II. Definitions

The following definitions are key to understanding and applying this policy:

Anonymity involves the researcher’s ability to limit the possible linkage between a participant and the data.  

Benefit describes a valued or desired outcome; an advantage.

Confidentiality is the assurance to subjects that the access of others to information about themselves will be controlled in a way that is acceptable to them.

Federalwide assurance (FWA) is an assurance of compliance with the federal regulations for the protection of human subjects in research.  Institutions engaged in human subjects research that is supported by the U.S. Department of Health and Human Services must submit an FWA to the Office of Human Research Protections (OHRP).

Human subject means a living individual about whom a researcher (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual and/or (2) identifiable private information.

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.

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 within the constraints set forth by the IRB and by other institutional requirements.

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.

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.

Registration refers to institutional review board/institutional ethic committee (IRB/IEC) organization (IORG) registration with the OHRP.

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Signatory Official should be a high-level institutional official who has the authority to represent the institution named in the Federalwide Assurance (FWA), as well as all the institutional components listed in the FWA. This person is usually the President, Chancellor, Director General, Chief Executive Officer, or Chief Operating Officer.  OHRP recommends that the Signatory Official not be the chair or member of any IRB designated under the FWA.

Vulnerable populations include those persons who are likely to be subject to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. and for further information on complex issues of anonymity and confidentiality in research with human subjects.