Informed consent

From NursingWiki

informed consent is used in research to ensure that the subjects know about their role within the study and that they are free to participate.

Contents 1 information 2 consent 3 see also 4 weblinks

information

• all essential information on the research
• verbal explanation given of content
• written form
• minimum content:
  • this is research! (not treatment!)
  • purpose
  • people, organizations carrying the study
  • research funding
  • sample, inclusion, exclusion criteria
  • instruments, surveys
  • procedure, requirements for informants, withdrawal
  • voluntary
  • anonymity, confidentiality
  • costs
  • contact persons

Problems in information:

• limited information
• difficult information
• too much information
• standard information
• misleading information

consent

• understanding the information
• voluntary (free to leave or drop out of the study at any time)
• connection with treatment and/or care
• cognitive level
• roles of all involved

see also

• ethics

weblinks

http://www.fda.gov/cdrh/devadvice/ide/informed_consent.shtml

http://www.fda.gov/oc/ohrt/irbs/informedconsent.html