Presentation on theme: "What happens when research is over – whose obligation? Global Forum for Bioethics in Research VI: What happens when research is over – obligation Banson."— Presentation transcript:
What happens when research is over – whose obligation? Global Forum for Bioethics in Research VI: What happens when research is over – obligation Banson Barugahare Senior Scientist Joint Clinical Research Centre, Kampala - Uganda This presentation will probably involve audience discussion, which will create action items. Use PowerPoint to keep track of these action items during your presentation In Slide Show, click on the right mouse button Select “Meeting Minder” Select the “Action Items” tab Type in action items as they come up Click OK to dismiss this box This will automatically create an Action Item slide at the end of your presentation with your points entered.
Background ”Beneficent gifts will assuage the ills of the poor from which enlightenment will result for the preservation of the rich. Yes, rich benefactors, generous men, this sick man laying in the bed that you have subcribed is now experiencing the disease that will be attacking you; he will be cured or perish; but in either event, his fate may enlighten your physician and save your life” (In S.F Spicker, et. Al., 1988: The use of human Being in Research)
Background 1947 - The Nuremberg Code 1948 - Universal Declaration of Human Rights 1964 – 2000 WMA Declaration of Helsinki 1966 - 1967 Henry Beecher and Pappworth 1966 – 1981 Establishment of IRC/B (IRB, IEC) 1979 – The Belmont Report 1991 - CIOMS – Epidemiology studies 1993 – CIOMS – Human experimentation 1996 – ICH –GCP (Pharmaceutical products) 2000 – UNAIDS guidance document 2000 – WHO operational guidelines for RECs
Background WMA Declaration of Helsinki, 2000 Principle 30: ”At the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study.”
Background Council for International Organisations of Medical Sciences (CIOMS), 2002 Guideline 10: ” Before undertaking research in a population or community with limited resources, the sponsor and investigator must make every ffort possible to ensure that: any intervention or product developed, or knowdge generated, will be made reasonably available fo the benefit of that population.... In geneal, if the there is good reason to believe that a product developed or knowledge gernerated by rsearch is unlikely to be reasonably available or applied to the benefit of the population of the host country or community after the conclusion of the research, it is unethical to conduct the research in that community”
Background 1. ”Insisting on reasonable availability precludes the community to deciding which benefits it prefers. Reasonable availability should not be imposed as an absolute ethical requirement for research in developing countries without affirmation with countries themselves” 2. ”Reasonable availabilty fails to ensure a fair share of benefits. In addition, it has a norrow concept of benefits because, it does not consider other potential benefits of research like capacity building and infrastructure development. Therefore it fails to avoid exploitation” ( Science: December, 20002 )
Who are the Partners in the Research Enterprise and what are their roles? The Sponsor: An individual, company or insititution taking responsibility for the initiation, management and financing the research. Securing aggrements from all parties involved including the investigators Supply of the investigational intervention Registering the successfull intervention for marketing Providing the beneficial intervetion to the research participants until the intervention is on open market Have policies and procedures to address the costs of treatment of trial subjects in the event of trial-related injuries in accordance with the applicable regulatory requirement (s)
Who are the Partners in the Research Enterprise and what are their roles? The Investigator/Researcher: A person responsible for the conduct of the clinical at a trial site. Obliged to conduct the trial according to approved protocol and provide trial related health care to research participants Accountable to the sponsor
Who are the Partners in the Research Enterprise and what are their roles? Research Participants: These a sample of the population - that justifies the research. The participants are a means to the anticipated results of the research. They are the primary benefactors of the beneficial results of the research by default. They continue to be part of the population and sieze to be participants after the research is terminated.
Basis for ethical obligations to plan access to post - trial interventions A clinical trial is deliberate action (by agent(s)) that aims at a valuable consequence. The goodness valuable consequence is qualified by the motive of the action. The ethical principles of Utility Beneficence and Justice require that the agent(s) balance the benefits and cost to produce the net good. A net good therefore is that social value of the research that is accessable.
Access to the Net Good: Whose Obligation? The Sponsor The investigator/Researcher The host care providers Competent and independent Research Ethics committees Host regulatory frameworks for Health care access
Access to the Net Good: Mechanisms Considerations for the host countries/Researchers to drive the research agenda Reinforcing Research ethics committee competancies and functions Initial plans and agreements by the sponsors and the host country responsible parties Considerations to impliment investiments for local production and delivery of the intervetions Considerations for differential pricing of the intervetions Establishment of international legal framework