One might hope (or fantasize) that the world of research is pure and scientific and somehow free from the complexities of political and legal boundaries within which society in general must attempt to function. Unfortunately, nothing could be farther from the truth. A few brief examples will demonstrate the point.
Several years ago Congress passed the Health Insurance Portability and Accountability Act, which we have all come to know as HIPAA. Essentially an effort to support workers ability to maintain health insurance as they move from one employer to the next, this law attempted to provide broad protections for the privacy of personally identifiable health information. The issue is not trivial. If an employer or potential employer, or insurer were to learn that a given person is being treated for HIV, or for psychiatric illness or for any number of challenging conditions, what would be his employability or insurability? Even more vexing, suppose someone is well but has a genetic predisposition to some lethal condition, which he may or many not personally ever manifest? Does he enter a different insurance risk pool? Does he lose the opportunity to advance into long-term leadership positions? The debate over how well HIPAA actually protects medical privacy is a debate for another article, but, even without that discussion one can readily appreciate some of the issues that privacy protection presents for research.
In order to begin to understand some of the complex relationships that exist between genetic make-up and how this genetic constitution gets translated into clinical reality, the researcher needs large amounts of information. The more completely he can assess the prevalence of certain genetic patterns within a population, the better chance he has of correlating genes with diseases. Logic would therefore dictate that every patient who comes into a medical center should have blood drawn and stored for future genetic studies. Scientifically logical; socially untenable. Certainly we cannot collect information on someone without their knowledge and consent. And, given the potential risks and potential inadequacies of patient protection, how willing will someone be to give consent? Moreover, when patients come to the hospital, they are seeking care, not seeking to become research subjects the request for unrelated and even as yet unspecified future projects may seem disingenuous at best. And even if they might agree to be tested, what realistic assurances can be rendered that the information will be well sequestered from employers, insurers, computer hackers or other inappropriate hands? Given that many will agree and many will not agree based on the reason for entry into the hospital, severity of illness, social demographics and a host of other potential reasons how valid will the patient sampling be? How well will it reflect the general population vs. a hodge-podge of different selection criteria over which the researcher has no control?
Suppose the diligent researcher, genetic or otherwise, wants to better understand the impact of a given therapy on the long-term survival of patients in the real world? Simple right? He merely goes to the hospital records of all the people who had that treatment, contacts them and finds out how they are doing. Not so fast! How is it that this researcher had access to the information that this or that patient had such and such treatment for such and such disease? Is this not a violation of privacy of health care information? Under current regulations, the patient must give permission prior to treatment for a researcher to contact him in the future. In short, the researcher must know what he wants to study beforehand, or he can not ask the question.
In reality, the alert researcher must be sensitive to the legal rights and personal feelings of his subjects and must be prepared to deal with each of these issues as well as possible informed consent, protected databases, back-end statistical modeling to compensate for incomplete enrollment, prospective designs, etc. However, as an active player on the stage of human affairs, the researcher is no more immune or shielded from the legal and ethical realities of the time than the rest of the society in which he operates.
One might hope (or fantasize) that the world of research is pure and scientific and somehow free from the complexities of political and legal boundaries within which society in general must attempt to function. Unfortunately, nothing could be farther from the truth. A few brief examples will demonstrate the point. 
