Persons who are enrolled in research studies or who are otherwise the subjects of research.
The use of humans as investigational subjects.
The moral obligations governing the conduct of research. Used for discussions of research ethics as a general topic.
Human experimentation that is not intended to benefit the subjects on whom it is performed. Phase I drug studies (CLINICAL TRIALS, PHASE I AS TOPIC) and research involving healthy volunteers are examples of nontherapeutic human experimentation.
Hospital or other institutional committees established to protect the welfare of research subjects. Federal regulations (the "Common Rule" (45 CFR 46)) mandate the use of these committees to monitor federally-funded biomedical and behavioral research involving human subjects.
Voluntary authorization, by a patient or research subject, with full comprehension of the risks involved, for diagnostic or investigative procedures, and for medical and surgical treatment.
Human experimentation that is intended to benefit the subjects on whom it is performed.
Documents describing a medical treatment or research project, including proposed procedures, risks, and alternatives, that are to be signed by an individual, or the individual's proxy, to indicate his/her understanding of the document and a willingness to undergo the treatment or to participate in the research.
Fundamental claims of patients, as expressed in statutes, declarations, or generally accepted moral principles. (Bioethics Thesaurus) The term is used for discussions of patient rights as a group of many rights, as in a hospital's posting of a list of patient rights.
Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. (Webster, 3d ed)
A formal process of examination of patient care or research proposals for conformity with ethical standards. The review is usually conducted by an organized clinical or research ethics committee (CLINICAL ETHICS COMMITTEES or RESEARCH ETHICS COMMITTEES), sometimes by a subset of such a committee, an ad hoc group, or an individual ethicist (ETHICISTS).
Research that involves the application of the natural sciences, especially biology and physiology, to medicine.
A situation in which an individual might benefit personally from official or professional actions. It includes a conflict between a person's private interests and official responsibilities in a position of trust. The term is not restricted to government officials. The concept refers both to actual conflict of interest and the appearance or perception of conflict.
Duties that are based in ETHICS, rather than in law.
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Promotion and protection of the rights of patients, frequently through a legal process.
Payment, or other means of making amends, for a wrong or injury.
Research into the cause, transmission, amelioration, elimination, or enhancement of inherited disorders and traits.
A cabinet department in the Executive Branch of the United States Government concerned with administering those agencies and offices having programs pertaining to health and human services.
The principles of professional conduct concerning the rights and duties of the physician, relations with patients and fellow practitioners, as well as actions of the physician in patient care and interpersonal relations with patient families.
A plan for collecting and utilizing data so that desired information can be obtained with sufficient precision or so that an hypothesis can be tested properly.
Persons with no known significant health problems who are recruited to participate in research to test a new drug, device, or intervention as controls for a patient group. (from http://clinicalcenter.nih.gov/recruit/volunteers.html, accessed 2/14/2013)
Those individuals engaged in research.
The privacy of information and its protection against unauthorized disclosure.
Informed consent given by a parent on behalf of a minor or otherwise incompetent child.
Criteria and standards used for the determination of the appropriateness of the inclusion of patients with specific conditions in proposed treatment plans and the criteria used for the inclusion of subjects in various clinical trials and other research protocols.
Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.
Revealing of information, by oral or written communication.
Exercise of governmental authority to control conduct.
The act or fact of grasping the meaning, nature, or importance of; understanding. (American Heritage Dictionary, 4th ed) Includes understanding by a patient or research subject of information disclosed orally or in writing.
Groups of persons whose range of options is severely limited, who are frequently subjected to COERCION in their DECISION MAKING, or who may be compromised in their ability to give INFORMED CONSENT.
The term "United States" in a medical context often refers to the country where a patient or study participant resides, and is not a medical term per se, but relevant for epidemiological studies, healthcare policies, and understanding differences in disease prevalence, treatment patterns, and health outcomes across various geographic locations.
Financial support of research activities.
The terms, expressions, designations, or symbols used in a particular science, discipline, or specialized subject area.
Works about clinical trials that involve at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table.
Systematic gathering of data for a particular purpose from various sources, including questionnaires, interviews, observation, existing records, and electronic devices. The process is usually preliminary to statistical analysis of the data.
Research carried out by nurses, generally in clinical settings, in the areas of clinical practice, evaluation, nursing education, nursing administration, and methodology.
The qualitative or quantitative estimation of the likelihood of adverse effects that may result from exposure to specified health hazards or from the absence of beneficial influences. (Last, Dictionary of Epidemiology, 1988)
Predetermined sets of questions used to collect data - clinical data, social status, occupational group, etc. The term is often applied to a self-completed survey instrument.
The integration of epidemiologic, sociological, economic, and other analytic sciences in the study of health services. Health services research is usually concerned with relationships between need, demand, supply, use, and outcome of health services. The aim of the research is evaluation, particularly in terms of structure, process, output, and outcome. (From Last, Dictionary of Epidemiology, 2d ed)
The application of discoveries generated by laboratory research and preclinical studies to the development of clinical trials and studies in humans. A second area of translational research concerns enhancing the adoption of best practices.
Research carried out by nurses in the clinical setting and designed to provide information that will help improve patient care. Other professional staff may also participate in the research.
The study of laws, theories, and hypotheses through a systematic examination of pertinent facts and their interpretation in the field of dentistry. (From Jablonski, Illustrated Dictionary of Dentistry, 1982, p674)
Collaborative process of research involving researchers and community representatives.
Research that involves the application of the behavioral and social sciences to the study of the actions or reactions of persons or animals in response to external or internal stimuli. (from American Heritage Dictionary, 4th ed)
Any type of research that employs nonnumeric information to explore individual or group characteristics, producing findings not arrived at by statistical procedures or other quantitative means. (Qualitative Inquiry: A Dictionary of Terms Thousand Oaks, CA: Sage Publications, 1997)