Journal of Medical Ethics 40 (4):217-218 (2014)

When research concludes, post-trial access to the trial intervention or standard healthcare can be crucial for participants who are ill such as those in resource-poor countries with inadequate healthcare, British participants testing ‘last-chance drugs’ unavailable on the National Health Service and underinsured US participants. Yet, many researchers are unclear about their obligations regarding the post-trial period, and many research ethics committees do not know what to require of researchers. Consequences include participants who reasonably expect but lack PTA to the trial intervention, unplanned financial liabilities for NHS Trusts forced to fund this, negative press and potential to undermine public trust.1–3,iOne reason for the lack of clarity is controversy over whether and when participants should have access, after the study, to the study intervention. At one extreme is the view that continued access should be ensured when the intervention has benefited the participant or when it has proven safe and effective for the participant population, irrespective of the cost and burden of ensuring continued access. At the other extreme is the view that continued access need never be provided so long as non-availability of the study intervention post-trial was adequately disclosed when participants were invited to participate.6 There is also disagreement about when poststudy access to the study intervention should be considered beneficial for participants. The spectrum ranges from the view that the intervention should be regarded as beneficial for a proposed use only after the …
Keywords No keywords specified (fix it)
Categories (categorize this paper)
DOI 10.1136/medethics-2013-101398
Edit this record
Mark as duplicate
Export citation
Find it on Scholar
Request removal from index
Revision history

Download options

PhilArchive copy

Upload a copy of this paper     Check publisher's policy     Papers currently archived: 56,949
Through your library

References found in this work BETA

Add more references

Citations of this work BETA

Add more citations

Similar books and articles

The Ethics of Experimental Heroin Maintenance.R. Ostini, G. Bammer, P. R. Dance & R. E. Goodin - 1993 - Journal of Medical Ethics 19 (3):175-182.


Added to PP index

Total views
23 ( #451,513 of 2,409,938 )

Recent downloads (6 months)
1 ( #541,494 of 2,409,938 )

How can I increase my downloads?


My notes