Research Studies, Consent Forms, and Subject Protection

David Roeltgen, MD Health Guide
  • In my last blog I reviewed how, and to some extent why, a person might enter into a research study.  We left off after a brief discussion of consent forms.  Many of you may already have some experience with consent forms.  If you have ever had surgery or any procedure, such as a biopsy or an injection, including a flu shot, you probably signed a consent form.  Did you read it?  If you are like me or most of my patients, you probably did not sign it.  Not unlike a mortgage or a lease, a consent form is a document with a lot of writing that someone has summarized or explained it too you.  Besides, you probably think you won't be able to understand it anyway.  Therefore, you glance at it, take the pen and sign it.  Well, please read your consent forms, whether they are short and simple, or long and complex.  We should all be informed consumers.  But, I digress. 

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    Let's get back to Alzheimer's research studies and consent forms.  As I indicated in my last blog, they should be written at or below an eight grade level.  This is not always an easy task.  Why is this so?  The concepts being covered may be quite complex.  For example, let's review the Alzheimer vaccine trials.  These research trials are designed to give a vaccine that will decrease the abnormal protein amyloid from the brain, and in doing so, decrease the severity of the Alzheimer's disease.  The consent form must explain this process in a way that the person or persons signing the document understand the purposes, possible benefits and possible risks of this experimental treatment.  Writing the consent forms for drug trials of this type is sufficiently difficult, that there are professional medical writers who are frequently asked to do it. 


    The consent form is first reviewed by the researchers who have designed the research study.  These researchers have taken a course (it is required) on the ethics of medical research and the required contents of a consent form.  After it is reviewed by the researchers, it is presented to an Institutional Review Board (IRB). 

    Institutional Review Boards provide the local oversight of research performed on human subjects, and hence the alternative label applied to these groups, Human Studies Committees (HSC).  The local IRB or HSC have constituencies that reflect most of the important groups involved in research: researches, institutional representatives, ethics experts and community volunteers.  For most people, being on an IRB is a very serious service.


    These IRBs provide the local interpretation of the rules that have international acceptance.  There is an international Helsinki agreement on what is ethical in human research studies.  This agreement has in turn led to national policies.  The Department of Health and Human Services oversees the National Institutes of Health (NIH) and The Food and Drug Administration (FDA).  The former funds most university based human research and the latter oversees research done by pharmaceutical companies.  The NIH and FDA have specific guidelines for local IRBs and individual researchers to follow.  There are very severe penalties that are applied to both the individual and the organization if these guidelines are not followed.  Therefore, the consent forms are written and reviewed carefully.


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    Another role of the IRB is to monitor the research.  Every six months, researchers must make available to the local IRB copies of all consent forms, a summary of the research results and a list of any complications of the research.  Severe complications, know as severe adverse events (SAES) must be communicated to the IRB within 24 hours of the researcher learning of it.


    It should be fairly clear that studies involving human research are taken very seriously.  You, a member of your family or a friend should be able to enter into a research study with a strong belief that there are layers of safeguards that should help protect you from serious ethical concerns.  These safeguards do not necessarily protect you form something going wrong.  After all, it is research.  If there was certainty about the procedure or treatment, there would be no need to do the research.  However, it is with this research that our insight into, understanding of, and ability to treat Alzheimer's disease continues to grow.  All of us owe a lot to the many people who volunteer for research studies.  At this time of year as we rejoice for many things, let us appreciate the research volunteers, the IRB committee members and the dedicated researchers who are helping us to diminish the impact of Alzheimer's disease.



Published On: January 27, 2009