title: Ethical issues in research.
abstract: Biomedical research is currently guided by ethical standards that have evolved over many centuries. Historical and political events, social and legal considerations, and continuous medical and technological advances have led to the prevailing research ethics and practice. Currently, patients and research subjects have complete autonomy while under medical care or when volunteering as research subjects. Enrolling volunteers in human subjects research includes a detailed and meaningful informed consent process that follows the cardinal principles of ethics: autonomy, beneficence, nonmaleficence, and justice. These principles were gradually adopted after World War II, primarily in response to the unethical behavior of German physicians and scientists during the Third Reich. This review emphasizes the importance of historical milestones and the essential role that ethics has in contemporary medical research. Research protocols should achieve maximum benefits for the society, have clinical and scientific value, be subject to independent review, respect human dignity, and follow the principles of informed consent, and most importantly, subjects should have complete autonomy. However, current principles and regulations cannot cover every conceivable situation, particularly in view of the new advances in science and technology. New and evolving medical technology, genetic research, therapeutic interventions, and innovations challenge society to maintain the highest moral and ethical principles.
authors.affiliation: Department of Obstetrics, Gynecology and Women's Health, Saint Louis University, St. Louis, USA. Electronic address: artalr@slu.edu.
authors.forename: Raul
authors.initials: R
authors.lastname: Artal
authors.affiliation: Baylor College of Medicine, Center for Medicine After the Holocaust, Houston, USA.
authors.forename: Sheldon
authors.initials: S
authors.lastname: Rubenfeld
mesh_terms: D026686:Beneficence; D035843:Biomedical Research / Q000941:ethics*; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D026684:Personal Autonomy; D035842:Research Subjects
keywords: Nazi medicine; eugenics; informed consent; research ethics principles; the fetus as a patient; women subjects in research