A Need for a Simpler Informed Consent Document
April 19, 2005
Before participating in a clinical trial you or your parents are asked to sign an informed consent document. Because clinical trials involve the use of an experimental protocol, the consent form needs to provide thorough and understandable information for you to make informed participation choices. You should have a clear understanding of the procedure, know how care for participants differs from standard care, what additional care and test will be take place (i.e. will you need to have more blood tests), the physical and non-physical risks, benefits and alternatives. The document should also contain a copy of the confidentiality statement. The consent form should be the beginning of an on-going dialogue between the doctor and the patient and should be updated when new information is available that may affect participation.
A recent study found the complicated language on consent forms prevents people from having a complete understanding of the risks and benefits of participating. The study, conducted at the University of Michigan Medical School, presented a group of parents with two different consent forms. The first form was the current standard form and the second included diagrams, simplified language and was formatted for easier reading. After they signed the form, they parents were tested on the information contained in the consent form. Parents reading the modified version had a much clearer understanding of the trial and its risks and benefits.
Without a thorough understanding, a person may make uninformed decisions. They may also fail to do the needed follow-up or follow the protocol, thus putting themselves at risk.
In 1998, the cancer community recognized that problems with the consent forms and formed a committee through The National Cancer Institute to address these issues. The committee determined the need to reduce the length and simplify the language. However, these changes are not mandated and the clinical trial process can still be confusing. It is important that patients have access to clinical trials, but it is equally important that they understand the trail.
If you have questions, consult with your medical team. If feel you are not getting enough answers your social worker or a patient representative should be able to assist you in finding the information you need.
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April 19, 2005
Before participating in a clinical trial you or your parents are asked to sign an informed consent document. Because clinical trials involve the use of an experimental protocol, the consent form needs to provide thorough and understandable information for you to make informed participation choices. You should have a clear understanding of the procedure, know how care for participants differs from standard care, what additional care and test will be take place (i.e. will you need to have more blood tests), the physical and non-physical risks, benefits and alternatives. The document should also contain a copy of the confidentiality statement. The consent form should be the beginning of an on-going dialogue between the doctor and the patient and should be updated when new information is available that may affect participation.
A recent study found the complicated language on consent forms prevents people from having a complete understanding of the risks and benefits of participating. The study, conducted at the University of Michigan Medical School, presented a group of parents with two different consent forms. The first form was the current standard form and the second included diagrams, simplified language and was formatted for easier reading. After they signed the form, they parents were tested on the information contained in the consent form. Parents reading the modified version had a much clearer understanding of the trial and its risks and benefits.
Without a thorough understanding, a person may make uninformed decisions. They may also fail to do the needed follow-up or follow the protocol, thus putting themselves at risk.
In 1998, the cancer community recognized that problems with the consent forms and formed a committee through The National Cancer Institute to address these issues. The committee determined the need to reduce the length and simplify the language. However, these changes are not mandated and the clinical trial process can still be confusing. It is important that patients have access to clinical trials, but it is equally important that they understand the trail.
If you have questions, consult with your medical team. If feel you are not getting enough answers your social worker or a patient representative should be able to assist you in finding the information you need.
<< Back
