Implantable devices/implantation therapy invasiveness

We should note here that there are some special cases for which the use of healthy participants is not justified in early studies. For particularly invasive therapies (for example, implantation of a medical device) or therapies with known toxicity (for example, oncologies) it is not ethical to study healthy participants. The use of healthy participants in early studies may also provide a misleading result for future studies of participants with disease. For example, the maximum tolerated dose of new antidepressants or anxiolytics may differ quite markedly between healthy participants and those with the disease. 

Invasive as described in Section 3.5.2, either a minor or a major surgical procedure is required to initiate therapy. This requires the appropriate surgical personnel, and may be traumatic, time-consuming, cause some scar formation at the site of implantation and, in a very small portion of patients, may result in surgery-related complications. The patient may also feel uncomfortable wearing the device. 

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