Research is any systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains
(1) Data through intervention or interaction with the individual, or
(2) Identifiable private information
Interaction includes communication or interpersonal contact between investigator and subject.
Department or agency head means the head of any federal department or agency and any other officer or employee of any department or agency to whom authority has been delegated.
Institution means any public or private entity or agency (including federal, state, and other agencies).
Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.
Clinical trial- Research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the safest and fastest way to find treatments that work in people, and new ways to improve health.
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
Research subject to regulation, and similar terms are intended to encompass those research activities for which a federal department or agency has specific responsibility for regulating as a research activity, (for example, Investigational New Drug requirements administered by the Food and Drug Administration). It does not include research activities which are incidentally regulated by a federal department or agency solely as part of the department's or agency's broader responsibility to regulate certain types of activities whether research or non-research in nature (for example, Wage and Hour requirements administered by the Department of Labor).
Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject.
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). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
IRB means an institutional review board established in accord with and for the purposes expressed in this policy.
IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Certification means the official notification by the institution to the supporting department or agency, that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved assurance.
Phase I trials ensure the safe and effective use of the therapy. Generally using a small number of participants. Phase I trials for medications test a range of dosages.
Phase II trials test whether the medication is helpful in treating the targeted illness. These trials may also help determine other factors such as what types of patients may find the drug more effective than others.
Phase III trials are the largest and may take months or years to complete. The new medication is tested against existing drugs and placebo. A Phase III trial must show a drug's effectiveness and possible negative reactions.
OHRP The Office of Human Research Protections, the agency responsible for developing, monitoring and exercising compliance over the protections afforded human subjects in all research supported by the US Department of Health and Human Services (DHHS).
FDA (Food & Drug Administration) a federal agency in the Department of Health and Human Services established to regulate the release of new foods and health-related products