Is Clinical Research Ethical?

Before drug companies begin clinical research, they must have a systematic and coherent framework for evaluating clinical studies that incorporates all relevant ethical considerations. The Journal of American Medical Association (JAMA) delineates the following seven ethical requirements: (1) value; (2) scientific validity; (3) fair subject selection; (4) favorable risk-benefit ratio; (5) independent review; (6) informed consent; and (7) respect for enrolled subjects. These ethical requirements for clinical research aim to minimize the possibility of exploitation by ensuring that research subjects are not merely used for research purposes, but are treated with respect while they contribute to the social good.

Value
Clinical research must have the potential to improve health and well-being, or generate knowledge about structure or function of human biological systems.

Scientific Validity
In order for research to be considered ethical, it must be conducted in a methodical and rigorous manner. The methods used in the research must be valid and practically feasible, have a clear scientific objective, utilize accepted principles, methods, and reliable practices, have the ability to definitively test the objective, and offer a plausible data analysis plan.

Fair Subject Selection
Decisions about who will be included and excluded in the research must be based upon the scientific goals of the study, not vulnerability, privilege, or other factors unrelated to the goals of the study. Additionally, subject selection should be based upon risks and benefits. If a subject is eligible for participation based upon scientific goals, but are at a substantially higher risk of being harmed, the subject must be excluded from the study.

Favorable Risk-Benefit Ratio
Clinical research is justifiable only if three conditions are fulfilled: (1) the potential risks to the subjects are minimized; (2) the potential benefits to the subjects are enhanced; and (3) the potential benefits to the subjects and society are proportionate to or outweigh the risks.

Independent Review
An independent review by individuals unaffiliated with the clinical research helps to eliminate conflicts of interest. It is also important for social accountability. In the United States, independent evaluation of research projects occurs through multiple groups including granting agencies, local Investigational Review Boards (IRB), and data and safety monitoring boards.

Informed Consent
Subjects must be accurately informed of the purpose, methods, risks, benefits, and alternatives to the research, and understand the bearing this information has on their own situation. They must also be informed that their participation is voluntary and that they have the right to cease participation at any time.

Respect for Potential and Enrolled Subjects
The privacy of the subjects must be respected via confidentiality rules. Subjects may change their minds about participating. Any new information gained during the research about the subject’s clinical condition must be communicated to the subject. The welfare of subjects must be closely monitored and any adverse reactions should be treated appropriately. Lastly, subjects should be informed of what knowledge was gained from the study once it has concluded.

It is understandable to be concerned about the ethicality of clinical research. If you choose to participate in clinical research, know your rights. Ask a lot of questions. Do not participate until you have gathered enough information to feel comfortable with your decision. This is important not only for you and your health, but also because drug companies do not want to enroll subjects who end up dropping out of the study.

ClinicalTrials.gov
Provides regularly update information about federally and privately supported clinical research in human volunteers.