For institutions engaging in funded research by HHS, such as the NIH, and involving human participants, the U.S. Federal Government requires such institutions to have an IRB. In addition, the HHS regulations require a written assurance from the performance-site institution that the institution will comply with the HHS regulations regarding protection of human subjects. The institution must also formally register the members and policies of the IRB. At most institutions, the IRB applies HHS regulations regarding human participation to all studies conducted at the institution whether or not they are funded by a federal agency. The HHS regulations also mandate minimal requirements for the composition of an IRB; an IRB must consist of at least five members and

at least one member whose primary concerns are in scientific areas, at least one member whose primary concerns are in nonscientific areas . . . , and at least one member who is not affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution. (U.S. Department of Health and Human Services, 2009)

Members of an IRB need to possess the professional competence necessary to review the specific research activities and ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. Therefore, at least some members of an IRB must have knowledge of, and be familiar with, existing guidelines, regulations, and policies.

The IRB is formally designated by the institution to review and monitor research involving human subjects and has the authority to approve, require modifications in (to secure approval), or disapprove research. The purpose of an IRB review of a research protocol is to ensure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating in the research. The review encompasses research protocols and all related materials (e.g., informed consent documents, brochures, questionnaires/assessment instruments, recruitment materials). It is important to note that IRBs require that any changes to study materials or protocols must also be approved prior to using these materials or instituting these protocols. For example, if, during the early course of a study that is evaluating a new intervention for caregiver depression, an investigator decides that it would be helpful to include a short interview with the study participants during the 6-month outcome assessment, the protocol for doing so and any related documents would need to be submitted to the IRB for approval before these interviews could be conducted.

The type of review conducted by an IRB is also regulated according to specific criteria. For example, some minimal risk intervention research might be considered eligible for an “expedited review” in which the review of the protocol can be conducted by a smaller subgroup of a larger IRB or by the chair of the IRB or his or her designee. In the case of behavioral intervention research, this might occur for study designs such as focus groups, or surveys depending on the IRB and the content of the subject matter. For example, highly sensitive topics (e.g., sexual practices, substance abuse, HIV disclosure) typically would require full IRB review. The federal regulations include a list of expedited categories as well as categories of research that may be exempt from an IRB review such as studies that involve review of existing data that is publicly available. An intervention researcher may conduct a review of a public available database on the incidence of a particular disease at the “getting started phase” (see Chapter 3). In this case, it is likely that the protocol would likely be exempt from an IRB review. However, it is always necessary to consult with the institution’s IRB office to make these determinations. As rules and guidelines that are followed differ from one institution to the next, a research team cannot make these determinations alone and must consult with the IRB to obtain appropriate guidance.

Investigators involved in intervention research will need to interact with the institution’s IRB in the conduct of research at all phases of the pipeline and throughout their research career at that institution. Therefore, we recommend that investigators become familiar early on with the policies of the IRB and the IRB process. Many institutions offer training in these areas for new investigators or to inform seasoned investigators of changes in policies or protocols. Becoming familiar with the workings of an IRB will greatly facilitate the intervention research process. Lack of adherence to IRB submission requirements can significantly delay the start of a trial. It is generally a good idea to have a meeting with the IRB staff or chairperson prior to submitting an application. It is also prudent to document and keep records of all correspondence with the IRB in case there are questions or an audit of the study is conducted. Government agencies, the study sponsor, or the institution’s IRB may sometimes request an audit of a study. This may occur for cause (e.g., the IRB receives complaints from study participants; there are a large number of AEs) or at random to ensure that the study is proceeding as approved and that there are no problems with respect to the research participants. This also underscores the importance of ensuring that all members of the research team are well versed in the study’s goals, objectives, and protocols and well trained in the conduct of research. Finally, a good practice is for the investigator/team to periodically conduct their own internal audit in which all informed consent forms are reviewed to ensure proper signage, that all consents are available for enrolled study participants, and that signed informed consents reflect the most up-to-date approved IRB forms. Such internal audits and their outcomes should be documented and shared with the IRB with a description of any problems identified and their resolution. Self-audits represent ethical practice, can preempt external audits, and ensure continual compliance to these fundamental human protection procedures.

Interactions with an IRB can become more complex in the case of multisite trials or when an investigator is recruiting research participants at more than one institution. For example, if an investigator is recruiting participants for a cognitive intervention trial at the memory disorder clinic at his or her institution and from a memory disorder clinic at a local hospital, he or she would need IRB approval from both institutions. This can be time-consuming and can also create delays in the start of a trial. Therefore, when possible, it generally is a good idea for the investigators to work with the IRBs at their institutions to determine if an agreement can be set up so that their respective institutions can act as the primary IRB for the study and that consent forms approved by one can be used at another setting. The NIH is currently encouraging the use of single IRBs for multisite trials funded by an NIH Institute and, in fact, has a draft policy to promote the use of a single IRB in these circumstances (NIH Notice Number: NOT-OD-15-026). The goal of the policy is to enhance and streamline IRB review processes and reduce inefficiencies.

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