Wednesday, September 13, 2017


By Rachel Wheeler

Interpreting Informed Consent in Order to Preserve Participant’s Autonomy
Informed consent is a basic human right, and participants in clinical trials or those submitting to surgical procedures must have the risks made clear to them. The US Food and Drug Administration (FDA) and the Institutional Review Board (IRB) ensure these rights are protected through the use of informed consent forms (ICFs).

These must include relevant information about the procedure, trial, etc. that inform participants of the risks, benefits and other components. ICFs also serve the interest of the organization administering or overseeing the procedure as they minimize or remove liability.

The FDA mandates the use of ICFs, whilst the IRB goes one step further in ordering that these forms utilize medical interpreters from professional translation services to ensure the subject has a clear understanding of the risks and responsibilities of participating in a trial or undergoing treatment. Just as a professional translation makes a medical patent application more clear and benefits the organization abroad, a translated ICF serves a positive function for both the administering organization and patient, regardless of international language and cultural barriers.

Medical professionals who carry out trials or procedures without obtaining the correct level of informed consent expose themselves and their institutions to a range of ethical confrontations, malpractice suits, and even charges of assault.
What is Informed Consent?

Informed consent is a process that involves the medical professional providing the patient with all the necessary information to determine the risks and benefits of undergoing a procedure or test. This process should include: Follow-up discussions to clarify understanding; allow for questions the patient has; give the patient enough time to make a thought-out decision about their medical care.

After the participant has processed the information, he or she must sign the ICF to record their understanding and consent to the procedure or trial. In situations where participants of a trial are expected to include non-English speakers, clinical investigators must submit translated ICFs to the IRB before beginning the consent process.

After completing and obtaining signed ICFs, the entire procedure for informed consent will be reviewed by the IRB, which is purported by the FDA to “protect the rights and welfare of subjects participating in clinical investigations.”

The Eight Components of ICF
The FDA require a minimum of eight elements be included in ICFs to earn IRB approval, and it must be written in the participant’s native language or an officially acceptable translation.
1.    Description of Clinical Investigation: An explanation of the research being carried out, its purpose and the expectations of participants, and the length of the trial and how it will be carried out, including experimental procedures.
2.    Risks and Discomforts: The participant must be informed of reasonably foreseeable risks dangers and discomforts, including standard procedures, exams and tests and especially those which carry a risk of morbidity or mortality.
3.    Benefits: The description of the potential benefits must be clear, balanced and realistic, outlining the benefits not only to the participant but also others (e.g. future patients).
4.    Alternative Procedures or Treatments: Other options available to treat their medical problem(s) and the risks and benefits of those options must be fully explained to the subject.
5.    Confidentiality: Informing who will have access to their confidential medical records and for what length of time. The degree of confidentiality that can be expected and what circumstances could cause their records to be opened to a third party need to be detailed, and in all cases, the FDA may inspect medical records without permission from the subject.
6.    Compensation and Medical Treatment in the Event of Injury: Where there is more than minimal risk associated with a procedure, participants need to be informed of available compensation and medical treatment, and where they can obtain further information. Where no compensation or treatment is available, statements making this explicit should be used.
7.    Contacts: Complete contact information for further inquiries or complaints must be provided, and the contacts should be outside of the trial’s clinical team so the participant feels comfortable making a complaint or inquiry.
8.    Voluntary Participation: If withdrawal involves special procedures these need to be outlined in detail. Participants must also understand that they will not suffer penalties nor lose benefits if withdrawing from a study or trial. However, any data collected on a subject prior to withdrawal may still be included in the study.

Additional elements such as unforeseeable risks, involuntary termination of a subject’s participation, additional costs to the participant, and the consequences of a subject’s decision to withdraw should be included when applicable. Exculpatory language or language that appears to free an individual or entity from malpractice, negligence, blame, guilt or fraud must not be included in an ICF.
Translating ICFs

Scientific and medical research should be carried out free from considerations about the chief language spoken in an area: Regardless of the language spoken, test subjects should be able to take part in studies. Yet to maintain human rights, all foreign language speakers need to be able to make informed decisions.

Translating requirements instruct clinical investigators to deliver all relevant consent forms and consultations at a level of the subject’s understanding (without jargon), and in a language they speak fluently. For studies that pose more than minimal risk to participants, ICF translations must be undertaken by professional medical translators or a qualified Language Service Provider with medical translation professionals.

When is a qualified LSP necessary?

A professional translator must be used in the following circumstances:
·         The subject does not understand English, but is literate in other languages. A written ICF must be given in a language the subject understands, and a translator who is fluent in English and the subject’s spoken language must be present.
·         A participant does not understand English and is illiterate in other languages. In such cases, an oral explanation must be given through an interpreter in the presence of a witness. Both a short and long form of the presentation is needed in the participant’s language.
Participants’ Autonomy Must be Preserved

Scientific and biomedical trials using human subjects get to the core of personal autonomy. The law and regulations surrounding it ensures all participants in such studies have the capacity to consider alternatives and make choices without undue influence or interference of others, and in doing so that they fully understand the risks, benefits, options and procedures involved.

The FDA’s clear instructions ensure all necessary information is presented in a way that subjects can understand. The FDA’s guidelines should be followed as closely as possible not only to minimize liability, but also to ensure the freedoms of subjects and preserve their human rights. Ensuring the ICFs are handles by medical translation professionals when needed is critical to achieve this.

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