Canada: L'affaire Theranos, la suite : l'importance des approbations éthiques sur le maintien du caractère confidentiel de données de recherche

MHR : La compagnie Theranos fait encore les manchettes en ayant annoncé, le 31 août dernier, son retrait volontaire des recherches cliniques visant à valider sa trousse diagnostique pour la détection du virus Zika.[1] L'enquête de la Food and Drug Administration (FDA, organisme américain en charge de superviser et d'approuver les médicaments et les trousses diagnostiques) a révélé que Theranos n'a pas obtenu le consentement d'un comité d'éthique en ce qui a trait à la sécurité des patients participant à la recherche clinique.[2] De manière volontaire, Theranos a hâtivement mis un terme à la recherche clinique sur le virus Zika dans plusieurs sites dont la République Dominicaine.[3] Bien que la recherche clinique puisse servir à générer une technologie brevetable, elle est habituellement conduite pour permettre aux autorités compétentes (FDA aux États-Unis ou Santé Canada au Canada) d'autoriser la mise en marché d'un médicament ou d'une trousse diagnostique. J'ai donc demandé à ma collègue Véronique Barry de nous expliquer l'importance d'obtenir le consentement d'un comité d'éthique à la recherche afin de mener une recherche clinique.

VB : La recherche clinique vise à découvrir et à améliorer les moyens de prise en charge et de traitement de maladies, prédispositions et autres conditions médicales. Toutefois, comme la recherche demeure « un pas vers l'inconnu », il est important que celle-ci soit encadrée afin que ces avancements scientifiques se fassent dans le plein respect des sujets humains.

En matière de recherche clinique, l'évaluation éthique d'un projet vise à évaluer le niveau de risque pour l'intégrité physique, psychologique, morale et sociale des sujets humains afin de protéger adéquatement leur intégrité. Au Québec, cette obligation trouve assise dans le Code civil du Québec[4], de même que dans certains traités internationaux dont la Déclaration d'Helsinki[5].

En plus de ces textes législatifs, l'obtention d'approbations éthiques dans le cadre de projets de recherche clinique est aussi prévue dans plusieurs guides, traités et lignes directrices, dont les suivants :

  1. D'abord, Les bonnes pratiques cliniques: directives consolidées [6] [(les BPC) adoptées par Santé Canada prévoient une série de normes de qualité éthique et scientifique. Ces BPC encadrent non seulement la réalisation de tout projet de recherche, mais aussi sa conception et la communication de résultats une fois cette réalisation terminée. Aux termes des BPC, l'obtention d'une approbation ou opinion favorable du protocole par un comité d'éthique à la recherche (CÉR) indépendant doit être obtenu avant même de débuter tout projet. Afin d'être en mesure d'émettre telle opinion, le document rappelle qu'un CÉR sera en droit de d'exiger la communication de tout renseignement jugé pertinent.
  2. L'importance de la recherche et de l'éthique est aussi confirmée dans Énoncé de politique des trois Conseils : Éthique de la recherche avec des êtres humains (2010) [7]. Tout comme c'était le cas pour les BPC, l'énoncé indique que tout projet de recherche impliquant des sujets humains doit être évalué sur le plan éthique et approuvé par un CÉR, et ce, avant le début des travaux. L'énoncé justifie cette exigence sur la base que l'évaluation éthique permet à tous les intervenants d'un projet de réfléchir aux questions éthiques entourant ce projet et donc de protéger plus efficacement les sujets. L'énoncé précise de plus que l'évaluation éthique est tout particulièrement importante dans des domaines nouveaux ou émergents, où les enjeux éthiques ne sont pas encore bien cernés. Selon l'énoncé, cette réflexion devrait inclure un dialogue continu entre les CÉRs et les chercheurs pour que les pratiques en matière d'éthique puissent évoluer au besoin et s'accorder ainsi avec les principes de l'énoncé. À cet effet, l'énoncé précise qu'il revient aux chercheurs de fournir suffisamment de précisions pour permettre au CÉR d'évaluer en connaissance de cause l'acceptabilité éthique des travaux de recherche. Ceci comprend notamment une obligation de signaler au CÉR tout élément ou événement imprévu susceptible d'augmenter le niveau de risque pour les participants ou qui a d'autres incidences, sur le plan de l'éthique, mettant éventuellement en cause le bien-être des participants.
  3. Pour leur part, les Fonds de recherche en santé du Québec ont élaboré Les Standards du FRSQ sur l'éthique de la recherche en santé humaine et l'intégrité scientifique[8]. Selon ces standards, tout projet de recherche sur des sujets humains devra être approuvé et suivi par un CÉR dont le fonctionnement respecte certaines conditions préétablies[9]. Cette obligation, présentée comme étant le standard fondamental du Fonds, a pour but de garantir le caractère adéquat de la protection qui sera offerte aux sujets.

En plus des lignes directrices prévues à ces documents, le ministère de la Santé et des Services sociaux met à la disposition des CÉRs un service de consultation[10] qui a pour objectif de soutenir les membres des CÉR et leur personnel de soutien dans l'exercice de leur fonction[11].

En somme, en sus confirmer l'acceptabilité éthique des projets de recherche impliquant des sujets humains, l'évaluation éthique est d'autant importante qu'elle permet d'analyser les postulats de recherche afin d'éviter que l'engouement entourant certaines découvertes et avancées scientifiques ne se fasse au détriment des sujets et de la population en général. Ce faisant l'intervention des CÉRs permet une réconciliation entre la reconnaissance de la valeur sociale de la recherche en santé et la protection des sujets de recherche.

Au-delà des normes en vigueur, il sera intéressant de voir si les récents évènements entourant l'affaire Theranos inspirera une culture davantage « éthique » en matière de recherche. Chose certaine, cette affaire (de même que certaines autres) a su démontrer que l'évaluation de l'acceptabilité éthique par un CÉR demeure essentielle même si la validité scientifique d'un projet a déjà été établie par un comité scientifique en regard des normes scientifiques pertinentes, et ce non seulement afin de protéger les sujets humains, mais aussi la confiance de la population quant aux projets et initiatives en recherche.

[1] http://www.cnn.com/2016/08/31/health/zika-theranos-test-withdrawn/

[2] https://techcrunch.com/2016/08/31/fda-finds-further-flaws-in-theranos-this-time-around-its-zika-tests/

[3] http://www.wsj.com/articles/theranos-halts-new-zika-test-after-fda-inspection-1472598332

[4] Articles 20 et 21.

[5] http://www.wma.net/fr/30publications/10policies/b3/

[6] http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e6-fra.php#a3.0

[7] http://www.ger.ethique.gc.ca/pdf/fra/eptc2/EPTC_2_FINALE_Web.pdf

[8] http://www.frqs.gouv.qc.ca/documents/10191/186005/Standards_FRSQ_%C3%A9thique_recherche_humain_2009.pdf/cbeae223-69f0-4438-b8f2-7c8836564ef7

[9] Voir l'avis publié dans la Gazette officielle du Québec le 29 août 1998.

[10] http://ethique.msss.gouv.qc.ca/lethique-de-la-recherche/soutien-aux-cer.html

[11] Voir aussi : http://www.hc-sc.gc.ca/sr-sr/advice-avis/reb-cer/ethi-res/index-fra.php , http://ethique.msss.gouv.qc.ca/publications/publications-dinteret.html , http://www.cihr-irsc.gc.ca/f/29371.html


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