Glossary | Human Research Protections

Record:

A record is any information preserved in a fixed medium, whether on paper, electronically or otherwise.

IRB protocol records include protocol submissions, approved protocol documents (e.g., protocol application, recruitment materials, assessment instruments, and consent forms); all relevant correspondence between the IRB and investigators; and documentation of IRB review (e.g., reviewer checklists, file notes).

Recruitment Plan:

The plan that outlines how individuals will be recruited for the study and how the study will reach the recruitment goal.

Recruitment/Recruitment Materials::

Recruitment is the process by which potential subjects are informed about a study. Recruitment materials, such as fliers, email messages, newspaper ads, and phone calls, must be accurate, non-coercive, and must not emphasize monetary compensation. These materials must be approved by the IRB.

Reliance Agreement:

Also called institutional authorization agreement: A contract that allows one IRB office to rely on another IRB office for protocol review and oversight. The IRB that reviews and approves the research is called the “IRB of Record.” The IRB that does not review the research and relies on another IRB for review and approval of the project is called the “Relying IRB.” Reliance agreements are typically implemented for research with human subjects that is reviewed at the expedited or Full Board level. In rare cases, these may be completed for exemptions.

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.)

Research:

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

DHHS Definition: A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge [45 CFR 46.102(l)]. The following activities are deemed not to be research:
1. Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
2. Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
3. Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
4. Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
FDA Definition: Any experiment that involves a test article and one or more human subjects and that is either subject to requirements for prior submission to the FDA under section 505(i) or 520(g) of the Act, or is not subject to requirements for prior submission to the FDA under these sections of the Act, but the results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an application for research or marketing permit. The terms "research," "clinical research," "clinical study," "study," and "clinical investigations" are deemed to be synonymous for purposes of this part (21 CFR 50.3(c) and 21 CFR 56.102(c)

Research Affiliate:

An institution with whom the University has entered into an IRB Authorization Agreement (IAA), allowing the institution to designate a University IRB as IRB of record on the institution's FWA or vice versa.

Research Involving a Human Being as an Experimental Subject (Department of Defense):

According to the Department of Defense Directive 3216.02 section E2.1.3., this means an activity, for research purposes, where there is an intervention or interaction with a human being for the primary purpose of obtaining data regarding the effect of the intervention or interaction. Examples of interventions or interactions include, but are not limited to, a physical procedure, a drug, a manipulation of the subject or subject's environment, the withholding of an intervention that would have been undertaken if not for the research purpose. This does not include: (1) Activities carried out for purposes of diagnosis, treatment, or prevention of injury and disease in members of the armed Forces and other mission essential personnel under Force Health Protection programs of the Department of Defense. (2) Authorized health and medical activities as part of the reasonable practice of medicine or other health professions. (3) Monitoring for compliance of individuals and organizations with requirements applicable to military, civilian, or contractor personnel or to organizational units. This includes such activities as drug testing, occupational health and safety monitoring, and security clearance reviews.

Respect for Persons:

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

Retention Plan:

The plan that details the methods in which the study will use in order to retain study participation in the clinical trial.

Retrospective Study:

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.

Risk Determinations:

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.) These can include:

Moderate Risk: The subject will undergo procedures that will increase their risks above those normally encountered in daily life. Equivalent term is "more than minimal risk." These can include, but are not limited to: clinical drug trials, device trials, genetic studies, and risks that include insurability and employability.
Minimal Risk: The subject will undergo procedures that do not appear to increase the risks above those normally encountered in daily life. These can include but are not limited to studies that involve survey, questionnaire, interview, medical records review, observation of behaviors, drawing a small amount of blood from a healthy individual, etc.
Exempt: These studies are not usually reviewed by board members, but are reviewed by the chair/analyst. These have been determined to fit certain federal regulations as exempt from IRB review.

Risk/Benefit Ratio:

Comparing the potential benefits to the risks of participating in a research study.