Mariela Mautone - World Medical Association

ETHICS COMMITTEESMariela MautoneSindicato Médico del Uruguay

Presenter’s Details I am a Nephrologist and Professor in Bioethicsworking in the Facultad de Medicina de laUniversidad de la República (UDELAR) I represent the Uruguayan Medical Associationthe “Sindicato Médico del Uruguay (SMU)”

The region I represent.I am representing Uruguay, adeveloping world countrysitutated in South America.Latin America has the highestdegree of inequality in the world.I am independent of allpharmaceutical and institutionalinterests.I have five years experienceworking in two ethics committeesinvolving human research inUruguay.

Presentation Objective My objective today, is to talk about the mainfunctions that I consider an ethics committeemust have.

Functions of ethics committees The principle functionis to protect humanbeings frombiological, physical,emotional, mental,and social harm ordamage from medicalresearch that mayinfringe on their basichuman rights.Antonio Berni

What are the most important skills andatributes required for ethics committeemembers?It is the member’s RESPONSABILITY to becompletely independent of all institutional,governmental, pharmaceutical, and vested financialinterests.It is the member’s RESPONSABILITY to develop thenecessary skills for studying scientific issues: theymust understand completely the human research thatis being proposed (or they must consult with aspecialist in these issues).They must be able to assess the social value of theresearch, identifying any possible harm that mayoccur to vulnerable research participants.

Member skills and atributescontinued... Committee members must check and ensurethat all of the information given to the researchparticipants is clear to read, and easy for themto understand. The information must not bedeceptive, mis-leading or have a negativeeffect on the research participants individualautonomy.

What are the key personal qualities needed forethics committee members? They must possess a high level of honestyand personal integrity. They must be STRONG defenders of theirfindings and recommendations

Procedures for assessing researchprotocols Assess how HUMAN DIGNITY is affected bythe research project. Assess how the intrinsic value of all humanbeings will be affected. Assess possible research consequences andeffects on the individual and on the society.Reviewing both the positive and negativepossibilities of all aspects.

Procedures for assessing researchprotocols continued… Assess the impact the research will have on theindividuals autonomy. Assess if individuals have rights to legally redressany negative effects they may experience fromthe research. Only after reviewing the research project detailsand finding them acceptable, do you go aheadand review the Informed Consent document.

Procedures for assessing researchprotocols continued… Assess the research information from theindividual committee member’s perspective. Assess the research information based on theDeclaration of Helsinki 2002. (subsequest Declaration of Helsinki reviews haveweakened the protections of human beings). Assess the research information based on theUniversal Declaration on Bioethics and HumanRights (2005) Assess the research information based on theUniversal Declaration of Human Rights signed1948 .

Framework and Levels of Accountability needed forimplementing effective protection of Human Beingsinvolved in medical research National governments must have a interest inprotecting the basic social needs of theircitizens. National political systems must become moreactive in protecting the welfare of theirpopulations. National Health departments must be active incoordinating all national research projects andmonitoring their outcomes National legal systems must become active increating laws for the protection of their citizensfrom harmful research projects and practices.

Framework and levels of accountibilitycontinued… Establishment of National Ethics Committees. Establishment of local institutional EthicsCommittees in hospitals and medicalinstitutions. Teaching of ethics committee courses inmedical universities.

In Conclusion: Ethics committees without a national supportstructure will not be able to protect humans beingsand their rights in medical research projects. Blindly following of procedural rules or check listsis not the solution to protecting human fromunethical research. More is needed! Signing a research project’s Informed consentdocument without close consideration may notprotect the human rights of participatingindividuals.