FAQ

I am doing a study that involves children; do I need to provide any special details in my grant proposal?

In Reply: Undertaking research with children is a sensitive topic, and one the European Commission pays particular attention to in order to ensure the ethical standards are conducted in the utmost rigorous manner. Ideally, before sending your proposal, you need to demonstrate excellent awareness to the ethical concerns of your study. If you are collecting data from children, you should have some type of consent form prepared, to show you have understood the ethical concerns about consent and assent. If your study is complex and has interventions on children, then you may wish to seek the advice of an independent ethics advisor within your project. In cases of studies using vulnerable children, it may be that an ethics board, or in some cases an ethics workpackage, is needed . 

I am undertaking a study with research that involves complex interventions with clinical trials which may have risk to volunteers; do I need ethical approval at local level before I submit this to the European Commission?

In Reply: No, you do not need ethical approval before submitting your proposal to the European Commission. However, if you have ethical approvals for a related study, then it’s good to mention that this is for a related study for which you have already obtained ethical approval and here also indicate where the ethical approvals will be obtained from. This demonstrates to the ethical review panel that you are familiar with the processes that you need to follow.  Also, some applicants may wish to include example copies of related informed consent documents if this is available. This all aids in supporting your ethical review and shows the planning you have undertaken.  

Do I need to provide copies of ethical approvals for a study I have recently obtained local approval for and that the European Commission may fund?  

In Reply:  It is not required that you send copies of local ethical approvals. However, if you have these, it can show you are prepared and will aid in the process of ethical review in the European Commission.  

Does the European Commission Ethical review process pay much attention to matters of privacy such as the use of personal data about health or other personal views?  

In Reply: Yes, it is very important that the applicant pay particular attention to all issues regarding data protection and privacy. The applicant should ensure that, in their ethics section, they have addressed all the concerns about privacy and the use of personal data.

My study involves interviews with professionals rather than patients where I will be obtaining a large amount of information about their political and social believes and attitudes; do I need to obtain written informed consent?

In Reply: Yes, it is very important that even professionals who are involved in a research study are aware of this fact and that you have documented that you have gone through the informed consent process. You should demonstrate in your proposal that you will get consent from all your participants.  

What are the most common mistakes an applicant makes when addressing ethics in proposals?

In Reply: This depends on the topic of research. However, in studies with humans involved, attention is often lacking in regard to the informed consent process. Frequently, applicants do not cite relevant ethical regulation. In some cases, applicants may cite the regulations, but as a list of references totally unrelated to the project that is being proposed.