Frequently Asked Questions

Q. How do I determine if my project falls into the domain of IRB review?

First, your project must involve research involving living human subjects. Please see "Definitions" for guidance. If you still are in doubt about whether your project should be submitted to the IRB, please contact the IRB Chair.

Q. How do I contact the IRB Chair?

Kyle Roberts
Simmons Hall, 306
214.768.4494
kyler@smu.edu

Q. What is the process for reviewing my application?

Once we receive your application, it will be reviewed for completeness by the IRB Chair. If additional information is needed, you will be contacted at the e-mail address (or phone number) listed on your application. If your application appears to be exempt or eligible for expedited review, it will be sent to other IRB committee members for review. If your project requires review by the full IRB committee, you will be invited to attend the next regularly scheduled IRB meeting.

Q. How long is the review process?

Once your application is complete (including a Consent Form, if applicable), it will be sent out for review. After all reviews have been received by the IRB Chair, a decision for "exempt" status or "expedited approval" can be made. If the initial reviews suggest the need for a full committee review, the cycle of regular monthly meetings will dictate the number of weeks involved in the review process. Since the regular meetings take place on the first Thursday of each month (except January) during the academic year, approval may be as short as a few days or more than a month.

Q. How long is the IRB approval valid?

IRB approvals for specific projects are valid for twelve months. This period applies to the data collection phase during which there might be some "risk" to the human subjects involved in the research project. If the data collection phase of the project will take more than twelve months, a follow-up review and approval is necessary. It is important to do the follow-up review in a timely fashion so that no interruption occurs in your project schedule. You can submit the follow-up request on the regular HSR-6 and HSR-7 application forms. Be sure to specify that you are submitting a "follow-up renewal" application.

Q. How do I handle changes in my project that might have an impact on the risks to human subjects?

You should notify the IRB Chair about any changes in your project that are likely to have an impact on the risks to the human subjects involved in your project. Please do this before you implement the changes in the project. In most cases, the IRB Chair will contact you on behalf of the Committee to approve the proposed changes. If the proposed changes are substantial, you may be asked to attend a regular IRB meeting to discuss the changes with the full committee.

Q. What's the difference between a Consent Form and an Assent Form?

A consent form is used to gain permission from parents or other adult subjects (18 years of age or older) for participation in the research project. For children, both an assent form and a parental consent form are required.

An assent form is used to gain consent from minor subjects (under the age of 18 years old). This form should be either written or read to subjects in language and terms that they can understand.

Q. Do projects involving ethnographic research procedures need to be reviewed by the IRB committee?

If ethnographic research is limited to observing public behavior in public places and does not involve the identification of specific individuals, then such research usually is "exempt" from IRB review. For ethnographic research involving non-public data or research procedures that go beyond unobtrusive observation, IRB review is needed. The questions of "risk" and "benefits" of the research will be determined on a case-by-case basis. For further information on ethnography and IRB review, please read the statement issued in 2004 by the American Anthropological Association, available on the Internet at http://www.aaanet.org/stmts/irb.htm.

Q. Do oral history projects needed to be reviewed by the IRB committee?

If an oral history project is intended only to gather and archive information, and does not involve "research" in the ordinary sense of the term, then such a project may be exempt from IRB review. However, it is best to submit an application so that the IRB committee can make this determination. If a project includes oral history as only one element of the research protocol, then the overall project still needs to be approved by the IRB Committee.

Q. Do recently passed laws (e.g., the Patriot Act) concerned with "national security" have any impact on my research project?

Recent federal (and state) laws may compromise the presumed confidentiality of your data. Therefore, it is important to include a phrase such as "to the extent allowed by law" in all consent forms in the section concerned with confidentiality for subjects. For instance, in your Consent Form, you ought to include a phrase such as this: "Information obtained during the course of the study will remain confidential, to the extent allowed by law."