Abstract

This protocol will analyze consent forms for Phase I oncology trials to assess the manner in which the nature, risks, and potential benefits are communicated. Phase I consent forms are being sought from all of the NCI-designated comprehensive cancer centers and from major pharmaceutical companies that conduct Phase I oncology trials. Institutions have been contacted by phone and are sending consent forms. Data gathering is just beginning.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
Clinical Center (CLC)
Type
Intramural Research (Z01)
Project #
1Z01CL010514-01
Application #
6414371
Study Section
(CBD)
Project Start
Project End
Budget Start
Budget End
Support Year
1
Fiscal Year
2000
Total Cost
Indirect Cost

  Institution

Name
Clinical Center
Department
Type
DUNS #
City
State
Country
United States
Zip Code

  Publications

Horng, Sam; Emanuel, Ezekiel J; Wilfond, Benjamin et al. (2002) Descriptions of benefits and risks in consent forms for phase 1 oncology trials. N Engl J Med 347:2134-40