Literature DB >> 18316461

Should post-trial provision of beneficial experimental interventions be mandatory in developing countries?

Zhiyong Zong1.   

Abstract

The need for continuing provision of beneficial experimental interventions after research is concluded remains a controversial topic in bioethics for research. Based on the principle of beneficence, justice as reciprocity, concerns about exploitation and fair benefits, participants should be able to have continuing access to benefits beyond the research period. However, there is no consensus about whether or not post-trial provision of beneficial interventions should be mandatory for participants from developing countries. This paper summarises recommendations from international and national guidelines. Ethical principles and practical issues relating to post-trial provision are also discussed. In conclusion, post-trial provision is not necessary in all situations and a set of criteria are proposed to identify the situations that beneficial interventions should be provided beyond the research period. However, mandatory post-trial supply of beneficial experimental interventions should be assured for those who still need and are able to benefit from them but have no alternative access. Mandatory provision is based on universal bioethical principles such as beneficence and justice. Furthermore, difficulties associated with implementation of post-trial provision are not unmanageable. Careful advanced planning and a comprehensive partnership among relevant parties would be very helpful in solving these difficulties in practice, which therefore should not be taken as an excuse to escape post-trial responsibility.

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Year:  2008        PMID: 18316461     DOI: 10.1136/jme.2006.018754

Source DB:  PubMed          Journal:  J Med Ethics        ISSN: 0306-6800            Impact factor:   2.903


  11 in total

Review 1.  Human dignity as a basis for providing post-trial access to healthcare for research participants: a South African perspective.

Authors:  Pamela Andanda; Jane Wathuta
Journal:  Med Health Care Philos       Date:  2018-03

2.  The patient's safety and access to experimental drugs after the termination of clinical trials: regulations and trends.

Authors:  Ricardo Eccard da Silva; Angélica Amorim Amato; Thiago do Rego Sousa; Marta Rodrigues de Carvalho; Maria Rita Carvalho Garbi Novaes
Journal:  Eur J Clin Pharmacol       Date:  2018-05-12       Impact factor: 2.953

3.  Reasons Why Post-Trial Access to Trial Drugs Should, or Need not be Ensured to Research Participants: A Systematic Review.

Authors:  Neema Sofaer; Daniel Strech
Journal:  Public Health Ethics       Date:  2011-07-11       Impact factor: 1.940

4.  Ethics in clinical research: the Indian perspective.

Authors:  J Sanmukhani; C B Tripathi
Journal:  Indian J Pharm Sci       Date:  2011-03       Impact factor: 0.975

5.  Reciprocity-based reasons for benefiting research participants: most fail, the most plausible is problematic.

Authors:  Neema Sofaer
Journal:  Bioethics       Date:  2013-12-06       Impact factor: 1.898

6.  Assessing the implementation effectiveness and safety of 1% tenofovir gel provision through family planning services in KwaZulu-Natal, South Africa: study protocol for an open-label randomized controlled trial.

Authors:  Leila E Mansoor; Quarraisha Abdool Karim; Kathryn T Mngadi; Sarah Dlamini; Carl Montague; Nelisiwe Nkomonde; Nomzamo Mvandaba; Cheryl Baxter; Tanuja N Gengiah; Natasha Samsunder; Halima Dawood; Anneke Grobler; Janet A Frohlich; Salim S Abdool Karim
Journal:  Trials       Date:  2014-12-19       Impact factor: 2.279

Review 7.  The clinical investigator-subject relationship: a contextual approach.

Authors:  David B Resnik
Journal:  Philos Ethics Humanit Med       Date:  2009-12-03       Impact factor: 2.464

8.  Canadian research ethics board members' attitudes toward benefits from clinical trials.

Authors:  Kori Cook; Jeremy Snyder; John Calvert
Journal:  BMC Med Ethics       Date:  2015-12-02       Impact factor: 2.652

9.  Protections for clinical trials in low and middle income countries need strengthening not weakening.

Authors:  Rafael Dal-Ré; Paul Ndebele; Elizabeth Higgs; Nelson Sewankambo; David Wendler
Journal:  BMJ       Date:  2014-07-04

10.  The 'experimental public' in longitudinal health research: views of local leaders and service providers in rural South Africa.

Authors:  Rhian Twine; Gillian Lewando Hundt; Kathleen Kahn
Journal:  Glob Health Res Policy       Date:  2017-09-06
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