Frequently Asked Questions

Q: I am conducting a secondary analysis of existing data. Do I need to obtain approval from the IRB?

A: Yes. Research involving the secondary analysis of existing data must be reviewed by the IRB to ensure that the original data were properly and ethically obtained and that the objectives of the secondary analysis are in keeping with those for which consent was obtained.

Q: I think my research is exempt. Do I still need to hand in a protocol?

A: Absolutely. All research that involves human subjects, exempt and non-exempt, must be reviewed by the Institutional Review Board (IRB) or by the IRB office.

Check our section on “Does My Research Require Review?” to find out if your research does not involve human subjects, or does not fit the definition of “systematic research designed to develop or contribute to generalizable knowledge.”

Q: Why do I have to get letters of permission?

A person in authority must be aware of and approve your recruiting from among the clients, students, etc. of the organization you want to study. Please note if you intend to conduct research on the same premises, or with the same group, the letter should also include permission to conduct research with this population, as well as recruit subjects from it. This is especially true if you will be using class time, client appointment time, etc. to administer your survey or conduct your interviews.

The person signing the permission letter must also know what your research topic and title are. Frequently it is easier for you to write the letter for them, have their office copy it on school or agency letterhead, and then have the director or principal/assistant principal sign it.

Q: I am interviewing Key Informants for my research? Do they need consent forms?

A: Key informants or content experts or a panel of experts do not require consent forms, because they are not considered human subjects needing protection if you are asking them questions that relate solely to their field of expertise, and the questions are factual in nature. However, as a courtesy, you should provide them with a brief information sheet with your contact information, your advisor’s contact information and the title of your research.

Q: Why do I need a literature review in my protocol statement?

A: Federal regulations regarding ethical research require that risks to human subjects be minimized by using procedures which are consistent with sound research design, and which do not unnecessarily expose subjects to risk (45 CFR 46.111(a)(1). A literature review:

allows the IRB to know more about your topic,
demonstrates that you are aware of prior research in this field, including hypotheses, methods, and outcomes of previous research,
indicates that this knowledge has informed your proposed use of human subjects,
should justify and support the purpose of your own study, and its importance in your academic field.

Q: Why do I need to include my data analysis methods?

A: A discussion of your data analysis methods indicates that you have a plan to evaluate your data in the light of your research question. If your data will not answer your research question or hypothesis, your study will be meaningless, and thus of no benefit. If there is no benefit whatsoever to conducting your research, even the slightest risk is outweighed by the lack of benefit. In this case you will need to revise your protocol, questionnaires, interview questions or survey instruments to make sure you will elicit the data that will answer your research question or fulfill the research purpose.

The data analysis section should address all sources of data you are collecting. Describe the method of analysis, any software you will use, any collection notes or data sheets you have devised to help you collect information.

If you are conducting a qualitative study, state specifically which qualitative method of analysis you will use, cite the relevant literature, and tell us what that means with regard to your own research. For instance, if you are collecting interview data and looking for common themes throughout, please state this, mention a potential theme or two, and reference Glaser and Strauss in your lit review. If you are using the data anecdotally to support your own observations, field notes, or journals, please state this.

Q: Why do I need to include the age of the participants?

A: The IRB uses age of participants as one of the criteria used to determine whether your research is exempt or non-exempt. Participants under 18 years old are minors, and considered a vulnerable population. Research with minors would make an otherwise exempt survey or interview non-exempt, and would call for a full committee review, which can add time to the approval process. Interviewing or surveying adults is almost always exempt.

Q: What does “identifiable information” mean?

A: Identifiable information is any information that can single out a participant. This includes, but is not limited to, name, job title, age, fingerprints, biometric data, gender, birth date, ethnicity or race, medical records number, and even zip code if less than 20,000 people live in that zip code. Please tell us what information on your subjects you do have or will collect, and we can then determine if it is identifiable for your research population.

“Unidentifiable” is not the same as anonymous, which only refers to not knowing someone’s name. You cannot know or use a participant’s name and still be able to identify that participant through a combination of other identifiers.

Q: What should I include in my “recruiting script?”

A: “Recruiting scripts” refer to the the content of an in-class presentation or a telephone call, the text of an e-mail, letter, or newspaper advertisement, or the copy of a flyer you will post to inform prospective participants about your research. These scripts should be brief, about a paragraph long, and objective. They should be a simple invitation to participate in the research.

Recruiting scripts should briefly include: who you are, what your study is about, what will happen to the participants, when and where it will happen, and how long it will take, and your contact information. Include specific inclusion or exclusion criteria for participation on your script (must be 21, must be computer science students, must have asthma, etc.).

Q: What happens after I drop off my protocol in ADM 254?

Your protocol now enters the “revision cycle.” A reviewer determines its status, and screens the complete protocol package to ensure that all necessary documents are included.
Next, a protocol analyst looks for substantive issues that need clarification, and determines the changes necessary to bring the protocol into compliance. At this point, an email will be sent to the researcher, requesting changes.
We communicate exclusively by e-mail, so all requests for changes, clarifications, or additions will be sent from protocol@sfsu.edu. Provide us with your University sfsu.edu e-mail address.
Please check with the office if you haven’t heard that your protocol or revisions have been received. We usually send the e-mail confirmation within a week of a protocol’s arrival.
After the November 1 deadline for the next spring semester’s thesis courses, the office is swamped with protocols. Be aware that at this time, protocols go through your department for signature, then through the Grad Studies office, then come to our office, so there will a time lag between your turning your protocol in to your department, and our office receiving it.

Q: What happens to my revisions?

We request that you e-mail your revisions to the office, so any minor changes can be made electronically by staff.
Once your revisions are submitted, they will be reviewed in the order in which they are received, to make sure all requested changes have been made, and to review any additional material you may have provided.
More revisions may be requested to correct any errors or omissions in the newly-submitted material, to include something that was missed the first time around, or to request again any prior changes that haven’t been made.
Exempt protocols will be certified as such in the office, once any required changes are received and accepted. You will receive an e-mail notifying you of its exemption from further review.
Non-exempt protocols will go to the committee for a full review, once preliminary changes have been made. In the period right after the semester deadlines, the committee is trying to review the bulk of the protocols we receive all year, so it may take some time to get on the agenda for a meeting. You will receive an e-mail once your protocol has been placed on an agenda.
The committee will very likely require more changes after its review. You will receive an email from the committee chair, notifying you of your protocol’s review status, and any final changes required by the committee.
Non-exempt protocols will receive an e-mailed official letter of approval with the protocol number, date of approval and an expiration date. Date of approval will be the date of the full committee review, regardless of when your final changes were accepted and approved.

Q. What are the options after full committee review?

A. The committee can give full approval, contingent approval (contingent on fulfilling some minor conditions before full approval is granted), or can defer your protocol for serious substantive changes. If the protocol is deferred, the revisions will have to return to the committee for approval. If given contingent approval, the revisions can be approved in the office and signed by one of the committee chairs. You have not been fully approved until you receive the official letter of approval from the IRB office.

Q: When is the date of approval?

A: If your protocol is approved immediately, the approval date will be the date of the full committee meeting at which the protocol was reviewed. If it’s given contingent approval, the approval date will also be the date of the full committee review meeting, regardless of when your final revisions are received and approved. If it’s deferred, and your revisions are reviewed at the second committee meeting and accepted, the approval date will be the date of the second full committee meeting.

Q: How long does the approval last?

A: All protocols have to be reviewed once a year, at a minimum. Protocol approvals expire one year from the date of the full committee meeting at which the protocol was approved or contingently approved.

However, the committee may approve protocols for less than a year if they feel the risks, population, consent issues, or other considerations warrant an earlier review.

Q: How long does it take to get approval?

A: The process usually takes between 4-12 weeks. This timeline is contingent upon receipt of a full protocol package and quick responses from the researcher. During our “high season,” that is, between November 1 and February 1, when we receive the bulk of protocols from spring graduates, review can take longer due to full committee agendas.

For this reason, we encourage students to consider exempt research projects, because they do not require a full committee review. They can be reviewed and certified as exempt from further review by administrative staff in the office.

Q: How do I make changes to a protocol that has already been approved?

A: Submit a Modification Request form. Explain the changes you want to make and your reasons for making them. Attach all revised IRB documents. For instance, if you are changing the recruiting information, submit the revised flyer, recruiting script or text. Highlight changes so we can compare the old and new documents. If the changes are substantive, or involve higher risk to the participants, you would also have to incorporate the changes in a revised protocol, which may have to go to the full committee.

Q. Once my protocol is approved, does anyone ever check to see I am following it?

A. Student advisors have let us know in the past if they were afraid a student’s research was going off in an unapproved direction, or hadn’t been explained fully, and we have worked with the student to correct the errors, or incorporate the modification as approved.

One of the IRB’s responsibilities is to monitor research, especially the recruiting and consent processes and documents. The office will be able to undertake this task for the first time in fall, 2008. We will concentrate on funded research to begin with, and will add spot checks of student protocols by the end of the semester.

Q: How can I get help on the application process?

A: Do explore this web site. All the information, forms and templates are here. If you still need help, contact our office via email at protocol@sfsu.edu. We can answer any questions you may have about the protocol process. We are also available to meet with you by appointment to discuss your draft protocol, draft consent or draft culminating experience description.

Last Updated: June 2007