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Research Participants
A research participant, also called a human subject or an experiment, trial, or study participant or subject, is a person who voluntarily participates in human subject research after giving informed consent to be the subject of the research. A research participant is different from individuals who are not able to give informed consent, such as children, infants, and animals. Such individuals are preferentially referred to as subjects. Rights In accordance with modern norms of research ethics and with the Declaration of Helsinki, researchers who conduct human subject research should afford certain rights to research participants. Research participants should expect the following: *to be the target of beneficence *to experience research justice *to get respect for persons *to have privacy for research participants *to be informed *to be safe from undue danger Terminology There are several standard themes in the choice of words (''participant, subject, patient, control''): * In sc ...
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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 ...
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Research Ethics
Research is " creative and systematic work undertaken to increase the stock of knowledge". It involves the collection, organization and analysis of evidence to increase understanding of a topic, characterized by a particular attentiveness to controlling sources of bias and error. These activities are characterized by accounting and controlling for biases. A research project may be an expansion on past work in the field. To test the validity of instruments, procedures, or experiments, research may replicate elements of prior projects or the project as a whole. The primary purposes of basic research (as opposed to applied research) are documentation, discovery, interpretation, and the research and development (R&D) of methods and systems for the advancement of human knowledge. Approaches to research depend on epistemologies, which vary considerably both within and between humanities and sciences. There are several forms of research: scientific, humanities, artistic, econ ...
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Declaration Of Helsinki
The Declaration of Helsinki (DoH, fi, Helsingin julistus, sv, Helsingforsdeklarationen) 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. Its role was described by a Brazilian forum in 2000 in these words: "Even though the Declaration of Helsinki is the responsibility of the World Medical Association, the document should be considered the property of all humanity." Principles The Declaration is morally binding on physicians, and that obligation overrides any national or local laws or regulations, if the Declaration provides for a higher standard of protection of humans than the latter ...
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Beneficence (ethics)
Beneficence is a concept in research ethics that states that researchers should have the welfare of the research participant as a goal of any clinical trial or other research study. The antonym of this term, maleficence, describes a practice that opposes the welfare of any research participant. According to the Belmont Report, researchers are required to follow two moral requirements in line with the principle of beneficence: do not harm and maximize possible benefits for research while minimizing any potential harm on others. The concept that medical professionals and researchers would always practice beneficence seems natural to most patients and research participants, but in fact, every health intervention or research intervention has potential to harm the recipient. There are many different precedents in medicine and research for conducting a cost–benefit analysis and judging whether a certain action would be a sufficient practice of beneficence, and the extent to which trea ...
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Justice (ethics)
In research ethics, justice is the fair selection of research participants. Justice is the ideal distribution of risks and benefits when scientists conducting clinical research are recruiting volunteer research participants to participate in clinical trials. The concept gives guidelines on how scientific objectives and not membership in either a privileged or vulnerable population should determine which members of which communities should meet inclusion criteria to participate in research in order to most equitably share the risks and benefits of the research. Defining research justice The most commonly recognized source for drawing attention to the importance of justice is the Belmont Report The ''Belmont Report'' is a 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 ..., which used the term "justice" to describ ...
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Respect For Persons
Respect for persons is the concept that all people deserve the right to fully exercise their autonomy. Showing respect for persons is a system for interaction in which one entity ensures that another has agency to be able to make a choice. This concept is usually discussed in the context of research ethics. It is one of the three basic principles of research ethics stated in the Belmont Report issued by the Office of Human Subject Research; it comprises two essential moral requirements: to recognize the right for autonomy and to protect individuals who are disadvantaged to the extent that they cannot practice this right. An autonomous person is defined as an individual who is capable of self-legislation and is able to make judgments and actions based on their particular set of values, preferences, and beliefs. Respecting a person's autonomy thus involves considering their choices and decisions without deliberate obstruction. It also requires that subjects be treated in a non-degrad ...
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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 ...
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Connotation
A connotation is a commonly understood cultural or emotional association that any given word or phrase carries, in addition to its explicit or literal meaning, which is its denotation. A connotation is frequently described as either positive or negative, with regard to its pleasing or displeasing emotional connection. For example, a stubborn person may be described as being either ''strong-willed'' or ''pig-headed''; although these have the same literal meaning (''stubborn''), ''strong-willed'' connotes admiration for the level of someone's will (a positive connotation), while ''pig-headed'' connotes frustration in dealing with someone (a negative connotation). Usage "Connotation" branches into a mixture of different meanings. These could include the contrast of a word or phrase with its primary, literal meaning (known as a denotation), with what that word or phrase specifically denotes. The connotation essentially relates to how anything may be associated with a word or phras ...
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Data Anonymization
Data anonymization is a type of information sanitization whose intent is privacy protection. It is the process of removing personally identifiable information from data sets, so that the people whom the data describe remain anonymous. Overview Data anonymization has been defined as a "process by which personal data is altered in such a way that a data subject can no longer be identified directly or indirectly, either by the data controller alone or in collaboration with any other party." Data anonymization may enable the transfer of information across a boundary, such as between two departments within an agency or between two agencies, while reducing the risk of unintended disclosure, and in certain environments in a manner that enables evaluation and analytics post-anonymization. In the context of medical data, anonymized data refers to data from which the patient cannot be identified by the recipient of the information. The name, address, and full postcode must be removed ...
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Control Group
In the design of experiments, hypotheses are applied to experimental units in a treatment group. In comparative experiments, members of a control group receive a standard treatment, a placebo, or no treatment at all. There may be more than one treatment group, more than one control group, or both. A placebo control group can be used to support a double-blind study, in which some subjects are given an ineffective treatment (in medical studies typically a sugar pill) to minimize differences in the experiences of subjects in the different groups; this is done in a way that ensures no participant in the experiment (subject or experimenter) knows to which group each subject belongs. In such cases, a third, non-treatment control group can be used to measure the placebo effect directly, as the difference between the responses of placebo subjects and untreated subjects, perhaps paired by age group or other factors (such as being twins). For the conclusions drawn from the results of an e ...
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