What Are Informed Consent Documents and Why Are They So Important?
Informed consent documents use extremely precise medical and legal language to explain crucial elements of a procedure or study to a potential patient. They are required by law to contain certain elements, and contrary to common misconception, informed consent is not just about obtaining the patient or subject’s signature of approval.
According to the FDA, “Informed consent involves providing a potential subject with adequate information to allow for an informed decision about participation in the clinical investigation, facilitating the potential subject's comprehension of the information, providing adequate opportunity for the potential subject to ask questions and to consider whether to participate, obtaining the potential subject's voluntary agreement to participate, and continuing to provide information as the clinical investigation progresses or as the subject or situation requires.
To be effective, the process must provide sufficient opportunity for the subject to consider whether to participate.” Thus, the language in an informed consent is performing many difficult tasks: it must be concise but thorough, it must be accessible to most readers (many regulations suggest maintaining an 8th grade reading level) while explaining complex procedures, and it must cover all necessary information required by regulations for the particular procedure or study.
How Do We Work with Informed Consent Documents at Language Concepts?
Translation of informed consent documents for medical purposes is one of the most requested services by our clients in the healthcare industry. We translate consent documents needed at hospitals, outpatient clinics, universities, medical clinics, multicenter research trials, medical device companies, biotech companies, contract research organizations, and more.
We take translating informed consent documents extremely seriously, since the legal language requirements are strict and most especially because it will affect the information and care patients receive, which is crucial to us and our clients.
For example, informed consent documents are used for medical trials and studies, oftentimes needing healthy volunteers who will undergo experiments and thus risk their lives. Many other informed consent documents are intended for patients who are facing clinical trials, usually due to severe illnesses. These trials are their last hope to find a cure.
While the trial may be their last medical option, it is important for them to understand the risks and potential outcomes or consequences of unknown outcomes. These patients are usually not in the best physical, mental, and/or emotional state to understand these documents already, and reading them in a language that is not native to them makes the situation even more stressful.
Offering individuals consent translation documents in their native language or language of preference will provide them with peace of mind and relief, and is required by law. Federal regulations enforced by the Office for Human Research Protections (45 CFR 46.116) and the Food and Drug Administration (21 CFR 50.20) state that informed consent "shall be in language understandable to the subject or the representative" (Source). Most states and universities have additional legal language stating the informed consent document must be written in a language in which the patient is fluent, not just understandable.
There are exceptions for “the occasional and unanticipated non-English-speaking [patient], however “routine use of this method is strongly discouraged by [universities, research publications,] and federal regulators” (Source). Thus, especially in states with high populations of Spanish speakers, there is no reason not to have informed consent documents on hand for patients more fluent in Spanish than English.
Translation of informed consent documents is challenging because it needs to be accurate and yet simple. Even writing these documents in their primary language is challenging in terms of thoroughly covering the risks and medical details while remaining concise and at an 8th grade reading level at the same time. Thus, this kind of translation calls for skilled professionals who have years of experience translating for the medical, pharmaceutical, biochemical, statistical, administrative, and even legal fields, and are able to produce a rendition that is very easy to understand for any regular individual while omitting nothing from the original version.
We take this very seriously since any errors would result in legal repercussions for doctors, research advisory boards, and researchers, and most especially because of the ethical and health repercussions for patients.
Languages We Offer for Informed Consent Document Translation
We translate consents from English to:
We have performed countless informed consent translation for clinical trials and/or studies. Examples, among others, include:
A Phase 1, Multicenter, Open-Label Study of CC-98633, BCMA Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in Subjects with Relapsed and/or Refractory Multiple Myeloma
Bringing HOPE2 Mental Health Access and Care for Hispanics
Chemotherapy Side Effects
Development of a Novel Early Detection Test to Reduce Racial Disparities in Endometrial Cancer (EC) Mortality Methylation
Early Arthritis Cohort Study
Genetic Testing After a Cancer Diagnosis
Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis Study
Optimizing Treatment of Metastatic Breast Cancer through Real-Time Disease Monitoring
Piloting a Community-engaged, Interactive Biospecimen & Patient Registry to Address Health Equity in Hispanic Population
Pregnancy during Covid
Registry of Racial/ethnic Minority Populations who Consent to be Contacted for Biomedical Research (including clinical trials and bio-specimen research)
Research Study on Pregnancy and Caring for Your Baby
Research Study to Explore Beliefs of Laryngectomy Patients about Laryngeal Transplantation (LT).
Return of Actionable Variants Empirical Study
Sleep for Stroke Management and Recovery Trial
Study to develop a biorepository of samples (from cancer patients) to be used for future biomarker discovery and other translational studies.
Study to understand the prevalence of genetic mutations in cancer patients and to evaluate the integration of genetic testing into a clinical cancer practice
Study to determine the prevalence of genetic mutations in cancer patients from various ethnic populations seeking care
The Abnormal Menses and Prevention of Neoplasia Tampon Study
The Electronic Medical Records and Genomics Network Genomic Risk Assessment
The Role of Genetics and Socioeconomic Factors in Outcomes after Kidney Transplantation in Hispanics and American Indians
TrAstuzumab Cardiomyopathy Therapeutic Intervention with Carvedilol (TACTIC)
Why Should We Go Through Language Concepts for Our Informed Consent Documentation Translation Needs?
Our patients need these documents in a language they have equal opportunity to fluently understand what they are consenting to have done to their bodies. Additionally, providing informed consent documents in multiple languages is not only just the right thing to do for patients, but it is also required by law to be compliant with state and federal regulations.
We can guarantee you the utmost quality of translation for these documents because of our years of experience and understanding of the gravity of these documents.
While this kind of translation can be costly with the numerous pages and highly skilled translation required, we are able to apply discounts for repetitions and existing translations thanks to the translation memory we build per client.
In other words, the more content we translate for you, the more translated content we store in our memories, and the more you save. Translation memories also allow us to save time and achieve consistency in terms of vocabulary and terminology in all our client's documentation.
Our society needs translated forms to conduct clinical studies, safe surgeries, and design research that furthers our collective medical knowledge. Accurate and native quality consent translation is extremely important for all the reasons mentioned earlier. Language Concepts Consulting´s team consists of human, certified and highly skilled translations with the subject matter expertise you require. If you have any questions, we are happy to help.