Definitions

ASSURANCE: A formal written, binding commitment that is submitted to a federal agency in which an institution promises to comply with applicable regulations governing research with human subjects and stipulates the procedures through which compliance will be achieved.

BENEFICENCE: An ethical principle discussed in the Belmont Report that entails an obligation to protect persons from harm. The principle of beneficence can be expressed in two general rules: (1) do not harm; and (2) protect from harm by maximizing possible benefits and minimizing possible risks of harm.

BENEFIT: A valued or desired outcome; an advantage.

CLINICAL TRIAL: A controlled study involving human subjects, designed to evaluate prospectively the safety and effectiveness of new drugs or devices or of behavioral interventions.

COMPENSATION: Payment or medical care provided to subjects injured in research; does not refer to payment (remuneration) for participation in research. (Compare: Remuneration.)

CONFIDENTIALITY: Confidentiality means respecting a potential participant or participant’s right to be free from unauthorized release of information, particularly if it could be prejudicial to a participant’s interest. Confidentiality concerns records of private information relating to participants, particularly the researcher’s agreement with the participant about how the participant’s records of private information will be handled, managed, and disseminated (e.g., shared with others). For example,
it would include the manner for safeguarding and sharing a list of clients
seen at the pregnancy counseling center. Only an “unauthorized” release
of research information implicates an individual’s confidentiality.

CONTROL (SUBJECTS) or CONTROLS: Subject(s) used for comparison who are not given a treatment under study or who do not have a given condition, background, or risk factor that is the object of study. Control conditions may be concurrent (occurring more or less simultaneously with the condition under study) or historical (preceding the condition under study). When the present condition of subjects is compared with their own condition on a prior regimen or treatment, the study is considered historically controlled.

DEOXYRIBO-NUCLEIC ACID (DNA): Genetic material contained in cells organized in several large structures called chromosomes.

DEVICE (MEDICAL): See Medical Device.

DRUG: Any chemical compound that may be used on or administered to humans as an aid in the diagnosis, treatment, cure, mitigation, or prevention of disease or other abnormal conditions.

FDA: Food and Drug Administration; an agency of the federal government established by Congress in 1912 and presently part of the Department of Health and Human Services.

GRANT: Financial support provided for research study designed and proposed by the principal investigator(s). The granting agency exercises no direct control over the conduct of approved research supported by a grant.

HUMAN SUBJECT RESEARCH: See Determining if Activities Meet Organizational Definition of Human Subject Research.

INVESTIGATOR: In clinical trials, an individual who actually conducts an investigation. Any interventions (e.g., drugs) involved in the study are administered to subjects under the immediate direction of the investigator. (See also: Principal Investigator.)

OFFICE FOR HUMAN RESEARCH PROTECTIONS (OHRP): The office within the Department of Health and Human Services, responsible for implementing DHHS regulations (45 CFR Part 46) governing research involving human subjects.

PRINCIPAL INVESTIGATOR: The scientist or scholar with primary responsibility for the design and conduct of a research project. (See also: Investigator.)

PRIVACY: Privacy means, in the context of a protocol, respecting an individual’s right to be free from unauthorized or unreasonable intrusion related to the individual’s private information, including control over the extent, timing and circumstances of obtaining such information. Privacy concerns participants or potential participants as “people,” in terms of access to personal information from or about them. For example, individuals may not want to be seen entering a place that might stigmatize them, such as a clearly-identified pregnancy counseling center. Both an “authorized” and an “unauthorized” release of research information implicates an individual’s privacy, because it provides access to information about the individual.

PROTOCOL DIRECTOR: The scientist or scholar with primary responsibility for the design and conduct of a research project. (See also: Investigator.)

QUALITY IMPROVEMENT ACTIVITIES:—Quality improvement (QI) activities may, but do not necessarily, constitute human research. QI attempts to measure the effectiveness of programs or services, often medical services or treatment. Such activities may constitute human research, if they are designed or intended to contribute to generalizable knowledge. If they are designed solely for internal program evaluation purposes, with no intended external application or generalization, they do not require IRB review and approval (although in some cases the exempt status of the activity may need to be confirmed by the RCO).

REMUNERATION: Payment for participation in research. (NOTE: It is wise to confine use of the term "compensation" to payment or provision of care for research-related injuries.) (Compare: Compensation.)

TRANSLATOR/INTERPRETER: Person fluent in English and in the necessary second language, who can accurately speak, read, and readily interpret the necessary second language. Has the ability to translate the names of body parts and to describe competently symptoms and injuries in both languages. [California Health & Safety Code 1259 (b)(1)].

VOLUNTARY: Free of coercion, duress, or undue inducement. Used in the research context to refer to a subject's decision to participate (or to continue to participate) in a research activity.