Glossary of Human Subjects and IRB Related Terms
There are currently 78 names in this directory
An action to temporarily stop data collection and analysis on a project. This is a voluntary action by the Principal Investigator.
Any untoward occurrence in a research participant. The occurrence need not have a clear causal relationship with the individual’s participation in the research; an AE can be any unfavorable and unintended sign, symptom, event, or occurrence affecting a participant’s physical, mental, social, financial, legal, or psychological well-being. An unanticipated AE should be reported to the committee as soon as possible after it is identified.
Information that was previously recorded without any HIPAA identifiers and no code and key that would allow identification of individual subjects.
agreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research. An assent is typically paired with permission from a parent/guardian or Legally Authorized Representative, and together they comprise the informed consent to participate.
Certificate of Confidentiality
a certificate issued by the National Institutes of Health that protects identifiable research information of a sensitive nature from forced disclosure. It is typically requested when the researcher believes his/her research objectives could not be met without this form of protection. For additional information, please see the NIH Certificates of Confidentiality website.
Persons who have not attained the legal age for consent to research; individuals under the age of 18 in Virginia are considered children for most research situations.
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.
Identifying information (such as name or social security number) that would allow a researcher to readily ascertain the identity of the individual to whom the private information/data/specimens pertain has been replaced with a number, letter, or combination thereof (i.e., the code); a key to decipher the code exists, enabling linkage of the identifying information to the private information/data/specimens.
The act of forcing or compelling one to take action against one’s will. Coercion can be overt or perceived, and it can occur when the researcher is in a position of authority or power over the subject (for example, teachers over students or physicians over patients). It can also occur when incentives become so great that the participant will only participate to attain the incentive.
Having either a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders, or dementia) or a developmental disorder that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished. Others, including persons under the influence of or dependent on drugs or alcohol, those suffering from degenerative diseases affecting the brain, terminally ill patients, and persons with severely disabling physical handicaps, may also be compromised in their ability to make decisions in their best interests.
Pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others without permission in ways that are inconsistent with the understanding of the original disclosure.
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. In addition to complying with university policies and procedures related to human subjects, investigators with conflicting interests may need to comply with university policy 4001.
A non-IRB member who, at the request of RDIA or the IRB, provides advice or serves as an ad hoc reviewer of IRB applications. Consultants may have access to all project related documents and participate in IRB discussions but may not vote and are not counted towards quorum.
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.
Periodic review of research activities at intervals appropriate to the degree of risk, but not less than once per year.
Data Safety Monitoring Board (DSMB)
An independent committee formed to monitor data throughout the duration of a study to ensure continuation of the study is scientifically and ethically appropriate.
Data Safety Monitoring Plan (DSMP)
A plan for a project that assures an appropriate system for oversight and monitoring of data to ensure that continuation of a study is scientifically and ethically appropriate.
Data that has been stripped of all identifiers, as defined by HIPPA, so that information may not be traced back to an individual.
A faculty member trained and authorized by the IRB to approve exempt Human Research conducted by students as part of a classroom assignment.
The IRB chair or an Experienced IRB Member designated by the IRB chair to conduct Non-Committee Reviews.
Any departure from the IRB approved study design and procedures, forms, or other approved materials. Protocol deviations must be reported to the IRB office within 10 business days of occurrence or identification using the amendment form.
George Mason University is considered engaged in research when its employees or agents, for the purposes of non-exempt research project obtain (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; (3) the informed consent of human subjects for the research; or (4) when the institution receives a direct federal award to conduct human subject research, even when all activities involving human subjects are carried out by a subcontractor.
Ex Officio/Administrative Representative
An individual who receives all IRB information, attends meetings, and participates in discussions due to their position with the university. These individuals are non-voting and do not count toward quorum.
GMU has identified several categories of research available for exempt review. This determination must not be made by the PI, but by the IRB or someone appointed by the IRB.
45 CFR 46.110 and 21 CFR 56.110 identifies several categories of minimal risk research that may be reviewed through an expedited review process. For more information, please see OHRP’s “Categories of Research that may be Reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure.”
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. Under federal regulations, IRB approval of non-exempt projects is valid for a maximum period of one year. The approval period will be listed on approval letters posted to investigators in IRBNet, including both the approval date and the expiration date. Researchers wishing to continue study activities, including data collection and analysis, beyond the expiration of IRB approval must submit and receive approval for renewal prior to the expiration.
Family Educational Rights and Privacy Act (FERPA)
This act defines the rights of students and parents concerning reviewing, amending, and disclosing educational records and requires written permission to disclose personally identifiable information from a student’s education record, except under certain circumstances such as an order of subpoena.
Federalwide Assurance (FWA)
A formal written, binding assurance filed with and accepted by the federal Department of Health and Human Services committing George Mason University to compliance with 45 CFR 46.
Full Board Review
Review of proposed research at a convened meeting at which a majority of the membership of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. For the research to be approved, it must receive the approval of a majority of those members present at the meeting. Generally, studies that undergo full board review are studies involving greater than minimal risk, risky, novel procedures, or vulnerable populations.
Health Insurance Portability and Accountability Act (HIPAA)
The rule which protects the privacy of individually identifiable health information. The privacy rule provides federal protections for personal health information held by covered entities and gives patients specific rights with respect to that information.
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. The terms “Human Subject Research,” “Research Involving Human Subjects,” “Human Subject Research,” “Research Involving Human Subjects,” “Clinical Research,” “Clinical Investigation,” “Clinical Study” and similar phrases are considered to be synonyms for the term Human Research.
Human Subject as Defined by DHHS
Human subject means a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and, uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
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.
Human Subject as Defined by Virginia Code
Virginia Code (§32.1-162.1) references the DHHS definition of “human subject.”
a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
Compensation for time, effort, and/or unreimbursed expenses offered to subjects participating in a given research project. Payment should never be considered a benefit for participation. The amount should be related to time, effort, and/or inconvenience for participating in the research.
Individually Identifiable Information
Any information collected from an individual (including demographics) that there is a reasonable basis to believe could lead to identification of the individual.
An individual’s voluntary agreement, based on 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.
The signatory on the federal-wide assurance. A high-level official who has the authority to represent the institution in matters related to the human subjects protection program.
Institutional Review Board (IRB)
A body specifically constituted as required in 45 CFR 46 which provides review and oversight of all human subjects research at George Mason University. This board is charged with protecting the rights and welfare of human subjects recruited to participate in research in which the university is engaged.
Physical procedures by which data or biospecimens are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
An official determination by the IRB that the research has been reviewed and may be conducted within the constraints set forth by the IRB and other institutional and federal requirements.
IRB Authorization Agreement
A formal, written, agreement in which the reviewing IRB agrees to serve as the IRB of record for the relying organization.
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 a research study.
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. 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 change to an IRB-approved study protocol, regardless of the level of review it receives initially.
an IRB member who is not, and whose immediate family members are not, affiliated with George Mason University appointment on the IRB.
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.
Office for Human Research Protections (OHRP)
The office within the Department of Health and Human Services that is responsible for implementing 45 CFR 46.
Agreement of parent(s) or guardian(s) to allow participation of their child or ward in research.
An individual, as defined in university policy number 4012, who is ultimately responsible for the design, conduct, and reporting of a human subjects project. Each project must have a Principal Investigator.
Any individual involuntarily confined or detained in a penal institution. This term encompasses 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.
Control over the extent, timing, and circumstances of disclosing personal information (physical, behavioral, or intellectual) with others.
Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place. It also includes information that has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e. g., 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 the acquisition of the information to constitute research involving human subjects.
an activity that seeks to enroll prospective subjects into a research study by presenting information about the research including a summary of eligibility requirements. All recruitment materials must be consistent with application and informed consent documents.
Related to the Research
A financial interests 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.
Research as Defined by Virginia Code
Virginia Code (§32.1-162.1) references the DHHS definitions of “research.”
Research Integrity & Assurance (RDIA)
The George Mason University office that serves as an administrative hub for the university’s oversight of human subjects research.
The probability and magnitude 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. Risks include immediate risks of study participation as well as risks of long- term effects.
Suspension of IRB Approval
An action of the IRB, IRB designee, Organizational Official, or designee of the 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, IRB designee, Organizational Official, or designee of the 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 Risks to Subjects or Others
Any information that is (1) unanticipated and (2) indicates that subjects or others are at increased risk of harm.
occurs through an offer of excessive or inappropriate reward or other proposition in order to obtain compliance (generally, offers that get people to do things they would not otherwise do). For example, an investigator may offer students extra credit if they participate in research. If this is the only way a student can earn extra credit, then the investigator is unduly influencing the potential subjects. However, if comparable, non-research alternatives are also offered for extra credit, this possibility of undue influence is lessened.
Waiver of consent
The Common Rule (45CFR46) allows the IRB to approve a waiver, or an alteration, of the requirement for informed consent to the research if the proposed protocol meets the following specific criteria found at 45 CFR § 46.116(d): 1.) The research involves no more than minimal risk to the privacy of the subjects. 2.) The research could not practicably be carried out without the waiver or alteration. 3.) The research could not practicably be conducted without access to and use of this identifiable protected health information. 4.) Whenever appropriate (generally, when there is a health justification), the subjects will be provided with additional pertinent information after participation. Additional information: http://answers.hhs.gov/ohrp/questions/7268
Waiver of documentation of Consent
Per 45 CFR 46.117, an IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:(1) That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern; or (2) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research. Additional information: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.117