Declaration of HelsinkiThe Declaration of Helsinki (DoH, Helsingin julistus, ) is a set of ethical principles regarding human experimentation developed originally in 1964 for the medical community by the World Medical Association (WMA). It is widely regarded as the cornerstone document on human research ethics. It is not a legally binding instrument under the international law, but instead draws its authority from the degree to which it has been codified in, or influenced, national or regional legislation and regulations.
Human subject researchHuman subject research is systematic, scientific investigation that can be either interventional (a "trial") or observational (no "test article") and involves human beings as research subjects, commonly known as test subjects. Human subject research can be either medical (clinical) research or non-medical (e.g., social science) research. Systematic investigation incorporates both the collection and analysis of data in order to answer a specific question.
Medical ethicsMedical ethics is an applied branch of ethics which analyzes the practice of clinical medicine and related scientific research. Medical ethics is based on a set of values that professionals can refer to in the case of any confusion or conflict. These values include the respect for autonomy, non-maleficence, beneficence, and justice. Such tenets may allow doctors, care providers, and families to create a treatment plan and work towards the same common goal.
Nuremberg CodeThe Nuremberg Code (Nürnberger Kodex) is a set of ethical research principles for human experimentation created by the court in U.S. v Brandt, one of the Subsequent Nuremberg trials that were held after the Second World War. Though it was articulated as part of the court's verdict in the trial, the Code would later become significant beyond its original context; in a review written on the 50th anniversary of the Brandt verdict, Jay Katz writes that "a careful reading of the judgment suggests that [the authors] wrote the Code for the practice of human experimentation whenever it is being conducted.
Informed consentInformed consent is a principle in medical ethics and medical law and media studies, that a patient must have sufficient information and understanding before making decisions about their medical care. Pertinent information may include risks and benefits of treatments, alternative treatments, the patient's role in treatment, and their right to refuse treatment. In most systems, healthcare providers have a legal and ethical responsibility to ensure that a patient's consent is informed.
Clinical trialClinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought.
Experimental psychologyExperimental psychology refers to work done by those who apply experimental methods to psychological study and the underlying processes. Experimental psychologists employ human participants and animal subjects to study a great many topics, including (among others) sensation & perception, memory, cognition, learning, motivation, emotion; developmental processes, social psychology, and the neural substrates of all of these.
Nazi human experimentationNazi human experimentation was a series of medical experiments on prisoners by Nazi Germany in its concentration camps mainly between 1942 and 1945. There were at least 15,754 documented victims from a variety of nationalities and age groups, although the plurality were young adults at the time of the experiment. Although most victims survived, many suffered disability as a result. Nazi physicians and their assistants forced prisoners into participating; they did not willingly volunteer and no consent was given for the procedures.
Medical researchMedical research (or biomedical research), also known as experimental medicine, encompasses a wide array of research, extending from "basic research" (also called bench science or bench research), – involving fundamental scientific principles that may apply to a preclinical understanding – to clinical research, which involves studies of people who may be subjects in clinical trials. Within this spectrum is applied research, or translational research, conducted to expand knowledge in the field of medicine.
Belmont ReportThe Belmont Report is a 1978 report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Its full title is the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report summarizes ethical principles and guidelines for human subject research.
Tuskegee Syphilis StudyThe Tuskegee Study of Untreated Syphilis in the Negro Male (informally referred to as the Tuskegee Experiment or Tuskegee Syphilis Study) was a study conducted between 1932 and 1972 by the United States Public Health Service (PHS) and the Centers for Disease Control and Prevention (CDC) on a group of nearly 400 African American men with syphilis. The purpose of the study was to observe the effects of the disease when untreated, though by the end of the study medical advancements meant it was entirely treatable.
Clinical researchClinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment.
Milgram experimentThe Milgram experiment(s) on obedience to authority figures were a series of social psychology experiments conducted by Yale University psychologist Stanley Milgram. They measured the willingness of study participants, 40 men in the age range of 20 to 50 from a diverse range of occupations with varying levels of education, to obey an authority figure who instructed them to perform acts conflicting with their personal conscience. Participants were led to believe that they were assisting an unrelated experiment, in which they had to administer electric shocks to a "learner".
Good clinical practiceGood clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and enforces tight guidelines on ethical aspects of clinical research. High standards are required in terms of comprehensive documentation for the clinical protocol, record keeping, training, and facilities, including computers and software.
