Regulatory Criteria for Approval

Question 1

Criteria for IRB Approval of Research - 1

Answer 1

Risks
(risks are minimized)

Question 2

Criteria for IRB Approval of Research - 2

Answer 2

Reasonable Risks
(risks are reasonable in relation to potential benefits)

Question 3

Criteria for IRB Approval of Research - 3

Answer 3

Equitable Subject Selection
(fair exclusion/inclusion Criteria)

Question 4

Criteria for IRB Approval of Research - 4

Answer 4

Voluntary Informed Consent Sought

Question 5

Criteria for IRB Approval of Research - 5

Answer 5

Consent Appropriately Documented or Waived

Question 6

Criteria for IRB Approval of Research - 6

Answer 6

Good Data and Safety Monitoring Plan

Question 7

Criteria for IRB Approval of Research - 7

Answer 7

HIPAA Plan Good

(Adequate provisions will be provided to protect privacy and maintain confidentiality)

Question 8

Criteria for IRB Approval of Research - 8

Answer 8

Additional Safeguards For The Vulnerable (Children, Prisoners, etc.)

Question 9

Criteria for IRB Approval of Research - 9

Answer 9

Limited IRB review required when using Exempt Category 7.

Question 10

What review categories require the criteria for IRB approval to be met?

Answer 10

Full Committee and Expedited Review