Spring 2009 IRB Meeting Schedule: 2/5, 3/5, 4/2, 5/7

All students doing research with human subjects must go through an Institutional Review Process and complete their Certification Training (see link below) before any type of subject recruitment or data collection can begin. For students, this process officially begins after the successful defense of the dissertation or thesis proposal. It is essential that you familiarize yourself with the human subjects policies and procedures guide available from the link below, before you construct your methodology section (Chapter 3) and proceed with your proposal defense.

The St. Mary's University IRB website offers extensive information regarding each step of this process. It is important to keep in mind that the national Institutional Review Board process takes, on average, 6 months to complete. While the St. Mary’s IRB committee attempts to review all applications in a timely manner, please remain flexible in your planning as to avoid any unnecessary frustrations.

Once the dissertation or thesis proposal has been completed, submit the first draft of your IRB application and supporting materials to Dr. Dana Comstock, the Area Representative for the Department of Counseling and Human Services. It is preferred that you submit both hard copies and electric/digital files. Hard copies can be dropped off to our Departmental Secretary, Mr. Francis Farrell, and electronic files may be submitted to dcomstock@stmarytx.edu. Once the editorial phase has been completed, the timeline of which varies from study to study, you will be asked to submit:

1. One (1) copy of the final draft of your proposal that is in perfect APA format and includes ALL recommended changes from your proposal meeting AND reflects any changes in procedure that might have been adjusted during the IRB editorial process. Unnecessary edits at this phase can add up to six weeks to the IRB review process, and subsequently delay the implementation and completion of your study as well as your projected graduation date.

2. Ten (10) copies of the final draft of your IRB application (with signatures) and all other supporting materials. Supporting materials might include approval to do research within any cooperative institutions such as school districts, medical facilities or community agencies.

3. The “Proposal Review Checklist,” which is found on the last page of the
” Request for Proposal Review” file.

The St. Mary’s University IRB website is very explicit and comprehensive so read through each link carefully before proceeding with the creation of the methodology for your study and your IRB process and application.

Click here to view the website.

Tips for Successful Progression Through the IRB Review Process

1. To avoid unnecessary corrections, it is advised that you have an editor review your completed proposal before submitting the final copy of it to the IRB Area Representative. The Graduate School will reimburse doctoral students up to $300.00 for professional editorial services so keep your receipts!

2. The dissertation proposal submitted with your IRB application and supporting materials needs to be written in future tense. “This study will attempt to…”

3. Expect there will be some edits to the first draft of your IRB application and supporting materials so do not submit multiple copies of anything until your IRB edits are completed by the Area Representative.

4. Take pride in working creatively within the system. The IRB process is an integral part of the development of all research endeavors. Even though time consuming multiple steps may be required involving IRB processes from cooperative institutions, it can and has been done.

5. The Policies and Procedures Guide provides explicit examples of items that need to be incorporated into your Informed Consent, Cover Letter, and Assent Form (if necessary). Be careful not to include verbatim material from the guide if it does not pertain to your study. All too often students are working to make sure they cover everything and end up including lines or statements that are direct quotes from the given examples that don’t make sense for their study.

6. Do not, under any circumstances, use other students’ dissertations, theses or IRB materials as guides for the structure and analysis for your dissertation or thesis.

7. Students attempting to conduct research that does not fall within Federal Guidelines (regardless of any formal or informal approval by their dissertation chair, committee members or cooperative institutions) are at risk for being expelled from the University.

8. At the end of the review process you will be notified of the status of your application. If you get notification that your study has been approved, you must obtain the stamped “Approved” copy of your informed consent from our Departmental Secretary before you can begin recruiting subjects. You are only permitted to use duplicated copies of stamped “Approved” forms while conducting your study.

9. Keep in mind that the contact you have with your participants will be in the role of Primary Researcher and as such you are acting as a representative of the University. Conduct yourself in a professional manner. Be on time for scheduled appointments, return phone calls in a timely manner and limit the amount and structure of contact with participants to reflect the methodology that you have built into your design. For example, if you proposed that you would conduct an interview and make one follow-up phone call, then this is the limit on the contact for which you have been approved. If you conduct interviews in a participant’s home, it is recommended (not required) that you are not alone in their home. Do not exceed the estimated time of contact for which they have given consent and do not take any personal items from your participants even if they have requested you do so.

Advice from a Doctoral Student on Surviving the IRB and Dissertation Process:

Scotia McClung, a recent Ph.D. graduate has graciously agreed to share some advice on getting through the dissertation and IRB process. Scotia’s dissertation research was unique in that she:

1. Researched a vulnerable population (adolescent girls).

2. Requested and received school district approval before her dissertation proposal defense.

3. Had to request and secure parental and participant consent for participation through the use of both Parental Informed Consent and the Assent Form for minors. Assent forms are challenging in that they have to be worded in such a way as to reflect the common language of the respective population.

Along with her advice, she agreed to allow the Department to post her Parental Consent, Cover Letter and Assent forms as to provide students encouragement and creative inspiration if they may be considering similar types of studies. Her forms are not being made available as examples, but are being shared to simply encourage students not to give up should their studies involve complicated and/or time consuming steps with outside agencies or vulnerable populations.

• Assent form
• Cover letter
• Consent for a minor

Advice for Students

As I began the dissertation process I did not realize how many different channels I would have to go through in order to interview my participants. Not only did I have to go through the IRB, but I had to go through the Austin Independent School District (AISD), the Principal and Counselors of the school involved and of course the parents of the potential participants. Once I was through all of those channels I had to have the participants assent to the study. While this was daunting at first it was actually an important part of writing my dissertation - not only because it was the ethical way to
do it, but because it helped me to think more in depth about how I wanted to run my study. Also, having several other people look over it helped me to cover all my bases, so when it came time to do the study all went smoothly.

It is important to allot for extra time while waiting on the IRB and other channels to okay the study. A dissertation takes time - but you don't have to spend the rest of your life on it. I started writing my dissertation in January and was finished by July. However, I worked hard to get it turned into the IRB and AISD as fast as I could. While
I was waiting for them to accept the study I was talking with the school counselors informally setting up a place/time to interview potential participants for my study. Therefore, once it was accepted I was ready begin the recruitment process.

I am living proof that a dissertation can be started and completed within a relatively short amount of time. It takes planning, good timing, focus and lots of patience. I took it one chapter at a time -- making sure chapter 1, 2 & 3 were perfect before getting it to the
IRB so I didn't have to go back and rewrite, rearrange, or make other changes. Spending a couple days focusing on polishing each chapter at a time was the best way for me to accomplish this huge undertaking. Breaking it down into chapters makes it a lot less daunting and instead of writing a long dissertation it was like writing a series of five papers, each with their own interesting focus and purpose.

While the process of writing the dissertation can by scary and can seem impossible -- it can be done. You can persevere the process as long as you put your mind to it. Just know that it will be frustrating and you will come up against set backs from time to time,
but keep pressing on toward your goal. It is an incredible feeling when you are done and you have achieved your highest potential!

Scotia McClung

Postscript: Scotia gave birth to a beautiful baby girl shortly after she had completed her data collection, and successfully defended her dissertation with baby in tow! Congratulations Scotia!