LATEST IMPROVEMENTS FROM THE PURDUE HUMAN RESEARCH PROTECTION PROGRAM

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NOVEMBER-DECEMBER 2019 |

Purdue’s HRPP summarizes major programmatic changes made in 2019 designed to maximize protections for human research participants and increase efficiency for researchers. 

The Purdue Human Research Protection Program (HRPP) implemented major programmatic changes in 2019 aimed at maximizing human research participant protections and providing increased efficiency for researchers. Here we provide a year-end summary:

New Purdue IRB

On July 1, 2019, the Purdue HRPP combined the Biomedical and Social Science Institutional Review Boards (IRBs) to form one IRB. This new structure was designed to provide researchers with more consistent reviews, speed the pace of reviews by allowing the IRB to convene more frequently, and to more fully consider interdisciplinary perspectives as part of the protocol review process. In addition to an overall Chair, the new Purdue IRB features two Associate Chair positions, who focus on researcher education and on post approval monitoring of protocols.

Full Accreditation by AAHRPP

For the first time, the Purdue HRPP applied for and earned full accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP), effective September 15, 2019.  AAHRPP applies the highest standards to ensure that IRBs, university administration, researchers, and study participants work together to achieve discoveries following ethically sound processes.

The process leading to accreditation was both thorough and informative. Our thanks to the members of the Purdue community who met with AAHRPP site visitors and assisted with amassing the requisite documentation throughout the process. Obtaining full accreditation represents the Purdue HRPP’s dedication to continuous quality and clear standards in human research protections. This distinction also assists in collaborations with other institutions and research sponsors.

SMART IRB Participating Institution

For research involving multiple sites, many federal agencies encourage or require that a single institution spearhead IRB review and approval. The SMART IRB initiative was designed to simplify the documentation and review process associated with designating a single IRB. SMART IRB is widely used by IRBs throughout the US to transfer documents and review local context considerations at each site. As a function of having received AAHRPP accreditation, Purdue HRPP joined the SMART IRB initiative and can now utilize this system to facilitate review and approval of multi-site studies.

New Electronic Protocol Submission System: Cayuse IRB

Beginning at the start of the 2019 Fall Semester in August, Purdue HRPP introduced a cloud-based system, Cayuse IRB, for protocol submission and review. Initially, Cayuse IRB was used only for the submission and review of new IRB protocols. However, after a quick but thorough conversion of previously approved protocols by HRPP staff, Cayuse IRB is now ready to accept modifications, renewals, and closures for studies previously approved in other systems (e.g., in Coeus). Investigators can see the status of all open studies along with required renewal dates. Directions for using Cayuse and for requesting protocol changes can be found on the HRPP IRB website at https://www.irb.purdue.edu/after-approval/

What’s next?

We continue to seek feedback on how best to serve Purdue’s human subject research community. We also are continuing to provide monthly educational opportunities. Through the use of the Cayuse IRB system, we can now obtain meaningful review metrics and will post achieved and anticipated turnaround times on a quarterly basis.  Our goals are to remain approachable, helpful, clear, and focused on mitigating risks and maximizing benefits for people who participate in research. We hope that the latest improvements facilitate achievement of these goals. Please feel free to contact HRPP with your comments or suggestion, or to schedule an appointment to discuss your protocols (see www.irb.purdue.edu/contact).

Writer: Chris Agnew, associate vice president for research, agnew@purdue.edu