Informed Consent: 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.Consent Forms: 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.Presumed Consent: 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.Parental Consent: Informed consent given by a parent on behalf of a minor or otherwise incompetent child.Mental Competency: The ability to understand the nature and effect of the act in which the individual is engaged. (From Black's Law Dictionary, 6th ed).Research Subjects: Persons who are enrolled in research studies or who are otherwise the subjects of research.Third-Party Consent: Informed consent given by someone other than the patient or research subject.Human Experimentation: The use of humans as investigational subjects.Disclosure: Revealing of information, by oral or written communication.Ethics, Research: The moral obligations governing the conduct of research. Used for discussions of research ethics as a general topic.Therapeutic Human Experimentation: Human experimentation that is intended to benefit the subjects on whom it is performed.Nontherapeutic Human Experimentation: 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.Comprehension: 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.Personal Autonomy: Self-directing freedom and especially moral independence. An ethical principle holds that the autonomy of persons ought to be respected. (Bioethics Thesaurus)Ethics, Medical: 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.Beneficence: The state or quality of being kind, charitable, or beneficial. (from American Heritage Dictionary of the English Language, 4th ed). The ethical principle of BENEFICENCE requires producing net benefit over harm. (Bioethics Thesaurus)Minors: A person who has not attained the age at which full civil rights are accorded.Ethics Committees, Research: 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.Biological Specimen Banks: Facilities that collect, store, and distribute tissues, e.g., cell lines, microorganisms, blood, sperm, milk, breast tissue, for use by others. Other uses may include transplantation and comparison of diseased tissues in the identification of cancer.Biomedical Research: Research that involves the application of the natural sciences, especially biology and physiology, to medicine.Genetic Research: Research into the cause, transmission, amelioration, elimination, or enhancement of inherited disorders and traits.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.Confidentiality: The privacy of information and its protection against unauthorized disclosure.Patient Rights: 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.Informed Consent By Minors: Voluntary authorization by a person not of usual legal age for diagnostic or investigative procedures, or for medical and surgical treatment. (from English A, Shaw FE, McCauley MM, Fishbein DB Pediatrics 121:Suppl Jan 2008 pp S85-7).Paternalism: 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.Patient Advocacy: Promotion and protection of the rights of patients, frequently through a legal process.Ethics, Clinical: The identification, analysis, and resolution of moral problems that arise in the care of patients. (Bioethics Thesaurus)Decision Making: The process of making a selective intellectual judgment when presented with several complex alternatives consisting of several variables, and usually defining a course of action or an idea.Patient Selection: 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.Legal Guardians: A legal concept for individuals who are designated to act on behalf of persons who are considered incapable of acting in their own behalf, e.g., minors and persons found to be not mentally competent.Patient Participation: Patient involvement in the decision-making process in matters pertaining to health.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.Researcher-Subject Relations: Interaction between research personnel and research subjects.Bioethical Issues: 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.Truth Disclosure: 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).Physician-Patient Relations: The interactions between physician and patient.Privacy: The state of being free from intrusion or disturbance in one's private life or affairs. (Random House Unabridged Dictionary, 2d ed, 1993)Child Advocacy: Promotion and protection of the rights of children; frequently through a legal process.Helsinki Declaration: 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.Ethical Review: 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 Design: 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.Questionnaires: 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.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.Ethics Committees: 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.Communication: The exchange or transmission of ideas, attitudes, or beliefs between individuals or groups.Liability, Legal: Accountability and responsibility to another, enforceable by civil or criminal sanctions.Professional Staff Committees: Committees of professional personnel who have responsibility for determining policies, procedures, and controls related to professional matters in health facilities.Government Regulation: Exercise of governmental authority to control conduct.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.Tissue Banks: Centers for acquiring, characterizing, and storing organs or tissue for future use.Morals: Standards of conduct that distinguish right from wrong.Research Personnel: Those individuals engaged in research.Treatment Refusal: Patient or client refusal of or resistance to medical, psychological, or psychiatric treatment. (APA, Thesaurus of Psychological Index Terms, 8th ed.)Moral Obligations: Duties that are based in ETHICS, rather than in law.Persons: Persons as individuals (e.g., ABORTION APPLICANTS) or as members of a group (e.g., HISPANIC AMERICANS). It is not used for members of the various professions (e.g., PHYSICIANS) or occupations (e.g., LIBRARIANS) for which OCCUPATIONAL GROUPS is available.Vulnerable Populations: 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.Randomized Controlled Trials as Topic: 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.United StatesMalpractice: Failure of a professional person, a physician or lawyer, to render proper services through reprehensible ignorance or negligence or through criminal intent, especially when injury or loss follows. (Random House Unabridged Dictionary, 2d ed)Public Opinion: 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.Prospective Studies: 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.Voluntary Programs: Programs in which participation is not required.Bioethics: 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: Knowledge, attitudes, and associated behaviors which pertain to health-related topics such as PATHOLOGIC PROCESSES or diseases, their prevention, and treatment. This term refers to non-health workers and health workers (HEALTH PERSONNEL).Jurisprudence: The science or philosophy of law. Also, the application of the principles of law and justice to health and medicine.Therapeutic Misconception: Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.Documentation: Systematic organization, storage, retrieval, and dissemination of specialized information, especially of a scientific or technical nature (From ALA Glossary of Library and Information Science, 1983). It often involves authenticating or validating information.Audiovisual Aids: Auditory and visual instructional materials.AIDS Serodiagnosis: Immunologic tests for identification of HIV (HTLV-III/LAV) antibodies. They include assays for HIV SEROPOSITIVITY and HIV SERONEGATIVITY that have been developed for screening persons carrying the viral antibody from patients with overt symptoms of AIDS or AIDS-RELATED COMPLEX.Codes of Ethics: Systematic statements of principles or rules of appropriate professional conduct, usually established by professional societies.Ethics, Professional: 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)Therapeutic Equipoise: Expectation of real uncertainty on the part of the investigator regarding the comparative therapeutic merits of each arm in a trial.Trust: Confidence in or reliance on a person or thing.Ethics: The philosophy or code pertaining to what is ideal in human character and conduct. Also, the field of study dealing with the principles of morality.Genetic Privacy: The protection of genetic information about an individual, family, or population group, from unauthorized disclosure.Mentally Ill Persons: Persons with psychiatric illnesses or diseases, particularly psychotic and severe mood disorders.Control Groups: Groups that serve as a standard for comparison in experimental studies. They are similar in relevant characteristics to the experimental group but do not receive the experimental intervention.Defensive Medicine: 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.Multimedia: Materials, frequently computer applications, that combine some or all of text, sound, graphics, animation, and video into integrated packages. (Thesaurus of ERIC Descriptors, 1994)Risk Assessment: 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)Internationality: The quality or state of relating to or affecting two or more nations. (After Merriam-Webster Collegiate Dictionary, 10th ed)Principle-Based Ethics: An approach to ethics that focuses on theories of the importance of general principles such as respect for autonomy, beneficence/nonmaleficence, and justice.Great BritainSelection Bias: The introduction of error due to systematic differences in the characteristics between those selected and those not selected for a given study. In sampling bias, error is the result of failure to ensure that all members of the reference population have a known chance of selection in the sample.Human Rights: The rights of the individual to cultural, social, economic, and educational opportunities as provided by society, e.g., right to work, right to education, and right to social security.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.Social Responsibility: The obligations and accountability assumed in carrying out actions or ideas on behalf of others.Patients: Individuals participating in the health care system for the purpose of receiving therapeutic, diagnostic, or preventive procedures.Attitude: An enduring, learned predisposition to behave in a consistent way toward a given class of objects, or a persistent mental and/or neural state of readiness to react to a certain class of objects, not as they are but as they are conceived to be.Attitude to Health: Public attitudes toward health, disease, and the medical care system.Patient Satisfaction: The degree to which the individual regards the health care service or product or the manner in which it is delivered by the provider as useful, effective, or beneficial.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.Judicial Role: The kind of action or activity proper to the judiciary, particularly its responsibility for decision making.Pilot Projects: Small-scale tests of methods and procedures to be used on a larger scale if the pilot study demonstrates that these methods and procedures can work.Surgical Procedures, Operative: Operations carried out for the correction of deformities and defects, repair of injuries, and diagnosis and cure of certain diseases. (Taber, 18th ed.)Pregnant Women: Human females who are pregnant, as cultural, psychological, or sociological entities.Freedom: The rights of individuals to act and make decisions without external constraints.Emergency Medicine: The branch of medicine concerned with the evaluation and initial treatment of urgent and emergent medical problems, such as those caused by accidents, trauma, sudden illness, poisoning, or disasters. Emergency medical care can be provided at the hospital or at sites outside the medical facility.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.Parents: 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: Organized procedures for establishing patient identity, including use of bracelets, etc.Information Dissemination: The circulation or wide dispersal of information.Tissue Donors: Individuals supplying living tissue, organs, cells, blood or blood components for transfer or transplantation to histocompatible recipients.General Surgery: A specialty in which manual or operative procedures are used in the treatment of disease, injuries, or deformities.Compensation and Redress: Payment, or other means of making amends, for a wrong or injury.War Crimes: Criminal acts committed during, or in connection with, war, e.g., maltreatment of prisoners, willful killing of civilians, etc.Treatment Outcome: Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series.Mental Recall: The process whereby a representation of past experience is elicited.Empirical Research: The study, based on direct observation, use of statistical records, interviews, or experimental methods, of actual practices or the actual impact of practices or policies.Embryo Disposition: Utilization or disposal of an embryo that is fertilized but not immediately transplanted and resulting course of action.Research: 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)Cross-Sectional Studies: Studies in which the presence or absence of disease or other health-related variables are determined in each member of the study population or in a representative sample at one particular time. This contrasts with LONGITUDINAL STUDIES which are followed over a period of time.Access to Information: Individual's rights to obtain and use information collected or generated by others.Anesthesiology: A specialty concerned with the study of anesthetics and anesthesia.Sensitivity and Specificity: Binary classification measures to assess test results. Sensitivity or recall rate is the proportion of true positives. Specificity is the probability of correctly determining the absence of a condition. (From Last, Dictionary of Epidemiology, 2d ed)Professional-Family Relations: The interactions between the professional person and the family.Behavioral Research: 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)Medical Records: Recording of pertinent information concerning patient's illness or illnesses.Attitude of Health Personnel: Attitudes of personnel toward their patients, other professionals, toward the medical care system, etc.Focus Groups: A method of data collection and a QUALITATIVE RESEARCH tool in which a small group of individuals are brought together and allowed to interact in a discussion of their opinions about topics, issues, or questions.Data Collection: 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.IndiaInstitute 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.Genetic Testing: 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.Federal Government: The level of governmental organization and function at the national or country-wide level.Interviews as Topic: Conversations with an individual or individuals held in order to obtain information about their background and other personal biographical data, their attitudes and opinions, etc. It includes school admission or job interviews.Death: Irreversible cessation of all bodily functions, manifested by absence of spontaneous breathing and total loss of cardiovascular and cerebral functions.Legislation, Medical: Laws and regulations, pertaining to the field of medicine, proposed for enactment or enacted by a legislative body.Educational Status: Educational attainment or level of education of individuals.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.Family: A social group consisting of parents or parent substitutes and children.Feasibility Studies: Studies to determine the advantages or disadvantages, practicability, or capability of accomplishing a projected plan, study, or project.Pamphlets: Printed publications usually having a format with no binding and no cover and having fewer than some set number of pages. They are often devoted to a single subject.Cultural Diversity: Coexistence of numerous distinct ethnic, racial, religious, or cultural groups within one social unit, organization, or population. (From American Heritage Dictionary, 2d college ed., 1982, p955)Physician Impairment: The physician's inability to practice medicine with reasonable skill and safety to the patient due to the physician's disability. Common causes include alcohol and drug abuse, mental illness, physical disability, and senility.Qualitative Research: 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)Germany, WestReproducibility 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.Communication Barriers: Those factors, such as language or sociocultural relationships, which interfere in the meaningful interpretation and transmission of ideas between individuals or groups.Clinical Protocols: Precise and detailed plans for the study of a medical or biomedical problem and/or plans for a regimen of therapy.Journalism, Medical: The collection, writing, and editing of current interest material on topics related to biomedicine for presentation through the mass media, including newspapers, magazines, radio, or television, usually for a public audience such as health care consumers.Consumer Participation: Community or individual involvement in the decision-making process.Hospitals, Teaching: Hospitals engaged in educational and research programs, as well as providing medical care to the patients.Donor Selection: 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.Emergencies: Situations or conditions requiring immediate intervention to avoid serious adverse results.Forms and Records Control: A management function in which standards and guidelines are developed for the development, maintenance, and handling of forms and records.Mass Screening: Organized periodic procedures performed on large groups of people for the purpose of detecting disease.Risk Factors: An aspect of personal behavior or lifestyle, environmental exposure, or inborn or inherited characteristic, which, on the basis of epidemiologic evidence, is known to be associated with a health-related condition considered important to prevent.Social Justice: An interactive process whereby members of a community are concerned for the equality and rights of all.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.Pregnancy: The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH.Editorial Policies: The guidelines and policy statements set forth by the editor(s) or editorial board of a publication.