Definitions

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Adverse Event: Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research.

Allegation of Non-Compliance: An unproved assertion of Non-Compliance.

Community Based Participatory Research (CBPR): CBPR includes community members in all aspects of research including the conception, design, analysis and dissemination of the research. This approach to research engages community partners in collaboration with researchers to solve problems relevant to human health in communities.

Continuing Non-Compliance: A pattern of Non-Compliance that indicates a deficiency likely to result in further Non-Compliance or a circumstance in which an investigator fails to cooperate with investigating or correcting Non-Compliance.

Experienced IRB Member: An IRB member is considered experienced if the member has three years of IRB experience (serving as an IRB member or working in the Office of Regulatory Affairs & Research Compliance) and is considered to be knowledgeable by the IRB chair.

Expiration Date: The first date that the protocol is no longer approved. The date after the end date of the approval period.

Designated Reviewer: The IRB chair or an Experienced IRB Member designated by the IRB chair to conduct Non-Committee Review.

Finding of Non-Compliance: Non-Compliance in fact.

Human Research: Any activity that either*:

Human Subject as Defined by DHHS: 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) information that is both Private Information and Identifiable Information.

For the purpose of this definition:

  • Intervention: 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: Communication or interpersonal contact between investigator and subject.
  • Private Information: 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).
  • Identifiable Information: Information that is individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information).

Human Subject as Defined by FDA: An individual who is or becomes a subject in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. A human subject includes an individual on whose specimen a medical device is used.

Immediate Family: Spouse, domestic partner; and dependent children.

Institutional Official: Associate Dean of Research (ADR) is designated as the Institutional Official (IO) for HSPH.

Legally Authorized Representative: An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the participant’s participation in the research procedure(s).

Non-Committee Review: Any of the following:

  • Determination of whether an activity is Human Research
  • Determination of whether Human Research is exempt from regulation.
  • Reviews of non-exempt research using the expedited procedure.
  • Determination of which subjects can continue in expired research.

Non-Compliance: Failure to follow the regulations, or the requirements or determinations of the IRB.

  • In the case of research funded or conducted by the Department of Defense, non-compliance includes failure to comply with Department of Defense directives regarding protection of human subjects.
  • In the case of research funded or conducted by the Department of the Navy, non-compliance includes failure to comply with Department of the Navy instructions regarding protection of human subjects.

Related to the Research: A financial interest is Related to the Research when the interest is in (1) the sponsor of the research; (2) a competitor of the sponsor of the research; (3) the product or service being tested; or (4) a competitor of the product or service being tested.

Research as Defined by DHHS: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Research as Defined by FDA: Any experiment that involves a test article and one or more human subjects, and that meets any one of the following:

  • Must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) of the Federal Food, Drug, and Cosmetic Act meaning any use of a drug other than the use of an approved drug in the course of medical practice;
  • Must meet the requirements for prior submission to the Food and Drug Administration under section 520(g) of the Federal Food, Drug, and Cosmetic Act meaning any activity that evaluates the safety or effectiveness of a device; OR
  • Any activity the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit.

Restricted: Applies to investigators or research staff members who are delinquent in meeting IRB requirements.

Serious Adverse Event: Any Adverse Event that (1) results in death; (2) is life-threatening (places the subject at immediate risk of death from the event as it occurred); (3) results in inpatient hospitalization or prolongation of existing hospitalization; (4) results in a persistent or significant disability/incapacity; (5) results in a congenital anomaly/birth defect; or (6) based upon appropriate medical judgment, may jeopardize the subject’s health and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.

Serious Non-Compliance: Non-Compliance that affects the rights or welfare of participants.

Suspension of IRB Approval: An action of the IRB, IRB designee, or Organizational Official to temporarily or permanently withdraw IRB approval of some or all research procedures short of a Termination of IRB Approval. Suspended studies remain open and are subject to continuing review.

Termination of IRB Approval: An action of the IRB or Organizational Official to permanently withdraw IRB approval of all research procedures. Terminated studies are permanently closed and no longer require continuing review.

Unanticipated Problem Involving Risk to Participants or Others: Any information that is (1) unanticipated; (2) related or possibly related to participation in the research; and (3) indicates that participants or others are at increased risk of harm.

References:

  • AAHRPP Evaluation Instrument for Accreditation: I.3.C, I.3.I, I.3.J, I.4.A, I.4.B, I.5.C, II.2.A, II.2.B, II.4.D
  • 45 CFR §46.102
  • 21 CFR §50.3, 21 CFR §56.102, 21 CFR §312.3, 21 CFR §812.2(a). 21 CFR 812.3(p)