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TABLE 9.1. What makes oncology research ethical?

Requirement

Underlying ethical values

Explanation

Collaborative partnership

Nonexploitation and respect for community's self-determination

Inclusion of the patients, representatives of advocacy groups, and other community members in determining research funding, research priorities, ethical oversight, and strategies for studies.

Social or scientific Scarce resources and value nonexploitation

Evaluation of a treatment, intervention, or hypothesis with the aim of improving health and well-being or increasing knowledge.

Scientific validity

Scarce resources and nonexploitation

Use of accepted scientific principles and methods, including statistical techniques, to produce reliable and valid data.

Benchmarks for fulfillment

Ensure appropriate representation of researchers, health policymakers, and the community. Involve researchers, health policymakers, and the community to share responsibilities for determining the importance of health problem, assessing the value of the research, planning, conducting, and overseeing the research, and integrating the research into the healthcare system.

Respect the community's values, culture, traditions, and social practices.

Contribute to developing the capacity for researchers, health policymakers, and the community to become full and equal partners in the research enterprise. Ensure recruited participants and communities receive benefits from the conduct and results of research. Share fairly the financial and other rewards of the research.

Specify the beneficiaries of the research. Assess the importance of the health problems being investigated and the prospect of value of the research for each of the beneficiaries.

Enhance the value of the research for each of the beneficiaries through dissemination of knowledge, product development, long-term research collaboration, and/or health system improvements. Prevent supplanting the extant health system infrastructure and services.

Ensure the scientific design of the research realizes social value for the primary beneficiaries of the research. Ensure the scientific design realizes the scientific objectives while guaranteeing research participants the healthcare interventions they are entitled to. Ensure the research study is feasible given the social, political, and cultural environment and with sustainable improvements in the local healthcare and physical infrastructure.

Fair subject selection

Favorable risk-benefit ratio

Distributive justice

Nonmalefi cence, beneficence, and nonexploitation

Selection of research participants so that stigmatized and vulnerable individuals are not targeted for risky research and favored or privileged individuals not preferentially enrolled in potentially beneficial research.

Minimization of risks; enhancement of potential benefits. Risks to the individual participants are proportionate to the benefits to the individual participants and to society.

Independent review

Public accountability, minimizing influence of potential conflicts of interest

Review of the design of the research trial, its proposed subject population, and risk-to-benefit ratio by individuals unaffiliated with the research.

Informed consent Respect for persons, autonomy

Provision of information to participants about purpose of the research, its procedures, potential risks, benefits, and alternatives so that the individual understands this information and can make a voluntary decision whether to enroll and continue to participate.

Respect for potential Respect for persons, and enrolled subjects autonomy, and welfare

1. Permitting withdrawal from the research

2. Protecting privacy through confidentiality

3. Informing of newly discovered risks or benefits

4. Informing about results of clinical research

5. Monitoring of the health and well-being of participants and providing treatments for adverse reactions from the research.

1) Select the study population to ensure scientific validity of the research.

2) Select the study population to minimize the risks of the research and enhance other principles, especially collaborative partnership and social value.

3) Identify and protect vulnerable populations.

1) Assess the potential risks and benefits of the research to the study population in the context of its health risks.

2) Assess the risk-benefit ratio by comparing the net risks of the research project with the potential benefits derived from collaborative partnership, social value, and respect for study populations.

1) Ensure public accountability through reviews mandated by laws and regulations.

2) Ensure public accountability through transparency and reviews by other international and nongovernmental bodies.

3) Ensure independence and competence of the reviews.

1) Involve the community in establishing recruitment procedures and incentives.

2) Disclose information in culturally and linguistically appropriate formats.

3) Implement supplementary community and familial consent procedures where culturally appropriate.

4) Obtain consent in culturally and linguistically appropriate formats.

5) Prevent penalization for withdrawal from the research.

1) Develop and implement procedures to protect the confidentiality of recruited and enrolled participants.

2) Ensure participants know they can withdraw without penalty.

3) Provide enrolled participants with information that arises in the course of the research study

4) Monitor and develop interventions for medical conditions, including research related injuries, of enrolled participants that are at least as good as existing local norms.

5) Inform participants and the study community of the results of the research.

such as mental incompetence or emergency research, the consent of the individual research participant can be waived. Furthermore, these principles are universal; they apply to research in all countries, although precisely how they are fulfilled may vary depending on the particular economic, social, and cultural circumstances. For instance, in cultures in which signatures are not the common form of consenting, other mechanisms may be used.10 Finally, in designing any particular research study, tensions between the principles may arise. Different principles may have to be balanced against other principles; for some studies, lowering risk may have to be balanced against scientific validity or social value. Such balancing is inevitable. It means that there can be several different ethically acceptable ways to conduct a research study.

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