Definitions for Human Subjects Research

This page provides a glossary of definitions and acronyms used in Human Subjects Research to ensure a shared understanding among researchers, IRB members, and staff.

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Acronyms | Definitions

Commonly Used Acronyms

A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z

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  • 501K: A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device. If a device has received a 510k premarket notification, the FDA will provide documentation regarding the permitted indications for use and other details. See the FDA Guidance for more information about 510(k) submissions.

A

  • Abbreviated IDE: The FDA considers an investigation of a non-significant risk device to have an abbreviated Investigational Device Exemption (IDE) when the IRB concurs with the non-significant risk determination and approves the study. The sponsor must also comply with the abbreviated IDE requirements under 21 CFR 812.2b. Under an abbreviated IDE, no IDE application is required to the FDA.
  • Adults: Persons who have 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. In most cases, adults will be individuals over the age of 18. However, there may be contexts and jurisdictions where individuals under the age of 18 could be considered adults (e.g., emancipated minors, minors 15 years old or older giving consent for medical treatment).
  • Allegation of Non-Compliance: An unproved assertion of Non-Compliance.
  • Anonymous data/specimens: Data/specimens collected without any identifiable information and in no way can be linked to an individual.
  • Approval-in-Principle (AIP): A type of submission for funded research lacking definite plans for the involvement of human subject research (also see 45 CFR 46.118). For example, projects in which human subjects' involvement is planned for a later phase of the research, but it is not possible to know the details for that phase because they will depend upon completion of instruments, prior animal studies, or purification of compounds. No human subjects may be involved in any project supported by these awards until the details and documents describing the human subjects research have been provided and the project has been reviewed and approved by the IRB. For more information, see the RCS AIP webpage.
  • Artificial Intelligence (AI): A machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations or decisions influencing real or virtual environments (also see 15 U.S.C. 9401(3)). Artificial intelligence systems use machine and human-based inputs to:
    • (A) perceive real and virtual environments;
    • (B) abstract such perceptions into models through analysis in an automated manner; and
    • (C) use model inference to formulate options for information or action.
    • AI broadly encompasses all the following:
      • Rule-Based Systems (e.g. Decision Trees, Chatbots)
      • Machine Learning tools (e.g. SensorFlow, Scikit-Learn, PyTorch, Azure ML)
      • Natural Language Processing tools (e.g. Siri, Alexa, Grammarly)
      • Large Language Models (ChatGPT, Gemini, Claude)
  • Assent: Affirmative agreement to participate in research from a child or an adult who lacks capacity to consent for themselves (e.g., due to decisional impairment). Absent affirmative agreement, mere failure to object should not be construed as assent.
  • Autonomous Person: An individual capable of deliberation about personal goals and of acting under the direction of such deliberation.

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B

  • Belmont Report: The Belmont Report outlines the basic ethical principles in research involving human subjects: (1) respect for persons, (2) beneficence, and (3) justice. Named after the Belmont Conference Center, where the Commission met when drafting the report.
  • Beneficence: A principle from the Belmont Report that persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harms.
  • Benign Behavioral Intervention (BBI): Benign behavioral interventions are harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects and are neither offensive nor embarrassing. Medical interventions (including medical tests, procedures and devices) may not be used.
    • Behavioral interventions employ research procedures in the study of psychological states and processes, cognition, ideas and attitudes, or behavior. They do not include physical (bodily) tasks or physical manipulations unless these are minor activities that are incidental to the behavioral intervention and do not increase risk. Behavioral interventions typically rely only on communication or interpersonal contact with the participant, the performance of a cognitive, intellectual, educational or behavioral task, or manipulation of the subject’s physical, sensory, social, or emotional environment.
    • Exempt category 3 is limited to interventions that are not expected to cause physical or emotional harm, persistent discomfort, be experienced by the subject as embarrassing, or offensive. Ordinary, mild, transient forms of discomfort, such as the stress associated with completing a timed cognitive task, anxiety about performance, and boredom, are consistent with the intent of the exemption. Similarly, while research cannot meaningfully eliminate all risk of embarrassment or offense, the research should include only interventions that the researcher has no reason to think participants will find offensive or embarrassing considering the characteristics of the participant population, the research context, and how they might impact the participant’s experience of the research intervention.
  • Biologics/Biological products: Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. Biologics are isolated from a variety of natural sources - human, animal, or microorganism - and may be produced by biotechnology methods and other cutting-edge technologies. Although biological products are generally regulated as drugs by the FDA, they differ from most drugs that are chemically synthesized and their structure is known. Most biologics are complex mixtures that are not easily identified or characterized. Biological products, including those manufactured by biotechnology, tend to be heat sensitive and susceptible to microbial contamination.
  • Biospecimens: Samples or specimens of material, such as urine, blood, saliva, tissue, cells, DNA, RNA, and protein.
  • Brief in Duration: In the context of benign behavioral interventions (BBI) for exempt category 3, brief in duration refers to the intervention itself. Data collection activities can proceed over a longer period of time separate from the intervention. However, if the intervention and the data collection are intertwined or difficult to separate, the entirety of the activity should be brief in duration. To qualify as “brief in duration” for exempt category 3, the benign behavioral intervention should last a few minutes to a few hours. While it does not have to occur in a single session, the entire time for the intervention should only add up to no more than a few hours. The more irritating or unpleasant the intervention will be, the less time a participant can be involved before it stops being 'brief'. For example, looking at images that are not upsetting may be brief for a few hours, while sitting in a particularly uncomfortable chair may stop being brief within a few minutes.

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C

  • Certificate of Confidentiality (CoC): A Certificate of Confidentiality (CoC) is a document issued by a component of HHS such as the National Institutes of Health (NIH), to protect the privacy of research participants enrolled in research that collects or uses identifiable, sensitive information. With limited exceptions, researchers may not disclose names or any information, documents or biospecimens containing identifiable, sensitive information. The Certificate prohibits disclosure in response to legal demands, such as a subpoena. For more information, see the NIH Frequently Asked Questions for CoCs.
  • Certification: The official notification by the institution to the supporting Federal department or agency component that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved assurance.
  • Children/Child: Persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted. Also see Adults above.
  • Clinical Decision Support (CDS): Software that provides Health Care Professionals (HCPs) and patients with knowledge and person specific information, intelligently filtered or presented at appropriate times, to enhance health and health care. CDS may include a variety of tools including, but not limited to: computerized alerts and reminders for providers and patients; clinical guidelines; condition-specific order sets; focused patient data reports and summaries; documentation templates; diagnostic support; and contextually relevant reference information. View the FDA Clinical Decision Support Software Guidance.
  • Clinical Investigation (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.
  • Clinical Trial (FDA – 42 CFR 11.10): A clinical investigation or a clinical study in which human subject(s) are prospectively assigned, according to a protocol, to one or more interventions (or no intervention) to evaluate the effect(s) of the intervention(s) on biomedical or health-related outcomes.
    • Note: not all studies that meet the above clinical trial definition are required to meet the clinical trial registration and reporting requirements. Unless the study is NIH funded or otherwise federally funded, an FDA regulated study must meet one of the applicable clinical trial definitions below (i.e., Applicable Device Clinical Trial or Applicable Drug Clinical Trial) to be required to comply with the clinical trial registration and reporting requirements. However, researchers can choose to adhere to those requirements voluntarily.
  • Clinical Trial (FDA -Applicable Device Clinical Trial): A prospective clinical study of health outcomes comparing an intervention with a device product subject to section 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360(k), 21 U.S.C. 360e, 21 U.S.C. 360j(m)) against a control in human subjects (other than a small clinical trial to determine the feasibility of a device product, or a clinical trial to test prototype device products where the primary outcome measure relates to feasibility and not to health outcomes); (2) a pediatric postmarket surveillance of a device product as required under section 522 of the FD&C Act (21 U.S.C. 360l); or (3) a clinical trial of a combination product with a device primary mode of action under 21 CFR Part 3, provided that it meets all other criteria of the definition under this part. [Source: 42 CFR 11.10(a)].
  • Clinical Trial (FDA - Applicable Drug Clinical Trial): A controlled clinical investigation, other than a phase 1 clinical investigation, of a drug product subject to section 505 of the FD&C Act (21 U.S.C. 355) or a biological product subject to section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262), where “clinical investigation” has the meaning given in 21 CFR 312.3 and “phase 1” has the meaning given in 21 CFR 312.21. A clinical trial of a combination product with a drug primary mode of action under 21 CFR Part 3 is also an applicable drug clinical trial, provided that it meets all other criteria of the definition under this part. [Source: 42 CFR 11.10(a)].
  • Clinical Trial (HHS): 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 the interventions on biomedical or behavioral health-related outcomes.
    • This definition applies to federally funded or supported studies.
    • The NIH definition for NIH funded research is equivalent to this definition and you can find additional resources for NIH clinical trials on NIH’s Definition of a Clinical Trial webpage.
  • Closure/Closed: When researchers are done with their study, they will need to close their IRB submission. A study can be closed when the following criteria are met:
    • Study is permanently closed to enrollment (i.e., no new participants will be recruited, consented or enrolled and no new identifiable data/specimens will be added to the study)
    • All participants have completed all study related interventions and interactions
    • Collection of identifiable private information and identifiable biospecimens is complete
    • Analysis of identifiable private information and identifiable biospecimens is complete
    • In some cases, an ongoing study can be closed at the UO if IRB oversight has been transferred to another IRB of record. A closure is submitted in the RAP through a Continuing Review (CR) submission type.
  • Coded information/ specimens: Information and/or specimens that are associated with identifiers indirectly. The data/specimens have been stripped of direct identifiers and replaced with a code (e.g., 001, 002) and a key is maintained separately that links that code back to identifiers. Coding is one method for limiting access to identifiable information (also see confidential information/specimens). Because identifiers are maintained and can still be associated with the information/specimens, coded information/specimens are not entirely de-identified or anonymous to those who have access to the linking key or other means to re-identify participants.
  • Code of Federal Regulations: The codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government.
  • Coercion: An action is considered coercive if it entails an overt or implicit threat of harm/negative consequence which could compel involuntary participation and/or compliance. For example, telling a prospective subject they will lose access to needed services if they do not participate in the research is coercive and would not be permitted. See also undue influence.
  • Coded Data/Biospecimens: Data/biospecimens labeled with a unique code (e.g., study ID). A separate link (key) is kept which connects this ID number to an identifier (e.g., name, medical record numbers, etc.). Data/biospecimens are usually coded if an investigator anticipates that they may need to gather additional data or verify data at more than one point over the life of the study. If a link exists, data are considered indirectly identifiable and not anonymous, anonymized or de-identified to those who have access to the link.
  • Collaborative Study: A study in which two or more institutions coordinate, with each institution completing a portion of the human research activities outlined in a specific protocol (e.g., one institution does consenting, interactions/intervention and data collection while other institution does data analysis only).
  • Committee for the Protection of Human Subjects (CPHS): The name of the University of Oregon’s Institutional Review Boards (IRBs).
  • Common Rule: The Federal Policy for the Protection of Human Subjects promulgated by Department of Health and Human Services and adopted by at least 15 other federal departments and agencies.
    • Pre-2018 Common Rule/old rule/Common Rule: regulations promulgated between 1991-January 18, 2018. Pre-2018 studies can be transitioned to the 2018 Common Rule.
    • 2018 Common Rule/revised 2018 Common Rule/revised regulations/final rule: Refers to the regulations effective January 19, 2018 and on.
  • Confidential information/specimens: Information and/or specimens that may be identifiable but will remain protected from unauthorized access and disclosure. The research team is obligated to keep confidential information/specimens private. For example, responses may be combined and reported in aggregate form. To ensure confidentiality, there should also be other mechanisms limiting access to identifiers (e.g., securely storing the data, removing identifiers from the data and replacing it with a code and maintaining a separate key to the code that is securely stored separately from the data, using passwords and encryption to make data available only to authorized users).
  • Confidentiality: Refers to the researcher’s agreement with the participant about how the participant’s identifiable private information will be handled, managed, and disseminated.
  • Conflicting Interest/Conflict of Interest (COI): An individual involved in research review is automatically considered to have a conflicting interest when the individual or their Relative 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 they cannot be independent. Not all conflicting interests are financial in nature. Even if you do not have a financial conflict, you should address in your IRB submission any circumstances that may impact your ability to be impartial. For more information about types of conflicting interest and how to manage them, see the UO Conflict of Interest webpage or contact COI (COI@uoregon.edu).
  • Continuing Non-Compliance: A pattern of Non-Compliance that, in the judgment of a convened IRB:
    • Indicates a lack of understanding or disregard for the regulations or institutional requirements that protect the rights, safety and/or welfare of participants;
    • Compromises the integrity of a study such that important conclusions can no longer be reached;
    • Suggests a likelihood that noncompliance will continue without intervention; and/or
    • Involves frequent instances of minor noncompliance, for example, repetitive protocol non-compliance or unreviewed deviations that were not needed to address an immediate safety risk.
    • Examples:
      • Generally, persistent failure to adhere to the laws, regulations, or policies governing human research would be regarded as continuing non-compliance. This typically would include (but is not limited to) the following:
      • Repeated failure to respond to requests, directives, or requirements of the IRB
    • Repeated lapses in approval of non-exempt research
    • Noncompliance that continues to occur after IRB discovery of noncompliance and/or implementation of a corrective action plan
  • Continuing Review (CR): A process where the IRB periodically re-evaluates an approved research study to ensure it is still being conducted ethically and in compliance with regulations, including monitoring for any new risks or changes in the study design, and to extend the study's approval period if necessary. The regulations require continuing review annually for greater than minimal risk research, FDA regulated research, and non-exempt research under the pre-2018 common rule. The UO IRB also requires non-regulatory continuing reviews at minimum every five years to ensure an ongoing study remains appropriate and safe for participants. A CR submission type in the RAP can be used to extend or close a study and does not allow for any document changes. See the RCS continuing review webpage for more information.

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D

  • Data Safety Monitoring Board (DSMB): An independent group of experts that monitors research to ensure the safety of participants and the integrity of the study. They are responsible for evaluating adverse events and conducting interim reviews. When a study is funded by the National Institutes of Health (NIH), a DSMB is required for all phase III clinical trials. The NIH and other funders may also require a DMSB for phase I or phase II studies that are greater than minimal risk. The Food and Drug Administration (FDA) also recommends the use of a DSMB if participants are at risk of serious morbidity or mortality (e.g., hospitalization, heart attack, stroke, death) or study products could cause serious unexpected adverse events.
  • Data Management and Sharing Plan (DMS): Effective January 2023, the National Institutes of Health (NIH) requires researchers to submit a plan outlining how scientific data from NIH-funded research will be managed and shared. This plan must be submitted with grant applications for research generating scientific data, and it becomes part of the grant's terms and conditions upon approval. A DMS plan is different from a Data and Safety Monitoring Plan (DSMP). Although there can be some overlap between the two, the DMS focuses on how scientific data will be managed and shared during and after the funded period, while the DSMP focuses on participant safety and data integrity within the study. Visit the NIH website on the Data Management and Sharing Policy for additional information.
  • Data Safety Monitoring Plan (DSMP): A plan to ensure appropriate oversight and monitoring of the conduct of an investigation. All greater than minimal risk studies must have a DSMP either within the research plan or in a separate document.
  • Data Use Agreement (DUA): A legally binding agreement required under the HIPAA Privacy Rule when a covered entity (e.g. hospital or health plan) discloses a limited data set to another party for research, public health, or heath care operations. DUAs may also be required when sending data to or receiving from an external institution when there need to be specific terms associated with the data use and maintenance. The DUA outlines the permitted uses and disclosures of the data and the recipient’s obligations to protect the data. Requests for DUAs and signatures should be routed through Industry, Innovation, and Translation (IIT) but may also sometimes be prepared through Purchasing and Contracting Services (PCS). Researchers should reach out to IIT first (techtran@uoregon.edu). View the UO DUA webpage for more information.
  • Dead fetus: A fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, nor pulsation of the umbilical cord.
  • Debriefing: The process through which participants are given previously undisclosed information about the research project following completion of their participation.
  • Deception: Deception involves intentionally providing inaccurate or false information to subjects. For example, telling participants that they will be interacting with another participant online by playing a game together when they are actually playing against a computer.
    • Incomplete disclosure is another form of deception that involves withholding information about the study purpose and/or details about the study procedures. Incomplete disclosure is often used to minimize the chance of biasing results or priming participants. For example, telling participants that they will be asked to provide information about their perceptions about people based on their photographs but not informing them that researchers are interested in seeing how the race or gender of the person pictured impacts their perceptions.
    • For exemption under category 3, no deception may be used or if deception is used, the participants must be told that they will be kept unaware of or misled regarding the nature or purpose of the research. For example, participants may be informed that they will not be told the purpose of the research until after the study session is completed as long as they are informed of what will occur during the session.
  • De-identified: Refers to data or specimens that was initially associated with identifiers but have been stripped of personally identifiable information.
  • Delivery: Complete separation of the fetus from a pregnant person by expulsion or extraction or any other means.
  • Designated Reviewer: The IRB chair or an Experienced IRB Member designated by the IRB chair to conduct Non-Committee Reviews.
  • Device (FDA): An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
    • (A) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
    • (B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in humans or other animals, or
    • (C) intended to affect the structure or any function of the body of humans or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of humans or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
    • Note: software, applications and Artificial Intelligence (AI) can also sometimes be considered an FDA regulated device when FDA criteria are met.
  • Discard (RAP): A button in the RAP that allows researchers or RCS to remove a study from review. A discarded project can still be viewed and copied to create a new submission but cannot be edited and/or resubmitted. If a researcher would like to pursue a discarded study, they will need to create a separate new study. A project or a follow-on may be discarded by RCS if requested by the researcher (e.g., they no longer want to do the study), if the wrong type of submission was created by mistake (e.g., researcher created a study team member only modification when they actually needed to change other parts of the study), a researcher leaves the UO without completing a submission, and/or if a study has been waiting with a researcher for more than 45 days after clarifications have been requested and RCS received no response to check-in communications. When a researcher does not respond to a request for changes and check in communications, the next step is usually to withdraw the submission rather than discard it. However, if the study continues to remain in the same state unchanged for an extended period of time and no communication is received from the researchers, a submission will eventually be discarded. If researchers find that they cannot make the requested changes within 45 days, they should email the person named in the RAP as your IRB Coordinator or use Add Comment on the submission in the RAP (and check IRB Coordinator in the comment box) to let them know you need more time. RCS will generally send check-in communications via the RAP and/or via email before discarding a study for lack of response.
  • Drug (FDA): A substance that meets one or more of the following criteria:
    • recognized by an official pharmacopoeia or formulary.
    • intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
    • intended to affect the structure or any function of the body (and is not food or a dietary supplement)
    • intended for use as a component of a medicine but not a device or a component, part or accessory of a device.
    • Biological products are included within this definition and are generally covered by the same laws and regulations, but differences exist regarding their manufacturing processes (chemical process versus biological process).

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E

  • Educational Tests: Tests of cognitive, diagnostic, aptitude, or achievement. Examples include the SATs, ACTs, and placement tests to determine if a student should be placed in an advanced or intermediate class.
  • Encrypt: To change information from one form to another in order to hide its meaning. With encryption, words or data are scrambled in a methodical way so that only those with the ability to unscramble it can access the true meaning of the words or data. There are a range of encryption software packages and services available for individuals and organizations that want to better protect their communications and data. Refer to the UO minimum information security controls standard webpage for more details about UO-specific requirements for encryption. Also see the Data Security Resources on the UO Safety Monitoring, Participant Privacy and Confidentiality of Data webpage.
  • Engaged: When an activity or role requires an Institution to provide IRB oversight or enter into a reliance agreement for oversight, that institution is considered “engaged” in the research.
  • Enrolled: A participant counts towards enrollment if they meet the definition of human subject at any point in their involvement.
    • This includes someone who signs the consent document but does not complete the study.
    • It also includes situations when researchers obtain identifiable private information or identifiable biospecimens about or from an individual, even if the researchers do not interact directly with the individual.
    • Example: A potential participant who completes pre-screening prior to consent is not considered enrolled in the research unless the pre-screening data will also be used for research analyses or future research. However, if the pre-screening data will be used for research purposes or if an individual signs a consent form and there is further screening and they screen fail at that point, that participant was enrolled and considered a withdrawal.
    • For flexibility, we recommend that researchers describe how many participants they plan to consent/enroll and how many participants they need to complete all study activities to achieve study aims.
  • Established or commonly accepted educational settings: Settings where specific educational offerings normally take place or a setting where one would go in order to have an educational experience. Examples include K-12 schools and college classrooms, after-school programs, preschools, vocational schools, alternative education programs, professional development seminars, and religious education settings.
  • Exempt Review: Research involving human subjects for which all activities determined to meet at least one of the eight categories established by the US Department of Health & Human Services and adopted by at least 15 other federal department or agencies qualifies for an exempt review process. The determination of “exempt” must be made by RCS.
  • Expedited Review: Research involving human subjects for which all activities determined to meet at least one of the nine categories established by the US Department of Health & Human Services qualifies for an expedited review process. In order to qualify for the expedited review process, the research must also present no more than minimal risk to the participants.
  • Experienced IRB Member: An IRB member is considered experienced if the IRB chair considers the IRB member to have sufficient experience in and knowledge of conducting IRB reviews.
  • Experimental Subject (per DOD): For Department of Defense (DOD) research, research involving an “experimental subject” is 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. Research involving “experimental subjects” is a subset of research involving human participants.
  • Expiration Date: The first date that the protocol is no longer approved. The date after the end date of the approval period. All research activities involving human subjects must stop after IRB approval expires, unless it is determined to be in the best interest of already enrolled subjects to continue participating in the research. Enrollment of new subjects cannot occur after the expiration of IRB approval.

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F

  • Family Educational Rights and Privacy Act (FERPA): A federal law that was enacted to protect the privacy of parents and students and provides guidelines for maintaining the confidentiality of education records for students. It gives parents/caregivers and adult students control over the students’ education records and prevents schools from sharing information without written consent unless certain exceptions are met. FERPA applies to educational agencies/institutions such as elementary schools, middle schools, high schools, and universities that receive federal funds.
    • Note: If research involves access to and/or release/transfer of FERPA protected education records, signed and dated written consent must be obtained before an educational agency or institution discloses personally identifiable information from the student's education records (see 34 CFR 99.3 for FERPA specific definitions). Opt-out or “passive consent” will not fulfill this requirement. It also requires additional details to be included in the consent materials (e.g., specify the records that may be disclosed, purpose of disclosure, parties or class of parties who will have access to the records). See 34 CFR 99.31 for details about FERPA exceptions to consent.
  • Federal Wide Assurance (FWA) or Assurance: Documentation of an institution's commitment to comply with Federal regulations and maintain policies and procedures for the protection of human participants. See OHRP’s FWA website for more information.
  • Fetus: The product of conception from implantation until delivery.
  • Finding of Non-Compliance: Non-Compliance in fact.
  • Focus group: A group of participants convened to discuss a specific topic, conduct an evaluation, or test new ideas.
  • Follow-on Submissions: After a study is approved, there can be several follow-on submissions which change a study, provide additional details or allow a study to continue. Follow-on submissions include MODs, CRs, MODCRs, and RNIs. Each follow-on submission in the RAP gets its own identification number. When that follow-on is approved, the applicable details from that follow-on submission are transferred to the parent study. For example, if a new consent form is added to an approved study via a modification, that new consent form will appear in the parent study once that modification is approved. You can see all follow-on submissions for a project in the RAP by clicking on the Follow-on Submissions tab for the parent study.
  • Food and Drug Administration (FDA): The Food and Drug Administration (FDA) regulates products such as drugs, devices, and biologics. When those products are used in human research, FDA regulations will apply that are different from and in addition to the HHS regulations (e.g., 21 CFR 50, 21 CFR 56, 21 CFR 312, 21 CFR 812).
  • Full Board Review: Research involving human subjects which potentially pose a greater than minimal risk to the participants or involve certain participant populations require review by a fully convened IRB/CPHS. Research that does not qualify under the nine categories established by the US Department of Health & Human Services for expedited review, research involving ionizing radiation and research involving invasive procedures will always require a full board review.
  • Future Research: Refers to the potential use of research data/biospecimens for purposes that may be related or distinct from the original study for which they were collected. The use of data/specimens for future research purposes should be specified in the consent form of the original study and may require additional approval or oversight.

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G

  • Generalizable knowledge: Information that expands the knowledge base of a scientific discipline or other scholarly field of study and yields one or both of the following:
    • Results that are applicable to a larger population beyond the site of data collection or the specific participants studied and/or
    • Results that are intended to be used to develop, test, or support theories, principles and statements of relationships and/or to inform policy beyond the study.
    • Although publications/presentations alone are not always indicative of generalizable knowledge, they are often a means of making research findings available for the development of knowledge beyond the scope of the study.
  • Genetic Characteristic: State of Oregon Definition: Includes a gene, chromosome or alteration thereof that may be tested to determine the existence or risk of a disease, disorder, trait, propensity or syndrome, or to identify an individual or a blood relative. “Genetic characteristic” does not include family history or a genetically transmitted characteristic whose existence or identity is determined other than through a genetic test.
  • Genetic Information: State of Oregon Definition: Information about an individual or the individual’s blood relatives obtained from a genetic test.
  • Genetic Services: Federal Definition: A genetic test, genetic counseling (including obtaining, interpreting, or assessing genetic information), or genetic education.
  • Genetic Test: Federal Definition: An analysis of human DNA, RNA, chromosomes, proteins, or metabolites that detects genotypes, mutations, or chromosomal changes.
    • State of Oregon Definition: A test of determining the presence or absence of genetic characteristics in an individual or the individual’s blood relatives, including tests of nucleic acids, such as DNA, RNA, and mitochondrial DNA, chromosomes or proteins in order to diagnose or determine a genetic characteristic.
  • Guardian: An individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care.

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  • Health and Human Services (HHS): The US government’s principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. The Office for Human Research Protections (OHRP) is housed with HHS and is the office that promulgates and enforces the Common Rule.
  • Health Care Professional (HCP): An individual who is licensed, registered, or certified by a State, territory, or other governing body, to administer health care, including but not limited to, nurse practitioner, registered nurse, licensed practical nurse, clinical social worker, dentist, occupational therapist, pharmacist, physical therapist, physician, physician assistant, psychologist, respiratory therapist, speech-language pathologist, technologist, or any other practitioner or allied health professional.
  • Humanitarian Use Device (HUD): A medical device intended to benefit patients by treating or diagnosing a disease or condition that manifests itself in fewer than 8,000 individuals in the United States per year. The HUD designation provides an incentive for the development of devices for use in the treatment or diagnosis of diseases affecting these populations. The FDA often regulates HUDs through the Humanitarian Device Exemption (HDE) pathway, which allows for marketing approval without the requirement to demonstrate effectiveness through clinical trials, as is typically required for other medical devices. See the FDA Humanitarian Use Device (HUD) Designations website for more information.
  • HIPAA Privacy Rule: The HIPAA Privacy Rule establishes national standards to protect individuals’ medical records and other personal health information. HIPAA applies to health plans, health care clearinghouses, and those health care providers that conduct certain health care transactions electronically. See the RCS HIPAA webpage for more information.
  • Human Research: Any activity that either:
    • Is Research as Defined by DHHS and involves Human Subjects as Defined by DHHS; or
    • Is a Clinical Investigation as Defined by FDA and involves Human Subjects as Defined by FDA.
  • Human Subject/Human Participant: DHHS Definition: Living individual about whom an investigator (whether professional or student) conducting research obtains: (1) information or biospecimens through Intervention or Interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
    • FDA Definition: an individual who is or becomes a participant in research/clinical investigation, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. For devices, a subject is also a human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control.

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  • IDE Exempt: A designation for a clinical investigation involving a device that does not require the submission of an Investigational Device Exemption (IDE) application to the FDA. IDE exempt studies are exempt from a majority of the requirements in 21 CFR 812 but are still considered FDA regulated and must comply with the FDA requirements for IRB review (21 CFR 56) and informed consent (21 CFR 50). A study is IDE exempt when specific criteria outlined in the FDA regulations are met(21 CFR 812.2(c)).
  • Identifiable Biospecimen: Biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
  • Identifiable Data/ Information: Information that by itself, or in combination with other information, could be used by the researchers or another party to identify a participant in the research and/or the participant’s contributions during the research process. For example, legal names, email addresses, and even screen names can be used to identify individuals. Similarly, personal information that is disclosed during research about a person’s identity and/or experiences (e.g. their narrative of a particular event) could also be considered identifiable information. The dataset needs to be considered in its entirety and considered within the context of the study population to determine if it is identifiable. Different regulations may have different standards for what may be considered identifiable information. For example, both HIPAA and FERPA regulations provide a list of specific variables that make data/specimens identifiable. When those regulations are not applicable, UO applies the readily ascertainable standard (i.e., data/specimens are identifiable when the identity of the subject is or may readily be ascertained by the investigator or associated with the information).
  • Identifiable Private Information: Private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information. Also see identifiable data/information above and Protected Health Information.
  • IND Exempt: A designation for a clinical investigation involving a drug product that does not require the submission of an Investigational New Drug (IND) application to the FDA. This exemption applies when specific criteria outlined in the FDA regulations (21 CFR 312.2(b)) are met.
  • Individual Investigator: Researchers who are not working on a project as an employee or agent of the UO or another institution that has a federal wide assurance (FWA) but is Engaged in the human subjects research. Individual investigators may be affiliated with an institution that has an FWA but are doing the research independent from that affiliation or are researchers who are not affiliated with any institution that has an FWA. For more information, see our Collaborations in Research webpage.
  • Individual Investigator Agreement (IIA): A mechanism that allows an institution holding an OHRP-approved Federalwide Assurance (FWA) to extend the applicability of its FWA to cover individual investigators who are not affiliated with the UO or another institution with an FWA. For more information, see our Collaborations in Research webpage.
  • Informed Consent: An active process of sharing information between the investigator and prospective participants that informs them about their rights and what they will experience during the research. The informed consent process involves three key features: (1) disclosing to potential research participants 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 free from coercion and undue influence, legally effective, and prospectively obtained. The procedures used in seeking and obtaining informed consent should be designed to communicate with the participant population in terms that they can understand. Information about a research project must be presented in such a way that enables each person to voluntarily decide whether or not to participate in research. Thus, the information must be conveyed in language understandable to those being asked to participate in the research. For more information, see the RCS informed consent webpage.
  • Institution: Any public or private entity, or department or agency (including federal, state, and other agencies).
  • Institutional Official/ Organizational Official (IO/OO): 
    • Institutional Official (IO): Term utilized by DHHS.
      • The Institutional Official (IO) is the individual who is legally authorized to act for the institution and, on behalf of the institution, obligates the institution to the terms of the Federalwide Assurance (FWA). The IO is responsible for ensuring that the Human Research Protection Program (HRPP) functions effectively and that the institution provides the resources and support necessary to comply with all requirements applicable to research involving human subjects. The IO represents the institution named in the FWA. The IO is designated by the University President. The IO may then delegate scoped authority to the Research Compliance Services Director
    • Organizational Official (OO): Term utilized by AAHRPP.
      • An identified, knowledgeable leader of the HRPP who is responsible for the program and has the authority to implement the program. This individual may rely on others for the interpretation of laws, regulations, codes, and guidance and the day-to-day operations of the HRPP, and should have a basic understanding of the relevant laws, codes, regulations and guidance that govern research involving human participants, the responsibilities of an organizational official, and the responsibilities of the IRB or EC and researchers and research staff in protecting research participants. This individual should be directly involved in the allocation of resources to the HRPP. In some circumstances, more than one individual serves in this capacity.
  • Institutional Profile: A record of information an institution keeps about another collaborating institution/organization for one or more Collaborative or Multi-Site Studies. Creating an institutional profile is the first step in adding another institution into the RAP that could be an IRB of record or a pSite for a collaborative or multi-site study. An institutional profile only needs to be set up once for each institution.
  • Institutional Review Board (IRB): An independent committee that has been formally designated to approve, monitor, and review research involving humans.
  • Interaction: Communication or interpersonal contact between investigator and subject.
  • Interim Findings: Preliminary results or observations from a research study that are reported to the IRB, sponsor, Data and Safety Monitoring Board or regulatory body before the study is fully completed. Interim findings usually provide an update on the progress of the research and identify possible safety concerns or ethical issues that may need to be addressed mid-study.
  • Intervention: Both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
  • Interviews: Information collected about individuals through conversations or discussions. Interviews can be in person, over the phone, or online using platforms such as zoom. They may be audio or video recorded. Interviews can be individual or can include activities such as focus groups.
  • Investigation: A searching inquiry for facts; detailed or careful examination.
  • Investigational Brochure (IB): A comprehensive document prepared by a drug sponsor that provides essential information about the investigational product to investigators participating in clinical trials. It serves as a key resource for understanding the drug's characteristics, potential risks, and how to safely administer it. The IB is not just a summary of available information but also includes details about the investigational product's pharmacology, toxicology, pharmacokinetics, and clinical trial data, both from non-clinical and clinical studies.
  • Investigational device exemption (IDE): A regulatory pathway established by the Food and Drug Administration (FDA) that allows a medical device to be used in a clinical investigation designed to collect safety and effectiveness data about the device. An IDE is required for significant risk devices. With an IDE, manufacturers and researchers can study a medical device in humans even when the device is not yet approved or cleared for marketing or when an approved device is modified or used for a new indication. See the FDA IDE website for more information.
  • Investigational New Drug (IND): A new drug or biologic that is regulated as a drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes. Drugs that require an IND require an Investigational New Drug application to be submitted to the FDA that authorizes researchers to administer a drug to participants during research. If the drugs used in this study do not qualify for an IND exemption, an IND will be required from the FDA. See the FDA IND website for more information.
  • In Vitro Diagnostic (IVD) products: In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. The FDA classifies IVDs are medical devices and may also be biological products in some cases.
  • Ionizing Radiation: Radiation consisting of particles, X-rays, or gamma rays with sufficient energy to liberate electrons from atoms or molecules. Examples of devices/materials that involve ionizing radiation include but are not limited to Computed Tomography (CT) scans, X-rays, Dual-energy C-ray Absorptiometry (DEXA) scans, Positron Emission Tomography (PET) scans, Radio-labeled materials.
  • IRB Authorization Agreement (IAA): A type of reliance agreement between two institutions that are engaged in human subjects research when both institutions have Federal Wide Assurances (FWAs). This agreement allows one institution to extend its FWA to cover another institution. These agreements are intended to minimize the regulatory burden on IRB review as only one IRB will be the IRB of record and the other IRB will rely on the other IRB for a regulatory review.
  • IRB of Record: The IRB conducting the regulatory review and serving as the IRB for a study. This term is most often used in the context of collaborative or multi-site studies where there is more than one site engaged in the research and the IRB of record is serving as the IRB for all of the sites.

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J

  • Justice: The principle in the Belmont Report which refers to the distribution of benefits and burdens to participants in research.
  • Just-in-Time (JIT): A procedure for certain award programs such as the NIHthat allow some elements of the application, such as IRB approval, to be submitted later in the application process after the application is in serious consideration for funding. If your grant application receives a just-in-time notice, you still need to submit a complete IRB submission for review to the IRB if you have not already done so. As soon as you receive the first auto-generated JIT email request and determine that your score is likely to be competitive for an award, you should begin the initial new protocol submission or modification process with the IRB. If your IRB submission’s approval is pending as the JIT submission date approaches, the pending status does not jeopardize your funding opportunity and there is no cause for alarm. Often, informing the funder of the anticipated IRB review date or letting them know that the application is under review is sufficient. If your IRB submission is still under review, inform your Grant Officer, who will then inform the funding agency.

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L

  • Lapse in Approval/Lapsed: A lapse in approval occurs when a research study's IRB approval has expired. This often happens because the investigator did not submit a timely continuing review submission or forgot to close their study when they were done, resulting in the study no longer having active ethical clearance to conduct research activities with human subjects. To minimize the chance of a lapse occurring, researchers should plan to submit a continuing review (CR) submission to either request continuation of their project or to request study closure at least 45 days prior to the study’s expiration date. Researchers will receive reminders in the RAP when their study is coming up for continuing review. The regulations make no provision for any grace period extending conduct of research beyond the expiration date of IRB approval. All research activities involving human subjects must stop after IRB approval expires, unless it is determined to be in the best interests of already enrolled subjects to continue participating in the research. Enrollment of new subjects cannot occur after the expiration of IRB approval.
  • Legally Authorized Representative (LAR): 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 procedures(s) involved in the research.
    • Note: The UO relies on the State of Oregon’s medical definition of LAR for the purposes of research. In the State of Oregon, the following individuals meet this definition (in descending order): competent adults who are appointed to make health care decisions, spouse, adult designated by an authorized parents/guardian (when there is no objection by the parent/guardian), majority of their adult children who can be located, either parent, majority of adult siblings, any adult relative or adult friend.
  • Letter of Acknowledgment (LOA): Similar to IAAs, a letter of acknowledgment (LOA) is a type of reliance agreement between two institutions that are engaged in human subjects research when both institutions have Federal Wide Assurances (FWAs). However, this type of agreement is unique to institutions who use SMART IRB. LOAs are generally paired with a document called an implementation checklists which further describes the terms and responsibilities of each institution.
  • Limited Data Set: A HIPAA specific term that applies to a data set that is HIPAA protected and contains city, state, zip code, age, and/or dates related to the individual (e.g., birth date, date of death, dates of service) but excludes other direct identifiers. Limited data sets generally require a data use agreement (DUA) prior to disclosure.
  • Long-Term Follow-up: The continued monitoring and data collection from research participants even after they have completed the primary intervention phase of a study, allowing researchers to track the long-term effects of the research intervention. Long-term follow-up may include:
    • Research interactions that involve no more than minimal risk to subjects (e.g., quality of life surveys); and
    • Collection of follow-up data from procedures or interventions that would have been done as part of routine clinical practice to monitor a subject for disease progression or recurrence, regardless of whether the procedures or interventions are described in the research protocol.
    • Note: long-term follow-up excludes research interventions that would not have been performed for clinical purposes, even if the research interventions involve no more than minimal risk.

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M

  • 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.
    • In research involving prisoners: Minimal risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.
    • Note: The above definitions refers to the daily life of the average person. If participants experience significant risks in their everyday life, they should not be exposed to greater risks for research and still have the research be considered “minimal risk” (e.g., life or death situations experienced by military service members, law enforcement, and people who engage in high-risk behaviors, severe pain and discomfort caused by pre-existing medical conditions).
  • Mobile Medical Applications (MMAs): Mobile apps that incorporate device software functionality and meet the definition of a device in section 201(h) of the FD&C Act because it is intended to do one or both of the following:
    • To be used as an accessory to a regulated medical device
    • To transform a mobile platform into a regulated medical device.
    • For more information about MMAs, see the FDA MMA website and associated guidance.
  • Modification (MOD) / Amendment: A modification is a submission type in the RAP that allows researchers to make changes to their previously approved materials, procedures, personnel and other details. For non-exempt studies, the IRB is required to review and approve all changes to the research prior to the implementation of those changes with the only exception being changes performed to eliminate apparent immediate hazards to the participants. This includes minor changes that do not impact risk. Changes to previously approved exempt research will also generally require review and approval by RCS before implementing changes with the exception of certain minor changes (e.g., editorial changes, wordsmithing, addition of clarifying questions, deletion of questions, minor changes to recruitment materials). When in doubt about whether a modification is required, researchers should Contact RCS. For more information about modifications, see the RCS Modifying an Existing Protocol webpage.
  • Modification/Continuing Review (MODCR): A submission type in the RAP that combines a modification and a continuing review. Changes submitted at time of continuing review via a MODCR should be limited to minor changes. Making substantial changes at time of continuing review (e.g., adding a greater than minimal risk procedure/test article, adding new sub-study) may result in a lapse in approval and should be avoided whenever possible.
  • Multi-Site Study: A study in which two or more institutions coordinate, with each institution completing all research activities outlined in a specific protocol.

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N

  • Neonate: A newborn (28 days old or younger).
  • Non-Committee Review: Reviews that are not conducted by the fully convened IRB at a board meeting. Non-committee review may include any of the following:
    • Determination of whether an activity is Human Research.
    • Determination of whether Human Research is exempt from regulation.
    • Reviews of non-exempt research using the expedited procedure.
    • Determinations of which subjects can continue in expired research.
    • Concurrence of IRB Chair or designee for non-emergency individual patient/small group expanded access for an unapproved medical device (commonly known as Compassionate Use) or non-emergency individual patient expanded access IND with request for authorization to use alternative IRB review procedures.
  • Non-Compliance: Failure to follow the regulations, the requirements and/or determinations of the IRB.
  • Non-Significant Risk Device (NSR Device): Under FDA regulations a non-significant risk device is a medical device that does not pose a significant risk to the health, safety, or welfare of subjects participating in a clinical study. Unlike significant risk devices, NSR devices do not require the sponsor to submit an Investigational Device Exemption (IDE) application to the FDA before initiating a study. Instead, the Institutional Review Board (IRB) makes the determination of whether a device is NSR, and their approval is sufficient for the study to proceed. An NSR device falls under the Abbreviated IDE requirements.
  • Nonviable Neonate: A neonate after delivery that, although living, is not viable.
  • Normal Educational Practices: The term “normal educational practices” refers to proven instructional techniques or classroom management already in use. Examples of research that would fall under exempt category 1 would be a study to evaluate the use of accepted or revised standardized tests or evaluation of a continuing education program. However, a randomized controlled trial with the control group receiving the “normal educational practice” and the experimental group receiving a new or innovative practice would generally not fall under this exemption. Exempt category 1 includes research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

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  • Package Insert: A comprehensive prescribing information prepared by the drug manufacturer and approved by the U.S. Food and Drug Administration (FDA). This document contains detailed instructions on how to use a particular medication safely and effectively and also includes known side effects, warnings and population specific considerations specific to the drug.
  • Parent: A child's biological or adoptive parent.
  • Parent Study: When a new study is created in the RAP, that new study will become the parent study for the project once approved. Unless it is a study that has migrated into the RAP from the legacy system, the parent study will have a number assigned to it that begins with “STUDY” (e.g., STUDY00000000). This parent study can be modified over time. Once a modification is approved, the parent study information and materials are updated to reflect the most up to date versions approved. Parent studies that are set up to be multi-site/collaborative studies allow researchers and RCS staff to add pSites as well. The parent study describes activities and personnel at the UO and houses documents applicable to the study as a whole (i.e., materials for all sites) or documents that are only used at the UO while the pSite contains materials and information specific to each pSite.
  • Participating Site (pSite): An institution that participates in a Single IRB (sIRB) Study and will rely on the IRB of record. pSites are also a submission type in the RAP that houses reliance agreements and other reliance materials for researchers external to the University of Oregon (UO) that document UO’s willingness to serve as the IRB of record for their site. A pSite only needs to be created when researchers at another site are Engaged in the human subjects research.
  • Permission: The agreement of parent(s) or guardian to the participation of their child or ward in research.
  • Pilot Study: An initial research study created to assess and modify procedure in readying for a subsequent and more complex research project intended to test the viability of proposed research.
  • Pregnancy: The period of time from implantation until delivery. An individual of child-bearing potential shall be assumed to be pregnant if they exhibit any of the pertinent presumptive signs of pregnancy, such as missed menses, until the results of a pregnancy test are negative or until delivery.
  • Premarket Approval (PMA): Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of medical devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. PMA is the most stringent type of device marketing application required by FDA. The applicant must receive FDA approval of its PMA application prior to marketing the device. See the FDA website for more information.
  • Principal Investigator: The primary person responsible forthe design, conduct, execution, and/or reporting of research.
  • 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. Individuals are prisoners if they are in any kind of penal institution, such as a prison, jail, or juvenile offender facility, and their ability to leave the institution is restricted. Prisoners may be convicted felons, or may be untried persons who are detained pending judicial action, for example, arraignment or trial.
  • Privacy: Refers to a person’s desire to control the access of others to themselves.
  • 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, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
  • Protected Heath Information (PHI): Individually identifiable health information transmitted or maintained in any form or medium by a HIPAA covered entity such as a hospital or medical clinic. In order to be PHI, the information must contain one or more of the 18 HIPAA identifiers and health information (e.g., medications, diagnoses, surgeries). See the RCS HIPAA webpage for more information.
  • Protocol: The official procedure or system in place, including standard materials, by which research is conducted.
  • Public Behavior: Behavior that occurs in a public place where there is no expectation of privacy and where no special permission is required to observe others. Public behavior is behavior that can be observed by anyone and observations should not be considered inappropriately intrusive. Behavior in classrooms or other venues that require special permission to access or behavior in restrooms or other venues where there is an expectation of privacy are not considered public behavior.
  • Publicly Available: Data and/or biospecimens that are accessible to anyone in the general public, without the need for special qualifications, permissions, or privileges. Access may be free or provided at a nominal cost. The source may be from a commercial entity if the information can be obtained by members of the general public. Examples include data/biospecimens available for public purchase, searchable online, or available at a library. Data and/or biospecimens that are restricted and require special qualifications to access may not be able to be considered publicly available. Contact RCS to discuss the specifics.
  • Public Health Authority: An agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate.

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R

  • Recipient Investigator: A researcher who wishes to use data/biospecimens stored in a repository for research purposes. Recipient investigators must sign a sharing agreement for the repository and must comply with all requirements of the repository and terms of any usage and/or submittal agreements. Requests by a recipient investigator to access identifiable data and/or biospecimens from any existing research repository requires IRB approval separate from the repository.
  • Related to the Research: A financial interest is Related to the Research when the interest is in:
    • A sponsor of the research;
    • A competitor of the sponsor of the research;
    • A product or service being tested; or
    • A competitor of the product or service being tested.
  • Relative: Any of the following:
    • The spouse, parent, stepparent, child, sibling, stepsibling, son-in-law or daughter-in- law of the public official or candidate;
    • The parent, stepparent, child, sibling, stepsibling, son-in-law or daughter-in-law of the spouse of the public official or candidate;
    • Any individual for whom the public official or candidate has a legal support obligation;
    • Any individual for whom the public official provides benefits arising from the public official’s public employment or from whom the public official receives benefits arising from that individual’s employment; or
    • Any individual from whom the candidate receives benefits arising from that individual’s employment.
  • Reliance Agreement: Reliance agreement is a general term (also called an Authorization Agreement) for an agreement that documents respective authorities, roles, responsibilities, and communication between an institution/organization providing the ethical review (IRB of record) and a participating institution (pSite) relying on the ethical review. They are specific to multi-site/collaborative studies. Reliance agreements can also be between an institution and an individual investigator who is not affiliated with an institution with an FWA when that investigator is engaged in the human subjects research. There are many types of reliance agreements including IAAs, IIAs, and SMART IRB LOAs.
  • Reportable New Information (RNI): Submission type in the RAP that allows researchers to report events such as unanticipated problems involving risk, non-compliance and other reportable events related to the research. Events must be reported promptly. See the RCS Report new Information webpage for more information.
  • Repository: A mechanism to collect, store, use and/or distribute data/biospecimens for future research. Any collection of data and/or human biological materials is considered a repository when there is no explicit plan to destroy the materials when the specific research project that generates the materials ends and data/biospecimens may be reused. Repositories include data banks, tissue banks, and registries.
  • Repository Guardian: A person who has primary control of data/biospecimens and maintenance of a repository. This person may be the Principal Investigator (PI) of a repository or a person delegated by the PI. However, the PI retains ultimate responsibility for the oversight of the repository.
  • Research Administration Portal (RAP): The online submission system for research administration used by the UO for units such as the IRB, IACUC, and COI. See the OVPRI RAP webpage and IRB specific RAP guidance for more information.
  • Research as Defined by DHHS: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. For examples of exceptions, see 45 CFR 46.102(l)(1-4).
  • Research Compliance Services (RCS): The office at the University of Oregon which supports and protects the interests of the University, faculty, staff, students and human research subjects in research compliance matters through guidance, education, and technical assistance.
  • Respect for Persons: The principle from the Belmont Report incorporating at least two ethical convictions: first, that individuals should be treated as autonomous agents and second, that persons with diminished autonomy are entitled to protection.
  • 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 research.

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S

  • Secondary Research: Research with biospecimens and/or data that was initially collected for purposes other than the planned research. The biospecimens/data might have initially been collected for non-research purposes (for example, as part of routine clinical care) or as part a different research protocol.
  • Serious Non-Compliance: Non-Compliance, including behavior, action or omission in the conduct or oversight of human research may be considered serious non-compliance in the judgment of the convened IRB based on the following principles if there was:
    • An effect on rights, safety and/or welfare of participants;
    • Harm or potentially increased risk of harm to a research participant(s) or others
    • Compromise in the integrity or validity of the research and/or
    • Intentional, reckless or knowing misconduct on the part of the researcher(s)
    • Examples: Generally, failure to adhere to the laws, regulations, or policies governing human research would be regarded as serious non-compliance. This typically would include (but is not limited to) the following:
    • Conducting research without appropriate IRB approval,
    • Conducting research without appropriate informed consent,
    • Implementing changes to IRB approved research without IRB approval (except those necessary to address an immediate safety risk to one or more human subjects) and/or
    • Enrolling participants who fall outside inclusion/exclusion criteria without appropriate notification/approval by the IRB
    • For Department of Defense (DOD) research Serious Non-Compliance includes failure of a person, group, or institution to act in accordance with Department of Defense (DOD) Instruction 3216.02 and its references such that the failure could adversely affect the rights, safety, or welfare of a human subject; place a human subject at increased risk of harm; cause harm to a human subject; affect a human subject’s willingness to participate in research; or damage or compromise the scientific integrity of research data.
  • Sharing Agreement for Repositories: An agreement made between researchers requesting data/biospecimens from a repository (recipient investigator) and the repository guardian or PI that acknowledges the conditions for use of the data/biospecimens. It ensures recipient investigators are aware of and agree to comply with ethical standards, consent limitations, and privacy regulations (like HIPAA) by outlining permitted use, security requirements, and other restrictions/requirements.
  • Significant Risk Device (SR Device): Under FDA regulations a significant risk device is a medical device that presents a potential for serious risk to the health, safety, or welfare of a subject. These devices often involve implants, devices that support or sustain human life, or are substantially important in diagnosing, curing, mitigating, or treating disease. Studies involving significant risk devices require an IDE from the FDA and Institutional Review Board (IRB) approval before clinical investigation can begin.
  • Single IRB (sIRB): Study A study in which two or more institutions (participating sites, or pSites) coordinate to complete the research activities, but all institutions rely on a single institution’s/organization’s IRB for ethical review. The reviewing IRB (also called the IRB of record) may or may not be affiliated with any of the pSites. sIRB is mandated for federally funded studies.
  • Smartform: Within the RAP, the smartform is the series of questions built into the RAP that you complete when creating a new study or when creating a follow-on submission. The smartform will branch based on your answers and may present additional questions if needed. Additional documents may also need to be uploaded into the smartform to provide the IRB with a complete submission. The smartform is what you see when you click View Study or Edit study or View Modification/CR or Edit Modification/CR etc. in the RAP.
  • SMART IRB: A platform designed to ease common challenges associated with initiating multisite research and to provide a roadmap for institutions to implement the sIRB mandate for federally funded research. Participating institutions using SMART IRB have agreed to certain terms for collaborative/multi-site research. Institutions using SMART IRB can either use the SMART IRB Online Reliance System or they can choose to draft and sign a SMART IRB Letter of Acknowledgment (LOA). Institutions using the SMART IRB Online Reliance System or SMART IRB LOA do not also need an IAA.
  • Submittal Agreement for Repositories: An agreement made between researchers submitting data/biospecimens into a repository and the repository guardian or PI that attests that data and/or biospecimens collected were obtained with written informed consent of the donor-subjects utilizing an informed consent document approved by the local IRB or under an IRB Approved waiver of informed consent. Submittal agreements also include information about requirements or limitations associated with the use of the data/biospecimens
  • Surveys: Information collected about individuals through questionnaires or similar procedures
  • Suspension of IRB: An action of the IRB, IRB designee, Institutional Official/Organizational Official, or designee of the Institutional Official/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. However, researchers cannot conduct any research activities involving human subjects until the suspension is lifted.
  • Systematic: Having or involving a system, method, or plan.

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  • Termination of IRB Approval: An action of the IRB, IRB designee, Institutional Official/Organizational Official, or designee of the Institutional Official/Organizational Official to permanently withdraw IRB approval of all research procedures. Terminated studies are permanently closed and no longer require continuing review. Unless otherwise documented, an administrative closure issued by the UO RCS/IRB office is not the same as a termination of IRB approval.
  • Test Article: Any drug (including a biological product), and/or medical device for human use, human food additive, color additive, electronic product, or any other article subject to FDA regulations under the act or under sections 351 and 354-360F of the Public Health Service Act (42 U.S.C. 262 and 263b-263n).
  • Therapeutic Misconception: The tendency to view experimental research procedures and test articles as effective methods/treatments that will directly benefit research subjects/participants. Therapeutic misconception can make it difficult to get meaningful consent from subjects/participants as they may have unreasonable expectations of the research. This could include expecting benefits of the research that are unrealistic, falsely assuming they are receiving safe and/or effective treatment or other effects from the experimental research that are not known, and the possibility of unreasonably discounting the research risks of harm.

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  • Unanticipated Adverse Device Effects: Any serious adverse effect on health or safety, 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 application; or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects. The sponsor must report the results of an evaluation of an unanticipated adverse device effect to FDA, all reviewing IRBs and investigators within 10 working days after the sponsor first receives notice of the adverse effect.
  • Unanticipated Problem Involving Risks to Subjects or Others: Any incident, experience or outcome that is (1) unanticipated, (2) related to the research, and (3) indicates that subjects or others are at increased risk of harm.
    • For Department of Defense (DOD) research the term Unanticipated Problem Involving Risks to Subjects or Others includes any incident, experience, or outcome that meets ALL three of the following conditions:
    • Is unexpected (in terms of nature, severity, or frequency) given the procedures described in the research protocol documents (e.g., the IRB- approved research protocol and informed consent document) and the characteristics of the human subject population being studied.
    • Is related or possibly related to participation in the research (in this Instruction, possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research).
    • Suggests that the research places human subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized, even if no harm has actually occurred.
  • Undue influence: An act that includes an excessive or inappropriate persuasion, authority, reward or other overture to pressure an individual to participate in research. Undue influence may be unintentional and result from a power differential between the investigator and the potential participants (e.g., Employers targeting own employees as participants and employees feel like they cannot say no to the research without repercussions, Offering college students $100 each to complete a 20-minute survey on illegal drug and alcohol use could also be viewed as unduly influential because the amount could entice students to disclose information that they would not otherwise willfully disclose). See also coercion.

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  • Viable: As it pertains to the neonate, means being able, after delivery, to survive (given the benefit of available medical therapy) to the point of independently maintaining heartbeat and respiration.
  • Vulnerable populations: People who are more likely to be susceptible to coercion or undue influence, such as children, prisoners, pregnant persons, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons. Vulnerable populations may also be susceptible to increased harm due to pregnancy or medical conditions.
  • Voluntary: Free of coercion, duress, or undue inducement.

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  • Waiver of Consent: When certain criteria are met, the IRB may approve research involving human subjects without any informed consent process or documentation. The criteria that must be met for a waiver of informed consent include:
    • (i) The research involves no more than minimal risk to the subjects;
      (ii) The research could not practicably be carried out without the waiver (i.e., research could not be done with informed consent);
      (iii) If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;
      (iv) The waiver will not adversely affect the rights and welfare of the subjects; and
      (v) Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.
    • All criteria must be met and the waiver approved by the IRB before non-exempt research can be conducted without informed consent. Passive consent procedures must also meet all waiver of consent criteria to be approved. See the RCS informed consent webpage for more information.
  • Waiver of Documentation of Consent: When certain criteria are met, the IRB may approve research involving human subjects with an informed consent process that does not involve documenting consent with a signed informed consent document. This is a waiver of the signature requirement only. A non-exempt study with a waiver of documentation of consent still has a consent process where participants are provided with consent details that contain all elements of consent, but participant consent is provided verbally or by other means other than a signed consent form. There are several different ways of getting a waiver of consent documentation. The waiver must be approved by the IRB before non-exempt research can be conducted without signed informed consent. See the RCS informed consent webpage for more information.
  • Withdraw/withdrawal (participant): Participants must be free to leave a study at any time without penalty or negative consequences. When a participant decides to withdraw from all components of a research study, researchers must discontinue research activities involving the participant's participation including
    • Interacting or intervening with the participant in order to obtain additional data and/or biospecimens for the research study
    • Obtaining additional identifiable private information about or identifiable biospecimens related to the participant from any source.
    • Obtaining additional identifiable private information about the participant by observing or recording their private behavior.
    • When a participant withdraws, researchers may ask the participant if they would like to withdraw from theintervention but still continue with other research activities (e.g., follow-up interviews, obtain data from medical records or other sources. Continued participation in secondary components of a research study may be particularly important in clinical trials designed to evaluate the safety and effectiveness of specific interventions in the management of diseases or disorders. For this reason, OHRP guidance on this topic recommends that the investigators conducting the clinical trial should ask the withdrawing participant to clarify whether they wish to withdraw from all components of the trial or only from the primary interventional component of the trial and their wishes should determine if follow-up is still okay.
    • Investigators can retain and analyze data collected prior to withdrawal, provided such analysis falls within the scope of the analysis described in the IRB-approved protocol and consent form. For research not subject to FDA regulations, investigators can choose to honor a research participant's request that the investigator exclude the participant's data from any analysis. However, for FDA regulated research, the data collected on the participant to the point of withdrawal remains part of the study database and may not be removed.
  • Withdraw (RAP): A button in the RAP that allows researchers or RCS to put a study back in the pre-submission phase of review. A withdrawn project can be edited by the researchers and resubmitted again. A submission may be withdrawn if it is incomplete upon submission (e.g., missing a key document needed before the review can begin), if there is no faculty advisor on a student led project, or if a study has been waiting with a researcher for 45 days after clarifications have been requested and RCS received no response to their communications. If researchers find that they cannot make the requested changes within 45 days, they should email the person named in the RAP as the IRB Coordinator or use Add Comment on your submission in the RAP (and check IRB Coordinator in the comment box) to let them know more time is needed. RCS will generally send check-in communications via the RAP and/or via email before withdrawing a study for lack of response.
  • Written, or In Writing: Written, or in writing, refers to writing on a tangible medium (e.g., paper) or in an electronic format.

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