What is an Informed Consent Form?

An informed consent form is a requirement, not an option. A human can not partake in the research process during a clinical trial without signing one. These forms obtain a participant’s consent to participate and inform them of their rights. A participant should expect to find the following information on an informed consent form in a clearly described and understandable way.

• A summary of the procedure or study.
• The purpose of it.
• The duration and schedule.
• Expected procedures.
• Potential benefits and risks.
• Alternatives to participating.
• The rights and responsibilities of those involved (the participant, study administrators, sponsors, etc.).

The requirements of an informed consent form ensure that a subject’s participation is voluntary. Informing participants about all aspects of the trial is required both ethically and legally. 

Informed consent forms consist of two parts. One part is the information sheet that includes the aspects outlined above. The second part is the certificate of consent. Participants receive a copy of their informed consent form and information sheet. 

Where Does Translation Come In to Play?

Ensuring all research participants are properly informed of what a medical study entails is vital, or else you risk violating a participant’s rights. Being prepared to overcome language barriers can be necessary to ensure no violations occur. A language barrier or poor translation efforts can derail a clinical trial. A barrier can also harm a participant. Particularly if they do not understand what they are agreeing to.   

The proper translation of informed consent forms is a more pressing need than ever before due to the increase in medical research conducted in developing countries. These locales are often chosen as the site of clinical trials because they offer reduced costs. As well as access to affected populations who may benefit from the trial. For some, these trials are the only access to medical care they have. 

What is at Risk?

These trials can lead to new treatments, vaccines, and medications. But they can also violate the ethical rights of the at-risk populations found in developing countries. These violations can occur in first-world countries too. Particularly, in locations like the United States, where different cultures and languages frequently mix. Working with a seasoned translation expert can help avoid these violations and contribute to the success of a clinical trial.

It is not appropriate to exclude a participant due to their inability to read or understand a particular language. Doing so violates the governing principles of human subject research. Respect for persons, beneficence, and justice. Researchers must communicate directly with a subject or provide a trustworthy alternative to ensure they understand their rights, risks, and what their participation will entail. 

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Progress is a collaborative effort. By tapping into an international network, researchers can learn, discover, and create at a faster rate than ever before. In order to collaborate across the globe, the translation of medical research becomes an unavoidable need.

Medical research is defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” under the Health Insurance Portability and Accountability Act (HIPAA). This broad definition can include biomedical research, health services research, and epidemiological studies. It can also include studies of the behavioral, social, and economic factors that affect health.

Medical research provides a high value to society. This research can provide vital information regarding:

• The outcomes of treatment or public health interventions
• Functional abilities
• Health care costs and use
• Disease trends
• Risk factors
• Patterns of care

Clinical trials are one of the more familiar forms of health research. A clinical trial involves patients volunteering to participate in studies so that researchers can test the safety and effectiveness of new medical interventions.

The Need for Translation of Medical Research

Because an increasingly large portion of health research is information based, there is a great need for the translation of medical research. This research is heavily information based. It can include the analysis of data and biological samples required for the purposes of diagnostic, treatment, or billing.

As the field of science is changing rapidly and increasing in complexity, it is impossible for any single researcher or institution to have the required expertise to develop and validate the safety of a given medical innovation. The sharing of information between medical institutions is essential to the success and safety of medical advancements.

The Language Barrier

Until recently, English has been considered the lingua franca (aka a language that is adopted as a common language between speakers whose native languages are different) in medicine. As of 2012, roughly 80% of all scientific journals indexed in Scopus (a large abstract and citation database) were published in English. But as more and more scientific cultures are now developing in many countries around the world, there is an increasing amount of journals being published in the national languages.

Non-English language-based medical communities are growing in strength. Germany is one such country expressing a strong interest in working with materials written in their native language. When polled, seven out of 10 German physicians reported that it was important or very important that the medical articles they read are in German.

In India, authorities are pushing to provide all research papers bilingually, so there is less of a language barrier. K Vijay Raghavan, a principal scientific advisor to the Government of India, told the Education Times, “The power to grasp complex scientific concepts and analyze problems comes best to researchers when they are pursuing science in their own language.” He noted that researchers also need to have a proficient understanding of English as it is still the international language of science. “Thus, our goal is to have all kinds of literature and reference material — from school to research — available bilingually so that researchers who work in native languages can benefit from them,” Raghavan said.

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The Stakes

There are regulations in place designed to protect patients who take part in a clinical trial. Protecting patients through a well-designed clinical trial is of the utmost importance. Legitimate translation of clinical trials can help avoid dangerous mistakes. The following steps of a trial require careful consideration because if there is a failure to meet the ethical and specified guidelines, there is the danger of incurring health risks and even causing patient fatality. Generally, Patient Reported Outcomes (PRO) have to be evaluated. The drug must also be determined as safe for human consumption.

The risks of mistranslation can include:

• The improper translation may cause the patient to not understand or properly follow instructions.
• The likelihood of appropriate follow-up and treatment of any side effects of the trial decreases.
• There may be disparities in the prescription and administration of the study preparation.
• Aside from the participant’s needs, faulty translation can cause damage to the credibility and economic revenues.

The Reach

In recent years, more and more clinical trials are not held in their country of origin. The 20 largest pharmaceutical companies based in the United States conduct one-third of their clinical trials solely in foreign locations. It has also been found that the majority of study sites are outside the United States. This shift to holding foreign trials means proper translation services are necessary to accurately implement and portray the outcome of a clinical trial. Foreign trial locations may have different languages and cultures which can lead to confusion. A clinical translator can also help interpret PROs.

Source: clinicaltrials.gov

The Regulations

The obligation to translate documents related to clinical trials may vary from country to country. But in the United States there are set guidelines. Any documentation used for patients or investigators must be in the local language. When research by US companies is conducted in another country, the FDA still requires the company to comply with ethical standards.

While it may be tempting to conduct a trial without complete translation, this is the wrong course of action to take. Skipping proper translation of clinical trial efforts to reduce cost or time spent on a trial can be detrimental to a trial’s outcome. Translation services should be involved at many stages, including clinical research, regulator submission and review, production, and marketing. Improving your trial’s quality with translation services can in fact save more time and money than skipping this important step. Reducing the chances of facing a lawsuit or rejection by regulators are two more benefits of using a qualified translation service. But the safety of the final product and the trial itself should always be a company’s top priority.

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