Investigational Subjects Bill of Rights:  You and everyone in a medical research study have the rights that are listed below.  You have the right:

1.         To be told about the kind of research study this is and the purpose of the research. 
2.         To be given an explanation about all the study procedures to be used and of any drug or device to be used. 
3.         To be given a description of any risks or discomforts which can reasonably be expected to happen. 
4.         To be given an explanation of any benefits you may have as a result of this research. 
5.         To be told about any appropriate alternative procedures, drugs, or devices that you can choose instead of this research study and of their relative risks and discomforts. 
6.         To be told about any medical treatment you can get if you are injured from a study drug, study device or a study procedure. 
7.         To be given a chance and encouraged to ask any questions about the study or the procedures involved in this research. 
8.         To be told that you can take back your agreement to be in this research study at any time and you can stop being in this study without affecting the health care your doctor is giving you now or in the future.  
9.         To be given a copy of the signed and dated written consent form if requested.

This consent may be hard to understand in places.  Please ask questions if there are parts you do not understand.  This is a research study. It includes only individuals who choose to take part. Please take your time to make your decision. Discuss it in confidence with your regular doctor, friends and family if you want.  Be sure to ask questions about anything you don’t understand. You are being asked to take part in this study because you are a patient at San Diego Sexual Medicine who has been evaluated by Dr. Goldstein, Dr. Hartzell and Ms. Cohen and returned for at least one follow-up visit. 
PURPOSE & DESCRIPTION OF THE STUDY The purpose of this study is to find out what you think about being seen by a physician, sex therapist and physical at a single site for the diagnosis and treatment of your sexual health concern(s). This research is being done because we are interested in learning whether our model of care by the providers in the three disciplines all under one roof is preferable for your care than if you had been seen by only one healthcare provider at San Diego Sexual Medicine.  There will be no changes to your regular care as a result of your participation in this research. HOW LONG IS THIS STUDY? HOW MANY OTHER PEOPLE WILL BE IN THIS STUDY?  Up to 100 people will take part in this study at this site.  You will be in the study for less than an hour because all you will be asked to do is complete a single questionnaire. You can stop participating at any time. WHAT IS INVOLVED IN THE STUDY? If you take part in this study, you will have the following tests and procedures: ·      Read and sign this consent form electronically. ·      Complete the questionnaire that will appear after you sign the consent form. There is no medication to be taken, no examination required and no need to come to San Diego Sexual Medicine to complete the study. INFORMATION ABOUT THE STUDY QUESTIONNAIRE The questionnaire will have many places where your yes or no response will trigger another specific question, and then bring you back to the next main question.   Please answer as truthfully as you are able in order to help us with this research. RISKS AND DISCOMFORTS  There may be risks to being in this study that we cannot predict. There is the rare risk that you will be distressed by answering questions about you think about your sexual health problem and the care provided to you.                     ARE THERE BENEFITS TO TAKING PART IN THE STUDY? If you agree to take part in this study, there may or may not be direct medical benefit to you. We hope the information learned from this study will benefit others in the future. ALTERNATIVES This study is not designed to diagnose, treat or prevent any disease. Your alternative is to not participate. CONFIDENTIALITY No personal information will be collected.  No information from medical records will be attached to the questionnaires.  Medical records will be reviewed to identify possible subjects who meet inclusion and exclusion in order to send an email invitation to participate.  All emails will be blind copied to invitees to maintain confidentiality. Aspire Independent Review Board (IRB) may inspect the anonymous quesitonnaires for quality assurance and data analysis.  Aspire IRB protects the rights and welfare of research subjects. The study doctor may publish the results of this study but you will not be identified. In the rare event that your information is required to be disclosed by law to another entity, privacy laws may not apply, and neither Dr. Goldstein nor Aspire IRB can protect your information. WHAT ARE THE COSTS? There is no cost involved in participation and no payment will be made toward your medical care. INVESTIGATOR PAYMENT                                       This investigator is not receiving any money to perform this research. WHAT HAPPENS IF YOU HAVE COMPLICATIONS OR ARE INJURED? As this is a research project involving completion of a questionnaire only, you will be responsible for payment of any medical treatment and you will be responsible for the costs your insurance does not cover.   No form of compensation is being offered but that doesn’t mean you are giving up any of your legal rights to sue. WILL YOU BE COMPENSATED DURING THE STUDY? You will not be compensated for taking part in this study.  YOUR RIGHTS AS A RESEARCH SUBJECT Taking part in this study is voluntary. You may choose not to take part or may leave the study at any time. Refusing to take part or leaving the study will not result in any penalty or loss of benefits to which you are entitled. We will tell you about new information that may affect your health, welfare, or willingness to stay in this study. WHO TO CALL IF YOU HAVE QUESTIONS For questions, concerns, or complaints about the study or a research-related injury, contact the study doctor at (see top this form). For questions about your rights as a research subject (and not about study visits or procedures), please contact the QA & Compliance Administrator of Aspire IRB by calling 619-469-0108 (collect calls are accepted) or visit www.aspire-irb.com.  Call us also if you have questions, concerns, or complaints that are not answered by the study doctor or if you want to talk to someone else. Aspire IRB is a group of people who perform independent review of research. Although Aspire IRB has approved the information provided in this informed consent form and has granted approval for the investigator to conduct the study this does not mean Aspire has approved your participation in the study. You must evaluate the information in this informed consent form for yourself and decide whether or not you wish to participate. SIGNATURE AND CONSENT TO BE IN THE STUDY
If you consent to be in this study simply click on the link below. This will mean you have provided consent and will take you to the questionnaire. If you choose not to consent to this study simply close your browser.                                                                                                                                          

· Government agencies such as the Food and Drug Administration (FDA)

· Ethics committees that oversee the research


Aspire Independent Review Board (IRB) may inspect the anonymous questionnaires for quality assurance and data analysis.  Aspire IRB protects the rights and welfare of research subjects.

The study doctor may publish the results of this study but you will not be identified. 


WHAT ARE THE COSTS?

There is no cost involved in participation and no payment will be made toward your medical care.


INVESTIGATOR PAYMENT

This investigator is not receiving any money to perform this research.


WHAT HAPPENS IF YOU HAVE COMPLICATIONS OR ARE INJURED?

As this is a research project involving completion of a questionnaire only, you will be responsible for payment of any medical treatment from any injury incurred while completing the questionnaire, and you will be responsible for the costs your insurance does not cover.   No form of compensation is being offered but that doesn’t mean you are giving up any of your legal rights to sue.


WILL YOU BE COMPENSATED DURING THE STUDY?

You will not be compensated for taking part in this study.  


YOUR RIGHTS AS A RESEARCH SUBJECT

Taking part in this study is voluntary. You may choose not to take part or may leave the study at any time. Refusing to take part or leaving the study will not result in any penalty or loss of benefits to which you are entitled. 

We will tell you about new information that may affect your health, welfare, or willingness to stay in this study. 


WHO TO CALL IF YOU HAVE QUESTIONS

For questions, concerns, or complaints about the study or a research-related injury, contact the study doctor at (see top of this form).

This study was reviewed by Aspire Independent Review Board (IRB). An IRB reviews research to protect the rights and welfare of study participants. If you have problems, concerns, suggestions, questions or information about the study, and for information regarding research subject's rights, please call Aspire's Quality Assurance and Regulatory Compliance Department at 1-877-366-5414 (toll free). 

Although Aspire IRB has approved the information provided in this informed consent form and has granted approval for the investigator to conduct the study this does not mean Aspire has approved your participation in the study. You must evaluate the information in this informed consent form for yourself and decide whether or not you wish to participate.


SIGNATURE AND CONSENT TO BE IN THE STUDY

By clicking on the link below you agree that you have read the above information about this study and have had a chance to ask questions to help you understand what you will do in this study, and they have been answered to your satisfation.  This also means that you have been told, or understand from reading this document, that you can change your mind later if you want to. You can stop answering questions and exit the website at any time.

You are invited to print, sign, and date a copy of this consent form and keep it for your records.