IRB and Human Subjects Definitions
IRB and Human Subjects Definitions
Adverse Events: any undesirable and unintended effect, whether anticipated or not, experienced by a research subject occurring as a result of participating in a research project. Adverse events may be anticipated or unanticipated, be related or unrelated to the research, occur at a frequency greater than expected, and/or be serious in nature. Examples of adverse events include:
- Breaches in confidentiality (including loss of or infiltration of identifiable data)
- Physical, social, psychological, financial (employability), or legal harms
- Subject complaints indicating an undesirable or unintended effect
- Investigator findings indicating an undesirable or unintended effect
- Subject complaints that cannot be resolved by investigators
- Any finding that increases overall risk profile
- An unexpected risk or discomfort that has not been previously observed
Anonymous: unidentified (i.e., personally identifiable information was not collected, or if collected, identifiers were not retained and cannot be retrieved); information or materials (e.g., data or specimens) that cannot be linked directly or indirectly by anyone to their source(s).
Anticipated: any adverse event that is previously identified in the IRB approved protocol and not occurring at a rate higher than expected.
Approval Date: the date research is approved and can initiate. This date is stated in the IRB approval email. Human subjects research may not proceed until it is approved.
Approval Term: the period for which the human subjects portions of a study are approved. Approval terms are defined in the initial approval and continuing approval emails.
Assent: a subject's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. Assent is most typically associated with children or individuals with decisional impairments.
Authorization: signed permission to allow a covered entity to use or disclose protected health information. (see also HIPAA)
Business Associate: a person or entity who, on behalf of a covered entity, performs or assists in performance of a function or activity involving the use or disclosure of individually identifiable health information. (See also HIPAA)
Children/Child: person(s) 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.
Clinical Trial: per NIH, 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 those interventions on health-related biomedical or behavioral outcomes.
Clinical Research: is research that typically focuses on the treatment, prevention, or diagnosis of medical condition(s). (https://www.fda.gov/patients/clinical-trials-what-patients-need-know/what-are-different-types-clinical-research).
Coded: direct personal identifiers have been removed (e.g., from data or specimens) and replaced with words, letters, figures, symbols, or a combination of these for purposes of protecting the identity of the source, but the original identifiers are retained in such a way that they can still be traced back to the source. Note: Sometimes also referred to as a “key” “link”, or “map”.
Coercion: persuasion to do or agree to something by using obvious or implied force or threats.
Confidentiality: maintaining subject identities in a manner that prevents inadvertent or inappropriate disclosure of participants’ identifiable information.
Conflict of Interest: this occurs when the relationship between an individual's private interests and his or her professional obligations to the university is such that an independent observer might reasonably question whether the individual's professional actions or decisions are determined by considerations of personal gain, financial or otherwise. An "actual" conflict of interest depends on the situation and not on the character or actions of the individual. (see Policy Register 10-04.1 for a more detailed description)
Consent: the consent process involves three key features: (1) disclosing to potential research subjects information needed to make an informed decision; (2) facilitating the understanding of what has been disclosed; and (3) promoting the voluntariness of the decision about whether or not to participate in the research. Informed consent must be legally effective and prospectively obtained. HHS regulations at 45 CFR 46.116 and 45 CFR 46.117 describe the informed consent requirements.
Continuing Noncompliance: is multiple or repeated instances of non-compliant activity, which may involve concerns that have or have not been previously reported to the IRB.
Covered Entity: a health plan, a health care clearinghouse, or a health care provider who transmits health information in electronic form in connection with a transaction for which HHS has adopted a standard. Covered entities can be institutions, organizations, or persons. (see also HIPAA)
Data and Safety Monitoring: the process for reviewing data collected as research progresses to ensure the continued safety of current and future participants as well as the scientific validity and integrity of the research.
- Data and Safety Monitoring Board (DSMB) or Committee (DSMC): A group comprised of expert(s) in the field of medicine and/or science applicable to the research, statistician(s), lay representative(s), and others as necessary to monitor study progress. A data and safety monitoring board reviews study-specific data periodically throughout the research to ensure continued participant safety and scientific validity and to make recommendations whether to continue, modify, or terminate the study. Note: The following terms are interchangeable – data and safety monitoring board, data and safety monitoring committee, and data monitoring committee.
- Data and Safety Monitoring Plan: The plan for reviewing research data to ensure the safety of participants and scientific validity of the research, including who will perform the monitoring, the type and frequency of review, and procedures for notifying appropriate entities (e.g., investigators, sponsor, etc.) of the results. Note: Monitoring performed by a data and safety monitoring board is one type of data and safety monitoring plan.
Data Use Agreement: a contractual document used for the transfer of non-public or restricted use data.
Debriefing: information about the research that is provided to participants after study completion. A debriefing session is used to provide important information about the nature of the research, additional information for educational purposes, or additional resources that may be appropriate for, or useful to, participants. Debriefing is often required when the research involves deception or incomplete disclosure. In general, this type of debriefing explains any deception or incomplete disclosure, provides information about why it was necessary to use deception or incomplete disclosure to conduct the research, and provides other options available to participants (e.g., the ability to withdraw their data).
Deception: a procedure in which investigators deliberately mislead participants during research by withholding information or providing false information. As a result, participants are not fully informed about the research when they consent to participate.
De-identified: all direct personal identifiers are permanently removed from the data, no code or key exists to link the data to the original source or to the individual, and the remaining information cannot be used to reasonably identify the individual. Please refer to the IRB Policy on PHI for information on de-identification under the HIPAA laws.
Decisional Impairments: relates to individuals that may lack the ability to provide valid informed consent to participate in research; sometimes as a result of trauma, mental health concerns, dementia, or cognitive impairment. Impairments may temporary, permanent, progressive, or fluctuating during the research.
Disapproved: an IRB action taken when the determinations required for approval of research cannot be made. Research can only be disapproved through a full board process.
Disclosure: the release, transfer, access to, or divulging of information in any other manner outside the entity holding the information. (see also HIPAA)
Effective Dose: a measure used to estimate the risk resulting from an exposure of ionizing radiation, calculated as a weighted average of exposure to different body tissues. The effective dose is measured in rems or sieverts.
Engaged: an institution or individual is considered engaged in research when its employees or agents for the purposes of the 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; or (3) the informed consent of human subjects for the research. An organization also becomes engaged when it receives a direct federal award to support the research.
Exempt Research: sometimes referred to level I research, is minimal risk research that involves human subjects as defined by federal regulations and university policy. Note: Investigators performing exempt research must comply with the requirements of the HSPP even when the research is exempt.
Existing: available or “on the shelf” (e.g., data, specimens) at the time the research is submitted for a determination of whether the research is exempt.
Expedited Review: process by which designated IRB members, on behalf of the full IRB, approve a limited class of research activities through reviews conducted outside of the convened IRB meeting.
Expiration Date: the date that the IRB’s approval of research has lapsed, and research can no longer be performed.
Generalizable Knowledge: information from which one may infer a general conclusion; knowledge brought into general use or that can be applied to a wider or different range of circumstances. For example, publication and presentation are typical methods used to disseminate research findings, thereby contributing to “generalizable knowledge.” However, not all information that is published or presented represents generalizable knowledge. Generalizable knowledge is also interpreted to include data intended for general use, regardless of its eventual distribution or acceptance.
Guardian: an individual has been formally appointed as a guardian or legal representative by a court to care for a child, including to consent on behalf of a child to general medical care. Ohio law does not permit grandparents or other family members who are not formally appointed as guardians or legal representatives by a court generally do not have the authority to provide consent on behalf of a child without consent by the child’s parents.
Health Information: any information, whether oral or recorded in any form or medium, that (1) is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse; and (2) relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual. (see also HIPAA)
Health Insurance Portability and Accountability Act (HIPAA, also known as the privacy rule): establishes national standards to protect individual’s medical records and other personal health information and applies to health plans, health care clearinghouses, and those health care providers that conduct certain health care transactions electronically. The Rule requires appropriate safeguards to protect the privacy of personal health information and sets limits and conditions on the uses and disclosures that may be made of such information without patient authorization. The Rule also gives patients’ rights over their health information, including rights to examine and obtain a copy of their health records, and to request corrections.
HIPAA has three components, all of which are enforced by the federal Office for Civil Rights:
- HIPAA Privacy Rule: protects the privacy of individually identifiable health information
- HIPAA Security Rule: sets standards for the security of electronic protected health information
- HIPAA Breach Notification Rule: requires covered entities and business associates to provide notification following a breach of unsecured protected health information
Human Subjects Protection Program: is a program designed to protect the rights, dignity, welfare, and privacy of human subjects in all research conducted on behalf of KSU.
- DHHS: 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.
- FDA: an individual who is or becomes a participant in research, either as a recipient of a test article or as a control. A subject may be either a healthy human or a patient. For research that involves medical devices, a human subject also includes an individual on whose specimen an investigational device is used.
- DOD: an activity, for research purposes, where there is an intervention or interaction with a living individual for the primary purpose of obtaining data regarding the effect of the intervention or interaction. Note: This definition applies only to activities that are considered to be research involving human subjects and does not include activities that meet the exemption criteria at 32 CFR 219 (Common Rule) or research involving the collection or study of existing data, documents, records, or specimens from living individuals. Research involving a human being as an experimental subject is a subset of research involving human subjects; used only when 10 USC 980 (Limitation on Use of Humans as Experimental Subjects) applies.
Hybrid Entity: a single legal entity that is a covered entity, performs business activities that include both covered and non-covered functions, and designates its health care components as provided in the Privacy Rule. KSU is a hybrid entity. (See also HIPAA)
Indirect Identifier: is more than one data element that can be used to ascertain an individual’s identity.
Individual Investigator Agreement: a written agreement between an organization and a collaborating external investigator who will be engaged in the organization’s non-exempt human subjects research that describes each party’s responsibilities for research conduct and oversight.
Individually Identifiable: the identity of the participant is or may readily be ascertained by the investigator or the investigator’s staff or is associated with the information.
- Information is individually identifiable under the HIPAA Privacy Rule (45 CFR Part 160) if it contains any one of 18 identifiers as defined by 45CFR160.
Interaction: communication or interpersonal contact between an investigator and participant.
Intervention: manipulation of the subject’s physical, sensory, social or emotional environment. Also, physical procedure (e.g. venipuncture, exercise) by which data are gathered. Intervention can be defined in many different ways; this definition is non-inclusive.
Investigator: an individual performing various tasks related to the conduct of human subjects research activities, such as obtaining informed consent from subjects, interacting with subjects, and communicating with the IRB. The IRB does not distinguish be key personnel and Co-investigators. See also Principal Investigator.
Institutional Review Board (IRB): a body established to ensure that human subjects research is conducted in a way that protects the rights and welfare of subjects.
Ionizing Radiation: any radiation capable of displacing electrons from atoms or molecules, thereby producing ions. Examples include alpha, beta, gamma, and X-rays. High doses of ionizing radiation may produce severe skin or tissue damage.
IRB Authorization Agreement: a written agreement between organizations collaborating in non-exempt human subjects research that describes each organization’s responsibilities for IRB review and oversight of the research.
IRB of Record: the IRB responsible for review of research and for determining that the research meets the regulatory requirements for approval.
Leftover/Remnant Specimen: remaining portion of a specimen obtained for clinical purposes that is no longer needed for its original purpose and that would otherwise be discarded.
Legally Authorized Representative: legally authorized representative (LAR) 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. The issue as to who can be a LAR is determined by the laws of the jurisdiction in which the research is conducted (e.g., local or state law). Some states have statutes, regulations, or common law that specifically address consent by someone other than the subject for participation in research. Most states have no law specifically addressing the issue of consent in the research context. In these states, law that addresses who is authorized to give consent on behalf of another person to specific medical procedures or generally to medical treatment may be relevant if the research involves those medical procedures or medical treatment.
Limited Data Set: health information that excludes certain direct identifiers, but may include city, state, and ZIP code; elements of date; and other numbers, characteristics, or codes that cannot be used to identify an individual or the individual’s relatives, employers, or household members. Information that may remain in a limited data set is Dates, City, state, zip code, age. (see also HIPAA)
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.
Minor Changes: changes to research that in the judgment of the IRB do not affect assessment of the risks and benefits of the study by substantially altering any of the following. Multiple minor changes (requested at one time or multiple individual changes) can be considered a significant change as determined by the IRB.
Noncompliance: is failure to comply with applicable policies, laws, regulations, protocols, or IRB requirements. Noncompliance may be intentional or unintentional. Noncompliance may be non-serious or serious. Examples of non-compliant activities include:
- Conducting non-exempt research without IRB approval
- Conducting research on an expired or unapproved protocol
- Failure to obtain consent or use of an inadequate consent process
- Inadequate Principal Investigator (PI) oversight of research activities or research personnel
- Initiating changes to non-exempt research without IRB approval unless the change is to eliminate apparent or immediate hazard to subject
Non-Scientist: an individual appointed to the IRB who (due to training, background, and/or occupation) is inclined to view research activities from the standpoint of someone outside the scientific or scholarly discipline of the IRB on which he/she serves.
Non-serious Noncompliance: does not increase risk to research participants, compromise participants’ rights or welfare, or affect the integrity of the research/data or the human subjects research protection program.
Parent: a child’s biological or adoptive mother or biological or adoptive father.
Performance Site: a site whose staff, facilities or private records of individuals are engaged in the conduct of research; or a site that receives HHS funds. The performance site is the actual place where the research activity (e.g., site where staff are consenting subjects).
Parental Consent: the agreement of a parent(s) or legal guardian to the participation of his/her child or ward in research.
Principal Investigator (PI): in accordance with guidance published from the Office of Human Research Protections (OHRP) the PI has overall responsibilities for studies involving human subjects.
Prisoner: an individual involuntarily confined or detained in a penal institution (e.g., prison, jail, or juvenile offender facility), with restricted ability to leave the 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 that provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.
Privacy: the control over the extent, timing, and circumstances of sharing oneself with others.
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, or information that has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public. Classrooms are considered private.
Procedure: a series of actions conducted in a certain order or manner; operational methods are used. Procedures can be social/behavioral, psychological, educational, biomedical, or clinical.
Protected Health Information (PHI): individually identifiable health information held or transmitted by a covered entity or its business associates, in any form or media, whether electronic, paper, or oral.
Recruitment: a process by which suitable subjects are attracted to a study. Recruitment should be supported by recruitment media/materials
Related: associated with or having a timely relationship with, as in a reasonable possibility exists that an outcome may have been caused or influenced by the research, even if an alternative explanation is present.
Repository: collection of data and/or specimens obtained and stored for future research uses and/or distribution, including a collection not originally or primarily obtained for research purposes.
Research: a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
Research Performance Site: location/site at which human subjects research may be performed because of an understanding of the local research context and appropriate oversight mechanisms that ensure protection of research participants.
Restricted Data: datasets that cannot be distributed to the general public, because of, for example, participant confidentiality concerns, third-party licensing agreements, or national security considerations.
Routine (Not-for-Cause) Review: an assessment or examination of something (e.g., a practice or procedure) with the possibility or intention of instituting change if necessary.
Secondary Research: study of existing information or materials (e.g., data or specimens) that have been previously collected for a purpose (including non-research purposes) other than the currently proposed activity.
Serious Adverse Event: an event that results is fatal or life threatening, permanently disabling, requires prolonged hospitalization, or results in a significant disability or anomaly.
Serious Noncompliance: increases risk to research participants, compromises participants’ rights or welfare, or affects the integrity of the research/data or the human subjects research protection program.
Specific Component (DOD): any one of the military branches or organizational entities within the Department of Defense, including the Army, Navy, Air Force, Coast Guard, or Marine Corps.
Specimen: human biological material, including solid material (e.g., tissue, organs) body fluid (e.g., blood, urine, saliva, semen, cerebrospinal fluid), and cells.
Sponsor-Investigator: an individual who initiates (i.e., obtains an IND or IDE) and conducts an investigation and under whose immediate direction an investigational drug or device is administered, dispensed, or used. Note: The regulatory requirements applicable to a sponsor-investigator include those applicable to both an investigator and a sponsor.
Summary Document: a written version of the full information presented to a subject or the subject’s legally authorized representative during the informed consent process, used in conjunction with a short form consent document. For non-English speaking individuals, the IRB-approved English language consent form may serve as the summary when an appropriately translated document is not available.
Suspension: an action taken by the IRB withdraw approval for some or all research activities, temporarily or permanently. The Institutional Official may also suspend research on an urgent basis. Note: Similar actions taken by investigators or sponsors to stop research activities are not suspensions as described by HRPP policy.
Systematic Investigation: implementation of rules-based methods that are repeated with multiple participants in a consistent manner across the participants. Alternatively, the method may be implemented according to specified rules with a single participant for types of investigations.
Tabled: an IRB “action” that indicates that review was not initiated or was not completed, resulting in postponement of IRB review, usually due to loss of quorum or other administrative issue. Research tabled at a convened meeting will be reviewed at a future convened meeting.
Termination: an action taken by the convened IRBs to permanently withdraw approval for all research activities (except for those follow-up procedures that may be necessary to protect the health and/or welfare of participants). Note: Similar actions taken by investigators or sponsors to stop research activities are not necessarily terminations.
Unanticipated Problem Involving Risks to Subjects or Others: the Office of Human Research Protections considers unanticipated problems, in general, to include those events that: (1) Are not expected given the nature of the research procedures and the subject population being studied; and (2) Suggest that the research places subjects or others at a greater risk of harm or discomfort related to the research than was previously known or recognized. Unanticipated problems can occur in any type of research (medical or non-medical) and may involve physical, psychological, social, legal, or economic harms.
Unrelated: has no association with the research; evidence exists that an outcome is definitely related to an event external to the research.
Use: with respect to individually identifiable health information, the sharing, employment, application, utilization, examination, or analysis of such information within the entity or health care component (for hybrid entities) that maintains such information. (See also HIPAA)