+---+---------------------+---+---+--------------------------------------+
| ! | [IRB                |   | ! | [Expedited                           |
| [ | R                   |   | [ | Review](#Expedited_Review)           |
| ] | oster](#IRB_Roster) |   | ] |                                      |
| ( |                     |   | ( |                                      |
| m |                     |   | m |                                      |
| e |                     |   | e |                                      |
| d |                     |   | d |                                      |
| i |                     |   | i |                                      |
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| / |                     |   | / |                                      |
| i |                     |   | i |                                      |
| m |                     |   | m |                                      |
| a |                     |   | a |                                      |
| g |                     |   | g |                                      |
| e |                     |   | e |                                      |
| 1 |                     |   | 1 |                                      |
| . |                     |   | . |                                      |
| p |                     |   | p |                                      |
| n |                     |   | n |                                      |
| g |                     |   | g |                                      |
| ) |                     |   | ) |                                      |
| { |                     |   | { |                                      |
| w |                     |   | w |                                      |
| i |                     |   | i |                                      |
| d |                     |   | d |                                      |
| t |                     |   | t |                                      |
| h |                     |   | h |                                      |
| = |                     |   | = |                                      |
| " |                     |   | " |                                      |
| 0 |                     |   | 0 |                                      |
| . |                     |   | . |                                      |
| 1 |                     |   | 1 |                                      |
| 2 |                     |   | 2 |                                      |
| 5 |                     |   | 5 |                                      |
| i |                     |   | i |                                      |
| n |                     |   | n |                                      |
| " |                     |   | " |                                      |
| h |                     |   | h |                                      |
| e |                     |   | e |                                      |
| i |                     |   | i |                                      |
| g |                     |   | g |                                      |
| h |                     |   | h |                                      |
| t |                     |   | t |                                      |
| = |                     |   | = |                                      |
| " |                     |   | " |                                      |
| 0 |                     |   | 0 |                                      |
| . |                     |   | . |                                      |
| 1 |                     |   | 1 |                                      |
| 2 |                     |   | 2 |                                      |
| 5 |                     |   | 5 |                                      |
| i |                     |   | i |                                      |
| n |                     |   | n |                                      |
| " |                     |   | " |                                      |
| } |                     |   | } |                                      |
+---+---------------------+---+---+--------------------------------------+
| ! | [IRB                |   | ! | [Continuing                          |
| [ | Min                 |   | [ | Review](#Continuing_Review)          |
| ] | utes](#IRB_Minutes) |   | ] |                                      |
| ( |                     |   | ( |                                      |
| m |                     |   | m |                                      |
| e |                     |   | e |                                      |
| d |                     |   | d |                                      |
| i |                     |   | i |                                      |
| a |                     |   | a |                                      |
| / |                     |   | / |                                      |
| i |                     |   | i |                                      |
| m |                     |   | m |                                      |
| a |                     |   | a |                                      |
| g |                     |   | g |                                      |
| e |                     |   | e |                                      |
| 1 |                     |   | 1 |                                      |
| . |                     |   | . |                                      |
| p |                     |   | p |                                      |
| n |                     |   | n |                                      |
| g |                     |   | g |                                      |
| ) |                     |   | ) |                                      |
| { |                     |   | { |                                      |
| w |                     |   | w |                                      |
| i |                     |   | i |                                      |
| d |                     |   | d |                                      |
| t |                     |   | t |                                      |
| h |                     |   | h |                                      |
| = |                     |   | = |                                      |
| " |                     |   | " |                                      |
| 0 |                     |   | 0 |                                      |
| . |                     |   | . |                                      |
| 1 |                     |   | 1 |                                      |
| 2 |                     |   | 2 |                                      |
| 5 |                     |   | 5 |                                      |
| i |                     |   | i |                                      |
| n |                     |   | n |                                      |
| " |                     |   | " |                                      |
| h |                     |   | h |                                      |
| e |                     |   | e |                                      |
| i |                     |   | i |                                      |
| g |                     |   | g |                                      |
| h |                     |   | h |                                      |
| t |                     |   | t |                                      |
| = |                     |   | = |                                      |
| " |                     |   | " |                                      |
| 0 |                     |   | 0 |                                      |
| . |                     |   | . |                                      |
| 1 |                     |   | 1 |                                      |
| 2 |                     |   | 2 |                                      |
| 5 |                     |   | 5 |                                      |
| i |                     |   | i |                                      |
| n |                     |   | n |                                      |
| " |                     |   | " |                                      |
| } |                     |   | } |                                      |
+---+---------------------+---+---+--------------------------------------+
| ! | [Research           |   | ! | [Exempt Review](#Exempt_Review)      |
| [ | Protocols](#        |   | [ |                                      |
| ] | Research_Protocols) |   | ] |                                      |
| ( |                     |   | ( |                                      |
| m |                     |   | m |                                      |
| e |                     |   | e |                                      |
| d |                     |   | d |                                      |
| i |                     |   | i |                                      |
| a |                     |   | a |                                      |
| / |                     |   | / |                                      |
| i |                     |   | i |                                      |
| m |                     |   | m |                                      |
| a |                     |   | a |                                      |
| g |                     |   | g |                                      |
| e |                     |   | e |                                      |
| 1 |                     |   | 1 |                                      |
| . |                     |   | . |                                      |
| p |                     |   | p |                                      |
| n |                     |   | n |                                      |
| g |                     |   | g |                                      |
| ) |                     |   | ) |                                      |
| { |                     |   | { |                                      |
| w |                     |   | w |                                      |
| i |                     |   | i |                                      |
| d |                     |   | d |                                      |
| t |                     |   | t |                                      |
| h |                     |   | h |                                      |
| = |                     |   | = |                                      |
| " |                     |   | " |                                      |
| 0 |                     |   | 0 |                                      |
| . |                     |   | . |                                      |
| 1 |                     |   | 1 |                                      |
| 2 |                     |   | 2 |                                      |
| 5 |                     |   | 5 |                                      |
| i |                     |   | i |                                      |
| n |                     |   | n |                                      |
| " |                     |   | " |                                      |
| h |                     |   | h |                                      |
| e |                     |   | e |                                      |
| i |                     |   | i |                                      |
| g |                     |   | g |                                      |
| h |                     |   | h |                                      |
| t |                     |   | t |                                      |
| = |                     |   | = |                                      |
| " |                     |   | " |                                      |
| 0 |                     |   | 0 |                                      |
| . |                     |   | . |                                      |
| 1 |                     |   | 1 |                                      |
| 2 |                     |   | 2 |                                      |
| 5 |                     |   | 5 |                                      |
| i |                     |   | i |                                      |
| n |                     |   | n |                                      |
| " |                     |   | " |                                      |
| } |                     |   | } |                                      |
+---+---------------------+---+---+--------------------------------------+
| ! | [Basic Informed     |   |   |                                      |
| [ | Conse               |   |   |                                      |
| ] | nt](#Basic_Consent) |   |   |                                      |
| ( |                     |   |   |                                      |
| m |                     |   |   |                                      |
| e |                     |   |   |                                      |
| d |                     |   |   |                                      |
| i |                     |   |   |                                      |
| a |                     |   |   |                                      |
| / |                     |   |   |                                      |
| i |                     |   |   |                                      |
| m |                     |   |   |                                      |
| a |                     |   |   |                                      |
| g |                     |   |   |                                      |
| e |                     |   |   |                                      |
| 1 |                     |   |   |                                      |
| . |                     |   |   |                                      |
| p |                     |   |   |                                      |
| n |                     |   |   |                                      |
| g |                     |   |   |                                      |
| ) |                     |   |   |                                      |
| { |                     |   |   |                                      |
| w |                     |   |   |                                      |
| i |                     |   |   |                                      |
| d |                     |   |   |                                      |
| t |                     |   |   |                                      |
| h |                     |   |   |                                      |
| = |                     |   |   |                                      |
| " |                     |   |   |                                      |
| 0 |                     |   |   |                                      |
| . |                     |   |   |                                      |
| 1 |                     |   |   |                                      |
| 2 |                     |   |   |                                      |
| 5 |                     |   |   |                                      |
| i |                     |   |   |                                      |
| n |                     |   |   |                                      |
| " |                     |   |   |                                      |
| h |                     |   |   |                                      |
| e |                     |   |   |                                      |
| i |                     |   |   |                                      |
| g |                     |   |   |                                      |
| h |                     |   |   |                                      |
| t |                     |   |   |                                      |
| = |                     |   |   |                                      |
| " |                     |   |   |                                      |
| 0 |                     |   |   |                                      |
| . |                     |   |   |                                      |
| 1 |                     |   |   |                                      |
| 2 |                     |   |   |                                      |
| 5 |                     |   |   |                                      |
| i |                     |   |   |                                      |
| n |                     |   |   |                                      |
| " |                     |   |   |                                      |
| } |                     |   |   |                                      |
+---+---------------------+---+---+--------------------------------------+
| ! | [Additional         |   |   |                                      |
| [ | Elements of         |   |   |                                      |
| ] | Informed            |   |   |                                      |
| ( | Con                 |   |   |                                      |
| m | sent](#AddElements) |   |   |                                      |
| e |                     |   |   |                                      |
| d |                     |   |   |                                      |
| i |                     |   |   |                                      |
| a |                     |   |   |                                      |
| / |                     |   |   |                                      |
| i |                     |   |   |                                      |
| m |                     |   |   |                                      |
| a |                     |   |   |                                      |
| g |                     |   |   |                                      |
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| 1 |                     |   |   |                                      |
| . |                     |   |   |                                      |
| p |                     |   |   |                                      |
| n |                     |   |   |                                      |
| g |                     |   |   |                                      |
| ) |                     |   |   |                                      |
| { |                     |   |   |                                      |
| w |                     |   |   |                                      |
| i |                     |   |   |                                      |
| d |                     |   |   |                                      |
| t |                     |   |   |                                      |
| h |                     |   |   |                                      |
| = |                     |   |   |                                      |
| " |                     |   |   |                                      |
| 0 |                     |   |   |                                      |
| . |                     |   |   |                                      |
| 1 |                     |   |   |                                      |
| 2 |                     |   |   |                                      |
| 5 |                     |   |   |                                      |
| i |                     |   |   |                                      |
| n |                     |   |   |                                      |
| " |                     |   |   |                                      |
| h |                     |   |   |                                      |
| e |                     |   |   |                                      |
| i |                     |   |   |                                      |
| g |                     |   |   |                                      |
| h |                     |   |   |                                      |
| t |                     |   |   |                                      |
| = |                     |   |   |                                      |
| " |                     |   |   |                                      |
| 0 |                     |   |   |                                      |
| . |                     |   |   |                                      |
| 1 |                     |   |   |                                      |
| 3 |                     |   |   |                                      |
| 8 |                     |   |   |                                      |
| 1 |                     |   |   |                                      |
| 9 |                     |   |   |                                      |
| 4 |                     |   |   |                                      |
| 4 |                     |   |   |                                      |
| 4 |                     |   |   |                                      |
| 4 |                     |   |   |                                      |
| 4 |                     |   |   |                                      |
| 4 |                     |   |   |                                      |
| 4 |                     |   |   |                                      |
| 4 |                     |   |   |                                      |
| 4 |                     |   |   |                                      |
| 4 |                     |   |   |                                      |
| 4 |                     |   |   |                                      |
| 5 |                     |   |   |                                      |
| i |                     |   |   |                                      |
| n |                     |   |   |                                      |
| " |                     |   |   |                                      |
| } |                     |   |   |                                      |
+---+---------------------+---+---+--------------------------------------+
| ! | # [Approved Cons    |   |   |                                      |
| [ | ent Forms -- Paymen |   |   |                                      |
| ] | t and Exculpatory L |   |   |                                      |
| ( | anguage](#Approved) |   |   |                                      |
| m |                     |   |   |                                      |
| e |                     |   |   |                                      |
| d |                     |   |   |                                      |
| i |                     |   |   |                                      |
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| i |                     |   |   |                                      |
| m |                     |   |   |                                      |
| a |                     |   |   |                                      |
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| 1 |                     |   |   |                                      |
| . |                     |   |   |                                      |
| p |                     |   |   |                                      |
| n |                     |   |   |                                      |
| g |                     |   |   |                                      |
| ) |                     |   |   |                                      |
| { |                     |   |   |                                      |
| w |                     |   |   |                                      |
| i |                     |   |   |                                      |
| d |                     |   |   |                                      |
| t |                     |   |   |                                      |
| h |                     |   |   |                                      |
| = |                     |   |   |                                      |
| " |                     |   |   |                                      |
| 0 |                     |   |   |                                      |
| . |                     |   |   |                                      |
| 1 |                     |   |   |                                      |
| 2 |                     |   |   |                                      |
| 5 |                     |   |   |                                      |
| i |                     |   |   |                                      |
| n |                     |   |   |                                      |
| " |                     |   |   |                                      |
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| i |                     |   |   |                                      |
| g |                     |   |   |                                      |
| h |                     |   |   |                                      |
| t |                     |   |   |                                      |
| = |                     |   |   |                                      |
| " |                     |   |   |                                      |
| 0 |                     |   |   |                                      |
| . |                     |   |   |                                      |
| 1 |                     |   |   |                                      |
| 3 |                     |   |   |                                      |
| 8 |                     |   |   |                                      |
| 1 |                     |   |   |                                      |
| 9 |                     |   |   |                                      |
| 4 |                     |   |   |                                      |
| 4 |                     |   |   |                                      |
| 4 |                     |   |   |                                      |
| 4 |                     |   |   |                                      |
| 4 |                     |   |   |                                      |
| 4 |                     |   |   |                                      |
| 4 |                     |   |   |                                      |
| 4 |                     |   |   |                                      |
| 4 |                     |   |   |                                      |
| 4 |                     |   |   |                                      |
| 4 |                     |   |   |                                      |
| 5 |                     |   |   |                                      |
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| n |                     |   |   |                                      |
| " |                     |   |   |                                      |
| } |                     |   |   |                                      |
+---+---------------------+---+---+--------------------------------------+

![](media/image2.png){width="1.16875in" height="0.5986111111111111in"}

+---+----------------------------------------------+---+----------------+
| ! | **IRB Roster**                               | ! | [**Back to     |
| [ |                                              | [ | Main           |
| ] |                                              | ] | Menu*          |
| ( |                                              | ( | *](#Main_Menu) |
| m |                                              | m |                |
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+---+----------------------------------------------+---+----------------+
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| . |                                              |   |                |
+---+----------------------------------------------+---+----------------+

+----------------------------------------------+---+---+---+--------------+
| > **IRB ROSTER \*Must Pass Element\***       | * | * | * | **Comments** |
|                                              | * | * | * |              |
|                                              | Y | N | N |              |
|                                              | * | * | / |              |
|                                              | * | * | A |              |
|                                              |   |   | * |              |
|                                              |   |   | * |              |
+----------------------------------------------+---+---+---+--------------+
| 1.  Does the IRB roster include at least     |   |   |   | IRB Element  |
|     five members?                            |   |   |   | 1A, Factor 1 |
|                                              |   |   |   |              |
|                                              |   |   |   | Page 29      |
+----------------------------------------------+---+---+---+--------------+
| 2.  Does the IRB roster include at least one |   |   |   | IRB Element  |
|     member whose primary area is non         |   |   |   | 1A, Factor 2 |
|     --scientific?                            |   |   |   |              |
|                                              |   |   |   | Page 29      |
+----------------------------------------------+---+---+---+--------------+
| 3.  Does the IRB roster include at least one |   |   |   | IRB Element  |
|     member whose primary area of interest is |   |   |   | 1A, Factor 3 |
|     scientific?                              |   |   |   |              |
|                                              |   |   |   | Page 29      |
+----------------------------------------------+---+---+---+--------------+
| 4.  Does the IRB roster include members of   |   |   |   | IRB Element  |
|     more than one profession?                |   |   |   | 1A, Factor 4 |
|                                              |   |   |   |              |
|                                              |   |   |   | Page 29      |
+----------------------------------------------+---+---+---+--------------+
| 5.  Does the IRB roster include at least one |   |   |   | IRB Element  |
|     member who is not otherwise affiliated   |   |   |   | 1A, Factor 5 |
|     with the VA or affiliated university     |   |   |   |              |
|     HRPP and who is not part of the          |   |   |   | Page 29      |
|     immediate family of a person affiliated  |   |   |   |              |
|     with either organization?                |   |   |   |              |
+----------------------------------------------+---+---+---+--------------+
| 6.  Does the IRB roster include diversity of |   |   |   | IRB Element  |
|     membership based on consideration of     |   |   |   | 1A, Factor 6 |
|     race, gender, and cultural background?   |   |   |   |              |
|                                              |   |   |   | Page 29      |
+----------------------------------------------+---+---+---+--------------+
| 7.  Does the IRB roster include at least one |   |   |   | IRB Element  |
|     member who is a VA representative (if an |   |   |   | 1A, Factor 7 |
|     affiliated university)?                  |   |   |   |              |
|                                              |   |   |   | Page 29      |
+----------------------------------------------+---+---+---+--------------+
| 8.  Does the IRB Roster indicate that the    |   |   |   | IRB Element  |
|     IRB Chairperson has a VA appointment     |   |   |   | 1A, Factor 8 |
|     (for VA IRBs)?                           |   |   |   |              |
|                                              |   |   |   | Page 29      |
+----------------------------------------------+---+---+---+--------------+
| 9.  Does the IRB roster indicate that at     |   |   |   | IRB Element  |
|     least one member is from the VA Research |   |   |   | 1A, Factor 9 |
|     and Development Committee (for VA IRBs)? |   |   |   |              |
|                                              |   |   |   | Page 29      |
+----------------------------------------------+---+---+---+--------------+
| > **TOTAL FOR IRB ROSTER**                   |   |   |   |              |
| >                                            |   |   |   |              |
| > **(Add numbers of checked boxes in each    |   |   |   |              |
| > column)**                                  |   |   |   |              |
+----------------------------------------------+---+---+---+--------------+

+---+---+----------------------------------------------+---+----------------+
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+---+---+----------------------------------------------+---+----------------+
| ! |   | **IRB Minutes**                              | ! | [**Back to     |
| [ |   |                                              | [ | Main           |
| ] |   |                                              | ] | Menu*          |
| ( |   |                                              | ( | *](#Main_Menu) |
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+---+---+----------------------------------------------+---+----------------+

+----------------------------------------------+---+---+---+--------------+
| > **IRB MINUTES**                            | * | * | * | **Comments** |
|                                              | * | * | * |              |
|                                              | Y | N | N |              |
|                                              | * | * | / |              |
|                                              | * | * | A |              |
|                                              |   |   | * |              |
|                                              |   |   | * |              |
+----------------------------------------------+---+---+---+--------------+
| 1.  Did the IRB minutes contain sufficient   |   |   |   | **IRB        |
|     detail to show attendance at the         |   |   |   | Element 5A,  |
|     meeting?                                 |   |   |   | Factor 1**   |
|                                              |   |   |   |              |
|                                              |   |   |   | **Page 51**  |
+----------------------------------------------+---+---+---+--------------+
| 2.  Was a quorum of the IRB membership       |   |   |   | **IRB        |
|     present for each vote?                   |   |   |   | Element 5A,  |
|                                              |   |   |   | Factor 4**   |
|                                              |   |   |   |              |
|                                              |   |   |   | **Page 51**  |
+----------------------------------------------+---+---+---+--------------+
| 3.  Do the minutes of the IRB meeting        |   |   |   | **IRB        |
|     document that a non-scientific member    |   |   |   | Element 5A,  |
|     was present for each vote?               |   |   |   | Factor 4**   |
|                                              |   |   |   |              |
|                                              |   |   |   | **Page 51**  |
+----------------------------------------------+---+---+---+--------------+
| 4.  Do the minutes of the IRB meeting        |   |   |   | **IRB        |
|     document types of actions taken by the   |   |   |   | Element 5A,  |
|     convened membership?                     |   |   |   | Factor 2**   |
|                                              |   |   |   |              |
|                                              |   |   |   | **Page 51**  |
+----------------------------------------------+---+---+---+--------------+
| 5.  How many controverted issues are present | * |   |   |              |
|     in the IRB meeting minutes?              | * |   |   |              |
|                                              | N |   |   |              |
|                                              | U |   |   |              |
|                                              | M |   |   |              |
|                                              | B |   |   |              |
|                                              | E |   |   |              |
|                                              | R |   |   |              |
|                                              | = |   |   |              |
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|                                              | _ |   |   |              |
|                                              | * |   |   |              |
|                                              | * |   |   |              |
+----------------------------------------------+---+---+---+--------------+
| 6.  Do the minutes of the IRB meeting        |   |   |   | **IRB        |
|     document summary of the discussion of    |   |   |   | Element 5A,  |
|     controverted issues and their            |   |   |   | Factor 5**   |
|     resolution?                              |   |   |   |              |
|                                              |   |   |   | **Page 51**  |
+----------------------------------------------+---+---+---+--------------+
| 7.  Do the minutes of the IRB document the   |   |   |   | **IRB        |
|     number of members voting for, against,   |   |   |   | Element 5A,  |
|     and abstaining on each action?           |   |   |   | Factor 3**   |
|                                              |   |   |   |              |
|                                              |   |   |   | **Page 51**  |
+----------------------------------------------+---+---+---+--------------+
| 8.  Do the minutes of the IRB meeting        |   |   |   | **IRB        |
|     document members who did not participate |   |   |   | Element 5A,  |
|     in deliberations or voting in matters in |   |   |   | Factor 6**   |
|     which they had conflicts of interest?    |   |   |   |              |
|                                              |   |   |   | **Page 61**  |
+----------------------------------------------+---+---+---+--------------+
| > **TOTAL**                                  |   |   |   |              |
| >                                            |   |   |   |              |
| > **(Add numbers of checked boxes in each    |   |   |   |              |
| > column)**                                  |   |   |   |              |
+----------------------------------------------+---+---+---+--------------+

+-----------------------------------------------------------------------+
| **Please check your response to the following question:**             |
|                                                                       |
| Would the minutes of this meeting achieve at least 50% score of IRB,  |
| Element 5A (Page 51 of the NCQA Accreditation Standards, Version      |
| 2.1)?                                                                 |
|                                                                       |
| YES NO                                                                |
|                                                                       |
| To achieve a 50% score, four (4) of the factors must be scored as     |
| "Y".                                                                  |
+-----------------------------------------------------------------------+

+---+----------------------------------------------+---+----------------+
| ! | **Research Protocols**                       | ! | [**Back to     |
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| q |                                              |   |                |
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| s |                                              |   |                |
| . |                                              |   |                |
+---+----------------------------------------------+---+----------------+

+----------------------------------------------+---+---+---+--------------+
| > **GENERAL EVALUATION**                     | * | * | * | **Comments** |
|                                              | * | * | * |              |
|                                              | Y | N | N |              |
|                                              | * | * | / |              |
|                                              | * | * | A |              |
|                                              |   |   | * |              |
|                                              |   |   | * |              |
+----------------------------------------------+---+---+---+--------------+
| 1.  Do the new protocol application          |   |   |   | CRB Element  |
|     materials describe where the research    |   |   |   | 6B, Factor 2 |
|     (setting) is to be conducted?            |   |   |   |              |
|                                              |   |   |   | Page 77      |
+----------------------------------------------+---+---+---+--------------+
| 2.  Do the new protocol application          |   |   |   | CRB Element  |
|     materials contain information concerning |   |   |   | 2C, Factor 1 |
|     the reasons for including vulnerable     |   |   |   |              |
|     subjects in the research?                |   |   |   | Page 63      |
+----------------------------------------------+---+---+---+--------------+
| 3.  Do the new protocol application          |   |   |   | CRB Element  |
|     materials contain information addressing |   |   |   | 2C, Factor 2 |
|     additional safeguards included to        |   |   |   |              |
|     protect the rights and welfare of        |   |   |   | Page 63      |
|     vulnerable subjects?                     |   |   |   |              |
+----------------------------------------------+---+---+---+--------------+
| 4.  Did the IRB consider the information     |   |   |   | CRB Element  |
|     concerning the reasons for including     |   |   |   | 2E, Factor 1 |
|     vulnerable subjects in the research to   |   |   |   |              |
|     be appropriate and/or sufficient?        |   |   |   | Page 66      |
+----------------------------------------------+---+---+---+--------------+
| 5.  Did the IRB consider the information     |   |   |   | CRB Element  |
|     addressing additional safeguards         |   |   |   | 2E, Factor 2 |
|     included to protect the rights and       |   |   |   |              |
|     welfare of vulnerable subjects?          |   |   |   | Page 66      |
+----------------------------------------------+---+---+---+--------------+
| **BENEFITS EVALUATION**                      |   |   |   |              |
+----------------------------------------------+---+---+---+--------------+
| 6.  Do the new protocol application          |   |   |   | CRB Element  |
|     materials contain information about the  |   |   |   | 3A, Factor 1 |
|     anticipated benefits of the research to  |   |   |   |              |
|     research subjects?                       |   |   |   | Page 68      |
+----------------------------------------------+---+---+---+--------------+
| 7.  Do the new protocol application          |   |   |   | CRB Element  |
|     materials contain information about the  |   |   |   | 3A, Factor 2 |
|     importance of the knowledge that may be  |   |   |   |              |
|     reasonably expected to result from       |   |   |   | Page 68      |
|     research?                                |   |   |   |              |
+----------------------------------------------+---+---+---+--------------+
| 8.  Did the IRB consider the information in  |   |   |   | CRB Element  |
|     the new protocol application in its      |   |   |   | 4A, Factor   |
|     approval of the research in relation to  |   |   |   | NA           |
|     anticipated benefits (if any) to         |   |   |   |              |
|     subjects, and the importance of          |   |   |   | Page 69      |
|     knowledge that may be reasonably         |   |   |   |              |
|     expected to result from research?        |   |   |   |              |
+----------------------------------------------+---+---+---+--------------+
| **RISK EVALUATION**                          |   |   |   |              |
+----------------------------------------------+---+---+---+--------------+
| 9.  Do the new protocol application          |   |   |   | CRB Element  |
|     materials contain information about the  |   |   |   | 6B, Factor 1 |
|     purpose of the study?                    |   |   |   |              |
|                                              |   |   |   | Page 77      |
+----------------------------------------------+---+---+---+--------------+
| 10. Do the new protocol application          |   |   |   | CRB Element  |
|     materials contain information about the  |   |   |   | 2B, Factor 1 |
|     study design?                            |   |   |   |              |
|                                              |   |   |   | Page 62      |
+----------------------------------------------+---+---+---+--------------+
| 11. Did the IRB consider the impact of the   |   |   |   | CRB Element  |
|     proposed research protocol's study       |   |   |   | 2D, Factor 2 |
|     design on risk?                          |   |   |   |              |
|                                              |   |   |   | Page 65      |
+----------------------------------------------+---+---+---+--------------+
| **Research Protocols Continued...**          |   |   |   |              |
+----------------------------------------------+---+---+---+--------------+
| 12. Do the new protocol application          |   |   |   | CRB Element  |
|     materials contain information about      |   |   |   | 2B, Factor 2 |
|     provisions for safety monitoring?        |   |   |   |              |
|                                              |   |   |   | Page 62      |
+----------------------------------------------+---+---+---+--------------+
| 13. Did the IRB consider the information in  |   |   |   | CRB Element  |
|     the new protocol application materials   |   |   |   | 2D, Factor 3 |
|     about provisions for safety monitoring?  |   |   |   |              |
|                                              |   |   |   | Page 65      |
+----------------------------------------------+---+---+---+--------------+
| 14. If an investigational device is used,    |   |   |   | CRB Element  |
|     did the IRB determine the risk level of  |   |   |   | 2D, Factor 5 |
|     the investigational device?              |   |   |   |              |
|                                              |   |   |   | Page 65      |
+----------------------------------------------+---+---+---+--------------+
| 15. Do the new protocol application          |   |   |   | CRB Element  |
|     materials identify physical,             |   |   |   | 2A, Factor 1 |
|     psychological, social, and/or economic   |   |   |   |              |
|     risks that may result from participation |   |   |   | Page 59      |
|     in the research?                         |   |   |   |              |
+----------------------------------------------+---+---+---+--------------+
| 16. Do the new protocol application          |   |   |   | CRB Element  |
|     materials describe steps that are taken  |   |   |   | 2A, Factor 2 |
|     to minimize physical, psychological,     |   |   |   |              |
|     social, and/or economic risks that may   |   |   |   | Page 59      |
|     result from participation in the         |   |   |   |              |
|     research?                                |   |   |   |              |
+----------------------------------------------+---+---+---+--------------+
| 17. Did the IRB consider the risks of the    |   |   |   | CRB Element  |
|     proposed research?                       |   |   |   | 2D, Factor 1 |
|                                              |   |   |   |              |
|                                              |   |   |   | Page 65      |
+----------------------------------------------+---+---+---+--------------+
| 18. Did the IRB document its determination   |   |   |   | CRB Element  |
|     of whether risks have been minimized to  |   |   |   | 2D, Factor 4 |
|     the extent possible?                     |   |   |   |              |
|                                              |   |   |   | Page 65      |
+----------------------------------------------+---+---+---+--------------+
| **SUBJECT SELECTION AND RECRUITMENT**        |   |   |   |              |
+----------------------------------------------+---+---+---+--------------+
| 19. Do the new protocol application          |   |   |   | CRB Element  |
|     materials contain information that       |   |   |   | 5B, Factor 3 |
|     describes the methods used to identify   |   |   |   |              |
|     and recruit potential subjects?          |   |   |   | Page 74      |
+----------------------------------------------+---+---+---+--------------+
| 20. Do the new protocol application          |   |   |   | CRB Element  |
|     materials contain information about      |   |   |   | 6B, Factor 3 |
|     scientific and ethical justification for |   |   |   |              |
|     excluding classes of persons who might   |   |   |   | Page 77      |
|     benefit from the research?               |   |   |   |              |
+----------------------------------------------+---+---+---+--------------+
| 21. Do new protocol application materials    |   |   |   | CRB Element  |
|     contain subject inclusion criteria?      |   |   |   | 6B, Factor 4 |
|                                              |   |   |   |              |
|                                              |   |   |   | Page 77      |
+----------------------------------------------+---+---+---+--------------+
| 22. Do the new protocol application          |   |   |   | CRB Element  |
|     materials contain subject exclusion      |   |   |   | 6B, Factor 5 |
|     criteria?                                |   |   |   |              |
|                                              |   |   |   | Page 77      |
+----------------------------------------------+---+---+---+--------------+
| 23. Do the new protocol application          |   |   |   | CRB Element  |
|     materials contain information about the  |   |   |   | 5B, Factor 1 |
|     nature of compensation offered to        |   |   |   |              |
|     subjects for participation in the        |   |   |   | Page 74      |
|     research?                                |   |   |   |              |
+----------------------------------------------+---+---+---+--------------+
| 24. Do the new protocol application          |   |   |   | CRB Element  |
|     materials contain information about      |   |   |   | 5B, Factor 2 |
|     proposed advertisements and other        |   |   |   |              |
|     recruitment methods for subjects?        |   |   |   | Page 74      |
+----------------------------------------------+---+---+---+--------------+
| **CONFIDENTIALITY**                          |   |   |   |              |
+----------------------------------------------+---+---+---+--------------+
| 25. Do the new protocol application          |   |   |   | CRB Element  |
|     materials describe methods used to       |   |   |   | 7B, Factor 1 |
|     obtain information about participants?   |   |   |   |              |
|                                              |   |   |   | Page 81      |
+----------------------------------------------+---+---+---+--------------+
| 26. Did the IRB consider the information     |   |   |   | CRB Element  |
|     describing methods used to obtain        |   |   |   | 7C, Factor 1 |
|     information about participants in the    |   |   |   |              |
|     new protocol application materials?      |   |   |   | Page 83      |
+----------------------------------------------+---+---+---+--------------+
| 27. Do the new protocol application          |   |   |   | CRB Element  |
|     materials describe provisions for        |   |   |   | 7B, Factor 2 |
|     protecting the confidentiality of        |   |   |   |              |
|     research data?                           |   |   |   | Page 81      |
+----------------------------------------------+---+---+---+--------------+
| 28. Did the IRB consider the information     |   |   |   | CRB Element  |
|     describing provisions for protecting the |   |   |   | 7E, Factor 2 |
|     confidentiality of research data in the  |   |   |   |              |
|     new protocol application materials?      |   |   |   | Page 83      |
+----------------------------------------------+---+---+---+--------------+

+----------------------------------------------+---+---+---+--------------+
| **Research Protocols Continued...**          |   |   |   |              |
+----------------------------------------------+---+---+---+--------------+
| **IRB DECISIONS**                            |   |   |   |              |
+----------------------------------------------+---+---+---+--------------+
| 29. If the proposed research protocol was    |   |   |   | CRB Element  |
|     approved, did the IRB document in        |   |   |   | 2F, Factor 1 |
|     correspondence the continuing review     |   |   |   |              |
|     interval?                                |   |   |   | Page 67      |
+----------------------------------------------+---+---+---+--------------+
| 30. Did the IRB document the continuing      |   |   |   | CRB Factor   |
|     review interval in relation to its       |   |   |   | 2F, Factor 2 |
|     determination of the risk of the         |   |   |   |              |
|     research protocol?                       |   |   |   | Page 67      |
+----------------------------------------------+---+---+---+--------------+
| > **TOTALS:**                                |   |   |   |              |
| >                                            |   |   |   |              |
| > **(Add numbers of checked boxes in each    |   |   |   |              |
| > column)**                                  |   |   |   |              |
+----------------------------------------------+---+---+---+--------------+

+---------------------------------------------+---+---+---+---+---+---+---+
| **List the question numbers that were       |   |   |   |   |   |   |   |
| answered "N" in each of these areas.**      |   |   |   |   |   |   |   |
+---------------------------------------------+---+---+---+---+---+---+---+
|                                             | * |   |   |   |   |   |   |
|                                             | * |   |   |   |   |   |   |
|                                             | Q |   |   |   |   |   |   |
|                                             | u |   |   |   |   |   |   |
|                                             | e |   |   |   |   |   |   |
|                                             | s |   |   |   |   |   |   |
|                                             | t |   |   |   |   |   |   |
|                                             | i |   |   |   |   |   |   |
|                                             | o |   |   |   |   |   |   |
|                                             | n |   |   |   |   |   |   |
|                                             | N |   |   |   |   |   |   |
|                                             | u |   |   |   |   |   |   |
|                                             | m |   |   |   |   |   |   |
|                                             | b |   |   |   |   |   |   |
|                                             | e |   |   |   |   |   |   |
|                                             | r |   |   |   |   |   |   |
|                                             | 1 |   |   |   |   |   |   |
|                                             |   |   |   |   |   |   |   |
|                                             | - |   |   |   |   |   |   |
|                                             | 3 |   |   |   |   |   |   |
|                                             | 0 |   |   |   |   |   |   |
|                                             | * |   |   |   |   |   |   |
|                                             | * |   |   |   |   |   |   |
+---------------------------------------------+---+---+---+---+---+---+---+
| > General Evaluation                        |   |   |   |   |   |   |   |
+---------------------------------------------+---+---+---+---+---+---+---+
| > Benefits Evaluation                       |   |   |   |   |   |   |   |
+---------------------------------------------+---+---+---+---+---+---+---+
| > Risk Evaluation                           |   |   |   |   |   |   |   |
+---------------------------------------------+---+---+---+---+---+---+---+
| > Subject Selection And Recruitment         |   |   |   |   |   |   |   |
+---------------------------------------------+---+---+---+---+---+---+---+
| Confidentiality                             |   |   |   |   |   |   |   |
+---------------------------------------------+---+---+---+---+---+---+---+
| > IRB Decisions                             |   |   |   |   |   |   |   |
+---------------------------------------------+---+---+---+---+---+---+---+

+---+----------------------------------------------+---+----------------+
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+---+----------------------------------------------+---+----------------+

+----------------------------------------------+---+---+---+--------------+
| > **EXPEDITED REVIEW**                       | * | * | * | **Comments** |
|                                              | * | * | * |              |
|                                              | Y | N | N |              |
|                                              | * | * | / |              |
|                                              | * | * | A |              |
|                                              |   |   | * |              |
|                                              |   |   | * |              |
+----------------------------------------------+---+---+---+--------------+
| 1.  Did the IRB Chairperson or designee      |   |   |   | IRB Element  |
|     conduct the expedited review action?     |   |   |   | 4B, Factor 1 |
|                                              |   |   |   |              |
|                                              |   |   |   | Page 45      |
+----------------------------------------------+---+---+---+--------------+
| 2.  Was the IRB notified of the expedited    |   |   |   | IRB Element  |
|     review actions of the IRB Chairperson or |   |   |   | 4B, Factor 2 |
|     designee?                                |   |   |   |              |
|                                              |   |   |   | Page 45      |
+----------------------------------------------+---+---+---+--------------+
| 3.  Did the expedited action meet the        |   |   |   | IRB Element  |
|     regulatory requirements for use of       |   |   |   | 4B, Factor 3 |
|     expedited procedures?                    |   |   |   |              |
|                                              |   |   |   | Page 45      |
+----------------------------------------------+---+---+---+--------------+
| 4.  Did the IRB document the basis for       |   |   |   | IRB Element  |
|     allowing the expedited review            |   |   |   | 4B, Factor 4 |
|     procedures?                              |   |   |   |              |
|                                              |   |   |   | Page 45      |
+----------------------------------------------+---+---+---+--------------+
| > **TOTALS:**                                |   |   |   |              |
| >                                            |   |   |   |              |
| > **(Add numbers of checked boxes in each    |   |   |   |              |
| > column)**                                  |   |   |   |              |
+----------------------------------------------+---+---+---+--------------+

+-----------------------------------------------------------------------+
| **Please check your response to the following question:**             |
|                                                                       |
| Would the conduct of the expeditable review action achieve at least   |
| 50% score of IRB, Element 4B (Page 45 of the NCQA Accreditation       |
| Standards, Version 2.1)?                                              |
|                                                                       |
| YES NO                                                                |
+-----------------------------------------------------------------------+

+---+----------------------------------------------+---+----------------+
| ! | **Continuing Review**                        | ! | [**Back to     |
| [ |                                              | [ | Main           |
| ] |                                              | ] | Menu*          |
| ( |                                              | ( | *](#Main_Menu) |
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+---+----------------------------------------------+---+----------------+
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| . |                                              |   |                |
+---+----------------------------------------------+---+----------------+

+----------------------------------------------+---+---+---+--------------+
| > **CONTINUING REVIEW**                      | * | * | * | **Comments** |
|                                              | * | * | * |              |
|                                              | Y | N | N |              |
|                                              | * | * | / |              |
|                                              | * | * | A |              |
|                                              |   |   | * |              |
|                                              |   |   | * |              |
+----------------------------------------------+---+---+---+--------------+
| 1.  Did the IRB review the protocol prior to |   |   |   | IRB Element  |
|     expiration of the continuing review      |   |   |   | 3D, Factor   |
|     period or not allow the study to         |   |   |   | NA           |
|     continue if continuing review expired?   |   |   |   |              |
|                                              |   |   |   | Page 42      |
+----------------------------------------------+---+---+---+--------------+
| 2.  Did the IRB receive information from the |   |   |   | CRB Element  |
|     principal investigator documenting the   |   |   |   | 6C, Factor 1 |
|     number of subjects entered into the      |   |   |   |              |
|     study?                                   |   |   |   | Page 78      |
+----------------------------------------------+---+---+---+--------------+
| 3.  Did the IRB receive information from the |   |   |   | CRB Element  |
|     principal investigator documenting the   |   |   |   | 6C, Factor 2 |
|     gender of subjects entered into the      |   |   |   |              |
|     study?                                   |   |   |   | Page 78      |
+----------------------------------------------+---+---+---+--------------+
| 4.  Did the IRB document its review of       |   |   |   | CRB Element  |
|     serious adverse events during the        |   |   |   | 4B, Factor 1 |
|     continuing review evaluation?            |   |   |   |              |
|                                              |   |   |   | Page 70      |
+----------------------------------------------+---+---+---+--------------+
| 5.  Did the IRB document its review of       |   |   |   | CRB Element  |
|     amended or updated Investigator's        |   |   |   | 4B, Factor 2 |
|     Brochures during the continuing review   |   |   |   |              |
|     evaluation?                              |   |   |   | Page 70      |
+----------------------------------------------+---+---+---+--------------+
| 6.  Did the IRB document its review of new   |   |   |   | CRB Element  |
|     information available regarding the      |   |   |   | 4B, Factor 3 |
|     research project that may change the     |   |   |   |              |
|     risk/benefit ratio during the continuing |   |   |   | Page 70      |
|     review evaluation?                       |   |   |   |              |
+----------------------------------------------+---+---+---+--------------+
| 7.  Did the IRB document its review of       |   |   |   | CRB Element  |
|     research findings to date, including     |   |   |   | 4B, Factor 4 |
|     summary of subject experiences           |   |   |   |              |
|     (benefits, adverse reactions) during the |   |   |   | Page 70      |
|     continuing review evaluation?            |   |   |   |              |
+----------------------------------------------+---+---+---+--------------+
| 8.  Did the IRB document its review of the   |   |   |   | CRB Element  |
|     summary of safety monitoring reports     |   |   |   | 4B, Factor 5 |
|     during the continuing review evaluation? |   |   |   |              |
|                                              |   |   |   | Page 70      |
+----------------------------------------------+---+---+---+--------------+
| 9.  Did the IRB document its review of       |   |   |   | CRB Element  |
|     unanticipated problems involving risks   |   |   |   | 4B, Factor 6 |
|     to subjects during the continuing review |   |   |   |              |
|     evaluation?                              |   |   |   | Page 70      |
+----------------------------------------------+---+---+---+--------------+
| 10. Did the IRB document its review of       |   |   |   | CRB Element  |
|     enumeration of subjects withdrawn, and   |   |   |   | 4B, Factor 7 |
|     the reasons for withdrawal during the    |   |   |   |              |
|     continuing review evaluation?            |   |   |   | Page 70      |
+----------------------------------------------+---+---+---+--------------+
| > **TOTALS:**                                |   |   |   |              |
| >                                            |   |   |   |              |
| > **(Add numbers of checked boxes in each    |   |   |   |              |
| > column)**                                  |   |   |   |              |
+----------------------------------------------+---+---+---+--------------+

+-----------------------------------------------------------------------+
| **Please check your response to the following question:**             |
|                                                                       |
| Would the conduct of the continuing review process achieve at least   |
| 50% score of CRB, Element 4B (Page 70 of the NCQA Accreditation       |
| Standards, Version 2.1)?                                              |
|                                                                       |
| YES NO                                                                |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
|   -------                                                             |
| -------------------------------- ------------------------------------ |
| ------- --------------------------------------- --------------------- |
|   !                                                                   |
| [](media/image1.png){width="0.125in"   **Exempt Review**              |
|               ![](media/image1.png){width="0.125in"   [**Back to Main |
|   heigh                                                               |
| t="0.125in"}                                                          |
|           height="0.125in"}                       Menu**](#Main_Menu) |
|                                                                       |
|   -------                                                             |
| -------------------------------- ------------------------------------ |
| ------- --------------------------------------- --------------------- |
+-----------------------------------------------------------------------+
| []{#Exempt_Review .anchor}                                            |
|                                                                       |
| **Date Of Review:      **                                             |
|                                                                       |
| **Protocol Number:      **                                            |
|                                                                       |
| **Protocol Name:      **                                              |
|                                                                       |
| **DIRECTIONS:** Complete the "Exempt Review" tool by selecting at     |
| least three (3) VA research protocols that have been classified as    |
| exempt in the previous 12 months. Use a new "Exempt Review" tool for  |
| each separate VA research protocol. **Please mark "Y" for Yes, "N"    |
| for No, or "N/A" for not applicable to answer the following           |
| questions.**                                                          |
+-----------------------------------------------------------------------+

+--------------------------------------------+---+---+---+----------------+
| ** EXEMPT REVIEW**                         | * | * | * | **Comments**   |
|                                            | * | * | * |                |
|                                            | Y | N | N |                |
|                                            | * | * | / |                |
|                                            | * | * | A |                |
|                                            |   |   | * |                |
|                                            |   |   | * |                |
+--------------------------------------------+---+---+---+----------------+
| 1.  Did the research meet the regulatory   |   |   |   | IRB Element    |
|     requirements for use of exempt         |   |   |   | 4D, Factor 1:  |
|     allowable categories of research?      |   |   |   | Name           |
|                                            |   |   |   | regulatory     |
|                                            |   |   |   | reference:     |
|                                            |   |   |   |                |
|                                            |   |   |   | \_\_\_         |
|                                            |   |   |   | \_\_\_\_\_\_\_ |
|                                            |   |   |   | \_\_\_\_\_\_\_ |
|                                            |   |   |   | \_\_\_\_\_\_\_ |
+--------------------------------------------+---+---+---+----------------+
|                                            |   |   |   | Page 48        |
+--------------------------------------------+---+---+---+----------------+
| 2.  Did an authorized individual (IRB      |   |   |   | IRB Element    |
|     Chairperson or designate,              |   |   |   | 4D, Factor 2:  |
|     institutional official) conduct the    |   |   |   | Name           |
|     exempt review action?                  |   |   |   | authorized     |
|                                            |   |   |   | individual:    |
+--------------------------------------------+---+---+---+----------------+
|                                            |   |   |   |                |
+--------------------------------------------+---+---+---+----------------+
|                                            |   |   |   |  \_\_\_        |
|                                            |   |   |   | \_\_\_\_\_\_\_ |
|                                            |   |   |   | \_\_\_\_\_\_\_ |
|                                            |   |   |   | \_\_\_\_\_\_\_ |
+--------------------------------------------+---+---+---+----------------+
|                                            |   |   |   | Page 48        |
+--------------------------------------------+---+---+---+----------------+
| 3.  Did the IRB or institutional official  |   |   |   | IRB Element    |
|     generate a document that describes the |   |   |   | 4D, Factor 3:  |
|     basis for allowing the exempt review   |   |   |   | Type and Date  |
|     procedures?                            |   |   |   | of Exempt      |
|                                            |   |   |   | Review         |
|                                            |   |   |   | Documentation: |
|                                            |   |   |   |                |
|                                            |   |   |   | Type of        |
|                                            |   |   |   | Document:      |
|                                            |   |   |   |                |
|                                            |   |   |   | \_\_\_         |
|                                            |   |   |   | \_\_\_\_\_\_\_ |
|                                            |   |   |   | \_\_\_\_\_\_\_ |
|                                            |   |   |   | \_\_\_\_\_\_\_ |
|                                            |   |   |   |                |
|                                            |   |   |   | Date:          |
|                                            |   |   |   |                |
|                                            |   |   |   | \_\_\_         |
|                                            |   |   |   | \_\_\_\_\_\_\_ |
|                                            |   |   |   | \_\_\_\_\_\_\_ |
|                                            |   |   |   | \_\_\_\_\_\_\_ |
+--------------------------------------------+---+---+---+----------------+
|                                            |   |   |   | Page 48        |
+--------------------------------------------+---+---+---+----------------+
| **TOTALS:**                                |   |   |   |                |
+--------------------------------------------+---+---+---+----------------+
| **(Add numbers of checked boxes in each    |   |   |   |                |
| column)**                                  |   |   |   |                |
+--------------------------------------------+---+---+---+----------------+

+-----------------------------------------------------------------------+
| **Please check your response to the following question:**             |
|                                                                       |
| Would the conduct of the exempt review action achieve at least 50%    |
| score of IRB Element 4D (Page 48 of the NCQA Accreditation Standards, |
| Version 2.1)?                                                         |
|                                                                       |
| YES NO                                                                |
+-----------------------------------------------------------------------+

+---+---+----------------------------------------------+---+----------------+
| ! |   | []{#Basic_Consent .anchor}**Basic Elements   | ! | [**Back to     |
| [ |   | of Informed Consent**                        | [ | Main           |
| ] |   |                                              | ] | Menu*          |
| ( |   |                                              | ( | *](#Main_Menu) |
| m |   |                                              | m |                |
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+---+---+----------------------------------------------+---+----------------+

+--------------------------------------------------+---+---+---------+---+
| **BASIC ELEMENTS OF INFORMED CONSENT \*Must Pass | * | * | **IRB   | * |
| Element\***                                      | * | * | Con     | * |
|                                                  | Y | N | sidered | N |
|                                                  | * | * | &       | / |
|                                                  | * | * | Doc     | A |
|                                                  |   |   | umented | * |
|                                                  |   |   | Excl    | * |
|                                                  |   |   | usion** |   |
+--------------------------------------------------+---+---+---------+---+
| 1.  Does the ICF contain a statement that the    |   |   |         |   |
|     study involves research?                     |   |   |         |   |
|                                                  |   |   |         |   |
| > **ICS Element 1A, Factor 1, Page 84**          |   |   |         |   |
+--------------------------------------------------+---+---+---------+---+
| 2.  Does the ICF contain a statement of the      |   |   |         |   |
|     explanation of the purposes of the           |   |   |         |   |
|                                                  |   |   |         |   |
| > research?                                      |   |   |         |   |
| >                                                |   |   |         |   |
| > **ICS Element 1A, Factor 2, Page 84**          |   |   |         |   |
+--------------------------------------------------+---+---+---------+---+
| 3.  Does the ICF contain a statement of the      |   |   |         |   |
|     expected duration of the subject's           |   |   |         |   |
|     participation?                               |   |   |         |   |
|                                                  |   |   |         |   |
| > **ICS Element 1A, Factor 3, Page 84**          |   |   |         |   |
+--------------------------------------------------+---+---+---------+---+
| 4.  Does the ICF contain a description of the    |   |   |         |   |
|     procedures to be followed?                   |   |   |         |   |
|                                                  |   |   |         |   |
| > **ICS Element 1A, Factor 4, Page 84**          |   |   |         |   |
+--------------------------------------------------+---+---+---------+---+
| 5.  Does the ICF contain a statement of          |   |   |         |   |
|     identification of any experimental           |   |   |         |   |
|     procedures?                                  |   |   |         |   |
|                                                  |   |   |         |   |
| > **ICS Element 1A, Factor 5, Page 84**          |   |   |         |   |
+--------------------------------------------------+---+---+---------+---+
| 6.  Does the ICF contain a statement of a        |   |   |         |   |
|     description of any reasonably foreseeable    |   |   |         |   |
|     risks or discomforts to the subject?         |   |   |         |   |
|                                                  |   |   |         |   |
| > **ICS Element 1A, Factor 6, Page 84**          |   |   |         |   |
+--------------------------------------------------+---+---+---------+---+
| 7.  Does the ICF contain a description of any    |   |   |         |   |
|     benefits to the subjects or to others, which |   |   |         |   |
|     may reasonably be expected from research?    |   |   |         |   |
|                                                  |   |   |         |   |
| > **ICS Element 1A, Factor 7, Page 84**          |   |   |         |   |
+--------------------------------------------------+---+---+---------+---+
| 8.  Does the ICF contain a description of        |   |   |         |   |
|     appropriate alternative procedures or        |   |   |         |   |
|     sources of treatment (if any) that might be  |   |   |         |   |
|     advantageous to the subject?                 |   |   |         |   |
|                                                  |   |   |         |   |
| > **ICS Element 1A, Factor 8, Page 84**          |   |   |         |   |
+--------------------------------------------------+---+---+---------+---+
| 9.  Does the ICF contain a statement describing  |   |   |         |   |
|     the extent (if any) to which confidentiality |   |   |         |   |
|     of records identifying the subject will be   |   |   |         |   |
|     maintained?                                  |   |   |         |   |
|                                                  |   |   |         |   |
| > **ICS Element 1A, Factor 9, Page 84**          |   |   |         |   |
+--------------------------------------------------+---+---+---------+---+

+--------------------------------------------------+---+---+---------+---+
| **Basic Elements of Informed Consent             | * | * | **IRB   | * |
| Continued...**                                   | * | * | Con     | * |
|                                                  | Y | N | sidered | N |
|                                                  | * | * | &       | / |
|                                                  | * | * | Doc     | A |
|                                                  |   |   | umented | * |
|                                                  |   |   | Excl    | * |
|                                                  |   |   | usion** |   |
+--------------------------------------------------+---+---+---------+---+
| 10. If the study is FDA regulated, does the ICF  |   |   |         |   |
|     contain a statement that the FDA may inspect |   |   |         |   |
|     the records?                                 |   |   |         |   |
|                                                  |   |   |         |   |
| > **ICS Element 1A, Factor 10, Page 84**         |   |   |         |   |
+--------------------------------------------------+---+---+---------+---+
| 11. If the research is greater than minimal      |   |   |         |   |
|     risk, does the ICF contain an explanation as |   |   |         |   |
|     to whether any compensation exists if injury |   |   |         |   |
|     occurs?                                      |   |   |         |   |
|                                                  |   |   |         |   |
| > **ICS Element 1A, Factor 11 Page 84**          |   |   |         |   |
+--------------------------------------------------+---+---+---------+---+
| 12. If the research is greater than minimal      |   |   |         |   |
|     risk, does the ICF contain an explanation as |   |   |         |   |
|     to whether any medical treatments are        |   |   |         |   |
|     available if injury occurs, and if so, what  |   |   |         |   |
|     they consist of or where further information |   |   |         |   |
|     may be obtained and an explanation of whom   |   |   |         |   |
|     to contact in the event of a                 |   |   |         |   |
|     research-related injury to the subject?      |   |   |         |   |
|                                                  |   |   |         |   |
| > **ICS Element 1A, Factor 12, Page 84**         |   |   |         |   |
+--------------------------------------------------+---+---+---------+---+
| 13. Does the ICF contain an explanation of whom  |   |   |         |   |
|     to contact for answers to pertinent          |   |   |         |   |
|     questions about research and research        |   |   |         |   |
|     subjects' rights?                            |   |   |         |   |
|                                                  |   |   |         |   |
| > **ICS Element 1A, Factor 13, Page 84**         |   |   |         |   |
+--------------------------------------------------+---+---+---------+---+
| 14. Does the ICF contain a statement that        |   |   |         |   |
|     participation is voluntary?                  |   |   |         |   |
|                                                  |   |   |         |   |
| > **ICS Element 1A, Factor 14, Page 84**         |   |   |         |   |
+--------------------------------------------------+---+---+---------+---+
| 15. Does the ICF contain a statement that        |   |   |         |   |
|     refusal to participate will involve no       |   |   |         |   |
|     penalty or loss of benefits to which the     |   |   |         |   |
|     subject is otherwise entitled?               |   |   |         |   |
|                                                  |   |   |         |   |
| > **ICS Element 1A, Factor 15, Page 84**         |   |   |         |   |
+--------------------------------------------------+---+---+---------+---+
| 16. Does the ICF contain a statement that the    |   |   |         |   |
|     subject may discontinue participation at any |   |   |         |   |
|     time without penalty or loss of benefits to  |   |   |         |   |
|     which the subject is otherwise entitled?     |   |   |         |   |
|                                                  |   |   |         |   |
| > **ICS Element 1A, Factor 16, Page 85**         |   |   |         |   |
+--------------------------------------------------+---+---+---------+---+

+-----------------------------------------------------------------------+
| **Please check your response to the following question:**             |
|                                                                       |
| Would the Informed Consent Form achieve at least a 50% score of ICS,  |
| Element 1A, (Pages 84-85 of the NCQA Accreditation Standards, Version |
| 2.1)?                                                                 |
|                                                                       |
| YES NO                                                                |
+-----------------------------------------------------------------------+

+---+----------------------------------------------+---+----------------+
| ! | []{#AddElements .anchor}**Additional         | ! | [**Back to     |
| [ | Elements of Informed Consent**               | [ | Main           |
| ] |                                              | ] | Menu*          |
| ( |                                              | ( | *](#Main_Menu) |
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| d |                                              |   |                |
| c |                                              |   |                |
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| . |                                              |   |                |
| * |                                              |   |                |
| * |                                              |   |                |
+---+----------------------------------------------+---+----------------+

+-------------------------------------------+---+---+----------+--------+
| **ADDITIONAL ELEMENTS OF INFORMED         | * | * | **IRB    | *      |
| CONSENT**                                 | * | * | Co       | *N/A** |
|                                           | Y | N | nsidered |        |
|                                           | * | * | and      |        |
|                                           | * | * | Do       |        |
|                                           |   |   | cumented |        |
|                                           |   |   | Exc      |        |
|                                           |   |   | lusion** |        |
+-------------------------------------------+---+---+----------+--------+
| 1.  Is there a statement in the ICF that  |   |   |          |        |
|     a particular treatment or procedure   |   |   |          |        |
|     may involve risks to the subject (or  |   |   |          |        |
|     to the embryo or fetus, if the        |   |   |          |        |
|     subject is or may become pregnant)    |   |   |          |        |
|     which are currently unforeseeable?    |   |   |          |        |
|                                           |   |   |          |        |
| **ICS Element 1B, Factor 1, Page 86**     |   |   |          |        |
+-------------------------------------------+---+---+----------+--------+
| 2.  Is there a statement in the ICF of    |   |   |          |        |
|     anticipated circumstances under which |   |   |          |        |
|     the subject\'s participation may be   |   |   |          |        |
|     terminated by the investigator        |   |   |          |        |
|     without regard to the subject\'s      |   |   |          |        |
|     consent?                              |   |   |          |        |
|                                           |   |   |          |        |
| **ICS Element 1B, Factor 2, Page 86**     |   |   |          |        |
+-------------------------------------------+---+---+----------+--------+
| 3.  Is there a statement in the ICF of    |   |   |          |        |
|     any additional costs to the subject   |   |   |          |        |
|     that may result from participation in |   |   |          |        |
|     the research, consistent with the     |   |   |          |        |
|     Federal laws concerning veterans\'    |   |   |          |        |
|     eligibility for medical care and      |   |   |          |        |
|     treatment?                            |   |   |          |        |
|                                           |   |   |          |        |
| **ICS Element 1B, Factor 3, Page 86**     |   |   |          |        |
+-------------------------------------------+---+---+----------+--------+
| 4.  Is there a statement in the ICF of    |   |   |          |        |
|     the consequences of a subject\'s      |   |   |          |        |
|     decision to withdraw from the         |   |   |          |        |
|     research and procedures for orderly   |   |   |          |        |
|     termination of participation by the   |   |   |          |        |
|     subject?                              |   |   |          |        |
|                                           |   |   |          |        |
| **ICS Element 1B, Factor 4, Page 86**     |   |   |          |        |
+-------------------------------------------+---+---+----------+--------+
| 5.  Is there a statement in the ICF that  |   |   |          |        |
|     significant new findings developed    |   |   |          |        |
|     during the course of the research     |   |   |          |        |
|     which may relate to the subject\'s    |   |   |          |        |
|     willingness to continue participation |   |   |          |        |
|     will be provided to the subject?      |   |   |          |        |
|                                           |   |   |          |        |
| **ICS Element 1B, Factor 5, Page 86**     |   |   |          |        |
+-------------------------------------------+---+---+----------+--------+
| 6.  Is there a statement in the ICF of    |   |   |          |        |
|     the approximate number of subjects    |   |   |          |        |
|     involved in the study?                |   |   |          |        |
|                                           |   |   |          |        |
| > **ICS Element 1B, Factor 6, Page 86**   |   |   |          |        |
+-------------------------------------------+---+---+----------+--------+

+-------------------------------------------+---+---+-----------+--------+
| **Additional Elements Of Informed Consent | * | * | **IRB     | *      |
| Continued...**                            | * | * | C         | *N/A** |
|                                           | Y | N | onsidered |        |
|                                           | * | * | and       |        |
|                                           | * | * | D         |        |
|                                           |   |   | ocumented |        |
|                                           |   |   | Ex        |        |
|                                           |   |   | clusion** |        |
+-------------------------------------------+---+---+-----------+--------+
| > **TOTALS**                              |   |   |           |        |
| >                                         |   |   |           |        |
| > **(Add numbers of checked boxes in each |   |   |           |        |
| > column)**                               |   |   |           |        |
+-------------------------------------------+---+---+-----------+--------+

+-----------------------------------------------------------------------+
| **Please check your response to the following question:**             |
|                                                                       |
| Would the Informed Consent Form achieve at least a 50% score of ICS,  |
| Element 1B, (Pages 86-87 of the NCQA Accreditation Standards, Version |
| 2.1)?                                                                 |
|                                                                       |
| YES NO                                                                |
+-----------------------------------------------------------------------+

+---+----------------------------------------------+---+----------------+
| ! | []{#Approved .anchor}**Approved Consent      | ! | [**Back to     |
| [ | Forms -- Payment and Exculpatory Language**  | [ | Main           |
| ] |                                              | ] | Menu*          |
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+---+----------------------------------------------+---+----------------+

+-------------------------------------------+---+---+-----------+--------+
| **Approved Consent Forms -- Payment and   | * | * | **IRB     | *      |
| Exculpatory Language**                    | * | * | C         | *N/A** |
|                                           | Y | N | onsidered |        |
|                                           | * | * | and       |        |
|                                           | * | * | D         |        |
|                                           |   |   | ocumented |        |
|                                           |   |   | Ex        |        |
|                                           |   |   | clusion** |        |
+-------------------------------------------+---+---+-----------+--------+
| 1.  Does the ICF contain a statement      |   |   |           |        |
|     concerning the amount of payment to   |   |   |           |        |
|     subjects?                             |   |   |           |        |
|                                           |   |   |           |        |
| > **ICS Element 1C, Factor 1, Page 88**   |   |   |           |        |
+-------------------------------------------+---+---+-----------+--------+
| 2.  If the subject is receiving payment   |   |   |           |        |
|     for research participation, does the  |   |   |           |        |
|     ICF contain a schedule of when        |   |   |           |        |
|     payments will be made to the subject? |   |   |           |        |
|                                           |   |   |           |        |
| > **ICS Element 1C, Factor 2, Page 88**   |   |   |           |        |
+-------------------------------------------+---+---+-----------+--------+
| 3.  Does the ICF contain any exculpatory  |   |   |           |        |
|     language through which the subject or |   |   |           |        |
|     the subject's legally authorized      |   |   |           |        |
|     representative is made to waive or to |   |   |           |        |
|     appear to waive any of the subject's  |   |   |           |        |
|     legal rights, or releases or appears  |   |   |           |        |
|     to release the investigator, the      |   |   |           |        |
|     sponsor, the institution or its       |   |   |           |        |
|     agents from liability for negligence? |   |   |           |        |
|                                           |   |   |           |        |
| > **ICS Element 1C, Factor 3, Page 88**   |   |   |           |        |
+-------------------------------------------+---+---+-----------+--------+
| > **TOTALS**                              |   |   |           |        |
| >                                         |   |   |           |        |
| > **(Add numbers of checked boxes in each |   |   |           |        |
| > column)**                               |   |   |           |        |
+-------------------------------------------+---+---+-----------+--------+

+-----------------------------------------------------------------------+
| **Please check your response to the following question:**             |
|                                                                       |
| Would the Informed Consent Form achieve at least a 50% score of ICS,  |
| Element 1C, (Pages 88) of the NCQA Accreditation Standards, Version   |
| 2.1)?                                                                 |
|                                                                       |
| YES NO                                                                |
|                                                                       |
| NOTE: An answer of "N" on Question 3 allows the factor to be scored   |
| as met.                                                               |
+-----------------------------------------------------------------------+