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2.4. Participating in a clinical trial
The choice of whether to participate in an experimental research study can be one of the most important life decisions a person makes. Here are some key points to keep in mind if you're considering participation in a trial.
There should be 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.
Eligibility criteria for SCI research studies may include factors like age, gender, extent and duration of injury, previous treatment history, and presence or history of 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.
Expected benefits need to be weighed against potential risks. Assuming that the research study is well designed and implemented, participants might obtain the benefit of access to promising new therapies 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, possibly involving 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, especially in a "blind" pharmaceutical study in which some participants do not receive the actual medication, but rather a "placebo."
Most research studies are sponsored by medical institutions, foundations, the pharmaceutical industry, or Federal agencies such as the NIH, 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.
Research candidates must understand their legal rights and obtain informed consent before participating in any clinical trial. The research candidate should meet with a member of the clinical team, preferably a physician, and 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 might be helpful for a family member or friend to participate in this meeting for support and possible follow-up questions. Suggested lines of inquiry include:
- Purpose and duration of the study
- Eligibility criteria
- Details regarding the medical procedures involved
- Likely benefits and risks, and possible impacts on daily living
- Physician who is primarily responsible
- Location where treatments will be performed
- Prior results of comparable studies
- Person or entity paying for the treatments
- Whether the participant must bear any out-of-pocket expenses
- How participant can monitor his or her personal progress
- Any requirements for follow-up care
- Whether participant will receive a copy of ultimate results
The study's clinical team will be composed of doctors, nurses, social workers, and other professionals. They should check the health of the participant at the beginning of the trial, provide directions for participating in the study, monitor the participant throughout the trial, and perform follow-up tests. To protect confidentiality, his or her name should remain secret and not be disclosed in any published reports.
During the study, participants 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 making a commitment to participate, they are free to change their minds. Informed consent should not be viewed as a binding contract; one can leave an experimental trial at any time. When withdrawing from the study, however, the participant should inform the research team and offer his or her reasons for leaving the study.
Participating in a research study can offer profound benefits to an individual with SCI, and to the disability community at large. When carefully conceived and performed, research studies provide one of the fastest and safest ways to test new theories for improving quality of life with SCI, yet one must seriously consider these key legal issues to consider before taking part in any research study or clinical trial.