i-CONSENT: A new perspective

 

Informed Consent is a key aspect in the decision process to participate in a study. During the Informed Consent process participants learn the most relevant aspects of the study and accept to participate in it or not. At present, most of Informed Consent documents are complex, difficult to understand and drafted without patients’ perspective. There is a need to improve informed consent process through the implementation of innovative proposals adapted to participants needs. This new perspective will facilitate and improve the participant’s autonomy in decision making and empower the participant.

Why i-Consent?

i-CONSENT places innovation at the centre of its actions:

 

  1. Understanding Informed Consent as a communication process
  2. Including gender perspective in the informed consent process
  3. Taking into consideration vulnerability factors such as age, gender and cultural background
  4. Usage of new technologies for acquiring informed consent
  5. Including all the interested parties in the investigations and decision making

    Objectives

    The i-CONSENT project has 6 main objectives

    Z

    1. Assess all stakeholders’ needs in relation to Informed Consent.

    2. Identify gaps, barriers and challenges in the process of Informed Consent.

    3. Analyse risks and opportunities of using digital technologies (ICT).

    4. Develop tailored strategies for the development of Informed Consent.

    5. Analyse the legal aspects of Informed Consent in relation to Social Media use.

    6. Create and validate guidelines to improve citizen’s participation in research.

    Outcomes

    Workshops

    Organise workshops in order to interact with all potential stakeholders and assess their needs
    w

    Innovative Resources

    Develop new resources to facilitate the understanding of Informed Consent using digital and non-digital tools

    l

    Guidelines

    Develop, validate and publish comprehensive guidelines to improve the Informed Consent process

    Publications

    Develop, validate and publish comprehensive guidelines to improve the Informed Consent process

    Fundamentals of Informed Consent Process

    Informed consent is a bidirectional communication process that begins with the first contact with the potential participant and continues throughout the entire study until its end.

    During this process, continuous feedback and communication between the participant and investigation team is essential.

    The aim of the informed consent is to respect the autonomy of the potential participant. To raise critical awareness, enabling potential participants to take decisions about their own health. They need to have easy access to all relevant information in an understandable format.

    The informed consent process must ensure that participant’s decision about whether or not to participate (or continue) in a study is done without coercion and any form of undue inducement.

    The entire process of informed consent must be carried out in compliance with ethical and legal standards. The protocol of the study, recruitment procedures, all information materials, the informed consent form and any further changes, should be submitted to and approved by an Institutional Review Board (IRB) or an Independent Ethics Committee (IEC) before use.

      Timeline

      The i-CONSENT project main milestones.

      2017

      Project launch

      i-CONSENT starts.

      j

      In depth understanding of the context

      and workshop with patients to assess needs.

      Report on age and gender

      related issues regarding Informed Consent.

      Digital technologies:

      systematic review of the use of digital technologies for Informed Consent.

      Development

      of innovative tools strategies for patient involvement in clinical trials.

      U

      Evaluation

      of the draft guidelines and workshops with stakeholders.

      N

      Validation

      of the guidelines.

      i
      2020

      Publication

      and dissemination of i-CONSENT guidelines for informed consent.