boston Medical Center or Boston University Medical Campus). Send any inquiries to email@example.com to ask if the IRB will consider being the IRB of Record for your proposed multi-site study; and provide a brief description of the study, list the prospective Relying Sites, and confirm whether or not you will be recruiting and consenting subjects. If the IRB is willing, then proceed with step b.
If the answer is YES, then submit your INSPIR application, listing the external sites in section 9.0 “Study Site Information.” A recent change provides some good news: Only the Principal Investigator from each external site needs to be listed in INSPIR (along with their CV). If there is already a SMART IRB or traditional IRB Authorization Agreement in place for the study under “Other Study Documents – IAA/IAA Agreement” for the external investigator’s home institution or IRB of record, then in most instances* you no longer need to submit an amendment to add additional external investigators from an institution already listed in section 9.0 because they will be covered under the existing Agreement, and adding them to the study team and tracking their training requirements is the responsibility of the Relying Institution. The BMC/BU Medical Campus Principal Investigator has the responsibility to maintain their own records of additional external investigators being added under existing SMART IRB or traditional IAA Agreements, and confirm with the additional external investigators that they meet the cede requirements of their home institutions and that they have taken the required CITI training (either through the Medical Campus or their own institution). See “Adding External Investigators From Institutions with a Federalwide Assurance Number to Your INSPIR Study.”
*The BU Charles River Campus is an exception to this rule. At the moment, the BMC/BUMC IRB is tracking all BU-CRC external investigators who are under an IAA, and therefore they need to be added via an amendment submission and all engaged BU-CRC investigators need to be listed in the TABLE OF EXTERNAL INVESTIGATORS in 10.2.
- Do the external investigators who are “engaged in research” come from institutions that are SMART IRB members? Look up their home institution at www.smartirb.org; then click the link to Participating Institutions. If not, then are they from institutions that have a current Federalwide Assurance Number? Look up their institution at the OHRP Federalwide Assurance Number database: http://ohrp.cit.nih.gov/search/FwaDtl.aspx, click the tab for “FWA”, enter the Institution Name in the text box, then click SEARCH. OR, ask the External Investigators to provide you with their Federalwide Assurance Number, then look up the Number in the OHRP database to see if it has a current expiration date.
If the answer is YES , then list the desired Relying Sites in Section 9.0 “Study Site Information” in your initial submission or amendment – see “Adding External Investigators From Institutions with a Federalwide Assurance Number to Your INSPIR Study.”
If the answer is NO: If an external investigator has a home institution and the institution does not have a Federalwide Assurance Number, then see “Collaborating Institutional Investigator Agreement.”
If the answer is NO: If an external investigator is independent and unaffiliated, and is not performing research activities on your study in connection with an employer or institution, or is not seeking academic credit, then see “Individual Investigator Agreement.”
This Feature Article will assist you and your research staff in determining how to add external investigators to your INSPIR studies, and how to participate in studies being reviewed by another IRB. Collaborating with other SMART IRB member institutions simplifies the reliance agreement process.
Recent change: when there is an existing SMART IRB or traditional reliance agreement already in place with a Relying Site for a study, then in most instances, once the Principal Investigator has been listed for a Relying Site in INSPIR, no further amendments need to be submitted to the IRB to add other external investigators from that Relying Site. However, the BMC/BU Medical Campus Principal Investigator must maintain records of the additional external investigators, including confirmation that they comply with their home institution’s requirements for ceded research and CITI training.