Human Subjects Research: IRB

IRB protocol submissions are reviewed on a rolling basis all year long.

Submission Writing Tips

• Use plain language: Write to an audience of educated non–subject matter experts. Avoid jargon.
• Check submission for consistency: Ensure the information provided is consistent throughout, including attachments.
• Use provided templates: Check the IRB Templates Library for customizable templates for consent, assent, letter of permission to recruit and so on. Using the templates ensures that documents include all elements required to meet IRB regulatory standards.
• When in doubt, reach out!: Faculty advisor involvement in students’ IRB submissions can reduce review times and is encouraged. We are also available for submission guidance and questions. 

Use of AI

Artificial Intelligence (AI) may be used to assist with IRB submission materials; however, researchers are responsible for reviewing and editing all content to ensure it is accurate, concise, and specific to their study. Submissions containing generic or irrelevant information or excessive formatting may be returned for revision, which can delay review.

All individuals conducting human subjects research are required to pass an online research ethics training course. This includes not only the principal investigator but also all co-investigators, faculty advisors, research technicians, research assistants and student assistants who have contact with research participants or identifiable data.

Register for training at CITI Program using SFSU credentials.

Once we receive an IRB submission, we determine the category under which it will be reviewed. We always conduct a pre-review to ensure the submission is clear and organized. We may request clarification or additional information during this time. 

If the review category is Exempt, Human and Animal Protections reviews the submission and emails an exempt determination notification. Research may begin upon receipt of the email, but notify us of any planned changes to the study.

If the review category is Expedited, an IRB designee reviews the submission. Revisions may be requested or the submission may be approved. If approved, an approval letter will be emailed. Research may begin upon receipt of the approval letter, but notify the IRB of any planned changes to the study and renew the study before expiration, if applicable. 

If the review category is Full Board, all IRB members review the submission at the next convened meeting. Meetings occur on the first Wednesday of the month if any full board studies are to be reviewed. The IRB will issue a determination letter within 7–10 days after the meeting. 

Review Time Frame

While the time frame for review greatly depends on the queue of submissions and promptness in responding to revision and clarification requests, approximate review time frames are as follows: 

• Exempt: 1–2 weeks
• Expedited: 2–4 weeks
• Full Board: 4–8 weeks 

After an IRB submission has been reviewed and all requested revisions have been completed, you will be notified of one of the following outcomes. 

If the submission was reviewed at the exempt level, you will receive an exempt notification email and only then may begin research. The exempt determination is good for the life of the project, however, changes to the research may require IRB review. View the Modification Guide and/or contact us for help determining whether an IRB Modification Form is required for the desired change. 

A submission reviewed at the expedited or full board levels receives approval. You will receive an approval letter with the approval date, expiration date, if applicable, and terms of approval. 

Conditional approval is awarded for full board studies if minor correctable issues are found in the submission. You will receive a letter requesting revisions and/or clarifications necessary for IRB approval. Research may not begin until revisions are addressed and accepted by the IRB chair and you receive an IRB approval letter. 

A submission is deferred if there are substantive issues that require correction, major clarifications are needed on risk or procedures or information is needed to continue review. Research may not begin until information, clarification or revision is provided and the IRB has reviewed and approved the response at a second convened meeting. The approval date will be the date of the second full board meeting when the approval is granted. The expiration date will be one year from the date of the second convened meeting. 

If the research is disapproved, you may not conduct the proposed research. You will receive an email detailing the reason for the IRB's decision. You will have the opportunity to respond to the IRB in writing or in person. You may resubmit the submission to the IRB for review if the reasons given for disapproval can be addressed.

Modification

Modification to any aspect of the project must first be reviewed and approved by the IRB, which may take up to three weeks. We may request clarification or revision that must be addressed before changes can be approved. See the Modification Guide for help determining whether an IRB Modification Form should be submitted.

Renewal

Some expedited and full board protocols require annual renewal, which requires the submission of an Annual Renewal Form in IRBManager. The form should be submitted at least three weeks before the protocol expiration date. We may request clarification or revision that must be addressed for the renewal to be approved.                                                   

Adverse Event

An adverse event is an event that occurs during the course of research that causes or increases the risk of physical or psychological harm to a research participant or results in a loss of privacy and/or confidentiality to the participant or others.

We encourage contacting us with questions about whether an event is considered adverse. We will maintain confidentiality until a formal adverse event report is filed; however, we are required to follow up on any indication that a serious or significant adverse event has occurred. Adverse events can be reported via an IRB Incident Report in IRBManager.

Adverse events may be any of the following:

• Anticipated: An adverse event that is reasonably expected in nature, severity and frequency and is included in the IRB submission and consent form as a possible risk of participation.
• Unanticipated: An adverse event whose nature, severity or frequency was not identified in the IRB submission and consent form as a possible risk of participation.
• Related: Only adverse events that are caused by or affect the study design or procedures of the research must be reported.
• Serious: A serious adverse event includes death, life-threatening experience, hospitalization, disability or incapacity or congenital abnormality or birth defect. A serious adverse event must be reported within five working days via the IRB Incident Report Form in IRBManager. This form must be completed and signed by the principal investigator. A copy of the informed consent document and any other supporting documentation is required. Usually, mitigation necessitates modification of the study. If this is the case, submit an IRB Modification Form in IRBManager detailing any changes and adverse event mitigation strategies. The serious adverse event may also need to be reported to the federal Office for Human Research Protections.
• Minor: A minor adverse event includes mild, transient harms that are easily tolerated, require no medical evaluation and cause no disruption to participants’ normal activities. A minor adverse event should be reported only if it results in a modification of the research procedures or documents to mitigate the risk of event occurrence and detriment to participants or others. The minor adverse event may be reported through the IRB Incident Report Form in IRBManager.

Deviation or Violation

Not adhering to procedures outlined in an approved or exempted IRB submission is considered a deviation or violation.

A minor deviation is a departure from IRB-approved procedures or instruments that does not significantly impact the (a) safety, rights or welfare of participants, (b) participants’ willingness to participate in the study or (c) integrity or scientific soundness of the data. Examples of minor deviations include changing minor wording on a survey, altering time required for an interview and making minor administrative changes to participant-facing documents, such as correcting a telephone number or email address. A minor deviation should be reported to Human and Animal Protections when discovered and no later than five business days after the occurrence.

A major deviation is any unauthorized departure from IRB-approved procedures or instruments that significantly impacts participants’ safety, rights or welfare or compromises the integrity of research data. Examples of major deviations include neglecting to obtain informed consent prior to collecting data, not following stated inclusion or exclusion criteria, changing procedures without authorization or collecting data after protocol approval expiration. A major deviation should be reported via IRB Incident Report in IRBManager. The IRB will review the report and may request additional corrective action; subsequent submission of an IRB Modification Form may be required. A major deviation should be reported when discovered and no later than five business days after the occurrence.

A protocol violation is a serious, often intentional, deviation from an IRB-approved study plan that compromises participants’ safety, rights or data integrity. These situations are considered research misconduct and initiate immediate investigation from Human and Animal Protections and the IRB chair. Protocol violations are reported to the institutional official, dean of Graduate Studies, federal Office for Human Research Protections, research sponsors and any other appropriate external agencies. A protocol violation can result in the suspension or termination of research. Examples include failure to report a serious adverse event, purposeful incorrect study drug dosage or administration and unauthorized personnel performing study procedures. A protocol violation must be reported via IRB Incident Report in IRBManager within five business days of the occurrence.

Study Completion

When participant enrollment has ended, all data have been collected and the only remaining research activity is analysis of deidentified data, submit a Study Completion & Closure Form in IRBManager. This form notifies the IRB that no further data collection will take place for the study.

Cooperative Research

Cooperative research involves one or more researchers from SFSU and one or more researchers from another institution. A reliance agreement for cooperative research may be required if researchers at both campuses do the following:

• Collect informed consent
• Collect data (identifiable or not)
• Analyze identifiable data

A reliance agreement is a formal agreement between two institutions in which one institution agrees to rely upon the IRB of the other institution for the review and oversight of human subjects research. This reduces confusion and contradiction from regulatory decisions and requirements from each institution and minimizes administrative burden. A reliance agreement involves the cooperation of both campuses and administrators of both IRBs must be included in the communication and routing of the agreement.

If conducting cooperative research, contact us and provide the following:

• Brief project description
• IRB approval letter
• All researchers’ names and respective institutions

Note: SFSU does not engage in reliance agreements for exempt research per regulation: 45 CFR 46.114.

Research at Another Institution

To conduct research at another institution, SFSU faculty, staff or students who are not the sole principal investigator on a project must receive approval from the SFSU IRB before engaging in the research. Contact us and we will work with you to ensure the proper approvals and any inter-institutional agreements are in place.

External Researchers 

External researchers with IRB approval or an exempt determination from their home institutions who seek participants at SFSU should submit a request to protocol@sfsu.edu. Include a brief explanation of the study and attach the following:

• Recruitment materials
• Consent forms
• IRB approval or exempt determination letter
• Letter of permission to recruit from the relevant SFSU department or office (permission letter template)

Additional information may be requested.

Consent Forms

• Standard Informed Consent Form
• Implied Consent Form
• Verbal Consent Form
• Parental Permission Consent Form
• Witness/Translator Addendum
• Focus Group Addition
• FERPA Clause Addition
• HIPPA Authorization Addition
• SFSU Employee Compensation Addition

Image Release Forms

• Photo Release Form
• Video Release Form

Recruitment Forms

• Letter of Permission to Recruit
• Verbal Recruiting Script

Miscellaneous Forms

• Research Debriefing Form