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Frequently Asked Questions (FAQ) - Approval (Ethics / Orphan drug)

Do we need to obtain Ethics Approval for the proposed study? (rather than after the project is approved).
Answer: 

You cannot start any project activity without ethics approval. Ethics approval is not required by the time you submit your proposal (even though you should add any relevant documentation that you already have in place), but is indispensable for the start of activities. If your project is selected for funding and your ethics approvals are not in place yet, you should start the procedure immediately. Once you obtain your ethics approvals, they have to be submitted to the EC.

What if, once a project is financed, the Ethics Committee of one center does not approve the study?
Answer: 

If possible, try to address the issues that were raised and led to the rejection, so that you fully comply with the requirements of the Ethics Committee and file again. If it is clear that you cannot get approval for that center, you have to adjust your workplan and recruit from different centers. In any case you cannot start any project activity without ethics approval.

Is a control arm necessary for an IVD CT validation? If yes, how can we manage ethical issues concerning the control arm that will not receive the best drug according to current guidelines?
Answer: 

Please follow the EU regulations on IVD: http://www.namsa.com/blog/View/entryid/190/blogid/2/update-on-the-new-eu...

Concerning the ethics issues: do you need approval for your ethics at the proposal stage, or is it sufficient to describe how you will deal with the ethical concerns?
Answer: 

It is sufficient to describe how you are planning to deal with ethical concerns and what the status of your ethical approval process is. To emphasize the likeliness and to increase the credibility that the ethical approval will be granted for this trial, it is helpful to mention your experience with any similar Clinical Trials (e.g. on national level) and explaining that you received ethical approval for those.

Do the clinical trials have to be performed according to GCP? This is a quality issue, is it really necessary?
Answer: 

Yes it is necessary. The ethical approval will only be granted if the CT will be performed according to GCP.

When do we need to comply with the new European CTR?
Answer: 

According to the European Commission’s website on Medicinal products for human use http://ec.europa.eu/health/human-use/clinical-trials/index_en.htm and the respective document, http://ec.europa.eu/health/files/eudralex/vol-1/reg_2014_536/reg_2014_53..., the directive has been effective since April 2014.

Regarding ethical issues: at the time of the writing of the proposal, you might not have all required documentation (e.g. ethics approval).
Question details: 
Regarding ethical issues: at the time of the writing of the proposal, you might not have all required documentation (e.g. ethics approval). Is it sufficient to mention you will obtain all the documents you listed?
Answer: 

Yes.

How do we support compliance to National/EU Bioethics regulations in the proposal? What kind of information is necessary?
Answer: 

You should mention the national Ethic regulations of the respective countries and state that you will perform your trials in accordance to those.

Does the Ethics Approval need to be sent with the proposal? (Normally ethical approval will be sought at the early stages once the project has been approved.)
Answer: 

No.

Do you need to provide evidence of National or Institutional Ethics Approval for each partner involved in clinical trials at the proposal stage?
Answer: 

No.

Does CT approval by the national ethics committee have to be included in the full proposal?
Question details: 
No. What might be helpful for your application: show that you have ethic committees at (some of) your partner institutions, show that you have experience with similar CTs in the past, or that you are already in discussions with ethic committee, and sometime an ethical board (with supervisory function) may be a good idea, if e.g. with transplanting organs, you have VERY sensible aspects.
Can Scientific advice and orphan drug approval from EMA (such as is required for CTs projects in the rare diseases program) be received from FDA instead, or must it be from EMA?
Answer: 

Approval needs to granted by EMA, but they offer a lot of assistance - contact them EARLY enough! The FDA approval might help as enabler/ door opener so you might receive Orphan drug designation earlier.