What’s New with Ceded StudiesOctober 2018 IssueAuthor(s):
IntroductionLast October, the feature article in the Clinical Research Times was entitled: “The Complexities of “Simplification” – Using a Single IRB to Review for Multiple Sites.” This current article is an update to last year’s article, covering issues that arise both when an external IRB is overseeing a local study (when we cede IRB review to another institution), and when we oversee an external site (IRB review is ceded to us). The following are the four issues:
Requirement for a single IRB for NIH-supported multi-site studiesIf you are applying for an NIH new or competitive renewal grant to support a multi-site study that involves human subjects, then the grant application now includes a section where you must provide a plan for single IRB review. Some other funders, such as PCORI, also expect single IRB review. You should not assume that we can serve as the single IRB. If there are more than two additional sites, it is unlikely that we have the capability to provide the IRB review for all sites in your study; and you will need to make other arrangements. The alternatives are using a commercial IRB; or, if one of your co-investigators is at an institution with the willingness and capacity to review multi-site studies, that institution may be willing to serve as the single IRB. In either case, you will need to budget the fees associated with IRB review into your direct costs. It is also a good idea to budget for a position to fulfill the administrative tasks involved in coordinating IRB submissions and communicating IRB determinations among sites. The most important thing to do is to consult with me and/or the IRB Director Matt Ogrodnik well before your application deadline.
Review by commercial IRBsAs of last month, for an industry-sponsored multi-site study that is being done under an IND or IDE held by the sponsor, you now have the option of using the commercial IRB selected by the Industry-sponsor (previously, you could only choose HIRB or WIRB). The reviewing IRB must be AAHRPP-accredited (most are); and the commercial IRB must be willing to use the SMART IRB reliance platform (all of the ones we have asked have agreed to do this). You may also elect to have us do the IRB review. Many investigators have found this to be the most straightforward solution.
PI responsibilities – ceding to an external IRBEnsuring that a local research study is being conducted correctly involves more than simply IRB review. This is true whether you are asking us to cede review to an IRB mandated by NIH, to a commercial IRB used by your industry-sponsor, or to an IRB at one of the academic institutions also participating in your multi-site study. In all cases, you are required to submit an (abbreviated) cede application in INSPIR before we can formalize our agreement with the external IRB (called a reliance agreement). The reason for this requirement to submit a cede review application in INSPIR is to allow us to facilitate the completion of all required local ancillary reviews, and to ensure compliance with our local institutional requirements and policies. We evaluate the practicability of carrying out the study here, such as nursing requirements and compliance with our recruitment policies, as well as fulfill our agreement with the reviewing IRB to verify that all study personnel have met our training and conflict of interest (COI) requirements. A reviewing IRB will typically give you a form or two for you to fill out to provide information about the “local context” to help in their review. We are happy to help you fill out these forms, and are in the process of preparing some standard versions that the reviewing IRB may be willing to accept. Your responsibilities to us don’t stop once you have received approval from the reviewing IRB. Ceded studies are chosen for QA reviews just like non-ceded studies, and you are expected to cooperate with our QA team. In addition, you need to communicate with us, in addition to the reviewing IRB, in three circumstances. Numbers 1 and 3 are in our existing policy and cede letters; number 2 came about as a result of our recent review of ceding policies in preparation for compliance with AAHRPP.
PI Responsibilities – heading up a study where we review for external sitesIf you are the BMC or BU Medical Campus principal investigator of a study that involves external sites where we are the IRB of record, then you are responsible for all of the communications between the BMC/BU Medical Campus IRB and the external study sites. These responsibilities are detailed in our policy document in section 2.5.2.1. These are not new expectations, but they have not previously been spelled out. As the lead principal investigator:
ConclusionIt is becoming more and more apparent that single IRB review does not really eliminate complexities, but rather just shifts them around. We are committed to making sure that this rearrangement does not let human subjects protection fall through the cracks. Please contact us at medirb@bu.edu if you have any questions or need any help in navigating this new world.
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