If I am just talking with people about....I'm not doing anything to them--there are no experiments, no clinical trials, do I need human subjects approval?
Yes (and we are not kidding). Federal regulations define human subjects research broadly to cover interactions as well as interventions with human subjects for research purposes. So. . . surveys, interviews, questionnaires and oral history interviews, etc. are all covered by the federal regulations. And, yes, you need prior committee approval. Most of this type of research, however, qualifies as “EXEMPT.”
If my research qualifies as "exempt" under the federal regulations, must I submit an application for approval?
Yes. The term “exempt” in terms of the review process really means “exempt from full committee review.” It is the policy of Indiana University to review all research in order to ensure that the research is, in fact, exempt. The application for exempt research is less extensive, and under most, but not all, circumstances, written, signed informed consent is not required. We do, as a general matter, require investigators give to their subjects a written statement containing information about the study and their part in it.
If I am using data compiled by other third parties, do I need approval?
Yes. Use of existing data is exempt research but still requires prior approval. Even if you have worked with the original investigator in obtaining the data, your independent use of the data requires approval. This issue comes up often with Ph.D. dissertation research. All Ph.D. candidates must get their own human subjects approval for their research even if it involves working with data collected by a collaborator with his or her own human subjects approval.
What are some common things that may disqualify research as "exempt" research?
- Use of identifiers
- Use of minors
- The subject of research relates to sensitive information where the names of the subjects may be capable of being identified.
- Research requires subjects to do a task , for example, write responses to certain objects shown on a computer screen, or give responses to vignettes shown on a videotape.
If my research is not exempt, must I obtain written signed consent, even if there is minimal risk?
Yes . The regulations require written consent in language understandable to the subjects. In appropriate circumstances, oral consent may be used. Waiver can be obtained in very limited circumstances with the approval of the full human subjects committee. A copy of the consent form must be given to each subject.
What do I do with the signed consent forms?
Save them for three years after the termination of your research. DO NOT THROW THEM AWAY. Make sure you give a copy to each subject. This is a federal requirement.
Suppose I want to make a minor change in the study, do I need to do anything?
Yes . Any change for ANY reason requires filing an amendment to the study. No matter how minor, the change must be approved before it is instituted. Is this a pain? Yes, but it is the law. The form is quite simple, and it is important that the University's records accurately reflect the research actually being conducted.
When do I need to file a continuing review form?
If your research is “exempt,” only a termination report is required. For all other research a continuing review form is required at least on an annual basis. For some research, the committee might require more frequent reviews. The office notifies you when your review form is due. Continuing reviews are required as long as data from the study is being analyzed. So, even if no human subjects are currently in the study and none will be recruited, continuing review is still required if you are using or analyzing the data.
What else do I need to submit with my application?
Any test instruments, questionnaires, recruitment flyers, newspaper ads, e-mail ads, phonesolicitations, or other communications with the subjects. For individual or group interviews, we must have a list of the types of questions you will ask. We understand that you may not in every instance be able to anticipate the direction that some interviews will take. For our purposes, however, we need to know the range of questions and general areas to be explored.