PCL WEEK 3&4

Ethics

Values pertaining to human conduct, including rights and responsibilities, and concepts of right and wrong.

Nonmaleficence

The ethical principle of doing no harm, assessing whether the benefits outweigh the burdens.

Beneficence

The ethical principle involving actions taken for the benefit of others to help prevent harm.

Autonomy

The right of patients to make their own decisions about their bodies, even if they differ from physicians' advice.

Declaration of Helsinki

An international document providing ethical guidelines for biomedical research involving human subjects.

Informed consent

The process where participants make voluntary and informed decisions regarding their participation in research.

Nuremberg Code

A set of ethical research principles that emphasizes voluntary consent and the necessity of ethical scrutiny.

Fair subject selection

Ensuring that participant recruitment is done fairly without undue risk to vulnerable populations.

Favorable risk-benefit ratio

An evaluation ensuring that potential benefits of research are proportional to the risks involved.

Clinical trials

Research studies conducted to evaluate the effects, safety, and efficacy of medical interventions.

Pharmacokinetics

The study of how a drug moves through the body, including absorption and elimination processes.

Serious adverse events

Events such as death, life-threatening conditions, or permanent disability that occur during clinical trials.

Placebo

An inactive substance or treatment given to a control group in clinical trials to compare with the active drug.

Single ascending dose study

A type of trial design that tests increasing doses of a drug to determine safety and tolerability.

Screening visit

An appointment where potential participants undergo evaluations to determine eligibility for clinical trials.

Exclusion criteria

Conditions that disqualify potential participants from joining a clinical trial to protect them from harm.

Independent review board (IRB)

A group that oversees the ethical conduct of clinical trials, ensuring participant rights and safety.

Biomarkers

Biological markers used to measure the effects of a drug or the disease state during clinical trials.

Adverse events

Undesirable experiences reported by participants during a clinical trial, which may relate to the study drug.

Voluntary consent

The process by which participants agree to participate in research based on full understanding and freedom from coercion.