Research suggests that clinical research subjects often fail to appreciate significant elements of what their informed consent because of the """"""""therapeutic misconception."""""""" The therapeutic misconception involves patient/subjects failing to grasp the difference between participating in a clinical research project and receiving ordinary clinical care. We do not know how: 1) prevalent it is, 2) with which personal and situational variables the therapeutic misunderstanding is associated, 3) how seriously this misconception affects other aspects of a decision to participate in research, 4) what its effects are on patients' experience of research participation and 5) how it affects the rate of recruitment to, and dropout from clinical research. This proposal aims to remedy these lacks of knowledge by interviewing in depth 200 subjects from 10 different clinical research projects and then reinterviewing them after they have completed their participation in the project. This will facilitate new approaches to gaining consent and reduce potential sources of public disaffection with clinical research.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project (R01)
Project #
5R01MH058097-03
Application #
6186463
Study Section
Special Emphasis Panel (ZRG2-SSS-F (04))
Program Officer
Heinssen, Robert K
Project Start
1998-09-20
Project End
2001-03-31
Budget Start
2000-04-01
Budget End
2001-03-31
Support Year
3
Fiscal Year
2000
Total Cost
$269,802
Indirect Cost
Name
University of Massachusetts Medical School Worcester
Department
Psychiatry
Type
Schools of Medicine
DUNS #
660735098
City
Worcester
State
MA
Country
United States
Zip Code
01655
Lidz, Charles W; Appelbaum, Paul S; Grisso, Thomas et al. (2004) Therapeutic misconception and the appreciation of risks in clinical trials. Soc Sci Med 58:1689-97
Lidz, Charles W; Appelbaum, Paul S (2002) The therapeutic misconception: problems and solutions. Med Care 40:V55-63