Abstract
Objective
We reviewed the content of IVF consent documents (i.e., consent forms and accompanying
information sheets) used by Canadian IVF clinics in 1991, 2004, and 2014, paying particular
attention to the inclusion of information that should be provided to patients in accordance
with minimum ethical standards for disclosure.
Methods
We contacted all Canadian IVF clinics in operation in 1991 (17 clinics), 2004 (24
clinics), and 2014 (35 clinics) by mail and requested blank copies of their IVF consent
documents. Documents received were reviewed for the inclusion of information about
the nature of IVF, the potential benefits of IVF, the potential harms and inconveniences
of IVF, confidentiality, voluntariness, and options for the use or discarding of embryos
not transferred in the original stimulated cycle (sometimes referred to as supernumerary,
excess, or spare embryos).
Results
We received responses from 11 of 17 clinics operating in 1991 (response rate 65%),
14 of 24 clinics operating in 2004 (response rate 58%), and 11 of 35 clinics operating
in 2014 (response rate 31%). In general, comparisons of the 1991, 2004, and 2014 data
sets showed a long-term decrease in documented disclosure of information that should
be provided to patients in accordance with minimum ethical standards. The only cases
in which this trend appeared to be reversed was with disclosure about the probability
of supernumerary embryos, long-term risks of treatment, the right to revoke consent
to the use or discarding of supernumerary embryos, and some of the options for the
use of supernumerary embryos. In these few instances, there was a notable improvement
in the disclosure of relevant information between 1991 and 2014.
Conclusion
The disclosure of information relevant to the interests of those undergoing IVF and
those who are born as a result of IVF appears to be decreasing. Furthermore, the information
that increasingly is being disclosed in consent documents appears to be directing
the orientation and content of these documents away from the primary interests of
the relevant women, couples, and children. These two trends are inconsistent with
the goal of informed consent.
Résumé
Objectif
Nous avons examiné le contenu de documents de consentement à la FIV (formulaires de
consentement et fiches d’information complémentaire) utilisés par les cliniques canadiennes
de FIV en 1991, 2004 et 2014. Nous avons accordé une attention particulière à l’inclusion
des renseignements qu’on devrait fournir aux patientes, conformément aux normes de
déontologie minimales de divulgation.
Méthodes
Nous avons communiqué par la poste avec toutes les cliniques canadiennes de FIV qui
étaient en service en 1991 (17 cliniques), en 2004 (24 cliniques) et en 2014 (35 cliniques),
en leur demandant de nous fournir une copie vierge de leurs documents de consentement
à la FIV. Nous avons examiné les documents reçus afin de déterminer l’inclusion de
renseignements sur la nature de la FIV, les avantages potentiels de la FIV, les dangers
et les inconvénients potentiels de la FIV, la confidentialité, le caractère volontaire
du consentement, ainsi que les options d’utilisation ou d’élimination des embryons
non transférés (parfois désignés par les expressions « embryons surnuméraires », ou
« embryons excédentaires ») lors du cycle de stimulation d’origine.
Résultats
Nous avons reçu des réponses de 11 des 17 cliniques en service en 1991 (taux de réponse
de 65 %), de 14 des 24 cliniques en service en 2004 (taux de réponse de 58 %) et de
11 des 35 cliniques en service en 2014 (taux de réponse de 31 %). En général, la comparaison
des ensembles de données de 1991, de 2004 et de 2014 a révélé une régression à long
terme de la divulgation documentée des renseignements qu’on devrait fournir aux patientes,
conformément aux normes de déontologie minimales. Les seuls cas dans lesquels cette
tendance a semblé être inversée sont ceux qui traitent de la divulgation des probabilités
relatives à la production d’embryons surnuméraires, des risques à long terme du traitement,
du droit de révocation du consentement à l’utilisation ou à l’élimination des embryons
surnuméraires, ainsi que de certaines des options d’utilisation des embryons surnuméraires.
Dans ces rares cas, nous avons constaté une amélioration notable de la divulgation
de renseignements pertinents entre 1991 et 2014.
Conclusion
La divulgation de l’information qui servirait les intérêts des personnes qui se soumettent
à la FIV et de celles qui naissent grâce à la FIV semble aller en s’amenuisant. En
outre, les renseignements de plus en plus divulgués dans les documents de consentement
semblent en détourner l’orientation et le contenu des intérêts fondamentaux des femmes,
des couples et des enfants concernés. Ces deux tendances entrent en contradiction
avec le but du consentement éclairé.
Key Words
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Article info
Publication history
Published online: April 29, 2016
Accepted:
January 27,
2016
Received:
October 26,
2015
Footnotes
Conflicting interests: None declared.
Identification
Copyright
Copyright © 2016 The Society of Obstetricians and Gynaecologists of Canada/La Société des obstétriciens et gynécologues du Canada. Published by Elsevier Inc. All rights reserved.
