We have shown that informed consent documents (ICDs) for clinical trials do not function well as decision aids i.e. tools to help decision makers through a systematic and deliberative decision making process. Here we examine what information (identified from regulatory documents such as Health Canada’s Good Clinical Practice, the Tri-Council Policy Statement, and the Code of Federal Regulations) is most often missing from a random sample of ICDs, and whether the situation is improving over time.
Method:
139 ICDs for trials registered with ClinicalTrials.gov were obtained from study investigators. Using a 4-point scale (strongly agree, agree, disagree, strongly disagree), two raters assessed each ICD on 35 items. Mean ratings of Strongly Agree or Agree were taken as conforming to the item.
Result:
Overall agreement between raters was 95.1%. For the 8 items focused on key concepts of informed consent, 2 items were only rarely presented (“describes how personal health information will be protected”, “statement about compensation for patient enrolment”: 33% and 6% of ICDs respectively). For the 9 items about study specific information, 3 items (“expected duration of the study as a whole”, “describes reversibility of side effects of participation, “describes time of onset of side effects of participation”) were present in less than 8% of ICDs. For the 6 items describing study design and procedures, 1 item (‘describes which procedures are solely for research purposes”) was present in 29% of ICDs. For the 5 items describing responsible parties associated with the study, all items were present in over 64% of ICDs. For 7 items focused on formatting and style, all items were present in over 85% of ICDs. Of the 6 rarely present items, none increased in prevalence over the time period of the sample (2004- 2010).
Conclusion:
This study identifies specific areas where ICDs can be improved.