Preserving medical tourism patient autonomy with English interpretations of informed consent in foreign countries

✎ by Rachel Wheeler

Preserving the Autonomy of Patients Abroad

As medical tourism grows worldwide and people become more aware of global treatments and medical trials, it is important to be aware of your rights. The laws and regulations surrounding medical procedures generally guarantee participants fully understand the risks, benefits, alternatives and procedures in such a way as to enable them to make clear and informed decisions, thereby avoiding concerning consequences of their medical travel decisions.Informed consent is a process involving the medical professional presenting a patient with all relevant information regarding a test, trial, or procedure. Informed consent allows prospective medical trial participants and patients to understand all relevant risks and benefits and helps medical organisations and practitioners support basic human rights

The World Health Organization (WHO) forewarns, “Patients' rights vary in different countries and in different jurisdictions, often depending upon prevailing cultural and social norms.’ WHO further explains, “The Universal Declaration of Human Rights has been instrumental in enshrining the notion of human dignity in international law, providing a legal and moral grounding for improved standards of care on the basis of our basic responsibilities towards each other as members of the “human family”, and giving important guidance on critical social, legal and ethical issues. But there remains a great deal of work to be done to clarify the relationship between human rights and right to health, including patient rights.”

An alien in a foreign country should expect initial discussions, the provision of documentation about the procedure, and follow-up discussions to clarify understanding and allowing for questions the patient may have. All of this must be completed in a time frame which allows a patient to make a considered, informed decision about their medical care.

The risks of surgical and clinical procedures are made clear to patients through informed consent. In the US Food and Drug Administration (FDA) and the Institutional Review Board (IRB) maintain these protections for the USA though informed consent forms (ICFs) with specific guidelines for their application. These may or may not be applicable in foreign countries. 

The WHO has organized templates for informed consent which may be more adaptable in your destination country: 

Informed Consent Form Templates

(language used throughout form should be at the level of a local student of class 6th/8th)

Notes to Researchers:

  • Please note that these are templates developed by the WHO ERC to assist the Principal Investigator in the design of their informed consent forms (ICF). It is important that Principal Investigators adapt their own ICFs to the outline and requirements of their particular study. The logo of the Institution must be used on the ICF and not the WHO logo.
  • The informed consent form consists of two parts: the information sheet and the consent certificate.
  • Do not be concerned by the length of these templates. They are long only because they contain guidance and explanations which are for you and which you will not include in the informed consent forms that you develop and provide to participants in your research.
  • These templates include examples of key questions that may be asked at the end of each section, that could ensure the understanding of the information being provided, especially if the research study is complex. These are just examples, and suggestions, and the investigators will have to modify the questions depending upon their study.
  • In these templates:
    • square brackets indicate where specific information is to be inserted
    • bold lettering indicates sections or wording which should be included
    • standard lettering is used for explanations to researchers only and must not be included in your consent forms. The explanation is provided in black, and examples are provided in red in italics. Suggested questions to elucidate understanding are given in black in italics.

CFs also minimize or remove liability from organizations administering or overseeing procedures and clinical trials by including all relevant information to inform patients and participants of the risks, benefits, and other elements of a procedure.

Who Ensures ICF’s are Applied Correctly?

The use of ICFs is mandated by the FDA in the USA. Additionally, the IRB orders for a medical interpreter to translate these forms in order to provide the patient with an understanding of the risks, benefits, responsibilities, and rights clear to all participating in trials or undergoing treatment. A destination country’s health department should be able to offer guidance on medical trials and practices, with informed consent. 

A translated ICF provides security for both the patient and administering organization, regardless of cultural barriers and native language. Without obtaining the correct level of understanding in regard to ICFs, medical professionals are vulnerable to a range of pitfalls, including malpractice suits and charges of assault. 

Once this information has been processed, the participant must sign an ICF to provide evidence of their understanding and consent to the trial or procedure. In instances where trial participants include non-English speakers, medical investigators need to supply translated ICFs to the IRB before beginning the consent process.

Upon completion of the consent process, the IRB will review the entire informed consent procedure, espoused by the FDA as protecting the rights and welfare of subjects participating in clinical investigations.

ICF Translation Requirements

No matter the trial, scientific and medical research using human subjects must be carried out in consideration of all languages spoken by participants. In order to accommodate this approach and to maintain all participants’ human rights, translated ICFs must be of a quality allowing foreign language speakers to fully understand a procedure and make an informed decision.

Translation requirements direct clinical investigators to provide consultations and ICFs at a level of the patient’s understanding (in their preferred language) and free from complex jargon. Furthermore, studies that present more than minimal risk to patients require ICF translations to be completed by professional medical translators or a qualified Language Service Provider with subject matter experts (SMEs) in the medical field on hand.

ICF is Comprised of Eight Elements

In the USA the FDA mandates a minimum of eight components be included in ICFs to receive IRB approval. All must be written in the patient’s native language or an officially acceptable translation. You might compare WHO and your clinical provider’s ICF to this model:

  1. Description of Clinical Investigation: The purpose and expectations of participants and the length and how a trial will be carried out, including experimental procedures, must be included in the explanation of the research being undertaken.
  2. Risks and Discomforts: All reasonably foreseeable risks, dangers and discomforts including those associated with standard procedures, examinations, and tests must be made clear to participants. 
  3. Benefits: Benefits must be realistically portrayed and clear, including direct and ongoing benefits (i.e.: those experienced by the participant and also future patients).
  4. Alternative procedures and treatments: Alternate options available for treating medical conditions and their risks and benefits must be fully explained to the patient.
  5. Confidentiality: Advising on both the length of time and which individuals and organizations will have access to their confidential medical records must be made clear. The level of confidentiality to be expected and the circumstances where their records could be made available to a third party must be detailed. In all cases the FDA may inspect medical records without the patient's consent.
  6. Compensation and Treatment in the Event of Injury: Where more than a minimal risk of injury is linked to a procedure, patients must be advised of available compensation and medical treatment and where to find further information. When no compensation is provided, explicit statements to this effect must be used.
  7. Contacts: Full contact information for inquiries or complaints that are outside the trials’ clinical team should be given to ensure participants feel comfortable making a complaint or inquiry.
  8. Voluntary participation: It must be made clear to participants that they will not endure penalties or lose benefits if they recant from a study or trial. If removing oneself from a trial involves special procedures, these need to be detailed clearly, along with data collection policies regarding the study period.

Unforeseeable risks, involuntary termination of a subject’s participation, and other additional elements pertaining to a trial should be included when relevant. Exculpatory language that seems to free an individual or organization from malpractice, negligence, blame, guilt or fraud must never be used in an ICF.

Are Qualified LSPs Required?

Professional medical translators must be used when the subject does not understand English, but is conversant or literate in other languages. A written ICF must be given in a language the participant understands and in situations where a subject cannot read in any language. An oral explanation must be given by a qualified medical interpreter in the presence of a witness. Short and long forms of these presentations are needed in the patient’s language.

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