WHO issues ethics guidance to protect the rights of TB patients (22 March 2017)

Today, 24 March 2017, is World Tuberculosis Day. The theme for this year is ‘Leave No One Behind. Unite to End TB’.

In the run-up to World TB Day 2017, the World Health Organization (WHO) has issued ethics guidance to protect the rights of patients with Tuberculosis (TB).

Key Messages:

The new document updates several of the recommendations released by WHO in 2010 in the Guidance on ethics of tuberculosis care, prevention and control.

The goal of the guidance document is to assist those working towards ending TB in the 21st century by proposing practical answers to key ethical questions and enabling patients, families, civil society, health workers and policy makers to move forward and address current challenges.

Ethical principles and values particularly important to TB care and control:

Equity
Common good
Solidarity
Reciprocity
Harm Principle
Duty to Care
Trust and Transparency
Efficiency
Effectiveness
Proportionality
Participation and Community Engagement
Respect and Dignity
Autonomy
Privacy and confidentiality

Not all principles will be applicable in all situations, and judgement must be used about which are relevant and how they can be used to articulate related obligations.

Governments have an ethical obligation to provide free, universal access to essential medicines and TB care, including those with Multi-Drug/ Rifampicin- Resistant TB (MDR/ RR-TB).

Governments have an ethical obligation to provide quality assured drugs for the treatment of TB.

The international community has an obligation to provide financial and other assistance to countries that cannot offer universal access to care on their own.

Individuals who undergo TB testing should receive adequate information about the nature of TB, i.e. how TB is transmitted, why is testing required, what are the implications of not being tested, and what are the implications of the results of the test for the individual and his or her family.

Individuals who are diagnosed with TB must be given information about the risks and benefits of the treatment (for both the patient and others in the community), the importance of adhering to treatment, and to the infection control measures.

Systematic contact investigation as part of routine TB care is justified.

WHO recommends that health care providers notify all people diagnosed with TB to the local public health surveillance system.

In the investigation of TB by public health authorities, health care workers have to balance the need to persuade persons with TB to notify their contacts as per protocol, with the potential negative unintended effects on contacts and patients, such as stigma and discrimination.

TB programmes have the ethical duty to provide persons with all assistance and support needed to prevent and mitigate stigma and discrimination that may result from a contact investigation.

The non-consensual disclosure of a patient’s TB status should be viewed as a last resort option, to be considered only after all reasonable efforts to engage the patient’s cooperation have failed.

Non-consensual disclosures should be made only to close contacts who would be at a significantly higher risk of having acquired infection or of developing disease.

Person with TB should be notified when all options are exhausted and a non-consensual disclosure has to be carried out.

Signing an informed consent form at the beginning of treatment or research without providing information is insufficient to protect autonomy throughout the course of therapy or a research project, as the informed consent should be seen as a continuous process.

Because patients’ implicit consent to testing is premised on the assumption that treatment will be offered for any conditions that are diagnosed, it cannot reasonably be applied to tests for conditions when no treatment is available. Thus, when patients are offered drug-susceptibility testing in the absence of treatment, they should be informed of the risks and benefits of testing and specifically asked if they are willing to consent to testing even though treatment is not yet available to them.

When patients are offered treatment for TB, for either latent TB infection or active disease, they should be informed about and asked for their specific consent, just as they would be for any other significant medical interventions.

It is ethically correct to offer a test that detects drug-resistant TB even when the corresponding treatment is not available.

When migrants are screened for active TB, they may also be automatically screened for latent TB infection. Screening for either condition should always be done with the intention to provide appropriate medical care, and never to exclude or preclude entry.

For latent TB infection, explicit consent is generally required since the subject does not pose a present risk to others and because of possible uncertainty concerning diagnostic and follow-up tests.

There is an ethical duty to provide social support to persons with TB.

It is an ethical duty of health care providers to support people with TB to adhere to treatment and all other guidelines.

All health care providers have an ethical obligation to “follow up” with patients who are having problems with adherence.

Treatment monitored under a patient-centred Directly Observed Treatment (DOT) may be an effective way to ensure adherence to treatment but it is an option that should not be enforced on patients.

It is ethically unacceptable to refuse to provide treatment when it appears that a particular patient is unlikely to adhere to the prescribed regimen.

There is an ethical obligation to deliver palliative care to persons with MDR/RR-TB in need.

It is ethical to stop TB medication when:

it has no proven prospects of success- restrict pharmacological treatment to symptom management.
side-effects outweigh possible benefits
the costs to the health system are not serving the needs of the patient

It is ethical to ask terminal patients to participate in research studies.

There is a duty to care for children with TB even if they are not a major source of transmission, and therefore no major impact on public health is expected.

It is unethical to hospitalize children for the delivery of TB medication in the absence of medical justification.