Announcing a new, non-profit, independent IRB providing no-cost reviews for COVID-19-related research |
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W H A T I S A L E A R N I N G I R B ?
The Learning IRB is an innovative, alternative IRB model. We incorporate continuous learning into our decision-making processes, employ an open and transparent review process and deploy innovative evaluation tools, all to decrease review times, mitigate conflicts and measurably improve the quality of decisions. |
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S E R V I C E S P R O V I D E D:
W E A R E E Q U I P P E D T O S U P P O R T P R O T O C O L S F R O M T H E F O L L O W I N G:
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S I N G L E I R B R E V I E W :
The Learning IRB provides a new option for institutions who must comply with the single IRB mandate while conducting research related to COVID-19. At the same time, it avoids the financial conflicts-of-interest of for-profit IRBs by operating as a nonprofit entity without owners or investors who stand to profit from review fees. The Learning IRB will address these issues by allowing institutions to use their own IRBs to support local impact and local approaches to the pandemic, while providing single IRB review which are sensitive to these local impacts and approaches. |
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H E A L T H E Q U I T Y A N D T H E
R E S E A R C H L A N D S C A P E: The Learning IRB will address the inability of existing IRB models to evaluate research studies in their full context by using processes and information systems that allow reviewers to see "horizontally" across the research enterprise and "vertically" into the history of a particular intervention. Issues of justice and scientific generalizability can then be properly addressed. Reviewers will have access to prior reviews and to relevant external resources like clinicaltrials.gov, PubMed and Google Scholar. |
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C O V I D - 1 9:
The Learning IRB will address the need to fully evaluate the local response to the pandemic through its staffing model and processes designed to support multi-site review. In addition, by providing no-cost pandemic related reviews, it will facilitate research to address COVID-19. The processes and systems of the Learning IRB will also allow it to fully consider the research landscape, avoiding the cost and risk exposure of duplicative or poorly designed studies; a particularly pressing need in the context of the COVID-19 pandemic. |
W H O W E A R E
Ross Hickey
J.D., CIP, CPIA Ross Hickey will be the Principal Investigator. He is a frequent speaker at national IRB conferences and is co-chair of the CIP council which oversees the primary certification for IRB professionals. Mr. Hickey will serve as the team personnel manager to coordinate and prioritize efforts during the grant period, including management. He will serve as primary liaison officer for broader coordination with USM and University of Maine System administrative personnel. |
Stephen Rosenfeld
M.D., M.B.A Stephen Rosenfeld is the Chair of the Learning IRB, and will also advise the IRB on process optimization, systems and strategy. Dr. Rosenfeld is well known in the human research protections community, serving as the current chair of the HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP). He is also on the boards of Public Responsibility in Medicine and Research (PRIM&R) and the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Dr. Rosenfeld has extensive experience in both the conduct and management of clinical research, having been an investigator in the NIH’s intramural program and Chief Information Officer of the NIH Clinical Center. He also brings experience in the implementation and use of information systems in clinical medicine, having served as the CIO of MaineHealth. Dr. Rosenfeld is a past CEO of Western IRB (WIRB), and served as the Executive Review Board Chair at Quorum Review. |
George Shaler
MPH, Senior Research Associate George Shaler will be the lead evaluator. Mr. Shaler has been at the Muskie School since 1999 and currently is the Managing Director of the Children, Youth and Families-Justice Policy program area. He has worked on several contracts with the Maine Center for Disease Control and Prevention and is the Maine Statistical Analysis Center (SAC) Director. In his role as SAC Director he provides program evaluation and consultation services to state and local government agencies as well as community-based organizations. On this proposal, Mr. Shaler will lead the evaluation activities and prepare presentations, manuscripts, and reports, in collaboration with the PI and IRB Chair. |
Jennifer Pratt
BA, Research Analyst at the University of Southern Maine, Muskie School and Project Manager of MeRTEC Jennifer Pratt will provide support and coordinate the Learning IRB meetings, as well as help with evaluation data collection and analysis activities. Since 2001, Ms. Pratt has worked closely with research teams conducting quantitative and qualitative research. Ms. Pratt has strong organizational skills, which impact a variety of environments in her role, as she guides process flow for several interdisciplinary teams. On past projects, she’s provided technical support and assistance in CQI tools that streamline agency processes, improve customer service and enhance agency efficiency and effectiveness. Jennifer can be reached at jennifer.l.pratt@maine.edu |
S U P P O R T E D B Y
Support for the COVID-19 Learning IRB was provided by the Robert Wood Johnson Foundation. The views expressed here do not necessarily reflect the views of the Foundation.
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H O S T E D B Y
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