ROARS Patient Informed Consent

REGISTRY PARTICIPANT CONSENT AND PRIVACY AUTHORIZATION FORM

Title: Registry of Outcomes from AntiReflux Surgery (ROARS).

Protocol No.: None
WIRB® Protocol #20161006

SPONSOR: The Heartburn Foundation

INVESTIGATOR:

Reginald C.W. Bell, M.D.
401 W Hampden Place #230
Englewood, Colorado 80110
United States

SITE(S): SurgOne Foregut Institute
401 W Hampden Place #230
Englewood, Colorado 80110
United States

STUDY-RELATED
PHONE NUMBER(S): Reginald C.W. Bell, M.D.
(303)788-7700 (24 Hours)

The following information is provided to inform you about this research registry for comparing patient outcomes after certain laparoscopic antireflux procedures. Please read this form carefully as it tells you what we would like to do and the possible benefits and risks of participation in this registry. If there is anything you do not understand, please ask questions. You can decide if you want to give your permission to participate or not.

WHAT IS THE REGISTRY?

The Registry collects information about your health as it relates to your reflux disease and/or your hiatal hernia, for use in medical research.

Up to 1000 patients will be included in the registry.

WHY IS THIS REGISTRY BEING DONE? WHAT ARE THE COSTS?

You are being asked to take part in the Registry because you are being evaluated and/or treated for gastroesopahgeal reflux disease (GERD), and/or Barrett’s esophagus, and/or a hiatal hernia. The goal of this registry is to collect data about standard antireflux surgical treatment options in everyday clinical practice to better understand the disease and develop better methods to treat it so we may improve patient care.

There is no cost to participate in the Registry.

You will not be paid for being in this Registry.

WHAT IS INVOLVED IN THE REGISTRY?

You are being asked to give permission to this clinic to allow our clinic to collect detailed medical and demographic information from your medical records regarding your antireflux procedure and its outcome now and for 5 years in the future as part of the registry. Several times during your registry participation you will be asked to complete a questionnaire about your heartburn treatment and symptoms. Researchers may also contact you to ask follow-up questions about your treatment or health status. You may choose whether or not to participate in this part of the research at that time.

WHAT ARE THE RISKS OF THE REGISTRY?

There are no additional medical procedures required to allow you to participate in this Registry. There is no physical risk to you. There is some risk that your personal health or other information could be learned by those not authorized to see your information. We will make every effort to prevent this from happening.

ARE THERE BENEFITS TO TAKING PART IN THE REGISTRY?

While there is no direct benefit to you of allowing us to collect your information, information in the Registry may be used to advise your treating physician on techniques that may improve outcomes in the treatment of this disease. The information may also help others with heartburn in the future.

WHAT OTHER OPTIONS ARE THERE?

This is not a treatment study. Your option is to not participate. It is not necessary to participation in this registry to have your antireflux procedure done.

VOLUNTARY PARTICIPATION/WITHDRAWAL

Your participation in this Registry is entirely voluntary. You are free to say yes or no, or to withdraw later, and your decision will not result in any penalty or loss of benefits to which you are entitled or change your current or future health care.

Your participation in this registry may be stopped at any time by the study doctor or the sponsor without your consent for any reason. If you withdraw or are taken out of the registry, this will not affect your care for your heartburn or your relationship with your doctor.

WHO WILL SEE MY HEALTH INFORMATION?

Your privacy is very important to us and we will make every effort to protect it. Federal and state laws and the federal Privacy Rule also protect your privacy. In addition to authorized researchers and the research team here at this clinic, it is possible that other clinics participating in the registry may have access to your personal health information. Your information may be given out if required by law. By signing this form, you provide your permission, called “authorization,” for the use and disclosure of information protected by the Privacy Rule. You do not have to give permission to use and give out your health information, but if you do not, you will not be able to be in this research registry.

If we think your participation in this Registry may affect your medical care, information about your Registry participation may be included in your medical record.

There are organizations that may inspect your records. These organizations are required to make sure your information is kept private, unless required by law to provide information. Some of these organizations are:

  • The Institutional Review Board, IRB, is a group of people who review the research with the goal of protecting the people who take part in the Registry.
  • The Food and Drug Administration and similar agencies reviewing the Registry.

Your information will be used and/or given to others to do the research, to study the results, and to see if the research was done right. If the results of this study are made public, information that identifies you will not be used.

Because of the need to release information to the above parties, total confidentiality and privacy cannot be guaranteed. There is a risk that your information will be given to others without your permission.

Before sharing your data or information with any other party, we will first remove direct identifiers (such as your name). Your de-identified information may be shared with other repositories or databases that allow more access to information to do research.

You may review or copy your information, but you may not be able to see your registry information until after the research is over.

CAN I REMOVE MY DATA ONCE IT IS PUT IN THE REGISTRY?

This Consent and Authorization Form has no expiration date. However, you can change your mind at any time and ask that information about you no longer be collected and added to the Registry by contacting:

  • Reginald Bell, MD
  • SurgOne Foregut Institute
  • 401 W. Hampden PL #230
  • Englewood, CO 80110
  • Phone: (303) 788-7700

Data already collected with your consent and authorization cannot be withdrawn. Registry information collected prior to the revocation of this Consent and Authorization may continue to be used and disclosed in order to preserve the scientific integrity of this Registry.

If you withdraw your permission, you will not be able to stay in this registry.

WHO DO I CONTACT FOR QUESTIONS?

If you have more questions, concerns or complaints about the Registry, or think you were harmed because of your participation, let Reginald Bell, MD know right away by calling 303-788-1636 or 303-788-7700.

If you have questions about your rights in this Registry, if you have questions, concerns or complaints about the registry, or want to report any problems, you can call:

  • Western Institutional Review Board (WIRB)
  • 1019 39th avenue SE suite 120
  • Puyallup, Washington 98374-2115
  • Telephone: 1-800-562-4789 or 360-252-2500
  • Email: help@wirb.com

WIRB is a group of people who perform independent review of research.

WIRB will not be able to answer some study-specific questions, such as questions about appointment times. However, you may contact WIRB if the research staff cannot be reached or if you wish to talk to someone other than the research staff.

WHAT DOES YOUR SIGNATURE ON THIS CONSENT AND AUTHORIZATION FORM MEAN?

Your signature on this form means that:

  • You understand the information given to you in this form
  • You accept the provisions in the form
  • You agree to participate in the Registry

YOUR CONSENT AND AUTHORIZATION TO PARTICIPATE IN THE REGISTRY

Date: _____________

Name: ___________________________________________________________

Signature: ______________________________________________________

________________________________________ __________________
Printed Name of Person Conducting the Position
Informed Consent Discussion

________________________________________ __________________
Signature of Person Conducting the Date
Informed Consent Discussion (if applicable)

You will receive a copy of this consent for your records.