Small Group Exercise

1

• Small Group Exercise
• Individual IRB Study File Review
• Part II
• ACE! Training
• Human Research Protection Programs
• Karen Jeans

2
Small Group Exercise

• RESULTS DISCUSSION
• FROM
• INDIVIDUAL GROUP ACTIVITY

3
Small Group Exercise IRB Roster

• IRB Roster(s) reviewed off-site
• MUST-PASS Element IRB Element 1A
• 5.8 points
• Lets Review the Assessment Tool

4
Small Group Exercise IRB Roster

• Did the MTVHS roster achieve at least 50 score
  on IRB Element 1A?

5
Small Group Exercise IRB Roster

• Data Collection Tool
• NINE Factors
• Seven met 1, 2, 3, 4, 5, 8, 9
• One not met unable to ascertain Factor 6
  (diversity of membership) based on presented
  information
• One not applicable - 7
• Score 75 level 4.35 points
• Meets the Must-Pass Criteria for this Element

6
Small Group Exercise - MINUTES

• IRB Minutes reviewed off-site
• Element IRB Element 5A
• 2.0 points
• Lets Review the Assessment Tool

7
Small Group Exercise - MINUTES

• Problems
• Controverted Issues
• Recording of Votes
• Conflict of Interest Documentation
• WOULD THE MTVHS MINUTES OF OCTOBER 14, 2002
  ACHIEVE AT LEAST 50 SCORE OF IRB ELEMENT 5A?

8
Small Group Exercise - MINUTES

• Data Collection Tool
• Three of six factors met
• Not Met Factors 3 (number of members voting
  for, against, and abstaining on each
  action)
• Factor 4 (the required quorum was present
  for the vote, including a non- scientific
  member)
• Factor 6 (members did not participate in
  the deliberations or voting on matters in
  which they had conflicts of interest)
• Scoring To achieve a 50 score, four factors
  must be present in the IRB Minutes

9
Small Group Exercise - MINUTES

• Score 0 points

10
Small Group Exercise Initial Review

• NCQA Elements Reviewed
  
• 1. CRB Element 2A RISK 2.0 O
• 2. CRB Element 2B RISK 2.0 O
• 3. CRB Element 2C Vulnerable Subjects 2.0 O
• 4. CRB Element 2D RISK 0.2 D
• 5. CRB Element 2E Vulnerable Subjects 2.0 D
• 6. CRB Element 2F Continuing Review 2.0 D
• 7. CRB Element 3A Benefits 2.0 O
• 8. CRB Element 4A Benefits 5.8 D
• 9. CRB Element 5B Recruitment 2.0 O
• 10.CRB Element 6B Subject Selection 2.0 O
• 11.CRB Element 7B Confidentiality 2.0 O
• 12.CRB Element 7C Confidentiality 0.2 D
• TOTAL
  24.2

11
Small Group Exercise Initial Review

• Sample for Initial Review
• Sixteen (16) Research Protocols Approved by the
  Convened Institutional Review Board
• Initially drawn from 3-month look-back period
• Lets Review the Assessment Tool

12
Small Group Exercise Initial Review

• Issues
• 1. Vulnerable Populations
• 2. Compound Statements
• 3. Devices
• 4. Categories of Risk
• A. Physical
• B. Psychological
• C. Social/Economic
• 5. Continuing Review Determination

13
Small Group Exercise Continuing Review

• CRB Element 2F Continuing Review 2.0 D
• Factors 1 of 2 met
• Score 50 compliancy rate 0 points

14
Small Group Exercise Initial Review

• Do you believe that Dr. Bilows Protocol Would
  Pass NCQA Criteria for IRB Evaluation of the
  Following
• 1. Vulnerable Populations
• 2. Benefits Evaluation
• 3. Risk Evaluation
• 4. Subject Selection and Recruitment
• 5. Confidentiality
• 6. IRB Decisions

15
Small Group Exercise Initial Review 1. Vulnerab
le Populations

• A. CRB Element 2C Vulnerable Subjects 2.0 O
• Factors 0 out of 2 met
• Score 0
• B. CRB Element 2E Vulnerable Subjects 2.0 D
• Factors 0 out of 2 met
• Score 0
• ANSWER NO

16
Small Group Exercise Initial Review 2. Benefits
Evaluation

• A. CRB Element 3A Benefits 2.0 O
• Factors 2 out of 2 met
• Score 100
• B. CRB Element 4A Benefits 5.8 D
• Factors 1 out of 1 met
• Score 100
• ANSWER YES

17
Small Group Exercise Initial Review 3. Risk
Evaluation

• A. CRB Element 2B RISK 2.0 O
• Factors 2 out of 2 met
• Score 100
• B. CRB Element 2D RISK 0.2 D
• Factors 2 out of 4 met
• 1 Factor not applicable - 5
• INVESTIGATIONAL DEVICE
• Score 50 of individual file compliant 0
  points
• ANSWER YES

18
Small Group Exercise Initial Review 4. CONFIDEN
TIALITY

• CRB Element 6B Subject Selection 2.0 O
• Factors 5 out of 5 met
• Score 100
• ANSWER YES

19
Small Group Exercise Initial Review5. SUBJECT
SELECTION AND RECRUITMENT

• A. CRB Element 7B Confidentiality 2.0 O
• Factors 1 of 2 met
• Score 50 file compliancy rate 0 points
• B. CRB Element 7C Confidentiality 0.2 D
• Factors 1 of 2 met
• Score 50 file compliancy rate 0 points
• ANSWER NO

20
Small Group Exercise Initial Review 6. IRB
Decisions
21
SMALL GROUP EXERCISE EXPEDITED REVIEW

• The example expedited review action used in this
  exercise is not an example of the type of action
  that will be used by NCQA
• Lets Review the Assessment Tool

22
SMALL GROUP EXERCISE EXPEDITED REVIEW

• IRB Element 4B
• Two (2) of Four (4) Factors Met
• Score 50 of file compliance 0 score

23
SMALL GROUP EXERCISE EXPEDITED REVIEW

• Would the conduct of the expeditable review
  action achieve at least a 50 score of CRB
  Element 4B?
• NO

24
SMALL GROUP EXERCISE CONTINUING REVIEW

• CONTINUING REVIEW
• Approval by convened IRB
• Approved by expedited review
• Lets Review the Assessment Tool

25
SMALL GROUP EXERCISE CONTINUING REVIEW

• IRB Element 3D
• 2.0 points
• One of One Factor Met
• Score 100 of file compliant 2.0
• CRB Element 4B
• 5.8 points
• Two (2) of Seven (7) Factors Met
• One (1) Factor (2 Investigational Device) Not
  Applicable
• Score 2/6 33 0 points
• CRB Element 6C
• 2.0 points
• One (2) of Two (2) Factors Met
• Did not obtain information on sex of subjects
• Score 50 of file compliant 0 score

26
SMALL GROUP EXERCISE CONTINUING REVIEW

• Would the conduct of the continuing review
  approval of Dr. Bilows research protocol by the
  MTVHS IRB achieve at least 50 score of CRB,
  Element 4B?
• NO

27
SMALL GROUP EXERCISE Basic Elements of Informed
Consent

• ICS Element 1A
• Must Pass Element
• 16 Components/Factors
• 5.8 points
• Lets Review the Assessment Tool

28
SMALL GROUP EXERCISE Basic Elements of Informed
Consent

• Would the Informed Consent Form (Version 2.0,
  dated October 17, 2002) achieve at least 50
  score of ICS, Element 1A?
• YES

29
SMALL GROUP EXERCISE Additional Elements of
Informed Consent

• ICS Element 1B
• Not Must Pass Element
• 2.0 points
• Not penalized if research protocol does NOT meet
  criteria for inclusion, yet reviewers indicate
  evaluation
• Lets Review the Assessment Tool

30
One Last Problem -
31
Importance of File Reviews

• Appendix E PAC Decision Rules
• If a VAMC scores less than 50 of available
  points for any single category
• Lower accreditation outcome by one level
• If VAMC scores less than 50 of available points
  for two categories
• Not accredited

32

One Last Problem -

33
SMALL GROUP EXERCISE

• The End