FAQ for filing for CCI Human Subjects Review

1. Do I need to file an application for my study?

Federal rules require that all "research" that involves interactions with people requires review.

1.A. OMG, really? Everything?

Not quite everything. The two keys are "research" and "interaction".
a). You can use existing human subjects data (since you aren't the one collecting it and can presume that they passed their IRB review).
b). You can use observations of people in public places (as long as you don't initiate contacts).
c). You can do things that aren't "research." This includes things like journalistic interviews, oral histories, evaluations, and data collected as part of classes, as long as it's not identified as research and it's not publicized as such. (A word of warning: using interviews or oral history as methods to conduct research does not qualify for this exemption - the distinction is the purpose, not the methodology. Interviewing a subject for a news story is not considered research so it's ok. Collecting oral histories for an archive is also not specifically considered to be research. Doing an interview or an oral history to answer a specific research question resulting in a research presentation or publication constitutes "research" and requires review).


1.B. What if I want to use the data later for a research project?

You will need to get the IRB application reviewed and approved before you collect the data. Official policy is no retroactive approvals. If you think you might want to use the information in research, play it safe and get the project reviewed.

1.C. What about dissertations, theses, and Master's projects?

All of these are considered to be "published" research, and thus will need review if you collect information by interacting with people. And yes, they check before accepting your thesis or dissertation.

2. What do I have to do to get my project reviewed?

The first step is to determine what type of application to file. There are basically two classes of research projects: those that qualify as "Exempt from Review" and those who need "Review." The "Exempt" label is slightly misleading, in that you still need your project reviewed as to whether or not it qualifies for the exemption from UT IRB review, but it is a generally faster process as it is handled primarily within the College.

"Exempt" research basically covers cases using normal methods with normal adults, where there is little or no foreseeable risk to participants. As a general rule, the data must be collected and recorded in a way such that individuals can not be linked to information recorded about them. The information collected cannot include anything whose exposure would place them at risk. To apply for "Exempt" status, use the Form A application.

Everything else needs to be formally reviewed at both the College and University levels, and you need to use the Form B application. Further, Federal rules mandate "Review" if any of the following conditions apply:
a). Your subjects include minors (those under 18), or other "protected" populations (basically where there is a concern about the ability to freely and legally provide "informed consent").
b). You plan on using recording (audio or video) equipment for data collection. This is because subjects are identifiable on recordings.
c). Your data collection poses some risk to participants, collects medical samples or records, or exposes them to radiation. Risk refers not only to risk of physical harm. Any potential for negative consequences constitutes risk, including asking questions where the responses could embarrass or have negative consequences for subjects, or might trigger emotional or psychological reactions.

Projects that need "Review" but pose minimal risks may qualify for expedited review.

2.A. How do I get the forms, and how should I fill them out?

Copies of forms are available at the UT Office of Research Compliance website, and at the CCI Research website, under IRB information. Also at the CCI IRB website is a "Best Practices" guide for filling out the forms. Don't forget to include the informed consent form/statement!

If you have any other questions, feel free to ask members of the CCI Review committee.

2.B. Can I get approvals for studies where there is risk?

The goal of IRBs are not to prevent risk, but to try to see that any risk or potential harm is minimized, that potential subjects are made aware of the risk and still are willing to participate, and that the potential value of the research outweighs the potential risk. To get approval for projects with more than minimal risk, the application will need to include:
a) a full discussion of the type and extent of the risk, some indication of its likelihood, and a discussion of what steps will be taken to minimize that potential or risk, and/or what steps will be taken to mitigate any harm later.
b) the informed consent form must provide a reasonably complete statement about the potential for risk, and the level of possible harm
c) the researcher will need to provide a greater justification of the potential value of the study (the greater the risk, the more justification is needed).

3. So I've filled out my application, what next?

The next step is to have your application reviewed. To expedite things, we suggest that you first email the completed application as an attachment (Word or PDF file, please) to the head of the CCI DRC committee. Having them in this format helps speed review, although eventually you will need to provide a hard copy of the application with original signatures for listed investigators and/or advisors before the application can be approved.

3.A Who do I need signatures from, again?

Every research project has a Principal Investigator (PI). That's you. You can also list as many co-PIs as you want to, as collaborators, but remember you need to get signatures from everyone listed. By signing the form, the PI and any co-PIs agree to follow the procedures and protections outlined. You can have people from outside UT listed as co-PI.
If you are a student, you will need to also list a full-time UT employee as "Advisor." This can be your regular advisor, or the professor teaching the course you're doing the study for.
It is important that at least one of the above signatures is from a full-time UT employee (faculty or staff), for legal purposes.

4. How long does a review take?

The goal is to process Form A applications within a couple of business days at the College level. They also need to be checked with the UT Research Compliance officer, which can add a few more days.

Form Bs must be reviewed initially by at least three members of the CCI Review committee. It may need to be revised and resubmitted. This can take a couple of weeks. Once past the College, the application is forwarded to the UT IRB for review. Expedited reviews can take another couple of weeks; if a full review is needed, it can take much longer. The good news is that we rarely need full reviews for CCI projects.

The biggest delay in most reviews happens when you have to revise and resubmit an application if you haven't followed directions or we need clarifications. Here, having email attachments and addresses really helps speed things up.

5. When can I start my research project?

Officially, you're not supposed to start data collection until the application has been approved at the University level.
However, you can start subject recruitment for projects once the CCI DRC chair has approved any recruitment materials and plans.

The UT IRB is considering a process where you can start data collection before final approvals at the University level are granted, but only if there are no more than minimal changes required before approval. This is primarily for class projects that you think you may also want to use as "research" that will be made public outside the classroom. You will still need to file the application, and if approved at the CCI level, you may collect data for use in the class. You may be able to keep and use the data that were collected "conditionally" for public "research" if that application is later approved by the UT IRB without substantive changes to methods or informed consent. On the other hand, if they require changes, you will be required to destroy the data collected under the initially reviewed procedures. This possibility may be of most use to those needing Form B reviews, but whose project is fairly simple and poses no likely risk, as the University review may take several additional weeks past CCI Review approvals. However, you need to be aware that any required change in substance of the research or informed consent process will require you to discard the data and start over. It is best to wait for final approval if you can, or if you really want to use the data.


(by Benjamin J. Bates, adopted November 1, 2007)