4th International AIDS Society Conference on HIV Pathogenesis and Treatment


Sydney, Australia - July 22 - 25, 2007

ETHICAL CONSIDERATIONS RELATED TO THE PROVISION OF CARE AND TREATMENT IN VACCINE TRIALS

IAS Conf HIV Pathog Treat 2007 Jul 22-25;4th: Abstract No. MOAC304

Tarantola D.1, Macklin R.2, Reed Z.H.3, Osmanov S.4, Strobie M.5, Hankins C.6, Kieny M.P.3
1University of New South Wales, Faculty of Medicine, WHO Consultant, Sydney, Australia, 2The Albert Einstein Medical Centre, WHO HIV Vaccine Advisory Committee, New York, United States, 3The Initiative on Vaccine Research, World Health Organization, Geneva, Switzerland, 4The WHO/UNAIDS HIV Vaccine Initiative, IVR, World Health Organization, Geneva, Switzerland, 5AAVP Ethics, Law and Human Rights Working Group, School of Psychology, University of KwaZulu Natal, Pietermaritzburg, South Africa, 6Department of Policy, Evidence and Partnerships, UNAIDS, Geneva, Switzerland

OBJECTIVES: To propose a structured approach to consensual decision making on access to care, treatment and support by participants in clinical trials of HIV and other new vaccines.

METHODS: Setting standards of care provided to participants in vaccine clinical trials has been the subject of long-standing debate. The central questions that arise are: Is there an obligation to provide care to trial participants? What is the source of the obligation? Who should benefit from care? What care and prevention should be offered and for how long? Who bears the responsibility of providing care, in what form and within what limits? In 2005-2006, recognizing the pressing need for practical guidance to researchers, research institutions and sponsors, national health authorities and communities hosting clinical vaccine trials, the World Health Organization Initiative on Vaccine Research (WHO/IVR) embarked on a series of regional consultations. These consultations mapped out current guidance and approaches applied in field situations; set out criteria for defining obligations and obstacles to providing care in the context of vaccine trials; and developed mechanisms and approaches conducive to the attainment of the highest possible synergy between scientific quality, outcome of research, and protection of trial participants.

RESULTS: The series of consultations resulted in a guidance revolving around a concept of Good Research Governance. The guidance document, to be presented, proposes a pathway for consensual decision making on standards applicable to care and treatment in vaccine trials.

CONCLUSIONS: A structured approach involving investigators, sponsors, trial communities and other stakeholders in research should ensure that the needs and legitimate expectations of trial participants are appropriately met and obligations towards them delivered. This is a necessary, if not sufficient, condition for facilitating ethical research in the interest of public health. The experience acquired in actual field settings will be applied to the further elaboration of the guidance provided.

Acrobat ReaderDownload PDF of this abstract.

Power Point PresentationDownload Power Point Presentation.

2007-07-22
MOAC304
Ethics In Biomedical Prevention

Copyright © 2007 - International AIDS Society (IAS). All information and content relating to the abstracts from the 3rd International AIDS Society Conference on HIV Pathogenesis and Treatment, such as text, graphics, logos, button icons, images, audio clips, and software is protected by copyright. Permission is hereby granted for the non-commercial use or reproduction of the information on this web site, provided that the use of such information is accompanied by an acknowledgement that IAS is the source of the information and the name of the author of the article.

AEGiS is made possible through unrestricted funding from Boehringer Ingelheim, Bridgestone/Firestone Charitable Trust, Bristol-Myers Squibb Company, Elton John AIDS Foundation, the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 2007. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2007. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. Permission is hereby granted for the non-commercial use or reproduction of the information herein, provided that the use of such information is accompanied by an acknowledgement that IAS is the source of the information and the name of the author of the article.