Standard Operating Procedures : Definitions
Allegation of Non-Compliance:
An unproved assertion of Non-Compliance.
A biomedical or behavioral research study of human subjects designed to answer specific questions about diagnostic procedures or therapeutic interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether new diagnostic procedures or therapeutic interventions are safe, efficacious, and effective.
An individual involved in research review is automatically considered to have a conflicting interest when the individual or the individual’s Immediate Family have any of the following:
Involvement in the design, conduct, or reporting of the research.
Ownership interest, stock options, or other ownership interest Related to the Research of any value exclusive of interests in publicly-traded, diversified mutual funds.
Compensation Related to the Research of any amount in the past year or of any amount expected in the next year, including compensation for costs directly related to conducting research.
Proprietary interest Related to the Research including, but not limited to, a patent, trademark, copyright or licensing agreement.
Any other reason for which the individual believes that he or she cannot be independent.
A pattern of Non-Compliance that indicates a deficiency likely to result in further Non-Compliance or a circumstance in which an individual fails to cooperate with investigating or correcting Non-Compliance.
The IRB chair or an Experienced IRB Member designated by the IRB chair to conduct Non-Committee Reviews.
Experienced IRB Member:
An IRB member is considered experienced if the IRB chair considers the IRB member to have sufficient experience in and knowledge of conducting IRB reviews.
The first date that the protocol is no longer approved. The date after the end date of the approval period.
Finding of Non-Compliance:
Non-Compliance in fact.
Any activity that either:
Is Research as Defined by DHHS and involves Human Subjects as Defined by DHHS; or
Is Research as Defined by FDA and involves Human Subjects as Defined by FDA.
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.
Spouse, domestic partner; and dependent children.
The probability and magnitude of harm or discomfort anticipated in the research that 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. 3.13.1 For research involving prisoners Minimal Risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.
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.
Determinations of which subjects can continue in expired research.
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 (DOD), Non- Compliance includes failure to comply with the Department of Defense directives regarding protection of Human Subjects.
In the case of research funded or conducted by the Department of the Navy (DOD), Non- Compliance includes failure to comply with the Department of the Navy instructions regarding protection of Human Subjects.
The Vice Provost for Research or Designee.
Related to the Research:
A financial interest is Related to the Research when the interest is in:
A sponsor of the research;
A competitor of the sponsor of the research;
A product or service being tested; or
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.
Applies to investigators who are delinquent in meeting IRB requirements.
Non-Compliance that adversely affects the rights or welfare of subjects.
Suspension of IRB Approval:
An action of the IRB, IRB designee, Institutional Official, or designee of the Institutional 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, IRB designee, Institutional Official, or designee of the Institutional Official to permanently withdraw IRB approval of all research procedures. Terminated studies are permanently closed and no longer require continuing review.
Unanticipated Problem Involving Risks to Subjects or Others:
Any information that is (1) unanticipated and (2) indicates that subjects or others are at increased risk of harm.