Is ethical review required for medical device human factors testing?
This is a common question we at THAY Medical are asked. It is not a “yes” or a “no” answer though. It depends on a number of human factors. This includes the actual location(s) the testing is to be performed at, the subjects who will be involved in the testing, what stage in the testing is in the development process.Geographic LocationWhere are you planning to perform the testing?If it is in the USA, then ethical review is mandatory and is called an IRB Review (IRB meaning Independent Review Board). If it is in Europe, Asia, Africa, South America or Australasia, then it is not mandatory – but may still be required. In the UK for example, ethical review is required if you are using people who use the National Health Service (NHS) - unless you have a justification from an ethical committee or responsible organisation as to why ethical review is not required[1].Test SubjectsWho are you planning to evaluate?If the intended or actual users of the medical devices have been defined, then it will be clear on who will be required to be evaluated. It is prudent to define what we call “user groups” – groups of the intended or actual users who will/do use the medical device in the same manner with the same level of use safety. If a user group is or includes the following people, then ethical review must be gained:
- Users of Health Services
- Test subjects from other clinical trials
- Known to be pregnant women
- Currently serving prisoners
- Vulnerable people
- Children or minors under the legal age of adulthood (many variations globally)
- People who are not completely in control of their actions
To be clear, a person who is not completely in control of their own actions may have Dementia, Alzheimer’s disease, Parkinson’s disease, Epilepsy, Tourette’s syndrome, and many other cognitive conditions. Also, this may include people who use body enhancers such as robotic aids or externally-controlled mobility aids.The reason why ethical review is required is very simple. If you are directly planning to interact with the human body as part of the testing, then can you predict the risk and potential harm the interaction will do with the test subjects? In some cases, interaction is minimal, but with some medical devices, there may be significant interactions that cannot be predicted – and this is where an independent review of the planned testing is logical to have.Testing typesWhen are you performing the testing?Most human factors testing falls into three areas of a device life-cycle – during conception (along with market research), during design and development, and post-launch as part of post-market surveillance and clinical feedback.
As a general rule applied, unless the geographic location or the test subject requires ethical review, all test types require ethical review unless justified as why none is required. Commonly many types of testing performed in the Concept and Feasibility stage of device life-cycle do not need ethical reviews since they use low-fidelity devices to evaluate human factors (prototypes, mock-ups, software only etc.), and as such the potential harms can be deemed controllable and possibly negligible. It is mainly for testing in Design and Development as well as in Post-market Surveillance and Clinical Feedback that ethical reviews should be considered, performed or rationalised.Testing methodsHow are you testing the device?If you plan to interact with the test sunjects in any way, then unless you can predict the reaction of the test subjects to the device being evaluated, then there is a variable that may be difficult to control. In the case of human factors testing, the interaction is generally due to skin contact (with fingers, hands, parts of the body) and as long as there is biocompatibility data available (or planned) that ensures minimal irritation, then the risk of harm is likely to be low to negligible during and after the human factors testing.As a rule, human factors testing should simulate or replicate real life as far as safely possible, with safe interaction between device and participant. For example – if you are evaluating a drug delivery injection device – then rather than actually injecting test subjects in a human factors test, it would be ideal to use a clinical injection training aid and get the participant to wear it where they would intend to inject. Thus, there is hopefully minimal harm in performing the injection and there is negligible risk of an unpredictable reaction between the participant and the device.In addition, if though the testing is longer than a day for example, the risk of harm may increase and as such, the test subjects may have a reaction to the product – which may make it a simulated clinical trial rather than a human factors test. As a rule, there must be no cognitive or physical harm received by the test subject in human factors testing – otherwise the testing is clinical in nature and is not just assessing the human factors and usability of the device.SummaryIt is never a “one judgement fits all” picture of whether ethical reviews are required for human factors testing or not. It depends on a number of human factors that will need to be assessed (ideally through risk assessment) or independent ethical review. Ethical review is a protection for human factors testing and should be regarded as such. It is there to assess safety for all involved so that the outcome is high quality data, generated by safe and efficient methods, resulting in a positive user experience.THAY Medical regularly perform human factors testing and always evaluate whether ethical review is required as part of human factors testing. If you have any questions or comments on this blog post, please get in touchThe staff at THAY Medical[1] http://www.hra.nhs.uk/resources/before-you-apply/is-nhs-rec-review-required/
