Abstract
Abstract Risk and benefit assessment is one of the fundamental requirements in the ethical review of research involving human participants. As a result, researchers should evaluate and seek to minimize all foreseeable risks involved in their proposed research and members of research ethics committees should evaluate and balance the risks and potential benefits involved in each research proposal as a part of their ethical obligations regarding research protocols. However, current literature provides little detailed guidance on the specifics of how this balancing process should occur. Consequently, this article provides some details of the process to balance risks and benefits in biomedical research and reminds members of research ethics committees of their responsibility to protect those who are vulnerable from exploitation in research projects.
Highlights
Risk and benefit assessment is one of the fundamental requirements in the ethical review of research involving human participants
Researchers should evaluate and seek to minimize all foreseeable risks involved in their proposed research and members of research ethics committees should evaluate and balance the risks and potential benefits involved in each research proposal as a part of their ethical obligations regarding research protocols
A review of the published literature revealed that much discussion has occurred regarding risks and benefits in research, no publication was found that could guide research ethics committee members and researchers regarding the detailed determination of risk, its levels and possible categories, and how to balance these risks and potential benefits
Summary
Health and biomedical research seeks to benefit all members of society, but greater attention should be given to those research endeavours that involve those who may be considered vulnerable or disenfranchised 9. People with good mental capacity may still be regarded as being in vulnerable situations, such as when they are in junior positions in a hierarchical group or society, or are institutionalized in situations that limit their autonomy and decision-making Examples of these include students involved in health care or research training, employees in pharmaceutical companies, members of a country’s national security forces or the elderly in nursing homes. Researchers, sponsors, governments in host countries, as well as local research ethics committees should be sensitive to all these issues and seek to protect all people from possible exploitation in biomedical research
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