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.
An institutional policy of granting authority to health personnel to perform procedures on patients or to remove organs from cadavers for transplantation unless an objection is registered by family members or by the patient prior to death. This also includes emergency care of minors without prior parental consent.
Informed consent given by someone other than the patient or research subject.
Revealing of information, by oral or written communication.
Therapeutic Human Experimentation
Nontherapeutic Human Experimentation
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.
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.
Ethics Committees, Research
Biological Specimen Banks
Refusal to Participate
Refusal to take part in activities or procedures that are requested or expected of an individual. This may include refusal by HEALTH PERSONNEL to participate in specific medical procedures or refusal by PATIENTS or members of the public to take part in clinical trials or health promotion programs.
Informed Consent By Minors
Interference with the FREEDOM or PERSONAL AUTONOMY of another person, with justifications referring to the promotion of the person's good or the prevention of harm to the person. (from Cambridge Dictionary of Philosophy, 1995); more generally, not allowing a person to make decisions on his or her own behalf.
Promotion and protection of the rights of patients, frequently through a legal process.
Clinical Trials as Topic
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.
Clusters of topics that fall within the domain of BIOETHICS, the field of study concerned with value questions that arise in biomedicine and health care delivery.
Patient Education as Topic
The teaching or training of patients concerning their own health needs.
Truthful revelation of information, specifically when the information disclosed is likely to be psychologically painful ("bad news") to the recipient (e.g., revelation to a patient or a patient's family of the patient's DIAGNOSIS or PROGNOSIS) or embarrassing to the teller (e.g., revelation of medical errors).
An international agreement of the World Medical Association which offers guidelines for conducting experiments using human subjects. It was adopted in 1962 and revised by the 18th World Medical Assembly at Helsinki, Finland in 1964. Subsequent revisions were made in 1975, 1983, 1989, and 1996. (From Encyclopedia of Bioethics, rev ed, 1995)
Conflict of Interest
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.
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).
Duty to Warn
A health professional's obligation to breach patient CONFIDENTIALITY to warn third parties of the danger of their being assaulted or of contracting a serious infection.
Committees established by professional societies, health facilities, or other institutions to consider decisions that have bioethical implications. The role of these committees may include consultation, education, mediation, and/or review of policies and practices. Committees that consider the ethical dimensions of patient care are ETHICS COMMITTEES, CLINICAL; committees established to protect the welfare of research subjects are ETHICS COMMITTEES, RESEARCH.
Professional Staff Committees
Tissue and Organ Procurement
The administrative procedures involved with acquiring TISSUES or organs for TRANSPLANTATION through various programs, systems, or organizations. These procedures include obtaining consent from TISSUE DONORS and arranging for transportation of donated tissues and organs, after TISSUE HARVESTING, to HOSPITALS for processing and transplantation.
Those individuals engaged in research.
Duties that are based in ETHICS, rather than in law.
Randomized Controlled Trials as Topic
The attitude of a significant portion of a population toward any given proposition, based upon a measurable amount of factual evidence, and involving some degree of reflection, analysis, and reasoning.
Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group.
A branch of applied ethics that studies the value implications of practices and developments in life sciences, medicine, and health care.
Health Knowledge, Attitudes, Practice
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Codes of Ethics
The principles of proper conduct concerning the rights and duties of the professional, relations with patients or consumers and fellow practitioners, as well as actions of the professional and interpersonal relations with patient or consumer families. (From Stedman, 25th ed)
Mentally Ill Persons
The alterations of modes of medical practice, induced by the threat of liability, for the principal purposes of forestalling lawsuits by patients as well as providing good legal defense in the event that such lawsuits are instituted.
An approach to ethics that focuses on theories of the importance of general principles such as respect for autonomy, beneficence/nonmaleficence, and justice.
Guidelines as Topic
A systematic statement of policy rules or principles. Guidelines may be developed by government agencies at any level, institutions, professional societies, governing boards, or by convening expert panels. The text may be cursive or in outline form but is generally a comprehensive guide to problems and approaches in any field of activity. For guidelines in the field of health care and clinical medicine, PRACTICE GUIDELINES AS TOPIC is available.
Records as Topic
The commitment in writing, as authentic evidence, of something having legal importance. The concept includes certificates of birth, death, etc., as well as hospital, medical, and other institutional records.
The kind of action or activity proper to the judiciary, particularly its responsibility for decision making.
Surgical Procedures, Operative
Clinical Trials, Phase I as Topic
Works about studies performed to evaluate the safety of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques in healthy subjects and to determine the safe dosage range (if appropriate). These tests also are used to determine pharmacologic and pharmacokinetic properties (toxicity, metabolism, absorption, elimination, and preferred route of administration). They involve a small number of persons and usually last about 1 year. This concept includes phase I studies conducted both in the U.S. and in other countries.
Persons functioning as natural, adoptive, or substitute parents. The heading includes the concept of parenthood as well as preparation for becoming a parent.
Surgical Procedures, Elective
Surgery which could be postponed or not done at all without danger to the patient. Elective surgery includes procedures to correct non-life-threatening medical problems as well as to alleviate conditions causing psychological stress or other potential risk to patients, e.g., cosmetic or contraceptive surgery.
United States Office of Research Integrity
An office of the UNITED STATES PUBLIC HEALTH SERVICE organized in June 1992 to promote research integrity and investigate misconduct in research supported by the Public Health Service. It consolidates the Office of Scientific Integrity of the National Institutes of Health and the Office of Scientific Integrity Review in the Office of the Assistant Secretary for Health.
Clinical Trials, Phase IV as Topic
Planned post-marketing studies of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques that have been approved for general sale. These studies are often conducted to obtain additional data about the safety and efficacy of a product. This concept includes phase IV studies conducted in both the U.S. and in other countries.
Patient Identification Systems
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)
Access to Information
Sensitivity and Specificity
The interactions between the professional person and the family.
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)
Attitude of Health Personnel
Attitudes of personnel toward their patients, other professionals, toward the medical care system, etc.
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.
Institute of Medicine (U.S.)
Identifies, for study and analysis, important issues and problems that relate to health and medicine. The Institute initiates and conducts studies of national policy and planning for health care and health-related education and research; it also responds to requests from the federal government and other agencies for studies and advice.
Detection of a MUTATION; GENOTYPE; KARYOTYPE; or specific ALLELES associated with genetic traits, heritable diseases, or predisposition to a disease, or that may lead to the disease in descendants. It includes prenatal genetic testing.
Practice Guidelines as Topic
Directions or principles presenting current or future rules of policy for assisting health care practitioners in patient care decisions regarding diagnosis, therapy, or related clinical circumstances. The guidelines may be developed by government agencies at any level, institutions, professional societies, governing boards, or by the convening of expert panels. The guidelines form a basis for the evaluation of all aspects of health care and delivery.
Interviews as Topic
Clinical Trials Data Monitoring Committees
Committees established to review interim data and efficacy outcomes in clinical trials. The findings of these committees are used in deciding whether a trial should be continued as designed, changed, or terminated. Government regulations regarding federally-funded research involving human subjects (the "Common Rule") require (45 CFR 46.111) that research ethics committees reviewing large-scale clinical trials monitor the data collected using a mechanism such as a data monitoring committee. FDA regulations (21 CFR 50.24) require that such committees be established to monitor studies conducted in emergency settings.
A social group consisting of parents or parent substitutes and children.
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)
Reproducibility of Results
The statistical reproducibility of measurements (often in a clinical context), including the testing of instrumentation or techniques to obtain reproducible results. The concept includes reproducibility of physiological measurements, which may be used to develop rules to assess probability or prognosis, or response to a stimulus; reproducibility of occurrence of a condition; and reproducibility of experimental results.
The procedure established to evaluate the health status and risk factors of the potential DONORS of biological materials. Donors are selected based on the principles that their health will not be compromised in the process, and the donated materials, such as TISSUES or organs, are safe for reuse in the recipients.
Forms and Records Control
Duty to Recontact
The ethical and/or legal obligation of a health provider or researcher to communicate with a former patient or research subject about advances in research relevant to a treatment or to a genetic or other diagnostic test provided earlier, or about proposed new uses of blood or tissue samples taken in the past for another purpose.