decision, protecting the right of the patient to be involved in medical decision-making, and assigning
associated duties and obligations to health-care providers.”107
100.
The European Convention on Human Rights and Biomedicine 108 also refers to this
matter at Article 5, which provides: “An intervention in the health field may only be carried out after
the person concerned has given free and informed consent to it. This person shall beforehand be
given appropriate information as to the purpose and nature of the intervention as well as on its
consequences and risks….”
101.
A systematic interpretation of the applicable standards in this area allows one to
establish that a process of informed consent should include the following three elements, which are
intimately interconnected: (i) inform as to the nature of the procedure, treatment options, and
reasonable alternatives, which includes the possible benefits and risks of the procedures proposed;
(ii) take into account the needs of person and ensure that the person understands the information
provided; and (iii) ensure that the consent that is given is free and voluntary. This process includes
adopting legislative, public policy, and administrative measures and extends to the physicians, health
professionals, and social workers at both public and private hospitals and other health institutions as
well as detention centers.109
102.
As regards the first element in the informed consent process – informing on the
nature of the procedure, treatment options, and reasonable alternatives, which includes the potential
benefits and risks of the proposed procedures – the Commission has indicated that the information
that is provided to the patient should be complete, accessible, reliable, timely, and diligent.110 In
order for the information to be thorough, the health professionals must obtain and divulge all of the
relevant information, and information of the highest quality, on the diagnosis and the treatment
proposed, including its effects, risks, as well as alternatives. In order for it to be accessible, it must be
“presented in a manner culturally and otherwise acceptable to the person consenting,” 111 which
includes the use of translation and interpretation services. In addition to being complete and
accessible, the information must also be reliable. Finally, the information must be provided in a
timely and diligent manner, i.e. prior to applying the procedure and without any need for a direct
request.
103.
With respect to the second element of informed consent – take into account the
needs of the person and ensure that he or she understands the information provided – the IACHR
observes that medical professionals have an important duty to ensure that information given is
understood, the aim being for the patient or his representatives to make a truly informed decision
with respect to the intervention and/or treatment proposed. In this sense, one should pay special
107 IACHR. Report No. 72/14. Case 12.655. Merits. I.V. Bolivia. August 15, 2014. Para 117. Quoting: United Nations,
Report of the Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and
mental health, Anand Grover, presented in keeping with resolution 6/29 of the Human Rights Council, A/64/272, of August 10,
2009, para. 9.
108 IACHR. Report No. 72/14. Case 12.655. Merits. I.V. Bolivia. August 15, 2014. Para 116. Quoting: Council of Europe,
Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and
Medicine: Convention on Human Rights and Biomedicine, signed April 4, 1997 in Oviedo, Spain, entered into force on December
1, 1999.
109 IACHR. Report No. 72/14. Case 12.655. Merits. I.V. Bolivia. August 15, 2014. Para 119. Quoting: IACHR, Access to
Information on Reproductive Health from a Human Rights Perspective, November 22, 2011, para. 44.
110 IACHR. Report No. 72/14. Case 12.655. Merits. I.V. Bolivia. August 15, 2014. Para 120. Quoting: IACHR, Access to
Information on Reproductive Health from a Human Rights Perspective, November 22, 2011, para. 45.
111 IACHR. Report No. 72/14. Case 12.655. Merits. I.V. Bolivia. August 15, 2014. Para 120. Quoting: United Nations,
Report of the Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and
mental health, Anand Grover, presented in keeping with resolution 6/29 of the Human Rights Council, A/64/272, of August 10,
2009, para. 23.
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