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Frequently Asked Questions

Why should I participate in clinical research study?

New medical treatments and equipment must have FDA approval before they can become available to the public. Clinical studies that demonstrate efficacy are a part of the required government approval procedure. Individuals who volunteer to join these studies can have a great impact on the lives of thousands of people. Volunteer involvement allows research trials to proceed and helps to clear the way for advanced treatments to be accessible to those who need them.

As a volunteer participant, you also may have some significant health benefits:

  • A thorough medical history, physical exam and laboratory services (if needed) will be done for you at no cost.
  • Depending on the type of study, free monitoring supplies for certain health conditions (such as diabetes) may be available to you if appropriate.
  • You may have early access to a new and advanced treatment.

You will also be gratefully appreciated for your contribution to the advancement of medical science and health care.

Who will take care of me during a clinical research study?

Your study-related care is provided by our team of physicians, nurses, research coordinators and other medical professionals.

How are my personal information and my health protected?

Your identity and other personal information, including that which pertains to your health, medical care and study participation, are protected according to the regulations set forth by both the United States and Texas state governments.* These rules do permit the sharing of some of your information with the research sponsor and certain government officials under very specific circumstances. This allows the sponsoring organization to consult with us about the progress and result of the study and also contributes to the protection of both your health and privacy during your participation. Research organizations are also subject to inspections by the FDA and the research sponsor, and to questioning by Institutional Review Boards and Data Monitoring Committees. Confidentiality regulations apply in these situations. There are also other legal and ethical guidelines that must be followed by medical professionals as well as their office staff.

In addition, we are required by law to provide you with detailed information about the study so that you may give your “informed consent” to become a study volunteer. These details will discuss study purpose, procedures, duration, possible risks and benefits, protection of your health and privacy, optional health treatments that you may wish to consider, treatment of any health problems that could be encountered as a result of study participation and other important information.

We will also answer your questions about these or any other study-related topics when you visit our office. To read our Privacy Policy Statement, please click here.

* For more information about medical privacy regulations, please visit www.fda.gov or http://www.legis.state.tx.us/billlookup/text.aspx?LegSess=81R&Bill=HB300  

Will there be any cost to me to participate in a clinical trial or will I be compensated for my participation?

There is no cost to participants in a clinical study. All medical care, medications and equipment related to the research investigations are provided at no charge. Most participants are reimbursed an amount to cover time and travel for office visits. The reimbursement rate varies with each study and will be discussed with you for your consideration before you give your written consent to participate.

Can I withdraw from a study or must I continue to participate until it ends?

You may discontinue participation at any time for any reason. The informed consent document that you must sign is not a contract and does not state that you must remain in a research study. You may be offered suggestions about how to leave the study, especially if trial medication needs to be stopped gradually or you need to return study medication or other materials. It could be helpful, although not required, to inform the researchers about your reasons for the decision to discontinue. This information may assist researchers in improving the clinical trial process and make the results of the study more reliable. Your reasons for withdrawal will be kept confidential in accordance with professional ethical guidelines and government privacy regulations.

Will the study doctors continue to take care of me when the research ends?

Most clinical trials include medical care related only to the purpose of the study and do not offer extended or total primary or specialty health care. You should continue seeing your primary and/or specialty medical professionals during and after the completion of your study participation.
 

 

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