Research ethics and the importance of determining risk
Clinical research is governed by standards for scientific merit as well as ethical criteria intended to protect the rights of subjects and to ensure that risks to research subjects are both reasonable and justifiable.
The goal of research is to improve treatments designed to cure or prevent disease, extend the lifespan of those with incurable illnesses and enhance the comfort as well as activities of daily living for those with chronic conditions. There is reason to be enormously grateful for the skilled science and technology behind these medical innovations as well as for the dedicated scientists behind the research.
At the same time, respect must be shown for the courageous individuals who agree to be research subjects in the hope of furthering scientific understanding of disease and the promotion of healing as well as identifying optimum care strategies.
The medical innovations that result from such research are rarely discovered in time to benefit the subjects themselves. Understanding of risk, often defined by researchers and identified by research ethics boards, should include the opinions and experiences of research subjects as well.
How much risk or what kinds of risks are acceptable for research subjects whose interests lay at the heart of why research ethics boards were conceived and developed? In lay terms, risks should be reasonable and in proportion to the likely benefits afforded to science, society or future patients with similar conditions.
Risks are often measured against those risks associated with more conventional forms of treatment. Some in the bioethics community argue that patients themselves should have more say in how much risk is acceptable or whether patients regarded as too vulnerable to be part of clinical research should, in fact, be given the right to make an informed choice about participating in research trials or qualitative studies (Berry, 2004).
Research ethics boards, scientists and health care professionals, as well as those from the pharmaceutical manufacturing industry, share a common obligation to examine acceptable levels for risks associated with biomedical research. Responsible scientists and professionals, as well as members of research ethics boards have a duty to ensure that the interests and safety of research subjects are not only protected, but also adequately understood from the perspective of subjects themselves.
It is, therefore, important that former research subjects and family members whose loved ones participated as research subjects are among the community members that sit on research ethics boards. In addition, former research subjects, or substitute decision-makers can provide valuable insight and speak to such issues in educational forums provided for health care professionals and researchers.
In addition, risks should be outlined to subjects in lay terms, with understandable concepts or terminology, in ways that provide as much opportunity as necessary to ensure that subjects are well-informed. We, as a society, owe an enormous debt to the individuals who, by volunteering as research subjects, furthered medical science and provided the research community with many valuable lessons about the protection of the rights and the safety of research subjects.
