CTU Bern (Clinical Trials Unit)

New swissethics guideline on appropriate periods for reflection

22.11.2017

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.  

Legal context
The Human Research Act (HRA) explicitly states that study participants must be given enough time to consider whether they want to participate in a clinical research project or not:
 	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)
	
It is the responsibility of the ethics committees to assess whether research projects and the conduct thereof comply with the ethical, legal and scientific requirements as stated in the HRA. In particular, they shall assess whether the protection of the persons concerned is guaranteed. This also includes the specific review of the planned period for reflection:
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)
Reflection periods in clinical practice according to Swiss Federal Court decision
  • 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.
Suggested reflection periods for research
The swissethics guideline gives researchers an idea of appropriate reflection periods by defining certain principles:
  • 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: