IRB Tutorials and FAQs

Briefly, the purpose of the IRB is to protect the rights of the human subjects who participate in research and to ensure that they are not harmed in any way by their participation in your research.

Federal regulations define research as "a systematic investigation….designed to develop or contribute to generalizable knowledge." "Generalizable knowledge" is usually interpreted to mean that the research will be made public (presented at a conference or other public forum, published in a journal etc.). Thus, anyone who is doing research with human subjects that will be made public needs to have their research approved by the IRB. This is why the research with human subjects that you do in a class does not need to go through the IRB. The purpose of the research is not to develop or contribute to generalizable knowledge; instead the research is being done strictly for educational purposes (e.g. to teach and demonstrate research methodology). Because of this, it does not qualify as research according to the federal guidelines.

In some cases, research may be exempt from federal regulations designed to protect human subjects but the IRB makes the final determination of whether or not the research is exempt. It is important to note that being exempt does not mean your research does not have to be approved by the IRB. There is more about this below.

It is unethical to conduct research with human subjects that has not been approved by the IRB. Furthermore, if you do so and a subject is harmed then you as the investigator will be personally liable for any damages incurred. Finally, such research may not be made publicly available in any form. The investigator will be expected to sign a nondisclosure agreement in which he/she agrees that the data will not be made public either through presentation at a conference or other forum or through publication in a journal.

You should submit your application to the IRB approximately 1 month prior to when you anticipate beginning your data collection. How much lead time you need depends, at least partially, on the type of review required for your project (see below) but allowing 1 month should, in most cases, give you enough time if any changes or additions to your application are required before it can be approved.

It is important to keep in mind that your research must be approved by the IRB before you begin collecting any data (i.e., you must have received an official letter from the Director of the Institute for Research and Scholarship (BIRS) notifying you that your research has been approved).

There are guidelines from the federal regulations provided on the BIRS website to help you make this determination. In addition, the forms themselves are laid out in such a way to help you figure this out. In particular, the exempt form includes a number of "Yes/No" questions that you need to answer and if you have to answer "yes" to any of them, then your project is not exempt.

Exempt projects generally fall into one of the following categories:

• Research on teaching or instructional methodologies that are conducted in regular education settings (e.g. schools or universities)
• Survey, interview or observational research (as long as the information is recorded so that subjects cannot be directly linked to the data they provide AND you are not asking about sensitive aspects of the subject's behavior that might put them at risk for criminal or civil liability or that might harm their employability, reputation or financial standing)
• Observations of public behavior
• Chart reviews (retrospective or prospective, as long as the data are publicly available OR the information is recorded so that subjects cannot be identified)

A project moves up to the expedited category if it involves deception, could embarrass or threaten a subject, collects information of a sensitive nature, involves biomedical procedures, collects information in a way that allows subjects to be linked with their data, involves vulnerable subject groups (e.g. children or people under the age of 18, physically or mentally impaired people, prisoners etc.) or involves videotaping or audio taping of subjects.

YES! The IRB is responsible for making the final determination of whether or not your project is actually exempt. Exempt does not mean you do not need to have your project approved by the IRB; it just means that you are exempt from the follow-up and reporting requirements of expedited and full review projects.

Informed consent is telling subjects what is involved in their participation in the research so that they can make an informed choice about whether or not they wish to participate. Informed consent involves three things:

• Providing subjects with full information about what their participation will entail, including any possible risks to them, or benefits (to them or in general).
• Ensuring that subjects comprehend the information you have provided; depending on the subject population this may require you to actually read the information to them to be sure that they understand; it may also require that the consent form be translated into the subject's native language if they do not speak or understand English.
• Ensuring that the subjects' perceive their participation to be voluntary; i.e., that they do not feel coerced to participate.

According to the federal regulations, research that is exempt does not require documented informed consent (i.e., having them sign a written consent form). Expedited and full review projects do, in most cases, require informed consent to be documented.

Although informed consent is not required for exempt projects, it is still a good idea to let participants know what they are agreeing to do before they decide to do it. Thus, it would be a good idea to include a brief statement at the top of a questionnaire briefly describing what participation will involve and indicating that they are free to choose not to participate and that there will be no penalty if they don't participate or if they choose to withdraw during the research. This is especially the case for research conducted during a class at Butler (or elsewhere) so that students do not feel coerced to participate. However, having a signed consent document is not necessary and may, in some situations, even be detrimental if the signed consent document is the only way in which the subject could possibly be identified. Then the document may actually hinder your ability to protect the identity of subjects.

Federal regulations require that the following be included (this information is on the BIRS website, as well):

1. a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
2. a description of any reasonably foreseeable risks or discomforts to the subject;
3. a description of any benefits to the subject or to others, which may reasonably be expected from the research;
4. a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
5. a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
6. for research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
7. an explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and
8. a statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

It is important to note that subjects should be given a copy of the consent form after they have signed it.

"Anonymous" means that no one, not even the researcher, knows which data come from which subject. "Confidential" means that the researcher knows who provided which data; however, the data are stored in such a way that if a third party got access to the data, they would not be able to link subject responses to particular people (i.e., subject identifying information is not stored with the actual data). One of the key principles of protecting human subjects is ensuring at least the confidentiality of their data.

Note that anonymity is not required, even for exempt projects. All you have to do is to explain specifically the procedures you will follow to ensure that confidentiality of subject data will be maintained.

Note: Ultimately, it is the responsibility of the researcher to familiarize him/herself with the federal guidelines to ensure that he/she is in compliance with them.