Determining whether or not a project meets the federal definition of human subjects research is a two-step process. Does your project 1) meet the definition of "Research"and 2) involve "Human Subjects"? The information below will help you answer these two questions and assess whether a project requires IRB review.
Does your project meet the federal definitions of research described below? If not, it may not need to be reviewed by the HSC. See below for examples of projects that are usually not human subjects research.
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Systematic investigation means a study or examination involving a methodical procedure or plan.
Generalizable knowledge means conclusions, facts, or principles derived from particulars (individual subjects, medical records, etc.) that are applicable to or affect a whole category (members of a class, kind, or group, a field of knowledge, etc.) and are intended for dissemination in the public domain, typically through publication.
Below are examples of activities that are typically NOT human subjects research:
If you answered “yes” to whether your project is considered research, does your project meet the federal definition of a “human subject”?
Human Subject means a living individual about whom an investigator conducting research: (1) 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.
Intervention includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between investigator and subject.
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 (e.g., a medical or school record). In order to meet the above definition, private information must be individually identifiable (i.e., the identity of the subject is known or may readily be ascertained by the investigator or associated with the information) in order for the investigation to constitute research involving human subjects. 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 individuals.
If you think your project does not require review and you require documentation for your records, then submit this form to the HSC for a formal determination.
Below are examples of activities that are typically NOT human subjects research:
Protocols may undergo the following different types of review. If you are unsure whether your project qualifies as “research involving human subjects”, please see the Does Your Project Require IRB Review section above.
Exempt Review
In order for research to be qualify as exempt, the project must fall into at least 1 of 6 federally-defined exempt categories and present no risk or no greater than minimal risk to the participants. Although this category is called exempt, this type of research does require prospective IRB review. Researchers must submit an exempt application in order for the HSC to assess whether the project qualifies as exempt research. Projects that are low risk may be considered exempt. Some examples of exempt research are:
For more information on exempt research, please see our article on the term "exempt research."
Expedited Review
In order for research to be eligible for expedited review, the activities must be considered no greater than minimal risk to the human subjects and fall into at least 1 of 9 federally-defined categories. Once a project is submitted for review, the HSC will assess the level of risk to the human subjects. Some examples of expedited research are:
Full Board Review
Studies that are determined to be greater than minimal risk and do not qualify for exempt or expedited review are reviewed at a convened meeting of the HSC by full board review. Some examples of research reviewed by full board are:
Please see the submission deadlines page for Exempt, Expedited and Full Board review dates.
Yes. A pilot study is considered a preliminary investigation of the feasibility of a study, usually done on a small scale (approximately 10 or fewer subjects) and exploratory in nature. It is designed to help the investigator refine data collection procedures and instruments or prepare a better, more precise research design. Even if the pilot data are not used in the final results or included in publications, pilot studies involving human subjects in the initial stages of research (research development) are considered human subjects research and require IRB review. If the pilot research helps, for example, refine the survey instrument or experimental design that will then be used to collect data and contribute to generalizable knowledge, the pilot study is still part of that process.
It is important to inform the research participants that they are participating in a pilot study and whether their data will be used to refine the survey instrument, data collection procedures, and/or used as research data in the larger research study.
A Blanket “In Concept” is 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 meets the requirements of 45 CFR 46.118, “Certain types of applications for grants, cooperative agreements, or contracts are submitted to Federal departments or agencies with the knowledge that subjects may be involved within the period of support, but definite plans would not normally be set forth in the application or proposal. These include activities such as institutional type grants when selection of specific projects is the institution's responsibility; research training grants in which the activities involving subjects remain to be selected; and projects in which human subjects' involvement will depend upon completion of instruments, prior animal studies, or purification of compounds.”
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.
Below are definitions and examples of commonly used terms for research involving human subjects at UCSB.
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 (also 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 if 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 known as the IRB of Record).
Systematic investigation - is a study or examination involving a methodical procedure or plan
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:
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:
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:
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 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:
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:
Example of incomplete disclosure that is also deception:
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
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