HAP: Human Subjects Research (IRB)

Tips for Submission Writing 

• Use simple language
  Write as though your audience are educated individuals who are not experts in your particular field of study. Reviewers are educated non-subject matter experts.
• 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 HAP Forms Library for customizable templates for consent, assent, letter of permission to recruit, etc. Using these templates is a good way to ensure that research documents include all elements to meet IRB regulatory standards.
• When in doubt reach out!
  Faculty advisor involvement in students' IRB submissions is encouraged and reduces review times and back-and-forth with the IRB office. Human and Animal Protections (HAP) office staff are available for submission guidance and questions and can be reached at protocol@sfsu.edu, at 415-450-8039, or by booking a meeting through the Human and Animal Protections (HAP) Office Hours section at the bottom of this web 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

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, coinvestigators, 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

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 a designee of the IRB, which is currently the IRB leadership.  Revisions may be requested or the protocol may be approved.  The principal investigator will receive an approval letter via email from protocol@sfsu.edu. You may begin your research upon receiving the approval letter, but you must notify us of any planned changes in your study and renew your project one year from the date of approval, if applicable.

If the review category is Full Board, it will be reviewed at a convened meeting of the IRB, which includes all IRB members.  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 letter within 7-10 days after the meeting with their decision. See Review Outcomes for actions that may be taken by the IRB at the culmination of a review. 

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

Review times may be extended in October and March right before the Graduate Studies deadlines:
Exempt: 2-3 weeks
Expedited: 3-6 weeks
Full Board: 4-8 weeks

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

Exempt Determination

If the protocol 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. Take the IRB Review Decision Tree and/or check with Human and Animal Protections at protocol@sfsu.edu for help determining whether a 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.

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) bein 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 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.

IRB Unanticipated Problem Report (LINK)

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 to HAP only if they result in a modification of the protocol to mitigate and/or detail this event.

Reporting adverse events:

• Serious and Significant adverse events must be reported to HAP as soon as possible for the protection of the research volunteer, but within at least 5 working days using the Serious/Significant Adverse Event Report Form. This form must be completed and signed by the Principal Investigator, although an electronic notification from the PI is acceptable with a signed, hard-copy follow-up. The report will include actions taken to mitigate the current adverse event and to avoid the adverse event in the future, if appropriate. A copy of the current informed consent document and any other supporting documentation must be included for review. This event will usually trigger a modification of the protocol and related documents. All resulting modifications to the protocol must be approved by the IRB.
   
• Minor adverse events that require reporting should be reported on the Minor Adverse Event Report Form to HAP in a timely manner.

Researchers are expected to adhere to the procedures as outlined in their IRB submissions and consent documents that were as approved or determined exempt by the IRB.

Planned protocol modifications: Modifications to the protocol must be submitted to HAP on the IRB Modification Form. They must be approved by the IRB before their implementation.

Unplanned protocol deviations/violations and unanticipated problems:
For unanticipated problems, see Adverse Events.

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

IRB Unanticipated Problem Report (LINK)

Protocol Violations

Protocol violations are extremely serious situations that require immediate investigation by Human and Animal Protections and the IRB Chair and are reported to the Institutional Official (Vice Provost of Academic Affairs), the Dean of Graduate Studies, and the appropriate external agencies, including the Office for Human Research Protections (OHRP), when warranted. Examples of protocol violations include: events that result from willful or knowing misconduct on the part of the investigator; events that impact ethical principles; events that undermine the scientific integrity of the data; procedures not approved by the IRB that cause or have the potential to cause substantive harm to participants; failure to use an approved informed consent form; failure to report a known, significant/serious adverse effect.

Alleged or known protocol violations will be investigated by the IRB Chair, who will determine the validity of the complaint. Both the IRB and the Institutional Official (or the Dean of Graduate Studies for students) will be notified of all complaints and the outcome of any investigation. If, after investigation by the Chair, the violation is verified, the situation will be forwarded to the Institutional Official (or the Dean of Graduate Studies for students) for further action. Reports, including the actions the institution takes to address the noncompliance (e.g., educate the investigator and/or the research staff, suspend the protocol, suspend the investigator, expulsion of a student etc.) will be sent as required to OHRP, sponsors, and/or the FDA.

Protocol Deviations:

A minor deviation does not harm or potentially harm a research volunteer, e.g., changing minor wording on a survey, altering time required for interview, administrative changes to research volunteer documents (phone number). These should be reported to HAP when discovered during the course of the research and/or no later than 5 working days after their occurrence. These deviations can be reviewed in HAP; they may or may not require a modification (see Modifying your Protocol).

Major deviations may include such things as neglecting to obtain signatures on a part of a consent form; 'interviewing' a survey participant; not following stated inclusion/exclusion criteria; making substantive changes (not administrative) to documents, including materials given to research volunteers; lapse in approval; collecting data after protocol approval expiration. These should be reported to HAP when discovered during the course of the research and/or no later than 5 working days after their occurrence.

Major deviations need to be reviewed by the IRB to decide action. These deviations may or may not require a modification (see Modifications), which will need to be reviewed by the IRB. The IRB may give permission to the investigator to use data collected during non-compliance.

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

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 (HAP) Office Hours section below for contact information.

Secondary Analysis of Existing Data

Research involving the secondary analysis of existing data must be reviewed by the IRB.

The researcher will need to provide:

1. An IRB submission for the secondary study that includes:
   1. The details of primary data collection; and
   2. If the data are not publicly available, a letter from the source authorizing access to the data or, if the data were purchased commercially, a copy of the contract authorizing the use of the data.

The IRB will then provide either an approval or determination for the submission, just as in submissions that generate primary (or new) data.

Research Done at Another Institution

To conduct research at another institution, SF State faculty, staff or students who are not the sole Principal Investigator on a project must receive approval from the SF State IRB before research may begin. If the researcher is the sole Principal Investigator on the project, the SF State IRB will review the other institution's approved protocol.

Non-Principal Investigators must submit:

• A signed Protocol Approval Form, with signatures from the SF State faculty, (not faculty from the institution where research will be carried out.)
• A copy of the application to the research institute's IRB. (If the institution has no IRB, indicate this and SF State can serve as the IRB of record.)
• A copy of the research institution?s IRB approval letter.
• An SF State protocol detailing the researcher's role in the overall project, and the part of the research that he/she will be conducting.
• A letter from the PI giving you permission to use the data generated for your research.

Unaffiliated investigators who plan to conduct a study that engages the University in research and involves human research volunteers must receive approval from SF State’s IRB prior to initiating recruitment/data collection at SF State. To request approval, unaffiliated investigators should send an email to SF State’s Human and Animal Protections  office (protocol@sfsu.edu) with the following information:

• Description of the study
• Copy of the IRB approval letter from investigator’s home institution
• Copies of the recruitment materials and consent form
• Letter of support from the relevant department at SF State (i.e. if the study will be surveying Biology faculty and students, then a letter from the Chair of the Biology Department would be required)

Note: Depending on the nature of the study, additional information may be requested.

Questions? Contact Human and Animal Protections 

Human and Animal Protections (HAP) Office Hours

Email: protocol@sfsu.edu

Phone: (415) 338-1093