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Clinical Research Ethics
Clinical research ethics are the set of relevant ethics considered in the conduct of a clinical trial in the field of clinical research. It borrows from the broader fields of research ethics and medical ethics. Governance Most directly a local institutional review board oversees the clinical research ethics of any given clinical trial. The institutional review board understands and acts according to local and national law. Each countries national law is guided by international principles, such as the Belmont Report's directive that all study participants have a right to "respect for persons", "beneficence", and "justice" when participating in clinical research. Study participant rights Participants in clinical research have rights which they should expect, including the following: *right to informed consent *shared decision-making *privacy for research participants *return of results *right to withdraw Vulnerable populations There is a range of autonomy which study participants ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Ethics
Ethics or moral philosophy is a branch of philosophy that "involves systematizing, defending, and recommending concepts of right and wrong behavior".''Internet Encyclopedia of Philosophy'' The field of ethics, along with aesthetics, concerns matters of value; these fields comprise the branch of philosophy called axiology. Ethics seeks to resolve questions of human morality by defining concepts such as good and evil, right and wrong, virtue and vice, justice and crime. As a field of intellectual inquiry, moral philosophy is related to the fields of moral psychology, descriptive ethics, and value theory. Three major areas of study within ethics recognized today are: # Meta-ethics, concerning the theoretical meaning and reference of moral propositions, and how their truth values (if any) can be determined; # Normative ethics, concerning the practical means of determining a moral course of action; # Applied ethics, concerning what a person is obligated (or permitted) to do ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Return Of Results
Return of results is a concept in research ethics which describes the extent of the duty of a researcher to reveal and explain the results of research to a research participant. Return of results is particularly discussed in the field of biobanks, where a typical case would be that many members of a community donate biobank specimens for medical research. In the course of the research, especially in human genomics research, scientists may discover personal health information which could influence the behavior of specimen donors if they had this information. For different cases, there are arguments for and against revealing study information to participants and in many cases the morally correct choice is not self-evident. Example situation The following example shows some possible outcomes of trying to fulfill the return of results in genomic research. this example is a restatement of examples given in the article A healthy person donates a biological specimen and agrees to have th ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
The Oxford Textbook Of Clinical Research Ethics
''The Oxford Textbook of Clinical Research Ethics'' is a textbook on clinical research ethics edited by Ezekiel Emanuel Ezekiel Jonathan "Zeke" Emanuel (born September 6, 1957) is an American oncologist, bioethicist and senior fellow at the Center for American Progress. He is the current Vice Provost for Global Initiatives at the University of Pennsylvania and chai ..., Christine Grady, Robert A. Crouch, Reidar Lie, Franklin G. Miller and David Wendler. References 2008 non-fiction books Oxford University Press books Clinical research ethics Ethics books Medical textbooks {{ethics-book-stub ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Unethical Human Experimentation
Unethical human experimentation is human experimentation that violates the principles of medical ethics. Such practices have included denying patients the right to informed consent, using pseudoscientific frameworks such as race science, and torturing people under the guise of research. Around World War II, Imperial Japan and Nazi Germany carried out brutal experiments on prisoners and civilians through groups like Unit 731 or individuals like Josef Mengele; the Nuremberg Code was developed after the war in response to the Nazi experiments. Countries have carried out brutal experiments on marginalized populations. Examples include American abuses during Project MKUltra and the Tuskegee syphilis experiments, and the mistreatment of indigenous populations in Canada and Australia. The Declaration of Helsinki, developed by the World Medical Association (WMA), is widely regarded as the cornerstone document on human research ethics. Nazi Germany Nazi Germany performed human experimen ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Ethical Problems Using Children In Clinical Trials
In health care, a clinical trial is a comparison test of a medication or other medical treatment (such as a medical device), versus a placebo (inactive look-alike), other medications or devices, or the standard medical treatment for a patient's condition. To be ethical, researchers must obtain the full and voluntary informed consent of participating human subjects. If the subject is unable to consent for him/herself, researchers can seek consent from the subject's legally authorized representative. For a minor child this is typically a parent or guardian since as under the age of 18 cannot legally give consent to participate in a clinical trial. International standards According to International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good clinical practice, all trials involving unapproved medical treatments are reviewed for ethics before the study begins. These approving groups are typically called Institutional Re ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Insanity
Insanity, madness, lunacy, and craziness are behaviors performed by certain abnormal mental or behavioral patterns. Insanity can be manifest as violations of societal norms, including a person or persons becoming a danger to themselves or to other people. Conceptually, mental insanity also is associated with the biological phenomenon of contagion (that mental illness is infectious) as in the case of copycat suicides. In contemporary usage, the term ''insanity'' is an informal, un-scientific term denoting "mental instability"; thus, the term insanity defense is the legal definition of mental instability. In medicine, the general term psychosis is used to include the presence either of delusions or of hallucinations or both in a patient; and psychiatric illness is " psychopathology", not ''mental insanity''. An interview with Dr. Joseph Merlino, David Shankbone, ''Wikinews'', 5 October 2007. In English, the word "sane" derives from the Latin adjective ''sanus'' meaning "heal ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Incarceration
Imprisonment is the restraint of a person's liberty, for any cause whatsoever, whether by authority of the government, or by a person acting without such authority. In the latter case it is "false imprisonment". Imprisonment does not necessarily imply a place of confinement, with bolts and bars, but may be exercised by any use or display of force (such as placing one in handcuffs), lawfully or unlawfully, wherever displayed, even in the open street. People become prisoners, wherever they may be, by the mere word or touch of a duly authorized officer directed to that end. Usually, however, imprisonment is understood to imply an actual confinement in a jail or prison employed for the purpose according to the provisions of the law. Sometimes gender imbalances occur in imprisonment rates, with incarceration of males proportionately more likely than incarceration of females. History Africa Before colonisation, imprisonment was used in sub-Saharan Africa for pre-trial detention, ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Right To Withdraw
The right to withdraw is a concept in clinical research ethics that a study participant in a clinical trial has a right to end participation in that trial at will. According to ICH GCP guidelines, a person can withdraw from the research at any point in time and the participant is not required to reveal the reason for discontinuation. Children in research When children participate in clinical research their parents or guardians must give assent for them to participate, but ethics dictate that even in this case it is best to get the consent of the research subject. Studies have shown that children participating in research have little understanding of the right to withdraw when they are presented with the option. Biobanks Withdrawal from participating in biobank A biobank is a type of biorepository that stores biological samples (usually human) for use in research. Biobanks have become an important resource in medical research, supporting many types of contemporary research like ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Privacy For Research Participants
Privacy for research participants is a concept in research ethics which states that a person in human subject research has a right to privacy when participating in research. Some typical scenarios this would apply to include, or example, a surveyor doing social research conducts an interview with a participant, or a medical researcher in a clinical trial asks for a blood sample from a participant to see if there is a relationship between something which can be measured in blood and a person's health. In both cases, the ideal outcome is that any participant can join the study and neither the researcher nor the study design nor the publication of the study results would ever identify any participant in the study. Thus, the privacy rights of these individuals can be preserved. Privacy for medical research participants is protected by several procedures such as informed consent, compliance with medical privacy laws, and transparency in how patient data is accumulated and analyzed. Peo ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Trial
Clinical 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. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Shared Decision-making
Shared decision-making in medicine (SDM) is a process in which both the patient and physician contribute to the medical decision-making process and agree on treatment decisions. Health care providers explain treatments and alternatives to patients and help them choose the treatment option that best aligns with their preferences as well as their unique cultural and personal beliefs. In contrast to SDM, the traditional biomedical care system placed physicians in a position of authority with patients playing a passive role in care. Physicians instructed patients about what to do, and patients rarely took part in the treatment decision. History One of the first instances where the term ''shared decision-making'' was employed was in a report on ethics in medicine by Robert Veatch in 1972. It was used again in 1982 in the "President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research." This work built on the increasing interest in p ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Informed Consent
Informed consent is a principle in medical ethics and medical law, 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. This principle applies more broadly than healthcare intervention, for example to conduct research and to disclosing a person's medical information. Definitions of informed consent vary, and the standard required is generally determined by the state. Informed consent requires a clear appreciation and understanding of the facts, implications, and consequences of an action. To give informed consent, the individual concerned must have adequate reasoning faculties and possess all relevant facts. Impairments to reasoning an ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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