Definitions
Adverse Event
An event that occurs during the course of the research that either causes physical or psychological harm or increases the risk of such harm or results in a loss of privacy or confidentiality to a research participant or to others. The IRB must determine with the help of the PI if such events are anticipated or unanticipated, and also if they are serious and related to the research.
Assent
Affirmative agreement by an individual not competent to give legally valid informed consent (e.g., a child or person who is cognitively impaired) to participate in research.
Attrition
A reduction or decrease in numbers. Subject attrition is the withdrawal of a research subject from a study.
Belmont Report
A statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in 1979.
Broad Consent
Written consent, granted at a prior time for use of an individual’s identifiable private information and/or biospecimen(s) allowing future research to take place with that information and/or biospecimen(s).
Child/Minor
A person who has not attained the legal age for consent to treatments or procedures involved in the research.
Clinical Trial
A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.
Coercion
Use of a credible threat of harm or force to control another. Pertaining to unacceptable subject recruitment methods which involve undue influence or indirect pressure for participation from a subject. (For example, an employee may feel pressure from their supervisor if told to participate in a research project or a subject may feel coerced to participate if the payment were unusually large.)
Common Rule
The central federal policy adopted “in common” by 16 federal departments and agencies (and concurred, with some modifications, by the FDA) that support and/or conduct research involving human subjects. The adoption of the federal policy in 1991 implements a recommendation of the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research that all federal departments and agencies “adopt as a common core the regulations governing research with human subjects issued by the Department of Health and Human Services (codified at 45 CFR 46, Subpart A), as periodically amended or revised, while permitting additions by any department or agency that are not inconsistent with these core provisions” (OPRR Guidebook, Chapter 2).
Confidentiality
Confidentiality refers to data. It is the treatment of information already revealed and states that there is an expectation that it will not be divulged to others in ways that are inconsistent with the understanding of the original disclosure without authorization.
Consent
See Informed Consent
Co-PI
Co-Principal Investigator. Any individual who collaborates with the PI in the design and/or conduct of a research project, including those with access to data.
Data
Refers to information that is collected for analysis or used to reason or make a decision.
Deception
Withholding particular information about the research project from participants until completion of their participation when prior knowledge would adversely affect the integrity of the data gathered.
Exempt
Exempt does not mean review is not required. Some research may be eligible for an exemption from IRB review (expedited or full board review) according to the Common Rule codified in 45 CFR 46.104. Only minimal risk research qualifies for exemption and shall only be determined by the IRB, not the investigator.
Expedited
A level of review by the committee. The Common Rule codified in 45 CFR 46.110specifies that research activities may be eligible for expedited review if the protocol involves only minimal risk or a previously reviewed protocol is receiving modifications that are only minor. Expedited review is carried out by the IRB Chair or by one or more experienced reviewers designated by the chair. Such expedited reviews have the force of full reviews, except that if the protocol is found not acceptable, then it must receive review by the full committee; the chair or designee alone cannot reject a protocol.
Full Board
A level of review by the committee. This category of review applies to all research that does not fall under exempt or expedited review categories. In general, full board review will be required for all projects involving: a) more than minimal risk to participants, b) the deception of subjects, c) sensitive behavioral research (such as research relating to illegal or sexual activity), and d) at-risk populations (e.g., pregnant women, human fetuses, neonates, prisoners, children, individuals with cognitive impairments).
FWA
Federalwide Assurance. A written documentation of an institution’s commitment to comply with the federal regulations that establishes standards for human subjects research. The FWA is submitted to and approved by the Office for Human Research Protection (OHRP). Boise State University has received an FWA.
Guardian
An individual who is authorized under applicable state or local law to consent on behalf of another person (e.g., children).
Human Subject
A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, (2) identifiable private information, or (3) identifiable biospecimen. 45 CFR 46.102(e)(1)
Identifiable Biospecimen
A biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen. 45CFR46.102(e)(6)
Identifiable Private Information
Private information for which the identity of the subject is or may readily be ascertainedby the investigator or associated with the information. 45CFR46.102(e)(5)
Informed Consent
An individual’s voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence.
Institution
Any public or private entity, or department or agency (including federal, state, and other agencies), or IRB for the purpose of enacting an Institutional Authorization Agreement. 45CFR46.102(f)
Institutional Authorization Agreement (IAA)
A signed Agreement between two Institutional Review Boards designating the primary and secondary responsibilities of IRB review and oversight as outlined by OHRP Template.
Interaction
Communication or interpersonal contact between investigator (or designee) and subject. 45CFR46.102(e)(3)
Intervention
Both physical procedures by which information or biospecimens are gathered (e.g. venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. 45CFR46.102(e)(2)
IRB
Institutional Review Board. An institutional committee formed to ensure the protection of human subjects in research per federal mandates. 45CFR46.102(g)
IRB Approval
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. 45 CFR 46.102(h)
Legally Authorized Representative
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, including parent or guardian (as designated by law) and recognized by institutional policy as acceptable for providing consent on behalf of the subject. 45CFR46.102(i)
Limited IRB Review
A type of review that uses identifiable private information and/or identifiable biospecimens for research, gaining access to that data through consent granted previously with Broad Consent.
Minimal Risk
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. 45 CFR 46.102(j)
OHRP
Office of Human Research Protections. The office under the Department of Health and Human Services (DHHS) responsible for monitoring and promoting compliance with regulations (45 CFR 46) governing the ethical standards of biomedical and behavioral/social science research involving human subjects.
ORC
Office of Research Compliance. The administrative office responsible for oversight of the human subjects review process, whether funded or not funded.
Principal Investigator. The individual with the primary responsibility for the design and conduct of a research project.
The IRB requires PIs to be a Boise State University full, assistant, or associate professor, or director. Visiting faculty, adjuncts, instructors, and staff may be listed as a PI as long as a Boise State full, assistant, or associate professor or director is listed as the co-PI.
If you are not affiliated with Boise State, the IRB will review your research for approval, but you may be charged. Please contact the Office of Research Compliance for additional information.
If this protocol application is part of a grant requesting federal money, the PI must fall under the Boise State PI eligibility policy 5020.
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 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record). 45CFR46.102(e)(4)
Protocol Application
The form used to summarize the formal design or plan of an experiment or research activity to be reviewed by the IRB committee for approval. Often referred to as just “protocol.”
Public Health Authority
An agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from a contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate. 45 CFR 46.102(k)
Research
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. 45 CFR 46.102(l)
Secondary Research
Research using data gathered initially for non-research purposes.
Special Populations
The Office for Human Research Protections (OHRP) has identified populations in need of special protections in research, including fetuses, children and minors, those with impaired decision-making abilities or susceptible to coercion or undue influence, and prisoners. IRBs must apply additional regulations and criteria and give special consideration to recruitment, subject selection, informed consent, privacy, and confidentiality issues before approving research involving these populations.
Unanticipated Problems
OHRP guidance, unanticipated problems or events include any incident, experience, or outcome that meets all of the following criteria:
- unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
- related or possibly related to participation in the research (in this guidance document, possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
- suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
Written, or In Writing
Refers to writing on a tangible medium (e.g. paper) or in an electronic format.