Informed consent and confidentiality in clinical research

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 its a good idea?
• Whatever you say is fine
• You know best
• Oh, Ive 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 effectsCommon side effects
  includedizziness,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