Below are definitions and examples of commonly used terms for research involving human subjects at UCSB.
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,
- Participants who don’t know they are in a research study are observed to see how they behave when they find valuables (e.g., wallet, laptop) unattended in a public location,
- 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.
Administrative – Role in ORahs. UCSB personnel (staff only). Role has read-only access to ORahs and can view all ORahs submissions associated with their department and are authorized to receive all automated email communications on behalf of their department.
Adverse event – Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research. Adverse events may by physical or psychological in nature (for example, severe anxiety or psychological distress).
Anonymous – Anonymous data collection means that no identifiable information (e.g., name, address, student ID number, email address, phone number, etc.) is connected to the data either directly or through a coding system at any point in the study. In addition to videotapes and photographs.
Assent – The agreement to participate in a research study given by a child or an adult who lacks full decision-making capacity or authority to give legally valid informed consent. In the absence of affirmative agreement, failure to object should not be construed as assent.
Associate – Role in ORahs. Student (post-doc, graduate, and undergraduate) students; may also include other individuals who are required to have a faculty advisor on the project (e.g., extra campus users). Associate cannot directly submit protocols to the HSC. The faculty advisor (i.e. “researcher” role) assigns the role of the “associate” to the student investigator under their faculty advisor’s researcher account.
Autonomy – Personal capacity to consider alternatives, make choices, and act without undue influence or interference of others.
Belmont Report – A statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in 1978.
Beneficence – An ethical principle discussed in the Belmont Report that entails an obligation to protect persons from harm. The principle of beneficence can be expressed in two general rules: (1) do not harm; and (2) protect from harm by maximizing possible benefits and minimizing possible risks of harm.
Benefit – A valued or desired outcome; an advantage. Note: Compensation or payment for participation in research is not considered to be a benefit of the research.
Benign behavioral intervention – 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 subjects playing an online game
- A study involving having subjects allocate resources (e.g., cash) between themselves and someone else
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 Repository/Storage – should only be selected when there are no definitive research plans and data is being collected as part of routine clinical practices and permission is being requested from patients and/or clients to store their data for potential future research. This type of submission must include a consent process for collecting and storing data for future research. This type of submission is not project specific. A separate protocol will need to be submitted for the use of data collected under this blanket submission.
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.
Clinical trial – 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 – An overt or implicit threat of harm/negative consequences or reprisal is intentionally presented by one person to another in order to obtain compliance.
Coded data set – Data that has been stripped of identifiers (such as name or social security number) and assigned an identity code (e.g., a random generated number) which is associated with and unique to each specific individual; and a key to decipher the code exists, enabling linkage of the data to personal identifiers. The identity code should not offer any clue as to the identity of an individual.
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.
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.
Continuing noncompliance (serious or non-serious) – A pattern of noncompliance (whether intentional or unintentional) that has been previously reported to the IRB, or a pattern of ongoing activities that indicate an inability, or unwillingness to comply with applicable requirements federal regulations, state or local laws, special conditions or the requirements or determinations of the IRB, or lack of understanding of human subjects protection requirements that may affect research participants or the validity of the research and suggest the potential for future noncompliance without intervention.
Deception – When an investigator gives false information to subjects or intentionally misleads them about some key aspect of the research. The action of deceiving someone.
De-identified data – Data that has been stripped of all elements (including but not limited to personal identifiers and codes with subsequent key codes) that might enable a reasonably informed and determined person to deduce the identity of an individual.
De-identified data under HIPAA – A record in which identifying information has been removed to render the health information not subject to HIPAA rules.
Information must be de-identified using either of the following methods (1) by removing all 18 identifiers that could be used to identify an individual or an individual’s relatives, employers, or household members or (2) by using statistical methods to establish de-identification.
A covered entity may assign a code or other means of record identification to allow de-identified information to be re-identified if needed; however, the code must not be derived from, or related to the removed identifiers and only the covered entity can have the re-linking information.
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?).
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.
Equitable – Fair or just; used in the context of selection of subjects to indicate that the benefits and burdens of research are fairly distributed.
Exempt – Human subjects research that may be considered exempt from the Federal Policy for the Protection of Human Subjects and fall under (1) of (6) categories of research under 45 CFR 46.104(d). Exempt research is still 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.
Experimental Subject’s Bill of Rights – A list of the rights described in California Health & Safety Code, Sections 24172 and 24173, that must be offered to all subjects of medical experimentation. This list of rights must be written in a language in which the subject is fluent.
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.
Full Board – Research activities that are greater than minimal risk are reviewed during a convened meeting of the entire IRB.
Full Waiver of Consent – Waive all elements of informed consent; no consent process.
Generalizable knowledge – 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 – A living individual about whom an investigator (whether professional or student) conducting research:
- Obtains information or biospecimens through intervention or interaction with the individual and uses studies, or analyzes the information or biospecimens; or
- Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. (45 CFR 46.102)
Identifiable information – information that can be linked to a specific individual either directly or indirectly through coding systems, or when characteristics of the information are such that by their nature a reasonably knowledgeable and determined person could ascertain the identities of individuals.
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 (45 CFR 46.102).
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.
Example of incomplete disclosure that is also deception:
- The study involves audiotaping or videotaping of subjects without their knowledge or prior consent
Information Sheet – A 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.
Informed Consent – A person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, and the institution or agents thereof from liability for negligence.
Interaction – Includes communication or interpersonal contact between an investigator or subject (45 CFR 46.102).
Intervention – Includes both physical procedures by which data are gathered (for example venipuncture) and manipulations of the subject or subject’s environment that are performed for research purposes (45 CFR 46.102).
IRB – Institutional review board, is 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 of Record – A reviewing IRB that assumes IRB responsibilities for another institution (as known as the Reviewing IRB).
Justice – An ethical principle discussed in the Belmont Report requiring fairness in distribution of burdens and benefits; often expressed in terms of treating persons of similar circumstances or characteristics similarly.
Legally Authorized Representative – 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).
Limited data set – Protected Health Information (PHI) that excludes 16 categories of direct identifiers outlined by HIPAA and may be used or disclosed, for the purposes of research, public health, or health care operations, without obtaining either an individual’s Authorization or waiver or an alteration of Authorization for its use and disclosure, with a data use agreement. All the following identifiers must be removed in order for health information to be a “limited data set”:
- street addresses (other than town, city, state and zip code);
- telephone numbers;
- fax numbers;
- e-mail addresses;
- Social Security numbers;
- medical records numbers;
- health plan beneficiary numbers;
- account numbers;
- certificate license numbers;
- vehicle identifiers and serial numbers, including license plates;
- device identifiers and serial numbers;
- IP address numbers;
- biometric identifiers (including finger and voice prints); and
- full face photos (or comparable images).
The health information that may remain in the information disclosed includes:
- dates such as admission, discharge, service, DOB, DOD;
- city, state, five digit or more zip code; and
- ages in years, months or days or hours.
It is important to note that this information is still protected health information or “PHI” under HIPAA. It is not de-identified information and is still subject to the requirements of the Privacy Regulations.
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.
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).
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.
Noncompliance – A failure (intentional or unintentional) to comply with applicable federal regulations, state or local laws, special conditions or the requirements or determinations of the IRB, or university policy regarding research involving human subjects. Noncompliance can result from action or omission and it may be non-serious (minor) or serious and/or it may be continuing.
Non-serious (minor) noncompliance – The noncompliance does not increase the risk to research participants or others, nor does the noncompliance compromise the participants’ rights or welfare, or affect the integrity of the research/data or the human research protection program or the University.
ORBiT – Office of Research web application used to track proposals and awards.
ORahs – Office of Research application for human subjects used to submit human subjects research protocols.
Partial Waiver of Consent – Alter one or more of the required elements of informed consent.
Possibly related to the research – A reasonable possibility that the problem, event, incident, experience or outcome may have been caused by the procedures involved in the research.
Pregnant woman – A woman who is in a state of pregnancy. A woman shall be assumed to be pregnant if she exhibits any presumptive sign of pregnancy such as missed menses or a positive pregnancy test. This “assumption” may be in error, but, for research purposes, investigators would presume that a living fetus was present until there is clear evidence to the contrary.
Prisoners – 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.
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 which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. (45 CFR 46.102) In general, private information is considered to be individually identifiable when it can be linked to specific individuals by the investigator(s) either directly or indirectly through coding systems, or when characteristics of the information obtained are such that by their nature a reasonably knowledgeable person could ascertain the identities of the individuals.
Protocol deviation – An unapproved change, deviation, or departure from the study design or approved procedures and are under the investigator’s control and have not been reviewed and approved by the IRB. Protocol deviations are divided into two categories: non-serious (minor) noncompliance, or serious noncompliance. Noncompliance may also be continuing.
Proxy – Typically UCSB personnel (staff only). This role is authorized to draft and submit human subjects protocols to a faculty advisor (i.e. “researcher” role). The “proxy” role is assigned under the “researcher” role account and the “proxy” role must be added to each individual protocol. The “researcher” is responsible for all “proxy” actions and the HSC considers any action taken by the “proxy” to be taken and approved by the “researcher.” The "proxy" role is able to access only specific protocols they have been assigned to.
Publicly available contacts – Contact information that is generally accessible to the interested public in any form.
Research – A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102).
Researcher – Only faculty, professional researchers, or certain staff may be assigned role. HSC assists with assigning this role.
Respect for Persons – An ethical principle discussed in the Belmont Report requiring that individual autonomy be respected and that persons with diminished autonomy be protected.
Restricted Use Data – Certain agencies and research organizations release files to researchers with specific restrictions regarding their use and storage. The records frequently contain identifiers or extensive variables that combined might enable identification, even though this is not the intent of the researcher. Research using these data sets often requires non-exempt level review, per the data holder’s request.
Risk – The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both magnitude of possible harm may vary from minimal to significant.
Risk/benefit ratio – The risk to a participant versus the potential benefits; the risk/benefit ratio differs depending on the nature of the research. The principle of beneficence requires a systematic assessment of all possible harms, including physical, psychological, social, and economic. The principle of beneficence requires both protecting participants against risk of harm and consideration of not only the benefits for the participant, but also the societal benefits that might be gained from the research.
Secondary research – The reuse of identifiable private information and/or identifiable biospecimens that are collected for some other primary or initial purpose.
Serious noncompliance – A failure (intentional or unintentional) to follow state or federal regulations or University policies or determinations of the IRB for the protections of the rights and welfare of study participants and that, in the judgment of the IRB, results in, or indicates a potential for (a) an increased risk to enrolled or potential participants or others, or (b) compromises the participants’ rights or welfare, or (c) affects the integrity of the research/data or the human research protection program or the University.
Systematic investigation – A study or examination involving a methodical procedure or plan.
Surrogate consent – Consent obtained from a legally authorized representative on behalf of a participant determined to lack decision-making capacity. AB 2328, codified as California Health & Safety Code Section 24178 and effective January 1, 2003, clarifies who may serve as a research subject’s “legally authorized representative”, referenced in 45 CFR 46 and therefore authorized under those federal regulations to provide surrogate consent for the potential research subject to participate in research.
Third party recruiter – Agencies or organizations hired to aid in recruiting participants for human subjects research studies.
Examples of professional recruitment agencies that are third party recruiters:
- Critical Mix
- Amazon Mechanical Turk
Unanticipated problem involving risks to participants or others – Involves risk to subjects or others and is an incident, experience, or outcome that meets all of the following criteria:
- unexpected (in term of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
- related or possibly related to participation in the research (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); and
- suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
Undue influence – Improper influence (whether intentional or not) that deprives a person of freedom of choice or substitutes another’s choice or desire for the person’s own.
Unexpected – An event is unexpected when its specificity and severity are not accurately reflected in the informed consent document.
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.
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 subjects 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
- Study involving participants living with HIV 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.