Clinical trials and end of life: Part I

Clinical research often has a negative connotation in modern society. People fear being seen as a guinea pig; they may associate trials with Mengele, Tuskegee, and Henrietta Lacks. Modern medicine has an incredibly dark history, particularly for people of color and other minorities. Because of healthcare inequities, it is generally white, college-educated urban dwellers who can take advantage of the best care; when organizations are able to provide clinical trials drug coverage to indigent patients, it may be seen as coercion.

There has been a push to increase the ethical standing of clinical research with organizations comprised of dozens of nations gathering to draft and publish documents laying out the ethical conduction of human research: the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report. These are all critical for trial conduct but do not necessarily discuss the conduct of interventional study investigators regarding follow up of terminal patients as they approach end of life.

The Nuremberg Code has nine principles: voluntary consent by a person who is legally capable of giving consent is required, experiments must be designed to yield fruitful results rather than being unnecessary, experiments must be well-designed following animal experimentation by someone familiar with the condition being treated, the experiment must avoid unnecessary pain and suffering, experiments must not be conducted if death is strongly believed to be the outcome, the risk should never exceed the benefit, protections must be in place for all subjects, only qualified and trained personnel should participate in human interventional research, the subjects must be able to revoke consent at any time, and the principal investigator must be willing to terminate the study at any time if it appears risks are greater than benefits for the subjects involved.

The Declaration of Helsinki focuses on the medical and academic sides of research, guiding physicians in the engagement of biomedical research.

The Belmont Report specifically addresses the bodies of institutional review boards and scientific review committees. The three ideas in the document are respect for persons, beneficence, and justice.