Definitions of Research Compliance Terms

Random Assignment – Assignment of subjects to different treatments, interventions, or conditions according to chance.

Recombinant DNA Technology – The ability to examine DNA and move the pieces, [which] permits the direct examination of the human genome, and the identification of the genetic components of a wide variety of disorders [Holtzman (1989), p. 1]. Recombinant DNA technology is also used to develop diagnostic screens and tests, as well as drugs and biologics for treating diseases with genetic components

Recruitment – The process of enrolling human subjects in research protocols.

Research – A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that 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 demonstrations and service programs may include research activities.

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

Retrospective Studies – Research conducted by reviewing records from the past (e.g., birth and death certificates, medical records, school records, or employment records) or by obtaining information about past events elicited through interviews or surveys. Case control studies are an example of this type of research.

Review (of Research) – The concurrent oversight of research on a periodic basis by an IRB. In addition to the at least annual reviews mandated by the federal regulations, reviews may, if deemed appropriate, also be conducted on a continuous or periodic basis [Federal Policy §___.108(e)].

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. Federal regulations define only "minimal risk." (See also: Minimal Risk.)