Part 56 - Institutional Review Boards

Question 1

IRB may use expedited review procedure to review either or both of the following:

Answer 1

1) some or all of the research appearing on the list and found by the reviewers to involve no more than minimal risk
2) minor changes in previously approved research during the period (of 1 year or less) for which approval is authorized

Question 2

Criteria for IRB approval of research

Answer 2

1) risks to subjects are minimized
2) risks to subjects are reasonable in relation to anticipated benefits (if any) & the importance of the knowledge that may be expected to result
3) selection of subjects is equitable
4) informed consent will be sought from each prospective subject or the subjects legally authorized representative
5) informed consent will be appropriately documented
6) research plan makes adequate provision for monitoring the data collected to ensure safety of subjects
7) adequate provisions to protect privacy of subjects