Legal Regulations, Research and Human Subjects

Reforming the regulations governing research with human subjects.

In the wake of the scandal surrounding the Tuskegee syphilis study, Congress established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The commission investigated and made recommendations regarding basic ethical principles guiding research with human beings and the special principles relating to research with fetuses, prisoners, and children...

The historical, ethical, and legal background of human-subjects research.

The current system of human-subject-research oversight and protections has developed over the last 5 decades. The principles of conducting human research were first developed as the Nuremberg code to try Nazi war criminals. The 3 basic elements of the Nuremberg Code (voluntary informed consent, favorable risk/benefit analysis, and right to withdraw without repercussions) became the foundation f...

Reforming legal regulations and internal rules

Human research subjects as human research workers.

Biomedical research involving human subjects has traditionally been treated as a unique endeavor, presenting special risks and demanding special protections. But in several ways, the regulatory scheme governing human subjects research is counter-intuitively less protective than the labor and employment laws applicable to many workers. This Article relies on analogical and legal reasoning to dem...

Ethical and legal issues in research involving human subjects: do you want a piece of me?

The conduct of biomedical research involving the participation of human beings implicates a variety of ethical concerns pertaining to such values as dignity, bodily integrity, autonomy, and privacy. These ethical concerns have been translated into a complex regulatory apparatus in the USA, containing specific legal provisions concerning such matters as participant safety, informed consent, and ...