Evaluation (Validation and Verification) - Medical Device Design: Innovation from Concept to Market - page 240

I suspect you are beginning to understand why the planning of a study is a professional job.
However, this does not give you the excuse to ignore your part in the planning stage. You
need to write a proper brief otherwise the “professional” can lead you a merry dance and you
will pay a lot of money for no worthwhile result.
9.6.3 Relationship with Ethical Committees
ISO 14155 (and just about every other guide you care to mention) will stipulate that all
studies on human subjects require approval by an ethical committee. This is where your links
with a local university or teaching hospital come into action. It is highly unlikely that you will
have your own ethical committee, but teaching hospitals and universities do. It is the ethical
committee that approves the study, and to meet the requirements of ISO 14155 you need this
approval documented. Unfortunately this will not be free, but most of these establishments
are looking for research projects for their professors and research staff and so long as you are
willing to allow publication (by an independent body - your marketing department will love
this) of the results, some form of financial arrangement is always possible.
It is important to note that not all hospital and university ethical committees work to ISO
14155. This is because their ethical committees look at more disciplines than simply medical
devices. To ensure your study meets the FDA and EC requirements you must ensure the
respective ethical committee understands that your study must meet the requirements of ISO
14155 even if it exceeds their individual requirements.
9.6.3.1 Informed Consent
As a part of the ethical approval process you and your investigation team will need to produce
a document that enables your subjects to give informed consent. This document is best
written by those trained in their production. However as the “sponsor” you will need to ensure
that it is done, approved, and enacted. It is unlikely that any teaching hospital or university
will want to lose its ability to give ethical approval and shortcut the process, but you still need
to be wary of rogue investigators (especially in nation states where human rights may not be
as well established as we would expect).
9.6.4 Relationship with Regulatory Bodies
If your product is already CE marked (or the FDA equivalent) then it is probably not
necessary for you to notify your regulatory body. However, if you are taking the device
outside of its agreed indication for use then you may well need to. If in doubt, contact them
directly and discuss what you are going to do with them. As I have stated earlier they are not
ogres, they will help - if they can.
If your product does not have a CE mark or 510 k and this study is a part of your clinical
evaluation prior to approval then you must notify the regulatory bodies and obtain formal approval
for the study to go ahead as this is now a clinical trial. This process will go hand-in-hand with the
ethical approval as nothing can go forward until both have been formally approved. Both the FDA
and EC regulatory bodies have guidelines and procedures in place.