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Frequently Asked Questions (FAQ) - Consortium / Partners / Third Parties

Question details: 
Our company has succesfully passed the 1st stage evaluation of the "H2020-PHC-2015-two-stage" call. Coordinator of the project is a new entity, subsidiary of a big dermatological company, but with no financial data at the moment. We wonder if this financial situation will penalize our stage 2 proposal. Will it be better that the parent company coordinates the project? Explaining that the parent company fully supports the new entity is it enough? Thank you for your help,
Answer: 

Regarding the very limited information given here, we strongly recommend to contact your local National Contact Point for "Legal and Finance" which you can find here: http://ec.europa.eu/research/participants/portal/desktop/en/support/nati... and Financial/1/1/0&+person.last_name/desc

If you are in doubt of the financial situation of your company, you can find information on the financial viability self-check here:
http://ec.europa.eu/research/participants/docs/h2020-funding-guide/grant...

In principle, a change of coordinator is possible, but needs to be very well justified.

Answer: 

Beneficiaries must award the subcontracts ensuring best value for money or, if appropriate, the lowest price. The best value-for-money principle does not require competitive selection procedures in all cases. However, if a beneficiary did not request several offers, it must demonstrate how best value-for-money was ensured. For the best price-quality ratio, price is an essential aspect (together with quality criteria, such as technical quality, etc.), but it is not automatically necessary to select the offer with the lowest price. In order to provide a good analysis of the price-quality ratio, the criteria defining ‘quality’ must be clear and coherent with the purposes of the action task that is subcontracted (AMGA, §13, S. 130-135).

Question details: 
I would be more than grateful if you could bring more clarity on subcontractors participation in a clinical trial. Is it fine to have a certain number of sub-contractors providing clinical recruitment and sample collection?
Answer: 

It is OK to subcontract in general. But it depends on the nature of the tasks. Core tasks cannot be subcontracted, they have to be done by partners. Minor tasks can be subcontracted. If subcontracting, you have to do so via procurement according to your organization's rules. So you cannot name the organization which will be subcontracted in the application.

Question details: 
Can you add a study site at a later stage, i.e. while the CT is running as subcontractor although centers with the same tasks i.e. conducting the trial, are listed as "partners" in the initial proposal? I guess the question is what are the options to add study site to a running CT, due to recruitment difficulties in the existing sites.
Answer: 

In this case you will have to make an amendment to your grant agreement. I understand that it is getting more difficult to add amendments. I would recommend to plan as conservative as possible and try to include "enough" study sites. We are not sure how high drop-out rates will be handled.

Question details: 
How should the hospitals recruiting patients be included in the project? As subcontractors, partners, service providers? Sometimes at the beginning of the project the list of the hospitals is not available or it is not possible to quantify how much budget they will need to manage the patients. In some case it is necessary to add additional hospitals during the project.
Answer: 

The EC prefers to include study sites as partners. Other options are to subcontract the task (Attention: Only minor tasks can be subcontracted), to include them as In-kind contributions provided by Third Parties against payment or affiliated entitities and third parties with a legal link to a beneficiary. Please refer to slide 29 and 30 of the first presentation (webinar on 18.3.2015) for details. If you need to add study centers during the running project, it depends on how you have included them in your project. If you need additional partners, you have to file an amendment.

Answer: 

Including them as a beneficiary is always the preferred option. However, subcontracting is also possible. This has to be decided individually for each project. The document “Frequently Asked Questions” concerning the Horizon 2020 societal challenge “Health, demographic change and wellbeing” says: Every clinical center can be a beneficiary, and the Commission will not oppose or discourage a large number of beneficiaries for this purpose. Alternative ways to include and reimburse such clinical centers are:

(i) As third parties providing in-kind contributions against payment (Art. 11 of the grant agreement). A requirement for this is a written agreement between the beneficiary and the third party prior to the start of the work. These third parties need to document their costs in the same way as beneficiaries (actual costs or unit costs). Wherever possible, third parties should be listed in section B4.2 of the full proposal.

(ii) As subcontractors (Art. 13 of the grant agreement). In this case, the beneficiary needs to ensure that it complies with the obligation to ensure the best value for money and institutional rules for subcontracting and if the beneficiary is a public body, with national and EU legislation on public procurement. Subcontractors would not usually be named in a proposal given the necessity to undertake the processes required to ensure compliance with the conditions described above. If however such processes have been undertaken in advance, subcontractors may be named in a proposal.

(iii) Another option, to participate as ‘linked beneficiary’, is limited to entities that fulfil the specific conditions of Art. 14 of the grant agreement on ‘affiliated entities and third parties with a legal link to a beneficiary’. As these conditions are rather specific, the use of this option is likely to be limited.

Question details: 
We are a SME in Barcelona. We have experience in several FP7 projects, developing the recruitment database for patient’s data collection. I don't know where to find Institutions and other partners that can be interested in such a partnership.
Answer: 
Question details: 
Does the rule of not subcontracting of core tasks also apply to PHC12, which is SME Instrument? A small biotech or IVD company might not have the capabilities to conduct the CT, so it must be obliged to subcontract them entirely.
Answer: 

The clinical study partners should be partners= beneficiaries whenever possible, this is right; but in PHC12 only SME are eligible for funding. So you either can identify a for-profit CRO that is willing to act as beneficiary (as it is 100% funding rate this is not too bad), or they act as subcontractor. If you are or prefer working with non-profit CROs or with academic partners (university hospitals), they must be subcontracted for this topic. The commission is aware of the dilemma, but confident that the amount of subcontracting will not be a major hurdle for the applicants respectively the evaluation result. Note that in PHC12 like in any other SME instrument topic, the “impact” is even more important than in research & innovation actions, compared to “excellence”. This is: plan and write your project proposal in the best way for your company so that you will be able to become a champion in your market.

Answer: 

"Too much" is not budget-wise. It is referring to amount and scope of tasks: how central/ crucial is the task you are going to subcontract, compared to the rest of you project?

Answer: 

No and yes, the task to be subcontracted must be named in the application, but not the name of the subcontractor. For any subcontracting, respect the guidelines on procurement (European, national and of your institution).