1.  What kinds of studies need IRB approval?

Any research conducted using human participants must be submitted for review (but, see question #3 below).  The submission entails filling out either a review form or a request for exemption.  Please keep in mind that research includes surveys and interviews as well as other types of data collection.  All Master’s theses must be reviewed.

The Office of Human Research Protections provides a useful chart to assist researchers with IRB questions concerning their research.

2. What about journalism, oral histories, or biographies?

Because biographers, journalists and historians are often working on research that is particular to the individual or individuals they are studying, their activities are outside of the purview of IRB and do not require review.  In other words, because the research is not meant to be generalized outside of a specific person or situation, it does not meet the definition of research as set forth in the federal guidelines.  Oral histories have recently been excluded from oversight by the IRB and no longer require review as they have in the past.   If you are uncertain about your project, please contact the IRB.

3. I am collecting data from my class to determine if students like a new teaching method.  Do I need to go through the IRB to collect these data?

The federal guidelines define research as “a systematic investigation…designed to develop or contribute to generalizable knowledge”.  The Department of Health and Human Services does not consider a study research unless you plan on disseminating the information you collect to a wider audience (e.g. through presentation or publication).  Therefore, if you are collecting the data only to improve your course and will not be sharing the results, you do not need to worry about IRB approval.    However, if you believe that you may present or publish your results, you need to submit an IRB form.  (Most classroom research on educational strategies would require only a request for exemption).  Make sure students know that refusing to participate will not affect their grades.  The collection of data from your class can be seen as coercive, so it is important to be extremely careful in this area.  It is always a good idea to keep anonymous any and all students who participated in your study.

4. What about student research?

This is a tricky one since federal and state policies do not specifically cover student projects. Because the results of projects are often not disseminated outside of the educational classroom setting, they technically do not fall under the purview of the IRB.   Therefore, the University of Mary Washington’s IRB does not require student projects conducted in courses to be reviewed if the purpose of these projects is only pedagogical in nature.  If you have students who might present their research outside of the classroom or submit a paper for publication, they must go through the IRB. Although the IRB does not require review of classroom projects, it assumes that instructors in these courses provide close supervision of students, teach students the ethics of human research, and ensure that students do not perform research that is at all questionable in terms of ethics.  If a student is dedicated to a class project that you believe should be reviewed, please feel free to submit it for review.

5. How do I apply for approval?

Your proposal will fit into one of three categories.  It will be considered exempt, expedited, or in need of a full board review.  After familiarizing yourself with the policies and procedures manual, fill out either a request for exemption or an expedited/full board review form.  The best thing to do is to look at the exempt form first.  Listed on the form are categories of exempt studies.  If your project fits into one of the exempt categories, fill out that form.  If your study does not fit into one of the categories, you will need to fill out the more detailed expedited/full board form.  Remember to fill out the forms completely or they cannot be reviewed.

6. Where do I submit the form?

Completed forms should be taken to the appropriate IRB Board member for review. The requestor will be notified via email if changes need to be made or if the project has been approved as is. All IRB requests will be forwarded to the Dean’s office of the College of Arts and Sciences to be archived.

7. How long with the review take?

If your study falls into the exempt or expedited categories, the process will usually be completed in less than two weeks.  If your study requires review by the full board (i.e. your study does not meet the expedited criteria), the review could take a month to 6 weeks.

8. Can I start collecting data before I receive approval?

Absolutely not.  You must have approval before any data are collected.

9. How will I know that my research has been approved?

You will receive an email from the chair of the IRB or designee indicating that you have been approved.  IRB approvals will be good for one year from the date of approval unless you state on your application that the data collection will last longer than one year.

10. Federal regulations require that all researchers receive training in ethics.  How do I meet this requirement?

Faculty, staff, and students who wish to submit research for review by the UMW IRB must complete the online training program available at www.citiprogram.org.  You will need to register for the course and select University of Mary Washington as the institution.  Once you have completed the training, please retain a copy of the training completion certificate for your records.  You will need to submit this certificate as proof of training with any IRB proposals.