Glossary of IRB Terms
Adverse Event means 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.
Adverse events encompass both physical and psychological harms. They occur most commonly in the context of biomedical research, although on occasion, they can occur in the context of social and behavioral research.
Allegation of Non-Compliance is an unproved assertion of non-compliance.
Assent means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.
The Belmont Report. On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, thereby creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report attempts to summarize the basic ethical principles identified by the commission in the course of its deliberations. It has become a seminal document in establishing principles for research with human subjects. Find the Belmont Report online.
Certification means the official notification by the institution to the supporting department or agency, in accordance with the requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved assurance.
Children are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.
The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the federal government. The CFR is divided into fifty titles that represent broad areas subject to federal regulation. The Metro State IRB Guidebook refers to CFR sections at times, and provides links to the online location of the pertinent information. Find the Code of Federal Regulations online.
Confidentiality means the state of treating information as private and not for distribution beyond a mutually agreeable scope, or the agreement not to use such information other than for specifically identified purposes.
Continuing Non-Compliance is a pattern of non-compliance that suggests likelihood that instances of noncompliance will continue without intervention. Continuing non-compliance also includes failure to respond to a request to resolve an episode of non-compliance within 30 days.
Dead fetus means a fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, nor pulsation of the umbilical cord.
Deception is when an investigator gives false information or misleads subjects.
Delivery means complete separation of the fetus from the woman by expulsion or extraction or any other means.
Department or agency head means the head of any federal department or agency and any other officer or employee of any department or agency to whom authority has been delegated.
Determination is the IRB decision regarding a researcher's Request for Review.
Determination Letter is the letter sent to the investigator stating the IRB determination. It is part of the official file for the Request.
DHHS is the Department of Health and Human Services.
Fetus means the product of conception from implantation until delivery.
Guardian of a minor means a person with the legal authority to make major decisions affecting a child including, but not limited to decisions regarding medical or surgical treatment and decisions of substantial legal significance concerning the child. Under Colorado statutes the Custodian may serve the same function (CRS 19-1-103).
Generalizable Knowledge is knowledge that is expressed in theories, principles, and statements of relationships that can be widely applied to our experiences. The term is used to refer to the intent to disseminate the research results and conclusions beyond an individual or an individual and his or her professor.
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information
Informed consent means the knowing, legally effective consent of any individual or the individual's legally authorized representative. Such consent can be obtained only under circumstances that provide the prospective subject or representative sufficient opportunity to consider whether or not to participate without coercion or undue influence. The nature of the information presented and the means of securing consent must be clearly understood by the potential subject. Informed consent is a process. A written informed consent documents this process but cannot serve as a substitute for it.
Institution means any public or private entity or agency (including federal, state, and other agencies).
Intervention includes both 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 includes communication or interpersonal contact between investigator and subject.
IRB means an institutional review board established in accord with and for the purposes expressed in 45 CFR 46.
IRB approval means 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.
Legally authorized representative means 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.
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.
Neonate means a newborn.
Non-Affiliated Member is a member of the IRB who has no ties (and whose immediate family members have no ties) to the parent institution, its staff, or faculty. This individual is usually from the local community [45 CFR 46.107(d); 21 CFR 56.107(d)].
Non-Compliance is the failure to comply with relevant federal, state, or local laws or regulations, IRB policies, or the determinations made by the IRB. This includes the initiation of research without IRB approval and/or conducting research found to be in an unethical manner. All forms of non-compliance must be reported to the IRB for review.
Non-Scientist Member is a member of the IRB who does not have a scientific background or who has not pursued any interest in their scientific field for the past 10 years, but may be affiliated with the institution [45 CFR 46.107(c); 21 CFR 56.107(c)].
Nonviable neonate means a neonate after delivery that, although living, is not viable.
Parent means a child's biological or adoptive parent.
Permission means the agreement of parent(s) or guardian to the participation of their child or ward in research.
Possibly Related means, that in the opinion of the PI, there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research.
Pregnancy encompasses the period of time from implantation until delivery. A woman shall be assumed to be pregnant if she exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until the results of a pregnancy test are negative or until delivery.
Private information includes 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). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
Prisoner means any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.
Protocol Deviation means change to the IRB-approved protocol. This term is synonymous with protocol exemption, exception, variance, violation, variation and other similar terms.
Related means, that in the opinion of the PI, the event was caused by the research procedures or the event affects the rights and welfare of current participants.
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities.
Research subject to regulation, and similar terms are intended to encompass those research activities for which a federal department or agency has specific responsibility for regulating as a research activity, (for example, Investigational New Drug requirements administered by the Food and Drug Administration). It does not include research activities which are incidentally regulated by a federal department or agency solely as part of the department's or agency's broader responsibility to regulate certain types of activities whether research or non-research in nature (for example, Wage and Hour requirements administered by the Department of Labor).
Review refers to the evaluation of a proposal by the Institutional Review Board consistent with the policies established by appropriate federal agencies and the Belmont Report. The review and subsequent approval are required before the study may be initiated.
Secondary Data includes all forms of data that exist at the time of IRB Request for Review. Prior consent for medical treatment, psychological counseling, or other informed consent for treatment or service is neither a substitute for nor an a priori equivalent to IRB requirements. If information is to be obtained from medical records a HIPAA Summary Form must be completed in addition to the Request for Human Subjects Approval.
Secretary means the Secretary of Health and Human Services and any other officer or employee of the Department of Health and Human Services to whom authority has been delegated.
Serious Non-Compliance means non-compliance that is determined to increase the risks of participants or adversely affect their rights or wellbeing. If the IRB finds that the investigator had intentionally mislead subjects, other investigators, study sponsors, or any others, then the non-compliance is considered serious.
Significant Risk is a potential for serious risk to the health, safety, or welfare of a subject.
Third Party Information is information provided by a participant about another person who has not consented to participate in the research.
Unanticipated Problem includes 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.
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;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.
Unrelated In the opinion of the PI, the incident, experience, or outcome was not caused by the procedures involved in the research.
Viable, as it pertains to the neonate, means being able, after delivery, to survive (given the benefit of available medical therapy) to the point of independently maintaining heartbeat and respiration.
Wards are children in the care or custody of the state, courts, or any other agency, institution or entity. Foster Care, under Colorado statutes, meets this federal definition (CRS 19-1-103).