Informed consent at the nexus of health and human rights, as reported by Special Rapporteur Anand Grover to the UN General Assembly

In his recent report for the United Nations General Assembly, Special Rapporteur Anand Grover emphasizes that informed consent should be a fundamental practice in a rights-based approach to health. He describes informed consent as “not mere acceptance of 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. Its ethical and legal normative justifications stem from its promotion of patient autonomy, self-determination, bodily integrity and well-being.”

Informed consent as a compulsory health practice and a categorical human right seems straightforward enough. But not everyone agrees. Informed consent is consistently recognized and protected in the context of law practice and legal discussions, Grover contends, but in health settings, where clinical practitioners and health researchers face innumerable and nuanced barriers to carrying out uniform standards of care, the application of informed consent can lack regulation and consistency. These barriers are built from what he calls “structural inequalities” and “the imbalance of power, experience and trust” in doctor-patient and researcher-subject relationships.

The varied — and constantly varying — policies that shape health care delivery and clinical trial procedures also undermine and cloud the meaning of informed consent, most notably in the case of HIV/AIDS testing. The Centers for Disease Control recommends voluntary HIV screening for every individual who enters a health care setting in the US. The patients are notified that the test will be carried out, but they do not need to sign a separate written consent form, and they are able to decline testing; this is known in medical practice as “opt-out” testing and means that the test takes place unless the patient explicitly chooses to “opt out” of this otherwise “routine” procedure. Proponents of this type of voluntary but less formal screening method argue that normalizing the test decreases testing stigma (because there is no need during a clinic visit to request the procedure), makes people aware of their diagnoses sooner, and, through prompt testing and treatment, will in time quell the spread of the disease.

However, proponents of formal informed consent argue that a positive HIV/AIDS status disclosed through opt-out or even involuntary screening can cause other problems: the patient may face faulty referral and support services, lack of information, and stigma. These potential consequences fall particularly hard on vulnerable or high-risk populations who seek treatment at resource-constrained clinics. Diagnosed as HIV-positive through the “opt-out” method in a clinic lacking supportive services, the patient may not be prepared emotionally or educated well enough to make autonomous and optimal treatment decisions. This is a structural infringement on their right to health, not a reflection of their personal deficiencies. With adequate resources after opt-out testing, the patient stands to better understand his or her diagnosis and treatment options and make decisions with less fear of stigma and alienation.

The provision and protection of informed consent is essential for certain groups who face increased vulnerability due to economic, social, and cultural factors. These groups include children, elderly persons, women, ethnic minorities, indigenous peoples, persons with disabilities, persons living with HIV/AIDS, persons deprived of liberty, sex workers, and persons who use drugs. As Mr. Grover points out, “Structural inequalities exacerbated by stigma and discrimination result in individuals from certain groups being disproportionately vulnerable to having informed consent compromised.” Ultimately, those in most need of informed consent are often the ones deprived of it.

Guaranteeing and monitoring the practice of informed consent in health care settings is a duty of the State and of third parties seeking to uphold right-to-health principles. The dissemination and accessibility of accurate information, the provision of supportive services such as counseling, and the development of targeted policies are some of the ways in which States can ensure that patients gain the maximum benefit from informed consent. Practitioners and researchers at the front line of delivering care and carrying out studies are also accountable for prioritizing informed consent and providing this kind of follow-up support.

Optimal mental and physical health depends on the recognition and protection of integrity in all phases of care and research. Realizing the right to health calls for protecting the “autonomy, self-determination and human dignity” of all parties in doctor-patient or researcher-subject relationships.