A variety of concerns emerge when considering the ethical protection of human subjects and the complex issues surrounding privacy and confidentiality in DNA profiling. This paper spotlights these concerns by examining (a) the science of DNA analysis and the identifiable nature of forensic DNA samples; (b) the ethical challenges forensic DNA samples pose to privacy, confidentiality, and respect for persons within human research and (c) the potential problem of exemption for DNA samples under 45 CFR 46.101. b. These issues point to the essential requirement that scientific progress must be tempered by the ethical parameters that maintain the human face of research. This convergence of the two roads of ethical standards and research advancement poses an unavoidable challenge to research executives whose leadership must promote research production but never at the expense of human protections.
Introduction: A Contemporary Challenge to the Rights and Welfare of Human Subjects in Research
History is replete with examples of the propensity of humankind to throw caution to the wind when searching for and learning about the untapped potential of scientific discovery in research. Sometimes this lack of caution has been the cause of tragedy. Two major instances immediately spring to mind: The Holocaust of World War II and the Tuskegee Syphilis Experiments conducted by the United States Public Health Service on poor disadvantaged African-Americans in the period between 1932 and 1972. Both disregarded the well being and rights of the individuals that were involved in the respective experiments. Some conjecture today that we may be on the cusp of a horrific déjà vu.
We live in the information age. Knowledge and information are power. Important information such as characteristics, disease, and personality is personal. Much of this information is locked inside of our DNA. Advances in modern science have provided keys that can unlock this mysterious Pandora's Box. Does the unlocking of our personal characteristics from our DNA pose dangers in human research?
Consider the following scenario which may not be that far fetched. Imagine going out for a meal and having a glass of water; then someone comes along, takes the glass, and through a simple manipulation, removes thousands of cells that you left behind. The DNA is extracted from the cells, copied, and then profiled, exposing genetic information that was unknown to you. Is this possible at die present? Yes. Is this happening in today's society? Unknown-for the moment! There would be nothing you or anyone could do about this situation. You did not consent to the testing, nor did you have a say as to who sees your information.
The gleaning of information from DNA samples occurs daily around the world in different settings. Two of those settings involve research and diagnostic applications. Typically these applications are looking for hereditary information (paternity or lineage) and genetic history (predisposition to disease or disorders). Law enforcement/forensic science uses a third application in which DNA information generates a genetic profile to serve as an identification tool. The profile is defined and stored in a database, and a sample is then stored in a DNA repository for future analysis at the discretion of a law enforcement agency. Could this sample be considered anonymous if used in a forensic DNA research study? The use of DNA in forensic science application makes an individual's DNA code a unique identifier. When DNA is used post-factum for research purposes, what ethical challenges are emerging for human subject protections and specifically what rights and privileges must one relinquish or be required to relinquish as a prisoner?
This question provides the essential energy behind the discussion to follow. To approach this question it will be necessary to focus on three areas: 1) The identifiable nature of forensic DNA samples; 2) the inviolability of privacy, confidentiality, and informed consent in human research; and 3) the question of exemption under 45 CFR 46. …