Adverse event (AE): Any undesirable and unintended (although not necessarily unexpected) effect occurring as a result of interventions, interactions, or collection of identifiable private information in research. In medical research, any untoward physical or psychological occurrence in research, including abnormal laboratory finding, symptom, or disease temporally associated with the use of (although not necessarily related to) a medical treatment or procedure. Adverse events involving drugs are also referred to as adverse drug experiences.
Affiliated: IRB membership status designating association with the university. Note: A member (or alternate) is considered to be affiliated if he/she or a member of his/her immediate family is a current or past (within the last 2 years): employee (full or part-time); clinical, adjunct, or visiting faculty member or instructor; paid or unpaid member of a university governing panel or board (not including the IRBs); healthcare provider holding credentials to practice at Ohio State; volunteer working at the university (unrelated to IRB service); or university consultant or advisor (paid or unpaid). An emeritus faculty or retired staff member is also considered to be affiliated if he/she has been retired or involved in paid or unpaid university activities (including research or service) within the last 2 years. Current undergraduate, graduate, and postdoctoral students are also considered to be affiliated, as described by HRPP policy.
Allegation of noncompliance: An unconfirmed report of noncompliance.
Alternate: An individual appointed to the IRB to serve in the same capacity as the specific IRB member(s) for whom the alternate is named, who substitutes for the member at convened meetings when the member is not in attendance. Note: IRB members and alternates have equal responsibilities in terms of required education, service, and participation.
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).
Appeal: Request for reconsideration of an IRB determination in research involving human subjects, including (but not limited to) decisions regarding approval status, conditions for approval, or noncompliance. Note: An appeal is reviewed by the convened IRB responsible for the determination being appealed; for a decision made by expedited review, the corresponding convened IRB may review the appeal. Also: request for reconsideration.
Approval Date: The first date that research can be performed (following notification from the IRB), consistent with federal regulations, state and local laws, and university policy. The approval date is the date that the research is approved by convened or expedited review, or if modifications are required (to secure approval), the date that modifications/conditions are met by the investigator. See also Approval Period.
Approval Period: For initial review, the interval that begins on the day research is approved by convened or expedited review, or if modifications are required (to secure approval), the date that modifications/conditions are met by the investigator. For continuing review, the interval that begins on the day research is re-approved (by convened or expedited review) or modifications are required. Note: An approval period for initial or continuing review may not be longer than one year.
Approved: An IRB action taken when the required determinations are made that allow research involving human subjects to proceed consistent with federal regulations, state and local laws, and university policy.
Assent: Agreement to participate in research expressed by an individual (e.g., a child) who cannot provide legally effective informed consent to participate on his/her own behalf. Note: Failure to object does not constitute assent.
Audit: A systematic review, inspection, or verification, typically conducted by an independent individual or group.
Bank: Also: 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.
Biological product: Also: biologic. A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product applicable to the prevention, treatment, or cure of a disease or condition of human beings. Note: Biological products also include immunoglobulin products, monoclonal antibodies, products containing cells or microorganisms, and most proteins intended for therapeutic use.
Child/Children: 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. For purposes of HRPP policy, individuals under 18 years of age are considered children in Ohio unless they meet the definition of emancipated minors.
Clinical Investigation: Also: research, clinical research, clinical study. Any experiment that involves a test article and one or more human subjects that either:
- Meets the requirements for prior submission to FDA under sections 505(i) or 520(g) of the Food, Drug, and Cosmetic Act; or
- Need not meet the requirements for prior submission to FDA under the sections noted above, but the results of which are intended to be later submitted to or held for inspection by FDA as part of an application for a research or marketing permit.
Note: Non-clinical laboratory studies are not considered to be clinical investigations. See the DHHS definition of research for DHHS-regulated research. See the DHHS definition of research for DHHS-regulated research.
Clinical Trial: Any investigation in human subjects intended to: discover or verify clinical, pharmacological, and/or other pharmacodynamic effects of an investigational product; identify any adverse reactions to an investigational product; and/or study absorption, distribution, metabolism, and excretion of an investigational product to determine its safety and/or efficacy. Note: Studies involving only behavioral interventions are not covered by this policy.
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 (not derived from or related to the personal information) for purposes of protecting the identity of the source(s); but the original identifiers are retained in such a way that they can be traced back to the source(s) by someone with the code. Note: A code is sometimes also referred to as a “key,” “link,” or “map.”
Coercion: Persuasion (i.e., of an unwilling person) to do or agree to something by using obvious or implied force or threats.
Compassionate Use: Use of an investigational drug or biologic or unapproved medical device for a single subject (or small group of subjects) with a serious disease or condition, who does not meet the requirements for inclusion in a clinical investigation, and for whom no standard acceptable treatment is available. Prior FDA and IRB approval are required for compassionate use. Note: The terms compassionate use and emergency use are not synonymous.
Compensation: Payment, merchandise, class credit, or other gift or service provided to research participants or their legally authorized representatives to reimburse them for their time, effort, and/or for any out-of-pocket expenses associated with research participation. Note: Compensation is sometimes distinguished from an incentive or inducement, which is generally thought of as a payment or other offering that is “over and above” reimbursement and intended to encourage research participation.
Confidentiality: In the context of human subjects research, the condition that results when data are maintained in a way that prevents inadvertent or inappropriate disclosure of participants’ identifiable information.
Conflict of Interest: A financial interest or other opportunity for tangible personal benefit of an individual or his/her immediate family that may exert a substantial and improper influence on the individual’s professional judgment in exercising any institutional duty or responsibility, including the review of research. Note: For IRB members and consultants, financial and non-financial interests/opportunities are included.
Continuing noncompliance: Noncompliance (serious or non-serious) that has been previously reported, or a pattern of ongoing activities that indicate a lack of understanding of human subjects protection requirements that may affect research participants or the validity of the research and suggest the potential for future noncompliance without intervention. Examples of continuing noncompliance may include, but are not limited to the following: repeated failures to provide or review progress reports resulting in lapses of IRB approval, inadequate oversight of ongoing research, or failure to respond to or resolve previous allegations or findings of noncompliance.
Convened IRB Review: Review of proposed human subjects research by an Institutional Review Board that meets the membership requirements specified in federal regulations regarding the number, qualifications, diversity, and affiliation of its members, at which a majority of the members are present including at least one member whose primary concerns are in nonscientific areas.
Custom Device: A device that necessarily deviates from devices generally available or from an applicable performance standard or pre-market approval requirement to comply with the order of an individual physician or dentist and that is:
- Not generally available or generally used by other physicians or dentists;
- Not generally available in finished form for purchase or for dispensing upon prescription;
- Not offered for commercial distribution through labeling or advertising; and
- Intended for use by an individual patient named in the order of a physician or dentist and is to be made in a specific form for that patient, or is intended to meet the special needs of the physician or dentist in the course of professional practice.
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.
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: Occurs when an investigator gives false information to, or otherwise intentionally misleads, a research participant about some key aspect of the research to avoid biased responses. If participants are given false information or are otherwise misled during a study, then the participants are not provided with all of the required elements of informed consent: in these instances, approval for a waiver or alteration of informed consent is required.
Deferred: An IRB action taken when the IRB cannot fully evaluate the research under review and make the determinations required for approval without modifications to the protocol and/or informed consent document, or submission of clarifications or additional materials prior to reconsideration of the research. Note: Convened IRB review of the investigator’s response(s) is required.
De-identified: All direct personal identifiers are permanently removed (e.g., from data or specimens), no code or key exists to link the information or materials to their original source(s), and the remaining information cannot reasonably be used by anyone to identify the source(s). Note: For purposes of HRPP policy, health information is de-identified when it does not contain any of the 18 identifiers specified by the HIPAA Privacy Rule at 45 CFR Part 164 (or has been determined to be de-identified by a statistician in accordance with the standards established by the Privacy Rule). For more information, including the list of identifiers that must be removed to de-identify health information, see HIPAA and Human Subjects Research.
Delivery: The process of giving birth; complete separation of the fetus from the woman by any means.
Device: Also: medical device. Instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article (including a component part), or accessory that is recognized in the official National Formulary or United States Pharmacopoeia (or any supplement to these) and is:
- Intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease in man or other animals, or
- Intended to affect the structure or any function of the body of man or other animals, that does not achieve any of its primary intended purposes through chemical action within or on the body, and is not dependent upon being metabolized for the achievement of any of its primary intended purposes.
Diminished decision-making capacity: As it applies to informed consent, lacking the ability to provide valid informed consent to participate in research, e.g., as a result of trauma, intellectual disability, certain mental illnesses, cognitive impairment, or dementia. Note: Diminished decision-making capacity may be temporary, permanent, progressive, or fluctuating.
Directed (For-Cause) Audit/Review: An audit of research and/or investigators initiated at the request of the IRB or Institutional Official to obtain or verify information necessary to ensure compliance with regulations and institutional requirements and to inform decisions about the conduct of human subjects research and/or human subjects protection.
Disapproved: An IRB action taken when the determinations required for approval of research cannot be made, even with substantive clarifications or modifications to the protocol and/or informed consent process/document. Note: Research cannot be disapproved by expedited review.
Dosimetrist: Individual with special training in radiation safety and in the accurate determination of radiation dosages.
Drug: Substance recognized in the United States Pharmacopoeia, Homeopathic Pharmacopoeia of the United States, or National Formulary (or any supplement to any of these), and is an article:
- Intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease or intended to affect the structure or any function of the body (other than food), or
- Intended for use as a component of any substance described above.
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.
Emancipated Minors: For purposes of HRPP policy, the following persons under the legal age of 18, who because of their unique circumstances have the legal rights of adults, including the right to consent to treatments or procedures involved in research:
- Persons under the age of 18 on active duty in the military
- Married persons under 18 years of age.
Note: Pregnancy or childbirth outside of marriage does not emancipate a minor in Ohio.
Emergency Use: Use of an investigational drug or biologic or unapproved medical device for a human subject in a life-threatening situation for which no standard acceptable treatment is available and when there is not sufficient time to obtain IRB approval. Note: Under FDA regulations, emergency use is a category of research (i.e., clinical investigation) that is exempt from the requirements for IRB review.
Engaged: Involved in human subjects research in such a way (or to the extent) that the ethical and regulatory requirements for human subjects protection are applicable. An individual (or organization) becomes engaged in human subjects research when for the purposes of non-exempt research the individual (or organization’s employee or agent) obtains any of the following:
- Data about research participants through intervention or interaction
- Identifiable private information about research participants
- Informed consent of research participants.
Note: An organization is also engaged in human subjects research whenever it receives a direct federal award to support the research.
Exculpatory Language: As it applies to informed consent, any written or verbal communication through which a research participant (or his/her legally authorized representative) is asked to waive or appear to waive any of the participant’s legal rights or to release (or appear to release) the investigator, sponsor, or institution or its agents from liability for negligence.
Exempt research: Research that involves human subjects that is not subject to regulations requiring IRB review and approval. Categories of research activities that may be determined to be exempt from review by the IRB are defined by federal regulations and university policy. Note: Investigators performing exempt research must comply with the requirements of the HRPP 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 IRB Reviewer: The IRB Chair and those experienced IRB members designated by the Chair who may perform some or all types of expedited reviews.
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.
Experienced IRB Member: An IRB member determined by the IRB Chair to be qualified to perform reviews using expedited procedures. The following criteria are considered when determining whether an IRB member is experienced: length of IRB service, training regarding expedited review procedures, research experience/expertise, and/or work with the research participants being studied.
Experiment: Any use of a drug except for the use of a marketed drug in the course of medical practice or any evaluation of the safety and efficacy of a medical device.
Expiration Date: The date that the IRB’s approval of research has lapsed and research can no longer be performed. Note: An expiration date may not be longer than one year from the date the approval period begins.
External event: An event occurring in research at a site(s) other than Ohio State, over which another (non-Ohio State) IRB has jurisdiction.
Family Member: For purposes of the waiver of informed consent for emergency research, any one of the following legally competent persons: spouse, parent, child (including an adopted child), brother, sister, spouse of a brother or sister, and any individual related by blood or affinity whose close association with the subject is the equivalent of a family relationship.
Fetus: Unborn child; the product of conception from implantation until delivery.
Financial Conflict of Interest: An interest of an individual (or his/her immediate family) of monetary value that would reasonably appear to be affected by the research or an individual’s interest in any entity whose financial interests would reasonably appear to be affected by the research. Note: Financial interests include (but are not limited to) salary or other payments for services (e.g., consulting fees or honoraria), equity interests (e.g., stocks, stock options, or other ownership interests), and intellectual property rights (e.g., patents, copyrights, and royalties from such rights).
Finder’s Fee: Payment made by an investigator or sponsor to an organization or individual (including non-research personnel or a research participant) for identifying and/or referring potential participants for research.
Finding of noncompliance: An occurrence or determination of noncompliance that does not require further confirmation or investigation (e.g., failure to respond to the IRB within established deadlines, allegation of noncompliance determined by the IRB to be true).
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.
Good Clinical Practice (GCP): Also: ICH E6. A standard established by the International Conference on Harmonisation for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. Note: In the United States, FDA has adopted GCP as guidance.
Guardian: An individual who is authorized under applicable state or local law to consent on behalf of a child to general medical care. In Ohio, a guardian may be a grandparent, other family member, or other person, association, or agency other than the biological or adoptive parents who 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. Note: 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.
HRPP Policies and Procedures: Policies and procedures of the Office of Research, IRBs, and Office of Responsible Research Practices that apply to the conduct, review, and oversight of human subjects research and describe the roles and responsibilities of those involved in these activities.
Human Subject (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. Note: See the FDA definition of human subject for FDA-regulated research.
Human Subject (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. Note: See the DHHS definition of human subject for DHHS-regulated research.
Human Subject Radiation Committee (HSRC): A subcommittee of The Ohio State University Radiation Safety Committee responsible for the review and approval of the research use of radiation in research involving human subjects. Note: The Medical Use Subcommittee of the university Radiation Safety Committee serves as the Human Subject Radiation Committee.
Humanitarian Device Exemption (HDE): An application that permits the marketing of a humanitarian use device.
Humanitarian Use Device (HUD): A device that is intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect (or are manifested in) fewer than 4000 individuals in the US per year.
Immediate Family: For purposes of HRPP policy, an IRB member or consultant’s spouse or domestic partner and dependent children.
Implant: A device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 30 days or more.
Incomplete Disclosure: Occurs when an investigator withholds or conceals information from a participant about the specific purpose of, or activities involved in, the research. If material information or activities are withheld that could potentially influence the decision of prospective participants to take part in the research, then the participants are not provided with all of the required elements of informed consent: in these instances, approval for a waiver or alteration of informed consent is required.
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. Note: Individually identifiable for the purposes of HRPP policy may be similar to, but is not the same as, individually identifiable health information or protected health information as defined by the HIPAA Privacy Rule at 45 CFR Part 160. Limited data sets released from data repositories with IRB approval to release such data sets are not considered to be individually identifiable.
Informed Consent: Agreement to participate in research expressed by an individual (or his/her legally authorized representative) authorized under applicable law to make such decisions, based on sufficient information (e.g., regarding possible risks and benefits of the research) and adequate opportunity to consider voluntary participation. Also: legally effective informed consent.
Interaction: Communication or interpersonal contact between an investigator and participant.
Internal event: An event occurring in Ohio State research at a site(s) under an Ohio State IRB’s jurisdiction.
International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH): Also: International Conference on Harmonisation. Voluntary, international initiative to increase coordination of the requirements for developing and marketing new drugs. The ICH includes representatives from the pharmaceutical industry and regulatory authorities from the United States, Japan, and the European Union.
Intervention: Physical procedure by which data are gathered, or manipulation of the participant or the participant’s environment for research purposes.
Investigational Device: A device (including a transitional device) that is the object of an investigation.
Investigational Device Exemption (IDE): An application that permits a device that would otherwise be required to comply with a performance standard (i.e., 510(k) submission) or to have pre-market approval by FDA to be legally shipped for a clinical investigation.
Investigational Drug: Also: investigational new drug. A new drug or biologic (i.e., not approved for marketing by FDA) used in a clinical investigation, including a biological product used in vitro for diagnostic purposes.
Investigational New Drug Application (IND): An application that permits an investigational drug that would otherwise be required to have pre-market approval by FDA to be legally shipped for a clinical investigation.
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.
Key Organizational Leader: For purposes of HRPP policy, a faculty member or administrator who has direct authority over personnel appointments, salaries, promotions, and/or allocation of organizational resources (e.g., funding, space, assignment of graduate students or other trainees) for individuals involved in the design, conduct, reporting, review, or oversight of human subjects research.
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: An individual, 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. For purposes of HRPP policy, the following are recognized in Ohio as legally authorized representatives:
- Persons appointed as health care agents under an Ohio Durable Power of Attorney for Health Care
- Court-appointed guardians
- Next of kin in the following order: spouse, adult child, parent, and adult sibling.
Life-threatening: Refers to diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted; also diseases or conditions with potentially fatal outcomes.
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. Note: Limited data sets may be used or disclosed for purposes of research with a data use agreement as described by the HIPAA Privacy Rule at 45 CFR Part 164. For more information, including the list of identifiers that must be removed from health information in a limited data set, see HIPAA and Human Subjects Research.
Minimal Risk: 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. Note: The regulatory definition of “minimal risk” for research involving prisoners differs from the definition of minimal risk for research involving participants who are not prisoners.
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: research aims or methodology, nature of subject participation, level of risk, proposed benefits, participant population, qualifications of the research team, or the facilities available to support the safe conduct of the research. Note: A minor change does not increase risk more than minimally or add procedures in research categories other than those that qualify for expedited initial review.
Modifications Required: An IRB action that specifies conditions under which research can be approved, pending the following: confirmation of specific understandings by the IRB about how the research will be conducted, submission of additional documentation, precise language changes to the protocol and/or informed consent document(s), and/or substantive changes to documents with specific parameters the changes must satisfy. Note: Verification that the investigator’s response(s) satisfies the conditions for approval set by the IRB may be performed by the IRB Chair and/or other designated individual(s). Also: contingent approval, approval with conditions.
Neonate: A newborn.
Noncompliance: Failure (intentional or unintentional) to comply with applicable federal regulations, state or local laws, the requirements or determinations of the IRB, or university policy regarding research involving human subjects. Noncompliance can result from action or omission. Noncompliance may be non-serious (minor) or serious, and may also be continuing.
Non-Financial Conflict of Interest: An interest other than monetary of an individual (or his/her immediate family) in the design, conduct, or reporting of the research or other interest that competes with an IRB member’s (or consultant’s) obligation to protect research participants and potentially compromises the objectivity and credibility of the research review process.
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 or minor noncompliance: Noncompliance that does not increase risk to research participants, compromise participants’ rights or welfare, or affect the integrity of the research/data or the human research protection program. Examples of minor noncompliance may include, but are not limited to the following: lapses in continuing IRB approval, failure to obtain exempt determination before exempt research involving human subjects is conducted, minor changes in or deviations from an approved protocol, or administrative errors.
Non-Significant Risk (NSR) Device: An investigational device that does not meet the definition of a significant risk device.
Nonviable Neonate: A neonate that (although alive following delivery) is not capable of surviving to the point of sustaining life independently, even with the support of available medical treatment, as determined by a physician who is not engaged in the research.
Nuclear Regulatory Commission: The independent government agency established by the Energy Reorganization Act of 1974 to regulate civilian use of nuclear materials.
Off-Site Research: Human subjects research sponsored or performed at a location/site that is not owned by or under the direct control of the organization responsible for the research.
Organizational Conflict of Interest (OCOI): A situation in which the financial investments or holdings of an organization (including licenses, royalties, intellectual property rights, patents, certain gifts) or the personal financial interests or holdings of a key leader might affect or reasonably appear to affect organizational processes for the design, conduct, reporting, review, or oversight of human subjects research.
Parent: A child’s biological or adoptive mother or biological or adoptive father.
Permission: The agreement of a parent(s) or legal guardian to the participation of his/her child or ward in research.
Planned Emergency Research: Research involving human subjects who are in need of emergency medical intervention (e.g., comparison of methods for providing cardiopulmonary resuscitation), but who cannot give informed consent because of their life-threatening medical conditions and who do not have an available legally authorized representative to provide consent.
Policy: Formal statement of principles on which action(s) for a specific issue are based.
Pre-review: The process performed by ORRP staff to determine that a submission for IRB review is complete, including the required materials, copies, and signatures, and that institutional requirements, such as completion of human subjects protection education and conflict of interest disclosure, have been met.
Pregnancy: The period of time from implantation (of a fertilized egg within the uterus) until delivery of the fetus.
Principal Investigator: An individual with the appropriate scientific and/or scholarly training and expertise to assume direct responsibility for the ethical conduct of a study involving human subjects, providing technical and administrative oversight of the research and making important study-related decisions. Note: For purposes of HRPP policy, only one individual is designated as the principal investigator of a human research study. For the university’s guidelines on requirements for PI status, see Principal Investigator Status Appointments.
Prior Consent (ED): Prior consent of the student, if the student is an adult or emancipated minor, or prior written consent of the parent or guardian if the student is not an emancipated minor.
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.
Prisoner of War (DOD): Individuals under the custody and/or control of the Department of Defense as defined in the Geneva Convention Relative to the Treatment of Prisoners of War of August 12, 1949, Articles 4 and 5. In particular, one who, while engaged in combat under orders of his government, is captured by the armed forces of the enemy. Note: Research involving a detainee (as defined in DOD Directive 2310.01E) as a human subject is prohibited.
Privacy: The state of being free from the observation, intrusion, or attention of 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. Examples of private information include medical or academic records or personal journals.
Procedure: A series of actions conducted in a certain order or manner; operational method by which policy is put into practice.
Quality Improvement: A process initiated to develop/enhance a practice or procedure and to institutionalize the practice or procedure.
Radiation Exposure: In health physics, the quantity used to indicate the amount of ionization in air produced by X-ray or gamma radiation while conducting radiologic procedures.
Radiologic (Radiological) Procedure: Any procedure involving radiation (e.g., X-ray) or a radioactive agent (e.g., radionuclide used in a nuclear medicine study).
Recruiting Methods: Materials, compensation, and other practices or procedures used to inform potential participants about research. Note: Methods for recruiting research participants are generally distinguished from those of marketing, advertising, or public relations’ efforts, which have promoting a product, service, or idea as goals.
Recruitment Bonus: Payment, merchandise, or other gift or service offered by a sponsor as an incentive or reward to an organization, investigator, or key personnel conducting research designed to accelerate recruitment that is tied to enrollment rate, timing, or numbers.
Recruitment Materials: Announcements; advertisements; flyers; posters; scripts for telephone or other oral communication; letters or email messages; bulletin board tear-offs; Internet postings; newspaper, radio, television, or video broadcasts, or other media used to attract potential participants for research.
Related: Associated or having a timely relationship with; a reasonable possibility exists that an outcome may have been caused or influenced by the event in question (e.g., administration of a study drug), although an alternative cause/influence may also be present. Related events may be definitely, probably, or possibly related.
Repository: Also: bank. 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. Note: See the FDA definition of research (clinical investigation) for FDA-regulated research.
Research or Experimentation Program or Project (ED): Any research program or project that is designed to explore or develop new or unproven teaching methods or techniques.
Research Involving a Human Being as an Experimental Subject (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.
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. Note: A list of approved Ohio State University research performance sites is available at Research Performance Sites.
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.
Sample: Also: specimen. Human biological material, including solid material (e.g., tissue, organs) body fluid (e.g., blood, urine, saliva, semen, cerebrospinal fluid), and cells.
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 (SAE): An adverse event that is fatal or life threatening, permanently disabling, requires or prolongs hospitalization, or results in significant disability, congenital anomaly, or birth defect.
Serious noncompliance: Noncompliance that has the potential to increase risk to research participants, compromise participants’ rights or welfare, or affect the integrity of the research/data or the human research protection program. Examples of serious noncompliance may include, but are not limited to the following: conducting or continuing non-exempt human subjects research without IRB approval; lack of legally effective informed consent from research participants; failure to report or review serious adverse events, unanticipated problems, or substantive changes in research; or inappropriate oversight of the research to ensure the safety of human subjects and the integrity of the research/data.
Severely Debilitating: Refers to diseases or conditions that cause major irreversible morbidity (e.g., blindness, loss of limb, loss of hearing, paralysis, or stroke).
Short Form: A written document stating that the elements of informed consent required by regulation have been presented orally to the subject or the subject’s legally authorized representative. The short form consent document must be written in a language understandable to the subject or the subject’s legally authorized representative.
Significant Risk (SR) Device: An investigational device that is:
- Intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;
- For use in supporting or sustaining human life and represents a potential for serious risk to the health, safety, or welfare of a subject;
- For a use of substantial importance in diagnosing, curing, mitigating, or treating disease or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or
- Otherwise presents a potential for serious risk to a subject.
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: Also: sample. 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 Chairs, Vice Chairs, or convened IRBs to withdraw approval for some research activities, temporarily or permanently, or all research activities temporarily, short of permanently withdrawing approval for all research activities. 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: A planned scientific or scholarly activity involving qualitative or quantitative data collection and/or data analysis that sets forth an objective(s) and a set of procedures intended to reach the objective(s), i.e., to acquire knowledge, develop a theory, or answer a question.
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 terminations as described by HRPP policy.
Test Article: Any drug (including a biological product) or medical device for human use, human food (including dietary supplements), food or color additive, infant formula, electronic product, or any other article subject to regulation by FDA.
Transitional Device: A device subject to section 520(l) of the Food, Drug, and Cosmetic Act; a device that FDA considered to be a new drug or an antibiotic drug before May 28, 1976.
Treatment or Professional Practice: Interventions designed solely to enhance the well-being of a particular individual.
Unanticipated adverse device effect: Any serious adverse effect on health or safety, or any life-threatening problem or death caused by (or associated with) a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application; any other unanticipated, serious problem associated with a device that relates to the rights, safety, or welfare of subjects.
Unanticipated problems involving risks to subjects or others: Unforeseen events (given the nature of the research procedures and subject population) that suggest subjects, research staff, or others are placed at greater risk by the research than previously expected. Unanticipated problems involving risks to subjects or others may be medical or non-medical in nature, and include – but are not limited to – serious, unexpected, and related adverse drug events and unanticipated adverse device effects.
Unapproved Medical Device: A device used for a purpose or condition for which the device would require but does not have pre-market approval or an approved investigational device exemption (IDE) from FDA.
Undue Influence: Excessive or inappropriate reward or other incentive in which a person is induced to act otherwise than by his/her own free will or without adequate consideration of the consequences.
Unexpected adverse event: An adverse event that has not been previously observed or is not consistent in nature, severity, or frequency with existing risk information, such as in the investigator’s brochure, research protocol, consent form, or other available information (e.g., IND application for an investigational drug).
Unrelated: Unassociated or without a timely relationship; evidence exists that an outcome is definitely related to a cause other than the event in question.
Viable Neonate: A neonate able to survive, given the benefit of available medical treatment, to the point of independently maintaining heartbeat and respiration as determined by a physician who is not engaged in the research.