Supplementing the Traditional Institutional Review Board with an Environmental Health and Community Review Board
Gilbert, Steven G., Environmental Health Perspectives
BACKGROUND: Community-based research often involves additional ethical, legal, and social considerations beyond those of the specific individuals involved in the study. The traditional institutional review board (IRB) typically focuses on protecting the rights and ensuring the safety of the individuals involved. For projects involving community members, IRBs should be more sensitive to issues related to the broader community concerns.
OBJECTIVES: The objective of this article is to discuss the concept of community-based participatory research and the shortcomings of the traditional IRBs in dealing with ethical issues associated with broader community concerns such as implications for family members, neighborhood groups, and local businesses. I examine the rationale and benefits for expanding the roles and responsibilities of review boards related to community-based issues.
DISCUSSION: I propose the development of environmental health and community review boards (EHCRBs) that combine the fundamental responsibilities and ethical concept of the traditional review boards with an expanded ethical construct of dignity, veracity, sustainability, and justice, with an added emphasis on community.
CONCLUSIONS: Only by acknowledging the needs of and working with the community can we ensure ethically based and socially responsible research. An EHCRB will allow researchers and community members to more fully address their mutual interest in conducting scientific, ethical, and socially responsible research.
KEY WORDS: autonomy, bioethics, community-based participatory research, dignity, environmental justice, institutional review board, justice, sustainability, veracity.
The purpose of this article is to consider the development of an environmental health and community review board (EHCRB). The EHCRB would function as a traditional institutional review board (IRB) but with added expertise and focus related to concerns of the community. Community-based research often involves ethical, legal, and social considerations beyond those of the specific individuals involved in the study. The current IRB system typically focuses on issues related to the individual, such as adequate informed consent, and may not be sensitive to the impact of the study on the community. For example, a study designed to identify children with elevated blood lead levels and sources of lead exposure may stigmatize the housing stock, which could affect the value of the real estate in the area. Additional conflict may arise over information directly related to specific individuals or businesses and their right to privacy. This may be in conflict with a community's need to know and understand information essential to making good decisions. The foundation for an EHCRB is built on an ethical construct of dignity, veracity, sustainability, and justice with an added emphasis on community. The need to expand or alter the current IRB, particularly related to advances in genomics, has been recognized (National Bioethics Advisory Commission 1999; Sharp and Foster 2002). To ensure adequate consideration of community issues, I propose the establishment of EHCRBs for research or studies focused on human health in communities and workplaces.
The Traditional IRB: History and Overview
The current or traditional IRB system of reviewing studies involving humans developed out of a recognized need to protect human study participants. The foundation of the IRB was built on acknowledging individual human rights. The Nuremberg Code and the Declaration of Helsinki (World Medical Association 2004) articulated a need for voluntary consent to any involvement in research. Furthermore, consent must be based on a full understanding of the proposed study or research. Involvement must be entirely voluntary and free of coercion. In addition, benefits from the study must outweigh any risks involved, which requires comprehensive evaluation and communication of the risks compared to the benefits. …