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Improving the guidelines for Informed Consent, including vulnerable populations, under a gender perspective

Periodic Reporting for period 2 - I-CONSENT (Improving the guidelines for Informed Consent, including vulnerable populations, under a gender perspective)

Reporting period: 2018-08-01 to 2021-03-31

The autonomy of the subject to decide his/her participation in clinical research (CR) is of major importance. Historically, the participation has not always been voluntary. The Declaration of Helsinki marked a turning point and provided the foundations of ethical research.
Informed consent (IC) is vital, enabling the subject to voluntarily decide whether or not participate in CR. However, the IC objectives are not always aligned for all the stakeholders involved in the research process. In general, the IC is prepared by only one of them, mainly considering their objectives without taking into account the views of the other stakeholders or the participant’s characteristics.
i-CONSENT understands IC as a process where people become increasingly literate in health, in which essential information about a CR is clearly presented and easy to understand, and different ways of communicating among all stakeholders involved in the research are enabled. Moreover, the gender, age and multicultural aspects are also integrated into the process.
The i-CONSENT consortium recommends that the Informed Consent Process (ICP) should be a continuous, bidirectional communication process that begins at the first contact with the potential participant and continues until the end of the study (Figure 1) [SEE IMAGE].
The main objective of i-CONSENT is to develop comprehensive guidelines on how to present IC to citizens in a way that is easy to understand, tailored to their needs and preferences, and facilitates participation in CR.
As a result of the project, several strategies have been identified to improve the understanding of ICP in clinical studies. Among these, four stand out: (1) consider consent a two-way continuous interaction that begins at the first contact with the potential participant and continues until the end of the study; (2) improve investigators’ communication skills; (3) co-create the information; and (4) use a layered approach, including information to compensate for the potential participant’s possible lack of health literacy and a glossary of terms.
The project has been structured in 6 work packages: 3 of them scientific; 1 dedicated to communication and dissemination; 1 to project management and the last one to ensure that all research was conducted in an ethical and legally compliant manner.
During the project, multiple reviews of scientific literature and ethical and legal texts have been carried out, as well as workshops, seminars and surveys that have allowed us to know the opinion, on different aspects of informed consent, of different people including: representatives of patients and potential participants in medical research, experts in legislation, experts in ethics, members of ethics committees, researchers, pharmaceutical industry personnel, legislators and cultural mediators.
This research work has allowed us to collect and analyse information from different disciplines and perspectives and to analyse how to apply gender, age and multicultural perspectives to ICP.
In addition, we have been able to: understand how socio-cultural, psychological and behavioural perspectives affect informed consent; identify ways to improve communication and increase understanding of IC; analyse the content and format of IC forms; analyse the use of new technologies and the opportunities they present for the health sector, especially for informed consent, and identify strategies to improve participation, health literacy and communication; address the challenges to informed consent posed by research with biological samples and the management of these samples (biobanks) and research in times of pandemics.
Based on this knowledge, more than 50 publications have been produced, including scientific papers, communication at congresses, reports, deliverables and guidelines, which can be accessed by the public from the project website (https://i-consentproject.eu/results/) or from CORDIS (https://cordis.europa.eu/project/rcn/210058/en).
Among all these publications, the "Guidelines for Tailoring the Informed Consent Process in Clinical Studies" (Figure 2) [SEE IMAGE], that are the final product of the project, stand out. The guidelines represent a change in mentality that gives greater prominence to IC, turning it into a process that adds value and prevents it from becoming a bureaucratic act centred solely on the participant's signature on the IC form. The guidelines have been extensively evaluated by different experts and representatives of different stakeholders, including the assessment of the appropriateness of the recommendations included in the guidelines by experts from different stakeholders.
Following the guidelines, 4 consent/assent materials have been prepared and validated in the target population. 3 for hypothetical clinical trials (CT) (minors; pregnant women; adults) in 3 countries (Spain; UK; Romania) (http://iconsent.pilotvalidation.eu) and 1 parental consent for a real CT with young children in Spain (https://estudiovigira.es). These materials are a good example for all those who want to develop informed consents following the guidelines.
The project involves, first and foremost, a unification and updating of the state of the art regarding informed consent. By analysing different types of texts (scientific, legal and ethical) and different perspectives, it has given a more complete view of the subject.
In addition, the impact of the use of digital technologies on the informed consent process has been analysed, including the ethical and legal challenges involved.
Strategies on key aspects of informed consent, such as the application of gender and multicultural perspectives and improving the health literacy of research participants, have also been addressed and developed.
The incorporation of representatives of the different stakeholders at different points of the project has allowed the guidelines developed to represent a meeting point between all of them. In addition, these guidelines represent a shift in the way ICP is conceived, adapting it to the needs and preferences of the target population.
These guidelines contain practical recommendations on specific consent issues as well as on more general issues. It also contains a user-friendly checklist to guide the researcher through the IC. The guidelines in many cases represent a materialisation into practical recommendations of aspects that have previously appeared in other ethical or legal documents in a more generic form, complementing them.
In addition, as the project has included the development of consent materials for different populations, following the guidelines, these serve as examples and inspiration for future users of the guidelines.
The project has also addressed the issues arising from the COVID-19 pandemic situation. The project has written several articles on the ethical dilemmas of health research in times of pandemic, and several recommendations have been included in the guidelines in this regard.
We believe that the results and recommendations of this project are not only of interest for the development and evaluation of informed consent processes, but can also be useful in the development and communication of any health information.
Figure 2. Guidelines cover page
Figure 1. Informed Consent Process i-CONSENT proposal