{"id":3827,"date":"2017-01-20T12:26:36","date_gmt":"2017-01-20T12:26:36","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/London_Post-trial_Access-London.pdf"},"modified":"2017-01-20T12:26:36","modified_gmt":"2017-01-20T12:26:36","slug":"london_post-trial_access-london-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/es\/london_post-trial_access-london-2\/","title":{"rendered":"London_Post-trial_Access-London"},"author":2,"comment_status":"open","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

London_Post-trial_Access-London<\/a><\/p>\n

Post-Study Arrangements
\nAlex John London, Ph.D.
\nProfessor of Philosophy &
\nDirector, Center for Ethics and Policy
\nCarnegie Mellon University
\n\u201cBenefits\u201d of Research
\nI. DoH 5: (Populations.) Access to research
\nconnected to the benefit of improved care.
\nII. DoH 17: (Populations.) \u201cresults of
\nresearch\u201d which could be new knowledge,
\ninformation, practices, interventions, or
\nprofits.
\nIII. DoH 33: (Participants.) Study findings
\nIV. DoH 14 & 33: (Participants.) Access to care
\nor other benefits.
\n2 London \u2013Helsinki Revision, Cape Town
\nResearch and Fairness
\nI. Research can overlap with, augment or supplant delivery of
\nhealth services to participants.
\n\u2022 Participants sometimes access improved standard of care
\n\u2022 Assume research related risks
\n\u2022 Care must be transferred back to providers after research.
\nII. Can reconfigure the way resources are used in a community
\nduring and after research:
\n\u2022 Utilizes personnel, equipment, supplies, time, clinical space,
\ntreatment, funding and other resources.
\n\u2022 Who benefits from this raises issues of equity and fairness
\n\u2022 Participants \/ non-participants
\n\u2022 Host countries \/ other countries
\nIII. Has diverse connections to health system:
\n\u2022 Shapes provider practice and patient expectation.
\n\u2022 Affects entitlements.
\n3 London \u2013Helsinki Revision, Cape Town
\nIntegrity of a Social Good
\nI. From person-to-person relations to research as a
\nsystem of social interaction.
\nII. System in which diverse stakeholders, who may
\nhave differing and even conflicting mandates,
\npursue diverse interests and goals.
\na. access to care
\nb. profit \/ personal advancement
\nc. scientific advance
\nd. improving standard of care
\n4 London \u2013Helsinki Revision, Cape Town
\nAn Adequate Research Ethics
\nIII. Set terms under which diverse stakeholders can
\nparticipate in the research enterprise and be
\nassured that the pursuit of private or personal
\ninterests does not compromise its ability to
\nproduce the unique social good of new knowledge
\nand interventions that enable health systems to
\nbetter meet health needs of the people they serve.*
\n*London AJ. 2012. A Non-Paternalistic Model of Research Ethics and Oversight: Assessing
\nthe Benefits of Prospective Review. Journal of Law, Medicine, and Ethics forthcoming.
\n*London AJ, Carlisle B and Kimmelman J. 2012. Rethinking Research Ethics: The Case of
\nPostmarketing Trials. Science 336 (May 4):544-545.
\n*London AJ. 2005. \u201cJustice and the Human Development Approach to International
\nResearch.\u201d The Hastings Center Report 35(1):24-37.
\n5 London \u2013Helsinki Revision, Cape Town
\nAn Adequate Research Ethics
\nI. Secure the rights and welfare of participants.
\n\u2022 Traditional research ethics focus.
\nII. Safeguard the integrity and reliability of research from
\nvarious parochial interests.
\n\u2022 Registration, publication, and oversight.
\nIII. Preserve the connection between research and the
\nhealth systems that rely on it for new knowledge
\nand interventions.
\n\u2022 Equity and fairness in resource use, access to research
\n(DoH 5), and improved health systems.
\n6 London \u2013Helsinki Revision, Cape Town
\nInformation as a Benefit
\nI. Treatment of information in the DoH has some exemplary
\nfeatures. A model for interventions.
\na. Recognized as a central benefit of research.
\nb. Emphasis on responsiveness and access.
\nc. Issues dealt with across the lifecycle of research.
\nd. Requirements identified related to preserving the integrity of
\nresearch.
\n1. Registration.
\n2. Publication, including negative findings.
\ne. Fuller range of stakeholders identified.
\nII. Access to other benefits\u2014which may also be important\u2014
\nshould not eclipse the centrality of the connection between
\nresearch and health systems.
\n7 London \u2013Helsinki Revision, Cape Town
\nInformation Across the Research
\nLifecycle
\nI. Access to research affects the ability of health systems to
\nimprove care for populations (DoH 5).
\nII. Study should be relevant to the health needs and priorities of the
\nhost community (DoH 17).
\n\u2022 Responsibility of: researchers, sponsors, and local \/ national
\nhealth authorities.
\nIII. Trial publically registered (DoH 19)
\n\u2022 Responsibility of: Researchers and sponsors.
\nIV. Participants should be informed of study outcomes (DoH 33)
\n\u2022 Responsibility of: Researchers and sponsors.
\nV. Findings (including negative) should be published (DoH 30)
\n\u2022 Responsibility of: researchers and sponsors, editors.
\nVI. Information should be integrated into health practices and
\npolicies.
\n\u2022 Responsibility of: Local and national health authorities with
\nassistance from sponsors or other development entities.
\n8 London \u2013Helsinki Revision, Cape Town
\nSuggested Language Para 5.
\nNew text is in italics:
\nMedical progress is based on research that ultimately
\nmust include studies involving human subjects. Research
\nshould be designed and conducted in ways that do not
\ndegrade, and are likely to enhance, the capacity of local
\nand national health institutions to provide equitable
\naccess to effective health services. Populations that are
\nunderrepresented in medical research should be provided
\nappropriate access to participation in research.
\n9 London \u2013Helsinki Revision, Cape Town
\nRationale
\n\u2022 Explicitly connects access to research with
\nimprovements in health systems.
\n\u2022 Assurance that research will not be
\nconducted in ways that leave communities
\nworse off.
\n10 London \u2013Helsinki Revision, Cape Town
\nSuggested Language Para 17
\nMedical research involving a disadvantaged or
\nvulnerable population or community is only
\njustified if the research is responsive to the
\nhealth needs and priorities of this population or
\ncommunity and if there is a reasonable
\nlikelihood that this population or community
\nstands to benefit from the results of the
\nresearch. from the knowledge, practices, or
\ninterventions that result from the research.
\n11 London \u2013Helsinki Revision, Cape Town
\nRationale
\n\u2022 5 & 17: communities should reasonably
\nexpect to benefit from research via the
\nquestions it addresses and the interventions
\nit assesses.
\n12 London \u2013Helsinki Revision, Cape Town
\nSuggested Language Para 14
\n\u2026The protocol should describe arrangements
\nfor post-study access by study subjects to
\ninterventions identified as beneficial in the
\nstudy or access to other appropriate care or
\nbenefits. This information should also be
\ndisclosed to participants during the informed
\nconsent process.
\n13 London \u2013Helsinki Revision, Cape Town
\nSuggested Language Para 33
\nAt the conclusion of the study, patients entered into the study are entitled
\nto be informed about the outcome of the study and to share any benefits
\nthat result from it, for example, access to interventions identified as
\nbeneficial in the study or to other appropriate care or benefits.
\nI agree with the Macklin\u2019s proposed revisions to paragraph 33:
\n\u201cIn advance of a clinical trial, sponsors, researchers, and
\nhost-country governments should make provisions for post-
\ntrial access for all participants who still need an intervention
\nidentified as beneficial in the study. All study participants
\nshould be informed about the outcome of the study.\u201d
\n14 London \u2013Helsinki Revision, Cape Town
\nParticipant Welfare
\nI. When researchers and sponsors assume
\nresponsibility for participant care, they assume
\nsome fiduciary responsibilities to participants.
\nII. The force of responsibility may vary according
\nto:
\na. Severity of the health consequences for
\nparticipants and others (e.g., drug resistance).
\nb. The ease of transitioning the care of participants to
\nanother provider (e.g., the local or national health
\nsystem).
\nc. The availability of the intervention or adequate
\nalternatives.
\n15 London \u2013Helsinki Revision, Cape Town
\nAppropriate Continuity of Care
\nIII. When participant health requires
\ncontinuing treatment, researchers,
\nsponsors, and local health authorities have
\na duty to ensure appropriate continuity of
\ncare.
\nIV. This should normally be understood as a
\nduty of researchers and sponsors to
\nfacilitate continued provision of care until
\nthat responsibility can be discharged within
\nthe relevant local or national health system.
\n16 London \u2013Helsinki Revision, Cape Town
\nJustice and Equity
\nIV. Equitable provision of health services is the
\nfunction of the health system.
\na. Prior to regulatory approval or sale, sponsors
\nmay need to facilitate access to study
\ninterventions.
\nV. In low-resource settings, inequitable
\nresource allocation in the health system
\nmay result if disproportionate share of host
\ncommunity resources are diverted to fulfill
\npost-trial obligations to participants.
\n17 London \u2013Helsinki Revision, Cape Town
\nJustice and Equity
\nVI.Sponsors, researchers, and host
\ngovernments should negotiate
\nmechanisms to avoid inequitable
\nresource allocation in under-
\nresourced settings.
\na. Pricing \/ licensing
\nb. Funding commitments
\nc. Partnerships
\n18 London \u2013Helsinki Revision, Cape Town
\nConclusion
\n\u2022 Communities should reasonably expect
\nresearch:
\n\u2022 to address questions and study
\ninterventions that are likely to expand the
\ncapacity of their health institutions to meet
\ncommunity health needs.
\n\u2022 To be carried out in a way that improves
\ncapacity of health institutions.
\n\u2022 Participants should reasonably expect:
\n\u2022 Respect for their rights and welfare.
\n\u2022 Appropriate continuity of care.
\n19 London \u2013Helsinki Revision, Cape Town<\/p>\n"},"caption":{"rendered":"

London_Post-trial_Access-London Post-Study Arrangements Alex John London, Ph.D. Professor of Philosophy & Director, Center for Ethics and Policy Carnegie Mellon University \u201cBenefits\u201d of Research I. DoH 5: (Populations.) Access to research connected to the benefit of improved care. II. DoH 17: (Populations.) \u201cresults of research\u201d which could be new knowledge, information, practices, interventions, or profits. III. […]<\/p>\n"},"alt_text":"","media_type":"file","mime_type":"application\/pdf","media_details":{},"post":null,"source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/London_Post-trial_Access-London.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media\/3827"}],"collection":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media"}],"about":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/types\/attachment"}],"author":[{"embeddable":true,"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/comments?post=3827"}]}}