True informed consent is a process—not merely an explanation and signing of documents. Informed consent requires that:
1. All the treatments available to the child have been laid on the table and discussed— not just the treatment available at your hospital or through your doctor, but all the treatments that could be beneficial, wherever they are given.
2. The parents and, to the extent possible, the child, have discussed these options and decided that they want to consider one of them.
3. The option selected is thoroughly discussed, with all its benefits and risks clearly explained.
4. Those aspects of the study that are considered experimental and those that are standard are clearly described.
A fully informed medical decision weighs the relative merits of a therapy after full disclosure of benefits, risks, and alternatives.
During the discussions between the doctor(s) and family, all questions should be answered in language that is clearly understood by the parents and child, and there should be no pressure to enroll the child in the study. The objective of the informed consent process is that the participants are comfortable with their choice and can comply with it.
We had many discussions with the staff prior to signing the informed consent to participate in the clinical trial. We asked innumerable questions, all of which were answered in a frank and honest manner. We felt that participating gave our child the best chance for a cure, and we felt good about increasing the knowledge that would help other children later.
The form that parents sign will have language similar to the following: "The study described above has been explained to me, and I voluntarily agree to have my child participate in this study. I have had all of my questions answered, and understand that all future questions that I have about this research will be answered by the investigators listed above."
The study that our institution was participating in at the time of my daughter's diagnosis was attempting to lessen the treatment to reduce neurotoxicity yet still cure the disease. My family began a massive research effort on the issue, and we had several family friends who were physicians discuss the case with the heads of pediatric oncology at their institutions. The consensus was that since my daughter was at the high end of the high-risk description, it was advisable to choose the standard care, which was more aggressive.
Although we believe strongly in clinical trials, we decided to opt for the standard treatment because she had a poor prognosis, and we felt that she would need the cranial radiation, despite the possibility of late side effects.
By the time a study is published in the literature, doctors on the cutting edge of treatment are two to four years into improving that treatment or learning of its shortcomings. For this reason, it is best to make decisions in partnership with knowledgeable medical caregivers, rather than in isolation.
No matter how comfortable you are with your child's treating oncologist, it may be helpful to have another medical caregiver help sort out your options. Often, that person will be the family's pediatrician or family doctor. Second opinions can be obtained from physicians at other institutions in your community or region, or any of the larger pediatric cancer centers. They will arrange to review the information and outline recommendations. It is most useful to get a second opinion from a center that treats significant numbers of patients with your childs diagnosis. Most pediatric oncologists are happy to facilitate this process for you.
When my son was diagnosed, we were told we had two options: a clinical trial or standard treatment. We decided to get a second opinion before making our decision. Our pediatrician, my husband, and I met in the doctor's office for a telephone conference with a pediatric oncologist from a major treatment center. We each presented our concerns. Our pediatrician thought of some issues neither my husband nor I had considered. I think we all came away better informed of our options.
Second opinions can also be arranged through the Childhood Cancer Ombudsman Program, which uses volunteer specialists to provide free help to families considering the range of treatment options and engaged in the informed consent process. (See Appendix C, Resource Organizations, for contact information.)
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Although nobody gets a parenting manual or bible in the delivery room, it is our duty as parents to try to make our kids as well rounded, happy and confident as possible. It is a lot easier to bring up great kids than it is to try and fix problems caused by bad parenting, when our kids have become adults. Our children are all individuals - they are not our property but people in their own right.