Informed consent

Notes on Informed Consent

Disclosure of risks rightly includes possible risks that are not verified as causally realted.

Examples:

• Uloric product warning: "A small number of heart attacks, strokes, and heart-related deaths were seen in clinical studies. It is not certain that ULORIC caused these events."

Disclosure is made even if a risk is suspected even though it has not been seen in clinical trials Examples:

• Didronel Side Effects: "In clinical studies, nausea, diarrhea, and bone pain were the most commonly reported side effects of Didronel. Side effects that were not seen in clinical studies but have been reported by healthcare providers include hair loss, confusion, and joint problems. In most cases, Didronel side effects do not require medical attention, but notify your healthcare provider immediately if you experience hallucinations, jaw or tooth problems, or severe heartburn.:
• "Patients who take Amevive are required to have their T-cell blood counts checked every other week. Amevive has the potential to increase the risk of infections although an increase in infection was not seen in clinical studies."

Search of "not seen in clinical trials."

In Abortion, Informed Consent, and Mental Health By Nancy Russo and Lisa Rubin:

Abortion counseling should be "tailored to the patient's individual situation and needs....Relative risks of abortion versus its alternatives will differ depending on the context. ...Providing informed consent for mental health outcomes of a pregnant woman's options is complex, particularly when a major determinant of how a woman responds to an abortion is how she appraises the meaning of abortion and its alternatives. Abortion can be viewed as a profound threat, a coping tool, or both.

These findings have profound implications for the informed consent process as well as effective prevention and intervention. They point to the importance of providing informed consent in ways that will help women to understand the role their appraisal process plays in shaping their psychological responses to however they choose to resolve their pregnancy.