Patient consent

V. Patient consent form for participation in a phase I clinical trial. 

Several patients who had tested positive and had been arrested on drug charges shortly after delivery of their babies filed a suit claiming that the drug testing had been illegal because it had been done without a warrant and without the patients consent. The district court instructed the jurors to find for the patients unless the tests had been consensual. The jury found for the hospital, saying that the tests had indeed been consensual. 

Adverse effects of the COMT inhibitors relate in part to increased levodopa exposure and include dyskinesias, nausea, and confusion. It is often necessary to lower the daily dose of levodopa by about 30% in the first 48 hours to avoid or reverse such complications. Other side effects include diarrhea, abdominal pain, orthostatic hypotension, sleep disturbances, and an orange discoloration of the urine. Tolcapone may cause an increase in liver enzyme levels and has been rarely associated with death from acute hepatic failure accordingly, its use in the USA requires signed patient consent (as provided in the product labeling) plus monitoring of liver function tests every 2 weeks during the first year and less frequently thereafter. No such toxicity has been reported with entacapone. 

An essential element of any medical program is informed patient consent prior to the performance of any test or procedure. Although informed consent is not specifically mentioned in the ACOEM components of occupational and environmental health programs, it is inherent in the ethical practice of medicine. The ACOEM Code of Ethical Conduct (adopted October 25,1993) states that physicians should relate honestly and ethically in all professional relationships. Also, the Association of Occupational and Environmental Clinics has issued guidance relative to patient consent, confidentiality of medical records, and communication of the results of tests and procedures (AOEC, 1987). 

Ideally, the therapist will receive a consultation note from the physician, and, if not, he or she should request one if the patient consents. This note is likely to contain the elements listed in Table 9.6 for the first visit only. Follow-up psychotropic medication visits should usually include the following ... 

Further cases of congenital malformations were reported in 1994 due to lax control of thalidomide use (Lancet 343 433 and 344 196). Thalidomide is available in the UK on a named-patient basis only, with a detailed patient information leaflet and with signed patient consent. 

Forged consent forms are one of the most common types of research fraud. A monitor from a Contract Research Organization (CRO) took the trouble to lay out all the patient consent forms at one site side by side. She noticed that the patients signatures looked similar to each other and some of the letters... 

Require patient consent and co-operation from the hospital pharmacy. 

For specific language and details concerning the informed patient consent and data use agreement, sponsors should review the information avail able from the Department of Health and Human Services Centers for Medi care and Medicaid Services or their privacy officers. (Seehttp //www.cms.hhs.gov/hipaa.) Another useful link to a guidance document specifically re lated to research under the HIPAA privacy regulations can be accessed at http //www.hhs.gov/ocr/hipaa/guidelines/research.pdf. (See Chaps. 20 and 24.)... 

The proposition that the use of illegal drugs is a brain disease poses problems of its own. Brain diseases cannot be treated without the patients consent. Fdow, then, do Leshner, Satel, and others justify using force to treat this brain disease, but not others Satel declares Addicts would be better off if more of them were arrested and forced to enroll in treatment programs. .. [this is] the essence of humane therapy. The truth is that persons with real brain diseases need not be coerced into treatment because they can be persuaded to accept it. Is it any surprise that coercion is necessary to treat nondiseases ... 

If the policy on civil commitment of the American Civil Liberties Union is ill conceived, its recommendations for further improvements are nothing less than terrifying "Anyone hospitalized for mental illness, the statement asserts, is entitled to medical and psychiatric care, appropriate to his particular case. In making this declaration, the American Civil Liberties Union not only supports commitment on the basis of an undefined concept of mental illness and as a legitimate medical function, but also advocates psychiatric treatment, regardless of whether or not the patient consents to it or of how dangerous or destructive such "treatment might be. Does the American Civil Liberties Union really believe... 

When protected health information is used for any purpose not generally associated with the treatment, payment, or health care operations of the covered entity, authorizations and acknowledgements from the patient must he obtained. Covered entities include health plans, clearinghouses, and health care providers. Health care providers include pharmacists and pharmacies. The general rule is health care providers must obtain patient consent prior to using or disclosing protected health information to carry out treatment, payment, or health care operations. 

Usg of Protected Health Information Without Patient Consent ... 

Health care providers may use protected health information without patient consent under the following conditions ... 

Most image-guided biopsies can be performed on an outpatient basis. Informed patient consent including possible conscious sedation after detailed explanation of... 

The patient consents and has capacity to do so. If so, the RC documents this and completes a form T2, listing all agreed medications. A new T2 must be completed if medication is changed (including dose or route). 

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