Patient consent is one of the most important elements of any clinical trial, yet is consistently the number three critical finding from regulatory inspections resulting in an (Food and Drug Administration) FDA Form 483. Typical citations are:
- Informed consent was not properly documented in that the written informed consent used in the study was not approved by the Institutional Review Board (IRB).
- The subject or the subject’s legally authorized representative did not sign the document at the time of consent.
- Consent was not dated by the subject or the subject’s legally authorized representative at the time of consent.
- There was a failure to obtain informed consent in accordance with 21 CFR (Code of Federal Regulations) Part 50 from each human subject prior to drug administration.
Why is this? Traditional patient consent is a time-consuming and inconsistent process that places additional demands on valuable site staff. It can be confusing and intimidating for patients who, as a result, are poorly informed and reluctant to ask important questions. This results in high consent withdrawal and patient dropout, both of which are expensive and introduce trial delays.
Guidance from authorities about eConsent does exist but is often not clear. TransCelerate Biopharma Inc., (a not-for-profit consortium of organizations in the life sciences space) has written a comprehensive implementation guide about informed consent. The guide is the product of a two-year initiative to gain insights on better practices for implementation from patient and site advocacy groups, (Clinical Research Organization) (CRO) forums, selected health authorities and ethics committees.
eConsent: Definitions & Details
eConsent is a technology-driven, patient-engagement tool that aims to improve site/patient discussions and clinical trial efficiency. It should provide a detailed overview of the clinical trial process in the patient’s own language, while including guided instructions for completing the eConsent and allowing the patient to electronically sign and optionally download the signed consent document. This helps to promote better comprehension of content by incorporating multi-media components like audio and video, or documents with voice-overs in the patient’s own language. The process also allows patients to explore trial-specific words and concepts at their own pace through linked text, which can improve the quality of discussions between site staff and patients in a less intimidating way.
The eConsent process provides a guided interaction, requiring acknowledgment of completion by section and safeguards, including timestamps to ensure a comprehensive review. A patient has the ability to enter questions for review and response by site personnel. Site staff can conduct a knowledge review of the patient’s responses to questions, which tests comprehension of the content to ensure the patient’s sufficient understanding of the material. This process also provides valuable feedback that the staff can use to update the content from frequently asked questions and incorrect test question responses.
Provision should be made for patients to revoke their eConsent and to re-consent following protocol amendments. Also, a traditional consent method must be available for those who do not wish to use an eConsent process.
In the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) announced in September 2018 that it would allow clinical trials to use electronic signatures when obtaining eConsent from a patient. MHRA provided the following high-level guidance:
- Alternative methods for providing consent should be available for those unable or unwilling to use electronic methods.
- Authentication methods of eSignatures should be proportionate to the nature and complexity of the research, risks, burdens, benefits and ethical issues at
- Simple eSignatures are sufficient for the majority of non-CTIMP (Clinical Trial of an Investigational Medicincal Product) research involving negligible or minimal risk.
In conclusion, an eConsent process can deliver:
- Improved patient understanding.
- Testing and reinforcement of participant comprehension.
- Feedback on how consent materials could be improved.
- Improved patient recruitment process and reduced dropout rates.
- Overall process efficiencies.
- Reduced site workload.
- Improved consistency – reducing compliance issues.
Join Neil Vivian, Senior Director of Business Solutions at OmniComm Systems, Inc on April 18 in a live webinar to learn more.
Neil Vivian joined OmniComm in 2009 as senior director of Business Solutions and product manager. He is responsible for providing technical support to the Business Development group’s strategy of positioning OmniComm applications and services to potential and existing clients. As a product manager, his responsibilities include providing guidance and insights about high-level business requirements for new product features. His role at OmniComm is based on his industry experience and understanding of new regulatory guidance related to risk-based monitoring, eSource and other areas. Prior to joining OmniComm, he was vice president of Technology Solutions at ERT, where he assisted in the development of ERT’s long-term architecture and product integration strategy.
He has worked closely with the sales and marketing group and developers to build a solid line of integrated products, using his technical background and understanding of the pharmaceutical industry and drug development. He has more than 38 years of experience in the software industry, including 24 years focused on the life sciences, built from a solid foundation in the defense industry.
He has a BSc in Physics and Engineering Science and MSc in Information Technology.