ORAHS 2.0 DEFINITIONS
Below are definitions and examples of commonly used terms for research involving human subjects at UCSB.
Benign behavioral intervention – means interventions (not biomedical) in conjunction with collecting information from an adult subject through oral or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the interventions and information collection and certain conditions are met. Benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the participants, and the investigator has no reason to think the participants will find the interventions offensive or embarrassing.
Examples of benign behavioral interventions:
- A study involving adult subjects playing an online game
- A study involving having adult subjects allocate resources (e.g., cash) between themselves and someone else
Click here for more examples of benign behavioral interventions.
Clinical trial – means a research study that involves (1) human participants; (2) one or more of those human subjects are prospectively assigned to one or more interventions (which may include placebo or other control); (3) the purpose is to evaluate the effects of the interventions on the participants; and (4) the effect will be evaluated on biomedical or behavioral health-related outcomes. If a study meets all 4 criteria above, then the research would be considered a clinical trial by NIH.
Coercion – a threat to violate someone else’s rights or to fail to satisfy an obligation to someone in order to obtain compliance in situations where that person has no reasonable alternative but to comply and could affect the ability to make an informed decision about participating in the research.
Collaboration – when two or more individuals or institutions are considered engaged in human subjects research through interaction or intervention with human research participants, or handling identifiable private information or identifiable biospecimens.
Engagement in research – a term used in the federal regulations to determine whether IRB oversight is required for a site or personnel participating in a human subjects research study or project. Individuals may be considered engaged in the research if they have contact or interaction with research participants or identifiable private information or identifiable biospecimens.
Federalwide Assurance (FWA) – a formal, written, binding attestation in which an institution assures the Department of Health and Human Services (DHHS) that it will comply with applicable regulations governing research with human subjects.
Generalizable knowledge - is a conclusion, facts, or principles derived from particulars (individual subjects, medical records, etc.) that are applicable to or affect a whole category (such as members of a class, kind, group, a field of knowledge, etc.) and are intended for dissemination in the public domain, typically through publication.
Health Insurance Portability and Accountability Act (HIPAA) – regulates the protection of private health information for individuals. HIPAA’s Privacy Rule sets standards for the use and disclosure of Protected Health Information (PHI) obtained from a Covered Entity.
Human Subjects - means a living individual about whom an investigator (whether professional or student) conducting research:
(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
(2) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens (45 CFR 46.102(e)(1))
Interaction - includes communication or interpersonal contact between an investigator and subject (45 CFR 46.102(e)(3)).
Intervention - includes 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 (45 CFR 46.102(e)(2)).
Identifiable Biospecimen - is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen (45 CFR 46.102(e)(6)).
Identifiable private information - is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information (45 CFR 46.102(e)(5)).
Institutional Review Board (IRB) - a committee established to review and approve research involving human subjects. The purpose of the IRB is to ensure that all human subject research be conducted in accordance with all federal, institutional, and ethical guidelines. At UCSB, the IRB is referred to as the Human Subjects Committee (HSC).
IRB Authorization Agreement (IAA) – a formal, written agreement in which the reviewing IRB agrees to serve as the IRB of record for a relying institution. Agreements are generally used to cover a single research study, categories of research studies, or all human subjects research under an organization’s Federalwide Assurance (FWA). If an IRB Authorization Agreement is needed, the UCSB Human Subjects Program facilitates the process of initiating such agreements.
IRB of Record – a reviewing IRB that assumes IRB responsibilities for another institution (as known as the Reviewing IRB).
Legally Authorized Representative – an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research (45 CFR 46.102(i)).
Minimal Risk – the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (45 CFR 46.102(j)).
Multisite Research – a multisite project is a project that is being conducted at one or more sites other than the site at UCSB with a Principal Investigator (PI) who is not the same as the PI at UCSB. All multisite research projects should be reviewed to determine whether sites or personnel are engaged in the research, and if so, how IRB oversight will be determined.
Personal Identifiers – includes 18 identifiers that can be used to identify, contact, or locate a single person or can be used with other sources to identify a single individual:
- Address (all geographic subdivisions smaller than state, including street address, city county, and zip code)
- All elements (except years) of dates related to an individual (including birthdate, admission date, discharge date, date of death, and exact age if over 89)
- Telephone numbers
- Fax number
- Email address
- Social Security Number
- Medical record number
- Health plan beneficiary number
- Account number
- Certificate or license number
- Any vehicle or other device serial number
- Web URL
- Internet Protocol (IP) Address
- Finger or voice print
- Photographic image - Photographic images are not limited to images of the face.
- Any other characteristic that could uniquely identify the individual
There are also additional standards and criteria to protect individual's privacy from re-identification. Any code used to replace the identifiers in datasets cannot be derived from any information related to the individual and the master codes, nor can the method to derive the codes be disclosed. For example, a subject's initials cannot be used to code their data because the initials are derived from their name. Additionally, the researcher must not have actual knowledge that the research subject could be re-identified from the remaining identifiers in the PHI used in the research study. In other words, the information would still be considered identifiable is there was a way to identify the individual even though all of the 18 identifiers were removed.
Personally Identifiable Information (PII) – also referred to as sensitive personal information (SPI), is information that can be used on its own or with other information to identify, contact, or locate an single person, or to identify an individual in context. Under the Health Insurance Portability and Accountability Act (HIPAA), there are 18 identifiers that are considered personally identifiable information.
Private Information - includes 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) (45 CFR 46.102(e)(4)).
Protected Health Information (PHI) – includes under US law, any information about health status that is created or collected by a “Covered Entity” (or Business Associated of a Covered Entity) and can be linked to a specific individual. When personally identifiable information is used in conjunction with one’s physical or mental health or condition, health care, or one’s payment for that health care, it becomes Protected Health Information (PHI).
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.
Research - means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102(l)).
Relying IRB – a relying IRB or organization that cedes IRB responsibilities to the Reviewing IRB.
Reviewing IRB – a reviewing IRB is the IRB that serves as the IRB of record and makes any required regulatory determinations (also called the IRB of Record).
Secondary research - the reuse of identifiable private information and/or identifiable biospecimens that are collected for some other primary or initial purpose.
Systematic investigation - is a study or examination involving a methodical procedure or plan.
Undue influence – an offer to provide an excessive reward, or influence by which a person is induced to act otherwise than by their free will, affecting the ability to make an informed decision about participating in the research.
Information Sheet – consent form that accurately explains the procedures and potential risks, but may leave out one of the required element of informed consent OR is a consent form used for an online study that is not collecting physical signed forms.
Full Waiver of Consent - waive all elements of informed consent; no consent process.
Partial Waiver of Consent - alter one or more of the required elements of informed consent.
Waiver of Consent - waive the requirement for obtaining informed consent or parental permission or to approve a consent procedure that leaves out or alters some or all of the elements of informed consent otherwise required under the regulations (45 CFR 46.116).
Examples of situations when a waiver of consent may be requested:
- A study involving decision-making games in which subjects were led to believe that they were interacting with another student in another room, but were actually interacting with a computer programmed to provide consistent responses to all subjects.
- Subjects may be told that a study is about perception of visual phenomenon, when in fact it is about susceptibility to peer pressure from the researcher's confederates.
- A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team.
Waiver of Written Documentation - potential participants are presented (either verbally or in writing) with the same information required in a written consent document, but documentation of the process (signing of the consent form) has been waived by the IRB (45 CFR 46.117).
Examples of waiver of written documentation:
- Administration of telephone interviews or online or mailed surveys when signed consent forms are not practicable and the research presents no more than minimal risk.
- A study involving undocumented immigrants and the signed consent forms could place the participants at risk to privacy or confidentiality and are the only record linking the identity of the subjects to the research.
- A study involving participants where signed consent is not the normal cultural practice.
Anonymous – anonymous means there are no identifiers that can be linked between a participant and the data collected as part of the research.
Confidentiality – confidentiality is an extension of the concept of privacy; it refers to the participant’s understanding of, and agreement to, the ways identifiable information will be collected, stored and shared. Identifiable information can be in printed, electronic, visual (photographs or video), and audio formats.
Prisoners - means 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 statue, 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.
Privacy – privacy refers to the ability of a participant to control how other individuals see, touch, or obtain information about the participant, such as the disclosure of personal or identifiable information.
Publicly available contacts – contact information that is generally accessible to the interested public in any form.
Third party recruiter – a neutral agency, organization, or individual aiding in the recruitment of participants for human subjects research studies.
Examples of third party recruiters:
- Professional or commercial entities hired to recruit volunteers (e.g., Critical Mix, YouGov, Amazon Mechanical Turk, Turk Prime, NORC).
- Research participants who tells friends, acquaintances, or others about a research study (i.e., snowball sampling).
- School administrators, physicians, nurses, or other service providers who agree to act on behalf of the researchers by providing recruitment information to potential participants.
Wards of the State - someone placed under the protection of a legal guardian. A court may take responsibility for the legal protection of an individual, usually either a child or incapacitated person.
Deception – the act of making someone believe something that is not true.
Active Deception - active deception occurs when an investigator gives false information to subjects or intentionally misleads them about some key aspect of the research.
Examples of active deception:
- The subject is given a "cover story" which falsely describes the purpose of the study, but provides a feasible account of the researcher's objective.
- Participants complete a quiz and are falsely told that they did poorly, regardless of their performance.
- The study includes a "confederate," an individual who poses as a participant, but whose behavior in the study is actually part of the researcher's experimental design.
Incomplete Disclosure - incomplete disclosure occurs when an investigator withholds information about the specific purpose, nature, or other aspect of the research. (Withholding information may or may not be considered active deception)
Examples of incomplete disclosure:
- Participants are asked to take a quiz for research, but they are not told the research question involves how background noise affects their ability to concentrate.
- Participants are told that they are participating in a study about environmental attitudes, but they are not told that the study will test the effectiveness of different types of persuasive messages on attitude change.
- Participants are told they are completing a survey to evaluate customer service when the true purpose of the study is to correlate psychological responses with patient care satisfaction.
Disposition - in human subjects research this means what is being done with the data. Will identifiers, either directly or indirectly, be stripped? How and where will data (e.g., notes, photos, audio, video recordings, etc.) be stored and protected, who will have access, will data be shared with others and in what form, and what will be done with the data (e.g., is it being kept indefinitely, used in future research, or will it be destroyed, when?).
Local Ethical Review – review of proposed research by a local IRB, local review body equivalent to the IRB, or if no such body exists, from a local community leader, stakeholder, colleague or expert who can attest to the host country standards for conducting human subjects research.
Review and Submission Types:
Blanket protocol – a protocol in which preliminary IRB approval is being requested, however the project lacks immediate plans for involvement of human subjects, their data and/or specimen use and a specific protocol has not been developed. No work with human subjects, including recruitment, consent, and data collection may be conducted under a blanket submission. A Blanket submission must describe the intent of the research/project and may only be selected if it falls under one of the following criteria:
Blanket In Concept Only – should only be selected when there is an intent or plan to use human subjects in research, but the research methodologies have not been fully developed and a protocol must be in place in order to release funding. This type of submission should only be selected when release of funding is dependent upon IRB approval. Sponsored Projects should verify that a blanket protocol is allowable under the award before creating a protocol in ORahs. Note: Some funding agencies do not accept blanket protocol approvals.
Blanket Subject Pool – should only be selected for creating prescreening tools for new subject pools or maintaining already existing pools for a given department. A Subject Pool is a pool of students from lower division courses who participate in human subjects research as part of their educational experience. This type of submission is for department pre-screening procedures and is not project specific. This type of submission must include a consent process for collecting and storing data for pre-screening purposes.
Exempt – human subjects research that may be considered exempt from the Federal Policy for the Protection of Human Subjects and fall under (1) of (8) categories of research under 45 CFR 46.104(b). Exempt research is considered human subjects research and does require IRB review.
Expedited – research activities that present (1) no more than minimal risk to the human subjects, and (2) involve only procedures listed in one or more of the categories under 45 CFR 46.110.
Full Board – research activities that are greater than minimal risk are reviewed during a convened meeting of the entire IRB.
ORahs – Office of Research application for human subjects.
ORBiT – Office of Research web application used to track proposals and awards.