Patient survey

 

Hello!  We are a research team from the vascular anomalies special interest group of the American Society of Pediatric Hematology and Oncology based at the University of North Carolina School of Medicine. We are seeking your help with a research study to learn whether men or boys with vascular anomalies, especially those that involve the pelvis or genital area, have concerns about their sexual function. Because sexual problems are very common in men in general, we also are interested in hearing from men with vascular anomalies that don’t involve the pelvis or genital area to compare results in both groups of individuals. We have been asked by some of our male patients or their parents what we know about this issue, and our answer has been “not much.”

 

Concise Summary

The purpose of this study is to learn whether men or boys with vascular anomalies, especially those which involve the pelvis or genital area, have concerns about their sexual function. Our anecdotal experience suggests that these vascular malformations can affect the physical and psychosocial wellbeing of older boys and men. There are no large studies of sexual function/fertility in males with vascular anomalies at any anatomic location, and we plan to address this issue by conducting an anonymous survey to learn whether men or boys with vascular anomalies, especially those that involve the pelvis or genital area, have concerns about their sexual function.  Your participation will be limited to answering a survey of questions which should take approximately 15 minutes to complete. The greatest risk is a breach of confidentiality.  However, we will not collect your name or your child’s name in order to minimize this risk.  Research is designed to benefit society by gaining new knowledge. You will not benefit personally from being in this research study.

 

If you are interested in learning more about this study, please continue to read below.

 

What are some general things you should know about research studies?

Joining the study is voluntary. You may choose not to participate, or you may withdraw your consent to be in the study, for any reason, without penalty. Research studies are designed to obtain new knowledge. This new information may help people in the future. There may be risks to being in research studies. Deciding not to be in the study or leaving the study before it is done will not affect your relationship with the researcher, your health care provider, or the University of North Carolina Medical Center. If you are a patient with an illness, you do not have to be in the research study in order to receive health care. Details about this study are discussed below. It is important that you understand this information so that you can make an informed choice about being in this research study. 

 

What are the possible risks or discomforts involved from being in this study? There may be uncommon or previously unknown risks. You should report any problems to the researcher. Risk is limited to a minimal risk of a breach of confidentiality. To minimize this risk, we will not identify you by name and the anonymous survey.

How will information about you be protected? Participants will not be identified in any report or publication about this study. We may use de-identified data from this study in future research without additional consent.

Although every effort will be made to keep research records private, there may be times when federal or state law requires the disclosure of such records, including personal information.  This is very unlikely, but if disclosure is ever required, UNC-Chapel Hill will take steps allowable by law to protect the privacy of personal information.  In some cases, your information in this research study could be reviewed by representatives of the University, research sponsors, or government agencies (for example, the FDA) for purposes such as quality control or safety.

What if you have questions about this study? You have the right to ask, and have answered, any questions you may have about this research. If you have questions about the study, complaints, concerns, or if a research-related injury occurs, you should contact the researchers listed at the end of this email.

What if you have questions about your rights as a research participant? All research on human volunteers is reviewed by a committee that works to protect your rights and welfare.  If you have questions or concerns about your rights as a research subject, or if you would like to obtain information or offer input, you may contact the Institutional Review Board at 919-966-3113 or by email to [email protected].

Study Contact Telephone Number: Dr. Jessica Stewart (919) 966-4292; Desma Jones (919) 843-9463; Terry Hartman (919) 966-4997; Travis Patterson (984) 974-8848

Study Contact Email: [email protected]; [email protected]; [email protected]; [email protected]

 

Parents or guardians are welcome to include experiences with their minor sons by completing the child question survey (< 18 years of age). Your participation will serve as your consent for you and for any of your minor children whose information you supply. 

 

The link below will take you to an anonymous survey, which should take 15 minutes to complete: https://unc.az1.qualtrics.com/jfe/form/SV_0U2T5Vmr1z1Qt2B

Page last updated July 21, 2020