21 CRF Part 56

Question 1

After how long must the IRB renew its registration

Answer 1

3 years

Question 2

IRB members

Answer 2

• cannot consist entirely of men or women
• may not consist entirely of members from 1 profession
• at least one member in science
• at least one member in non-science
• at least one member not affiliated with institution or related to someone who is
• no member can review a project in which there is conflicting interest
• can invite individuals with competence in special areas to assist in the review in areas that require expertise

Question 3

Expedited review

Answer 3

• no more than minimal risk
  AND/OR
• minor changes in previously approved research during the period (1 year of less) for which approval is authorized
• can be carried out by IRB chairperson or 1+ experienced reviewers designated by chairperson
• can only approve. Can’t disapprove without going through nonexpedited review procedurs

Question 4

What does 21 CFR Part 56.107 discuss

Answer 4

IRB membership

Question 5

What may disqualify an IRB

Answer 5

• The IRB refused or repeatedly failed to comply with any of the regulations
• The noncompliance adversely affects the rights or welfare of the human subjects in a clinical investigation

Question 6

Who can reinstate an IRB or institution after disqualification

Answer 6

The commissioner

Question 7

Could emergency use of test article be exempt from IRB review

Answer 7

Yes, provided the emergency use is reported to the IRB within 5 days

Question 8

Can the FDA waive IRB rights at any time?

Answer 8

yes