Human Subjects Research (IRB)

IRB Review Decision Tree

Take the IRB Review Decision Tree for help determining whether IRB submission is necessary.

Contact Human and Animal Protections for Assistance

Contact Human and Animal Protections for help understanding whether IRB submission is necessary and, if so, which form to submit. Navigate to the "Questions, Help, and Guidance" section below for contact information.

Cooperative research is research that 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 investigators at both campuses are:

• Collecting informed consent,
• Collecting data (identifiable or not), and/or
• Analyzing identifiable data.

 A reliance agreement is formal agreement between two institutions where 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.

This agreement involves the cooperation of both campuses, and administrators of both IRBs must be included in the communication and routing of the agreement.

If you will be conducting cooperative research involving SFSU or have questions about cooperative research, please email Human and Animal Protections at protocol@sfsu.edu and provide:

• Brief project description
• IRB approval letter

• All investigators' names and their respective institutions

   

Note: SFSU does not engage in Institutional Authorization Agreements for exempt research per the regulations at 45 CFR 46.114.

External researchers with IRB approval or an exempt determination from their home institution who seek participants at SFSU should:

1. Submit a request to the SFSU IRB office at protocol@sfsu.edu. Include a brief explanation of the study and attach:

   • Recruitment materials,
   • Consent form(s), and
   • IRB approval or exempt determination letter from your home institution

   Additional information may be requested.
    

2. IRB office secures approval from the appropriate signatories.
    
3. A signed approval letter (aka "External Investigator Request") from the IRB office is provided to the external investigator who can then work with their selected department or office to disseminate recruitment materials.

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. Please contact Human and Animal Protections at protocol@sfsu.edu and we will work with you to ensure the proper approvals and any inter-institutional agreements are in place. 

Tips for Submission Writing 

• Use plain language
  Plain language is grammatically correct and universally understood language that includes complete sentence structure and accurate word usage. Plain language is not unprofessional writing or a method of "dumbing down" or "talking down" to the reader. Writing that is clear and to the point takes less time to read and comprehend. Clear writing tells the reader exactly what the reader needs to know without using unnecessary words or expressions.
   
• Check submission for consistency
  Check all attachments to make sure the information is consistent with the contents of your submission.
   
• Don't reinvent the wheel
  Check the IRB Templates Library for customizable templates for consent, assent, letter of permission to recruit, etc. Using templates helps to ensure that research documents include all elements required to meet regulatory standards.
   
• When in doubt reach out!
  Faculty advisor involvement in students’ IRB submissions is encouraged. It can reduce review times and back-and-forth with the IRB office. Human and Animal Protections (HAP) staff are available for submission guidance and questions. We encourage early questions. Email HAP at protocol@sfsu.edu, call (415) 338-1093, or book a meeting through the Human and Animal Protections section at the bottom of the page. 

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.

IRBManager User Guide

IRBManager is the online IRB submission platform at SFSU. For help navigating IRBManager, please see the IRBManager User Guides or contact Human and Animal Protections at protocol@sfsu.edu.

IRB Submissions are reviewed on a rolling basis all year long. 

Required Elements of Informed Consent
 

Adapt each template to your study by adding relevant information and modifying the language as needed.

Guidelines for Obtaining Assent from Minors

Pparticipants who are minors (under the age of 18 and not legally emancipated) cannot give their "informed consent"; but they can "assent" to participate in research. Assent is defined as a child's affirmative agreement to participate in research.

Children 8 years of age and under

In minimal risk research, the children in this age group should simply be verbally told what the research activity will be, and the description should be simple and age-appropriate. For instance, "We will give you some stickers and you will tell us which one you like the most," or "You will tell us a story about something that happened to you and I will take notes."

Youth ages 9-13

The purpose of the assent form for this age group is to inform the youth of what will happen during the research procedures. This should be a written and form that is very simple and informative about what will happen. Keep it non-technical, jargon-free and age-appropriate language for your young prospective participants.

Youth ages 14-17

Since the adult consent form should be written at no higher than an eighth grade reading level, a 14-year-old should be able to understand the same form and concepts. This assent could be a simplified version of the standard informed consent for adults. Language should be non-technical, jargon-free and readable by the 14 to 17 year-olds who will participate in your research.

Note: Many minors at this age do not like to be referred to as children, so please refer to them as "youth, adolescents, or "students" (if applicable) in the assent form.

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 faculty advisors, co-investigators, research technicians, research assistants, and student assistants who have contact with the research participants or identifiable data.

Enroll and begin the course here: Social/Behavioral Research Course

Questions?

• Email: protocol@sfsu.edu
• Phone: (415) 338-1093

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

Once your IRB submission is received, your study will be assigned a review category based on its procedures, methodology, and potential risks to participants.

If the review category is Exempt, your submission is reviewed by Human and Animal Protections. You will likely receive one or more requests for revisions or clarifications. This is normal. You may begin your research upon receiving the exempt determination notification email. 95% of IRB submissions at SFSU qualify for exempt review.

If the review category is Expedited, the submission will be reviewed by an IRB reviewer. You will likely receive one or more requests for revisions or clarifications. This is normal. Upon expedited approval, the investigator will receive an approval letter via email. Research may begin upon receipt of the approval letter. 4% of IRB submissions at SFSU qualify for expedited review.

If the review category is Full Board, the submission will be reviewed at the next convened IRB meeting. A convened IRB meeting is a meeting in which all or most of the IRB members are present. Meetings occur on the first Wednesday of the month, however, the IRB does not necessarily meet every month as ~1% of IRB submissions at SFSU qualify for full board review. The investigator will receive an outcome letter via email 7-10 days after the meeting.

See Review Outcomes below for possible review determinations. 

Expected Review Turnaround Times

While the rate of the review process greatly depends on the queue of submissions preceding the researcher's and the researcher's 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

Note: As IRB reviewers are also faculty members, turnaround times may be longer during academic breaks.

After the IRB review is complete, the investigator will receive an email notifying them of the review outcome. Possible outcomes are listed below.

Exempt Determination

If the submission qualifies for exempt review, the investigator will receive an exemption notification by email. This email is to be regarded as approval to begin research. Exempt determinations do not expire; however, certain changes to the research may require IRB review. Consult the Modification Guide or contact Human and Animal Protections at protocol@sfsu.edu to determine whether a proposed change requires submission of an IRB Modification Form. Investigators are responsible for submitting a Study Completion & Closure Form when all data collection and analysis of identifiable information has concluded.

IRB Approval

When a study is approved, the investigator will receive an IRB approval letter by email. The letter will include the IRB-assigned study number, approval date, expiration date, if applicable, and terms of approval.

Conditional IRB Approval

Conditional approval may be granted when the IRB requires specific, minor revisions that do not raise substantive concerns about the research. The investigator will receive a letter identifying the revisions or clarifications required for final IRB approval. Research may not begin until the required revisions are accepted by the IRB Chair and the investigator receives an IRB approval letter.

Deferral

Review is deferred when substantive concerns or insufficient information prevent the IRB from making an approval determination. Research may not begin until the investigator addresses the IRB's concerns and the convened IRB reviews and approves the revised submission.

Disapproval

If the IRB disapproves the research, the investigator may not conduct the research as proposed. The investigator will receive written notice of the reasons for disapproval and an opportunity to respond to the IRB in person or in writing. The investigator may submit a revised protocol for IRB review that addresses the reasons for disapproval.

Modifying your IRB Submission

If you would like to make changes to any aspect of your project, these changes must be reviewed and approved by the IRB office. Note that no changes may be implemented before they are officially approved. Please allow up to three weeks for modification processing: our office may request clarifications or revisions that must be addressed by the submitter(s) before changes can be approved. See the Modification Guide for help determining whether an IRB Modification Form should be submitted. 

Renewing your Protocol

Some expedited and full board protocols require annual renewal. Annual renewal entails the submission of an Annual Renewal Form in IRBManager. The renewal should be submitted at least three weeks before the protocol expiration date. The office may request clarifications or revisions that must be addressed by the researcher(s) in order for the renewal to be approved.

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

Investigators are encouraged to contact Human and Animal Protections if they have any questions about whether or not an event is considered an adverse event. Human and Animal Protections 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:

• Anticipated: An adverse event that is reasonably expected in nature, severity, and frequency, and is included in the protocol and consent form as a possible risk of participating in the research
• Unanticipated: An adverse event whose nature, severity, or frequency was not identified in the protocol and consent form as a possible risk of participating in the research.
• Related: Only adverse events that are caused by or affect the study design or procedures of the research need to be reported to Human and Animal Protections.

Adverse events may be:

• Serious: adverse events include death, a life-threatening adverse experience, hospitalization or prolongation of hospitalization, a persistent or significant disability or incapacity, or a congenital abnormality/birth defect. Serious adverse events must be reported to HAP as soon as possible for the protection of the research volunteer, but at least within 5 working days and may need to be reported to the federal Office for Human Research Protections (OHRP).
   
• Significant: adverse events not specified by federal code; however, events that SF State considers grave, requiring immediate attention. These would include e.g., a psychotic or schizophrenic break not requiring hospitalization; a suicide attempt that does not result in hospitalization; suicide threat; a serious breach of confidentiality or privacy of research volunteers or others by the researcher or focus group members that results in or could result in, e.g., deportation, arrest, expulsion, suspension, loss of job, loss of family support; loss of laptop with private, identifiable information about research volunteers. Significant adverse events must be reported to HAP as soon as possible for the protection of the volunteer, but at least within 5 working days.
   
• Minor: Minor adverse events should be reported only if they result in a modification of the protocol to mitigate the event.

Reporting adverse events:

• Serious and Significant adverse events must be reported as soon as possible for the protection of the participants. Use the IRB Incident Report Form in IRBManager. This form must be completed and signed by the principal investigator. The form will ask about actions taken to mitigate the current adverse event and those taken to avoid recurrence of the event, if appropriate. A copy of the informed consent document and any other supporting documentation must be included. Usually, mitigation will necessitate modification of the study. If this is the case, the principal investigator should submit an IRB Modification Form in IRBManager detailing any changes and adverse event mitigation strategies.
   
• Minor adverse events may be reported through the IRB Incident Report Form in IRBManager.

Researchers must adhere to the procedures outlined in their approved or exempt-determined IRB submissions. 

Planned protocol modifications: Modifications to an IRB protocol should be submitted to HAP via the IRB Modification Form in IRBManager. Use the Modification Guide to determine whether a modification submission is appropriate.

Unplanned protocol deviations or violations: These include deviations from an approved protocol that have already occurred and breaches of scientific integrity or ethics on the part of the researchers.

Protocol Deviations:

A minor deviation is a departure from an IRB-approved protocol that does not significantly impact (a) safety, rights or welfare of participants, (c) the subject’s willingness to participate in the study, or (c) the integrity or scientific soundness of the research data. Examples of minor deviations include changing minor wording on a survey; altering time required for an interview; or administrative changes to participant-facing documents such as correcting a telephone number or email address. Minor deviations can be reported to the Office of Human and Animal Protections (HAP) by email at protocol@sfsu.edu. Often, the appropriate course of action will be to submit an IRB Modification Form to document and approve the changes. They should be reported when discovered and no later than 5 business days after they occur. 

A major deviation consists of any unauthorized departure from an IRB-approved protocol that significantly impacts participant safety, rights, or welfare, or compromises the integrity of the research data. Examples of major deviations include neglecting to obtain informed consent prior to collecting data; not following stated inclusion or exclusion criteria; unauthorized changes to procedures; or collecting data after protocol approval expiration. Major deviations should be reported via IRB Incident Report in IRBManager. They will be reviewed by the IRB and may require subsequent submission of an IRB Modification Form. The IRB may request additional corrective action from the researcher(s). Major deviations should be reported when discovered and no later than 5 business days after they occur. 

Continued occurrence of deviations may trigger a report to the Institutional Official (or the Dean of Graduate Studies for students) for further action.

Protocol Violations

A protocol violation is a serious, often intentional, deviation from an IRB-approved study plan that compromises subject safety, rights, or data integrity. These situations are considered research misconduct and initiate immediate investigation from Human and Animal Protections (HAP) and the IRB Chair. Protocol violations are reported to the Institutional Official, the Dean of Graduate Studies, the federal Office for Human Research Protections (OHRP), research sponsors, and any other appropriate external agencies. They 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; or unauthorized personnel performing study procedures. They must be reported via IRB Incident Report in IRBManager within 5 business days. 

When participant enrollment has ended, all data has been collected, and the only remaining research activity is analysis of deidentified data, a Study Completion & Closure Form must be submitted in IRBManager. This form notifies the IRB that participant enrollment has ended and no further data collection will take place for the study. Submission of this form helps the IRB track those studies that are currently active and those that are not.

Have questions? Need help or guidance? Contact Human and Animal Protections (HAP).
 

• Human and Animal Protections Office Hours - meet virtually with IRB staff
   
• Request an Information Session - request a presentation from IRB staff for your class or department
   
• Email: protocol@sfsu.edu
   
• Phone: (415) 338-1093