Clinical Trial Enrollment
Clinical studies are research studies in which real people participate as volunteers. Clinical research studies (sometimes called trials or protocols) are a means of developing new treatments and medications for diseases and conditions. There are strict rules for clinical trials, which are monitored by the National Institutes of Health and the U.S. Food and Drug Administration. Some of the research studies at the Clinical Center involve promising new treatments that may directly benefit patients.
The health of millions has been improved because of advances in science and technology, and the willingness of thousands of individuals like you to take part in clinical research. The role of volunteer subjects as partners in clinical research is crucial in the quest for knowledge that will improve the health of future generations. Without your help, the research studies at the Clinical Center cannot be accomplished.
The NIH compensates study participants for their time and, in some instances, for the inconvenience of a procedure. There are standard compensation rates for the participant’s time; the study’s principal investigator determines inconvenience rates. NIH reports compensation of $600 or more to the Internal Revenue Service and sends a “Form 1099-Other Income” to the participant at the end of the year. Please be aware that some or all of that compensation may be garnished if the participant has outstanding debts to the federal government.
For questions about our clinical trials contact:
Jim Outland, RN or Sharon Weiser, RN
Clinical Trials Coordinators
Medical research is dogged by the placebo effect – the real or apparent improvement in a patient’s condition due to wishful thinking by the investigator or the patient. Medical techniques use three ways to rid clinical trials of this problem. These methods have helped discredit some previously accepted treatments and validate new ones. Methods used are the following: randomization, single-blind or double-blind studies, and the use of a placebo.
Will my insurance cover my medical costs if I live outside of Louisiana and am eligible for one of your clinical trials?
You would need to visit our facility and be screened by our providers to determine eligibility for one of our trials. If it is determined you may be eligible for trial participation a qualified member of the clinical research team would provide you with the necessary information for you to make an informed decision. According to the American Society of Clinical Oncology (ASCO) “Routine patient costs include all items and services that the payer would cover for a patient not enrolled in a clinical trial. Items and services are not routine patient costs if they are investigational, solely for data collection and analysis purposes and not for direct clinical management of the patient, or for a service inconsistent with the established standards of care for the patient’s diagnosis. Payers may require a qualified individual to use an in-network provider for the approved clinical trial if that provider is a trial participant and will accept the patient. Payers are not required to provide out-of-network benefits unless such benefits are part of the patient’s coverage or the approved clinical trial is only offered outside the patient’s state of residence.” http://www.asco.org/sites/default/files/aca_summary_clinical_trials.pdf.
Additional information about your about your insurance carriers coverage for clinical trial participation may be found at the Affordable Care Act website https://www.healthcare.gov/.
Our Medical Benefits Specialist can review your coverage prior to your visit to in order to make an informed decision about your health visit. For more information about clinical trials visit our FAQ Clinical Trial section.
Risks are involved in clinical research, as in routine medical care and activities of daily living. In thinking about the risks of research, it is helpful to focus on two things: the degree of harm that could result from taking part in the study, and the chance of any harm occurring. Most clinical studies pose risks of minor discomfort, lasting only a short time. Some volunteer subjects, however, experience complications that require medical attention. The specific risks associated with any research protocol are described in detail in the consent document, which you are asked to sign before taking part in research. In addition, the major risks of participating in a study will be explained to you by a member of the research team, who will answer your questions about the study. Before deciding to participate, you should carefully weigh these risks. Although you may not receive any direct benefit as a result of participating in research, the knowledge developed may help others.
The following section describes safeguards that protect the safety and rights of volunteer subjects. These safeguards include:
a. The Protocol Review Process
b. Informed Consent Procedures
c. The Patient Representative
d. The Patient Bill of Rights
Protocol review. As in any medical research facility, all new protocols must be approved by an institutional review board (IRB) before they can begin. The IRB, which consists of medical specialists, statisticians, nurses, social workers, and medical ethicists, is the advocate of the volunteer subject. The IRB will only approve protocols that address medically important questions in a scientific and responsible manner.
Informed consent. Your participation in any Clinical Center research protocol is voluntary. For every study in which you intend to participate, you will receive a document called “Consent to Participate in a Clinical Research Study” that explains the study in straightforward language. A member of the research team will discuss the protocol with you, explain its details, and answer your questions. Reading and understanding the protocol is your responsibility. You may discuss the protocol with family and friends. You will not be hurried into making a decision, and you will be asked to sign the document only after you understand the nature of the protocol and agree to the commitment. At any time after signing the protocol, you are free to change your mind and decide not to participate further. This means that you are free to withdraw from the study completely, or to refuse particular treatments or tests. Sometimes, however, this will make you ineligible to continue the study. If you are no longer eligible or no longer wish to continue the study, you will return to the care of the doctor who referred you to NIH.
Bill of Rights. Finally, whether you are a clinical research or a patient volunteer subject, you are protected by the Clinical Center Patients’ Bill of Rights. This document is adapted from the one made by the American Hospital Association for use in all hospitals in the country. The bill of rights concerns the care you receive, privacy, confidentiality, and access to medical records.
For further information about clinical trials please visit the National Institutes of Health webpage at http://www.nih.gov/health/clinicaltrials/basics.htm