Is Independent Review Board Approval needed?
For any studies in the USA, Medical Device Usability will consider whether an IRB review is required. This includes all study participants, and in particular, pregnant women, children, prisoners and anyone who has an injury, condition, disease or impairment.
Medical Device Usability regularly use a number of Independent Review Boards who report back quickly.
The type of information needed by an Independent Review Board can consist of a study protocol, informed consent documents, recruitment screeners, advertising information, training materials, test venue health and safety assessments and instructions/directions for use and all user manuals.
Medical Device Usability help with all aspects of the Independent Review Board process and works closely with clients to ensure that the process is as straightforward and seamless as possible.
Most human factors studies do not require prior ethical review. However, there are some situations in which we would advise you to seek review, for example the inclusion of vulnerable adults, and those studies in which there some element of invasive procedure, such as applying part of the device to the body.
We can advise you about whether your HF study is likely to need prior ethical review of the protocol and informed consent process, if it does, we manage the whole process, from first contact with an IRB or ethics committee right through to successful approval.
Human factors and usability studies are distinctly different to clinical studies in that no drug is administered, and no medical procedure is undertaken.
However, there is always the potential for harm where procedures are involved, and therefore we always take a number of steps to minimise the risk of harm in your study.
- Risk assessment – we always conduct a risk assessment of the study protocol and take steps to reduce the risks to an acceptable level.
- Piloting – we pilot every study to road test the protocol, and uncover any hidden risks of harm
- Informed consent – we always use an informed consent procedure and agree the consent process with you beforehand.