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Examples of Information to Which Individuals are Exposed
(Page 3 of 3)
The heading on the advertisement on the right (click here for larger view) is suggestive that pain may interfere with the ability to execute everyday household chores. Upon further reading in the ad, one discovers that the purpose of the ad is to solicit subjects for a clinical trial which is being proposed. It is stated in the ad that there will be two groups. One group will receive specially-adapted household tools and the other group will receive the usual household tools. The ad contains information about what is expected of the subjects who volunteer. It is stated that the participants may keep the tools at the end of the study and that they will each receive $100 at the end of the study for their participation. What information do I need in order that I can make an informed decision as to whether I should volunteer?
1. How long will the study last?
2. Will I be assigned to the group who receives the specially-adapted tools? What does it mean to be randomly assigned?
3. Am I at risk for harm if I participate?
4. Will information about me be made public?
5. If I am assigned to the control group and if the adapted-tools really prove to be preferable, will I also receive a set of the adapted-tools?
It is reassuring to know that there are review boards which review protocols for studies like the one previously mentioned, as well as clinical trials and research involving animals. These are called Institutional Review Boards (IRBs). The IRB is comprised of health-care providers from a variety of disciplines as well as non-medical representatives from the community at large. IRB's play a very important role in research and the protection of subjects.
The following is a quote from the web site of the Institutional Review Board of the University of Missouri School of Medicine:
The purpose of the IRB is to protect the rights and welfare of research subjects and to ensure their informed consent to any research for which they volunteer. Pursuant to both federal and university regulations, all research projects involving human subjects must be submitted to the IRB for review and approval prior to initiation of the research. The IRB performs three levels of review:
EXEMPT projects involve very low-risk protocols, such as anonymous surveys, and are approved in the IRB office.
EXPEDITED review (approval by one IRB member) is required for specific types of minimal-risk projects.
FULL BOARD review is required for minimal-risk projects which cannot be expedited and for significant-risk projects.
Investigators who are planning a clinical trial are always looking for subjects to include in the trial. Why should an individual who has the condition that the trial is described to investigate volunteer to be a subject in the trial? This is a very good question, especially if it is a randomized trial and there is a reasonable chance of the individual ending up in the control group. Without clinical trials treatments which are proposed could not be certified as efficacious or safe. If the clinical trial establishes that the treatment is good, those subjects in the control group will reap the benefit of the new treatment once it is approved. Being in the control group simply means that you wait a little longer to receive the benefits of the new treatment.
There is an interesting article in the December 2004-March 2005 issue of the magazine entitled, "Fibromyalgia Aware" which is relevant to this discussion. The title of the article is, "To Volunteer or Not to Volunteer" to be a subject in fibromyalgia clinical trials. The following is a direct quote from this article:
"For participants, you have to realize there is a big chance that you will get a placebo instead of the drug itself. Ask yourself, why do you want to participate?" Says Mila Manajan, regulatory affairs administrator at Beverly Hills, CA's OMC Clinical Research Center. It's not just to help yourself, but to help others. People are hoping for a breakthrough treatment that will make dealing with an illness easier, or eliminate it altogether. Volunteers help make those discoveries available to people. It is stated that many subjects prefer to be in the placebo group since they will be part of helping the next generation without themselves being at risk. It is also stated that some physicians discourage patients from being a subject in a study during the first year after diagnosis.
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