Enrollment Process

Once you have completed our secure online eligibility survey are found to be eligible for the study, enrollment is simple!  

This page outlines the enrollment process, and provides details for each step.  The complete enrollment process only takes about 30 min in total.

Step 1 - Schedule an informed consent session via phone call with a member of the study staff.

The first step of the enrollment process will be to schedule a phone call with a member of the study staff to review the consent brochure and consent agreement.  Once you have completed the online eligibility survey and were found to be eligible, you will be contacted by a member of the study staff to arrange a time for the informed consent phone call.  These documents contain important information about requirements for participation, the anonymous nature of our study, and how your confidentiality will be maintained, and they can be downloaded from this page or will be sent to you via email prior to the scheduled call.  This phone call should only take about 10 - 15 minutes.  If, after, review of these materials by phone, you agree to enroll in our study, we will send you a study enrollment kit via FedEx. 


Step 2 - You will receive an enrollment kit via FedEx.  Please review the contents and complete required paperwork.  

This kit contains all of the materials necessary to complete the enrollment process including:

  • Study card, Consent brochure, Consent agreement, Demographic form, Questionnaire, Medical Record release information sheet and authorization form, and theOragene DNA collection kit

We suggest that you complete the additional paperwork while waiting to collect the DNA saliva sample.  In order to ensure that a quality DNA sample is provided, please do not eat or drink anything (including water, chewing gum, candy) at least 30 minutes prior to providing the sample.

Step 2A - Complete the demographic form.  This information is used only to re-contact you if we decide that additional data is necessary for the study.  Your demographic data is not sent to the lab asit is not attached to your DNA sample or your study questionnaire; therefore, maintaining the anonymous nature of the study.    

 

Step 2B - Please complete the study questionnaire.  The questionnaire may be completed either online or the hard copy included in the kit may be completed and returned with the other study materials.  The link to the secure online version of the questionnaire will be provided in the kit.  In either case, only the study number, indicated by the BOCGS sticker on the hard copy of the questionnaire, should be included on the questionnaire.  Should you have any questions as you are completing this form, please feel free to contact us.

  

Step 2C - If you have had a personal diagnosis of breast cancer, a previous breast biopsy, or clinical genetic testing for mutations in the BRCA1 and BRCA2 genes, we would like to request documentation of such information. We will need you to complete and sign the medical records request form included in the kit to access your records.  In order to produce high quality results and minimize biases in our study study design, it is necessary to obtain the most accurate and detailed information possible.  The Release of Medical Records info sheet included in your study kit and attached on the Study Documents page provides more details about what information we would like to collect and why.


Step 3: Provide a saliva sample using the collection kit.  An instruction pamphlet is included with the saliva collection kit, but the basic steps are as follows:

Step 3A - Please refrain from eating (including gum and candy), drinking (including water), and smoking for at least 30 minutes prior to collecting the saliva sample.  Also, please remove any lipstick prior to providing the saliva sample. 

Begin collecting the sample simply by spitting into the funnel-top tube.  You will notice that there are two black lines on the tube.  The bottom line is the bottom of the collection tube, and the top line inidcates how much saliva is needed to obtain a high-quality DNA sample.  You should aim to fill the tube with liquid saliva (no bubbles) up to this top black fill line with liquid.  It may help to tap the tube on a hard surface to move the liquid from the funnel top down into the tube.

Step 3B - Once you have reached the fill line, close the funnel top by pushing down hard on the lid.  This will release some additional liquid into the tube. 

Step 3C - Unscrew the tube from the funnel top being careful to keep the tube upright.  Discard the funnel top.  Place the small blue cap on the tube and be sure to close as tightly as possible. 

Step 3D - Place the tightly-closed collection tube back in the plastic Oragene box. 

 


Step 4: Place all materials back in the manilla envelope and then into the FedEx envelope to ship back to us.  A pre-paid return shipping label is provided in the study kit.  Your enrollment is complete! 

    


Thank you! We greatly appreciate your participation as it is essential to the success of this study.  We will notify all study participants from the results of the study as a whole after publication.  If you know of a friend or family member that might be interested in participating in our study, please share our study card with them or ask them to visit our site.