Recent work by Ignacio Mastroleo
The American Journal of Bioethics, 2020
During the Ebola virus disease outbreak in West Africa, an advisory panel to the World Health Org... more During the Ebola virus disease outbreak in West Africa, an advisory panel to the World Health Organization (WHO) argued that it can be ethically appropriate to offer individual patients experimental interventions on an emergency basis outside clinical trials provided that certain conditions are met (WHO 2014a). The panel referred to the use of experimental interventions under these circumstances as “monitored emergency use of unregistered and experimental interventions” (MEURI) (WHO 2014b). In the ethical framework subsequently developed to guide policy and practice related to MEURI, it was acknowledged that compounds qualifying for MEURI may not be available in large quantities, and so choices would have to be made about who receives each intervention (WHO 2016). While the MEURI framework offered some general considerations for allocating scarce unproven interventions (WHO 2016), it was largely silent on the specifics of allocation. As the current WHO working group struck to evaluate the utility of MEURI in the context of the COVID-19 pandemic, we commend Webb et al. (2020) for advancing detailed thinking around the allocation of scarce unproven interventions for COVID-19. In the spirit of finding common ground in the area of using unproven interventions during public health emergencies, in what follows we will (1) provide a brief introduction to MEURI, (2) compare Webb et al.’s proposal to the existing MEURI framework, and (3) outline key areas where the use and allocation of unproven interventions can be enhanced.
Revista de Bioética y Derecho, 2020
Propuesta para la elaboración de un protocolo de triaje en el contexto de la pandemia de COVID-19... more Propuesta para la elaboración de un protocolo de triaje en el contexto de la pandemia de COVID-19 Proposal for the elaboration of a triage guideline in the context of the COVID-19 pandemic Proposta per a l'elaboració d'un protocol de prova en el context de la pandèmia de COVID-19
Theoretical Medicine and Bioethics, 2021
Medical practice is ideally based on robust, relevant research. However, the lack of diseasemodif... more Medical practice is ideally based on robust, relevant research. However, the lack of diseasemodifying treatments for Alzheimer's disease has motivated "innovative practice" to improve patients' well-being despite insufficient evidence for the regular use of such interventions in health systems treating millions of patients. Innovative or new non-validated practice poses at least three distinct ethical questions: first, about the responsible application of new non-validated practice to individual patients (clinical ethics); second, about the way in which data from new non-validated practice are communicated via the scientific and lay press (scientific communication ethics); and third, about the prospect of making new non-validated interventions widely available before more definitive testing (public health ethics). We argue that the authors of metabolic enhancement protocols for Alzheimer's disease have overstated the evidence in favor of these interventions within the scientific and lay press, failing to communicate weaknesses in their data and uncertainty about their conclusions. Such unmeasured language may create false hope, cause financial harm, undermine informed consent, and frustrate the production of generalizable knowledge necessary to face the societal problems posed by this devastating disease. We therefore offer more stringent guidelines for responsible innovation in the treatment of Alzheimer's disease.
Wellcome Open Research, 2021
As the world reflects upon one year since the first cases of coronavirus disease 2019 (COVID-19) ... more As the world reflects upon one year since the first cases of coronavirus disease 2019 (COVID-19) and prepare for and experience surges in cases, it is important to identify the most crucial ethical issues that might lie ahead so that countries are able to plan accordingly. Some ethical issues are rather obvious to predict, such as the ethical issues surrounding the use of immunity certificates, contact tracing, and the fair allocation of vaccines globally. Yet, the most significant ethical challenge that the world must address in the next year and beyond is to ensure that we learn the ethical lessons of the first year of this pandemic. Learning from our collective experiences thus far constitutes our greatest moral obligation. Appreciating that decision-making in the context of a pandemic is constrained by unprecedented complexity and uncertainty, beginning in June 2020, an international group of 17 experts in bioethics spanning 15 countries (including low-, middle-, and high-income countries) met virtually to identify what we considered to be the most significant ethical challenges and accompanying lessons faced thus far in the COVID-19 pandemic. Once collected, the group met over the course of several virtual meetings to identify challenges and lessons that are analytically distinct in order to identify common ethical themes under which different challenges and lessons could be grouped. The result, described in this paper, is what this expert group consider to be the top five ethical lessons from the initial experience with COVID-19 that must be learned.
Law, Innovation and Technology, 2020
A significant part of the literature on innovative practice in medicine relates to seizing opport... more A significant part of the literature on innovative practice in medicine relates to seizing opportunities and curbing harms for patients in desperate situations. Unfortunately, the term innovation has multiple meanings and a rich rhetorical flourish that adds confusion and misunderstanding to an already difficult debate. This paper aims to enhance the current definition of innovative practice for medicine. First, we replace the term 'innovation' with the more literal 'new non-validated practice'. To identify this meaning, we analyse the traditional research ethics' distinction between research, validated practice, and innovation in the Belmont Report. Second, we propose the following explicit definition of new non-validated practice: the first or recent use of diagnostic, therapeutic or preventive interventions that introduce a significant change, with an insufficient level of evidence of safety or efficacy for regular healthcare, and with the main aim to benefit individual patients. This definition is a promising conceptual tool to inform empirical research, ethicists, and the harmonisation of regulation and legislation (e.g. right-to-try laws).
Integridad se dice de muchas maneras. En este trabajo, reconstruiremos tres sentidos de i... more Integridad se dice de muchas maneras. En este trabajo, reconstruiremos tres sentidos de integridad en investigación científica (reglas, virtudes y valores) que se encuentran en la literatura reciente. Al respecto, partiremos de la hipótesis de que contar con un concepto claro de integridad y buena conducta en investigación puede fomentar su uso apropiado. En este mismo sentido, sostendremos que una definición precisa de mala conducta, junto con su alcance, contribuirá a identificarla y, de esta manera, a intentar disminuir el daño que produce en la investigación clínica. Así, desarrollaremos cuatro sentidos de mala conducta (ética, legal, amplia y estrecha) y el problema que implica evaluar la intención de los agentes. Finalmente, analizaremos algunos posibles métodos de prevención de la mala conducta, tales como las prácticas educativas y las auditorías.
Book: M. Hevia & E. Rivera López (Eds.), Controversies in Latin American Bioethics. Springer. Zenodo Preprint, https://doi.org/10.5281/zenodo.2577257, 2019
The term "innovation" or what we call "new non-validated practice" has recently gained attention ... more The term "innovation" or what we call "new non-validated practice" has recently gained attention in the context of clinical research and practice regarding the use of novel and not yet fully validated medical interventions and technologies. Most notably, there have been various incidences of medical activities that fall into this category, such as stem cell treatments, genome sequencing for diagnostic purposes, or novel and yet non-validated reproductive technologies. Latin American countries are among the places where new and non-validated medical activities take place, notably due to a lack of clear regulations and the poor support of authorities of existent legal and ethical guidelines, which is driven by "hidden battles" on the moral status of certain interventions. The increasing importance of new and non-validated interventions underlines the importance of developing a general framework for these practices. Therefore, the present chapter scrutinizes this nascent line of research in Latin America and offers a framework for innovation understood as "new non-validated practice" as well as its ethical justification. We will argue that "responsible innovation" understood as "responsible new non-validated practice" is ethically permissible and poses an acceptable medical option in exceptional circumstances where no reasonable alternatives can be provided to an individual patient. Finally, we focus on the peculiarities and specific difficulties the category of new non-validated practice poses to the Latin American context. We will conclude the chapter by some remarks and recommendations we draw from our analysis for individual patients, doctors, and societies in Latin America.
Books by Ignacio Mastroleo
Book: Precision Medicine eds. Hans-Peter Deigner and Matthias Kohl eBook ISBN: 9780128054338 Paperback ISBN: 9780128053645
This chapter analyses and develops the concept as well as the ethics of “clinical innovation” in ... more This chapter analyses and develops the concept as well as the ethics of “clinical innovation” in the context of the emerging field of individualized approaches in medicine. We argue for clinical innovation as an alternative approach to clinical research in the context of the application of new and yet untested interventions. Even though clinical innovation applies to reasonable, but yet unproven novel health interventions, it does not aim to generate generalizable knowledge under a sound research design. We will characterize clinical innovation as “new and insufficiently validated practice” because it resembles medical practice in terms of the aim to directly benefit individual patients. However, clinical innovation departs in a significant way from validated medical practice because innovative medical procedures go along with unknown safety and efficacy features. We will argue that innovation understood as new and non-validated practice is ethically justified as an acceptable medical option when no reasonable alternatives can be provided to an individual patient. Thus, we show that clinical innovation is an ethically required category that falls under the category of clinical practice, which should be distinguished from clinical research.
Tesis / Dissertation by Ignacio Mastroleo
![Research paper thumbnail of La obligación de continuidad de tratamiento beneficioso hacia los sujetos de investigación [texto completo]](https://attachments.academia-assets.com/38647002/thumbnails/1.jpg)
Todos los días se prueban nuevos psicofármacos, tratamientos para el VIH/SIDA o el cáncer, entre ... more Todos los días se prueban nuevos psicofármacos, tratamientos para el VIH/SIDA o el cáncer, entre otras enfermedades. Algunos de esos tratamientos son lo suficientemente exitosos como para cronificar enfermedades antes consideradas mortales, como los antirretrovirales para el VIH/SIDA o el imatinib para la leucemia mieloide a principios del 2000. No obstante, antes de que puedan ser comercializados o estar disponibles en los sistemas de salud pública, deben pasar por una serie de rigurosas pruebas de calidad, seguridad y eficacia. Estas pruebas implican el testeo de las drogas en animales y su estudio en seres humanos, sanos o enfermos. Estrictas normas de buenas prácticas científicas y éticas regulan todo el proceso de las investigaciones biomédicas. El problema de mi tesis se centra en el momento de la finalización de los estudios en seres humanos. Alguien podría preguntarse qué pasa con las personas si se benefician clínicamente del tratamiento experimental durante el estudio cuando este finaliza. La interrupción abrupta de un tratamiento beneficioso podría poner en peligro la salud de los sujetos. Y en el caso de sujetos de investigación afectados por enfermedades crónicas, es probable que deban continuar con el tratamiento beneficioso u otra atención adecuada por el resto de sus vidas. Un sujeto de investigación estadounidense sin seguro de salud que participó en un estudio de largo plazo de diabetes resume estas preocupaciones: "de repente cortan la cuerda, y uno está solo por su cuenta ... O conseguís trescientos o cuatrocientos dólares por mes para seguir con esto o simplemente seguís adelante y morís". Este tipo de casos me llevaron a preguntar si existe alguna obligación moral de proveer el tratamiento beneficioso a un sujeto de investigación que no puede pagárselo. Muchas personas podrían pensar que interrumpir el tratamiento beneficioso al sujeto de investigación que padece de diabetes y no tiene seguro para cubrir un tratamiento es incorrecto, porque nadie debería morir de una enfermedad o dedicar todos los recursos disponibles para sobrevivir, especialmente cuando se contribuyó a encontrar una cura o a obtener la evidencia científica necesaria para desarrollar un mejor tratamiento que el existente. Otras personas podrían pensar que lo correcto es ofrecer el tratamiento a un "precio justo", y si la persona no puede pagar por la continuidad de tratamiento es su responsabilidad. Mi intuición es que una sociedad democrática justa tiene una obligación moral de establecer un sistema de continuidad de tratamiento beneficioso para los sujetos de investigación. En esta tesis intento justificar filosóficamente esta última intuición básica utilizando el marco teórico de la teoría de la justicia de Rawls. Elijo utilizar la teoría rawlsiana, porque esta teoría me permite ubicar los problemas morales con respecto a la continuidad de tratamiento beneficioso en su contexto social adecuado y en el contexto de la búsqueda general de una sociedad más justa. En particular, la encuentro especialmente adecuada para explicar fenómenos complejos de responsabilidad social como los que creo que subyacen en el problema de la obligación de continuidad de tratamiento beneficioso hacia los sujetos de investigación. Como mostraré más adelante, es imposible tener en cuenta los aspectos morales de la continuidad de tratamiento beneficioso aislada de la sociedad en la que se realizan los estudios con seres humanos.
Artículos / Papers by Ignacio Mastroleo
Revista Médica de Chile, 2017
En este trabajo discuto con los miembros de la Academia Chilena de Medicina sobre la reglamentaci... more En este trabajo discuto con los miembros de la Academia Chilena de Medicina sobre la reglamentación apropiada del acceso posinvestigación a una intervención beneficiosa en la ley Ricarte Soto. Aquí defiendo que el criterio apropiado para evaluar cuando una intervención resulta beneficiosa para un participante individual es el de interacción entre la evidencia individual y de la población del estudio. Podría ser el caso que, dadas ciertas características individuales y la falta de mejores alternativas, el participante perteneciera a un subgrupo de la población del estudio donde resulte o pueda resultar beneficiosa la intervención. Por lo tanto, la decisión clínica debería considerar la interacción entre la evidencia de riesgo-beneficio potencial a nivel individual y a nivel de la población del estudio (que incluye el análisis de riesgo-beneficio de las subpoblaciones).
![Research paper thumbnail of Democratic reciprocity model: a justification of continued access to an investigational medicine in clinical research / Modelo de reciprocidad democrática: una justificación de la continuidad de tratamiento beneficioso en la investigación clínica [artículo en español]](https://attachments.academia-assets.com/52302402/thumbnails/1.jpg)
[Abstract in English] This paper develops a normative model for the obligation of continued acces... more [Abstract in English] This paper develops a normative model for the obligation of continued access to an investigational medicine towards research subjects from the perspective of social or distributive justice inspired in the theory of justice of John Rawls. I call this the democratic reciprocity model. The original idea of the democratic reciprocity model is to claim that the obligation of continued access correlates with the right to health. Thus, within the Rawlsian framework, I argues that the moral reasons giving weight to the obligation of continued access are, indirectly, the principle of fair equality of opportunity and, directly, the duty of justice and/or the principle of fairness that apply to the members of a society understood as a system of social cooperation. #########################[Resumen en español] En este trabajo desarrollo un modelo normativo sobre la obligación de continuidad de tratamiento beneficioso hacia los sujetos de investigación desde la perspectiva de la justicia social o distributiva, inspirado en la teoría de la justicia de John Rawls. Llamo a esto, el modelo de reciprocidad democrática. La idea original del modelo de reciprocidad democrática es defender que la obligación de continuidad de tratamiento beneficioso tiene como derecho correlativo el derecho a la salud. Así, dentro del marco rawlsiano, argumento que las razones morales que dan peso a la obligación de continuidad de tratamiento beneficioso son, indirectamente, el principio de igualdad equitativa de oportunidades y, directamente, el derecho de justicia y/o el principio de equidad que se aplican a los miembros de una sociedad entendida como un sistema de cooperación social.
El Foro Global de Bioética en Investigación (GFBR por sus siglas en inglés) se reunió el 3 y 4 de... more El Foro Global de Bioética en Investigación (GFBR por sus siglas en inglés) se reunió el 3 y 4 de noviembre en Buenos Aires, Argentina, con el objetivo de discutir la ética de la investigación con mujeres embarazadas. El GFBR es una plataforma mundial que congrega a actores clave con el objetivo de promover la investigación realizada de manera ética, fortalecer la ética de la investigación en salud, particularmente en países de ingresos bajos y medios, y promover colaboración entre países del norte y del sur.a Los participantes en el GFBR provenientes de Latinoamérica incluyeron a eticistas, investigadores, miembros de comités de ética y representantes de autoridades sanitarias provenientes de Argentina, Brasil, Chile, Colombia, Ecuador, El Salvador, Guatemala, Honduras, Panamá, Perú, Nicaragua y la República Dominicana. Una legítima preocupación por la protección de las mujeres embarazadas y sus embriones o fetos ha llevado a la mayoría de los países de la Región de las Américas a limitar la realización de estudios con mujeres embarazadas exclusivamente a aquellos estudios específicos sobre el embarazo, y a requerir la exclusión sistemática de las mujeres embarazadas o de las mujeres que quedan embarazadas en el curso del estudio. Ciertamente, a lo largo de la historia de la ética de la investigación, se ha creído erróneamente que proteger a una población es sinónimo de excluirla de los estudios. Se sabe ahora que proceder así implica exponer a riesgos mucho mayores a la población que se busca proteger. El embarazo implica cambios fisiológicos sustantivos e impacta profundamente la manera como el cuerpo metaboliza los medicamentos. Sin embargo, por evitar hacer investigación con mujeres embarazadas, no se ha producido la evidencia científica necesaria para tomar decisiones sobre tratamientos e intervenciones preventivas con dosis eficaces y seguras para ellas y sus embriones o fetos. A manera de ilustración, en el 2001 había en los Estados Unidos apenas más de una docena de medicamentos aprobados para uso en el embarazo (1) y en el 2011 la Food and Drug Administration (FDA) aprobó por primera vez en 15 años un medicamento para su uso en el embarazo (2). Como consecuencia de no haber producido la evidencia necesaria, se pone en riesgo la salud de las mujeres embarazadas cada vez que se les da atención médica. Las mujeres embarazadas se enferman y las mujeres enfermas se embarazan, y no se sabe si los medicamentos que se les da son eficaces o siquiera seguros para ellas y sus embriones o fetos.
![Research paper thumbnail of MRCT Center Post-Trial Responsibilities Framework Continued Access to Investigational Medicines I. Guidance Document [Version 1.0, December 2016]](https://attachments.academia-assets.com/50849508/thumbnails/1.jpg)
I. EXECUTIVE SUMMARY
The MRCT Center Post-trial Responsibilities: Continued Access to an Investi... more I. EXECUTIVE SUMMARY
The MRCT Center Post-trial Responsibilities: Continued Access to an Investigational Medicine Framework outlines a case-based, principled, stakeholder approach to evaluate and guide ethical responsibilities to provide continued access to an investigational medicine at the conclusion of a patient’s participation in a clinical trial. The Post-trial Responsibilities (PTR) Framework includes this Guidance Document as well as the accompanying Toolkit. A 41-member international multi-stakeholder Workgroup convened by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University (MRCT Center) developed this Guidance and Toolkit.
Project Motivation
A number of international organizations have discussed the responsibilities stakeholders have to provide continued access to investigational medicines. The World Medical Association, for example, addressed post-trial access to medicines in Paragraph 34 of the Declaration of Helsinki (WMA, 2013):
“In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.”
This paragraph and other international guidance documents converge on several consensus points:
• Post-trial access (hereafter referred to as “continued access” in this Framework [for terminology clarification – see definitions]) is the responsibility of sponsors, researchers, and host country governments;
• The plan for continued access should be determined before the trial begins, and before any individual gives their informed consent;
• The protocol should delineate continued access plans; and
• The plan should be transparent to potential participants and explained during the informed consent process.
However, there is no guidance on how to fulfill these responsibilities (i.e., linking specific responsibilities with specific stakeholders, conditions, and duration). To fill this gap, the MRCT Center convened a working group in September of 2014 to develop a framework to guide stakeholders with identified responsibilities. This resultant Framework sets forth applicable principles, approaches, recommendations and ethical rationales for PTR regarding continued access to investigational medicines for research participants.
![Research paper thumbnail of Post-trial obligations in the Declaration of Helsinki 2013: classification, reconstruction and interpretation [pre-peer reviewed version]](https://attachments.academia-assets.com/39499869/thumbnails/1.jpg)
The general aim of this article is to give a critical interpretation of post-trial obligations to... more The general aim of this article is to give a critical interpretation of post-trial obligations towards individual research participants in the Declaration of Helsinki 2013. Transitioning research participants to the appropriate health care when a research study ends is a global problem. The publication of a new version of the Declaration of Helsinki is a great opportunity to discuss it. In my view, the Declaration of Helsinki 2013 identifies at least two clearly different types of post-trial obligations, specifically, access to care after research and access to information after research. The agents entitled to receive post-trial access are the individual participants in research studies. The Declaration identifies the sponsors, researchers and host country governments as the main agents responsible for complying with the post-trial obligations mentioned above. To justify this interpretation of post-trial obligations, I first introduce a classification of post-trial obligations and illustrate its application with examples from post-trial ethics literature. I then make a brief reconstruction of the formulations of post-trial obligations of the Declaration of Helsinki from 2000 to 2008 to correlate the changes with some of the most salient ethical arguments. Finally I advance a critical interpretation of the latest formulation of post-trial obligations. I defend the view that paragraph 34 of ‘Post-trial provisions’ is an improved formulation by comparison with earlier versions, especially for identifying responsible agents and abandoning ambiguous ‘fair benefit’ language. However, I criticize the disappearance of ‘access to other appropriate care’ present in the Declaration since 2004 and the narrow scope given to obligations of access to information after research.
El problema de la transición de los participantes desde una investigación hacia la atención de la... more El problema de la transición de los participantes desde una investigación hacia la atención de la salud apropiada es un problema global. La publicación de una nueva versión de la Declaración de Helsinki es una excelente oportunidad para repensar este problema. Según mi interpretación, la Declaración de Helsinki 2013 introduce dos tipos diferentes de obligaciones posinvestigación, a saber, (1) obligaciones de acceso a atención de la salud y (2) obligaciones de acceso a información. Los beneficiarios pretendidos de estas obligaciones son los participantes individuales de estudios de investigación. Y la Declaración identifica a los patrocinadores, investigadores y gobiernos de los países anfitriones como los principales agentes responsables de cumplir con las obligaciones posinvestigación. Para justificar esta interpretación de los tipos, agentes y beneficiarios de las obligaciones posinvestigación, presento primero una clasificación tentativa de las obligaciones posinvestigación. Luego hago una breve reconstrucción conceptual de las formulaciones de las obligaciones posinvestigación en las versiones anteriores de la Declaración y reviso las principales críticas. Finalmente presento un análisis crítico de la nueva formulación de las obligaciones posinvestigación basándome en la discusión de las secciones anteriores.
Journal of Medical Ethics , 2014
A commentary on “Models of Consent to Return of Incidental Findings in Genomic Research,” by Paul... more A commentary on “Models of Consent to Return of Incidental Findings in Genomic Research,” by Paul S. Appelbaum, Erik Parens, Cameron R. Waldman, Robert Klitzman, Abby Fyer, Josue Martinez, W. Nicholson Price II, and Wendy K. Chung, in the July-August 2014 issue.
Uploads
Recent work by Ignacio Mastroleo
Books by Ignacio Mastroleo
Tesis / Dissertation by Ignacio Mastroleo
Artículos / Papers by Ignacio Mastroleo
Versión 17 de mayo de 2017. Consejo de Organizaciones Internacionales de las Ciencias Médicas en colaboración con la Organización Mundial de la Salud (CIOMS-OMS). (2016). International Ethical Guidelines for Health-related Research Involving Humans. “Guideline 6: Caring for participant’s health needs”. http://cioms.ch/ethical-guidelines-2016/WEB-CIOMS-EthicalGuidelines.pdf
The MRCT Center Post-trial Responsibilities: Continued Access to an Investigational Medicine Framework outlines a case-based, principled, stakeholder approach to evaluate and guide ethical responsibilities to provide continued access to an investigational medicine at the conclusion of a patient’s participation in a clinical trial. The Post-trial Responsibilities (PTR) Framework includes this Guidance Document as well as the accompanying Toolkit. A 41-member international multi-stakeholder Workgroup convened by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University (MRCT Center) developed this Guidance and Toolkit.
Project Motivation
A number of international organizations have discussed the responsibilities stakeholders have to provide continued access to investigational medicines. The World Medical Association, for example, addressed post-trial access to medicines in Paragraph 34 of the Declaration of Helsinki (WMA, 2013):
“In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.”
This paragraph and other international guidance documents converge on several consensus points:
• Post-trial access (hereafter referred to as “continued access” in this Framework [for terminology clarification – see definitions]) is the responsibility of sponsors, researchers, and host country governments;
• The plan for continued access should be determined before the trial begins, and before any individual gives their informed consent;
• The protocol should delineate continued access plans; and
• The plan should be transparent to potential participants and explained during the informed consent process.
However, there is no guidance on how to fulfill these responsibilities (i.e., linking specific responsibilities with specific stakeholders, conditions, and duration). To fill this gap, the MRCT Center convened a working group in September of 2014 to develop a framework to guide stakeholders with identified responsibilities. This resultant Framework sets forth applicable principles, approaches, recommendations and ethical rationales for PTR regarding continued access to investigational medicines for research participants.
Versión 17 de mayo de 2017. Consejo de Organizaciones Internacionales de las Ciencias Médicas en colaboración con la Organización Mundial de la Salud (CIOMS-OMS). (2016). International Ethical Guidelines for Health-related Research Involving Humans. “Guideline 6: Caring for participant’s health needs”. http://cioms.ch/ethical-guidelines-2016/WEB-CIOMS-EthicalGuidelines.pdf
The MRCT Center Post-trial Responsibilities: Continued Access to an Investigational Medicine Framework outlines a case-based, principled, stakeholder approach to evaluate and guide ethical responsibilities to provide continued access to an investigational medicine at the conclusion of a patient’s participation in a clinical trial. The Post-trial Responsibilities (PTR) Framework includes this Guidance Document as well as the accompanying Toolkit. A 41-member international multi-stakeholder Workgroup convened by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University (MRCT Center) developed this Guidance and Toolkit.
Project Motivation
A number of international organizations have discussed the responsibilities stakeholders have to provide continued access to investigational medicines. The World Medical Association, for example, addressed post-trial access to medicines in Paragraph 34 of the Declaration of Helsinki (WMA, 2013):
“In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.”
This paragraph and other international guidance documents converge on several consensus points:
• Post-trial access (hereafter referred to as “continued access” in this Framework [for terminology clarification – see definitions]) is the responsibility of sponsors, researchers, and host country governments;
• The plan for continued access should be determined before the trial begins, and before any individual gives their informed consent;
• The protocol should delineate continued access plans; and
• The plan should be transparent to potential participants and explained during the informed consent process.
However, there is no guidance on how to fulfill these responsibilities (i.e., linking specific responsibilities with specific stakeholders, conditions, and duration). To fill this gap, the MRCT Center convened a working group in September of 2014 to develop a framework to guide stakeholders with identified responsibilities. This resultant Framework sets forth applicable principles, approaches, recommendations and ethical rationales for PTR regarding continued access to investigational medicines for research participants.