Informed Consent ~ Written by Deb O’Leary
Informed Consent basically means that a physician (or other medical provider) must tell a patient ALL of the potential benefits, risks, and alternatives involved in any surgical procedure, medical procedure or other course of treatment, and must obtain the patient’s consent to proceed. This is based on the principle that a physician has an obligation (both ethical and legal) to disclose information to the patient so he or she can make a reasonable decision regarding treatment.
The concept of Informed Consent in medical research arose following the Nuremberg trials after WWII. Nazi doctors and public health officials were found guilty of conducting barbaric and unsanctioned experiments on human subjects. The Nuremberg Code has ten principles or tenets summarized below.
- Voluntary consent without force or coercion or deceit.
- The experiment should be to yield positive results.
- The experiment should be designed and based on results or prior animal studies or history of the disease.
- The experiment should avoid all unnecessary physical and mental suffering or injury.
- No experiment should be conducted where there is reasonable knowledge that death or disabling injury will occur.
- The degree of risk taken should never be more than the humanitarian importance of the problem to be solved.
- Proper preparations should be made and facilities provided to protect subjects against even remote possibilities of injury, disability or death.
- The experiment/treatment/procedure should be conducted only by scientifically qualified persons.
- Human subjects should be at liberty to discontinue participation at any time.
- The scientist in charge must be prepared to terminate the study at any time if a continuation of the experiment is likely to result in injury, disability or death to the subject.
Rhode Island’s own Roger Williams had something to say about the right to choice. “Men’s consciences ought in no sort to be violated, urged or constrained.” While he was most likely referring to freedom from forced or government sponsored religion, this could easily be applied to today’s vaccine mandates.
So, what are our rights to informed consent when it comes to vaccination in Rhode Island?
We have the right to be informed of the risks and benefits of each vaccine offered by our physicians. We are entitled to complete information on side effects and ingredients not just just being told a vaccine is “safe and effective” or that “severe reactions are rare.” We also deserve statistical data on the effectiveness of a vaccine when it comes to actually preventing disease. We deserve more than a few minutes to read the one page vaccine information sheet (VIS) to make our informed consent decisions. We have the right to refuse or postpone any medical treatment or procedure if we are not convinced by the information given that it is right for ourselves or our children. If we wish for our children to attend public or private schools in Rhode Island, we must either vaccinate according to the schedule adopted by the Rhode Island Department of Health, file a religious exemption, or obtain a medical exemption. A medical exemption, the third option, requires that the patient have certain serious contraindications or medical conditions which may cause possible severe injury or death and only a physician can issue this exemption.
There are issues which impede our right to informed consent. In speaking to Rhode Island parents from all corners of the state it appears that informed consent rights are being violated in physician’s offices every day. Here are a few examples:
- Vaccine Information Sheets (VIS) being given after the vaccine is administered at the end of the office visit or at check-out.
- Parents not being told which vaccines are being administered.
- Parents being told that the vaccine(s) are mandatory for school admission. (Parents have the right to avail themselves of the Religious Exemption).
- That there have been no cases of adverse events. Not being informed about the Vaccine Adverse Events Reporting System. (VAERS)
- Parents not being informed that their physician is given financial incentives to vaccinate all patients.
- Parents not being informed that their Physician and the vaccine manufacturers are not liable for injury due to vaccines adverse reactions.
Greater transparency and accurate information shared between doctor and patient is the first essential element to making a good informed consent decision. Having the legal ability to opt out or file an exemption from one or more vaccines is the other. We are working to improve the first and to preserve and protect the latter.
Next week the General Assembly will be back in session and our Legislative Committee has completed the proposed legislation packet. This Monday our Governor, Representatives, and Senators here in RI will have received the proposed packet. We need your help contacting your RI State Senators and your RI State Representatives. Not sure what to write? For sample letters Click Here
Interested in learning more about informed consent? We found the Dr Rima Truth Report website to be a great resource!
© RI Alliance for Vaccine Choice and Vaccine Choice RI™, 2015. Unauthorized use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to RI Alliance for Vaccine Choice and Vaccine Choice RI™ with appropriate and specific direction to the original content.