I've heard that the Federal regulations make certain categories of research exempt. If my research fits into one of these categories, does this mean that I don't have to have it reviewed by the IRB?
Yes, but it is not up to the investigator alone to determine if a protocol is exempt. Troy University has promised the Federal government that properly trained and designated faculty have the responsibility for determining whether or not a protocol is exempt. "Exempt," as used here, means that it is exempt from a review by the IRB. The IRB Chair will determine whether a study is Exempt from review. It does not mean that the research need not be reviewed and approved before data collection can begin. Fill and and submit an Application form for EVERY study that deals with human subjects.
Can I recruit students from my own classes to participate in my research?
If you are the instructor or teaching assistant, or anyone the students would see as having power and authority over them, then the answer is generally "no." This is because the students could perceive the situation as one in which they really cannot refuse, even if they really did not want to be in your study. You must avoid even the perception of coercion. If your students have special skills that make them particularly valuable as potential research participants, the IRB may approve your request to use them provided that you structure your protocol in such a way that the coercive potential is eliminated.
If my research protocol is only for an undergraduate class, does it have to have IRB approval?
Not if it qualifies for an Exemption. If your research falls into a category that can be exempt from IRB review, your course instruction should be able to certify this exemption.
Is it true that I need IRB review even if I am not doing an experiment, but I am only conducting interviews, surveys, or simply observing people?
It depends. As long as your research involves living human beings If your research falls into a category that qualifies for an exemption from review, your supervisor should be able to certify this exemption. If your research falls outside this category, you need to have it reviewed by the IRB. Under no circumstances may Principal Investigators make the decision to exempt their studies from review.
If I am based at the Phenix City Campus, Montgomery Campus, Dothan Campus, or a TROY Global Campus site do I still need to get approval from you?
Yes. You need to get approval from this IRB before you can conduct research at ANY TROY site. A representative from each site has been appointed to the IRB.
How long will it take for me to obtain approval to do my study?
It depends on the nature of your study and the characteristics of the people you intend to recruit.
- Allow 4-6 weeks for studies that, in the judgment of the IRB, involve more than minimal risk to the participants, because your protocol will need to be reviewed at a monthly IRB meeting. If the IRB needs you to make extensive changes in your protocol and tables further discussion of it for the next meeting, then clearly the time could be longer. Most protocols that come to this IRB, however, are of such a nature that they need not be reviewed at a convened meeting.
- How will I know when my protocol is approved?
You will receive notification by email and by letter at the addresses that you provide when you submit your protocol to the IRB.
Do I always have to obtain informed consent?
There are limited exceptions. The IRB has the authority to waive the Federal requirements for informed consent in certain circumstances, such as when obtaining consent would not be practical.
For example, observational studies of public behavior would not require informed consent of the people you observe.
Do research participants always have to sign an informed consent?
No. There are several research situations, all involving no more than minimal risk, where the IRB can authorize you to obtain consent orally. For example, if your participants cannot write, the IRB will waive this requirement, provided that the study presents no more than minimal risk. Otherwise, you would have to obtain written consent from someone authorized to act on behalf of the participant. As another example, if the risk to your participants would increase markedly because they signed a consent form (as in an interview or survey that addressed the participant's HIV status), then the requirement could also be waived. You would still need to obtain informed consent, but it could be obtained orally.
What do you mean by "child assent script"?
When you intend to collect data from children who are capable of comprehending, after obtaining consent from one or both of their parents, you must tell the children what to expect if they agree to participate in your research. You must make as certain as possible that the child understands that he or she has a free choice in the matter. The words that you use to present your study to the children are your "script." The children must give you a positive affirmation of their interest in participating. This is their way of exhibiting "assent."
How do I get to do research in the public school system?
First, contact the appropriate school officials (Director of Research in most public school systems, or individual principals in private schools) about access to their students or teachers. Ask them to send you a letter of support for your research. Then you obtain IRB approval for your research. Attach the letter of support to your application.
My research will be done in another country. Do I have to obtain IRB review and approval?
Yes. Moreover, you may also need to provide the university (through the IRB) that you have authorization from the officials in that country to conduct your protocol there.
After I download the IRB form from the Internet and complete it, can I send it back to you by email?
Yes. You MUST email the form and other necessary documents. However, you will also have to fax or send the original form with official signatures.
May I get feedback on my application before I make hard copies to send to you?
Yes. You may email questions or a draft of your application to your College or Site representative. You may also call your College or Site representative with any questions you may have. See the Committee Members list to find your College or Site representative.
Will the Institutional Review Board operate during the Summer semesters?
No. Institutional Review Board members may not be on campus during the Summer semesters. If you wish to undertake research during the summer, you must have it approved before the end of the Spring semester. See the Meeting Schedule for submission deadlines and meeting dates.