particular reference has been made to informed consent as an ethical principle of respect for the autonomy of
persons, which requires that they understand the different options for treatment available to them and are
involved in their own health care. 302
159.
The European Court has also indicated that compliance with the positive obligation of the state
to effective ensure its citizens the right to physical and psychological integrity may require, in turn, adopting
provisions on access to information on the health of an individual. 303
160.
The international community has recognized informed consent 304 as an a active and
continuing process that seeks to ensure that no treatment is performed without the agreement of the person
to be treated, and without the person having been duly informed of its effects, risks, and consequences. 305 The
IACHR has noted that informed consent is an appropriate process for disseminating all the information needed
for a patient to be able to freely make his or her own decision to grant (or deny) his or her consent to a
treatment or medical intervention. This process seeks to ensure that persons see their human rights respected
in the area of health, and that can make truly free choices. 306
161.
In this respect, the Special Rapporteur on the right of everyone to the enjoyment of the highest
attainable standard of physical and mental health, Anand Grover, indicated: “Informed consent is not mere
acceptance of a medical intervention, but a voluntary and sufficiently informed decision, protecting the right of
the patient to be involved in medical decision-making, and assigning associated duties and obligations to
health-care providers.” 307
162.
The European Convention on Human Rights and Biomedicine 308 also refers to this matter at
its Article 5, establishing: “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..…”
163.
According to a systematic interpretation of the standards applicable to this area, a process of
informed consent should include the following three elements, which are closely interrelated: (i) inform on the
nature of the procedure, treatment options, and reasonable alternatives, including the possible benefits and
risks of the procedures proposed; (ii) take into account the needs of the person and ensure that they
understand the information provided; and (iii) ensure that the consent that is given is free and voluntary.
IACHR. Report No. 72/14. Case 12,655. Merits I.V. Bolivia. August 15, 2014. Para 115. Citing, IACHR, Access to Information on
Reproductive Health from a Human Rights Perspective, November 22, 2011, para. 43.
303 European Court of Human Rights, Case of RR v. Poland, Application 27617/04, May 26, 2011, para. 188. See also: IACHR, Access to
Information on Reproductive Health from a Human Rights Perspective, November 22, 2011, para. 61. In addition, for other treatments on
related matters in the international sphere, see: United Nations, Human Rights Council, Report of the Special Rapporteur on torture and
other cruel, inhuman and degrading treatment, Juan E. Méndez, A/HRC/22/53, February 1, 2013, paras. 32, 46, and 48.
304 IACHR. Report No. 72/14. Case 12,655. Merits. I.V. Bolivia. August 15, 2014. Para. 116. The term “informed consent” is the most widely
used term. Nonetheless, some argue that the term may be misinterpreted and should be replaced by the term “informed choice.” This is
because the choice not to consent is essential to the integrated concept of voluntary or consent given voluntarily. See B.M. Dickens, R.J
Cook, Dimensions of informed consent to treatment, Ethical and legal issues in reproductive health, International Journal of Gynecology &
Obstetrics 85 (2004), pp. 309‐314.
305 IACHR. Report No. 72/14. Case 12,655. Merits. I.V. Bolivia. August 15, 2014. Para. 116, citing 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,
submitted pursuant to resolution 6/29 of the Human Rights Council, A/64/272 of August 10, 2009; United Nations, Committee for the
Elimination of Discrimination against Women, Communication No. 4/2004, Case of A.S. v. Hungary, August 29, 2006,
CEDAW/C/36/D/4/2004, para. 11.3. For example, the Amsterdam Declaration on Patients’ Rights provides: “Patients have the right to be
fully informed about their health status, including the medical facts about their condition; about the proposed medical procedures,
together with the potential risks and benefits of each procedure; about alternatives to the proposed procedures, including the effect of
non-treatment; and about the diagnosis, prognosis and progress of treatment.” (ICP/HLE 121, 1994).
306 IACHR. Report No. 72/14. Case 12,655. Merits I.V. Bolivia. August 15, 2014. Para 115. Citing, IACHR, Access to Information on
Reproductive Health from a Human Rights Perspective, November 22, 2011, para. 42.
307 IACHR. Report No. 72/14. Case 12,655. Merits. I.V. Bolivia. August 15, 2014. Para. 117. Citing, 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,
submitted pursuant to resolution 6/29 of the Human Rights Council, A/64/272 of August 10, 2009, para. 9.
308 IACHR. Report No. 72/14. Case 12,655. Merits. I.V. Bolivia. August 15, 2014. Para. 116. Citing, 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 December 1, 1999.
302
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