As a patient or a parent of a child with a bleeding disorder, you may, at some point in time, have the opportunity to make a decision to participate in a clinical trial for a new factor product, a research project, or the genotyping project. This decision should not be taken lightly. All your questions should be addressed and you should thoroughly understand what you are signing. You should research the study or clinical trial on your own, as well. Don’t ever feel rushed into signing anything. Consult the three national organizations (HFA, NHF, & COTT) for guidance and more information. You can research any clinical trial online. Go to clinicaltrials.gov. Check with your local hemophilia chapter and see what information they have or questions they can answer. Investigate the clinical researchers involved in the studies or projects.
http://www.ClincalTrials.gov is a web site that provides patients, family members, healthcare professionals, and other members of the public easy access to information on clinical studies. The information is provided and updated by the sponsor or principal investigator of the clinical study, and the website is maintained by the U. S. National Library of Medicine at the National Institutes of Health.
Informed consent, the foundation of ethical research, includes four major elements: disclosure of essential information to the subject, comprehension, competency, and voluntarism (Elizabeth Winslow, PhD, RN, FAAN). According to the Nuremberg Code, the subject should have sufficient knowledge and comprehension of the elements of the subject matter involved to enable him to make an understanding and enlightened decision. Informed consent implies not only the imparting of information by the researcher, but also assessing the subject’s comprehension of the benefits and risks of and alternatives to participating in the research. The U. S. Department of Health and Human Services regulations relating to research of human subjects (21. C.F.R. Section 50.20) state that the information that is given to the subject should be written at a reading level understandable to the subject, use lay terminology (not professional jargon) and be worded without loaded terms that might coerce a subject into participating in the study without understanding its terms.
In the United States, the average reading level is no higher than the eighth grade. The average reading level of Medicaid enrollees is about the fifth grade. A 7 year old, in some cases, can sign a consent form. Despite this fact, research consent forms are often written at a college or graduate school level.
Also, make sure you know who has access to the information collected and the results. You should know who ultimately will own the information. Consider if the data will affect not only your generation but future generations. Will the information collected or the results make an impact on your future employment or access to insurance coverage? Once you opt into a study, you can opt out, but they get to keep the information you have already given them. You do not get it back, if so stated in the consent. If you are signing your minor child into a study, consider how it will affect them in the future.
Don’t be afraid to ask questions. Take all the time you need to truly give informed consent!
Lew is a clinician, lobbyist, educator, community activist and volunteer that has dedicated herself to improving the lives of those living with hemophilia. Her passion and commitment to education and awareness about bleeding disorders is evident by state and national legislation she has championed. Among her many notable achievements, she successfully lobbied the Texas Legislature for the reestablishment of the Texas Bleeding Disorders Advisory Council. Lew currently resides in the Dallas-Fort Worth area with her husband, Ray Dattoli, and sits on HFA’s board of directors.