HRPP Director Perspectives: Interacting with the HRPP/IRB
By Sanjur (Sandy) Brooks, DPS, MA; Director, Human Research Protections Program
In response to the rapidly changing nature of the research enterprise, Human Research Protection Programs (HRPP) and Institutional Review Boards (IRB) are pivoting, revising, and expanding their policies, procedures, and operational needs. These needs speak to the constant and consistent oversight of all active human research (i.e., clinical trials and social science) conducted at the respective institution, not just to a limited few studies.
To ensure effectiveness, HRPPs and IRBs must adapt to the needs and local context of their institution and community. These institutions serve to ensure the rights, welfare, and safety of the subjects are upheld for subjects enrolled in an active research study conducted under the HRPP and IRB purview. Each HRPP and IRB must focus heavily on compliance with the federal regulations, state laws, and best practices of the field, but the application of those regulations varies on the local context lens of the institution and the HRPP mission. Thus, communicating these variations and nuances of operations can be challenging for the HRPP and IRB within large academic institutions.
In an effort to avoid miscommunication, it is best practice for principal investigators and their research teams to engage the HRPP and IRB early on in their protocol development and/or initiation process, as well as during the lifecycle of the active study. Principal investigators and research teams must continue to review the most recent guidance from their respective HRPP and IRB office
The HRPP and IRB should not be viewed as a barrier to the investigator’s research but seen as a partner in the research to ensure that the study is conducted ethically and maintains compliance with the ruling regulations and laws. To that end, the HRPP and IRB at Virginia Commonwealth University are available to support and guide investigators and research teams throughout the lifecycle of the study.