Bob Wilffert

The patient‘s contribution to ethics committees in the

Netherlands

Is patient’s representation always needed in Ethics Committees?

It is a requirement for an accredited Ethics Committee

Task: • guarding the interests from and the attention for the trial participant/volunteer (risks

and burdening/importance, added value of the trial)• To balance scientific and societal needs representing a viewpoint independent from

research and science(protection for ivory tower of medical profession)

What patient’s representative should be invited to be part of Ethics Committees?

At least 5 years job experience (paid or unpaid)

Able to an independent judgment of medical scientific research from the perspective of the trial participant/volunteer, which implicates:• Not involved in performing medical scientific research• No profession in healthcare nor in the other obligatory disciplines of the EC

(medical doctor, jurist, methodologist, ethicist, hospital pharmacist, clinical pharmacologist)

• No representative of a patient organization • In case of an Institutional Review Board: not working in this institution(paid or not

paid)

What should be the characteristics of the patient representative?

May be a member of a patient organization, even with a function, but not a representative of a patient organization

The position of the patient representative in a patient organization may not arouse the suspicion of a biased/ not independent position