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Medical Research Ethics

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Privacy and Confidentiality

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Definition: Privacy is an individual's right to control access to personal information. Confidentiality is the responsibility to safeguard a participant's private information obtained during a research study. Ethical Consideration: Researchers must protect the privacy of participants and treat their data confidentially, particularly when handling sensitive information.

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Risk-Benefit Analysis

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Definition: A process by which the potential benefits of research are weighed against the inherent risks involved. The goal is to ensure that the potential outcomes justify exposing subjects to risk. Ethical Consideration: The ethical conduction of research requires that risks must be minimized and should be proportionate to the expected benefits.

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Nonmaleficence

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Definition: An ethical principle requiring that a procedure does not harm the patient involved or others in society. It complements beneficence and is often summarized by the phrase 'first, do no harm.' Ethical Consideration: In medical research, it mandates that the study should not cause unnecessary suffering or injury, either physical or psychological.

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Vulnerable Populations

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Definition: Groups that may be limited in their ability to give informed consent or may be at a higher risk of coercion or undue influence. Examples include children, prisoners, pregnant women, and economically or educationally disadvantaged persons. Ethical Consideration: Additional safeguards must be in place when research involves vulnerable populations to protect their rights and welfare.

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Informed Consent

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Definition: A process by which a subject voluntarily confirms their willingness to participate in a particular study, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Ethical Consideration: Ensuring truly informed consent requires that the information is presented in a way that is understandable to the subject, and that there is no coercion or undue influence.

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Justice

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Definition: The ethical principle concerned with equity in the distribution of burdens and benefits; refers to fairness in the selection of study subjects and the distribution of the impacts of research. Ethical Consideration: Research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research.

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Beneficence

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Definition: An ethical principle that refers to the act of doing good, demonstrating kindness, and helping others. In medical research, it relates to the obligation to prevent harm and ensure the well-being of participants. Ethical Consideration: Researchers must design studies that minimize potential harm and maximize potential benefits to participants.

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Autonomy

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Definition: In the context of medical research ethics, autonomy refers to the right of an individual to make decisions about their own body and health care. Ethical Consideration: Researchers must respect the decision-making capacities of autonomous persons and must obtain their voluntary informed consent before any interventions.

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