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Human Research Protections Program (IRB) FAQs

 Human Subjects Research

Submission & Review Process
Informed Consent
Confidentiality
What is a Federalwide Assurance (FWA)?

Human Subjects Research

Am I conducting research?

What is "research"?

Within the context of human subjects research, research is defined as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."

What is a "systematic investigation"?

A systematic investigation is an activity that involves a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question(s).

Usually, to be a systematic investigation, a research design would meet all of the following criteria:

  • Attempts to answer research questions (in some research, this would be a hypothesis).
  • Is methodologically driven, that is, it collects data or information in an organized and consistent way. 
  • The data or information is analyzed in some way, be it quantitative or qualitative.
  • Conclusions are drawn from the results.

What is "generalizable knowledge"?

Generalizable knowledge is information where the intended use of the research findings can be applied to populations or situations beyond that currently being studied.

The vast majority of scholarly work in academia is intended to be shared, published, presented to colleagues, and is intended to have an impact (theoretical or practical) on others within one’s discipline. Activities that are disseminated with the intent to influence behavior, practice, theory, future research  designs, etc. are contributing to generalizable knowledge.

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Does my study involve human subjects?

To determine if a study involves human subjects investigators must determine whether the activities are a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge in which an investigator (whether professional or student) conducting research obtains information or biospecimens through intervention or interaction with a living individual, and uses, studies, or analyzes the information or biospecimens; or obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Is my study human subjects research?

To determine whether your activities appear to be human subjects research, use the Cayuse Human Ethics Initial Submission. In the Getting Started section, choose the option "I need to know if my activity is considered "Human Subjects Research" and answer the additional questions. 

Additional information for determining whether or not study activities involve human subjects can be found using the OHRP Human Subject Regulations Decision Charts or the NIH Decision Tool.

How can I get a “not human subjects research” (NHSR) determination?

To receive an official human subjects research determination by ORCA, use the Cayuse Human Ethics Initial Submission. In the Getting Started section, choose the option "I need to know if my activity is considered "Human Subjects Research", answer all required questions for each section, and submit the form. If your study is determined to be human subjects research, you will be asked to provide more information in the Initial Submission so that your study may be reviewed.

What is a human subject?

Human subject means a living individual about whom an investigator (whether professional or student) conducting research:

  • Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
  • Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

What is “intervention”?

Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.

What is “interaction”?

Interaction includes communication or interpersonal contact between investigator and subject.

What is “private information”?

Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).

What is “identifiable private information”?

Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.

What is an “identifiable biospecimen”?

An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

What does "about whom" mean?

In order for a study to be considered human subjects research, the data obtained must be "about" the living individual. In some cases, an investigator may interact or intervene with a living individual, but the purpose is to obtain data about a topic other than the individual. These studies may not be considered human subjects research.

Some examples of activities that are not considered human subjects research because they do not meet the criteria of being about a living individual:

  • Asking a nongovernmental organization about its source of funding.
  • Asking an employee to describe the different functions performed by different positions at an organization and communication processes between departments, as long as no private, personally identifiable information is collected about individuals who have filled different positions.
  • Asking a teacher to describe teaching methods or techniques used in the classroom. 

Some examples of activities that are considered human subjects research because they meet the criteria of being about a living individual:

  • Asking a teacher to describe her or his personal experience using different teaching methods or techniques. Note: This would be considered human subjects research even if the overall purpose of the study were about teaching methods.
  • Asking a political scientist who is the strongest candidate in a political race. Note: This opinion question is about the individual because it seeks a general attitude from—that is, something about—the individual; and not a concrete assessment of something within their realm of expertise.
  • The purpose of the research is to determine within-rater reliability. The investigators ask engineers who have used Systems A and B to evaluate the systems (e.g., with instructions to rate each system on a scale of 1 to 10). The investigators perform an analysis that determines the engineers have low within-rater reliability.

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Examples of human subjects research activities:

  • obtaining information about living individuals by intervening or interacting with them for research purposes
  • obtaining identifiable private information about living individuals for research purposes
  • obtaining the voluntary informed consent of individuals to be subjects in research
  • studying, interpreting, or analyzing identifiable private information or data for research purposes

Generally, the IRB definition of "research" does NOT include:

  • Student Coursework, including undergraduate honors theses, unless they are to be made available to the public, used by other investigators, or there is a possibility that the research may lead to a formal presentation or publication. See “Does student research require IRB review?” for more information.
  • Oral History Projects are considered research only when they are intended to contribute to generalizable knowledge or there is a possibility that the resulting data will be used to contribute to generalizable knowledge. See “What if my project involves oral history?” for more information.
  • Program Evaluation, Quality Assurance and Quality Improvement Activities are considered research only when they are intended to contribute to generalizable knowledge or there is a possibility that the resulting data will be used to contribute to generalizable knowledge.  When the purpose of an activity is to assess the success of an established program in achieving its objectives and the information will be used to provide feedback to improve that program, the activity is not human subjects research.  When the evaluation is undertaken to test a new, modified, or previously untested intervention, service, or program to determine whether it is effective and can be used elsewhere, the activity is research. 

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Is an investigator engaged or not engaged in research on my project?

All UC Santa Cruz study investigators and external (non-UC Santa Cruz) collaborating investigators who will be engaged in human subjects research should be identified and added to the "Research Personnel" section of a study submission. Engagement includes any of the following:

  • Recruiting subjects (beyond just distributing a recruitment message for the UC Santa Cruz study investigators)
  • Obtaining subject consent
  • Interacting or intervening with subjects for research purposes
  • Accessing private identifiable information about subjects for research purposes
  • Using institutional facilities for conducting research (beyond just posting a recruitment message)

Is an institution engaged or not engaged in research on my project?

In general, an institution is considered engaged in a particular non-exempt human subjects research project when its employees or agents for the purposes of the research project obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research. 

More specifically, an institution is engaged in research when ANY of the following apply:

  • The institution is the awardee institution for a non-exempt human subjects research project, even if all human subjects research activities will be carried out by employees or agents of another institution. 
  • An employee or agent of the institution intervenes with human subjects for research purposes through: 
    • Invasive or noninvasive procedures (see examples below)
    • Manipulating the environment  (see examples below)
    • Interacting with any human subject of the research (see examples below)
    • Obtaining informed consent 
    • Obtaining identifiable private information or identifiable specimens, even if there is no direct interaction with human subjects (see examples below)

Examples
Examples of invasive or noninvasive procedures include:

  • drawing blood; 
  • collecting buccal mucosa cells using a cotton swab;
  • administering individual or group counseling or psychotherapy;
  • administering drugs or other treatments; 
  • surgically implanting medical devices; 
  • utilizing physical sensors; 
  • utilizing other measurement procedures. 

Examples of manipulating the environment include:

  • controlling environmental light, sound, or temperature;
  • presenting sensory stimuli; 
  • orchestrating environmental events or social interactions.

Examples of interacting include:

  • engaging in protocol dictated communication or interpersonal contact; 
  • asking someone to provide a specimen by voiding or spitting into a specimen container; 
  • conducting research interviews or administering questionnaires. 

Obtaining identifiable private information or identifiable specimens includes, but is not limited to:

  • observing or recording private behavior; 
  • using, studying, or analyzing for research purposes identifiable private information or identifiable specimens provided by another institution; and 
  • using, studying, or analyzing for research purposes identifiable private information or identifiable specimens already in the possession of the investigators 

See also Collaborative Research and What is "identifiable" information?

For more information about what it means to be engaged or not engaged in research, see the Department of Health and Human Services Guidance on Engagement of Institutions in Human Subjects Research.

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What if a project involves oral history?

Oral history projects are considered research only when they are intended to contribute to generalizable knowledge or there is a possibility that the resulting data will be used to contribute to generalizable knowledge. If you are unsure, the Cayuse Human Ethics Initial Submission includes questions to help make this determination.

General principles for evaluating oral history projects

  • Projects that involve oral histories, journalism, biography, literary criticism, legal research, or historical scholarship, including the collection and use of information, that focus directly on the specific individuals about whom the information is collected would not typically be considered human subjects research.
    • Example: An oral history video recording of interviews with holocaust survivors is created for viewing in the Holocaust Museum. The creation of the videotape does NOT intend to draw conclusions, inform policy, or generalize findings. The sole purpose is to create a historical record of specific personal events and experiences related to the Holocaust and provide a venue for Holocaust survivors to tell their stories.
  • Projects that involve systematic investigations with open-ended interviews that are designed to develop or contribute to generalizable knowledge (e.g., designed to draw conclusions, inform policy, or generalize findings) would typically be considered human subjects research.
    • Example: An open-ended interview of surviving Gulf War veterans to document their experiences and to draw conclusions about their experiences, inform policy, or generalize findings.

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What if a study involves field research?

In general, outdoor activities in remote or uncontrolled environments, conducted primarily for research purposes, constitute field research. While the IRB/ORCA is primarily concerned with the protection of human subjects, the University is also concerned with the safety of investigators. When planning human subjects research that involves conducting field research, be sure to review the information provided by EH&S at Field Research. Also, as federal export control regulations may affect activities related to field research, be sure to review the information provided by ORCA at Export Control.

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Does student research require IRB review?

Generally, the IRB definition of "research" does not include student coursework or undergraduate honors theses, unless they are to be made available to the public, used by other investigators, or there is a possibility that the research may lead to a formal presentation or publication. 

If an instructor determines that there is a possibility that a student's proposed research project may result in a formal presentation or publication, the student should submit the project for IRB review. 

When student work involving human subjects does not constitute research, the faculty member(s) who assign or supervise the work are responsible for educating their student(s) to safeguard the well being of the subjects. 

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What is the difference between public vs. private information when conducting internet-based research?

If individuals intentionally post or otherwise provide information on the internet, such information could be considered public unless the privacy policies and/or terms of service of the entity receiving or hosting the information indicate that the information should be considered private.

What is considered public on the internet? Public sites fall into one or more of the following categories:

  • Sites containing information that, by law, is considered public (many federal, state, and local government sites are included in this category: property tax records, birth and death records, real estate transactions, certain court records, voter registration and voting history records, etc.). 
  • News, entertainment, classified, and other information-based sites where information is posted for the purpose of sharing with the public.
  • Open access data repositories, where information has been legally obtained and is made available with no restrictions on its use.
  • Discussion formats that are freely accessible to any individual with Internet access, and do not involve terms of access or terms of service that would restrict research use of the information

However, an individual’s expectation of privacy is not always “reasonable” (see What is "private information"?) and someone may assume that the information provided or available on the Internet about them is private, when it is not. The Belmont Principle of beneficence may support a more conservative approach. A subject who incorrectly assumed their identifiable information was private, or restricted to a small group, might not have posted the information if they thought the information would be widely available, believing that the information could be embarrassing or damaging.

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What if a study involves a raffle, lottery, or a chance for subjects to win prizes?

In the State of California, it is illegal to give out a prize by chance in exchange for payment or “valuable consideration,” and participation in research has been interpreted as a type of valuable consideration. Therefore, to avoid violating California’s lottery law, investigators should:

  1. allow the drawing to be entered by anybody who asks, and
  2. allow subjects to stay entered in the drawing even if they withdraw.

Subjects should be informed that entry in the raffle or lottery is not contingent on participation in the study.

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What if an unanticipated problem occurs during the course of my research?

Review the information found on Unanticipated Problems (UPRs), Non-Compliance, and Other Reportable Incidents (Incident Submission). 

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Submission & Review Process

How is a study submitted?

Studies can be submitted by anyone affiliated with the study using Cayuse Human Ethics. Instructions and guidance can be found on ORCA’s Cayuse Human Ethics page.  

Who should be listed as an investigator?

An investigator is any individual who is involved in conducting human subjects research studies. Investigators can include professors, scientists, administrative staff, teachers, and students, among others.

Anyone that will be intervening or interacting with human subjects or with their personally identifiable data should be listed as investigators on the study. For new investigators added after the initial approval of a study, a modification to the study must be submitted and approved before they may commence work on a human subjects study.

Examples of involvement that would not need to be listed include:

  • laboratory personnel receiving samples for analysis that do not include any subject identifiable information (de-identified samples)
  • collaborators at other institutions who are receiving survey responses that do not include subject identifiable information
  • administrative personnel assisting with logistics who do not have access to study data/subject identifiable information

What if all the study investigators have not yet been identified, e.g., they are being recruited or will be assigned later on in the study?

Anyone not identified in the original submission will need to be added through a modification. This modification must be approved before they are permitted to work on the study. 

Why does the IRB need so much detail about the study?

Providing information with a high level of detail is necessary so that the UC Santa Cruz Institutional Review Board (UCSC IRB) Chair and/or IRB Chair’s designee(s) can make an informed decision about potential risks to subjects and ensure compliance with the appropriate federal guidelines and UC policies for human subjects research. Completing this process can also help investigators carefully evaluate procedures, refining as appropriate, prior to beginning research.

What happens after a Cayuse Human Ethics submission is completed?

When a submission has been completed and submitted, the PI, and Co-PI (if applicable), will receive an email notification letting them know they need to log in and certify the submission in Cayuse. Once certified, the submission will be routed to ORCA for review and the PI, Co-PI (if applicable), and Primary Contact will receive an acknowledgment email. 

Once a submission has been reviewed, the PI, Co-PI (if applicable), and Primary Contact will receive email notification with feedback regarding any additional steps required, or a determination for the submission.

How long will it take to review a submission?

The time it takes to receive feedback on the submission depends on the completeness of the submission, the complexity of the study, and the volume of studies already under review at the time the submission is received. Submissions are reviewed according to type and date received. The following are estimates only, and may be longer when an IRB meeting needs to be scheduled:

  • Initial Submissions: 3-8 weeks
  • Renewal Submissions: 2-4 weeks
  • Modification Submissions: 3-5 weeks
  • Incident Submissions: varies based on type of incident reported

We recommend allowing ample time for review and responding promptly to feedback. Final determinations are dependent on your timely and sufficient response to comments. 

Also, depending on the study procedures being performed, there may be ancillary reviews that affect a study start timeline even if not required to obtain IRB approval/exempt determination. Some examples are below:

  • A study in which a team member has a disclosable financial interest would require a COI disclosure and subsequent Conflict of Interest Review Committee (COIRC) review.
  • A study that involves use of a transcription service may require Risk Services review/approval in order to process a purchase order for funding the use.
  • A study that involves use of a non-UCSC approved survey platform (i.e., a platform other than Qualtrics) may require review by the PI’s ITS Divisional Liaison.
  • A study that involves collection or use of identifiable UCSC student educational records (GPA, SAT test scores, etc.) may be subject to the Family Educational Rights and Privacy Act (FERPA), and thus require investigators to follow the UCSC Policy on Privacy of Student Records.
  • A study that involves surveying 500+ UC Santa Cruz students, faculty, or staff or use of a survey that has a campus- or division-wide strategic goal(s) and/or includes questions about campus climate for diversity, equity, and inclusion may require review by the Institutional Research, Assessment, and Policy Studies (IRAPS) unit.
  • A study that involves receipt or use of human blood, body fluids, tissues, or cells (including stem cells/cell lines) may require:
  • A study that involves receipt or use of secondary data from a non-UCSC institution/entity may require establishment of a Data Transfer & Use Agreement (DTUA), which would require review Industry Alliances & Technology Commercialization (IATC) office review/approval.
  • A study that involves the use of human embryonic stem cells (hESC), induced pluripotent stem (iPS) cells, neural progenitor cells, human embryos, human gametes and other potentially pluripotent cells from any source is subject to Stem Cell Research Oversight (SCRO), and thus will require Human Gamete, Embryo and Stem Cell Research (GESCR) Committee review and approval.

How can an investigator see the status of a study? 

Study status can be viewed by any UCSC affiliates on the study team using Cayuse Human Ethics. Instructions and guidance can be found on ORCA’s Cayuse Human Ethics page.  

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Informed Consent

What is informed consent?

Informed consent involves an education and information exchange that takes place between the researcher and the potential subject. Both written and verbal consent for participation in research must involve an informed consent process. 

Informed consent should be documented by an IRB-approved written consent form that is signed (including in an electronic format) by the subject or the subject’s legally authorized representative (LAR). A written copy should be given to the person signing the informed consent form. More information can be found on the Informed Consent page.

What is assent?

In human subjects research studies that include children or minors as subjects, the consent process should include the assent, or agreement, of the child/adolescent. The primary focus should be enabling the subject to fully understand the explanation of the study. The need for and type of assent process may vary depending on various factors including, the age of the participants, literacy, or development. More information can be found on the Informed Consent page.

What is parent permission?

In human subjects research studies that include children or minors as subjects, the consent process should include the permission of the child’s parent(s) or legal guardian(s). More information can be found on the Informed Consent page.

What is a waiver of documented consent?

The UCSC IRB may waive the requirement for the investigator to obtain signed written consent for some or all subjects if certain requirements are met. More information can be found on the Informed Consent page.

What is a waiver of informed consent?

A waiver of informed consent is a waiver of the requirements to obtain informed consent, or a waiver or alteration of some of the required elements of informed consent. More information can be found on the Informed Consent page.

What is a waiver of parental permission?

In studies that include children or minors as subjects, the consent process must include the permission of the child’s parent(s) or legal guardian(s). If the IRB determines that parental or guardian permission is not a reasonable requirement to protect the subjects, such as in cases of neglected or abused children, they may approve a waiver of the requirement for permission. More information can be found on the Informed Consent page.

Is there guidance on when UCSC DocuSign be used to obtain signatures on consent forms?

The DocuSign FAQ information/guidance below was developed in collaboration with ITS.

Can UCSC DocuSign be used to obtain signautres on consent forms? 

DocuSign works with your CruzID email address (cruzid@ucsc.edu) only. It will not work with Google email aliases or other certain extensions such as @ucolick.org, @soe.ucsc.edu, or @scipp.ucsc.edu.

The current consent templates found on the Informed Consent page should be used when obtaining consent via DocuSign. UCSC's DocuSign page provides additional information related to the platform and instructions for its use.

An employee sending a document outside of the University for signature must have procedures in place to verify the identity of an external party who is the intended recipient and signatory. Authentication methods requiring the external party to provide additional information to verify their identity must be used before sending out a document for signature. These methods include passcodes or two-factor authentication such as SMS Text Messages and phone calls. Email authentication for non-UCSC emails may not be enough for many agreements. Please refer to the Summary of Two-Factor Authentication table below and contact the ITS Docusign team for more information.

It is important to remember that DocuSign is not a system of record retention. All documents are purged every 90 days. Study team members executing consent documents via DocuSign are responsible for ensuring the fully-executed documents (signed consent forms) and certificates of completion (CoCs), are stored in a manner consistent with the UCSC IRB Policy on Record Retention, the University’s Record Retention Policy and their own departmental requirements. 

When Can’t UCSC DocuSign be used?

  • UCSC’s implementation of DocuSign does not meet the needs for FDA regulated research under 21 CFR Part 11. Human subjects research studies that are FDA-regulated cannot use DocuSign.
  • DocuSign cannot be used in research that is subject to International Traffic in Arms Regulations (ITAR). 
  • DocuSign cannot be used to document the handling or transporting of hazardous or toxic materials.
  • DocuSign cannot be used for court orders, notices, or other official court documents.
  • Consult with the UCSC Office of Campus Counsel for international agreements.

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Confidentiality

What is "coded" data?

In the context of human subjects research, "coded" means that identifying information (such as name, address, phone number or social security number) of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol, or combination thereof (i.e., the code); and a key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens.

What is “identifiable” information?

For most human subjects research purposes at UCSC identifiable information means that the information includes direct/personal identifiers. Personal identifiers include the following:

  • Names
  • Phone numbers
  • Email addresses
  • IP addresses
  • Social security numbers
  • Photographs/images
  • Audio- or video-recordings
  • Street address
  • Identification (ID) numbers (driver's license, state ID card, passport, etc.)
  • Biometric identifiers (finger prints, voiceprints, etc.)
  • Information that would also be considered PHI. For definition of PHI see HIPAA section.
  • Information regulated by the Payment Card Industry (PCI) Data Security Standard
  • Codes that link unidentifiable data to identifiers

There are instances where an investigator may not be collecting any direct identifiers, such as names, but will be collecting enough indirect information about a group of people that a person familiar with the group could potentially identify subjects, or that information could be combined in such a way as to ascertain subjects' identities.

For example:

  • A study investigator collects both academic department and ethnicity at a university with a small number of ethnic minorities.
  • A study investigator collects demographic information about a group of employees at a small company.
  • A study investigator records the age, rank, and years of service of a group of Marines who served in a small base in Afghanistan in 2012.

When is information considered “anonymous”?

An individual’s participation in a research study can be described as anonymous when no one, including the study investigators, can identify them as a participant.

Data/specimens are anonymous when no one, including the study investigators, can connect the data to the individual participant (i.e., no personally identifying information is collected). Keep in mind that even when study investigators do not collect direct personal identifiers such as name or student ID number, collection of indirect identifiers, taken in combination, might make it possible for someone to identify an individual participant from among a pool of subjects - for example, academic department and ethnicity.

What is “private” information?

There are two kinds of private information included in the federal definition:

  • information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and
  • information that has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public, such as a medical or school record.

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What is a Federalwide Assurance (FWA)?

The Federal Policy (Common Rule) for the protection of human subjects requires that each institution "engaged" in federally-supported human subject research file an Assurance with the Department of Health and Human Services (DHHS) Office of Human Research Protections (OHRP). The Assurance, or FWA, formalizes the institution's commitment to protect human subjects by complying with the requirements for human subjects research set forth in the regulations at 45 CFR 46 and the Terms of Assurance.

UCSC's Federalwide Assurance number is FWA00002797. 

Investigators engaged in collaborative research who need to find the other institution’s FWA # for a submission can use the searchable database of assurances available at the Office for Human Research Protections.