• eConsent Survey for Institutional Review Boards and Ethics Committees

  • Introduction

    We are gathering information regarding industry experience, perceptions, and expectations around the use of electronic informed consent (eConsent) in clinical trials. Your responses will help inform strategies for improving the use of this technology for the benefit of participant, sites, and sponsors.

    The survey should take approximately 15-20 minutes to complete. Your responses are anonymous unless you chose, at the end, to provide your email for further involvement in this research or related initiatives from the European Forum for Good Clinical Practice.

    EFGCP eConsent initiative is a non-profit multistakeholder initiative focusing on harmonizing terminologies and processes associated with eConsent, to increase insight in different stakeholder value models and to provide a consistent country-level overview of acceptance/non-acceptance of certain eConsent aspects. A common misunderstanding on eConsent is that it is about remote consenting or electronic signatures, however these are just some of the features that could be used for eConsent. A glossary of various eConsent digital features has been created by the EFGCP eConsent team and can be accessed here.

  • Organization Information

  • Survey Questions

  •  

  • 8. For each of the consent scenarios below, please consider what the minimum requirement is for signature types in a Phase 1-3 interventional trial.

     
    In Europe, there are three types of electronic signature under eIDAS regulation:​
    1. Simple electronic: Any data in electronic form which is attached to or logically associated with other data in electronic form, and which is used by the signatory to sign.
    2. Advanced electronic​: Meets the following requirements: uniquely linked to the signatory, capable of identifying the signatory, created using means that signatories can maintain under their sole control, linked to the electronic document to be authenticated. This ensured that any subsequent change in that document is detectable.
    3. Qualified electronic​: An advanced electronic signature that is created by a qualified electronic creation device, which is based on a qualified certificate for electronic signatures.
    In the US, a biometric electronic signature is the equivalent of an advanced electronic signature in Europe. ​

    Other countries may use different designations and definitions.​
     
    The following question will ask you to consider the minimum signature requirement in each instance where the participants and the method of identity verification differs.
     
    For the purpose of this question, "on-site consent visit" is a visit where the study investigator and the potential participant are in the same location and the investigator personally validates the identity of the potential participant.
     
    For the purpose of this question, "remote consent visit" is a visit where the study investigator and the potential participant are not in the same location.
  •  

  • 14. Would your IRB/EC be supportive of a stipulation in the protocol that consent can only be given electronically?

    In many clinical trials there is no paper alternative to the use of electronic patient reported outcomes (ePRO) - the use of this technology is required for study participation.​
    The Netherlands has already approved that protocols may stipulate use of electronic consent without a paper alternative.

  • Terms of Use and Data Protection Policies 

  • Please find below the Data Protection Policies.
     
    Thank you for confirming your agreement by ticking the box at the bottom of this page before clicking on the « submit » button.
    Once your results are submitted, you will not be able to make changes anymore.
     
    If you want to receive your survey submission results by email, please tick the box below and enter your email in the field that will appear. This email address will be used to send the results automatically by Jotform and stored in JotForm, it will however not be used by EFGCP to contact you.

  •  
    By participating in this survey, you are consenting to have your responses used in the analysis and a publication of the results, if applicable. However, your responses will not be identified by name or any other identifying information.
     
    Your data will be provided to the EFGCP eConsent Database workstream carrying out the analysis of the results. The information will be handled by EFGCP within the framework of the eConsent Initiative according to the EFGCP Privacy Policy. If you have additional questions on data privacy policy or you might want to have your personal data deleted or amended, you can contact the EFGCP Data Protection Officer of the EFGCP in writing at secretariat@efgcp.eu.
     
    In the scope of this survey, EFGCP will process your data as data controller for the purposes that were presented to you. The legal basis for processing your personal data is consent (Article 6(1)(a) of Regulation (EU) 2016/679). Your data will be processed according to the EFGCP Privacy Policy.
     
    All data will be used exclusively within the framework of the EFGCP eConsent initiative.
     
    In case you have accepted to be contacted, within this survey, you agree for your personal data to be stored and accessible only to EFGCP Staff Members in the JotForm system, and made accessible to the EFGCP eConsent Database WS Lead(s) and EFGCP eConsent initiative lead. You have the right to ask your personal data to be amended or deleted by contacting secretariat@efgcp.eu.
     
    EFGCP will provide its services in a professional and compliant manner using best efforts to protect personal data. When sharing your personal data for the purpose of the eConsent Initiative to the participating stakeholders, EFGCP will implement appropriate safeguards. Each participating stakeholder is an independent controller and has agreed to carry out the tasks assigned to it in this Initiative with care and diligence applying their own safeguards for the received personal data. The parties hereto acknowledge and agree that nothing in this statement contained, and nothing done pursuant hereto by participating stakeholders shall be deemed to constitute a direct or indirect guarantee by EFGCP of any liability. EFGCP cannot be held responsible for any data leaks, IT issues, hacks, misuses, or any harms to you, your organizations or your activities, due to your involvement in the eConsent Initiative Activities.
     
    Personal Data Gathered (if agreed):
    - Name, Surname, Organization
    - eMail Address
  • Should be Empty: