AUGUST 19, 2016 BY MOLLY SKUBAK

Researcher Toolbox: The PaTH Network Protocol Review Committee

One of the most important goals of the PaTH Network is ensuring all PaTH-affiliated studies are guided by patient perspectives. The PaTH Network Protocol Review Committee (PNPRC) is a key innovation the network has developed to help reach this goal. The PNPRC is designed to complement standard Institutional Review Board (IRB) processes, which protect the rights and well-being of the research participants.

The PNPRC members are brought together on a conference call to get input from IRB professionals and community representatives from each PaTH site. As a result, our ethics review process emphasizes patient perspectives, helping to ensure that PaTH-affiliated studies are patient-centered. Likewise, input from clinicians and IRB representatives ensures clinical and ethical norms are maintained.

PNPRC participants have found that bringing together individuals from different institutions helps them to identify ways in which IRB norms and procedures differ across PaTH sites and find common solutions. In doing so, it helps to streamline the regulatory process for multi-site studies.

For example, the PNPRC has developed an approach to our patient consent procedure that is online, standardized across PaTH sites, and includes consent awareness questions. This approach adds ease to the consent process for both study participants and researchers collaborating across PaTH institutions. Further, the three consent awareness questions – in addition to the standard required information on the form – summarize subjects’ rights, what they can expect from the study, and how they can contact research staff members. In doing so, these questions provide a clear indication as to whether or not participants fully understand what they are agreeing to by consenting.

The PNPRC provides thoughtful written commentary to investigators, with suggestions for improving their study protocols prior to formal IRB submission.