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Overview of Informed Consent Form Translation
What Is an Informed Consent Form?
Informed consent forms are legal and ethical documents used in clinical trials, surgical procedures, genetic testing, and other medical interventions. Their primary purpose is to ensure that patients or research participants fully understand the nature of the procedure, its risks and benefits, and their rights before agreeing to participate or receive treatment.
Clarity and precision are essential, especially when dealing with complex medical terminology. Informed consent materials must be written at a comprehension level appropriate for the target audience while meeting stringent regulatory requirements. These include standards set by agencies such as the FDA, EMA, and HIPAA, as well as guidance from ICH-GCP, institutional review boards (IRBs), and local ethics committees.
Why Accurate Translation Is Critical
When informed consent forms are translated for multilingual use, the accuracy of language becomes legally and ethically binding. Poorly translated documents can lead to misunderstandings, invalid consent, and regulatory noncompliance.
Accurate translations help maintain the legal validity of consent, uphold participant rights, and support ethical standards across international trials and cross-cultural medical settings. Mistranslation risks include participant confusion, study delays, liability exposure, and potential trial rejection by oversight bodies. For global studies, informed consent translation is not only a best practice but also a regulatory and ethical imperative.
Types of Consent Forms We Translate
Sesen provides specialized translation services for a wide range of consent-related documents used across clinical, surgical, and healthcare settings. Each form is handled by experienced linguists with subject matter expertise to ensure clarity, regulatory compliance, and cultural appropriateness in over 150 languages.
Clinical Trial Informed Consent Forms (ICFs)
Translations for Phase I to IV clinical trials, aligned with ICH-GCP guidelines, IRB requirements, and global regulatory frameworks.
Surgical and Procedure Consent Forms
Language-specific consent forms covering surgical procedures, anesthesia, diagnostics, and interventional therapies.
Pediatric Assent and Parental Consent Forms
Age-appropriate assent forms and parental consents that account for literacy levels and regulatory protections for minors.
Genetic Testing Consent Forms
Translations tailored to consent for genomic and hereditary testing, addressing data usage, privacy, and ethical considerations.
Data Privacy and HIPAA Authorizations
Consent and authorization documents related to protected health information (PHI), meeting HIPAA, GDPR, and local data protection requirements.
Telemedicine and eConsent Documents
Consent forms for remote care services and digital platforms, adapted for screen-based readability and multilingual usability.
Multilingual Patient Information Sheets
Supplemental patient-facing documents that accompany informed consent, written in accessible language for diverse populations.
Our Informed Consent Form Translation Workflow
Sesen follows a structured and secure translation workflow to deliver informed consent documents that meet the highest linguistic and regulatory standards. Our process is designed for accuracy, consistency, and compliance across global clinical and healthcare environments.
Professional Native Linguists with Clinical and Regulatory Experience
Every project is assigned to linguists with subject matter expertise in healthcare, clinical trials, or regulatory affairs. Translators are native speakers of the target language and familiar with local medical terminology and cultural nuances.
Dual Review Process
We implement a two-step quality process that includes initial translation followed by either editing (T+E) or specialized medical validation, depending on regulatory and sponsor requirements.
Terminology Management
Consistency is maintained through the use of client-approved glossaries, style guides, and translation memory tools. This is especially critical for repeated or large-scale consent form projects.
Formatting Preservation
We support a wide range of file types and preserve the original layout of consent forms, including Word documents, PDFs, XML schemas, and digital eConsent formats used in platforms like REDCap and Medidata.
Secure AWS-Hosted Infrastructure
All files and workflows are managed within an AWS environment configured for privacy and data protection. This includes encryption, role-based access, and audit trails.
Optional Back Translation and Reconciliation
For IRB and regulatory submissions, we offer back translation and reconciliation services to validate linguistic accuracy and regulatory alignment. These services include documented comparisons and certification where required.
This workflow ensures that Sesen’s informed consent form translations are not only linguistically sound but also audit-ready and compliant with global regulatory expectations.
Back Translation and Reconciliation
Back translation is a critical step in high-stakes medical and clinical documentation, often required by regulatory authorities or ethics committees to confirm the accuracy of the translated content. Sesen offers back translation and reconciliation services to support submission-readiness and enhance quality assurance.
When and Why It’s Required
Back translation is commonly requested for informed consent forms submitted to institutional review boards (IRBs), the FDA, EMA, and other global regulatory bodies. It is especially important for multilingual clinical trials and studies involving vulnerable populations. The goal is to verify that the translated text preserves the intent, meaning, and regulatory integrity of the original source.
Side-by-Side Comparison and Reconciliation
A second linguist, who is not exposed to the original document, re-translates the target language back into the source language. Our senior reviewers then conduct a side-by-side comparison to identify discrepancies, ambiguities, or potential risks. Any differences are analyzed and resolved in collaboration with the original translator to achieve alignment.
Certification and Documentation
Upon request, we provide formal certification, translator affidavits, and reconciliation reports to support IRB or regulatory submission requirements. These documents help demonstrate due diligence in translation quality and compliance.
Back translation is not always mandatory, but it is a best practice for sensitive consent materials where precision and validation are essential.
Global Language Coverage with Local Knowledge
Sesen supports informed consent form translation in over 150 languages, helping healthcare providers and clinical research teams communicate clearly and responsibly with diverse patient populations worldwide.
Extensive Language Support
We provide professional translation services in all major languages, including Spanish, Chinese, Arabic, French, Vietnamese, and Russian. Additional support is available for rare and indigenous languages based on patient demographics and regional study locations.
Regional Variants and Literacy Adaptation
Our linguists account for regional language differences and literacy levels to ensure that translated consent forms are both accurate and understandable. This includes adapting terminology and tone for variants such as US Spanish, LATAM Spanish, or Simplified versus Traditional Chinese.
Cultural and Linguistic Sensitivity
We apply culturally appropriate language that respects the beliefs, health literacy, and socio-economic backgrounds of patients and participants. Special attention is given to vulnerable populations such as children, elderly individuals, and non-native speakers to support ethical and compliant consent processes.
Our localized approach ensures that consent forms meet both regulatory standards and real-world comprehension needs across global healthcare and research environments.
Digital eConsent Translation
As clinical trials and healthcare systems move toward remote and decentralized models, electronic informed consent (eConsent) has become a vital component of patient onboarding and regulatory compliance. Sesen provides specialized translation services for digital eConsent workflows across platforms and file types.
Platform Compatibility
We translate eConsent content for leading platforms such as DocuSign, REDCap, Medidata, and custom-built eConsent systems. Our linguists work with structured formats like XML and JSON, as well as screen-based interfaces and embedded content.
Formatting and User Experience
Translated content is adapted for readability and clarity on digital devices, with attention to layout, interface context, and screen constraints. We preserve usability while maintaining compliance and linguistic precision.
Compliance and Localization
eConsent translations are aligned with regional regulatory requirements and adapted for cultural appropriateness and literacy levels. This is critical for ensuring participant comprehension in multinational studies.
Secure Workflow and File Handling
All translation projects are managed within Sesen’s AWS-hosted infrastructure, with support for data encryption, access control, and audit-ready documentation. We offer version control and integration with electronic document management systems.
Digital eConsent solutions help streamline multilingual consent across geographies. Sesen supports this transition with translations that are accurate, accessible, and fully compliant.
Compliant Translation for Global Healthcare
Informed consent materials must meet stringent regulatory and ethical standards, particularly in clinical research and patient care involving multilingual populations. Sesen delivers translations that align with both international and local requirements to support legally valid and ethically sound consent.
Expertise in Global Regulatory Frameworks
Our team is well-versed in major international guidelines and region-specific regulations governing informed consent documentation. We support compliance with:
- ICH-GCP (International Council for Harmonisation – Good Clinical Practice)
- FDA 21 CFR Part 50 (Protection of Human Subjects)
- EMA and EC directives for clinical trials conducted in the European Union
- HIPAA (Health Insurance Portability and Accountability Act)
- GDPR (General Data Protection Regulation)
- Local IRB (Institutional Review Board) and EC (Ethics Committee) standards
Certified Quality Management Systems
Sesen operates under ISO-certified processes to ensure quality, consistency, and audit readiness:
- ISO 17100 for translation services
- ISO 13485 for medical device and life sciences projects
- ISO 9001 for general quality management and operational excellence
Our informed consent form translations are built to satisfy both regulatory scrutiny and real-world usability, helping clients avoid delays, mitigate risk, and maintain ethical integrity across borders.
Trusted Partner in Informed Consent Translation
Sesen is a specialized language service provider exclusively focused on life sciences. We understand the high stakes of informed consent and deliver translation solutions that support compliance, clarity, and patient understanding across global healthcare and clinical research settings.
100% Life Sciences Focus
All of our services are tailored to the unique needs of pharmaceutical, biotech, medical device, and healthcare organizations. We are not a generalist agency but a trusted partner deeply embedded in the life sciences ecosystem.
Clinical and Hospital Translation Expertise
Our linguists have hands-on experience translating informed consent forms for both hospital-based patient care and regulated clinical trials, supporting local procedures and global research protocols.
Secure AWS-Hosted Translation Environment
Files and workflows are managed within a private, access-controlled AWS cloud infrastructure that meets enterprise-level data security standards. This is essential for handling protected health information and regulatory documents.
Support for Paper-Based and Digital eConsent Workflows
We translate consent forms in traditional formats such as Word or PDF as well as XML and structured content for digital platforms like REDCap, Medidata, and DocuSign. Our team is equipped to meet evolving requirements for hybrid and decentralized trials.
Dedicated Project Managers and Fast Turnaround
Each project is led by an experienced manager who ensures consistency, accuracy, and timeliness. We offer flexible timelines based on project scope, including expedited services for urgent studies.
Optional NDA and Regulatory Documentation Support
We accommodate confidentiality requirements with customizable NDA agreements and provide translator affidavits, certification statements, and reconciliation reports upon request.
With Sesen, clients gain a partner who combines linguistic precision with deep regulatory understanding to support informed consent translation that is legally sound, ethically aligned, and ready for global deployment.
Frequently Asked Questions
Can you translate IRB-approved consent forms without altering content?
Yes. We follow a strict fidelity-first approach that preserves the intent and structure of IRB-approved forms. While ensuring cultural and linguistic appropriateness, we avoid modifications that could compromise regulatory acceptance or require resubmission.
Do you provide certified translations?
Yes. We offer certified translations with translator affidavits, notarization, or statement of accuracy where required. These documents support regulatory and ethics board submissions for clinical trials and institutional approvals.
How fast can you deliver?
Turnaround times depend on the document volume, language pairs, and review requirements. Standard projects typically range from 1 to 5 business days. Expedited services are available for time-sensitive studies or urgent hospital needs.
Do you support eConsent platform formats?
Yes. We translate content for a wide range of electronic consent platforms, including DocuSign, REDCap, and Medidata. Our team handles XML, structured content, and PDF forms while preserving formatting and compliance requirements for digital workflows.
Ready to Translate Your Consent Forms?
Whether you need multilingual informed consent for a clinical trial, a hospital procedure, or a digital eConsent rollout, Sesen provides accurate, regulatory-compliant translations you can trust. Our expert linguists and secure workflows ensure your materials are clear, culturally appropriate, and ready for submission or patient use.