Clinical Trials
Your Rights When Deciding Whether to Join a Clinical Trial
All research studies should follow an established protocol or plan which specifies the length of the study, what types of persons may participate, and the schedule of tests, treatments and procedures. One primary, threshold issue is whether a person will be eligible to participate in a particular study. Eligibility criteria for research studies may include factors like age, gender, extent and duration of injury, previous treatment history, and other medical conditions. Because many major studies are funded, at least in part, by government grants, guidelines typically specify that sponsors may not discriminate against candidates on the basis of improper, non-medical criteria.
In deciding whether to participate in a clinical trial, persons should weigh the expected benefits against the risks. Assuming that the research study is well designed and implemented, patients may be able to obtain the benefit of access to promising new treatments before they are generally available to the public. They may receive expert medical care at leading facilities not otherwise covered by their medical insurance. Participation offers the research subject the prospect of improved health and quality of life. It can also appeal to a patient's altruistic desire to help others by contributing to the general state of medical knowledge.
Of course, research studies can also involve substantial risks. There may be painful, serious or even life-threatening side affects to medical experiments. Adverse side affects may be both immediate and long-term and may not be fully known at the time of participation. Participation may also be burdensome. It may involve a substantial amount of time and effort for treatments and follow-up visits. Of course, there is also no guarantee of success. Experimental treatments may not benefit the patient at all.
As a result, it is especially important for research candidates to understand their legal rights and to obtain informed consent before participating in any clinical trial. Most research studies are sponsored by medical institutions, foundations, the pharmaceutical industry or Federal agencies such as the National Institute of Health, and are governed by comprehensive ethical and legal standards. For example, every clinical trial must be approved and monitored by an Institutional Review Board (IRB) composed of independent physicians, educators and community advocates. The IRB must initially approve the study's protocol and periodically review its findings to ensure that the researchers are following the established guidelines and procedures.
Before participating in a study, the research candidate should meet with a member of the clinical team involved, preferably a physician. Patients should be advised in a reasonable manner of all significant medical information that the physician possesses, or reasonably should possess, that is material to an intelligent decision whether to participate in the study. It may be helpful for a family member or friend to accompany the patient during this meeting for support and possible follow-up questions. Suggested lines of inquiry include the following:
*Purpose and duration of the study.
*Persons eligible to participate.
*Details regarding the medical procedures involved.
*Likely benefits and risks, and possible impacts on daily living.
*Physician primarily responsible for the patient's care.
*Location where treatments will be performed.
*Prior results of any similar or comparable research studies.
*Person or entity paying for the treatments.
*Whether the patient will be responsible for any out-of-pocket expenses.
*How patient can monitor his or her personal progress.
*Any requirements for follow-up care.
*Whether patient will receive a copy of ultimate results.
If the patient decides to participate, his or her clinical team will be composed of doctors, nurses, social workers and other professionals. They should check the health of the patient at the beginning of the trial, provide directions for participating in the study, monitor the patient throughout the trial, and perform follow-up tests. To protect the patient's confidentiality, his or her name should remain secret and not be disclosed in any published reports.
During the study, patients should continue to consult with their primary care physicians, as necessary, to ensure that their other medications or treatments do not conflict with the research protocol. Even after patients have made a commitment to participate, they are free to change their minds. Informed consent should not be viewed as a binding contract. The participant can leave an experimental trial at any time. When withdrawing from the study, however, the patient should let the research team know this fact and his or her reasons for leaving the study.
As with all important decisions in life, knowing as much as you can about both the process ahead and your likely prospects will help you make the best possible choice in the circumstances.