Definitions of Research Compliance Terms

Parental Permission – The agreement of one or both parents or a guardian to research involving a minor [45 CFR 46.402(c)].

Placebo – A chemically inert substance given in the guise of medicine for its psychologically suggestive effect; used in controlled clinical trials to determine whether improvement and side effects may reflect imagination or anticipation rather than actual power of a drug.

Policy – A written principle or rule to guide decision-making.

Practice – An activity that is actually routinely performed, regardless of whether it is required in POLICY or specified in PROCEDURE.

Preclinical Investigations – Laboratory and animal studies designed to test the mechanisms, safety, and efficacy of an intervention prior to its applications to humans.

Pregnancy – The period of time from confirmation of implantation of a fertilized egg within the uterus until the fetus has entirely left the uterus (i.e., has been delivered). Implantation is confirmed through a presumptive sign of pregnancy such as missed menses or a positive pregnancy test [45 CFR 46.203(b)]. This "confirmation" may be in error, but, for research purposes, investigators would presume that a living fetus was present until evidence to the contrary was clear. Although fertilization occurs a week or more before implantation, the current inability to detect the fertilization event or the presence of a newly fertilized egg makes a definition of pregnancy based on implantation necessary.

Principal Investigator – An individual who conducts an investigation, i.e., under whose immediate direction research is conducted, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team.

Prisoner – An individual involuntarily confined in a penal institution, including persons: (1) sentenced under a criminal or civil statue; (2) detained pending arraignment, trial, or sentencing; and (3) detained in other facilities (e.g., for drug detoxification or treatment of alcoholism) under statutes or commitment procedures providing such alternatives to criminal prosecution or incarceration in a penal institution [45 CFR 46.303(c)].

Prisoner Representative – A member of an IRB who has appropriate background and experience to represent the interests and concerns of an individual who is involuntarily confined to an institution [45 CFR 46.304(b)].

Privacy – Control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.

Private Information – Includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).

Proband – The person whose case serves as the stimulus for the study of other members of the family to identify the possible genetic factors involved in a given disease, condition, or characteristic.

Prophylactic – Preventive or protective; a drug, vaccine, regimen, or device designed to prevent, or provide protection against, a given disease or disorder.

Protocol – The formal design or plan of an experiment or research activity; specifically, the plan submitted to an IRB for review and to an agency for research support. It includes at a minimum the objective, rationale, design, eligibility requests for prospective subjects and controls; treatment regimen, proposed method of analysis of data; methods and other materials for the conduct of the research study.

Protocol File – The documents maintained by the IRB administration containing the protocol, investigator’s brochure, IRB/investigator communications, and all other supporting materials.

Public Responsibility in Medicine and Research (PRIM&R) – A national nonprofit organization dedicated to educating the medical and legal professions, industry and the public about the ethical, legal and policy dimensions of appropriate and ethic research.