i-CONSENT

Inspiration

The informed consent process (ICP) allows the potential participant to voluntarily decide whether or not to participate in a study. Generally, Informed Consents (ICs) are documents difficult to understand that do not include all stakeholders’ perceptions. Therefore, informative IC should be a process that includes needed information under a gender and age perspective, more importantly if these are vulnerable populations. The relationship between science and society should favour the engagement inclusion of citizens in the informed consent process, and this must be done with special attention to gender and ethics. The IC process should also improve health literacy in the citizens

What it does

i-CONSENT is a H2020 project (https://i-consentproject.eu) that aims to improve the informed consent process, making it easier to understand, responding to the potential participants’ needs and interests, under a gender perspective and relying on ICT tools. i-CONSENT is preparing guidelines that provide information and evidence to assist with the development, or review of the consent process for use in clinical studies with human participants.

How I built it

The guidelines were developed grounding on a review of the scientific and ethical literature; policy documents and legal instruments, also enlarging the perspective on international normative documents; comparative analysis of the legislations of selected countries; declarations of international organisms/institutions; reports and guidance documents; stakeholder consultation. The deliverables and articles produced during the project, which have been used for the elaboration of these guidelines, are available in CORDIS (https://cordis.europa.eu/project/rcn/210058/results/en), and on the project’s website (https://i-consentproject.eu/results/)

Challenges I ran into

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

• Understanding Informed Consent as a communication process
• Including gender perspective in the informed consent process
• Taking into consideration vulnerability factors such as age, gender and cultural background
• Usage of new technologies to better understand informed consent
• Involving all the interested parties in the development of the IC

Accomplishments that I'm proud of

Several papers and posts have been generated during the project (https://i-consentproject.eu/results/ and https://i-consentproject.eu/news/).

What I learned

Informed consent process (ICP) needs a change. ICP should be a continuous, bidirectional communication process that begins from the first contact with the potential participant and continues until the end of the study. It should incorporate key interventions designed to improve autonomy and inclusivity. This has the potential to generate research that is of higher quality, lower cost, and ethically justified.

What's next for i-CONSENT

• Prepare guidelines to improve the informed consent in clinical research in pandemic situations
• The guidelines are ready to be evaluated by experts and IC done following the guidelines will be tested in the population. If you are interested in participating in the evaluation of the guidelines or the preparation of the guidelines for pandemic situations, please contact us (iconsent.project@gmail.com).

Built With

• experts-opinion
• gender-perspective
• literature-review
• mix-methods
• panticipants-center-approach
• stakeholders-consultation