RESEARCHER ELECTRONIC PERSONALISED INFORMED CONSENT

14 January 2021

Get in touch!

Interesse?

More information available via:
prof. dr. Isabelle Huys, tel.: +32 16 33 04 09 (isabelle.huys@kuleuven.be)

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.

REF. BAP-2021-43

Apply before 22 February 2021

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.

Website van de eenheid

Functie

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:

  1. Ethical, legal and regulatory research questions about the scope and nature of information that should be communicated and level of personalization (e.g. communicating study-level results or incidental findings, re-consenting minors upon reaching adulthood, treatment of samples in biobanks, consent for research after death etc.), privacy, data storage and protection, legality of personalization, legality of eIC.
  2. Design research questions about usability, visualization to optimize information conveyance.

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:

  • You perform research in the described research domain. You are involved in the design, set-up and execution of the research, and you report on the results in scientific publications. You work alongside other PhD researcher(s) within the research programme exploring a regulatory framework and validated guidance for electronic personalized informed consent.
  • You have a coordinating role in monitoring the various deliverables of the multidisciplinary research project.
  • You coach master students carrying out their master thesis.
Profiel
  • Master in law, master in pharmaceutical sciences, master in drug development, master in biomedical sciences, master in medicine, master in bioengineering, master in bioethics, master in social sciences, or a relevant other degree with outspoken interest in clinical research and informed consent.
  • You have at least three years experience in academic research in a relevant field to this research domain. You have experience with empirical qualitative methods in the social and health sciences (e.g., document analysis, interviews, surveys) and you have published earlier in peer reviewed academic journals.
  • You have experience in coordination and supervision.
  • You will engage yourself with enthusiasm and perseverance. You are ambitious, dynamic, flexible and take an open attitude towards problems and evolutions.
  • You are directed towards innovation, including communication in an e-environment (website-skills).
  • You are able to work independently and take decisions.
  • You have excellent social and communication skills to deal with all stakeholders in this field. You are able to work in an international multidisciplinary team and cooperate with other team members.
  • You can speak fluently English and hence have good written and oral knowledge of English.
  • You have good didactic skills and you can coach and motivate other persons.
Aanbod

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.