TOPIC : The Ethics of informed consent in novel treatment including a gender perspective
|Publication date:||14 October 2015|
|Types of action:||CSA Coordination and support action|
|DeadlineModel: Opening date:||single-stage 13 April 2016||Deadline:||30 August 2016 17:00:00|
|Time Zone : (Brussels time)|
Topic DescriptionSpecific Challenge:
The exponential development of knowledge resulting from biomedical research challenges the ethics of informed consent. Patients, practitioners, researchers, health authorities and other stakeholders are confronted with the difficulty to reconcile their legal and administrative environment, biomedical ethics, Human Rights and the increasing global availability of new effective treatments. For some worldwide high mortality diseases, this includes an important gender dimension. In addition to the ethical and social aspects, the economic dimension and potential impact of this challenge on EU health budgets is very significant.Scope:
Although informed consent is the pillar of ethics in medical research, several cases with high public coverage have awakened society on the difficulty to simultaneously optimise the research objectives and the patients' wellbeing while limiting the various types of potential conflicts of interest. The proposed action shall study this complex and multidimensional ethics dilemma. The focus shall be on the involvement of patients in translational research and in clinical research based on existing and validated treatments. Similar type of clinical ethics challenges exists when physicians advise patients and have to handle financial aspects, notably the fact that some available effective treatments or tests are reimbursed or not (depending on the countries).
In this context, it is necessary to build up a set of guidelines helping the clinicians to find practical answers enabling the full respect of clinical ethics, in particular ensuring an actual informed consent for these patients involved or not in clinical studies. In order to be effective, the guidelines shall be elaborated with the active involvement of the different actors of the chain, from the clinical researchers/health practitioners and their institution to the health public authorities and the other actors of the health systems: the pharmaceutical industry, the patient groups etc. In order to increase the direct impact of the work, the general guidelines shall be applied to a minimum of two specific cases where the global availability of new treatments, tests/diagnosis tools challenge the clinical practice leading to different form of disparities. This shall include the additional complexity of the gender perspective and therefore be performed on at least one gender specific disease (e.g. breast/ovarian cancer).
The proposed action shall also analyse the use of social media and ICT technologies to facilitate the information supply and the interaction between the patients and the clinicians, particularly in cases where the optimal treatments become possible faster than through the institutional changes (public health measures) that make them available to society. The involvement of all relevant stakeholders is necessary for this step, including innovative industries and patients associations.
The Commission considers that proposals requesting a contribution from the EU of the order of EUR 3.8 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.
This action allows for the provision of financial support to third parties in line with the conditions set out in Part K of the General Annexes.Expected Impact:
Taking into account the gender dimension, will increase the EU standards of clinical research ethics, in particular the quality of informed consent by developing practical guidelines supporting the work of clinicians while stimulating innovation and increase the use of effective new treatments.
Topic conditions and documents
Please read carefully all provisions below before the preparation of your application.
- List of countries and applicable rules for funding: described in part A of the General Annexes of the General Work Programme.
Note also that a number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon 2020 projects (follow the links to Australia, Brazil, Canada, China, Hong Kong&Macau, India, Japan, Republic of Korea, Mexico, Russia, Taiwan).
- Eligibility and admissibility conditions: described in part B and C of the General Annexes of the General Work Programme [, with the following exceptions]:
Proposal page limits and layout: Please refer to Part B of the standard proposal template.
3.1 Evaluation criteria and procedure, scoring and threshold: described in part H of the General Annexes of the General Work Programme [, with the following exceptions]:
3.2 Submission and evaluation process: Guide to the submission and evaluation process
- Indicative timetable for evaluation and grant agreement:
Information on the outcome of single-stage evaluation: maximum 5 months from the deadline for submission.
Signature of grant agreements: maximum 8 months from the deadline for submission.
- Provisions, proposal templates and evaluation forms for the type(s) of action(s) under this topic:
Coordination and Support Action:
Specific provisions and funding rates
Standard proposal template
Standard evaluation form
H2020 General MGA -Multi-Beneficiary
Annotated Grant Agreement
- Additional provisions:
Horizon 2020 budget flexibility
Technology readiness levels (TRL) – where a topic description refers to TRL, these definitions apply.
Financial support to Third Parties – where a topic description foresees financial support to Third Parties, these provisions apply.
- Open access must be granted to all scientific publications resulting from Horizon 2020 actions, and proposals must refer to measures envisaged. Where relevant, proposals should also provide information on how the participants will manage the research data generated and/or collected during the project, such as details on what types of data the project will generate, whether and how this data will be exploited or made accessible for verification and re-use, and how it will be curated and preserved.
This topic participates per default in the open access to research data pilot which aims to improve and maximise access to and re-use of research data generated by projects:
• The pilot applies to the data needed to validate the results presented in scientific publications. Additionally, projects can choose to make other data available for open access and need to describe their approach in a Data Management Plan (to be provided within six months after the project start).
• Note that the evaluation phase proposals will not be evaluated more favourably because they are part of the Pilot, and will not be penalised for opting out of the Pilot.
• Projects can at any stage opt-out of the pilot.
The legal requirements for projects participating in this pilot are in the article 29.3 of the Model Grant Agreement.
Further information on the Open Research Data Pilot is made available in the H2020 Online Manual.
8. Additional documents:
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To access existing draft proposals for this topic, please login to the Participant Portal and select the My Proposals page of the My Area section.
|Type of Action||Coordination & support action [CSA]|
|Topic||The Ethics of informed consent in novel treatment including a gender perspective - SwafS-17-2016|
|Guidance on proposal submission:||H2020 online manual|
H2020 Online Manual your online guide on the procedures from proposal submission to managing your grant.
Participant Portal FAQ – Submission of proposals.
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