Antiracist Structural Intervention at the Emory University Institutional Review Board.

Although racial and ethnic categories are social constructs without inherent biologic or genetic meaning, race and ethnicity impact health outcomes through racism. The use of racial categories in biomedical research often misattributes the cause of health inequities to genetic and inherent biological differences rather than to racism. Improving research practices around race and ethnicity is an urgent priority and requires education as well as structural change. We describe an evidence-based intervention for an institutional review board (IRB). Our IRB now requires all biomedical study protocols to define racial and ethnic classifications they plan to use, to state whether they are describing or explaining differences between groups, and to provide justification for any use of racial or ethnic group variables as covariates. This antiracist IRB intervention is an example of how research institutions can help ensure the scientific validity of studies and avoid the unscientific reification of race and ethnicity as inherently biological or genetic concepts.

Developing a Rapid Response Single IRB Model for Conducting Research During a Public Health Emergency.

Research is foundational for evidence-based management of patients. Clinical research, however, takes time to plan, conduct, and disseminate-a luxury that is rarely available during a public health emergency. The University of Nebraska Medical Center (UNMC) developed a single institutional review board (IRB), with a vision to establish a rapid review resource for a network focused on clinical research of emerging pathogens in the United States. A core aspect of successful initiation of research during a pandemic or epidemic is the ability to operationalize an approach for rapid ethical review of human subject research and conduct those reviews at multiple sites-without losing any of the substantive aspects of ethics review. This process must be cultivated in anticipation of a public health emergency. US guidance for operationalizing IRB review for multisite research in a public health emergency is not well studied and processes are not well established. UNMC sought to address operational gaps and identify the unique procedural needs of rapid response single IRB (RR-sIRB) review of multisite research by conducting a series of preparedness exercises to develop and test the RR-sIRB model. For decades, emergency responder, healthcare, and public health organizations have conducted emergency preparedness exercises to test requirements for emergency response. In this article, we describe 2 types of simulation exercises conducted by UNMC: workshops and tabletops. This effort represents a unique use of emergency preparedness exercises to develop, refine, and test rapid review functions for an sIRB and to validate readiness of regulatory research processes. Such processes are crucial for conducting rapid, ethical, and sound clinical research in public health emergencies.

Sharing and Selling Images: Ethical and Regulatory Considerations for Radiologists.

Opportunities to share or sell images are common in radiology. But because these images typically originate as protected health information, their use admits a host of ethical and regulatory considerations. This article discusses four scenarios that reflect data sharing or selling arrangements in radiology, especially as they might occur in "big data" systems or applications. The objective of this article is to acquaint radiologists with a variety of regulatory standards and ethical perspectives that pertain to certain data use agreements, such that the attitudes and practices of data holders and their sharers or purchasers can withstand ethical or regulatory scrutiny and not invite undesirable outcomes.

Review of multinational human subjects research: experience from the PHFI-Emory Center of Excellence partnership.

Public Health Foundation of India (PHFI), New Delhi, India and Emory University, Atlanta, USA, are lead partners in the National Heart, Lung and Blood Institute/UnitedHealth funded Center of Excellence (COE) in Cardio-metabolic Risk Reduction in South Asia which provides a vehicle for the development of collaborative research projects. With funding from the National Institutes of Health/ Fogarty International Center, a project was commenced to ensure seamless, thorough and efficient review of this collaborative research. The primary activities of the project are: 1) fact-finding activities which included conduct of a case study and review of policies and procedures of the involved ethics review committees (ERCs); 2) training workshops for COE ERC members and staff and 3) piloting of parallel review of continuing reviews and amendments. A process of parallel review of collaborative research has now been initiated and projects are now submitted simultaneously to the Emory institutional review board (IRB) and PHFI institutional ethics committee (IEC).