More About Research
Understanding Research
Benefits and Risks
Ethical Considerations
Research oversight
Patient Confidentiality
Contacting Our Research Department
Understanding Research
Making the choice to participate in a research study is an important one. We want to be sure that you understand research, understand your responsibility as a research participant, and understand the potential risks and benefits to participating in research.
There is a wealth of information on the internet about research and the history of research. Please use the following links to familiarize yourself with the research process and the history of research. We hope that this information will provide you with the knowledge that you need to make an informed choice about possibly volunteering for a clinical trial as a research participant.
Please use the following link below on the clinical trials government website as a guide to understanding clinical trials:
http://www.clinicaltrials.gov/ct2/info/understand
Please use this link below as a guide to understanding informed consent on the National Cancer Institute Website:
http://www.cancer.gov/clinicaltrials/conducting/informed-consent-guide/page1
Benefits and Risks:
Why should you volunteer to participate in a clinical trial research study?
By participating in a clinical research study, a contribution to medicine and worldwide health is made. This data is being collected to determine if the date collected will assist in the possible FDA approval of the medication or device. We continue to study new treatments in an effort to bring better treatments to the market to improve worldwide health. A volunteer research participant is a key team player in this process. Research cannot be done without your help.
As a research participant, you will receive study related medical care at no cost to you. You are followed closer for your condition as a research participant and play a more active role in your healthcare. You gain access to new research treatments that are not yet widely available to the public.
Your participation is completely voluntary. You may or may not receive any benefit to participating in a research study. Most studies use a placebo treatment as a study control which you could possibly receive as treatment. If you participate in a research study and decide that you are no longer willing to participate, you may withdraw at any time with no penalty or cost to you.
Ethical Considerations:
Clinical trials are governed by clearly defined ethical and legal codes. In 1981, regulations of the Food and Drug Administration (FDA) made it a requirement that all federally regulated clinical trials be reviewed and approved by an Institutional Review Board (IRB) before and during the course of the trial. An IRB is a committee of volunteers including experts and lay people such as doctors, scientists, clergy and other community members. Their primary goals are to protect the public, to evaluate whether the potential benefits of the study participation outweigh the risks and to ensure that patients are not coerced into participation in a clinical trial.
Research oversight
Study plans and the progress of clinical trials are reviewed periodically by the IRB, by the study sponsor and the investigator. The FDA and other federal agencies such as the National Institute of Health oversee the Institutional Review Boards. Ongoing changes to clinical trial regulations and the review process help to ensure that the rights and welfare of study participants are protected more thoroughly than in the past years. Patients may call the IRB with questions about their rights as a research participant. The name and telephone number of the IRB overseeing the clinical trial is included in the informed consent form.
Patient Confidentiality
Patient confidentiality is maintained during and after a clinical trial. Outside of the research team, a participant's name may not be disclosed without the permission of the participant unless required by law. Generally, the sponsor, FDA and the IRB have access to the study patient's medical records. To ensure confidentiality, volunteers are assigned a patient number once they are enrolled in a trial and are identified by this number and their initials for the duration of the study. Patient confidentiality is maintained in the same manner when the results of a clinical trial are reported to government agencies and in scientific meetings and medical journals.
Contacting Urology Team Research Department
To learn more about research with Urology Team please call 901-9466 or email research@urologyteam.com