# Presentation: 464117

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

## Small Group Exercise

- RESULTS & DISCUSSION
-  FROM
- INDIVIDUAL GROUP ACTIVITY

## Small Group Exercise – IRB Roster

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

## Small Group Exercise – IRB Roster

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

## 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

## Small Group Exercise - MINUTES

- IRB Minutes reviewed off-site
- Element:  IRB Element 5A
- 2.0 points
- Let’s Review the Assessment Tool

## 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?

## 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

## Small Group Exercise - MINUTES

- Score – 0 points

## 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**
**	**

## 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
- 		Let’s Review the Assessment Tool

## 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

## Small Group Exercise – Continuing Review

**CRB Element 2F Continuing Review ****	****2.0****	****D**
**	****Factors:****	****1 of 2 met**
**	****Score:****	****50% compliancy rate = 0 points**

## Small Group Exercise – Initial Review

**Do you believe that Dr. Bilow’s 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

## Small Group Exercise – Initial Review	1.	Vulnerable 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**
**	**
**	****	**

## 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**
**	****	**

## 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**
**	**
**	****	****	**

## Small Group Exercise – Initial Review	4.	CONFIDENTIALITY

**	****CRB Element 6B****	****Subject Selection****	****2.0****	****O**
- 		Factors:		5 out of 5 met
- 		Score:			100%
- 		ANSWER:		YES
**	****	****	**

## Small Group Exercise – Initial Review5.	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**
**	**
**	****	****	**

## Small Group Exercise – Initial Review	6.	IRB Decisions

| Element | Points Possible | Topic | Points Obtained |
| --- | --- | --- | --- |
| CRB2D | 0.2 | Risk | 0 |
| CRB2E | 2.0 | Vulnerable Subjects | 0 |
| CRB2F | 2.0 | Continuing Review | 0 |
| CRB4A | 5.8 | Benefits | 5.8 |
| CRB7C | 0.2 | Confidentiality | 0 |
| TOTALS | 10.2 |  | 5.8 |

## 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
- 	Let’s Review the Assessment Tool

## SMALL GROUP EXERCISE – EXPEDITED REVIEW

- IRB Element 4B
- Two (2) of Four (4) Factors Met
- Score – 50% of file compliance = 0 score

## SMALL GROUP EXERCISE – EXPEDITED REVIEW

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

## SMALL GROUP EXERCISE – CONTINUING REVIEW

- CONTINUING REVIEW
- Approval by convened IRB
- Approved by expedited review
- Let’s Review the Assessment Tool

## 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

## SMALL GROUP EXERCISE – CONTINUING REVIEW

- Would the conduct of the continuing review approval of Dr. Bilow’s research protocol by the MTVHS IRB achieve at least 50% score of CRB, Element 4B?
- NO

## SMALL GROUP EXERCISE – Basic Elements of Informed Consent

- ICS Element 1A
- “Must Pass” Element
- 16 Components/Factors
- 5.8 points
- Let’s Review the Assessment Tool

## 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**

## 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
- 				 Let’s Review the Assessment Tool

## One Last Problem - 

|  | Documented Process | Reports | Records or Files | Total |
| --- | --- | --- | --- | --- |
| CRB | 6.4 |  | 32.0 | 38.4 |

## 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

- One Last Problem -

|  | Documented Process | Results | Records or Files | Total |
| --- | --- | --- | --- | --- |
| CRB | 6.4 |  | 32.0 | 38.4 |
| MTVHS CRB Evaluations | Unknown |  | 11.8 | (18.2)
Theoretical |

## SMALL GROUP EXERCISE 

- The End