More information available via:
prof. dr. Isabelle Huys, tel.: +32 16 33 04 09 (firstname.lastname@example.org)
Your solicitation is expected before February 22th 2021. Interviews are expected to take place in the last week of Februari 2021.
KU Leuven adopts a policy of equal opportunities and diversity.
Solliciteren voor deze vacature kan tot en met 22/02/2021 via onze online sollicitatietoepassing
KU Leuven wil een omgeving creëren waarin alle talenten maximaal tot ontplooiing kunnen komen, ongeacht gender, leeftijd, culturele herkomst, nationaliteit of functiebeperking. Hebt u vragen in verband met toegankelijkheid of ondersteuningsmogelijkheden, dan kan u ons contacteren via diversiteit.HR@kuleuven.be.
The unit Clinical Pharmacology and Pharmacotherapy, the Meaningful Interactions Lab (MINTLAB), the DISTRINET research group, the Interfaculty Center for Biomedical Ethics and law (CBMER) and the Leuven Centre for IT & IP Law (CiTiP) have established a multidisciplinary research programme exploring the establishment of a regulatory framework and validated guidance for developing a patient-centric electronic informed consent (ePIC) software system. We are now looking for a research collaborator to carry out a project on a framework for electronic personalised informed consent.
Informed Consent (IC) is the fundamental ethical principle whereby participants provide their consent to participate in a (clinical) study after being appropriately informed. Current IC practices often use long, legalized, difficult to understand paper-based documents in a static, “take it or leave it” approach. Such IC formats (i) fail to achieve the primary goal of IC, i.e. to truly inform the patients about procedures, potential risks and benefits causing delayed participant recruitment and increased drop-out, (ii) do not allow personalization of information needs, (iii) impede efficient long-term interaction with participants, although re-contacting patients is necessary sometimes, e.g. for sharing results, re-consenting patients in case of further research with patient data and/or samples, and (iii) thereby create significant costs for industry and ultimately society through increased drug pricing.
Electronic IC or e-consent (eIC) is a promising technology with the potential to solve many IC-related issues experienced today. Although a number of eIC solutions already exist today, adoption of eIC by stakeholders is slow.
Several issues with existing e-consent solutions: ethical (e.g. in terms of information content, research bias), legal (e.g. legal requirements differ between countries), regulatory (e.g. no real regulatory framework or support), technical (e.g. privacy, security issues), design (e.g. in relation to presentation of information, long-term interaction). Most importantly, currently available eIC tools fail to successfully address the needs of research participants, in particular the information and communication deficiency many experience. The societal challenge tackled by this project is outlining which form a trusted eIC platform should take, and converting this into a regulatory framework and user guidance. The results should be based on scientific evidence, and take all stakeholders’ best interests, to heart, especially those of the participants, such that the platform facilitates a true two-way dialogue between clinical trial participant and sponsor.
This research project will contribute to the development of regulatory framework and validated guidance for developing a patient-centric electronic informed consent (ePIC) software system, by studying which aspects are in particular relevant in terms of regulatory and social science point of view. Several studies will be conducted that address the following research questions:
The research project will be carried out from a multidisciplinary perspective, with a particular focus on regulatory sciences and human-computer interaction research as the study will be guided by the unit Clinical Pharmacology and Pharmacotherapy and MINTLAB. The PhD project requires collaboration with diverse stakeholders, including health care providers, regulators, health care payers, pharmaceutical industry, and patient organisations. The research will include quantitative studies (literature reviews, surveys, analysis of data) as well as qualitative studies (semi-structured interviews, expert panels, focus group discussion) and studies on meaningful interaction designs.
Description of function:
A full time position within an internationally leading multidisciplinary team with relevant experience and expertise. For this job, a contract of 1 year is offered that, after a positive evaluation, can be extended up to 2 years.