Parent: A child’s biological or adoptive parent.
Permission: The agreement of parent(s) or guardian to the participation of their child or ward in research.
Phase I, II, III, and IV Drug Trials:
- Phase I (One) Drug Trials. Phase 1 drug trials include the initial introduction of an investigational new drug into humans. These studies are typically closely monitored and are conducted with a small group of healthy volunteers (20-80); sometimes, where the drug is intended for use in patients with a particular disease, however, such patients may participate as subjects.
- Phase II (Two) Drug Trials. Phase 2 trials include controlled clinical studies conducted to evaluate the drug’s effectiveness for a particular indication in patients with the disease or condition under study, and to determine the common short-term side effects and risks associated with the drug. These studies are typically well controlled, closely monitored, and conducted with a larger number of subjects (100-300).
- Phase III (Three) Drug Trials. Phase 3 drug trials involve the administration of a new drug to a larger number of patients in different clinical settings to determine its safety, effectiveness, and appropriate dosage. They are performed after preliminary evidence of effectiveness has been obtained, and are intended to gather necessary additional information about effectiveness and safety for evaluating the overall benefit-risk relationship of the drug, and to provide an adequate basis for physician labeling. These studies are conducted with large groups of subjects (1,000-3,000).
- Phase IV (Four) Drug Trials. Concurrent with marketing approval, the FDA may seek agreement from the sponsor to conduct certain post-marketing (Phase 4) studies to delineate additional information about the drug’s risks, benefits, and optimal use. These studies could include, but would not be limited to, studying different doses or schedules of administration than were used in Phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time.
Privacy: Having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.
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. The protocol includes a description of the research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen(s), and the proposed methods of analysis that will be performed on the collected data.
Physician: For these purposes, anyone with a doctorate-level health science degree (M.D., D.O., O.D., DMD, DPM, PhD., etc.).
PRIM&R: Public Responsibility in Medicine and Research – 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 ethical research. www.primr.org
Principal Investigator: The scientist or scholar with responsibility for the design and conduct of a research project.
Prisoner: An individual involuntarily confined or detained in a penal institution.
Private Information: Information about behavior that occurs in a context 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).