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ORahs 2.0 Definitions

Below are definitions and examples of commonly used terms for research involving human subjects at UCSB.

General:

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

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 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 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 obtains

(1)        Data through intervention or interaction with the individual, or

(2)        Identifiable private information (45 CFR 46.102)

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 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)

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

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:

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 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

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).

Research - means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102)

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).

Systematic investigation - is a study or examination involving a methodical procedure or plan

Consent:

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

-          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

Participation:

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 – 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, YouGov, Amazon Mechanical Turk

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

Protocol:

Deception – the action of deceiving someone

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

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

Disposition - in human subjects research 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 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.

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 46.101(b). 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

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

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