Informed consent: Difference between revisions
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(Created page with "==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...") |
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* 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." | * 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.: | * 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." | * "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." | ||
[http://www.google.com/search?rlz=1C1CHFX_enUS381US381&sourceid=chrome&ie=UTF-8&q=not+seen+in+clinical+studies#hl=en&sugexp=gsqvhc&pq=reported%20but%20not%20seen%20in%20clinical%20studies&xhr=t&q=reported+but+%22not+seen+in+clinical+studies%22&cp=43&pf=p&sclient=psy&rlz=1C1CHFX_enUS381US381&source=hp&aq=f&aqi=&aql=&oq=reported+but+%22not+seen+in+clinical+studies%22&pbx=1&bav=on.2,or.r_gc.r_pw.&fp=d391891e6736cb98&biw=1028&bih=820 Search of "not seen in clinical trials."] | [http://www.google.com/search?rlz=1C1CHFX_enUS381US381&sourceid=chrome&ie=UTF-8&q=not+seen+in+clinical+studies#hl=en&sugexp=gsqvhc&pq=reported%20but%20not%20seen%20in%20clinical%20studies&xhr=t&q=reported+but+%22not+seen+in+clinical+studies%22&cp=43&pf=p&sclient=psy&rlz=1C1CHFX_enUS381US381&source=hp&aq=f&aqi=&aql=&oq=reported+but+%22not+seen+in+clinical+studies%22&pbx=1&bav=on.2,or.r_gc.r_pw.&fp=d391891e6736cb98&biw=1028&bih=820 Search of "not seen in clinical trials."] | ||
Revision as of 10:31, 28 May 2011
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."