For Researchers in Human Subjects

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:

• Classroom projects, research courses, and unfunded undergraduate thesis projects that involve research methodology and/or course-assigned projects, where data is collected from and about living individuals as part of a class exercise and/or assignment and is not intended for use outside of the classroom. Course instructors are still expected to train students to conduct their project ethically with the three core principles of the Belmont Report in mind. Note: There may be instances where a student or instructor wishes to use data that was previously collected for non-research (i.e., educational) purposes. In these instances, an application should be submitted to the HSC when the intent of the project has changed and is intended to contribute to generalizable knowledge.

• Quality improvement/assurance activities or program evaluations that are conducted or collected for internal, departmental, and/or other administrative purposes that are intended to measure the effectiveness and/or improvement of programs or services such as teaching evaluations, evaluating curriculum, improving a practice or process within a particular institution, etc. Note: Certain activities may fall under the definition of human subjects research, for example, if the project involves untested interventions, informs policies and procedures, or other programs similar in nature, if the results will be compared with other assessments, are designed to prove a relationship or correlation, or if certain publishers require IRB approval.

• Unidentifiable/de-identified or coded private information or specimens if the research team cannot readily ascertain the identifies to whom the data or samples belong to. Coded information or specimens that are not individually identifiable to the research team are not considered human subjects research if the private information or specimens were not collected specifically for the proposed research through interaction or intervention with living individuals AND the research team cannot identify the individual(s) because the investigators do not have the key to the coded information, there are IRB policies or procedures in place for a repository or data management center that prohibit sharing the key to the coded private information, or there are other legal requirements prohibiting the release of the key to the investigators, until the individuals are deceased.

• Case reports which are published and/or presented at national or regional meetings are not considered research if the case is limited to a description of the clinical features and/or outcome of a single patient. As the collection and organization of information for such reports usually involves no data analysis or testing of a hypothesis, they do not involve systematic investigation.

• Fact-collecting interviews of individuals where questions focus on things, products, or policies, rather than on people or their opinions, behavior, characteristics or experiences (e.g., canvassing recycling company about e-waste policies).

• Biographies or autobiographies that involve interviewing a living individual about their experiences and is not generalizable beyond that individual.

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:

• Classroom projects, research courses, and unfunded undergraduate thesis projects that involve research methodology and/or course-assigned projects, where data is collected from and about living individuals as part of a class exercise and/or assignment and is not intended for use outside of the classroom. Course instructors are still expected to train students to conduct their project ethically with the three core principles of the Belmont Report in mind. Note: There may be instances where a student or instructor wishes to use data that was previously collected for non-research (i.e., educational) purposes. In these instances, an application should be submitted to the HSC when the intent of the project has changed and is intended to contribute to generalizable knowledge.

• Quality improvement/assurance activities or program evaluations that are conducted or collected for internal, departmental, and/or other administrative purposes that are intended to measure the effectiveness and/or improvement of programs or services such as teaching evaluations, evaluating curriculum, improving a practice or process within a particular institution, etc. Note: Certain activities may fall under the definition of human subjects research, for example, if the project involves untested interventions, informs policies and procedures, or other programs similar in nature, if the results will be compared with other assessments, are designed to prove a relationship or correlation, or if certain publishers require IRB approval.

• Unidentifiable/de-identified or coded private information or specimens if the research team cannot readily ascertain the identifies to whom the data or samples belong to. Coded information or specimens that are not individually identifiable to the research team are not considered human subjects research if the private information or specimens were not collected specifically for the proposed research through interaction or intervention with living individuals AND the research team cannot identify the individual(s) because the investigators do not have the key to the coded information, there are IRB policies or procedures in place for a repository or data management center that prohibit sharing the key to the coded private information, or there are other legal requirements prohibiting the release of the key to the investigators, until the individuals are deceased. 
  
  The Secondary Uses Human Subjects Decision Tree may be used to help determine if research involving secondary or existing data requires Human Subjects Committee review.

• Case reports which are published and/or presented at national or regional meetings are not considered research if the case is limited to a description of the clinical features and/or outcome of a single patient. As the collection and organization of information for such reports usually involves no data analysis or testing of a hypothesis, they do not involve systematic investigation.

• Fact-collecting interviews of individuals where questions focus on things, products, or policies, rather than on people or their opinions, behavior, characteristics or experiences (e.g., canvassing recycling company about e-waste policies).

• Biographies or autobiographies that involve interviewing a living individual about their experiences and is not generalizable beyond that individual.

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:

• Anonymous surveys or interviews involving adults only
• Observation of public behavior without collecting identifiable information (Note: Some research in this example may NOT be human subjects research)
• Use of pre-existing data, documents/records, specimens if publicly available or de-identified prior to acquisition (Note: Some research in this example may NOT be human subjects research)
• Evaluating the effectiveness of school curriculum (Note: Some research in this example may NOT be human subjects research or may be eligible for Expedited Review)

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:

• Interviews on cultural beliefs or practices
• Research on individual or group identity
• Studies involving the collection of voice, video, digital, or images

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:

• Research involving vulnerable populations (e.g., prisoners, undocumented immigrants, etc.)
• Research involving active deception
• Research involving individuals who have self-identified as having experienced physical and/or emotional abuse
• Conducting interviews with gang members about illegal practices

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.
 

See this page for ORAHS Tutorials.

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 (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:

• Name
• 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 licence number
• Vehicle identifiers and serial numbers; including license plate numbers
• Device identifiers and 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 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

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

When do I modify an approved protocol?

Any modification to your research (exempt, expedited, or full board) requires HSC review and approval prior to implementation. Modifications that do not pose any new or additional risks to participants are typically handled via expedited review procedures.  Modifications that are substantive in nature and increase risk to the subjects are reviewed by the full board at a convened HSC meeting. Some examples of modifications are:

• Adding/removing a study or procedure
• Adding a new recruitment method or subject population
• Updating the consent process or form
• Updating questionnaires, surveys, or interview guides
• Changing the subject compensation

If you need to modify your protocol, click here for instructions.

When do I renew an approved protocol?

Exempt submissions are approved indefinitely and do not need to be renewed. Expedited and full board submissions must be renewed and approved annually prior to its expiration date for ongoing studies to avoid any lapses in protocol approval.

You will receive an email reminder 60, 30, and 14 days before your protocol expires. If you have not submitted a renewal by the protocol’s expiration date, you will receive an expiration notice and all research must cease until the renewal has been approved by the HSC.

Protocols should be renewed when any of the following activities are still ongoing:

• Subjects are being recruited and/or are enrolled in the study;
• Interventions or interactions with the subjects are occurring;
• The research team is obtaining or analyzing identifiable information

If you need to renew your protocol, click here for instructions.

If you are not sure if you can close your protocol, see the guidance on Closing a Project below.

Can I renew an expired protocol?

Yes, you have 180 days from the date of expiration to renew an expired protocol. After 180 days, the project will be automatically closed and the UCOP records retention period starts. If you would like to renew a protocol that has expired and been closed, you may base a new protocol off the closed protocol, but it will be reviewed as a new submission.

If you have been conducting research on an expired protocol, cease all activities and contact the HSC immediately.

Do I need to renew my protocol if I have finished data collection?

Whether or not you should close your protocol depends on the state of your data.

In order to close a protocol, all of the following conditions must be met:

• The research never started and will not be conducted

OR

• All subject recruitment and enrollment is complete;
• All subjects records, data, and/or specimens have been obtained;
• There will be no further interaction or interventions with the subjects;
• Analysis of identifiable private information (e.g., data, records, specimens, video/audio recordings) is complete; AND
• Data analysis (if applicable) is limited to anonymous data or data stripped of any identifying information (including codes linking subjects to data).

If you would like to close your protocol, click here for instructions.

Informed consent is a process and should always be obtained unless the IRB specifically approves a request to waive the requirement to obtain informed consent of research participants. For information on when a waiver of documentation or consent may be appropriate, visit the Waiver of Consent or Documentation page.

In certain instances, a Waiver of Consent may require participants to be debriefed at the conclusion of their participation in the research. For tips on writing a debrief and a sample debrief form, download this form.

For useful tips on writing consent forms, visit the Writing a Consent Form page.  See a sample consent form.

Basic elements of informed consent

In seeking informed consent from a potential human subject or their representative, a researcher must provide the participants with the following basic elements of informed consent:

1. A statement that the study involves research and an explanation of the nature and purpose of the research;
2. A description of the procedures to be used and the expected duration of the subject's participation;
3. A statement describing the extent, if any, to which confidentiality of records identifying the subjects will be maintained;
4. A statement that identifiers might be removed from identifiable private information or identifiable biospecimens and after such removal, the information or biospecimens could be used in future research without additional informed consent. OR, a statement that information or biospecimens, collected as part of this research, even if identifiers are removed, will not be used for future research studies.
5. A description of any attendant discomforts and risks reasonable to be expected or (rarely) that there are no foreseeable risks;
6. An explanation of any benefits to the subject or to society which may be reasonably expected from the research (note payment/class credit is not considered a benefit);
7. An offer to answer any questions concerning the study;
8. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss or benefits to which the subjects is otherwise entitled;
9. An explanation of whom to contact for information about the research. Include the investigator's name, phone number, and email address;
10. An explanation of whom (i.e. HSC) to contact for information about research subjects' rights.

Additional elements of informed consent

Whenever appropriate, one or more of the following elements of information may also be required to be provided to the subjects:

1. The approximate numbers of subjects involved in the study;
2. Any payment, reward or cost for participation and how payments or rewards will be prorated if the subject withdraws;
3. If extra credit for a class is given, an explanation of the non-research alternative available to earn equivalent credit;
4. Warning of UCSB’s mandatory child abuse reporting for studies through which the investigator might gain knowledge of child abuse;
5. An instruction that either the investigator or subject may terminate the subject's participation at any time;
6. For any study involving more than minimal risk which may result in physical injury, include the following standard language: If you are injured as a direct result of research procedures, you will receive reasonably necessary medical treatment at no cost. The University of California does not provide any other form of compensation for injury;
7. The disclosure of any alternative procedures, drugs or devices that might be advantageous to the subject; their relative risks & benefits;
8. An explanation of any drug or device to be utilized, & any foreign substance to be administered;
9. Identification of procedures, drugs, or devices that are experimental;
10. A statement that the particular treatment or procedure may involve risks to the subject (or embryo or fetus if the subject is or may be pregnant) which are currently unforeseeable;
11. Consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
12. A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject;
13. For any study which may result monetary gain for the researcher, add the following statement: The study investigator has a financial interest in this research and may benefit monetarily from this study. You may ask your investigator for more information on his or her interest;
14. If samples will be taken for research and development purposes not related to the subject’s treatment or condition, include the following standard language: Samples taken during this study may be used for research and development purposes not related to your treatment or condition. You will not have any property rights or ownership interest in products or data which may be derived from your samples;
15. A statement whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions;
16. For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing.

Unanticipated problems involves risk to subjects or others and is an incident, experience, or outcome that meets all of the following criteria:

• It is unexpected in nature, severity and/or frequency;
• It is related to, or possibly related to, participation in the research; AND
• It suggests that the research may place subjects or others at greater risk of harm than was previously known.

Unanticipated adverse event means any adverse event occurring in one or more subjects and is not consistent with either:

• The known or foreseeable risk of adverse events associated with the procedures in the approved protocol; OR
• The expected natural progression of any underlying disease, disorder or condition of the subject(s).

Other considerations

Data security breaches such as a lost or stolen laptop or lost USB drive may also be considered an unanticipated problem or adverse event since participant data may be compromised and should also be reported to the HSC.

Protocol noncompliance or deviations, such as not adhering to the approved protocol may also be considered an unanticipated problem or adverse event and should also be reported to the HSC. Examples of protocol noncompliance or deviations may include, but are not limited to:

• Failure to follow the approved protocol procedures;
• Failure to obtain prospective HSC review for additional research related activities not covered under the approved protocol such as adding a new study population, recruitment method, new measures or study procedures;
• Failure to obtain and/or document informed consent, unless a waiver is approved.

When do I report an unanticipated problem of adverse event?

Investigators are expected to report an unanticipated problem or adverse event when they are: 1) unexpected; 2) related or possibly related to participation in the study; and 3) suggest that the research places subjects or others at a greater risk of harm than was previously known or recognized.

An unanticipated problem that is serious in nature should be reported to the HSC within one (1) week of the investigator becoming aware of the event.

How do I submit a report of an unanticipated problem or adverse event?

Contact the HSC by email or by phone at (805) 893-3807 to submit an initial report of an unanticipated problem or adverse event.

For more specifics on reporting requirements, see HSC SOP 023 Unanticipated Problems or Adverse Events.

Overview

Research supported by the Department of Defense (DoD) must be reviewed by the IRB under an additional set of federal regulations (32 CFR 219) and requires compliance with additional directives and instructions.

What qualifies as Department of Defense research?

Research involves the DoD when any of the following apply:

• The research is funded by a component of the DoD (e.g., Navy, Army, Air Force)
• The research involves cooperation, collaboration, or other type of agreement with a component of the DoD
• The research uses property, facilities, or assets of a component of the DoD
• The subject population will intentionally include personnel (military or civilian) from a component of the DoD

Note:  DoD policies and requirements do not apply when DoD personnel incidentally participate as subjects in research that is not supported by DoD, and DoD personnel are not an intended population of the research.

What are the components of the Department of Defense?

Department of Defense (DoD) components include, but may not be limited to:

- Navy
- Office of Naval Research
- Naval Academy
- U.S. Naval Observatory
- Army
- U.S. Army Corps of Engineers
- Military Academy (e.g., West Point)
- Air Force
- Air Force Academy
- Marines
- Coast Guard
- Coast Guard Academy
- National Guard
- Missile Defense Agency
- Defense Advanced Research Projects Agency (DARPA)
- Pentagon Force Protection Agency
- Defense Intelligence Agency
- National Geospatial-Intelligence Agency
- National Security Agency
- National War College
- Other DoD facilities

Instructions for researchers

DoD-related research activities typically involve additional compliance requirements before investigators may begin their research. Researchers are expected to adhere to the following requirements for research involving the DoD:

1. Submit documentation of an independent scientific merit review along with the protocol for UCSB IRB review*;
2. Provide additional language in the protocol and consent form**; and
3. Submit the IRB approval and approved documents to the appropriate DoD Human Research Protection Program Officer (HRPPO) for final review.***
4. Researchers will be required to complete the DoD CITI training requirements and upload a copy of the completion certificate to the protocol. Please review our instructions for accessing and completing the training. The training must be renewed every three years;
5. For continuing review applications, researchers should include whether their research has resulted in any publications and/or presentations.

Note: For greater than minimal risk research activities, the IRB may require appointment of a research monitor. The IRB must review and approve a written summary from the PI regarding the monitor’s duties, authorities, and responsibilities.

*The Army and Navy require an independent scientific merit review and approval prior to IRB review. The scientific merit review is project specific and evidence of the review should be uploaded with the IRB application. For more information, please see our guidance on research involving the DoD, including specifics on scientific merit review.

** Consent forms must include a statement indicating that the DoD is providing support for the research project and a DoD representative may access research records for the protection of human subjects. If researchers will be sharing data with other institutions, this must be described in the Procedures section of the protocol and must also be included in the consent forms.

***Once UCSB IRB approval has been obtained, a review by HRPPO is required for research involving the DoD prior to initiation of any research involving human subjects. It is the investigator’s responsibility to submit the applicable documents for review and approval by the appropriate HRPPO before starting any research activities that involve human subjects.

Conducting research in an international setting involves adhering to additional sets of regulations, policies, and customs. Not only must researchers follow the same ethical and regulatory standards for conducting human subjects research in another country as they do in the U.S., but researchers must also conform to the applicable local laws and norms of the host country and community as well.

Planning the protocol

The HSC recommends submitting an application for review at a minimum of one month prior to the anticipated start date. Since international sites may have their own policies and procedures for allowing human subjects research to occur, planning your protocol in advance will help facilitate the review process.

Below are some items to consider when conducting research in an international setting:

• Research location(s): Identify cities, rural areas, spaces, and countries where the research will be conducted.
• Collaborator(s) and what the collaboration entails: Describe each collaborating site/agency/institution and define their role in the research (if applicable). Will these institutions be engaged in the research? Are they seeking their own IRB approval for the research activities?
• Local ethical review, permissions and requirements: Research in an international location often involves additional local ethical review, permissions, and may also require host country approval. A description of an appropriate local IRB or ethical review and how local permissions will be obtained should be documented in the ORahs protocol application. Consultation with community leaders (e.g., NGOs), stakeholders, or colleagues can aid in providing important insights about the local community in a research context. Note: Host country approval is different than a local ethical review and both may be required. The review should assess whether the project is culturally insensitive or offensive and whether participation could place the subjects at risk. The reviewer should be from the country or area targeted. The reviewer should also be able to understand the research. They should be independent of the research. For information on host country approvals, see OHRP's guidance on international research.
• Language and literacy: Language and literacy levels may vary by locale. What measures are taken to ensure subjects are informed about the research (i.e., informed consent) in a way that is appropriate to the cultural standards of the international location?
• Community and culture: Questions that may seem innocuous in the United States could be offensive and/or risky in another community or culture. An outline of the research team’s knowledge of the local community including the appropriateness of the research in context of the political and socio-economic climate, and societal norms should be described in the ORahs application.
• Payment to participants: Payments that are non-coercive in the United States could potentially be considered coercive in another community. Consider how you will ensure payment methods (if any), such as cash or goods, is non coercive and would be equivalent that what would be commonly available in the local community.
• Status of women: If the status of women in the international location(s) is different than the United States, what measures will be incorporated into the research to respect women’s autonomy to consent?
• Status of children: If the definition or guardianship of children in the targeted community is different than the United States, describe how your research team will adhere to these standards.
• Traumatized communities: Any risks and complications of conducting research with victims of violence or disasters should be discussed and a plan for minimizing any said risks should be included in the protocol application and consent process.
• Training: If your research team will be hiring individuals to conduct the research on your behalf (e.g., canvassing, recruiting participants, etc.) how are these individuals trained to conduct themselves in an ethical and non-coercive manner?

Consent process

In most instances, federal regulations require documented (i.e., signed consent) from research participants unless a waiver of consent or documentation is requested, justified and approved by the HSC.

Below are some items to consider when obtaining informed consent in an international setting:

• Appropriate language: In many instances, there may be multiple spoken languages, such as an official state language, local language, and/or local dialects. Consent should be obtained using a language that is most understandable to the subject, which could mean having multiple consent forms in several languages.
• Oral or written consent: The spoken language may not be written, or the literacy level may vary from the spoken language. A signed consent form may have connotations or consequences and it may not be appropriate for the subject population.
• Translators: If your research team is not fluent in the local language, a translator or interpreter may be appropriate for the project. However, considerations for the relationship between the translator/interpreter and the subjects must be taken into account since a translator could be seen as an individual of power and subjects may feel undue pressure or influence to participate in the research.
• Additional permissions: Are there other individuals or groups whose permission must be sought before obtaining consent? For example, in some communities, a spouse, a head of the household, or permission from a group leader may be required before obtaining consent from subjects.
• Local contact: Some individuals may not have access to a telephone or email. Is there a local contact person in case subjects have questions or concerns that arise?

For more information on working in an international setting, see the UCSB HSC SOP 024 on International Research.

Notice to Investigators: NIH Single IRB Mandate, effective January 25, 2018

The NIH Policy on the Use of a Single Institutional Review Board for Multi-site Research, effective January 25, 2018 will require all NIH funded multi-site studies, in which each site is conducting the same non-exempt human subjects research, to use a single IRB to obtain IRB review and approval for all participating sites.

The NIH policy applies to all studies that are:

• Funded through grants, cooperative agreements, contracts, or the NIH Intramural Research Program, and
• Involve non-exempt human subjects research, and
• Involve multiple sites, all of which are conducting the same protocol.

The policy does not apply to studies that are:

• Funded to foreign awardees and/or conducted at foreign sites, or
• Funded through career development, research training or fellowship awards, or
• Where review by the proposed sIRB would be prohibited by a federal, tribal, or state law, regulation, or policy, or
• Collaborative projects in which multiple sites are involved but different sites may complete different parts of the study.

If your proposal falls under this policy, please contact the Human Subjects staff at hsc@research.ucsb.edu and your Sponsored Projects team to coordinate your submission.

Collaborative non-exempt human subjects research with external institutions

Investigators “engaged” in collaborative human subjects research with an external institution or external individual may or may not need a reliance agreement to conduct the human subjects research activities. Individuals may seek IRB approval through their home institution to cover research activities that are occurring at their institution and likewise, UCSB investigators may obtain IRB approval from the UCSB IRB to cover their own research activities.

Below are examples of instances that may not require a reliance agreement:

• If one site is only analyzing coded, de-identified data, and no one at that site can ever access the key linking codes to identifiers, then that site may not be considered "engaged" in human subjects research and therefore a reliance agreement would not be required.

In instances where a reliance request may be needed, investigators may request UCSB to be the IRB of record or may request to rely on another IRB’s review of the research. UCSB must evaluate each reliance request on a case-by-case basis when determining if UCSB will be the Reviewing or Relying IRB. Typically, UCSB will only enter into reliance agreements with institutions operating under a current FederalWide Assurance (FWA). If your collaborator is not operating under an institution that has a current FWA, contact the Human Subjects staff to discuss the collaboration. The sections below are intended to assist investigators when a reliance is needed.

If you are requesting UCSB to be the Reviewing IRB:

The Human Subjects staff should be contacted to discuss the collaboration before a reliance agreement is initiated. The location of research activities, as well who is serving as the lead investigators and the human subjects interactions and interventions to occur will play a role in determining whether UCSB will be the Reviewing IRB. The Human Subjects staff will discuss roles and responsibilities with you to determine whether the UCSB IRB can serve as the Reviewing IRB (or IRB of record) for the particular study.

If it has been determined that UCSB will serve as the Reviewing IRB, you will need to submit a protocol application in ORahs. If your project qualifies for exemption, please contact the Human Subjects staff to discuss whether a reliance agreement is needed for your project.

The protocol application should include, at a minimum, a description of the following:

1. On the One Tab of the protocol, identify the investigators and the institutions they are affiliated with under the Collaborations section. Indicate whether they are obtaining IRB approval through their home institution or requesting to rely on UCSB’s IRB review of the research.
2. On the Locations Tab, identify the research activities that are occurring at off-site locations with the external investigators. Provide a brief description of each location of activity.
3. On the Procedures Tab, describe any human subjects research activities the external investigators will be conducting.

Depending on the collaborator’s role in the research, more information may be needed in the protocol application. For example, if you will be sharing identifiable private information with your collaborator, a description of the confidentiality/privacy risks and data sharing and storage may need to be included in your application.

It is important to coordinate the proposed research activity with your collaborator and their institution since each external institution will have local policies and procedures regarding their requirements for ceding review to the UCSB IRB. External investigators should discuss these requirements with their local IRB in advance of submitting a protocol through UCSB.

Once the protocol application has been reviewed and approved by the UCSB IRB, an IRB Authorization Agreement (IAA, i.e., a reliance agreement) will be negotiated.

Human subjects research may not commence until UCSB has approved the protocol and the reliance agreement has been executed.

If you are requesting UCSB to be the Relying IRB:

Contact the Human Subjects staff at hsc@research.ucsb.edu to discuss whether ceding review to another IRB is appropriate for the study.

If ceding review is appropriate for the study and the collaborating institution has agreed to serve as the IRB of record, then the following documents must be submitted to the Human Subjects staff before UCSB can agree to be the Relying IRB for the human subjects research activities:

1. UCSB HSC Non UC Reliance Application
2. UCSB HSC COI Checklist

After these forms have been completed, submit them to hsc@research.ucsb.edu for review. The Human Subjects staff will contact the Reviewing IRB to begin executing a reliance agreement. You will also be required to submit:

1. The approval notice from the Reviewing IRB
2. Approved consent forms
3. Approved protocol
4. Approved materials (such as the recruitment materials, surveys, questionnaires, instruments, etc.)

It is important to note that the Reviewing IRB may require additional documentation from you, such as completion of their training requirements, local recruitment materials, and documentation of ancillary reviews, etc. It is your responsibility to comply with any additional determinations and requirements of the IRB of record. It is recommended to coordinate external investigators to ensure you are in compliance with the Reviewing IRB’s requirements.

After the reliance agreement has been negotiated and executed, the Human Subjects staff will create a “Notice of Cede Review” for your record, which acknowledges the reliance agreement and outlines your investigator responsibilities, briefly summarized below.

Responsibilities of the UCSB Investigator:

1. Forward relevant information (e.g., ancillary approvals) to the Reviewing PI before the study is submitted to the Reviewing IRB for initial review, amendments, or continuing review.
2. Comply with the protocol as approved by the Reviewing IRB.
3. Report any unanticipated problems, adverse events, protocol non-compliance or incidents to the UCSB IRB.
4. Follow the Reviewing IRB standards for reporting any post-approval events, protocol violations, or incidents, in addition to following the UCSB IRB requirements for reporting.

Human subjects research may not commence until the Reviewing IRB has approved the protocol and the reliance agreement has been executed.

Collaborative non-exempt human subjects research with other UC institutions

If you are requesting a UC Reliance Agreement:

UCSB uses the online UC IRB Reliance Registry for all sites covered by the Memorandum of Understanding (MOU) between the UC campuses.

If you are a first-time user and have not used the Reliance Registry before, please see the:

• Reliance Registry FAQs
• UCSB Reliance Registry Process

Definitions:

See ORahs 2.0 Definitions

Creating a New Reliance Request

• If you are the Reviewing PI, click the Create Request tab and disclose if your study involves the Veteran Administration. Complete the information regarding your role in the study and the other required fields marked by an asterisk. Make sure to save your entries if you need to log out at any time.
• If you are a Student Investigator for the Reviewing or Relying Campus, you must identify yourself as a Research Coordinator and your faculty sponsor as the PI. You will have access to the online reliance request but only Reviewing PIs may formally submit it via the Registry.
• Identify your Relying PIs. The Registry will notify Relying PIs via email to register and confirm their involvement in the study. Email addresses must be entered accurately as there is no bounce-back function in the system.
• Once all Reviewing and Relying PIs have signed up for the study via the Registry, the Reviewing PI will be able to sign a reliance request form, convert it to a PDF and submit it with their protocol application to their campus IRB for review.
• Upon approval of the study, the Reviewing IRB will add the approval/expiration date, approved protocol, approval letter and any applicable consent forms to the study’s Registry record and an automated email notice will be sent to all PIs and the Relying IRB.
• The Relying IRB will review the documents and accept or deny the reliance via the Registry. If accepted, all PIs and the Reviewing IRB will be notified of this decision via automated email.

Submitting Renewals and Amendments

Reviewing PIs should submit Continuing Review applications of their studies to their campus IRB, per usual. Upon approval, the Reviewing IRB will update the study’s expiration date in the Registry. No Relying PI can continue work on the study if the Reviewing Campus does not submit a renewal on time.

Amendments must be submitted to the Reviewing IRB who will update any changes to the study in the Registry. The Relying PI is also responsible for informing the Reviewing PI of any necessary amendments.

Reporting Adverse/Unanticipated Events

Reports of adverse and/or unanticipated events must be submitted to the Reviewing IRB staff who will update any changes to the study in the Registry. The Relying PI is also responsible for informing the Reviewing PI of any adverse/unanticipated events.

For further assistance, please contact the HSC Coordinator at hsc@research.ucsb.edu.

If your study is greater than minimal risk and involves activities where a research-related injury is possible, OHRP requires that the consent form include an explanation of any voluntary compensation and treatment that will be provided. 

This section explains the University of California requirements and provides consent form guidance for PIs of such studies.

UC Policy
University Policy 18-300 for medical treatment of human subjects for injuries resulting from participating in research, was originally issued by Presidential Memorandum, January 19, 1979.

1. The University of California will provide to any injured subject any and all medical treatment reasonably necessary for any injury or illness which a human subject suffers as a direct result of participation in an authorized University activity covered by University policy on the protection of human subjects in research or reimburse the subject for the costs of such treatment, except when the injury or illness is a consequence of a medical research procedure which is designed to benefit the subject directly.
2. The obligation of the University undertaken in paragraph 1 is subject to the following conditions:
   1. It must be demonstrated that the injury resulted directly from participation in the specified activity.
   2. Written notification of any such injury is to be given to the University by the human subject within a reasonable time after discovery.
   3. Any claim for reimbursement is to be supported by appropriate documentation.

Standard Consent Form Wording
It is important that you promptly tell the researcher, [investigator’s name], if you believe that you have been injured because of taking part in this study. You can tell the researcher in person or call him/her/them at [telephone number].

If you are injured as a result of taking part in this study, University of California will provide necessary medical treatment. The costs of the treatment may be billed to your insurer just like other medical costs, or covered by the University of California or the study sponsor, depending upon a number of factors. The University and the study sponsor do not normally provide any other form of compensation for injury. For more information, email HSC at hsc@research.ucsb.edu.

Implementation
There are two major aspects of the UC policy: (1) treatment for injury and (2) compensation for injury. These two must be clearly distinguished in considering the University policy and the UCSB statement regarding that policy.

Appropriate treatment should be available to any subject injured as a result of participating in a research project. Treatment should be considered an ethical obligation rather than any admission of liability. 

Minimal Risk Activities
Minimal risk activities that require Treatment and Compensation for Injury in the informed consent form. (This is a non-exhaustive list.) Tip: If it’s a category 2 or 4 expedited study, add Treatment and Compensation for Injury language.

• Blood draw
• MRI (under 7T) without contrast
• Running on a treadmill
• Riding a stationary bike
• Walking or exercising

The IRB may require Treatment and Compensation for Injury language for other minimal risk activities depending on the particular activity, the context of the activity, the participants’ physical abilities and other circumstances.

As of January 25, 2023, new NIH applications will be required to include a two-page plan outlining how scientific data will be managed and shared. The new NIH Data Management & Sharing Policy prioritizes the sharing of data and making it publicly available. NIH promotes the responsible sharing of scientific data from human participants, consistent with protecting research participant privacy.

Award recipients must protect the privacy and confidentiality of every participant as described in applicable informed consent and in line with all applicable laws, regulations, and policies.

Award recipients are encouraged to:

• Proactively assess the protections needed for sharing scientific data from participants (e.g., through de-identification, Certificates of Confidentiality, and other measures,
• Researchers should develop robust consent processes that prioritize clarity regarding future sharing and use of scientific data, including limitations on future use, and general aspects regarding how data will be managed,
• Identify factors that might limit sharing, including when sharing would compromise the privacy or safety of participants and explicitly describe limitations in informed consent documents.

For general information on the new NIH Data Management & Sharing Policy, please visit the UCSB Library's guidance on developing a Data Management & Sharing Plan.