SSStudyParticipantsVulnerablePopulation object
Yes
Special provisions apply
Yes
Special provisions apply
Yes
Special provisions apply
Yes
Special provisions apply
1° the experiment relates directly to a clinical condition from which the subject, whose consent cannot be obtained due to emergency, suffers and which is life threatening or which can lead to serious and permanent injuries; the experiment is essential to validate data obtained in experiments on individuals capable to give informed consent or by other research methods;
2° the experiment has been designed to minimize pain, discomfort, fear and any other foreseeable risk in relation to the disease and developmental stage; both the risk threshold and the degree of distress shall be specially defined and constantly monitored;
3° the risks taken by the subject….are not disproportionate in relation to the benefit expected for that individual;
4° the positive opinion on the protocol is given by an ethics committee…;
5° no incentives or financial inducements are given with the exception of compensation;
6° the investigator shall respect the requirements referred to in Article 6 with regard to the subject as soon the individual regains the capacity to consent, or with regard to his representative, as referred to in Articles 7, 1° and 8, 1°, as soon as it is possible to contact him.
No national legal framework available
There are no explicit provisions for pregnant or lactating women mentioned in Law 7/2004.
