Human Subjects Research (IRB)

Tips for Submission Writing 

• Use simple language
  Write to an audience of educated non-subject matter experts. Do not assume reviewers know the jargon of your specific discipline.
• 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 IRB 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 platform for IRB submissions at SFSU. For help navigating IRBManager, please see the IRBManager User Guide or contact Human and Animal Protections (HAP).

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

Customize these templates with information from your study.

Guidelines for Obtaining Assent from Minors

Participants who are minors (under the age of 18 and not legally emancipated) cannot give their "informed consent"; but they may "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 14-17 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 or adolescents" 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.

To register for the course, go to http://www.citiprogram.org/

• Click Register
• Click Select Your Organization Affiliation
• Search San Francisco State University and click the check boxes
• Click Create a CITI Program Account
• Enter your information, username and password, and CE credit details.
• Select Curriculum:
  • Question 1: Select the Social/Behavioral Research Course
  • Skip all remaining Questions and scroll to the bottom of the page.
  • Click Submit
• View Courses Ready to Begin to initiate the 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, the office of Human and Animal Protections will review your documents to determine the category under which your submission will be reviewed. A pre-review is always conducted first to ensure the submission is clear and organized.  Human and Animal Protections may request clarification(s) or additional information during this time.

If the review category is Exempt, your submission is reviewed by the Office of Human and Animal Protections. You may begin your research upon receiving the exempt determination notification email, but you must notify us of any planned changes to your study.

If the review category is Expedited, the submission will then be reviewed by an IRB designee.  Revisions may be requested or the protocol may be approved.  The principal investigator will receive an approval letter via email from protocol@sfsu.edu. Research may begin upon receipt of the approval letter, however investigators must notify the IRB of any planned changes to their study, and must renew their study before expiration, if applicable.

If the review category is Full Board, the submission will be reviewed at a convened meeting of the IRB at which all IRB members are present.  The submission is reviewed at the next available IRB meeting. Meetings occur on the first Wednesday of the month if there are any full board studies. The IRB will issue a determination letter within 7-10 days after the meeting. See Review Outcomes below for possible determination outcomes. 

Expected Review Turnaround Times

While the rate of the review process greatly depends on the queue of protocols preceding the researcher's submission 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

After your IRB submission has been reviewed and all requested revisions have been completed, the investigator will receive notice of one of the following outcomes via e-mail.

Exempt Determination

If the submission is determined to fall under the Exempt review category, the researcher will receive an exempt notification e-mail. This email is to be regarded as approval to 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 check with Human and Animal Protections at protocol@sfsu.edu for help determining whether an IRB Modification Form is required for the desired change.

IRB Approval

When the research is approved, the IRB will send an email to the investigator with an approval letter attached. The letter will state the approval date, expiration date, if applicable, and terms of approval.

Conditional IRB Approval

A conditional approval is awarded if there are minor correctable issues found in the protocol and attached documents. The investigator will receive a letter requesting revisions and/or clarifications necessary for IRB approval. Research may not commence until the revisions have been addressed and accepted by the IRB Chair, and the investigator receives an IRB approval letter.

Deferral

A protocol is deferred if there are substantive issues that require correction; major clarifications needed on risk or procedures; or information needed to continue review. Research activity may not commence until the investigator has provided the information clarifications or revisions, and the IRB committee has reviewed and approved the response in a second full meeting. Approval date will be the date of the second full committee meeting at which the approval is granted. The expiration date will be one year from the date of this convened meeting.

Disapproval

If the research is disapproved, the investigator may not conduct the proposed research. The investigator will receive an email detailing the reason(s) for the IRB's decision. The investigator has the opportunity to respond to the committee in writing or in person. The investigator may resubmit a protocol to the IRB for review if the reasons given for disapproval can be corrected and addressed.

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 should be submitted in IRBManager. This form notifies the IRB that no further data collection will take place for the study.

IRB Review Decision Tree

Take the IRB Review Decision Tree for help determining:

• whether IRB submission is necessary
• if submission is required, which form to submit

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 Human and Animal Protections section below for contact information.

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. 

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

• Recruitment materials,
• Consent form(s), and
• IRB approval or exempt determination letter.

Questions? Contact Human and Animal Protections (HAP)

Human and Animal Protections Office Hours

Email: protocol@sfsu.edu

Phone: (415) 338-1093