Tutorial for using the IRB exempt form

Tutorial for using the IRB exempt form Written for School of Education student and faculty researchers at the College of Saint Rose • The College’s Institutional Review Board (IRB) is a body, required by federal law, which reviews all research protocols involving human subjects. The IRB is responsible for insuring that the rights of human subjects are protected. The IRB follows federal guidelines in carrying out its work. • Most research conducted by students and faculty in the School of Education is either exempt (poses minimal risk to human subjects) and is reviewed by one member of the IRB or is suitable for expedited review (poses potential psychological or physical risk) and is reviewed by at least 3 members of the IRB. • See the IRB FAQ list for more information on these levels of risk and the appropriate form to fill out for your study. • Also see the US Office for Human Research Protections for more information about these levels of risk and the federal regulations in place to protect human research participants from risk. • In order to make a decision about whether the study meets criteria for exempt status, the following materials must accompany the exempt form. 1. A one page description of the study that includes: a. A description of the participants b. The research question c. A description of the research methods 2. Copies of any instruments to be used in the study: a. examples: surveys, interview questions, questionnaires, checklists, observation sheets, etc. • The purpose of the one page description is to insure that what is indicated on the form fits clearly into the federal exemptions for research with human subjects. • The first part of this tutorial is designed to help researchers insure that their answers on the form and the description of research they provide correspond. What is the IRB looking for in this description? We are looking for more detail about your study in relation to what you’ve indicated in your form. 1. Make sure that your responses to K.1. and K.2. correspond clearly to what you write about the setting and activities in the methods used in your study. 2. Make sure that your responses to questions about demographics, confidentiality, risk, and the identity of your participants on your form correspond clearly to what you write about your study’s participants and the methods used in your study. What is the IRB looking for in this description? We are looking for more detail about your study in relation to what you’ve indicated in your form. 3. In your description of methods, make sure that you explain clearly who the participants are, what will be done to participants, what type of data you are collecting, how it will be collected, and how you will analyze the data. Use layperson’s terms when you explain your methods. Do not assume that your reader already knows about your intervention, instructional method, assessment, etc. • The next part of this tutorial is designed to provide more help to researchers who are using the exempt form because they understand that their study poses minimal risk to human subjects because it involves “research conducted in established or commonly accepted educational settings” involving “normal educational practices.” • In this case, the researcher will have responded “yes” to questions K.1. and K.2. on the exempt form. • Many studies conducted by students and faculty are exempt from review because they involve “research conducted in established or commonly accepted educational settings” involving “normal educational practices” • According to federal regulations, this falls under exempt status. • But what does “established or commonly accepted educational settings” mean? • • • “Established or commonly accepted educational settings” means K-12 and college classrooms. This term may also apply to after school programs, preschools, day care centers, vocational schools, alternative education programs, etc. which are affiliated with K-12 schools or colleges. Laboratory settings would not be included in this category. Other educational settings need to be considered case by case by the IRB. • If you respond “yes” to K.1., you need to indicate clearly in your one page description of the study that in fact your study will be conducted in “established or commonly accepted educational settings.” • If you respond “yes” to question K.2., you indicated that you are conducting research involving “normal educational practices.” • But what does “normal educational practices” mean? • • “Normal educational practices” means: research on regular and special education instructional strategies, or research on the effectiveness of or the comparison of instructional techniques, curricula, or classroom management methods. Normal educational practices include curriculum/instruction that is planned and implemented by the classroom teacher. This might also include surveys or tests that teachers commonly give to measure the effectiveness of an educational practice. Any material, intervention, activity, etc. suggested or implemented solely by the researcher is NOT considered to be a normal educational practice. • If you respond “yes” to K.2., you need to indicate clearly in your one page description of the study that in fact your study will involve “normal educational practices.” • There are some kinds of descriptions that will indicate to the IRB committee that you should be submitting an expedited form because they do not indicate “normal educational practices.” • Examples: – “The researcher will implement a social skills role play.” – “The researcher will conduct a body image interview.” – “The researcher will administer a survey about bullying and being victimized.” • If you respond “yes” to K.2., but you use descriptions like these, you will be asked to clarify or revise your form because these descriptions do not indicate “normal educational practices” and indicate neither teacher participation nor the teacher’s planned curriculum. Further, these descriptions are vague and suggest potential personal or sensitive topics. • There are some kinds of description that will show clearly that you are doing studies involving “normal educational practices.” • Examples: – “The researcher (who is the teacher in this classroom) will implement a social skills role play.” – “The researcher (who is helping the teacher implement her physical education curriculum) will conduct a body image interview.” – “The researcher will administer a survey about bullying and being victimized. This survey is being used by the teacher as part of a school wide program to prevent bullying. This survey is similar to a survey previously used by the teacher and its administration has been requested by the teacher.” • If you respond “yes” to K.2., and you use descriptions like these, there will be no disparity between what you’ve indicated on your form and in your description. • In all of the above examples, however, you need to give enough information to demonstrate to the IRB that what you are doing in the class is indeed part of the regular curriculum for this class. • Next, this tutorial will help researchers understand how the inclusion of copies of the instruments they will be using can impact their submission. • The IRB requires that you attach to the exempt form copies of the instruments to be used in your study. • Make every attempt to generate the questions that you might pose in an interview or that will appear in your survey. • The IRB needs to know if risky, personal, or sensitive topics will be raised for the participants in your study. • If you indicate “no” to items L.4. or L.5. on your form, but your interview or survey items are risky, personal, or sensitive, this will indicate to the IRB committee that you should be submitting an expedited form. • Exs. – Items that touch on issues of sexual activity or body issues; drug or alcohol abuse; violence; issues of self-esteem; strong feelings of anger toward self or others; feelings of despair, depression, fear, or anxiety; etc. – Generally, items that could possibly bring about psychological distress in particpants • The IRB hopes that the information provided in this tutorial is helpful to you. The IRB welcomes questions from researchers as they consider the submission process. The IRB also welcomes the concerns and questions of researchers as they participate in the IRB review process.