Consent Form

Introduction:
You are being asked to take part in a research study about understanding how women experience genetic testing for the BRCA 1/2 gene mutations. Our study will address how women deal with high risk for hereditary cancer and/or BRCA test results. We will examine individuals’ experiences surrounding their risk status, the impact on families as a whole, and how genetic counseling should approach the BRCA experience for women. You are being invited to participate in this research study because you have identified yourself as having undergone genetic testing for BRCA.

Your consent is completely voluntary and ongoing. There will be absolutely no penalization if you decide not to participate. If there is anything you do not understand, please ask questions by emailing Dr. Sharlene Hesse-Biber, the principle investigator of this study, at hesse@bc.edu.

Dr. Sharlene Hesse-Biber is a Professor of Sociology and Director of the Women’s and Gender Studies program at Boston College.
Dr. Hesse-Biber is a renowned researcher and writer in the field women’s body image and the issues of the commodification of women’s bodies. This research is a new area of exploration, but an extension of her long-term interests in women’s lived, embodied experiences; genetic testing; and BRCA1/2 mutations.
           
Dr. Hesse-Biber will be assisted by Boston College undergraduate and graduate students, as well as external research assistants.  IRB approval has been obtained from Boston College (Protocol Number 16.109.01). This study receives funding from Boston College’s Ignite Program. Neither Dr. Hesse-Biber nor her assistants are being funded by any interest groups or companies, and thus there are no potential conflicts of interest associated with this research.

If you would like a copy of this consent form, please either save or print this page after giving your consent at the bottom of this page.

Purpose:
In this project, we hope to address the substantial lack of research on how women decide to seek genetic testing and the ways in which women deal with test results for the BRCA 1/2 gene mutations. This project will make a significant contribution to our understanding of individuals’ experiences with genetic testing, how this impacts families and relationships, and how genetic counseling should approach the BRCA experience for women.

Procedures:
You are being asked to complete an anonymous, confidential online survey. The total amount of time you will be asked to volunteer will be approximately 30 minutes.
           
You will be asked to identify your perceptions and concerns surrounding genetic testing for the BRCA 1/2 gene. Please note that you can skip any question(s) that you do not wish to answer for any reason.
After completing the online survey, you will be asked if you would like to leave your email address so that you can be contacted for a phone interview. Phone interviews provide the opportunity for participants to expand upon some of the questions and topics included in the online survey. Phone interviews are optional and are conducted after the participant has completed the online survey. Phone interviews will be audio-recorded and will last approximately 60 minutes. Please be sure to leave your email address at the end of the survey if you would like to participate in a phone interview.

All of our data will be destroyed within 3 years of our data collection. Collected data will be kept in locked storage until that time. At no point will we publicly use any uniquely identifying information from your interview.

Benefits:
You will not receive any direct benefit from being in this research study, but you may feel gratified knowing that you have contributed to research on the BRCA gene mutation. We hope to gather information that will help us to better understand the experiences of those who have undergone genetic testing for the BRCA 1 and 2 gene mutations.

Costs:
There are no costs to you associated with your participation; however, you do need to have access to a web-enabled computer. There are no foreseeable risks or discomforts to you in completing this study. This study may include risks that are unknown at this time.

Compensation:
You will not be compensated for participating in this study.

Risks:
There are no foreseeable risks, discomforts, or side effects—physical, psychological, or otherwise—as a result of participation in this study. There may be unknown risks.

Decision to Withdraw from the Study:
Participation is entirely voluntary and you may choose to stop your participation in this study at any time.  There are no penalties for a decision to withdraw from the study.

Confidentiality:
We will not release (verbally or in print) any uniquely identifying information from your survey.  This informed consent along with any notes, and surveys will be stored in a locked cabinet of Dr. Hesse-Biber’s, and no one but Dr. Hesse-Biber and her research assistants for this project will have access to the cabinet while the study is being conducted.  Within three years after the data is collected, all materials apart from our intended publication will be destroyed (erased or shredded).

Although it happens very rarely, we may be required to show information that identifies you, like this informed consent document, to people who need to be sure we have done the research correctly.  These would be for people such as the Boston College Institutional Review Board that oversees research involving human participants.

Questions:
You are encouraged to ask questions now and at any time during the study.  You can reach Dr. Sharlene Hesse-Biber at her office at 617.552.4139 or email at hesse@bc.edu.

If you believe you may have suffered a research-related injury, please contact Dr. Hesse-Biber at 617.552.4139, and she will give you further instructions.

If you have any questions about your rights as a research subject, you may contact the Director of Office for Research Protection at Boston College at (617) 552-4778 or irb@bc.edu

Certification:
I have read (or have had read to me) the contents of this consent form and have been encouraged to ask questions. I have received answers to my questions. I give my consent to participate in this study. 

If you agree to the statements above and agree to participate in this study, please select the “I have given consent” option below.

*Please note: this survey does not work properly on mobile phones.