[Code of Federal Regulations]

[Title 45, Volume 1]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 45CFR46.102]



[Page 118]

 

                        TITLE 45--PUBLIC WELFARE

 

           SUBTITLE A--DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

PART 46_PROTECTION OF HUMAN SUBJECTS--Table of Contents

 

  Subpart A_Basic HHS Policy for Protection of Human Research Subjects

 

Sec. 46.102  Definitions.



    (a) 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.

    (b) Institution means any public or private entity or agency 

(including federal, state, and other agencies).

    (c) 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.

    (d) 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.

    (e) 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).

    (f) 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.



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.

    (g) IRB means an institutional review board established in accord 

with and for the purposes expressed in this policy.

    (h) 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.

    (i) 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.

    (j) Certification means the official notification by the institution 

to the supporting department or agency, in accordance with the 

requirements of this policy, that a research project or activity 

involving human subjects has been reviewed and approved by an IRB in 

accordance with an approved assurance.