Research Turn Around Times - Protection of Human Subjects

Question 1

21 CFR 50 (Protection of Human Subjects): Informed consent exception from general requirements. The documentation required shall be submitted to the IRB within (blank) after the use of the test article.

Answer 1

5 working days after use of test article

Question 2

21 CFR 50 (Protection of Human Subjects): Informed consent exception from general requirements. DOD has stated and justified the time period for which the waiver is needed, not to exceed (blank), unless separately renewed under these standards and criteria.

Answer 2

1 year waiver

Question 3

21 CFR 50 (Protection of Human Subjects): Informed consent exception from general requirements. The investigator must submit the written certification of the determinations made by the investigator and an independent physician to the IRB and FDA within (blank) after the use of the device.

Answer 3

5 working days

Question 4

21 CFR 50 (Protection of Human Subjects): Informed consent exception for emergency research. The IRB determinations and documentation are to be retained by the IRB for at least (blank) after completion of the clinical investigation, and the records shall be accessible for inspection and copying by FDA.

Answer 4

3 years retain IRB determinations