Update on relaxation in Audio-Visual Recording of Informed Consent Process By CDSCO.

CDSCO ON 31ST JULY 2015 HAS RELEASED GAZETTE NOTIFICATION.

CT

IMPORTANT POINTS :

  • Audio-Visual Recording  of Informed Consent Process shall only bemandatory for cases where vulnerable population is involved & the trial is of New Chemical Entity or New Molecular Entity.
  • And it shall contain procedure of providing information to the subject and his understanding on such a consent.
  • It shall be maintained  by the investigator for record.
  • For clinical trials of Anti-HIV and anti-Leprosy drugs, only audio recording of the informed consent process shall be mandatory.
  • This rule is applicable from immediate effect.

Click here for Gazette copy of the same.