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Legal frameworks that aim to protect individuals' personal data and privacy, while regulating the management and processing of this data by organizations, particularly in research.

A set of guidelines and regulations that govern the ethical use of animals in research to ensure the humane treatment of the animals and to consider the necessity and implications of their use.

A process by which a subject voluntarily confirms their willingness to participate in a particular clinical trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate.

The ethical and legal principle that allows research participants to withdraw from a study at any point without penalty or loss of benefits to which they are entitled.

A legal and ethical obligation of healthcare professionals to keep a patient's personal health information private unless consent to release the information is provided by the patient.

A mechanism to facilitate the availability and use of medical countermeasures, including vaccines and treatments, during public health emergencies, granted by the FDA under specific circumstances.

Ethical, legal, and professional obligations to protect research subjects from harm and to respect their dignity and privacy during research studies.

The process by which physicians and other healthcare providers must report any undesirable experiences encountered by participants during a clinical trial to ensure patient safety and alter the trial if necessary.

The use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration, which involves complex legal and ethical considerations in research.

A set of legal requirements and guidelines for conducting research on gene therapy, aiming to ensure safety, ethical considerations, and scientific quality in the development and testing of genetic treatments.

The ethical considerations and regulations around using a placebo control in clinical research, weighing the necessity for scientific rigor against the obligation to provide the best known treatment.

A situation occurring when an individual or organization is involved in multiple interests, one of which could possibly corrupt the motivation for an act in another.

Involves behaviors such as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.

An international quality standard that is provided by ICH (International Council for Harmonisation), governing the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials.

A committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the research subjects.

Legal rights that result from intellectual activity in the industrial, scientific, literary, and artistic fields, granting the creator exclusive rights to use and potentially benefit financially from their creation.

Occurs when a research subject fails to understand the distinction between the imperatives of clinical research and of ordinary treatment, and consequently has unreasonable expectations of the personal benefit from participation in research.

Legal and ethical considerations pertaining to the financial reimbursement or other compensatory measures provided to research subjects for injuries suffered as a result of their participation in a research study.

A detailed plan that outlines the objectives, design, methodology, statistical considerations, and the organization of a clinical trial. It must be approved by regulatory authorities and IRBs before a trial can commence.