IRB Reviewer Presentation Format

IRB Reviewer Presentation Format

Initial and Continuing Review

Presentation by primary reviewer

1.  Study summary

a.  Specific aims of the project

b.  Research plan, target population, recruitment procedures, study activities, and methods

2.  Describe how the criteria for IRB approval are met, or not met, by the research plan

a.  Risks to subjects are minimized (include assessment of risk level and risk category if children will be enrolled)

b.  Risks to subjects are reasonable in relation to anticipated benefits

c.  Selection of subjects is equitable

d.  Informed consent will be sought from each prospective subject

e.  Informed consent will be appropriately documented

f.  Provisions for monitoring the data collected to ensure the safety of subjects (as appropriate)

g.  Provisions to protect the privacy of subjects and to maintain the confidentiality of data (as appropriate)

3.  Informed Consent

a.  Type: Written, verbal; waiver of consent or documentation with justification

b.  Any missing, required elements or any deficiencies in the following areas:

i.  subject is provided sufficient opportunity to consider whether or not to participate

ii. possibility of coercion or undue influence is minimized

iii.  information is expected to be comprehensible to the target population

iv.  consent information does not include any exculpatory language

4.  If continuing review:

a.  Study summary

b.  Overview of progress

c.  Accrual

d.  Revisions throughout the approval period

e.  Unanticipated problems and adverse events

f.  Complaints

g.  New information or findings related to the risk/benefit assessment

5.  Suggest revisions, if any, and summarize unresolved issues

6.  Make a recommendation regarding the vote

Presentation by secondary reviewer (for initial review and as appropriate thereafter)

1.  Discuss points of disagreement or additions to the presentation made by the primary reviewer

2.  Make a recommendation regarding the vote

Chair calls for a motion (including review of stipulations and interval of IRB approval)

1.  Approve

2.  Minor revisions required (simple concurrence, with indication of who verifies adequacy of response)

3.  Major revisions required (back to full board for review)

4.  Disapprove

5.  Table

Chair calls for a second

Chair calls for a vote

1.  Approve

2.  Oppose

3.  Abstain

4.  Recuse