Towarda Construct Definition of Informed Consent Comprehension

Variation in how informed consent comprehension tests have been developed may be largely due to the absence of a standardized construct definition. Developing a construct definition would provide a standardized framework for determining how an instrument should be constructed, implemented, interpreted, and applied. Therefore, we utilized the Delphi consensus approach with an international expert panel (N= 19) to gather knowledge, opinions and eventually consensus for a construct definition. Expert consensus was achieved after three revision cycles. While acknowledging that there are limitations to this study, it nonetheless should be considered as a step toward standardization of a construct definition of informed consent comprehension.

[1]  D. Patrick,et al.  Quality-of-life outcomes in the evaluation of head and neck cancer treatments. , 2001, Archives of otolaryngology--head & neck surgery.

[2]  G. R. Potts,et al.  Incorporation versus compartmentalization in memory for discourse , 1985 .

[3]  Erik D. Reichle,et al.  Models of the reading process. , 2010, Wiley interdisciplinary reviews. Cognitive science.

[4]  J. Alderson.  Assessing Reading: Acknowledgements , 2000 .

[5]  M. Daneman,et al.  Susceptibility to semantic illusions: An individual-differences perspective , 2001, Memory & cognition.

[6]  Robert Edson,et al.  Evaluating the quality of informed consent , 2005, Clinical trials.

[7]  Ich Harmonised,et al.  INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE , 2006 .

[8]  Richard G. Netemeyer,et al.  Scaling Procedures: Issues and Applications , 2003 .

[9]  L. Gillam,et al.  Consent in paediatric research: an evaluation of the guidance provided in the 2007 NHMRC National statement on ethical conduct in human research , 2008, The Medical journal of Australia.

[10]  James Flory,et al.  Interventions to improve research participants' understanding in informed consent for research: a systematic review. , 2004, JAMA.

[11]  Charles Hulme,et al.  The science of reading: A handbook. , 2005 .

[12]  Gretchen M. Spreitzer,et al.  Toward the Construct Definition of Positive Deviance , 2004 .

[13]  Steven Joffe,et al.  Quality of informed consent in cancer clinical trials: a cross-sectional survey , 2001, The Lancet.

[14]  D. Eadie,et al.  “Hello, hello—it’s English I speak!”: a qualitative exploration of patients’ understanding of the science of clinical trials , 2005, Journal of Medical Ethics.

[15]  Thomas J. Grabowski,et al.  COMPREHENSION , 2010, Continuum.

[16]  J. Abraham.  The international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use , 2009 .

[17]  M. Ratain,et al.  Perceptions of cancer patients and their physicians involved in phase I trials. , 1995, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[18]  R. Barbarash,et al.  The Deaconess Informed Consent Comprehension Test: An Assessment Tool for Clinical Research Subjects , 1996, Pharmacotherapy.

[19]  M. Adler,et al.  Gazing into the oracle : the Delphi method and its application to social policy and public health , 1996 .

[20]  N. Lynöe,et al.  Informed consent: study of quality of information given to participants in a clinical trial. , 1991, BMJ.

[21]  B. Lewis,et al.  Patient comprehension and reaction to participating in a double-blind randomized clinical trial (ISIS-4) in acute myocardial infarction. , 2000, Archives of internal medicine.

[22]  J F Jekel,et al.  Perils, pitfalls, and possibilities in talking about medical risk. , 1999, JAMA.

[23]  E Bjørn,et al.  Can the written information to research subjects be improved?--an empirical study. , 1999, Journal of medical ethics.