General Framework

Clinical oncology research must fulfill eight ethical requirements (Table 9.1).2,3 First, research must reflect a collaborative partnership between researchers and the community from which participants are drawn.4 Typically, a collaborative partnership is manifest in support from patient advocacy groups and the public for research funding, as well as inclusion of lay or patient representatives in research advisory and oversight boards such as institutional review boards (IRBs). Second, the research must be socially valuable, addressing meaningful gaps in therapy or scientific understanding.5 "Me-too" studies confirming well-known findings are unethical. Third, the study must be conducted to generate reliable and valid data so that there is a reasonable chance the data will be able to advance therapy or contribute knowledge. Trivial questions, invalid or biased methods, and poor statistical techniques are unethical because worthless science cannot justify any risk or inconvenience to research participants. Consequently, there is no conflict between science and ethics. For research to be ethical, it must be good science.

Fourth, subject selection must be fair.6,7 The eligibility requirements and recruitment strategies must be defined by the scientific objectives of the research study, not by social vulnerability or status. After scientific objectives, individuals likely to experience lower risks and greater benefits should be considered for recruitment and enrollment. It is not permissible to enroll privileged individuals preferentially in studies that are perceived to be especially promising. It is unreasonable to recruit individuals of a certain group into a study for convenience alone, when the conduct or results of that study would not benefit that group. Fortunately, unfair subject selection is rarely a problem in cancer research, where recruitment is necessarily tied to the disease under study. Fifth, the research must have a favorable risk-to-benefit ratio. Although risks can rarely be eliminated, they should be minimized. Similarly, the potential benefits to the participants and to future patients should be enhanced. When the benefits to individual participants are minimal, the risks are justified by the benefits of advancing knowledge for society. Sixth, research must also undergo independent review by a committee of peers and laypersons, such as an institutional review board (IRB). Such review is intended to provide unbiased evaluation of the scientific and ethical aspects of research as well as institutional and public accountability for that research.

Seventh, subjects must offer their informed consent to participate in research.8,9 Informed consent has four requirements: (1) competence of the research participant to make decisions; (2) disclosure of relevant information by the researcher; (3) understanding of the information by the participant; and (4) voluntary consent by the participant to enroll. When participants lack competence, such as in pedi-atric research, permission from a surrogate is generally required. Finally, respect for persons does not end with informed consent. Researchers must respect the participants' rights to privacy and to relevant new findings and recognize the continued voluntary nature of participation in the study. Most importantly, researchers must monitor the health and well-being of research participants and intervene when it is threatened.

Each of these eight requirements must be satisfied; that is, all are necessary, although in particular circumstances,

10 Ways To Fight Off Cancer

10 Ways To Fight Off Cancer

Learning About 10 Ways Fight Off Cancer Can Have Amazing Benefits For Your Life The Best Tips On How To Keep This Killer At Bay Discovering that you or a loved one has cancer can be utterly terrifying. All the same, once you comprehend the causes of cancer and learn how to reverse those causes, you or your loved one may have more than a fighting chance of beating out cancer.

Get My Free Ebook


Post a comment