New swissethics guideline on appropriate periods for reflection
Swissethics has recently published a guideline on appropriate periods for reflection between study information and consent for (potential) participants of clinical trials.
The guideline combines the legal context for research involving human beings with the Federal Court's practice and the practice of expert associations (Verband der chirurgisch und invasiv tätigen Fachgesellschaften fmCh) in clinical routines. In short, swissethic has tried to derive guidelines for research from clinical routines. Through this approach, the guideline tries to narrow down reflection periods which can be considered appropriate in research.
Before a decision on consent is made by the persons concerned, they must be allowed an appropriate period for reflection. (HRA Art. 16 lit. 3)
The responsible ethics committee shall review the protocol with regard to the proposed procedure for providing information and obtaining consent, including the appropriateness of the period for reflection. (ClinO Art. 51)
- In case of serious intervention or when an intervention is associated with major risks, the minimum time for consideration between information and consent/intervention is three days.
- In case of not serious interventions or when an intervention is not associated with major risks, the minimum period of reflection is one day.
- Medically necessary interventions in emergencies constitute an exception.
- Assessments must always be made on a case-by-case basis.
In case a project involves surgical intervention, the reflection period should be - depending on the stress imposed on a participant due to his/her study participation - long enough, that is e.g. one to three days (following fmCh practice).
In case of serious intervention or when an intervention is associated with major risks, the minimum time for consideration should be three days.
In research projects where no direct benefits are expected for participants, an extended reflection period should be considered.
If the intervention is associated with low risks, consent can (exceptionally) be given on the same day (on the day of information).
Compliance with laws for data protection must be ensured at all times.
Examples for trials that should allow the participant more than a three days reflection period are: first-in-man studies, early phase studies with investigational medical products (IMPs), medical devices (MDs) or permanent changes of body parts. In research projects in the area of further use - projects that work with pre-existing health-related data or biological material - information and consent can occur on the same day. Further examples can be found in the guideline.
The guideline is available in German and French: