Correction: A previous version of this post did not list Michael J. Rossano as a co-author of the poster. PRIM&R regrets the error.
PRIM&R's Poster Program is a highlight of our annual conferences, giving members of our community the chance to share their research and/or innovative programs—as a poster—with their peers. Their work often doesn't stop there—many poster authors continue their research or program long after the conference. Read on for more from Deirdre Lombardi, MPH, CPH, CHES, Challace Pahlevan-Ibrekic, CIP, MS, Brenda Ruotolo, BA, CIP, and Alan Teller, CIP, about a poster titled Development of a Specialized IRB for Genetics and Genomics Research. This poster was authored by Lombardi, Michael J. Rossano, Ruotolo, and Teller, and presented at the 2016 Advancing Ethical Research Conference (AER16).
In 2015, Columbia University conceptualized a “Genetics IRB” specifically to handle research for which the primary aim is “next generation sequencing.” At the time we presented our poster at AER16 in November 2016, we anticipated that the Genetics IRB would not only increase the efficiency of the review process, but would also provide the most consistent approach to the complex issues often raised in the review of Genetics/Genomics Research. We anticipated a number of benefits from the development of this specialized IRB including:
- Expert understanding and awareness of the science
- Consistent resolution to any ethical issues that arose
- Demonstrable motivating factors for subjects to participate in the research
- Existing familiarity with CU policies, relevant state regulations, and IDE considerations.
Since the Genetics IRB first convened in January 2016, the number of approved new protocols has tripled (comparing the first quarter of 2016 to the first quarter of 2017). The IRB’s review process has become more and more streamlined as members gain familiarity with each other and the University’s revised genetic testing policy, which was released last year. Training has also been provided to IRB administrators and our research community to help them understand the implications and processes associated with that policy. The Genetics IRB members contributed significantly to the development of an online training course for study personnel responsible for obtaining informed consent when results of genetic tests are returned. This course was released to the research community in October 2016 and, to date, 112 researchers have completed the training.
Another benefit of the Genetics IRB we've found is that it can efficiently serve as a Central IRB for studies involving genetics/genomics research—because this IRB is knowledgeable in relevant New York State law, they are better situated to apply that knowledge to understanding the nuances and processes related to genetic testing laws in other states. In addition, some members of the IRB are also members of a Genetic Research Task Force that was recently formed at Columbia. This provides a forum in which the members discuss complex and often time-sensitive case studies, as well a platform for developing additional guidelines and educational tools for the IRB and the research community.
Challenges do exist. The Genetics IRB members frequently have conflicts of interest (COI) with protocols under review. To address this challenge, the IRB Chair and administrators work together to identify potential COIs during the administrative review. An additional challenge is expanding the scope to encompass studies for which sequencing is a secondary aim. The IRB will need to evolve by adding new members and developing an expanded body of knowledge. Finally, ensuring that reviews are conducted in a manner that reflects rapidly evolving regulatory, ethical, and legal opinions about genetic research will be an ongoing challenge. The IRB regularly assesses whether informed consent for genetic research is truly informed, and debates the pros and cons of returning results. We foresee this to be an evolving topic within the IRB and research community, though respect for persons guides the discussions.
Deirdre Lombardi, MPH, CPH, CHES, Challace Pahlevan-Ibrekic, CIP, MS, Brenda Ruotolo, BA, CIP, and Alan Teller, CIP, work for the Columbia University Human Research Protection Office. Lombardi is an IRB manager, Pahlevan-Ibrekic is the director of IRB management, Ruotolo is the executive director, and Teller is the director of IRB Operations.
Michael Rossano is currently an IRB Manager at Northwell Health.