Federal regulations and University policy use the following abbreviations:
    CFR     Code of Federal Regulations
    FDA      Food and Drug Administration
    DHHS  Department of Health and Human Services
    OHRP  Office for Human Research Protection
    IRB       Institutional Review Board
    PI          Principal Investigator
    OSRP  Office of Sponsored Research and Programs

Federal regulations and University policy define various terms in regard to protection of human research participants. 45 CFR 46, also know as the Common Rule, is the body of regulations promulgated by DHHS. Most projects at the University fall under these regulations. 45 CFR 46 includes the following definitions:

A.2.1    Definitions used by the Department of Health and Human Services

(1) Secretary means the Secretary of Health and Human Services and any other officer or employee of the DHHS to whom authority has been delegated.

(2) Department or Agency 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.

(3) Research means 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 purpose of the policy and procedures, whether or not they are supported or funded under a program which is considered research for other purposes.  For example, some demonstration and service programs may include research activities.

(4) Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (a) data through intervention or interaction with the individual, or (b) identifiable private information.
•  Intervention includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes (e.g., cognitive experiment).
•  Interaction includes communication or interpersonal contact between investigator and human subject (e.g., a telephone interview).
•  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 he or she can reasonably expect will not be made public (e.g., 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) in order for obtaining the information to constitute research involving human participants.

(5) 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.

(6) Vulnerable population means children, prisoners, pregnant women, mentally disabled persons, economically or educationally disadvantaged persons, individuals who are unable to give informed consent due to a physical or mental condition, or individuals whose circumstances may make them especially vulnerable to coercion (e.g., probationers).

(7) Prisoner means any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures that provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.  Prisoners receive additional protections under 45 CFR 46, Subpart C.

(8) Child means a person who has not yet attained the age of consent to treatments or procedures involved in the research, under the applicable laws of the jurisdiction in which the research will be conducted.  Children receive additional protections under 45 CFR 46, Subpart D.

(9) Parent means a child’s biological or adoptive parent.

(10) Guardian means an individual who is authorized under applicable state or local law to consent on behalf of a child to general medical care.

(11) Assent means a child’s affirmative agreement to participate in research.  Mere failure to object should not, absent affirmative agreement, be construed as assent.

(12) Permission means the agreement of parent(s) or guardian to the participation of their child or ward in research.

(13) Adverse effect means an undesirable and unintended, although not necessarily unexpected, result of therapy or other intervention (e.g., subject becomes upset following completion of a depression questionnaire or subject experiences intestinal bleeding associated with aspirin therapy) that is directly or indirectly due to participation in a research study.

Some studies may fall under the regulations promulgated by the FDA (21 CFR 50).  These will generally be studies that involve the testing of an investigational medication or a medical device. Refer to 21 CFR 50 for specific definitions regarding these studies. Some FDA definitions differ from the above DHHS definitions.