Journal of Medical Ethics 40 (4):217-218 (2014)
Abstract |
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 |
Options |
![]() ![]() ![]() ![]() |
Download options
References found in this work BETA
Reasons Why Post-Trial Access to Trial Drugs Should, or Need Not Be Ensured to Research Participants: A Systematic Review.N. Sofaer & D. Strech - 2011 - Public Health Ethics 4 (2):160-184.
Care After Research: A Framework for NHS RECs.Neema Sofaer, Penney Lewis & Hugh Davies - 2012 - Health Research Authority.
Citations of this work BETA
Post‐Trial Obligations in the Declaration of Helsinki 2013: Classification, Reconstruction and Interpretation.Ignacio Mastroleo - 2016 - Developing World Bioethics 16 (2):80-90.
Human Dignity as a Basis for Providing Post-Trial Access to Healthcare for Research Participants: A South African Perspective.Pamela Andanda & Jane Wathuta - 2018 - Medicine, Health Care and Philosophy 21 (1):139-155.
Similar books and articles
Reciprocity‐Based Reasons for Benefiting Research Participants: Most Fail, the Most Plausible is Problematic.Neema Sofaer - 2014 - Bioethics 28 (9):456-471.
Mind the Gap: An Empirical Study of Post‐Trial Access in HIV Biomedical Prevention Trials.Bridget Haire & Christopher Jordens - 2015 - Developing World Bioethics 15 (2):85-97.
Should Post-Trial Provision of Beneficial Experimental Interventions Be Mandatory in Developing Countries?Z. Zong - 2008 - Journal of Medical Ethics 34 (3):188-192.
Atención después de la investigación: un marco para los comités de ética de investigación del National Health Service (NHS) (borrador versión 8.0).Neema Sofaer, Penny Lewis & Hugh Davies - 2012 - Perspectivas Bioéticas 17 (33):47-70.
Post-Trial Period Surveillance for Randomised Controlled Cardiovascular Studies: Submitted Protocols, Consent Forms and the Role of the Ethics Board.M. I. Zia, R. Heslegrave & G. E. Newton - 2011 - Journal of Medical Ethics 37 (12):762-765.
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.
What's Missing From Current Clinical Trial Guidelines? A Framework for Integrating Science, Ethics, and the Community Context.H. J. Sutherland, E. M. Meslin & J. E. Till - 1994 - Journal of Clinical Ethics 5 (4):297-303.
Closing the Translation Gap for Justice Requirements in International Research.Bridget Pratt, Deborah Zion, Khin Maung Lwin, Phaik Yeong Cheah, Francois Nosten & Bebe Loff - 2012 - Journal of Medical Ethics 38 (9):552-558.
Controversial Choice of a Control Intervention in a Trial of Ventilator Therapy in ARDS: Standard of Care Arguments in a Randomised Controlled Trial.H. Mann - 2005 - Journal of Medical Ethics 31 (9):548-553.
Reasons Why Post-Trial Access to Trial Drugs Should, or Need Not Be Ensured to Research Participants: A Systematic Review.N. Sofaer & D. Strech - 2011 - Public Health Ethics 4 (2):160-184.
Subjects' Views of Obligations to Ensure Post-Trial Access to Drugs, Care and Information: Qualitative Results From the Experiences of Participants in Clinical Trials (EPIC) Study.N. Sofaer, C. Thiessen, S. D. Goold, J. Ballou, K. A. Getz, G. Koski, R. A. Krueger & J. S. Weissman - 2009 - Journal of Medical Ethics 35 (3):183-188.
Pharmaceutical Companies Vs. The State: Who Is Responsible for Post-Trial Provision of Drugs in Brazil?Daniel Wei L. Wang & Octavio Luiz Motta Ferraz - 2012 - Journal of Law, Medicine and Ethics 40 (2):188-196.
Patient Access to Experimental Drugs and AIDS Clinical Trial Designs: Ethical Issues.Udo Schüklenk & Carlton Hogan - 1996 - Cambridge Quarterly of Healthcare Ethics 5 (3):400.
Analytics
Added to PP index
2013-11-22
Total views
23 ( #451,513 of 2,409,938 )
Recent downloads (6 months)
1 ( #541,494 of 2,409,938 )
2013-11-22
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?
Downloads