Table 2 Differences in regulations on informed consent in Germany, Poland and Russia
From: Normative framework of informed consent in clinical research in Germany, Poland, and Russia
Germany | Poland | Russia | |
|---|---|---|---|
Content of information | |||
Scope of information | Selected information | Full information | Full information |
Method of information | |||
Language used | German binding, additional languages for comprehension facilitation | Polish | Russian |
Form of consent and its withdrawal | |||
Verbal consent requirements | One witness | Two witnesses | One witness |
Withdrawal of consent | Written or verbally | Not specified | Not specified |
IC in research with vulnerable groups | |||
Participation of incapacitated persons | Assent required if feasible Consent required from legal representative | Assent required if feasible Consent required from legal representative A guardianship court can override the decision of the legal representative | Consent required only from legal representative |
Participation of minors | Assent required if feasible Consent required from legal representative Withdrawal by expression of will | Assent required if feasible Consent required from legal representative Withdrawal if able to understand the situation | Inclusion not foreseen Consent required only from legal representative |
Participation in emergency situations | Subsequent consent required as soon as possible | Not specified | Not specified |