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Informed consent and confidentiality in clinical research

Informed consent and confidentiality in clinical research. Dr.Philip Marazzi The Medical Centre East Horsley Medical Executive, Profiad Ltd. Informed consent?. Competent individual Necessary information Adequately understood Information considered

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Informed consent and confidentiality in clinical research

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  1. Informed consent and confidentiality in clinical research Dr.Philip Marazzi The Medical Centre East Horsley Medical Executive, Profiad Ltd

  2. Informed consent? • Competent individual • Necessary information • Adequately understood • Information considered • Decision free from coercion, influence, inducement or intimidation

  3. True “informed consent” • A crucial part of any trial. • Lack of consent leads to many practical problems in addition to the obvious ethical ones. • Patient reasons • Doctor reasons

  4. Patient reasons • Altruism • Trust • Ignorance • Manipulation • Improved clinical care • Special groups

  5. Patients • “Do you think it’s a good idea?” • “Whatever you say is fine” • “You know best” • “Oh, I’ve forgotten my glasses, never mind” • “Just tell me where to sign”

  6. Doctor reasons • Ignorance • Workload • Pressure from sponsor • Communication • Money

  7. The Patient Information Sheet • Summary sheet • Clearly written • Explanation of technical “stuff” in appropriate terms • Risks in relevant perspective

  8. Patient Information Sheet • Recent study of AIIRA included this summary of side effects:”Common side effects include:dizziness,feeling sick, indigestion, diarrhoea, stomach ache, gastroenteritis, tiredness,sore throat,runny nose, bronchitis, flu like symptoms,cough,back pain,chest pain,joint pain,urinary tract infection,swollen ankles blood in urine……………………” • Paediatric asthma study for 6-12yr olds 6 sides of A4.

  9. Confidentiality • Notice in surgery/practice leaflet • Any patient not willing to participate in trials will have notes marked but ?not able to code specifically to exclude from computer searches • Searches undertaken by surgery staff who have full understanding of confidentiality • PAL • Other non surgery staff

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