Glossary of IRB Terms
ADVERSE EFFECT: An undesirable and unintended, although not necessarily unexpected, result of therapy or other intervention. Also referred to as an adverse event. See HRP-214 FORM: Reportable New Information .
AGENT: An institution's employees or agents refer to individuals who: (1) act on behalf of the institution; (2) exercise institutional authority or responsibility; or (3) perform institutionally designated activities. This can include staff, students, contractors and volunteers, among others, regardless of whether the individual is receiving compensation. A student's affiliation with an academic institution makes him/her an agent of that institution; and thus the academic institution is engaged in the research regardless of where the research takes place. See HRP-311 WORKSHEET: Engagement Determination and the Human Research Protection Plan.
ALLEGATION OF NON-COMPLIANCE: An unproved assertion of non-compliance. See HSPP Policies & Procedures.
ALTERNATE MEMBER: Alternate Institutional Review Board (IRB) committee members may be designated, as needed, for regular voting members. The appointment of alternate members should be based on expertise similar to that of the regular voting member. An alternate member may vote only when the regular voting member is absent.
AMENDMENT: Any change to an IRB-approved study protocol regardless of the level of review it receives initially. Also referred to as a modification. See HRP-103: Investigator Manual and HRP-213 FORM: Modification .
ANONYMITY: The condition achieved when the identities of subjects are unknown or when the researcher cannot link the data to the individual participant. With anonymity, the researcher does not know subjects' names or any characteristics that might reasonably lead the researcher (or anyone else) to discover their identities. Compare to confidentiality.
ANONYMOUS DATA: Information that was recorded or collected without any identifiers and no code is assigned that would allow data to be traced to an individual. See identifiable information.
ASSENT: Agreement by an individual not competent to give legally valid informed consent (e.g., a child or adult who is cognitively impaired) to participate in research. See HSPP Policies & Procedures.
ASSURANCE: A formal written, binding commitment that is submitted to a federal agency in which an institution promises to comply with applicable regulations governing research with human subjects and stipulates the procedures through which compliance will be achieved. Also referred to as a federalwide assurance or FWA. See Human Research Protection Plan.
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 1978.
BENEFICENCE: An ethical principle discussed in the Belmont Report that entails an obligation to protect persons from harm. The principle of beneficence can be expressed in two general rules: (1) do not harm; and (2) protect from harm by maximizing possible benefits and minimizing possible risks of harm.
BENEFIT: A valued or desired outcome; an advantage.
CHILDREN: Persons who have not attained the legal age for consent to treatment or procedures involved in the research, as determined under the applicable law of the jurisdiction in which the research will be conducted [45 CFR 46.401(a)] . See HRP-416 CHECKLIST: Children .
CLINICAL TRIAL: 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.
CLOSURE: Continuing review and re-approval of a study is required so long as the project continues to involve human subjects. When research activities no longer involves subjects or their identifiable data, the study may be closed with the IRB. If the all of the following are true, a study may be closed:
- The protocol is permanently closed to enrollment.
- All subjects enrolled have completed all protocol related interventions and interactions, including interventions and interactions related to collection of long-term follow-up data.
- No additional identifiable private information about the subjects is being obtained by this organization’s investigator(s).
- Analysis of private identifiable information at this organization is completed.
CODE OF FEDERAL REGULATIONS (CFR): Rules published in the Federal Register by the executive departments and agencies of the Federal Government. The CFR is divided into 50 titles that represent broad areas subject to Federal regulation. Each volume of the CFR is updated once each calendar year and is issued on a quarterly basis.
COGNITIVELY IMPAIRED: Having either a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders, or dementia) or a developmental disorder (e.g., mental retardation) 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.
COMPENSATION: Compensation is primarily a means to offset inconvenience, travel expenses and/or lost revenue due to participation in a research project, however, it may be structured to serve as a recruitment incentive as well. Alternate terms are payment, reimbursement, or remuneration. Compensation also refers to payments or treatments provided for research-related injury. See IRB Guidance on Compensation and HRP-316 WORKSHEET: Payments .
COMPETENCE: Technically, a legal term used to denote capacity to act on one's own behalf; the ability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice. See also incapacity and cognitively impaired.
CONFIDENTIALITY: 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 in ways that are inconsistent with the understanding of the original disclosure, without permission. Compare to anonymity and privacy.
CONFLICTING INTEREST: An individual involved in research review is automatically considered to have a conflicting interest when the individual or the individual’s spouse, domestic partner, children, and dependents have any of the following interests in the sponsor, product or service being tested, or competitor of the sponsor held by the individual or the individual’s immediate family:
- Involvement in the design, conduct, or reporting of the research.
- Ownership interest, stock options, or other ownership interest of any value exclusive of interests in publicly-traded, diversified mutual funds.
- Compensation of any amount in the past year or of any amount expected in the next year, excluding compensation for costs directly related to conducting research.
- Proprietary interest including, but not limited to, a patent, trademark, copyright or licensing agreement.
- Board or executive relationship, regardless of compensation.
- Reimbursed or sponsored travel by an entity other than a federal, state, or local government agency, higher education institution or affiliated research institute, academic teaching hospital, or medical center.
- Any other reason for which the individual believes that he or she cannot be independent.
CONSENT: See informed consent.
CONTINUING NON-COMPLIANCE: A pattern of non-compliance that suggests the likelihood that, without intervention, instances of non-compliance will recur, a repeated unwillingness to comply, or a persistent lack of knowledge of how to comply. See HSPP Policies & Procedures.
CONTINUING REVIEW: Periodic review of research activities at intervals appropriate to the degree of risk, but not less than once per year. The criteria for approval are defined by federal regulations. See HRP-212 FORM: Continuing Review and HRP-103: Investigator Manual.
DATA COLLECTION INSTRUMENTS: See study instruments.
DATA USE AGREEMENT: An agreement between an institution and the intended recipient of a limited data set that establishes the ways in which the information in the dataset may be used and how it will be protected.
DEBRIEFING: Giving subjects previously undisclosed information about the research following completion of their participation in research activities. Debriefing is often used as an extension of the informed consent process when incomplete disclosure or deception is used. Debriefing may also be used as an educational tool. (Note that this usage, which occurs within the behavioral sciences, departs from Standard English where debriefing is obtaining rather than imparting information.)
DECLARATION OF HELSINKI: A code of ethics for clinical research approved by the World Medical Association in 1964 and widely adopted by medical associations in various countries. It was revised in 1975 and 1989.
DE-IDENTIFIED DATA: Data that has been stripped of all identifiers so that the information cannot be traced back to an individual. De-identified data may also pertain to information that has been assigned and retains a code provided that:
- The code is not derived from or related to the information about the individual;
- The code could not be translated to identify the individual; and
- No link to identifiers exists, or the holder of the link record does not use or disclose the code for other purposes or disclose the mechanism for re-identification.
DESIGNATED REVIEWER: The IRB Chair or an experienced IRB member designated to conduct non-committee reviews (e.g., expedited review).
DHHS: Abbreviation for the U.S. Department of Health and Human Services, a federal agency. Also, abbreviated simply as HHS. The DHHS regulations on the Protection of Human Subjects, 45 CFR part 46, include four subparts: subpart A, also known as the Federal Policy or the “Common Rule”; subpart B, additional protections for pregnant women, human fetuses, and neonates; subpart C, additional protections for prisoners; and subpart D, additional protections for children.
DOCUMENTATION: The act or an instance of furnishing or authenticating with documents. Documentation of informed consent includes use of a written consent form (approved by the IRB) and signed and dated by the subject or the subject's legally authorized representative and, typically, by the person obtaining consent.
ELIGIBILITY CRITERIA: Requirements that must be met, or characteristics that he or she must have, for an individual to be included in a study. These include
EMANCIPATED MINOR: A legal status conferred upon persons who have not yet attained the age of legal competency as defined by state law (for such purposes as consenting to medical care), but who are entitled to treatment as if they had by virtue of assuming adult responsibilities such as being self-supporting and not living at home, marriage, or procreation.
ENROLLMENT: Occurs when an eligible, prospective subject undergoes the initial informed consent process and voluntarily agrees to participate in a research project. The number of enrolled subjects includes withdrawals.
EQUITABLE: Fair or just; used in the context of selection of subjects to indicate that the benefits and burdens of research are fairly distributed.
EXCLUSION CRITERIA: The factors (or reasons) that prevent a person from participating in a research study.
EXEMPT: Certain categories of human research may be exempt from federal regulation but require IRB review. It is the responsibility of the institution, not the investigator, to determine whether human research is exempt from IRB review. See HRP-103: Investigator Manualand HSPP Policies & Procedures.
EXPEDITED REVIEW: Review of proposed research by the IRB Chair, a designated voting member, or group of voting members rather than by the convened IRB. Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research. See HRP-313 WORKSHEET: Expedited Review .
EXPIRED: When continuing review of the research does not occur prior to the end of the approval period specified by the IRB, IRB approval expires automatically. The study expires on the date specified on the approval letter and the consent document. No activities can occur after the expiration date. Also referred to as a lapsed study or protocol.
FAMILY EDUCATIONAL RIGHTS AND PRIVACY ACT OF 1974 (FERPA): Federal legislation in the United States that protects the privacy of students' personally identifiable information (PII). The act applies to all educational institutions that receive federal funds. See HRP-331 WORKSHEET: FERPA Compliance .
FOOD AND DRUG ADMINISTRATION (FDA): An agency of the federal government established by Congress in 1912 and presently part of the Department of Health and Human Services. FDA regulations are published as part of chapter 21 of the CFR, and FDA’s human subject protection regulations are in parts 50, 56, 312 and 812.
FINDING OF NON-COMPLIANCE: Non-Compliance in fact.
FULL BOARD REVIEW: Review of proposed research at a convened meeting at which a majority of the membership of the IRB is 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.
GREATER THAN MINIMAL RISK: The research involves more than minimal risk to subjects. See minimal risk.
GUARDIAN: An individual who is authorized under applicable state or local law to give permission on behalf of a child to general medical care [45 CFR 46.402(3)].
HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA): Sets standards and regulations to protect patients from inappropriate disclosures of their protected health information (PHI) that could cause harm to their insurability, employability and their privacy. Also known as “The Privacy Rule.”
HIPAA AUTHORIZATION: A customized document or form that gives permission to use specified protected health information (PHI) for a specific purpose, or to disclose PHI to a third party specified by the investigator other than for treatment, payment or health care operations.
HUMAN RESEARCH: 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) identifiable private information. See intervention, interaction, identifiable information, and private 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.
HUMAN SUBJECT IDENTIFIER: Any word, number, symbol, or combination of words, numbers or symbols that can be used by a third party to uniquely identify an individual, such as name, Social Security number, address or patient registration number that is provided for use in a research protocol. See also identifiable information, personally identifiable information, and protected health information.
IDENTIFIABLE INFORMATION: Information that can be linked to specific individuals by the investigator(s) either directly or indirectly through coding systems. Identifiable information can include, but are not limited to:
Protected Health Information (PHI)
Personally Identifiable Information (PII)
The Privacy Rule (HIPAA) protects all individually identifiable health information held or transmitted by a covered entity or its business associate, in any form or media, whether electronic, paper, or oral.
PHI is information, including demographic data, that relates to:
and that identifies the individual or for which there is a reasonable basis to believe it can be used to identify the individual. PHI identifiers include:
The Family Educational Rights and Privacy Act (FERPA) specifically defines PII as including, but not limited to:
(a) The student's name;
(b) The name of the student's parent or other family members;
(c) The address of the student or student's family;
(d) A personal identifier, such as the student's social security number, student number, or biometric record;
(e) Other indirect identifiers, such as the student's date of birth, place of birth, and mother's maiden name;
(f) Other information that, alone or in combination, is linked or linkable to a specific student that would allow a reasonable person in the school community, who does not have personal knowledge of the relevant circumstances, to identify the student with reasonable certainty; or
(g) Information requested by a person who the educational agency or institution reasonably believes knows the identity of the student to whom the education record relates.
Many demographics (e.g. age, sex, ethnicity, etc.) on their own are not considered identifiable to individual subjects. However, researchers should be aware that a combination of demographic information may be sufficient to identify an individual within a group or a limited population.
Descriptions of personal and highly specific events may be sufficient to identify an individual in a known community even when typical identifiers, like names, are removed.
See also human subject identifier, personally identifiable information, and protected health information.
INCAPACITY: Refers to a person's mental status and means inability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice. Often used as a synonym for incompetence. See also competence and cognitively impaired.
INCLUSION CRITERIA: The factors (or reasons) that allow a person to participate in a research study.
INFORMED CONSENT: A person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. 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 [45 CFR 46.116; 21 CFR 50.20 and 50.25]. In the review and conduct of human research, informed consent refers as much to the process as to any particular form or document. The goal of the informed consent process is to protect participants. It begins when a potential participant first asks for information about a study and continues throughout the study until the study ends. Because giving consent to participate in research is not a contract, participants can leave a study at any time. See HSPP Policies & Procedures and HRP-103: Investigator Manual.
INSTITUTION: 1) Any public or private entity or agency (including federal, state, and local agencies). Or, 2) a residential facility that provides food, shelter, and professional services (including treatment, skilled nursing, intermediate or long-term care, and custodial or residential care). Examples include general, mental, or chronic disease hospitals; inpatient community mental health centers; halfway houses and nursing homes; alcohol and drug addiction treatment centers; homes for the aged or dependent, residential schools for the mentally or physically handicapped; and homes for dependent and neglected children.
INSTITUTIONAL ENGAGEMENT: An institution becomes "engaged" in human research when its employees or agents 1) intervene or interact with living individuals for research purposes, or 2) obtain individually identifiable private information for research purposes. An institution is also considered engaged in human research when it receives a direct Federal award to support the research. See HRP-311 WORKSHEET: Engagement Determination . See also agent.
INSTITUTIONAL OFFICIAL: At MSU Denver, the Associate Vice President of Curriculum and Academic Effectiveness is designated as the Institutional Official and is the Signatory Authority on the University’s federalwide assurance (FWA) with OHRP. Also referred to as the Organizational Official. See Human Research Protection Plan.
INSTITUTIONAL REVIEW BOARD (IRB): A specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or social-behavioral research.
INSTITUTIONALIZED: Confined, either voluntarily or involuntarily (e.g., a hospital, prison, or nursing home).
INTERACTION: Communication or interpersonal contact between investigator and subject.
INTERVENTION: Physical procedures by which data are gathered (for example, venipuncture) or manipulations of the subject or the subject’s environment that are performed for research purposes.
INVESTIGATOR: An individual (researcher, member of the research team, etc.) who interacts or intervenes with subjects for the purposes of the research or who has access to identifiable private information for research purposes. In clinical trials, an individual who actually conducts an investigation [21 CFR 312.3]. See HRP-103: Investigator Manual. See also Principal Investigator.
IRB APPROVAL: The determination of the IRB that the research study has been reviewed and meets the criteria set forth by the IRB, the institution, and other federal, state, and local requirements. See HRP-103: Investigator Manual and HRP-314 WORKSHEET: Criteria for Approval .
IRB AUTHORIZATION AGREEMENT: A formal, written agreement in which the reviewing IRB agrees to serve as the IRB of record for a relying institution, including an academic institution. Agreements are generally used to cover a single research study, categories of research studies, or research studies within a research program.
JUSTICE: An ethical principle discussed in the Belmont Report requiring fairness in distribution of burdens and benefits; often expressed in terms of treating persons of similar circumstances or characteristics similarly.
LEGALLY AUTHORIZED REPRESENTATIVE (LAR): A person authorized either by statute or by court appointment to make decisions on behalf of another person. In human subjects research, 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. See HSPP Policies & Procedures.
LIMITED DATA SET: A limited data set allows retention of specific elements of identifying private information: geographic subdivisions, town, city, state, ZIP code, dates, age. Limited data sets are not considered to be de-identified information.
MATERIAL TRANSFER AGREEMENT (MTA): A contract that governs the transfer of tangible research materials between two organizations when the recipient intends to use the materials for his or her own research purposes.
MENTALLY DISABLED: See cognitively impaired.
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(i)] See HSPP Policies & Procedures.
MODIFICATION: Any change to an IRB-approved study protocol regardless of the level of review it receives initially. Also referred to as an amendment. See HRP-103: Investigator Manual and HRP-213 FORM: Modification .
MONITORING: The collection and analysis of information or data as the project progresses to assure the appropriateness of the research, its design, and subject protections.
MULTICENTER RESEARCH: Research conducted at more than one location and under the jurisdiction of more than one IRB.
MULTI-SITE RESEARCH: Research conducted at more than one location and under the jurisdiction of only one IRB.
NATIONAL INSTITUTES OF HEALTH (NIH): A federal agency within the Public Health Service, DHHS, comprising 21 institutes and centers. It is responsible for carrying out and supporting biomedical and behavioral research.
NONAFFILIATED MEMBER: Member of an Institutional Review Board who has no ties (and whose immediate family has no ties) to the parent institution, its staff, or faculty. This individual is usually from the local community (e.g., minister, business person, attorney, teacher, homemaker).
NON-COMPLIANCE: Failure to follow the regulations, the requirements, and/or determinations of the IRB. See HSPP Policies & Procedures.
NUREMBERG CODE: A code of research ethics developed during the trials of Nazi war criminals following World War II and widely adopted as a standard during the 1950s and 1960s for protecting human subjects.
ORAL CONSENT: A spoken presentation of the elements of informed consent to the prospective subject or their legally authorized representative and received agreement (or refusal). The presentation may be based on information contained within an oral consent script or the written consent document. Oral consent is often associated with waiving the documentation of consent. Oral consent is usually documented in the research project files or, in some cases, may be audio or video recorded. Also referred to as verbal consent.
ORGANIZATIONAL OFFICIAL: See Institutional Official.
PAYMENT: See compensation.
PERFORMANCE SITE: A site where research is performed.
PERMISSION: The agreement of parent(s) or guardian to the participation of their child or ward in research [45 CFR 46.402(c)]. Permission may also be used more generally to refer to the consent of an adult participant or to the assent of a child participant.
PERSONALLY IDENTIFIABLE INFORMATION (PII): In US privacy and security laws, PII refers to information that can be used to distinguish or trace an individual’s identity, either alone or when combined with other personal or identifying information that is linked or linkable to a specific individual. The definition of PII is not anchored to any single category of information or technology. Rather, it requires a case-by-case assessment of the specific risk that an individual can be identified. In performing this assessment, it is important to recognize that non-PII can become PII whenever additional information is made publicly available that, when combined with other available information, could be used to identify an individual. See also identifiable information and FERPA.
PREGNANCY: The period of time from confirmation of implantation of a fertilized egg within the uterus until the fetus has entirely left the uterus (i.e. has been delivered). Implantation is confirmed through a presumptive sign of pregnancy such as missed menses or a positive pregnancy test [45 CFR 46.203(b)]. See HRP-412 CHECKLIST: Pregnant Women .
PRINCIPAL INVESTIGATOR (PI): For the IRB, the Principal Investigator is the individual who assumes overall responsibility for the ethical conduct of the study. MSU Denver's IRB requires that the Principal Investigator be a member of the University's faculty or staff. Multiple PIs are not allowed on an IRB submission. Students may not serve as the Principal Investigator on a research study. Submissions to the IRB must be made by the PI and IRB correspondence will be directed to the PI. See IRB Guidance on Investigator Responsibilities and HRP-103: Investigator Manual.
PRISONER: 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. [45 CFR 46.303(c)]. For Department of Defense (DOD) research the term includes military personnel in either civilian or military custody. See HRP-415 CHECKLIST: Prisoners .
PRIVACY: Control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others. Compare to confidentiality.
PRIVATE INFORMATION: 1) Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place. Or, 2) 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). [45 CFR 46.102(f)]
PROGRESS REPORT: Details of the study activity during the last approval period. Often requested when submitting for continuation or closure of your active IRB research study. See HRP-212 FORM: Continuing Review and HRP-103: Investigator Manual.
PROTECTED HEALTH INFORMATION (PHI): Individually identifiable health information transmitted or maintained by a covered entity or its business associate [45 CFR 160.103]. PHI and its potential uses in research are described in more detail in the Health Insurance Portability and Accountability Act (HIPAA). See also identifiable information.
PROTOCOL: The written description of a research study. It includes the study's objectives, design, and methods. It may also include relevant scientific background and statistical information. For IRB review, a protocol should include detailed information about the study population and components of human subjects protections (risks, benefits, recruitment, consent, etc.). See HRP-503a TEMPLATE PROTOCOL: Social-Behavioral .
PROTOCOL DEVIATION: A divergence (unintentional or intentional) from the IRB-approved protocol without significant consequences. A deviation generally (a) does not increase risk or decrease benefit, (b) does not have a significant effect on the subject's rights, safety, or welfare, and (c) does not impact the integrity of the data. Deviations may result from the action of the subject or the researcher. May also be non-compliance. Protocol deviations should be noted in the research records, but often don not require reporting to the IRB. See HRP-214 FORM: Reportable New Information . See protocol violation.
PROTOCOL VIOLATION: A divergence (unintentional or intentional) from the IRB-approved protocol that (a) increases risk or decreases benefit, (b) affects the subject's rights, safety, or welfare, or (c) impacts the integrity of the data. May also be non-compliance. See HRP-214 FORM: Reportable New Information . See protocol deviation. (Note: Deviation and violation may be used synonymously, but violation tends to be more serious.)
QUORUM: A majority of voting members of an IRB, including at least one member whose primary expertise is in a nonscientific area.
RE-CONSENTING: Process of notifying research subjects of changes (or new risks, problems, events, etc.) in the research, including documentation of the subject's continued informed consent through signature on a revised written consent form.
RECRUITMENT: Recruitment, a component of the consent process, is the process of distributing or presenting information that describes the research project and eligibility criteria so that a prospective subject may consider enrollment.
RELATED: An event or issue (e.g., unanticipated problem, side effect, etc.) is "related" if in the opinion of the investigator it is likely to have resulted from participation in the research study.
REPORTABLE NEW INFORMATION: Categories of information that require immediate or timely reporting to the IRB for review and determination. Includes, but is not limited to, information that indicates a new or increased risk to subjects or others, non-compliance, audits, unresolved complaints, and other unanticipated problems, events, acts, or omissions. See also unanticipated problem involving risks to subjects or others. Refer to page two of the HRP-214 FORM: Reportable New Information for a comprehensive list.
RESEARCH (as defined by DHHS): A systematic investigation, including research development, testing and evaluation designed to develop or contribute to generalizable knowledge. [45 CFR 46.102(d)]
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.
Note: FDA-regulation of research is not dependent on funding or funding sources.
RESEARCH MISCONDUCT: Any fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Research misconduct may or may not be non-compliance. See MSU Denver’s "Research Misconduct Policy and Procedures" available on the ASA Policy Manual webpage.
RESPECT FOR PERSONS: An ethical principle discussed in the Belmont Report requiring that individual autonomy be respected and that persons with diminished autonomy be protected.
RESTRICTED: Applies to investigators who are delinquent in meeting IRB requirements.
RISK: The probability 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. Federal regulations define only "minimal risk." See also minimal risk.
SERIOUS NONCOMPLIANCE: Noncompliance that adversely affects the rights and welfare of subjects. Serious noncompliance may also affect the subject’s willingness to participate in research or may affect the integrity of the data. In some cases, may also be research misconduct. See HSPP Policies & Procedures.
SHORT-FORM CONSENT PROCESS: A short form consent process is used with IRB approval when a subject or the subject’s legally authorized representative cannot read the standard written consent form. The short form consent document states the elements of consent that are presented orally and is translated into the appropriate language. The short form consent process requires a witness (and in some cases an interpreter or translator) and has specific requirements for documentation of consent. See HRP-317 WORKSHEET: Short Form of Consent Documentation .
STUDY INSTRUMENTS: Examples of study instruments include, but are not limited to:
- Questionnaires, surveys;
- Videotapes, audiotapes, and photographs;
- Interview and focus group questions, guides, and notes;
- Field notes, observation guides and notes;
- Data collection forms and spreadsheets;
- Verbal or written instructions given to participants for research activities; and/or
- May also include visual images, objects, tools, or devices used in the data collection.
Copies and/or detailed descriptions of all study instruments are required in the initial review, and submitted materials (and versions) are noted in the IRB approval. Proposed changes to approved study instruments must be submitted via a modification and must be reviewed and approved by the IRB before any changes are implemented. See HRP-103: Investigator Manual.
SUBJECTS: May also be referred to as participants. See human subjects.
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. See HSPP Policies & Procedures.
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. See HSPP Policies & Procedures.
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. See HSPP Policies & Procedures and HRP-214 FORM: Reportable New Information .
VERBAL CONSENT: See oral consent.
VOLUNTARY: Free of coercion, duress, or undue inducement. Used in the research context to refer to a subject’s decision to participate (or to continue to participate) in a research activity.
WARD: A child who is placed in the legal custody of the state or other agency, institution or entity, consistent with applicable federal, state or local law. See HRP-416 CHECKLIST: Children .
WITHDRAWAL: A subject who enrolled (i.e., consented to participate) but later withdrew from (i.e., discontinued his or her participation in) a study, either before, during, or after completing research procedures. For a variety of reasons, a subject enrolled in a research study may decide to withdraw from the research, or an investigator may decide to terminate a subject’s participation in research regardless of whether the subject wishes to continue participating (e.g., for non-compliance with research procedures). Withdrawals do not include individuals who failed initial eligibility screening.