Guidance for Transferring Studies to Another IRB

The FDA issued a guidance earlier this year that provides some great points to consider when transferring oversight of a study (or multiple studies) from one IRB to another.[1] This article provides the highlights of the recent guidance and some additional points to consider when implementing a transfer of one or more studies to another IRB. - See more at: http://www.quorumreview.com/guidance-transfer-studies-irb/#sthash.3PD6Y6E4.dpuf

As noted in the guidance, the FDA places responsibility for securing IRB review on the investigator; however, “the party that actually initiates the transfer process varies depending on the circumstances necessitating the transfer and the parties involved.”[2] The guidance describes the research entities involved in a transfer of IRB review responsibilities as follows:

• The original IRB, which, for the purpose of this guidance, means the IRB originally designated to review a clinical investigation and that transfers oversight responsibility to another IRB;

• The receiving IRB, which for purposes of this guidance, means the IRB that accepts responsibility for oversight of the clinical investigation;

• The sponsor who initiates the clinical investigation; and • The clinical investigator who conducts the investigation.

Often the IRB staff or research compliance office is responsible for effectuating these transfers and there is a lot of preparation and coordination needed to ensure the transfers go as smoothly as possible. Close communication between all parties, but particularly the original and receiving IRBs, is critical to ensuring an orderly transition and the continued protection of human subjects.

Assessing the Studies for Transfer

The first order of business when considering a transfer of studies is to assess the studies that will be transferred. This should include an evaluation of the IRB records related to the study(ies). If documentation is missing or incorrect, staff should attempt to locate the missing files and make corrections as needed. As part of this review, several points of information and documents should be gathered for each study that will be transferred, including:

• Study identifiers (protocol title, protocol number, internal reference number) • Study sponsor • Date of original review • Next date of continuing review • Status of study (i.e. enrolling, closed to enrollment, follow-up only) • Type of review (i.e. Expedited or Convened Board) • A copy of the current approved version of the Protocol and ICF(s)

It may be that some of this information is not available in the IRB file. This represents an opportunity to obtain updated information and often reveals studies that will close and not need to be transferred. As discussed in more detail below, this information is also incredibly valuable when discussing the transfer plan with the receiving IRB.

Understanding the Receiving IRB Requirements

Prior to beginning a transfer of studies, the Institution staff affiliated with the original IRB should have a clear understanding of the receiving IRB’s requirements for transferred studies. Some questions to ask of the receiving IRB include:

1. What are your timelines for review of transferred studies? 2. What is the fee for review of transferred studies? How do you bill for sponsored studies

and investigator-generated research? 3. What is your policy regarding the effective date of a transfer of IRB oversight? Note: The

FDA guidance recommends the receiving IRB review the study(ies) before accepting responsibility for the study(ies)[3]

4. What type of sign-off is needed from the Institution in order to process a study submission?

5. What are the required forms for transferring studies? Are there different forms for different types of studies (i.e. expeditable studies, social behavioral research, data collection-only studies)? Note: You should be able to obtain copies of all submission forms for review.

6. What additional documents will need to be provided in addition to the submission forms? (For example, minutes or IRB correspondence.)

7. What training can you provide to research office staff, investigators and study staff about your processes and requirements before studies are transferred?

8. What resources are available to research office staff, investigators and study staff? (For example, an investigator handbook, Account Managers, etc.)

9. What is your practice with consent form editing for transferred studies? Is a different approach to consent form editing taken if the study(ies) have no active subjects?

10. What are your expectations for investigator and study staff training? Note: It is important to note whether these differ from institutional requirements.

Getting responses to the questions above will give the original IRB and the Institution a good sense of the work involved to transfer studies to the receiving IRB and should also highlight areas where the receiving IRB’s policies may deviate from the original IRB’s policies. Once the parties have a clear understanding of the process and requirements for transferring studies, they will need to consider the contracts and the plan for the transfer.

Contract(s) for Transfer

The FDA guidance recommends a written agreement between the original and receiving IRBs to document the plan for the transfer process.[4] These details can generally be incorporated into a contract that covers the transfer process as well as details relating to billing, notifications, and other important points that Institutions generally want to cover in an agreement with an external IRB. The

following points should be addressed in an agreement between the two IRBs:

• Retention of records by the parties: The agreement should address whether the original IRB records prior to the transfer will be given to the receiving IRB, or if they will be retained by the original IRB. Keep in mind the obligation for IRB records to be retained for at least three (3) years after the completion of the research and that the records must be accessible for inspection and copying by the FDA at reasonable times and in a reasonable manner. If records will be retained by the original IRB, consider how the original IRB will receive notice when a study closes. If the original IRB is not able to commit to retaining records as required under FDA regulations, the FDA recommends contacting the agency to discuss possible retention arrangements.[5]

• Effective date for the transfer: This should be clearly laid out to avoid a lapse in approval. A best-practice is for the receiving IRB to review and approve the research prior to the effective date of the transfer. The original IRB should keep this in mind if there are plans to eliminate the IRB. The original IRB must remain in place until the transfer is effective or the study(ies) will not have appropriate oversight between the time the original IRB ceases operation and the receiving IRB takes on oversight. The original

IRB must continue functioning to address any safety issues or problems that may be reported, as well as changes to the research.[6]

• Type of IRB Review: The agreement should outline the type of review the receiving IRB will undertake prior to accepting oversight of the study(ies). The FDA guidance outlines a few options, but strongly recommends that the receiving IRB conduct an initial review of the study(ies) where the review by the original IRB may be questionable, or if the study(ies) are higher risk. Other options the FDA suggests in some cases is a continuing review at the time of transfer or a review that would occur at the next continuing review date.[7]

In addition to the contract between the original and receiving IRBs, the original IRB should ensure that it has permission from the sponsor of the research to provide information about the study(ies) to the receiving IRB. This may require a review of contracts with sponsors or CROs for the study(ies) that will be transferred and a notification plan to advise these entities of the plans for transfer.

Transfer Plan

The transfer plan may be included in or separate from the contract. If a large number of studies will transferred, the transfer plan may need to be updated throughout the process. In that case it is more practical to keep it separate from the contract. The transfer plan should address some of the following points:

• Pre-Transfer Training: Any training for research office staff, investigators and study staff should be delivered prior to the initiation of transfers. The training should generally cover topics such as the receiving IRB’s policies and forms and how to communicate with the receiving IRB and the original IRB staff during the transfer process.

• Communication Plan: The parties should establish the main points of contact on each side during the transfer process. It is advisable to establish routine calls between the main contacts when facilitating transfers for a large volume of studies to address questions and issues that come up.

• Timing of Transfers: A schedule should be established for transfer of studies. This schedule should address the rate at which the receiving IRB can receive transfer submissions. This will be limited by the resources the original IRB can provide for completion of forms and facilitation of the transfer. In general, the schedule should prioritize studies with the nearest continuing review dates. This helps to minimize work for both the original IRB staff and the investigator and his or her staff, as they will likely be involved in the paperwork for the transfer of jurisdiction.

• Plan for Consent Form(s): The original and receiving IRBs should agree on an approach for evaluating and editing consent forms for the transferred studies. The status

of the study(ies) should be considered when determining whether an ICF needs to be updated to include the new IRB information. Alternatively, it is possible to alert subjects of the change in IRB oversight via letter rather than an update to the ICF at the time of transfer. The parties should also keep in mind that the IRBs may have different standards or requirements based on their interpretations of the requirements for ICFs. A discussion of the receiving IRB’s approach to consent form editing may help to eliminate surprises following its review of the previously approved ICF.

In summary, the facilitation of a transfer of study(ies) to another IRB can be a major undertaking. It is important to allow time for planning and to ensure the agreement between the parties is documented in writing prior to initiating the transfer of IRB oversight. The points to consider above should be helpful when considering such a transfer.

- See more at: http://www.quorumreview.com/guidance-transfer-studies-irb/#sthash.3PD6Y6E4.dpuf