Combining value of information analysis and ethical argumentation in decisions on participation of vulnerable patients in clinical research

BMC Medical Ethics 19 (1):5 (2018)
Abstract
The participation of vulnerable patients in clinical research poses apparent ethical dilemmas. Depending on the nature of the vulnerability, their participation may challenge the ethical principles of autonomy, non-maleficence, or justice. On the other hand, non-participation may preclude the building of a knowledge base that is a prerequisite for defining the optimal clinical management of vulnerable patients. Such clinical uncertainty may also incur substantial economic costs. We present the participation of pre-menopausal women with atrial fibrillation in trials of novel oral anticoagulant drugs as a case study. Due to their non-participation in pivotal trials, it is uncertain whether for them, the risks that are associated with these drugs are outweighed by the advantages compared with conventional treatment. We addressed the question whether research of this new class of drugs in this subgroup would be appropriate from both, an ethical as well an economic perspective. We used the method of specifying norms as a wider framework to resolve the apparent ethical dilemma, while incorporating the question whether research of oral anticoagulants in premenopausal women with atrial fibrillation can be justified on economic grounds. For the latter, the results of a value-of-information analysis were used. Further clinical research on NOACs in premenopausal women with atrial fibrillation can be justified on both, ethical and economic grounds. Addressing apparent ethical dilemmas by invoking a method such as specifying norms can improve the quality of public practical reasoning. As such, the method should also prove valuable to committees that have formally been granted the authority to review trial protocols and proposals for scientific research.
Keywords No keywords specified (fix it)
Categories (categorize this paper)
DOI 10.1186/s12910-018-0245-x
Options
 Save to my reading list
Follow the author(s)
Edit this record
My bibliography
Export citation
Find it on Scholar
Mark as duplicate
Request removal from index
Revision history
Download options
Our Archive


Upload a copy of this paper     Check publisher's policy     Papers currently archived: 31,385
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
Practical Reasoning about Final Ends.Henry S. Richardson - 1996 - Tijdschrift Voor Filosofie 58 (4):782-783.

Add more references

Citations of this work BETA

No citations found.

Add more citations

Similar books and articles
Researchers Have a New Option for Testing Patients’ Role in Clinical Decisions.[author unknown] - 2003 - Journal of Medical Ethics 29 (5):266-266.
The Battering of Informed Consent.M. Kottow - 2004 - Journal of Medical Ethics 30 (6):565-569.
Added to PP index
2018-02-08

Total downloads
2 ( #855,937 of 2,225,946 )

Recent downloads (6 months)
2 ( #250,407 of 2,225,946 )

How can I increase my downloads?

Monthly downloads
My notes
Sign in to use this feature