SSStudyParticipantsVulnerablePopulation object

Yes
Special provisions apply

Clinical trials on minors include trials on: preterm newborns, full-term newborns (0-27 days), infants and small children (28 days-23 months), children (24 months-11 years) and teenagers (12-18 years). (Dz.U. 2004 nr 104 poz. 1108).

A specific regulation issued by the Minister of Health covers in detail the provisions for the conduct of clinical trials on minors: Order of the Minister of Health 30 April 2004

Art 37h Pharmaceutical Law 2001(en)
Order of the Minister of Health 30 April 2004/ Dz.U. 2004 nr 104 poz. 1108 (pl)

Yes
Special provisions apply

Art 37i Pharmaceutical Law 2001(en)/ Dz.U. 2008 nr 45 poz. 271 (pl)

Yes
Special provisions apply

Clinical trials involving subjects unable to provide their written informed consent but able to consent verbally with two witnesses present are possible under special provisions according to Art 37f.2 of the Pharmaceutical Law 2001.
Clinical trials involving subjects unable to provide their informed consent are possible under special provisions according to Art 37i of the Pharmaceutical Law 2001.

Yes
Special provisions apply

Immediate life saving interventions in sudden emergency situations without chances to obtain consent can be performed according to Art. 25. 8 of the Physicians Act.

Art 37f.2 & Art 37i of the Pharmaceutical Law 2001
Art. 25. 8 of the Physicians Act

Yes
Special provisions apply

Clinical trials on pregnant and lactating women are possible under special provisions according to Art 26(1&2) Physician’s Profession Act 1996 (Dz.U. 1997 nr 28 poz. 152).
Not explicitly mentioned in Pharmaceutical Law 2001.

Art 26(1&2) Physician’s Profession Act 1996 (Dz.U. 1997 nr 28 poz. 152)