Potential subjects' responses to an ethics questionnaire in a phase I study of deep brain stimulation in early Parkinson's disease

Journal of Clinical Ethics 23 (3):207-216 (2012)

Abstract
Background Central to ethically justified clinical trial design is the need for an informed consent process responsive to how potential subjects actually comprehend study participation, especially study goals, risks, and potential benefits. This will be particularly challenging when studying deep brain stimulation and whether it impedes symptom progression in Parkinson’s disease, since potential subjects will be Parkinson’s patients for whom deep brain stimulation will likely have therapeutic value in the future as their disease progresses.Method As part of an expanded informed consent process for a pilot Phase I study of deep brain stimulation in early stage Parkinson’s disease, an ethics questionnaire composed of 13 open-ended questions was distributed to potential subjects. The questionnaire was designed to guide potential subjects in thinking about their potential participation.Results While the purpose of the study was extensively presented during the informed consent process, in returned responses 70 percent focused on effectiveness and 91 percent included personal benefit as potential benefit from enrolling. However, 91 percent also indicated helping other Parkinson’s patients as motivation when considering whether or not to enroll.Conclusions This combination of responses highlights two issues to which investigators need to pay close attention in future trial designs: how, and in what ways, informed consent processes reinforce potential subjects’ preconceived understandings of benefit, and that potential subjects see themselves as part of a community of Parkinson’s sufferers with responsibilities extending beyond self-interest. More importantly, it invites speculation that a different paradigm for informed consent may be needed
Keywords No keywords specified (fix it)
Categories (categorize this paper)
Reprint years 2012
Options
Edit this record
Mark as duplicate
Export citation
Find it on Scholar
Request removal from index
Revision history

Download options

Our Archive


Upload a copy of this paper     Check publisher's policy     Papers currently archived: 47,283
External links

Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
Through your library

References found in this work BETA

No references found.

Add more references

Citations of this work BETA

Add more citations

Similar books and articles

Analytics

Added to PP index
2013-12-15

Total views
33 ( #281,630 of 2,290,687 )

Recent downloads (6 months)
4 ( #305,796 of 2,290,687 )

How can I increase my downloads?

Downloads

My notes

Sign in to use this feature