IRB FAQ

  1. Does my project involve human subjects?
  2. How long will it take to review my protocol?
  3. Does student research require IRB review?
  4. Internet-Based Research: Public vs. Private
  5. What if my research involves educational records?
  6. Do I need to renew my protocol if I am only doing data analysis?
  7. What kind of changes do I need to submit?
  8. Do I need approval from the UCSC IRB or a different IRB?
  9. What is "coded" data?
  10. What happens after I submit my protocol?
  11. What if my research involves oral history?

Does my project involve human subjects?

Who is a human subject?
Within the context of IRB review, a human subject is defined as a living person about whom a researcher obtains data through:
  • Intervention (for example, venipuncture or cognitive tests) or 
  • Interaction (for example, interviews) with the person, or 
  • Identifiable Private Information (for example, observations or private records). A person may be a "human subject" when a researcher obtains data about the person from a third party as well as from the person directly.
What is "intervention"?
An intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject's environment that are performed for research purposes.

What is "interaction"?
An 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 (for example, a medical record).
 
What is “identifiable” information?
In this context, identifiable means that the identity of the subject may readily be ascertained by the investigator or associated with the information obtained as part of the research.
 
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
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, a researcher 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 research that is NOT considered human subjects research:
  • 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. 
  • Asking a teacher to evaluate the effectiveness of different teaching techniques based on a set rubric, or on the performance of students in aggregate, without providing private, personally identifiable information about individual students.
  • The purpose of the research is to determine whether System A or B is better. The researchers ask 30 engineers who have used both systems to evaluate the systems (e.g., with instructions to rate each system on a scale of 1 to 10). The researchers perform an analysis that determines statistically which system is better.
Some examples of research that IS considered human subjects research:
  • 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 researchers 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 researchers perform an analysis that determines the engineers have low within-rater reliability.
To know if you are conducting "human subjects research",  also see Am I conducting research? Human subjects research projects must be reviewed and approved before you begin. 

How long will it take to review my protocol?

< Standard Service Level ExpectationsThese guidelines are based on the understanding that the ORCA office will receive a completed protocol, with all questions answered in a thorough and responsive manner, and all related requirements met. Requirements for IRB may include: CITI training, HIPAA training, EH&S clearance, and Field Study Plan approval. Some types of review may require extra time or additional reviews. If you have a project involving vulnerable populations (such as prisoners, children, or pregnant women), identifiable medical records, deception, collaboration with other institutions, or illegal activities please allow additional time for review. Additional time should also be allotted for protocols submitted outside of the school term or during vacation periods. The full IRB committee does not meet during the summer quarter. *For protocols requiring committee approval, please keep in mind that the IRB committee is comprised largely of academic volunteers who perform these tasks in addition to their other duties. Additional time should be allotted for any committee review, if possible. Submission Instructions Protocol applications must be submitted electronically as a single .pdf document to the ORCA by noon on the suggested day to ensure the review can be completed in time.
 
ORCA Administrative Tasks ​Standard Service Level Expectations
IRB Submission Inquiries Within 3 business days
IRB Protocol Screening Within 3 business days
Phone Calls (Responding) Within 3 business days
IRB Consultation (email or phone) Within 3 business days
Exempt Protocols Within 2 - 4 weeks
  
 
IRB Committee Processes Deadline
Protocols Qualified for Expedited Review* 4 - 6 weeks before work is scheduled to begin
Annual Renewals* 2 -4 weeks prior to anniversary date
Full Committee Review* 4 -6 weeks before research is scheduled to begin

Does student research require IRB review?

Generally, the IRB definition of "research" does not include student course work or undergraduate honors theses, unless they are to be made available to the public, used by other researchers, or there is a possibility that the research may lead to a formal presentation or publication. See Am I conducting human subjects research?

However, even when student work involving human subjects does not constitute research, the faculty members who assign or supervise the work are responsible for educating their students to safeguard the well being of the subjects. If an instructor determines that there is a possibility that a student's proposed research project may result in a formal presentation or publication, he/she should recommend that the student submit the project for IRB review.

Internet-Based Research: Public vs. Private

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 minimal or no restriction.
  • 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 considered private information?) and someone may assume that the information provided or available on the Internet about them is private, when it is not. The principle of beneficencemay support a more conservative approach. A subject who incorrectly assumed his/her identifiable information was private, or restricted to a small group, might not have posted the information if s/he thought the information would be widely available, believing that the information could be embarrassing or damaging.
Are avatars considered human subjects? If I study avatars, is the research considered anonymous?  Investigators should try to determine if an avatar or other Internet personae might be a virtual representation or a proxy for an individual. Avatars should be considered human subjects if during observation of their actions, or while interacting with them, personally identifiable information (PII) could be obtained.

What if my research involves educational records?

Principal Investigators are required to adhere to additional rules when student records are involved. These regulations exist separately from IRB decisions. That is, PIs must adhere to FERPA and PPRA as well as IRB decisions. IF FERPA and PPRA have more stringent rules, the PI must adhere to those. 

What is FERPA?

FERPA is a federal law that gives parents certain rights with respect to their children's education records. These rights transfer to the student when he or she reaches the age of 18 or attends a school beyond the high school level. 

What part of FERPA relates to UCSC IRB protocols?

Generally, schools must obtain written permission from the parent or eligible student in order to release any information from a student's education record. FERPA defines educational records as records containing information (in any medium - paper, electronic, microfilm, etc.) that are directly related to a student and are maintained by an educational institution or by a party acting for the institution.

FERPA Consent Form Requirements

The written consent authorizing the release of records release must:

  • Specify the records that may be disclosed
  • State the purpose of the disclosure; and
  • Identify the party or class of parties to whom the disclosure may be made.

If a parent or eligible student so requests, the educational agency or institution shall provide him or her with a copy of the records disclosed. Signed and dated written consent may include a record and signature in electronic form that identifies and authenticates a particular person as the source and also indicates such person's approval of the information contained in the electronic consent.

When Consent is NOT Required under FERPA

FERPA allows schools to disclose educational records, without consent, to the following parties or under the following conditions (34 CFR § 99.31):

  • School officials with legitimate educational interests
  • Other schools to which a student is transferring
  • Specified officials for audit or evaluation purposes
  • Appropriate officials in cases of health and safety emergencies
  • Appropriate parties in connection with financial aid to a student
  • Accrediting organizations
  • Organizations conducting certain studies for or on behalf of the school
  • State and local authorities within a juvenile justice system, pursuant to specific state law
  • Directory Information. FERPA permits the following as: the student's name, address, telephone listing, electronic mail address, photograph, date and place of birth, major fields of study, dates of attendance, grade level, enrollment status, participation in officially recognized activities and sports, weight and height of members of athletic teams, degrees, honors and awards received, and the most recent educational institution attended.

However, students should be given the opportunity to file a request to prevent disclosure of directory information.

What is PPRA? 

PPRA specifies the right of parents and guardians to inspect any instrument used to collect information concerning:

  • political affiliations or beliefs of the student or the student's parent
  • mental and psychological problems of the student or the student's family
  • sex behavior or attitudes
  • illegal, anti-social, self-incriminating, or demeaning behavior
  • critical appraisals of other individuals with whom respondents have close family relationships
  • legally recognized privileged or analogous relationships, such as those of lawyers, physicians, and ministers
  • income

Parental/guardian consent is required before such instruments can be used to gather information from a minor.

Tips for Researchers:

  • Check school district (or post secondary school) regulations and consent form requirements.

  • Make sure your consent forms comply with both UC Policy and FERPA and PPRA guidelines.

For more information, see US Department of Education FERPA website.

Do I need to renew my protocol if I am only doing data analysis?

You may still need to renew your protocol even if you are no longer directly interacting with human subjects. 

If you still have access to identifiable data, you must continue to renew your protocol until all analyses are complete or all identifiers have been destroyed. Identifiable data include audio/video recordings as well as coded data where the identifier key is retained. 

If all identifiable data fields have been destroyed and data analysis will be conducted using only de-identified data, no renewal application is necessary and the protocol may be closed.

What kind of changes do I need to submit?

Principal Investigators (PIs) are  responsible for submitting: 

  • modifications to the study, which must receive UCSC IRB approval before they are implemented (see Modifications to Previously Approved Research);

  • reports of adverse events, protocol violations/incidents, and other safety information meeting UCSC IRB reporting criteria (see Unanticipated Problems and Adverse Events); and

  • a de-novo submission at least 4 weeks prior to the study’s expiration date, if the study is still active.

Important:  If Federal funding is secured during the approval period, the PI is responsible for promptly submitting a modification to notify ORCA.

Do I need approval from the UCSC IRB or a different IRB?

Researchers, including students, faculty or staff, who are conducting Human Subjects research at UCSC, or research that is sponsored by UCSC, should get approval from the UCSC IRB. Human Subjects research at UCSC includes research that:

  • uses the facilities of the UCSC campus; 

  • is paid for by the campus or with funds administered by the campus; 

  • is conducted as part of a researcher's progress toward a campus degree; 

  • is conducted by a campus faculty member or employee in the course of employment by the UCSC campus; or

  • uses UCSC students as subjects.

If you are doing human subjects research at UCSC you will need to submit either an exemption request or a full protocol to be reviewed and approved by the UCSC IRB before the research begins. Please note, there are no provisions for retroactive approval of research protocols. 

Student Subjects Exception (“Survey Exception”)
University policy includes one exception to the above rules that allows outside researchers to use UCSC students as subjects without UCSC IRB review as long as the research is NOT being conducted using UCSC facilities – e.g. administering an online survey to UCSC students with no on-campus interaction or intervention. In such a case, the UCSC IRB must be notified of the planned research, but no protocol review is required.

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 happens after I submit my protocol?

Once ORCA has received your application, you will receive an acknowledgment email.  After that, you should hear back from ORCA within 2-4 weeks with either an approval notification or questions regarding your application.

What if my research involves oral history?

What is oral history?

In the context of human subjects research, oral history describes a method of gathering and preserving historical information through recorded interviews with participants in past events and ways of life.

Oral History and Human Subjects Research

Oral history projects and other activities that consist solely of open-ended qualitative-type interviews are subject to IRB oversight when they involve research, which federal regulations define as "a systematic investigation...designed to develop or contribute to generalizable knowledge."

Specifically, the evaluation of such interview projects hinges upon whether the investigator is engaged in the creation of "generalizable knowledge" that is, whether the activity represents a systematic investigation in which the person engaged in such activities intends to develop or contribute to generalizable knowledge.

While oral history projects and interviews can lend themselves to generalizations, individually-tailored interviews with a narrators' informed consent do not necessarily meet the federally-defined definition of research, even if conducted with people identified with a common group, theme or event, and whether or not the interviewer or other researchers might draw some historical generalizations from multiple interviews. The interviews must be designed specifically to produce generalizable knowledge in the scientific sense in order to constitute research.

General principles for evaluating oral history projects

  • Oral history activities, such as open ended interviews, that ONLY document a specific historical event or the experiences of individuals without an intent to draw conclusions or generalize findings would NOT constitute "research" as defined in 45 CFR 46.
    • 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.
  • Systematic investigations involving 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 constitute "research" as defined by HHS regulations at 45 CFR 46.
    • 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.
  • Oral historians and qualitative investigators may want to create archives for the purpose of providing a resource for others to do research. Since the intent of the archive is to create a repository of information for other investigators to conduct research as defined by 45 CFR 46, the creation of such an archive WOULD constitute research under 45 CFR 46.
    • Example: Open ended interviews are conducted with surviving Negro League Baseball players in order to create an archive for future research. The creation of such an archive would constitute research under 45 CFR 46 since the intent is to collect data for future research.