Terminology in Eliciting Truly Informed Consent

IRB Eliciting Truly Informed Consent

Terminology

Autonomy: Personal capacity to consider alternatives, make choices, and act without undue influence of interference of others.

Belmont Report: A statement of basic ethical principles governing research involving human subjects issue by the National Commission for the protection of Human subjects in 1978.

Beneficence: An ethical principle discussed in the Belmont Report that entails an obligation to protect persons from harm. The principle of beneficence can be expressed in two general rules: (1) do not harm; and (3) protect from harm by maximizing possible benefits and minimizing possible risks of harm.

Children: Persons who have not attained the legal age for consent to treatment or procedures involved in the research, as determined under the applicable law of the jurisdiction in which the research will be conducted.

Clinical Trial: A controlled study involving human subjects, designed to evaluate prospectively and safety and effectiveness of new drugs or devices or of behavioral interventions.

Cognitively Impaired: Having either a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders, or dementia) or a developmental disorder (e.g., mental retardation) that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished. Others, including persons under the influence of or dependent on drugs or alcohol, those suffering from degenerative diseases affecting the brain, terminally ill patients, and persons with severely disabling physical handicaps, may also be compromised in their ability to make decisions in their best interests.

Competence: Technically, a legal term, used to denote capacity to on one's own behalf; the ability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice.

Confidentiality: Pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others without permission in ways that are inconsistent with the understanding of the original disclosure.

Conflict of Interest : A conflict of interest is when a Principal Investigator, a member of the research team, or the institution has the possibility of personal or significant professional gain from a research study.

Experimental: Term often used to denote a therapy (drug, device, procedure) that is unproven or not yet scientifically validated with respect to safety and efficacy. A procedure may be considered “experimental” without necessarily being part of a formal study (research) to evaluate its usefulness.

Informed Consent: the process: a process of collaborative education and decision making that a prospective research subject must go through before they can freely volunteer to participate in a given research project.

Institutional Review Board: A committee constituted as directed by federal regulations and charged with the review and oversight of Human Research Studies in order to protect subjects' rights and welfare.

Principle Investigator (PI ): responsible for the design and conduct of a research study.

Research: A systematic investigation (i.e., the gathering and analysis of information) designed to develop or contribute to generalizable knowledge.

Research Team (RTM) : The research staff is composed of people trained and supervised by the Principal Investigator to help conduct the research study. As an example, research staff might help with informed consent, drawing blood or keeping study records.

Respect for Persons: An ethical principle discussed in the Belmont Report requiring that individual autonomy be respected and the persons with diminished autonomy be protected.

Risk: The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant.

System: the rules and relationships that determine and define how the research enterprise functions.

Therapy: Treatment intended and expected t alleviate a disease or disorder.

Treating Physician : Physician responsible for the care and treatment of a patient as opposed to the PI.

Therapeutic Misconception : False expectation of the therapeutic advantage of the trial drug, method, or procedure.

Voluntary: Free of coercion, duress, or undue inducement. Used in the research context to refer to a subject's decision to participate (or to continue to participate) in a research activity.