The IRB Challenge for Practice-based Research: Strategies of the American Academy of Family Physicians National Research Network (AAFP NRN)

AAFP IRB

The AAFP IRB was activated on January 2, 2006. The AAFP IRB is a diverse body which includes 7 members, 4 of whom are internal to the AAFP (2 physicians, 1 educator, and 1 researcher) and 3 external members from the Kansas City area community, including an ethicist, the Vice Provost for Research at a local university, and an administrator of a local academic IRB. Because most of the research conducted within the AAFP is conducted by the AAFP NRN, the Network played an active role in planning for and developing the AAFP IRB. Consequently, the IRB is extremely sensitive to PBRN issues, and its members took it on themselves to become informed about PBRN research. This relationship has allowed us to develop procedures that ensure compliance with the federal policy for the protection of human subjects¹³ while limiting the burden on participating practices. This relationship has also created a 2-way understanding of research methodology, such that the AAFP NRN does not have to continuously explain methodology to unfamiliar IRB members and, likewise, the IRB has helped the AAFP NRN develop an acceptable and recognized set of standard protocols for protecting human subjects.

When the AAFP IRB was developed it also was created to serve as a HIPAA Privacy Board.¹⁴ This allows the AAFP NRN to submit their protocols to only one board for both research and privacy issues. To date there have been no problems with other institutions accepting authorization forms or waivers of authorization which have been approved by the AAFP IRB.

Working with Practices That Do Not Report to a Local IRB

When clinicians first join the AAFP NRN, we ask whether they are required by their institution to report to a local IRB. Table 1 shows that just over one-half of the members indicate they are not required to report to a local IRB, although only 40% of our active members fit into this category.

If clinicians do not report to a local IRB, we ask them to sign an Unaffiliated Investigator Agreement (UIA) with the AAFP NRN. The UIA was developed in cooperation with the AAFP IRB and states that the clinician will (1) review and complete the appropriate human subjects protection training before participating in an AAFP NRN research study; (2) comply with the procedural standards of the US Department of Health and Human Services regulations for the protection of human subjects¹³; and (3) abide by all determinations of the IRB. Once the agreement is signed by all required parties, the AAFP IRB becomes the IRB of record for those AAFP NRN members and no additional IRB applications or HIPAA forms need to be submitted. The flow of IRB work for unaffiliated investigators is described in Figure 1. The clinicians sign the UIA upon enrollment in the AAFP NRN, and the agreement is good for a 3-year period. The AAFP NRN staff tracks all signed UIAs in a database and contacts the members 60 to 90 days before expiration. Members are required to renew their UIA before participating in research studies.

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Figure 1.

Flow of Institutional Review Board (IRB) work for the American Academy of Family Physicians National Research Network (AAFP NRN).

From the IRB’s point of view, it is important for them to be familiar with the practices that participate in NRN studies. For each research study, the AAFP NRN is required to notify the AAFP IRB of the name and location of all participating practices. This, coupled with the IRB’s familiarity with practice-based research, contributes to the IRB’s “knowledge of local context,” that is, their knowledge of the environment and context in which each study will be implemented. Because of its newness, the IRB has not yet initiated audit procedures of protocols that it has approved to ensure compliance. These procedures have been developed and will be part of the ongoing review process.

Human Subjects Protection

When AAFP NRN unaffiliated members sign the UIA, they agree to complete human subjects training before participating in an AAFP NRN study. The OHRP requires that all key personnel of a research study complete human subjects training. OHRP defines “key personnel” as “all individuals responsible for the design and conduct of the study.”¹⁵ The AAFP IRB interpreted this statement to include the practice lead physicians and study coordinators for each study, as well as practice staff who obtain consent from patients to participate in a study. The AAFP IRB selected the Web-based CITI program¹⁶ as the human subjects training program that all key personnel must complete. Although the CITI program is widely used and informative in terms of human subjects research and federal regulations, it is not always accessible to busy clinicians and practice staff, and it can require several hours to complete all modules. The AAFP NRN recognized this and worked with the AAFP IRB to select the appropriate level of training for clinicians and practice staff that is most relevant to PBRN research. The AAFP IRB requires that the key practice personnel of all unaffiliated practices complete the following 4 modules for all studies: (1) History and Ethical Principles; (2) Informed Consent; (3) Records-Based Research; and (4) HIPAA and Human Subjects Research. In addition, additional modules may be required, depending on unique characteristics of a particular protocol.

The AAFP NRN took steps to make the required human subjects training more accessible for busy clinicians and staff by offering alternative training formats. In addition to the Web-based training, we can provide a paper version of the modules. We also make available an electronic slideshow of human subjects training that the lead physician and study coordinator can present to the practice. We generally ask that all clinicians participating in a study and the staff who are involved in the patient consenting process complete the training. Many of the training formats originated from suggestions by clinicians and practice staff regarding efficient use of their time. We try to make this process as straightforward and trouble-free for the participating practices as possible. Once clinicians and staff complete the training, we keep a copy of their certificates of training completion. We also log and track the training completion date in a database and notify members and staff 60 to 90 days before expiration. The AAFP IRB requires that human subjects training certificates be renewed every 3 years, which benefits the clinicians by permitting them to renew the training at the same time they renew their UIAs.

Working with Practices That Are Required to Report to a Local IRB

When selecting sites for a study we generally choose practices with varied backgrounds. There are always some practices that are part of a larger health system, university system, or hospital system and that must report to a local IRB (see Table 1). In these instances, the AAFP NRN uses a centralized process for submitting and tracking the various local IRB applications. To reduce confusion, all submissions to local IRBs are coordinated through the project staff of the given study. When working with local IRBs, the project staff is responsible for completing all IRB materials for the physician. When the project staff receives approval from the AAFP IRB, he or she begins the process of contacting all practices in the study that are affiliated with a local IRB to begin the submission process. A copy of the AAFP IRB approval letter is always included in the submission to the local IRBs.

We submit applications and materials directly to the local IRBs when permitted, rather than go through the practice clinicians. A direct line of communication between the AAFP NRN staff and the local IRBs generally allows for a more efficient submission and approval process. However, some local IRBs will only communicate with the practice clinician, not with the AAFP NRN staff. In these latter situations, we assist the practice with the completion and submission process as much as possible. The AAFP NRN project staff keep copies of the IRB applications, approval letters, and correspondence from the local IRBs for tracking purposes. We also request a letter from the practices that certifies that all key personnel have completed the human subjects training required by the local IRB, describes the type of training, and affirms that all their certificates are on file and can be viewed on request by the AAFP NRN or AAFP IRB. Table 2 describes the length of time generally required to secure initial approval for AAFP NRN studies.

The project staff are also responsible for tracking, completing, and if possible, submitting annual project renewal applications to the local IRBs for a given study. They track all approval/renewal dates throughout the project. If they are not contacted by the local IRB or affiliated practice at least 2 months from expiration, the project team follows up with the appropriate practice lead physician or study coordinator on the status of the renewal. After clarifying and coordinating any changes to the protocol, the project staff typically complete the renewal application for the affiliated practice. As with the initial application, the submission process often varies. In some instances, the local IRB allows the AAFP NRN to directly submit a renewal application; in other instances, the lead physician may wish to participate in the submission process; and in some situations, the local IRB refuses all contact with the AAFP NRN and communicates only with the affiliated practice staff. Whenever possible, the project staff work to close the protocol after data collection has ended. The AAFP IRB allows a protocol to be closed and analyses to continue as long as the patient information has been de-identified. However, we have encountered cases in which a local IRB will not close a project until all analyses are completed.