Within clinical trial translations, informed patient consent forms (ICFs) are an important and mandatory prerequisite for all submissions that not only represent the patient’s individual rights but also serve as an underlying principle of medical ethics. Under the newly adopted EU Clinical Trials Regulation 536/2014 (EU-CTR), which broadly aims to uphold higher standards for patient safety and increase transparency, important patient-centric provisions for informed consent have been added to meet these objectives and create a more suitable environment for conducting clinical trials. With these massive regulatory changes now in affect and all clinical trials in the EU slated to be in compliance with the EU-CTR by January of 2025, Contract Research Organizations (CROs) and sponsors should be aware of the provisions to informed patient consent and the ways in which a trusted language service provider (LSP) can help with clinical trial translations to deliver a smooth transition under new EU regulations.

EU-CTR Informed Patient Consent

Informed consent as outlined in Article 29 of the EU-CTR requires detailed documentation with dates, signatures, witnesses, and or legal representatives and primarily serves to enable subjects to fully understand the nature, benefits and implications, objectives, and risks of the clinical trial. Under this regulation, improvements and expansions to definitions of clinical trial participants and guidelines for consent and patient involvement have been introduced as a driving force for enhancing safety standards. Specifically, articles have been added that focus on vulnerable subjects, with special considerations for:

  • Simplified consent for cluster trials
  • Consent for minors or incapacitated peoples
  • Consent for pregnant or breastfeeding women
  • Consent for other vulnerable populations
  • Consent during trials in emergency settings.

Even more, the EU-CTR has introduced new updates to the definition for a legally designated representative (LDR) as a person, body, or authority which according to EU law has the power to give informed consent on behalf of incapacitated subjects or minors.

The processing of personal data has also been an important focus in the provisions made on informed consent. The EU-CTR is careful to frame informed consent as a safeguard rather than a legal basis for the processing of personal data. Furthermore, the EU-CTR references Article 6 of the General Data Protection Regulation (GDPR), in which specific situations and guidelines for the processing of personal data are outlined, and all of which are based on given, specific, unambiguous, and informed consent by individuals who are allowing their data to be processed.

Increasing Patient Involvement for Better Clinical Trials

Another objective for overhauling patient consent guidelines, aside from enhancing the safety of the trial participants, is to promote patient involvement to foster a more inclusive environment for conducting clinical trials in the EU. For one, the legislation recommends that patients, or at least one layperson, be involved in reviewing clinical trial applications (CTAs) as a participant in the Ethics Committee (EC) as a way to promote meaningful patient involvement for better informed consent. Similarly, laypersons are required to be impartial to the sponsors and all trial-related specifics while also being representative of the community or population in which the trial will take place.

The new guidelines also reference the role of communications and the flow of information for increasing patient involvement and supporting informed consent. Specifically, with the establishment of the Clinical Trial Information System (CTIS) as a centralized digital approval and submission platform, there is a focus to promote digitized patient consent through platforms that are more user friendly and can be individually tailored to the study subjects.

Multilingual Translations for Clinical Trial Translations

To meet the standards and or update clinical trial documentation and communications under the Clinical Trials Regulation, CROs and sponsors can leverage LSPs to ensure that all clinical trial documents, including ICFs, are compliant to the newly adopted regulation and meet language requirements. Through ICFs, patients voluntarily confirm their willingness to participate in particular trial after being informed of all aspects of trial that are relevant to their decision to participate and mere fact that patients come from very diverse backgrounds requires ICFs to be available across a range of languages. Furthermore, ICFs need to be regularly updated and submitted for review and approval by the EC and the new EU CTR has posted updated, tight timelines for CROs and sponsors to communicate with EC. These new updates mean that LSPs must also be more supportive and responsive in quickly translating these comments and submitting updated ICFs to meet new timelines. Translating patient-facing documentation like as ICFs require LSPs to be more careful about language styles which must be adaptable for layperson (patients) in terms of readability and non-technical terminology.

Translations for technical documentation in the space of clinical trials serve a purpose beyond that of meeting language requirements for regulatory approvals, but also to broaden the scope of conducting clinical trials. With the EU-CTR extending language requirements to be defined at the EU Member State level, CROs and sponsors should consider the advantages of clinical trial document translations for dossiers, and especially ICFs, to meet new regulatory standards. Since the EU’s new regulation frames informed consent as means to uphold patient protection and rights, leveraging the best aspects of clinical translation to ensure that all communication and submissions for consent are compliant with these standards and are used in support of patient centricity are important considerations for sponsors and CROs. To learn more about CSOFT’s ICF translations and clinical trial translations for specialized documents that comply with global regulatory standards on informed patient consent, visit us here.