IRB Frequently Asked Questions
When to Obtain IRB Approval
- What exactly qualifies as human subjects research?
- How do I know if the research I plan to do requires IRB approval or registration?
- Do students' academic research projects require IRB approval?
- Does secondary analysis of a data set gathered for another purpose require a new research project for review?
- If departmental or personal funds are used to support research, is IRB approval required?
- When do oral histories qualify as human subjects research?
Protocol Questions
- Who needs to be listed on the protocol narrative? Do all researchers (including collaborators) need to be listed?
- Do I need to include my research staff or student researchers on the protocol application?
- I have submitted my e-IRB Application. Now what happens?
- What is the fastest way to find out what happened to my study at an IRB meeting?
- Can I share my IRB protocol approval with colleagues working on similar projects?
- How do I submit changes to a currently approved protocol?
- How are changes to an approved protocol reviewed?
- What is a Seven-Year De Novo Continuing Review
- When should I submit a closing report to the IRB?
Adverse Event / Unanticipated Problem/ Deviation and Violation Questions
- What is meant by an adverse event?
- What is the difference between a violation and a deviation?
- Do we still need to report Safety Reports?
- Do external Serious Adverse Event (SAE) reports need to be submitted to the IRB if the study is closed at UCI?
- What is an unanticipated problem involving risk to participants or others?
Tutorial Questions
- I've forgotten my UCINetID password. How can I find out what it is?
- Which IRB tutorials do I need to take?
- How can I find out which tutorials I've taken? How can I verify my study team has completed the required tutorials?
- I get the following message when I try logging on the tutorial: "Your Browser is not configured to accept Cookies." How do I fix this problem?
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When to Obtain IRB Approval
What exactly qualifies as human subjects research?
Any systematic investigation (including pilot studies, program evaluations, qualitative research), that is designed to develop or contribute to generalizable (scholarly) knowledge, and which uses living humans or identifiable private information about living humans qualifies as human subjects research. See Definition of Human Subjects Research for more information.
How do I know if the research I plan to do requires IRB approval or registration?
If the human subject data will be aggregated, analyzed or summarized for publication or presentation of any kind (whether inside or outside the University), it requires IRB approval or exempt registration. Exempt protocols are reviewed by the IRB and granted three years registration. Continuation of an Exempt protocol beyond three years requires submission of a three-year continuing renewal application. Expedited and Full Committee protocols are reviewed and approved for one year. Annual IRB review is required to maintain approval. For an explanation of the different categories of human subjects research, visit Levels of Review.
Do students' academic research projects require IRB approval?
Yes, if a student's research project qualifies as human subjects research; whether it is biomedical or social-behavioral in nature, IRB approval is required prior to initiation.
Students, fellows, residents are required to obtain a faculty sponsor to oversee the research. For more information on the requirements for faculty sponsor eligibility, see Lead Researcher Eligibility.
Does secondary analysis of a data set gathered for another purpose require a new research project for review?
Yes. Projects that use an existing data set gathered in earlier research projects require a new IRB protocol for review.
If the data are publicly available or the data were gathered by someone who has legitimate access to the records and who provides the UCI researcher only de-identified data (so that the researcher is unable to identify the subjects), the level of risk is lowered and the project may qualify for Exempt review under Category 4. For an explanation of the different categories of human subjects research, see Levels of Review.
If departmental or personal funds are used to support research, is IRB approval required?
Yes. UCI has assured the federal regulatory agencies that the institution will review and approve all research involving human subjects before it is initiated. This assurance covers all research regardless of funding.
When do oral histories qualify as human subjects research?
A decision whether oral history or other activities solely consisting of open ended qualitative type interviews are subject to IRB review is based upon the prospective intent of the investigator. If the activity meets the federal definition of "research", IRB review is required.
The evaluation of such activities depends on whether the investigator is engaged in the creation of "generalizable knowledge" that is, whether the activity represents a systematic investigation in which the investigator engaged in such activities intends to develop or contribute to generalizable knowledge. Oral history activities, as described to OHRP by the oral history representatives, in general are designed to create a record of specific historical events and, as such, are not intended to contribute to generalizable knowledge.
General principles for evaluating Oral History type activities:
- 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" and would not require IRB review.
- Example: An oral history video recording of interviews with World Trade Center (WTC) survivors is created for viewing in a 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 attack on the WTC and provide a venue for WTC 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" and require IRB review
- Example: Open ended interviews 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 human research, the creation of such an archive WOULD constitute research and require IRB review.
- Example: Open ended interviews are conducted with women basketball players in order to create an archive for future research. The creation of such an archive would constitute human subjects research since the intent is to collect data for future research.
Protocol Questions
Who needs to be listed on the protocol narrative? Do all researchers (including collaborators) need to be listed?
All researchers (including offsite collaborators) must be listed in the protocol narrative of the UCI IRB approved research project if they will:
- intervene with subjects by performing research procedures, or by manipulating the environment for research purposes;
- participate in the recruitment and/or selection of subjects;
- participate in the informed consent process;
- collect or report subject identifiable data; or
- have access to subject identifiable study data.
Note: Any collaborator receiving credit as an author on the published results must be included on the application as a co-investigator. A statement about whether the individual is engaged in human subjects research (as described above) is necessary.
If your research team should change once the project is approved, you must submit a modification to your protocol adding the new investigator(s) or removing those no longer involved.
Do I need to include my research staff or student researchers on the protocol application?
Yes, if the work performed on the research project would allow the staff person or student researcher to have direct contact with subjects and/or access to subject identifiable data in the context of research, or to receive credit in publications resulting from the research, then his or her name must be listed on the protocol.
For staff personnel - if the individual's role on the project is part of his or her regular paid duties (i.e. phlebotomist, x-ray technician) and involvement in the project is limited to performing those duties without contributing to the research endeavor, then such individuals need not be listed as co-investigators or research personnel.
I have submitted my e-IRB Application. Now what happens?
- The Lead Researcher and Administrative Contact(s) will receive an e-mail memo assigning a Human Subjects number (i.e., HS #). This takes place usually within 48 hours of electronic submission. Keep this number as all IRB correspondence will reference the study title and HS#.
- If you have not already done so, please submit the following hard copy documentation to the Institutional Review Board, Office of Research Administration (ORA), 300 University Tower, Zot Code 7600:
- One copy of e-IRBAPP signed by the Lead Researcher and Department Chair or ORU Director (also Faculty Sponsor, if applicable). Copies of the protocol narrative and consent/assent forms are no longer required.
- For clinical investigations, four copies of the Sponsor/Master Protocol and the Investigator's Brochure.
- For studies where some required documentation was not previously uploaded and submitted via the e-IRBAPP process (e.g., survey packets, interview schedules, and permission letters), four copies of these materials.
- Upon receipt of the required hard copy documentation, an administrative review will be conducted to ensure that all the necessary information is provided. If the application is in order it is assigned to an IRB Committee for review. If the application is incomplete (e.g., consent form or survey missing) the Lead Researcher and Administrative Contact (also Faculty Sponsor, if applicable) will receive an e-mail explaining how to correct the deficiency.
- Exempt and Expedited applications are reviewed by a subcommittee of IRB members. There are no submission deadlines for Exempt and Expedited e-IRB Applications. Exempt/Expedited reviews usually occur within 2-4 weeks of receipt of all required documentation.
- Full Committee applications are reviewed monthly. UCI has two biomedical IRBs and one Social/Behavioral IRB. See ORA Calendar and Deadlines for full Committee meeting dates and deadlines.
- The IRB will reviews the application and determine one of four actions:
- A - Approval
- M - Minor changes required
- T - Tabled for re-review. The application requires significant clarifications and revisions
- D - Disapproval
- For applications that receive a Committee determination of A - Approval, the Approval/Registration letter and stamped approved documents are sent to the Lead Researcher within 3-5 working days. Research studies should not begin until stamped approval documents are received.
- For applications that receive a Committee determination of M - Minor Changes or T - Tabled for Re-Review: the Lead Researcher, Administrative Contact, and Faculty Sponsor, when applicable, receive detailed comments from the IRB via e-mail within 10 working days. Research studies must not begin until stamped approval documents are received.
- For applications that receive a Committee determination of D - Disapproval, the Lead Researcher, Administrative Contact, and Faculty Sponsor, when applicable, receive detailed comments from the IRB via e-mail within 10 working days. Please note that only the full Committee can disapprove a protocol and disapprovals are rare.
What is the fastest way to find out what happened to my study at an IRB meeting?
Full Committee meeting results are posted to the web by 3 pm, the afternoon of each meeting. To get access to these same-day results for your submissions:
- visit Results of Full Committee Meeting,
- choose the appropriate meeting date, and
- locate your protocol number...it's that easy!
Note: This will provide you with the status of your protocol only. If your protocol is approved, approval documents will be sent to the Lead Researcher within five working days. If your protocol was not approved, detailed committee feedback will be sent directly to the Lead Researcher within 10 working days of the meeting at which the protocol was reviewed.
Exempt and Expedited protocols are reviewed by a subcommittee of IRB members and the results are not posted to the web. Check with the Research Protection staff for protocol status.
Can I share my IRB protocol approval with colleagues working on similar projects?
No. The IRB approves protocols with the understanding that the work will be conducted only by the investigators named in the protocol application. If your colleagues would like to work on your research project, you may modify your existing protocol to add them as co-investigators. Otherwise, they must apply for their own IRB protocol approvals. For more information on how to modify an approved protocol, visit Modifications to the Protocol.
How do I submit changes to a currently approved protocol?
To request approval of a proposed modification, complete and submit the electronic Modification request.
Upload two versions of all revised documents (i.e. protocol narrative, consent/assent forms, recruitment letters or ads, questionnaires, etc.) one version with the changes highlighted, one version without highlights. In addition include any new documents added as a result of the proposed change (Sponsor Amendment, questionnaires, etc.)
How are changes to an approved protocol reviewed?
Changes to an approved protocol are submitted to the IRB via an electronic Modification Request (e-MOD). Changes are categorized as either minor or significant. Minor changes do not significantly affect the risks and benefits assessment of the study and do not substantially change the specific aims or design of the study. Any change not considered a "minor" change is considered a "significant" change. Minor changes may include personnel changes, changes to recruitment materials, addition of non-sensitive questions to interview or survey format, addition of a new recruitment site. Minor changes qualify for expedited reviewed while significant changes require review by the full Committee.
What is Seven-Year De Novo Continuing Review?
Every 6th year of protocol approval will require submission of updated protocol documentation along with the electronic Continuing Protocol Application. This requirement goes into effect February 1, 2010 and applies to both Biomedical and Social Behavioral Research. This includes submission of the following:
- Updating the protocol narrative to the most current version of the protocol narrative available at the IRB Forms page; and
- Ensuring that the consent form or study information sheet meets the most current consent/study information sheet requirements. The consent templates are available at the IRB Forms page and requirements are available at the Informed Consent Preparation web page.
- Submitting all documentation for the protocol review such as any data collection instruments, recruitment, stimuli, etc. This includes re-submission of any applicable IRB appendices. The appendices are available for downloading under IRB Forms. Please review all the forms and submit any that are applicable. Even if the appendix was not available when the study was originally reviewed, it may still apply. If these documents are not available electronically, 3 hard copies should be submitted.
During the Committee’s Seven-Year De Novo review(s), the Committee will require that all documents be incorporated into the CURRENT UCI templates. This may involve disclosing new information that has not been previously requested and therefore, not previously reviewed by the Committee. As with any review, studies are subject to meet all current regulatory requirements, UC/ UCI policies and procedures. Lead Researchers should not assume that at a Seven-Year De Novo continuing review, nor a standard continuing review, will receive automatic approval. Accordingly, Lead Researchers are asked to follow the submission timeline guidelines for Seven-Year De Novo reviews, as well as standard continuing reviews, to help avoid a lapse in IRB approval.
Exceptions to the Seven-Year De Novo Review Requirement
There are two types of protocols do not require Seven-Year De Novo Review:
- Continuing review of research where:
- the research is permanently closed to the enrollment of new subjects;
- all subjects have completed all research-related interventions; and
- the research remains active only for long-term follow-up of subjects; or
- Continuing review of research where the remaining research activities are limited to data analysis.
Updating the IRB Protocol Number (HS#)
In order to track the number of Seven-Year De Novo Review Cycles, the Human Subjects Protocol Number (HS#) for all protocols will be expanded. For example, protocols that have not yet undergone Seven-Year De Novo review will have a number such as HS# 2009-9999-0 to show that the protocol is in its first review cycle. Upon approval after the Seven-Year De Novo Review in seven years, the last digit will be updated to 2009-9999-1.
When should I submit a closing report to the IRB?
A study may be closed when all of the following apply:
- All subject recruitment and enrollment is complete (i.e., no new subject recruitment or enrollment are ongoing)
- All subject specimens, records, data have been obtained (i.e., no further collection of data/information from or about living individuals will be obtained)
- No further contact with subjects is necessary (i.e., all interactions or interventions are complete and no further contact with enrolled subjects is necessary)
- Analysis of subject identifiable data, records, specimens are complete (i.e., use or access to subject identifiable data is no longer necessary. Note: this includes review of source documents by study sponsors).
Informed Consent Questions
Who needs to be listed on the informed consent document?
Only those individuals who will be involved in the informed consent process are to be listed on the consent form. Individuals who obtain informed consent must be appropriately qualified through their education, training or experience to obtain the legally-effective informed consent from a subject. See the Informed Consent Process for more information.
Who can consent on behalf of a subject for participation in a research study?
If an adult is unable to consent on his/her own behalf due to cognitive or medical incapacity, federal regulations permit researchers to obtain consent from a legally-authorized representative. CA Health & Safety Code 24178 defines the categories of individuals who are legally authorized in California to provide surrogate consent for research. For more information see Obtaining Surrogate Consent. In order for a researcher to have the option to obtain consent from a subject's legally-authorized representative, the IRB must specifically approve the use of surrogate consent for a given protocol. If there is no legally-authorized representative, and the adult patient cannot consent, the individual may not become a human subject. A minor is unable to consent on his/her own behalf. A parent or legal guardian usually provides permission for the minor to participate in research. The assent of the minor is typically obtained.
Is an English consent document okay to use when enrolling non-English-speaking subjects?
No. Study subjects are given a copy of the consent to be used as a reference document to reinforce their understanding of the study and, if desired, to consult with their physician or family members about the study.
In order to meet the requirements of federal regulations, the consent document must be presented in language understandable to the subject. When the prospective subject is fluent in English, the consent document and process should be conducted in English.
However, when it is anticipated that many of the study subjects will be non-English-speaking people, and it is anticipated that the consent process will likely be conducted in a language other than English, the LR should submit a certified, translated consent form for IRB review after approval of the English version.
A copy of the translated consent document must be given to each appropriate subject. While a translator may be used to facilitate conversation with the subject, ad hoc translation of the consent document cannot substitute for a written translation. See Non-English Speaking Participants for more information.
Who must sign the consent form?
Federal regulations require that the written consent form approved by the IRB be signed and dated by the subject or the subject's legally authorized representative (if approved by the IRB) at the time of consent. A copy should be given to the person signing the form.
It is the IRB's expectation that the person obtaining consent (the Lead Researcher, or another individual listed on the consent form), will also sign and date the form, attesting to the informed consent conversation. The LR should sign the form only if he or she was present for the consent process. In addition for clinical research, a witness to the informed consent conversation must also sign and date the consent form. See the Informed Consent Process and Non-English Speaking Participants for more information.
Is informed consent required even if the data/specimens will be collected from my friends and colleagues?
Yes. All research involving interaction with human subjects (including collection of specimens) requires informed consent regardless of who the subjects are. In some cases, written informed consent may be waived. Also, special rules apply to recruiting students and staff from within one's own department. See Vulnerable Subject Populations for more information.
Can I have my research coordinator or clinic manager respond to requests from the IRB on my behalf?
No. Federal regulations require that the IRB must communicate directly with the Lead Researcher regarding protocol-related issues. Accordingly, all correspondence to the IRB must be submitted with the Lead Researcher's signature.
The Lead Researcher has overall responsibility for the conduct of the research study, which includes responsibility for the submission of protocols and other correspondence to the IRB. The IRB may return any protocol-related correspondence that is received without evidence of the Lead Researcher's approval.
Adverse Event / Unanticipated Problem/ Deviation and Violation Questions
What is meant by an adverse event?
Adverse events are untoward or unfavorable occurrences in a human subject, including any abnormal sign (e.g., abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research.
Unexpected Adverse Event - Any adverse event occurring in one or more subjects in a research protocol, where the nature, severity, or frequency of which is not consistent with either:
- the known or foreseeable risk of adverse events associated with the procedures involved in the research that are described in (a) the IRB-approved documents (e.g., applicable investigator brochure, current protocol narrative, current informed consent document), and (b) other relevant sources of information, such as product labeling and package inserts; or
- the expected natural progression of any underlying disease, disorder, or condition of the subject(s) experiencing the adverse event and the subject’s predisposing risk factor profile for the adverse event.
All unexpected AEs at least possibly related to the research are reportable to the IRB within 10 working days of the researcher’s awareness of the event via the electronic Adverse Event/Unanticipated Problems (e-AE/UP) reporting process.
Serious Adverse Event (SAE) - Any adverse event temporally associated with the subject’s participation in research that meets any of the following criteria:
- results in death;
- is life-threatening (places the subject at immediate risk of death from the event as it occurred);
- requires inpatient hospitalization or prolongation of existing hospitalization;
- results in a persistent or significant disability/incapacity;
- results in a congenital anomaly/birth defect; or
- any other adverse event that, based upon appropriate medical judgment, may jeopardize the subject’s health and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition (examples of such events include: allergic bronchospasm requiring intensive treatment in the emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse).
Internal serious adverse events (occurs on a study under UCI IRB authority) that are unexpected and at least possibly related to the research should be reported to the IRB via the e-AE/UP reporting process within 5 working days of the researcher’s awareness of the event, followed by any follow-up reports, as applicable. Internal, unrelated serious adverse events (occurs on study under UCI IRB jurisdiction) that result in death should be reported to the IRB at the time of continuing review using the Internal Unrelated SAE Summary Log.
What is the difference between a violation and a deviation?
Both deviations and violations occur when the study is not conducted per the IRB-approved protocol. A deviation is an unintentional change to or noncompliance with the research protocol that does not have a significant effect on the subject's rights, safety or welfare, and/or on the integrity of the data. Deviations may result from the action of the participant, researcher, or research staff. Examples of deviations include: a rescheduled visit; an incomplete study visit; and failure to collect ancillary study measures (e.g., questionnaire, baseline BP).
A violation is an accidental or unintentional change to or noncompliance with the IRB-approved protocol that increases risk or decreases benefit and/or affects the subject's rights, safety, welfare, and/or the integrity of the data. Examples of incidents that may be considered violations include: enrolling a participant who does not meet the inclusion criteria; obtaining verbal consent before the initiation of study procedures when the IRB requires signed, written informed consent; and failure to collect screening labs before initiation of study procedures.
Violations must be reported to the IRB within 5 working days of the researcher’s knowledge of the event or problem via the AE/UP online reporting process. Deviations are not reportable to the IRB and we strongly encourage investigators to inform Study Sponsors of UCI’s reporting policy. A letter to study sponsors outlining the UCI IRB Reporting policy is available upon request. If, however, an investigator chooses to report deviations they must do so via the Tracking Log for Non-Reportable Events available on the IRB Applications and Forms webpage. This log will be reviewed by the HRP staff. They will confirm that the event(s) do not constitute reportable event(s) and will sign and return the original log to the Lead Researcher.
Do we still need to report Safety Reports?
Safety Reports are external adverse events. An external adverse event should be reported to the IRB when the event changes the risk/benefit profile of the study and/or when the IRB-approved documents (e.g., protocol and consent form) must be revised. Safety Reports that meet these criteria should be submitted via the AE/UP online reporting process as soon as possible, but no later than 10 working days after the researcher’s awareness of the event. A Modification request (e-MOD) must also be submitted to update the protocol narrative and consent form.
Do external Serious Adverse Event (SAE) reports need to be submitted to the IRB if the study is closed at UCI?
Assuming that all research procedures have been completed at UCI, a serious adverse event occurring at a non-UCI site would not be reportable to UCI's IRB unless the SAE involves some type of delayed reaction (e.g., toxicity, congenital anomaly/birth defect) related to the research intervention that could still affect participants who were enrolled at UCI.
What is an unanticipated problem involving risk to participants or others?
An unanticipated problem involving risk to participants or others is any event, experience, or problem that is: (1) unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the IRB-approved documents, such as the protocol and informed consent document, and (b) the characteristics of the subject population being studied; (2) related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or problem may have been caused by the procedures involved in the research); and (3) suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized. Protocol violations and serious adverse events would qualify as an unanticipated problem involving risk to participants or others.
The IRB will review e-AE/UP reports in a timely manner and determine whether the reported event represents an unanticipated problem involving risk to participants or others. The IRB will report any unanticipated problems involving risk to participants or others to the Lead Researcher, appropriate UCI officials, the funding agency or study sponsor, if applicable, the Office of Human Research Protections, and other applicable regulatory authorities. The IRB may also require that investigators take further actions. See the Reporting Adverse Events, Unanticipated Problems Involving Risk to Participants or Others, and Protocol Violations webpage for more information.
Tutorial Questions
I've forgotten my UCINetID password. How can I find out what it is?
UCINetID passwords are not known to anyone but you. If you've forgotten your password for your UCInetID, you need to have Network Academic Computing Services (NACS) reset your password and re-activate your UCInetID. See the NACS website for information and instructions.
Which IRB tutorials do I need to take?
All study team members must complete the Human Research tutorial. If the research involves protected (personal) health information, known as PHI, all study team members must also take the HIPAA Research tutorial. In order to receive credit for taking tutorials, you must log-in as an authenticated user (i.e., with your UCINetID and password).
For more information on required tutorials, see the Electronic Tutorials webpage. Also, to determine whether your research involves PHI, please see the Protected Health Information (HIPAA) webpage.
How can I find out which tutorials I've taken? How can I verify my study team has completed the required tutorials?
There is a tutorial verification page on the ORA website. Anyone can verify whether a person performing research has taken any of the electronic research tutorials for credit. To verify the completion of a tutorial for credit, go to Tutorial Verification and enter a first name, last name or both. The resulting page can be provided to the Office of Research Administration or others who require verification of tutorial completion.
I get the following message when I try logging on the tutorial: "Your Browser is not configured to accept Cookies." How do I fix this problem?
You need to reconfigure your browser setting to allow cookies. If you use Internet Explorer go to: Tools--Internet Options-Privacy--Advanced Privacy Settings. If you need more help with how to enable cookies, please check in with the computer support person in your department.
