**Office of Research Oversight (ORO)\
Human Research Protection Program (HRPP) Checklist**

**May 21, 2008**

This Checklist is provided to assist facilities in ensuring compliance
with regulations and policies for VA research involving human subjects,
including the Federal Policy (Common Rule) for the Protection of Human
Research Subjects at Title 38 Code of Federal Regulations (CFR) Part 16;
Food and Drug Administration (FDA) regulations at 21 CFR Parts 50, 56,
312, and 812; VHA Handbooks 1200.1 and 1200.5; and guidance from FDA and
the Office for Human Research Protections (OHRP). Please direct
questions about the checklist to your ORO Regional Office.

SOURCES OF DOCUMENTATION/EVIDENCE: Prior to conducting the review with
this checklist, it would be helpful to assemble the following documents:

1.  Institutional Review Board (IRB) and Research and Development (R&D)
    Committee minutes for the past 24 months

```{=html}
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```
1.  Current IRB and R&D Committee Membership Rosters (include
    credentials, representative capacity, and voting status)

2.  List of current approved projects/protocols involving human subjects

3.  IRB and R&D Committee Standard Operating Procedures

4.  Description of Human Research Protection Program (HRPP) with
    relevant organization chart(s)

5.  Current Federalwide Assurance (FWA) and VA FWA Addendum

6.  Annual IRB and HRPP Program Evaluations (if any)

8\. Internal and external inspection or monitoring reports of
investigators or research programs (if any) for the past 36 months

9\. Internal and external inspection or monitoring reports of the IRB(s)
of the HRPP for the past 36 months.

10.All existing Memoranda of Understanding or other agreements affecting
the HRPP, such as agreements for IRB services.

NOTE: The Association for Accreditation of Human Research Protection
Programs (AAHRPP) Evaluation Instrument for VA Facilities and their
academic affiliates may be found at:
[[http://www.aahrpp.org/Documents/D000103.PDF]{.underline}](http://www.aahrpp.org/Documents/D000103.PDF)

Please also see the ORO INSTITUTIONAL REVIEW BOARD (IRB) CHECKLIST and
THE ORO RESEARCH AND DEVELOPMENT COMMITTEE CHECKLIST located on ORO's
website at
[[http://www1.va.gov/oro/]{.underline}](http://www1.va.gov/oro/)

A list of acronyms related to human subject research is provided in the
Appendix.

VA Facility:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Reviewer:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Review Date:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

+------------------------+---+---+---+---+-------+-------+------+------------+
| ## **OFFICE OF RESE    |   |   |   |   |       |       |      |            |
| ARCH OVERSIGHT (ORO)** |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       |       |      |            |
| ## **HUMAN RESEARCH    |   |   |   |   |       |       |      |            |
| PROTECTION CHECKLIST** |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| **Element**            | > | > | > | > | **Re  | ###   | **AA | **Doc      |
|                        |   |   |   |   | gulat | # VHA | HRPP | umentation |
|                        | * | * | * | * | ion** |       | S    | / Evidence |
|                        | * | * | * | * |       | ####  | tand | / Notes**  |
|                        | Y | N | I | N |       |  Poli | ards |            |
|                        | e | o | n | / |       | cies  | &    |            |
|                        | s | * | - | A |       | & Gui | El   |            |
|                        | * | * | p | * |       | dance | emen |            |
|                        | * |   | a | * |       |       | ts** |            |
|                        |   |   | r |   |       |       |      |            |
|                        |   |   | t |   |       |       |      |            |
|                        |   |   | * |   |       |       |      |            |
|                        |   |   | * |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
|                        |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| **A. FEDERALWIDE       | * | * | * | * | **R   | **    | **   | **NOTES**  |
| ASSURANCE (FWA)**      | * | * | * | * | egs** | VHA** | AAHR |            |
|                        | Y | N | I | N |       |       | PP** |            |
|                        | * | * | P | A |       |       |      |            |
|                        | * | * | * | * |       |       |      |            |
|                        |   |   | * | * |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 1\. Copy of most       |   |   |   |   | [38   | VHA   | I    | OHRP FWA   |
| recent FWA submission  |   |   |   |   | CFR   | Han   | .1.A | Guidance   |
| is on file and         |   |   |   |   | 16.   | dbook |      |            |
| available for review.  |   |   |   |   | 103]( |       | I    |            |
| Facility will          |   |   |   |   | ../38 | 105   | .2.B |            |
| [not]{.underline} have |   |   |   |   | CFR16 | 8.03, |      |            |
| a copy of VA Addendum  |   |   |   |   | .htm# | 5     | I    |            |
| Page 2 signed by ORO,  |   |   |   |   | a103) |       | .3.K |            |
| or the FWA page signed |   |   |   |   |       | VHA   |      |            |
| by OHRP. These signed  |   |   |   |   | 45    | Han   |      |            |
| pages are not returned |   |   |   |   | CFR   | dbook |      |            |
| to the Facility but    |   |   |   |   | 4     | 12    |      |            |
| OHRP approval dates    |   |   |   |   | 6.103 | 00.5, |      |            |
| are verifiable on the  |   |   |   |   |       | 3.b.  |      |            |
| OHRP website           |   |   |   |   |       | and   |      |            |
|                        |   |   |   |   |       | 5.    |      |            |
|                        |   |   |   |   |       | a.(2) |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 2\. FWA is current     |   |   |   |   |       |       |      |            |
| (approved within the   |   |   |   |   |       |       |      |            |
| last 3 years).         |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 3\. FWA is signed by   |   |   |   |   |       |       |      |            |
| current Facility       |   |   |   |   |       |       |      |            |
| Director               |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       |       |      |            |
| (unless in position    |   |   |   |   |       |       |      |            |
| less than 30 days)     |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 4\. Human Protections  |   |   |   |   |       |       |      |            |
| Administrator          |   |   |   |   |       |       |      |            |
| designated on the FWA  |   |   |   |   |       |       |      |            |
| is current. (unless in |   |   |   |   |       |       |      |            |
| position less than 30  |   |   |   |   |       |       |      |            |
| days)                  |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 5\. FWA lists remote   |   |   |   |   |       |       |      |            |
| Facility sites         |   |   |   |   |       |       |      |            |
| conducting human       |   |   |   |   |       |       |      |            |
| research.              |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 6\. Copy of fully      |   |   |   |   |       |       |      |            |
| signed VA Addendum     |   |   |   |   |       |       |      |            |
| Page 1 is on file and  |   |   |   |   |       |       |      |            |
| available for review.  |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 7\. VA Addendum is     |   |   |   |   |       |       |      |            |
| current (approved      |   |   |   |   |       |       |      |            |
| within the last 3      |   |   |   |   |       |       |      |            |
| years).                |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 8\. VA Addendum is     |   |   |   |   |       |       |      |            |
| signed by current      |   |   |   |   |       |       |      |            |
| Facility Director.     |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       |       |      |            |
| (unless in position    |   |   |   |   |       |       |      |            |
| less than 30 days)     |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 9\. VA Addendum is     |   |   |   |   |       |       |      |            |
| signed by current      |   |   |   |   |       |       |      |            |
| Network Director.      |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       |       |      |            |
| (unless in position    |   |   |   |   |       |       |      |            |
| less than 30 days)     |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 10\. All changes in    |   |   |   |   |       |       |      |            |
| the FWA have been      |   |   |   |   |       |       |      |            |
| reported to OHRP       |   |   |   |   |       |       |      |            |
| through ORO. There is  |   |   |   |   |       |       |      |            |
| a 30-day time frame    |   |   |   |   |       |       |      |            |
| for reporting.         |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 11\. The facility's    |   |   |   |   |       |       |      |            |
| IRB(s) of record is    |   |   |   |   |       |       |      |            |
| (are) registered with  |   |   |   |   |       |       |      |            |
| OHRP.                  |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 12\. The facility's    |   |   |   |   | (see  | (see  | (see |            |
| IRB(s) of record is    |   |   |   |   | a     | a     | ab   |            |
| (are) designated in    |   |   |   |   | bove) | bove) | ove) |            |
| the FWA.               |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 13\. The membership    |   |   |   |   |       |       |      |            |
| roster(s) the          |   |   |   |   |       |       |      |            |
| facility's IRB(s) of   |   |   |   |   |       |       |      |            |
| record is (are)        |   |   |   |   |       |       |      |            |
| current.               |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 14\. All changes in    |   |   |   |   |       |       |      |            |
| IRB membership have    |   |   |   |   |       |       |      |            |
| been reported to OHRP  |   |   |   |   |       |       |      |            |
| through ORO. There is  |   |   |   |   |       |       |      |            |
| a 30-day timeframe for |   |   |   |   |       |       |      |            |
| reporting              |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 15\. IRB arrangements: |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       |       |      |            |
| \(a\) The facility     |   |   |   |   |       |       |      |            |
| operates its own       |   |   |   |   |       |       |      |            |
| IRB(s).                |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(1\) An IRB operated  |   |   |   |   |       |       |      |            |
| by the facility serves |   |   |   |   |       |       |      |            |
| as the IRB of record   |   |   |   |   |       |       |      |            |
| for another VA         |   |   |   |   |       |       |      |            |
| facility.              |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(2\) An IRB operated  |   |   |   |   |       |       |      |            |
| by the facility serves |   |   |   |   |       |       |      |            |
| as the IRB for a       |   |   |   |   |       |       |      |            |
| non-VA entity.         |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(b\) The facility     |   |   |   |   |       |       |      |            |
| relies upon IRB(s)     |   |   |   |   |       |       |      |            |
| operated by another    |   |   |   |   |       |       |      |            |
| entity. Suggest adding |   |   |   |   |       |       |      |            |
| the language in the    |   |   |   |   |       |       |      |            |
| handbook (see below).  |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(1\) The IRB is       |   |   |   |   |       |       |      |            |
| operated by an         |   |   |   |   |       |       |      |            |
| affiliated medical or  |   |   |   |   |       |       |      |            |
| dental school.         |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(2\) IRB associated   |   |   |   |   |       |       |      |            |
| with another VA        |   |   |   |   |       |       |      |            |
| facility or VA         |   |   |   |   |       |       |      |            |
| regional IRB.          |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(3\) The entity       |   |   |   |   |       |       |      |            |
| operating the IRB      |   |   |   |   |       |       |      |            |
| holds an FWA.          |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(4\) The facility     |   |   |   |   |       |       |      |            |
| uses the VA Central    |   |   |   |   |       |       |      |            |
| IRB (has current MOU   |   |   |   |   |       |       |      |            |
| with VHA HRPP)         |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(c\) The IRB is       |   |   |   |   |       |       |      |            |
| operated by another    |   |   |   |   |       |       |      |            |
| Federal Agency that is |   |   |   |   |       |       |      |            |
| signatory to the       |   |   |   |   |       |       |      |            |
| Common Rule (requires  |   |   |   |   |       |       |      |            |
| CRADO waiver).         |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+

+------------------------+---+---+---+---+-------+-------+------+------------+
| **B. TRAINING AND      | * | * | * | * | **R   | **    | **   | **NOTES**  |
| CREDENTIALS**          | * | * | * | * | egs** | VHA** | AAHR |            |
|                        | Y | N | I | N |       |       | PP** |            |
|                        | * | * | P | A |       |       |      |            |
|                        | * | * | * | * |       |       |      |            |
|                        |   |   | * | * |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 1\. The facility       |   |   |   |   |       | VHA   | I.   |            |
| maintains an education |   |   |   |   |       | Han   | 1.C, |            |
| plan and records of    |   |   |   |   |       | dbook | I.   |            |
| implementation for IRB |   |   |   |   |       | 12    | 4.A, |            |
| members, staff, and    |   |   |   |   |       | 00.5, | I    |            |
| investigators.         |   |   |   |   |       | 5.    | .4.B |            |
|                        |   |   |   |   |       | b.(3) |      |            |
|                        |   |   |   |   |       | &     |      |            |
|                        |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       | Fe    |      |            |
|                        |   |   |   |   |       | deral |      |            |
|                        |   |   |   |   |       | -wide |      |            |
|                        |   |   |   |   |       | Assu  |      |            |
|                        |   |   |   |   |       | rance |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 2\. The facility       |   |   |   |   | (see  | ORD   | (see |            |
| maintains a list of    |   |   |   |   | a     | Stand | ab   |            |
| all individuals        |   |   |   |   | bove) | Down  | ove) |            |
| involved in the        |   |   |   |   |       | M     |      |            |
| conduct of human       |   |   |   |   |       | emora |      |            |
| research.              |   |   |   |   |       | ndum, |      |            |
|                        |   |   |   |   |       | 3/6/  |      |            |
|                        |   |   |   |   |       | 2003, |      |            |
|                        |   |   |   |   |       | No.   |      |            |
|                        |   |   |   |   |       | 5.(a  |      |            |
|                        |   |   |   |   |       | )-(c) |      |            |
|                        |   |   |   |   |       | and   |      |            |
|                        |   |   |   |   |       | No.   |      |            |
|                        |   |   |   |   |       | 6.    |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 3\. All individuals    |   |   |   |   |       |       |      |            |
| involved in the        |   |   |   |   |       |       |      |            |
| conduct of human       |   |   |   |   |       |       |      |            |
| research have received |   |   |   |   |       |       |      |            |
| appropriate human      |   |   |   |   |       |       |      |            |
| research protection    |   |   |   |   |       |       |      |            |
| training on an annual  |   |   |   |   |       |       |      |            |
| basis.                 |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 4\. All individuals    |   |   |   |   |       |       |      |            |
| involved in the        |   |   |   |   |       |       |      |            |
| conduct of human       |   |   |   |   |       |       |      |            |
| research have received |   |   |   |   |       |       |      |            |
| appropriate GCP        |   |   |   |   |       |       |      |            |
| training on an annual  |   |   |   |   |       |       |      |            |
| basis.                 |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 5\. The facility       |   |   |   |   |       |       |      |            |
| maintains an accurate  |   |   |   |   |       |       |      |            |
| listing of the         |   |   |   |   |       |       |      |            |
| credentials and scope  |   |   |   |   |       |       |      |            |
| of practice for all    |   |   |   |   |       |       |      |            |
| individuals involved   |   |   |   |   |       |       |      |            |
| in the conduct of      |   |   |   |   |       |       |      |            |
| human research.        |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 6\. All unlicensed     |   |   |   |   |       | VA    |      |            |
| physicians (and all    |   |   |   |   |       | Dire  |      |            |
| other providers        |   |   |   |   |       | ctive |      |            |
| eligible for licensure |   |   |   |   |       | pe    |      |            |
| or certification under |   |   |   |   |       | nding |      |            |
| applicable state law)  |   |   |   |   |       |       |      |            |
| involved in research   |   |   |   |   |       |       |      |            |
| have specific scopes   |   |   |   |   |       |       |      |            |
| of practice            |   |   |   |   |       |       |      |            |
| appropriately limiting |   |   |   |   |       |       |      |            |
| their activities.      |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
|                        |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+

+------------------------+---+---+---+---+-------+-------+------+------------+
| **C. RESEARCH &        | * | * | * | * | **R   | **    | **   | **NOTES**  |
| DEVELOPMENT COMMITTEE  | * | * | * | * | egs** | VHA** | AAHR |            |
| (R&DC): HRPP           | Y | N | I | N |       |       | PP** |            |
| Responsibilities**     | * | * | P | A |       |       |      |            |
|                        | * | * | * | * |       |       |      |            |
|                        |   |   | * | * |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 1 The R&DC evaluates   |   |   |   |   |       | VHA   | I    |            |
| critically the         |   |   |   |   |       | Han   | .1.A |            |
| quality, design,       |   |   |   |   |       | dbook | ,B,C |            |
| desirability, and      |   |   |   |   |       | 12    |      |            |
| feasibility of each    |   |   |   |   |       | 00.1, | I.2  |            |
| new R&D proposal,      |   |   |   |   |       | 10.   | .A,B |            |
| continuing R&D         |   |   |   |   |       |       | ,C,D |            |
| project, application   |   |   |   |   |       |       |      |            |
| for funding,           |   |   |   |   |       |       | 1    |            |
| manuscript to be       |   |   |   |   |       |       | .3.A |            |
| submitted for          |   |   |   |   |       |       | ,B,C |            |
| publication, or other  |   |   |   |   |       |       | ,D,E |            |
| reporting activity to  |   |   |   |   |       |       | ,G,H |            |
| assure maintenance of  |   |   |   |   |       |       |      |            |
| high scientific        |   |   |   |   |       |       | 1.   |            |
| standards and          |   |   |   |   |       |       | 5.A, |            |
| protection of human    |   |   |   |   |       |       |      |            |
| subjects.              |   |   |   |   |       |       | II   |            |
|                        |   |   |   |   |       |       | .1.D |            |
|                        |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       |       | II.2 |            |
|                        |   |   |   |   |       |       | .A,B |            |
|                        |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       |       | II.7 |            |
|                        |   |   |   |   |       |       | ,C,D |            |
|                        |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       |       | II.  |            |
|                        |   |   |   |   |       |       | 3.A, |            |
|                        |   |   |   |   |       |       | A,B, |            |
|                        |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       |       | IV   |            |
|                        |   |   |   |   |       |       | .1,B |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 2\. The R&DC reviews   |   |   |   |   |       | VHA   |      |            |
| all human research     |   |   |   |   |       | Han   |      |            |
| under the auspices of  |   |   |   |   |       | dbook |      |            |
| the facility,          |   |   |   |   |       | 12    |      |            |
| initially and at least |   |   |   |   |       | 00.1, |      |            |
| once a year, including |   |   |   |   |       | 10.   |      |            |
| research determined    |   |   |   |   |       |       |      |            |
| exempt by the IRB.     |   |   |   |   |       | VHA   |      |            |
|                        |   |   |   |   |       | Han   |      |            |
|                        |   |   |   |   |       | dbook |      |            |
|                        |   |   |   |   |       | 12    |      |            |
|                        |   |   |   |   |       | 00.5, |      |            |
|                        |   |   |   |   |       | 4.b.  |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 3\. The facility's     |   |   |   |   |       | VHA   |      |            |
| designated IRB(s) is   |   |   |   |   |       | Han   |      |            |
| (are) established as   |   |   |   |   |       | dbook |      |            |
| an R&DC Subcommittee.  |   |   |   |   |       | 12    |      |            |
|                        |   |   |   |   |       | 00.5, |      |            |
|                        |   |   |   |   |       | 5.    |      |            |
|                        |   |   |   |   |       | a.(1) |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 4\. At least one of    |   |   |   |   |       | VHA   |      |            |
| the IRB members is a   |   |   |   |   |       | Han   |      |            |
| member of, or liaison  |   |   |   |   |       | dbook |      |            |
| to, the R&DC.          |   |   |   |   |       | 12    |      |            |
|                        |   |   |   |   |       | 00.1, |      |            |
|                        |   |   |   |   |       | 6.m.  |      |            |
|                        |   |   |   |   |       | &     |      |            |
|                        |   |   |   |   |       | 8.b.  |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 5\. Review of human    |   |   |   |   |       |       | (see |            |
| research by the R&DC   |   |   |   |   |       |       | ab   |            |
| includes review of any |   |   |   |   |       |       | ove) |            |
| financial conflicts of |   |   |   |   |       |       |      |            |
| interest related to    |   |   |   |   |       |       |      |            |
| all members of the     |   |   |   |   |       |       |      |            |
| research team and any  |   |   |   |   |       |       |      |            |
| others who may         |   |   |   |   |       |       |      |            |
| influence the conduct  |   |   |   |   |       |       |      |            |
| or the reporting of    |   |   |   |   |       |       |      |            |
| the research,          |   |   |   |   |       |       |      |            |
| including sponsors.    |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| **SEE SEPARATE ORO     |   |   |   |   |       |       |      |            |
| R&DC CHECKLIST FOR     |   |   |   |   |       |       |      |            |
| ADDITIONAL             |   |   |   |   |       |       |      |            |
| REQUIREMENTS.**        |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+

+------------------------+---+---+---+---+-------+-------+------+------------+
| **D. INVESTIGATORS'    | * | * | * | * | **R   | **    | **   | **NOTES**  |
| RESPONSIBILITIES**     | * | * | * | * | egs** | VHA** | AAHR |            |
|                        | Y | N | I | N |       |       | PP** |            |
|                        | * | * | P | A |       |       |      |            |
|                        | * | * | * | * |       |       |      |            |
|                        |   |   | * | * |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 1\. In interacting     |   |   |   |   |       |       | I    |            |
| with the IRB, R&D      |   |   |   |   |       |       | .4.B |            |
| Committee, and         |   |   |   |   |       |       |      |            |
| Sponsor, investigators |   |   |   |   |       |       | II   |            |
| fulfill all            |   |   |   |   |       |       | .7.D |            |
| requirements and       |   |   |   |   |       |       |      |            |
| maintains required     |   |   |   |   |       |       | II   |            |
| documentation related  |   |   |   |   |       |       | I.1. |            |
| to:                    |   |   |   |   |       |       | &    |            |
|                        |   |   |   |   |       |       | II   |            |
| \(a\) Initial          |   |   |   |   |       |       | I.2. |            |
| application.           |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(b\) Protocol or      |   |   |   |   | 21    |       |      | FDA        |
| research plan.         |   |   |   |   | CFR   |       |      | Guidance   |
|                        |   |   |   |   | 312   |       |      | on "Record |
|                        |   |   |   |   |       |       |      | Keeping in |
|                        |   |   |   |   | 21    |       |      | Clinical   |
|                        |   |   |   |   | CFR   |       |      | Inves      |
|                        |   |   |   |   | 812   |       |      | tigations" |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(c\) IRB-approved     |   |   |   |   | 38    | VHA   |      |            |
| Research Consent Form  |   |   |   |   | CFR   | Han   |      |            |
| ([VA Form              |   |   |   |   | 16.1  | dbook |      |            |
| 10-1                   |   |   |   |   | 09(c) | 1     |      |            |
| 086](../consent.doc)). |   |   |   |   |       | 200.5 |      |            |
|                        |   |   |   |   | 21    |       |      |            |
|                        |   |   |   |   | CFR   |       |      |            |
|                        |   |   |   |   |       |       |      |            |
|                        |   |   |   |   | 56.   |       |      |            |
|                        |   |   |   |   | 111(a |       |      |            |
|                        |   |   |   |   | )(1), |       |      |            |
|                        |   |   |   |   | (4-5) |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(d\) IRB-approved     |   |   |   |   |       | VHA   | I    |            |
| waiver of consent.     |   |   |   |   |       | Han   | .4.B |            |
|                        |   |   |   |   |       | dbook |      |            |
|                        |   |   |   |   |       | 12    | II   |            |
|                        |   |   |   |   |       | 00.5, | .7.D |            |
|                        |   |   |   |   |       | App.  |      |            |
|                        |   |   |   |   |       | C.    | II   |            |
|                        |   |   |   |   |       | 2.c.  | I.1. |            |
|                        |   |   |   |   |       | (2)   | &    |            |
|                        |   |   |   |   |       |       | II   |            |
|                        |   |   |   |   |       |       | I.2. |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(e\) IRB-approved     |   |   |   |   |       | VHA   |      |            |
| waiver of              |   |   |   |   |       | Han   |      |            |
| documentation of       |   |   |   |   |       | dbook |      |            |
| consent.               |   |   |   |   |       | 12    |      |            |
|                        |   |   |   |   |       | 00.5, |      |            |
|                        |   |   |   |   |       | App.  |      |            |
|                        |   |   |   |   |       | C.    |      |            |
|                        |   |   |   |   |       | 3.f.  |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(f\) HIPAA            |   |   |   |   |       | VHA   |      |            |
| authorization if       |   |   |   |   |       | Han   |      |            |
| separate from informed |   |   |   |   |       | dbook |      |            |
| consent.               |   |   |   |   |       | 12    |      |            |
|                        |   |   |   |   |       | 00.5, |      |            |
|                        |   |   |   |   |       | 10.j. |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(g\) IRB-approved     |   |   |   |   |       | ORD   |      |            |
| waiver of HIPAA        |   |   |   |   |       | Memo: |      |            |
| authorization.         |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       | HIPAA |      |            |
|                        |   |   |   |   |       | Pr    |      |            |
|                        |   |   |   |   |       | ivacy |      |            |
|                        |   |   |   |   |       | Rule  |      |            |
|                        |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       | 2/    |      |            |
|                        |   |   |   |   |       | 12/03 |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(h\) Investigator's   |   |   |   |   | 21CFR |       |      | FDA Form   |
| brochure (DRUGS).      |   |   |   |   | 3     |       |      | 1572       |
|                        |   |   |   |   | 12.53 |       |      | (DRUGS)    |
|                        |   |   |   |   | (c)   |       |      |            |
|                        |   |   |   |   | (1)(v |       |      |            |
|                        |   |   |   |   | i)(f) |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(i\) IRB-approved     |   |   |   |   | 21    |       |      |            |
| study advertising      |   |   |   |   | CFR   |       |      |            |
| material.              |   |   |   |   | 56.1  |       |      |            |
|                        |   |   |   |   | 09(a) |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(j\) Report of        |   |   |   |   | # 21  | VHA   |      | FDA Form   |
| Subcommittee on Human  |   |   |   |   | CFR 8 | Han   |      | 1572       |
| Studies (VA Form       |   |   |   |   | 12.60 | dbook |      | (DRUGS)    |
| 10-1223).              |   |   |   |   |  & 64 | 12    |      |            |
|                        |   |   |   |   |       | 00.5, |      |            |
|                        |   |   |   |   | 21CFR | 10.h. |      |            |
|                        |   |   |   |   | 3     |       |      |            |
|                        |   |   |   |   | 12.53 |       |      |            |
|                        |   |   |   |   | (     |       |      |            |
|                        |   |   |   |   | c)(1) |       |      |            |
|                        |   |   |   |   | (vii) |       |      |            |
|                        |   |   |   |   | &     |       |      |            |
|                        |   |   |   |   | 3     |       |      |            |
|                        |   |   |   |   | 12.66 |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 2\. Investigators      |   |   |   |   | #     | VHA   |      |            |
| fulfill all            |   |   |   |   |  21 C | Han   |      |            |
| requirements and       |   |   |   |   | FR 81 | dbook |      |            |
| maintain required      |   |   |   |   | 2.150 | 12    |      |            |
| documentation related  |   |   |   |   |       | 00.5, |      |            |
| to Continuing Review:  |   |   |   |   |       | 7.i.  |      |            |
|                        |   |   |   |   |       |       |      |            |
| \(a\) Progress reports |   |   |   |   |       |       |      |            |
| submitted to the       |   |   |   |   |       |       |      |            |
| reviewing IRB at       |   |   |   |   |       |       |      |            |
| interval determined by |   |   |   |   |       |       |      |            |
| the IRB, but not more  |   |   |   |   |       |       |      |            |
| than 365 days.         |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(b\) Report of        |   |   |   |   | # 21  | VHA   |      | NOTE: The  |
| Subcommittee on Human  |   |   |   |   | CFR 8 | Han   |      | sections   |
| Studies (VA Form       |   |   |   |   | 12.60 | dbook |      | of 312     |
| 10-1223) or other      |   |   |   |   |  & 64 | 12    |      | relate to  |
| official document      |   |   |   |   |       | 00.5, |      | using a    |
| approving continuing   |   |   |   |   | # 21C | 10.h. |      | properly   |
| review.                |   |   |   |   | FR 31 |       |      | c          |
|                        |   |   |   |   | 2.53  |       |      | onstituted |
|                        |   |   |   |   | (c)(1 |       |      | IRB and    |
|                        |   |   |   |   | )(vii |       |      | following  |
|                        |   |   |   |   | ) & 3 |       |      | the        |
|                        |   |   |   |   | 12.66 |       |      | re         |
|                        |   |   |   |   |       |       |      | gulations, |
|                        |   |   |   |   |       |       |      | NOT to     |
|                        |   |   |   |   |       |       |      | keeping    |
|                        |   |   |   |   |       |       |      | records.   |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(c\) Current version  |   |   |   |   | 38    | VHA   |      |            |
| of IRB-approved        |   |   |   |   | CFR   | Han   |      |            |
| Research Consent Form  |   |   |   |   | 16.1  | dbook |      |            |
| ([VA Form              |   |   |   |   | 09(c) | 1     |      |            |
| 10-1                   |   |   |   |   |       | 200.5 |      |            |
| 086](../consent.doc)). |   |   |   |   | 21    |       |      |            |
|                        |   |   |   |   | CFR   |       |      |            |
|                        |   |   |   |   |       |       |      |            |
|                        |   |   |   |   | 56.   |       |      |            |
|                        |   |   |   |   | 111(a |       |      |            |
|                        |   |   |   |   | )(1), |       |      |            |
|                        |   |   |   |   | (4-5) |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 3\. Investigators      |   |   |   |   |       | VHA   |      |            |
| fulfill all            |   |   |   |   |       | Han   |      |            |
| requirements and       |   |   |   |   |       | dbook |      |            |
| maintain required      |   |   |   |   |       | 12    |      |            |
| documentation related  |   |   |   |   |       | 00.5, |      |            |
| Adverse Events:        |   |   |   |   |       | 10.f. |      |            |
|                        |   |   |   |   |       |       |      |            |
| \(a\) Copies of SAE    |   |   |   |   |       |       |      |            |
| and/or UAE reports.    |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(b\) (DEVICE)         |   |   |   |   | 38    | VHA   |      |            |
| Documentation of       |   |   |   |   | CFR   | Han   |      |            |
| report to the sponsor  |   |   |   |   | 16    | dbook |      |            |
| and to the reviewing   |   |   |   |   | .103( | 12    |      |            |
| IRB of any             |   |   |   |   | b)(5) | 00.5, |      |            |
| unanticipated adverse  |   |   |   |   |       | 10.f. |      |            |
| device effects, within |   |   |   |   | 21    |       |      |            |
| 10 working days after  |   |   |   |   | CFR   |       |      |            |
| first learning of the  |   |   |   |   | 56.   |       |      |            |
| effect.                |   |   |   |   | 108(b |       |      |            |
|                        |   |   |   |   | )(1), |       |      |            |
|                        |   |   |   |   | 56.1  |       |      |            |
|                        |   |   |   |   | 15(a) |       |      |            |
|                        |   |   |   |   | (1),( |       |      |            |
|                        |   |   |   |   | 3-4), |       |      |            |
|                        |   |   |   |   |       |       |      |            |
|                        |   |   |   |   | 5     |       |      |            |
|                        |   |   |   |   | 6.113 |       |      |            |
|                        |   |   |   |   | &     |       |      |            |
|                        |   |   |   |   | 81    |       |      |            |
|                        |   |   |   |   | 2.150 |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 4\. Investigators      |   |   |   |   | #     | VHA   | (see | (DRUG) FDA |
| fulfill all            |   |   |   |   | 21 CF | Han   | ab   | Form 1572  |
| requirements and       |   |   |   |   | R 312 | dbook | ove) |            |
| maintain required      |   |   |   |   | .66,  | 12    |      |            |
| documentation related  |   |   |   |   | 312.5 | 00.5, |      |            |
| to protocol changes    |   |   |   |   | 3 (c) | 10.g. |      |            |
| and amendments:        |   |   |   |   | (1)(v |       |      |            |
|                        |   |   |   |   | ii),  | VHA   |      |            |
| \(a\) IRB-approved (VA |   |   |   |   | 812.6 | Han   |      |            |
| Form 10-1223 or other  |   |   |   |   | 0 & 8 | dbook |      |            |
| official document) and |   |   |   |   | 12.64 | 12    |      |            |
| R&D-approved           |   |   |   |   |       | 00.5, |      |            |
| modifications and      |   |   |   |   |       | 10.h. |      |            |
| amendments to the      |   |   |   |   |       |       |      |            |
| protocol packet or     |   |   |   |   |       |       |      |            |
| research plan .        |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(b\) Most recent      |   |   |   |   | 38    | VHA   |      |            |
| version of             |   |   |   |   | CFR   | Han   |      |            |
| IRB-approved Research  |   |   |   |   | 16.1  | dbook |      |            |
| Consent Form ([VA Form |   |   |   |   | 09(c) | 1     |      |            |
| 10-1                   |   |   |   |   |       | 200.5 |      |            |
| 086](../consent.doc)). |   |   |   |   | 21    |       |      |            |
|                        |   |   |   |   | CFR   |       |      |            |
|                        |   |   |   |   | 56.   |       |      |            |
|                        |   |   |   |   | 111(a |       |      |            |
|                        |   |   |   |   | )(1), |       |      |            |
|                        |   |   |   |   | (4-5) |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(c\) In situations    |   |   |   |   | 38    |       | ###  | (DRUG) FDA |
| where the protocol has |   |   |   |   | CFR   |       | ###  | Form 1572  |
| been modified prior to |   |   |   |   | 16    |       |      |            |
| IRB approval to        |   |   |   |   | .103( |       |      | #####      |
| protect the safety,    |   |   |   |   | b)(4) |       |      | # (DEVICE) |
| rights or welfare of   |   |   |   |   | (iii) |       |      |  Signed In |
| the subjects,          |   |   |   |   |       |       |      | vestigator |
| documentation is sent  |   |   |   |   | 21    |       |      |  Agreement |
| to sponsor and the     |   |   |   |   | CFR   |       |      |            |
| IRB.                   |   |   |   |   | 56.   |       |      |            |
|                        |   |   |   |   | 108(a |       |      |            |
|                        |   |   |   |   | )(4), |       |      |            |
|                        |   |   |   |   | 3     |       |      |            |
|                        |   |   |   |   | 12.53 |       |      |            |
|                        |   |   |   |   | (c)   |       |      |            |
|                        |   |   |   |   | (1)(v |       |      |            |
|                        |   |   |   |   | i)(a) |       |      |            |
|                        |   |   |   |   | &     |       |      |            |
|                        |   |   |   |   | 8     |       |      |            |
|                        |   |   |   |   | 12.43 |       |      |            |
|                        |   |   |   |   | (c)(  |       |      |            |
|                        |   |   |   |   | 4)(i) |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 5\. (DEVICE)           |   |   |   |   | 21    |       |      |            |
| Investigators fulfill  |   |   |   |   | CFR   |       |      |            |
| all requirements and   |   |   |   |   | 81    |       |      |            |
| maintain required      |   |   |   |   | 2.140 |       |      |            |
| documentation related  |   |   |   |   | (     |       |      |            |
| to correspondence with |   |   |   |   | a)(1) |       |      |            |
| other investigators,   |   |   |   |   |       |       |      |            |
| the IRB, the sponsor,  |   |   |   |   |       |       |      |            |
| monitors, or the FDA.  |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 6\. (Exempt Research)  |   |   |   |   |       | VHA   |      |            |
| Investigators fulfill  |   |   |   |   |       | Han   |      |            |
| all requirements and   |   |   |   |   |       | dbook |      |            |
| maintain required      |   |   |   |   |       | 12    |      |            |
| documentation related  |   |   |   |   |       | 00.5, |      |            |
| to exempt research.    |   |   |   |   |       | 8.b.  |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 7\. Investigators      |   |   |   |   | 21    | VHA   |      |            |
| fulfill all            |   |   |   |   | CFR   | Han   |      |            |
| requirements related   |   |   |   |   | 3     | dbook |      |            |
| to regulatory          |   |   |   |   | 12.60 | 12    |      |            |
| documentation:         |   |   |   |   |       | 00.5, |      |            |
|                        |   |   |   |   | &     | 14 &  |      |            |
| \(a\) (DRUG) A signed  |   |   |   |   | 81    | 15    |      |            |
| Statement of           |   |   |   |   | 2.100 |       |      |            |
| Investigator (FDA Form |   |   |   |   |       |       |      |            |
| 1572) or (DEVICE) a    |   |   |   |   |       |       |      |            |
| signed investigator's  |   |   |   |   |       |       |      |            |
| agreement.             |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 8\. Investigators      |   |   |   |   |       | VHA   |      |            |
| fulfill all            |   |   |   |   |       | Han   |      |            |
| requirements and       |   |   |   |   |       | dbook |      |            |
| maintain required      |   |   |   |   |       | 12    |      |            |
| documentation related  |   |   |   |   |       | 00.5, |      |            |
| to progress reports:   |   |   |   |   |       | 7.g.( |      |            |
|                        |   |   |   |   |       | 1)(a) |      |            |
| \(a\) Brief summary of |   |   |   |   |       |       |      |            |
| the research           |   |   |   |   |       |       |      |            |
| methodology and        |   |   |   |   |       |       |      |            |
| procedures.            |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(b\) Number of        |   |   |   |   |       | VHA   |      |            |
| subjects entered and   |   |   |   |   |       | Han   |      |            |
| withdrawn (including   |   |   |   |   |       | dbook |      |            |
| the reason for         |   |   |   |   |       | 12    |      |            |
| withdrawal) for the    |   |   |   |   |       | 00.5, |      |            |
| review period and      |   |   |   |   |       | 7.g.( |      |            |
| since the inception of |   |   |   |   |       | 1)(b) |      |            |
| the research project.  |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(c\) The gender and   |   |   |   |   |       | VHA   |      |            |
| minority status of     |   |   |   |   |       | Han   |      |            |
| those entered into the |   |   |   |   |       | dbook |      |            |
| protocol.              |   |   |   |   |       | 12    |      |            |
|                        |   |   |   |   |       | 00.5, |      |            |
|                        |   |   |   |   |       | 7.g.( |      |            |
|                        |   |   |   |   |       | 1)(c) |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(d\) Number of        |   |   |   |   |       | VHA   |      |            |
| subjects considered as |   |   |   |   |       | Han   |      |            |
| members of specific    |   |   |   |   |       | dbook |      |            |
| vulnerable             |   |   |   |   |       | 12    |      |            |
| populations.           |   |   |   |   |       | 00.5, |      |            |
|                        |   |   |   |   |       | 7.g.( |      |            |
|                        |   |   |   |   |       | 1)(d) |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(e\) A copy of the    |   |   |   |   |       | VHA   |      |            |
| proposal and all       |   |   |   |   |       | Han   |      |            |
| approved amendments.   |   |   |   |   |       | dbook |      |            |
|                        |   |   |   |   |       | 12    |      |            |
|                        |   |   |   |   |       | 00.5, |      |            |
|                        |   |   |   |   |       | 7.g.( |      |            |
|                        |   |   |   |   |       | 1)(e) |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(f\) A copy of the    |   |   |   |   |       | VHA   | (see |            |
| current consent        |   |   |   |   |       | Han   | ab   |            |
| document for the IRB   |   |   |   |   |       | dbook | ove) |            |
| to review.             |   |   |   |   |       | 12    |      |            |
|                        |   |   |   |   |       | 00.5, |      |            |
|                        |   |   |   |   |       | 7.g.( |      |            |
|                        |   |   |   |   |       | 1)(f) |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(g\) A copy of the    |   |   |   |   |       | VHA   |      |            |
| current HIPAA          |   |   |   |   |       | Han   |      |            |
| Authorization          |   |   |   |   |       | dbook |      |            |
| document, if separate  |   |   |   |   |       | 12    |      |            |
| from the informed      |   |   |   |   |       | 00.5, |      |            |
| consent.               |   |   |   |   |       | 7.g.( |      |            |
|                        |   |   |   |   |       | 1)(g) |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(h\) Information that |   |   |   |   |       | VHA   |      |            |
| may impact on the risk |   |   |   |   |       | Han   |      |            |
| benefit ratio such as  |   |   |   |   |       | dbook |      |            |
| AEs, unanticipated     |   |   |   |   |       | 12    |      |            |
| problems, and/or       |   |   |   |   |       | 00.5, |      |            |
| complaints regarding   |   |   |   |   |       | 7.g.( |      |            |
| the research.          |   |   |   |   |       | 1)(h) |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(i\) Research         |   |   |   |   |       | VHA   |      |            |
| findings to date, if   |   |   |   |   |       | Han   |      |            |
| available.             |   |   |   |   |       | dbook |      |            |
|                        |   |   |   |   |       | 12    |      |            |
|                        |   |   |   |   |       | 00.5, |      |            |
|                        |   |   |   |   |       | 7.g.( |      |            |
|                        |   |   |   |   |       | 1)(i) |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(j\) Summary of the   |   |   |   |   |       | VHA   |      |            |
| DSMB or DMC meetings   |   |   |   |   |       | Han   |      |            |
| (if applicable) or     |   |   |   |   |       | dbook |      |            |
| findings based on      |   |   |   |   |       | 12    |      |            |
| information collected  |   |   |   |   |       | 00.5, |      |            |
| by the data and safety |   |   |   |   |       | 7.g.( |      |            |
| monitoring plan        |   |   |   |   |       | 1)(j) |      |            |
| submitted in the       |   |   |   |   |       |       |      |            |
| initial proposal.      |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(k\) An assurance     |   |   |   |   |       | VHA   |      |            |
| that all SAEs and UAEs |   |   |   |   |       | Han   |      |            |
| have been reported, as |   |   |   |   |       | dbook |      |            |
| required.              |   |   |   |   |       | 12    |      |            |
|                        |   |   |   |   |       | 00.5, |      |            |
|                        |   |   |   |   |       | 7.g.( |      |            |
|                        |   |   |   |   |       | 1)(k) |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(l\) New scientific   |   |   |   |   |       | VHA   |      |            |
| findings in the        |   |   |   |   |       | Han   |      |            |
| literature, or other   |   |   |   |   |       | dbook |      |            |
| relevant findings,     |   |   |   |   |       | 12    |      |            |
| that may impact on the |   |   |   |   |       | 00.5, |      |            |
| research.              |   |   |   |   |       | 7.g.( |      |            |
|                        |   |   |   |   |       | 1)(l) |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 9\. Investigators      |   |   |   |   |       | VHA   |      |            |
| fulfill all            |   |   |   |   |       | Han   |      |            |
| requirements and       |   |   |   |   |       | dbook |      |            |
| maintain required      |   |   |   |   |       | 12    |      |            |
| documentation related  |   |   |   |   |       | 00.5, |      |            |
| to Data Safety         |   |   |   |   |       | 10.f  |      |            |
| Monitoring Board       |   |   |   |   |       |       |      |            |
| (DSMB) or Data         |   |   |   |   |       |       |      |            |
| Monitoring Committee   |   |   |   |   |       |       |      |            |
| (DMC), if used:        |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       |       |      |            |
| \(a\) Report of all    |   |   |   |   |       |       |      |            |
| events to the DSMB or  |   |   |   |   |       |       |      |            |
| DMC.                   |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(b\) Summary of the   |   |   |   |   |       | VHA   |      |            |
| DSMB or DMC findings   |   |   |   |   |       | Han   |      |            |
| reported to the IRB    |   |   |   |   |       | dbook |      |            |
| and other entities.    |   |   |   |   |       | 12    |      |            |
|                        |   |   |   |   |       | 00.5, |      |            |
|                        |   |   |   |   |       | 10.f  |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 10\. Investigators     |   |   |   |   |       | VHA   |      |            |
| fulfill all            |   |   |   |   |       | Han   |      |            |
| requirements and       |   |   |   |   |       | dbook |      |            |
| maintain required      |   |   |   |   |       | 12    |      |            |
| documentation related  |   |   |   |   |       | 00.5, |      |            |
| to study suspensions:  |   |   |   |   |       | 7. g. |      |            |
|                        |   |   |   |   |       | (2)   |      |            |
| \(a\) Documentation of |   |   |   |   |       |       |      |            |
| notification from      |   |   |   |   |       | "What |      |            |
| local research office  |   |   |   |   |       | to    |      |            |
| of study suspension.   |   |   |   |   |       | R     |      |            |
|                        |   |   |   |   |       | eport |      |            |
|                        |   |   |   |   |       | to    |      |            |
|                        |   |   |   |   |       | ORO"  |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(b\) Verify that no   |   |   |   |   |       |       |      | Note: New  |
| enrollment of new      |   |   |   |   |       |       |      | e          |
| subjects during study  |   |   |   |   |       |       |      | nrollments |
| suspension occurred.   |   |   |   |   |       |       |      | must be    |
|                        |   |   |   |   |       |       |      | suspended  |
|                        |   |   |   |   |       |       |      | if timely  |
|                        |   |   |   |   |       |       |      | continuing |
|                        |   |   |   |   |       |       |      | review     |
|                        |   |   |   |   |       |       |      | does not   |
|                        |   |   |   |   |       |       |      | occur.     |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(c\) Documentation    |   |   |   |   |       |       |      |            |
| that the PI            |   |   |   |   |       |       |      |            |
| immediately submitted  |   |   |   |   |       |       |      |            |
| to the IRB Chair, a    |   |   |   |   |       |       |      |            |
| list of research       |   |   |   |   |       |       |      |            |
| subjects for whom      |   |   |   |   |       |       |      |            |
| suspension of the      |   |   |   |   |       |       |      |            |
| research would cause   |   |   |   |   |       |       |      |            |
| harm.                  |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(d\) Documentation    |   |   |   |   |       |       | (see | \*\*\*     |
| that the sponsor, ORD, |   |   |   |   |       |       | ab   | Reporting  |
| ORO and other Federal  |   |   |   |   |       |       | ove) | not        |
| agencies have been     |   |   |   |   |       |       |      | required   |
| notified.\*\*\*        |   |   |   |   |       |       |      | for simple |
|                        |   |   |   |   |       |       |      | closure in |
|                        |   |   |   |   |       |       |      | absence of |
|                        |   |   |   |   |       |       |      | timely     |
|                        |   |   |   |   |       |       |      | continuing |
|                        |   |   |   |   |       |       |      | review.    |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(e\) Documentation of |   |   |   |   |       |       |      |            |
| IRB review and         |   |   |   |   |       |       |      |            |
| re-approval prior to   |   |   |   |   |       |       |      |            |
| re-initiation of the   |   |   |   |   |       |       |      |            |
| suspended research.    |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 11\. Investigators     |   |   |   |   |       | VHA   |      |            |
| fulfill all            |   |   |   |   |       | Han   |      |            |
| requirements and       |   |   |   |   |       | dbook |      |            |
| maintain required      |   |   |   |   |       | 12    |      |            |
| documentation related  |   |   |   |   |       | 00.5, |      |            |
| to study terminations: |   |   |   |   |       | 14.d. |      |            |
|                        |   |   |   |   |       |       |      |            |
| \(a\) (DRUG)           |   |   |   |   |       |       |      |            |
| Documentation of study |   |   |   |   |       |       |      |            |
| termination sent to    |   |   |   |   |       |       |      |            |
| Chief, Pharmacy        |   |   |   |   |       |       |      |            |
| Service.               |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(b\) (DEVICE) Report  |   |   |   |   | 21    |       |      |            |
| to the sponsor, within |   |   |   |   | CFR   |       |      |            |
| 5 working days, of the |   |   |   |   |       |       |      |            |
| withdrawal of approval |   |   |   |   | 812.1 |       |      |            |
| by the reviewing IRB   |   |   |   |   | 50(a) |       |      |            |
| of the investigator's  |   |   |   |   | (2)   |       |      |            |
| part of an             |   |   |   |   |       |       |      |            |
| investigation.         |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 12\. Investigators     |   |   |   |   | 21    |       |      |            |
| fulfill all            |   |   |   |   | CFR   |       |      |            |
| requirements and       |   |   |   |   | 3     |       |      |            |
| maintain required      |   |   |   |   | 12.64 |       |      |            |
| documentation related  |   |   |   |   |       |       |      |            |
| to final reports.      |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       |       |      |            |
| \(a\) (DRUG) Copy sent |   |   |   |   |       |       |      |            |
| to sponsor shortly     |   |   |   |   |       |       |      |            |
| after the completion   |   |   |   |   |       |       |      |            |
| of the investigator's  |   |   |   |   |       |       |      |            |
| participation in the   |   |   |   |   |       |       |      |            |
| study.                 |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(b\) (DEVICE) Copy    |   |   |   |   | 21    |       |      |            |
| sent to sponsor and    |   |   |   |   | CFR   |       |      |            |
| the reviewing IRB,     |   |   |   |   | 81    |       |      |            |
| within 3 months after  |   |   |   |   | 2.150 |       |      |            |
| termination or         |   |   |   |   |       |       |      |            |
| completion of the      |   |   |   |   |       |       |      |            |
| investigation          |   |   |   |   |       |       |      |            |
| participation in the   |   |   |   |   |       |       |      |            |
| study.                 |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| ## 1                   |   |   |   |   | 21    |       |      | OHRP       |
| 3. Investigators fulfi |   |   |   |   | CFR   |       |      | Guidance:  |
| ll all requirements an |   |   |   |   | 3     |       |      | Financial  |
| d maintain required do |   |   |   |   | 12.64 |       |      | Rel        |
| cumentation related to |   |   |   |   |       |       |      | ationships |
|  financial disclosure: |   |   |   |   | 21    |       |      | and        |
|                        |   |   |   |   | CFR   |       |      | Interests  |
| \(a\) Certification or |   |   |   |   | 81    |       |      | in Human   |
| Disclosure Statement   |   |   |   |   | 2.110 |       |      | Research   |
| (FDA Form 3454).       |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(b\) Updated          |   |   |   |   |       |       |      |            |
| certification or       |   |   |   |   |       |       |      |            |
| disclosure during      |   |   |   |   |       |       |      |            |
| study and for 1 year   |   |   |   |   |       |       |      |            |
| following the          |   |   |   |   |       |       |      |            |
| completion.            |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 14\. (DEVICE)          |   |   |   |   | 21    |       |      |            |
| Investigators report   |   |   |   |   | CFR   |       |      |            |
| to sponsor and IRB     |   |   |   |   |       |       |      |            |
| within 5 working days  |   |   |   |   | 812   |       |      |            |
| any deviation from the |   |   |   |   | .150( |       |      |            |
| investigational plan   |   |   |   |   | a)(4) |       |      |            |
| to protect life or     |   |   |   |   |       |       |      |            |
| physical well-being of |   |   |   |   |       |       |      |            |
| a subject in an        |   |   |   |   |       |       |      |            |
| ***emergency.***       |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 15\. (DEVICE)          |   |   |   |   | 21    |       |      |            |
| Investigators report   |   |   |   |   | CFR   |       |      |            |
| to sponsor and IRB     |   |   |   |   |       |       |      |            |
| within 5 working days  |   |   |   |   | 812   |       |      |            |
| use of device without  |   |   |   |   | .150( |       |      |            |
| obtaining informed     |   |   |   |   | a)(5) |       |      |            |
| consent.               |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 16\. (DEVICE)          |   |   |   |   | 21    |       |      |            |
| Investigator, upon     |   |   |   |   | CFR   |       |      |            |
| request by IRB or FDA, |   |   |   |   |       |       |      |            |
| provides accurate,     |   |   |   |   | 812   |       |      |            |
| complete, current      |   |   |   |   | .150( |       |      |            |
| information about      |   |   |   |   | a)(7) |       |      |            |
| study.                 |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 17\. (DEVICE) The      |   |   |   |   | 21    |       |      |            |
| protocol, with         |   |   |   |   | CFR   |       |      |            |
| documents showing the  |   |   |   |   | 812.1 |       |      |            |
| dates of, and reasons  |   |   |   |   | 40(4) |       |      |            |
| for, each deviation    |   |   |   |   |       |       |      |            |
| from the protocol.     |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 18\. (DEVICE) Any      |   |   |   |   | 21    |       | (see |            |
| other records that FDA |   |   |   |   | CFR   |       | ab   |            |
| requires to be         |   |   |   |   | 812.1 |       | ove) |            |
| maintained by          |   |   |   |   | 40(5) |       |      |            |
| regulation or by       |   |   |   |   |       |       |      |            |
| specific requirement   |   |   |   |   |       |       |      |            |
| for a category of      |   |   |   |   |       |       |      |            |
| investigations or a    |   |   |   |   |       |       |      |            |
| particular             |   |   |   |   |       |       |      |            |
| investigation.         |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 19\. Investigators     |   |   |   |   | # 21  |       |      |            |
| fulfill all            |   |   |   |   | CFR 3 |       |      |            |
| requirements and       |   |   |   |   | 12.68 |       |      |            |
| maintain required      |   |   |   |   |       |       |      |            |
| documentation for FDA  |   |   |   |   | # &   |       |      |            |
| inspection reports and |   |   |   |   |  812. |       |      |            |
| follow-up action.      |   |   |   |   | 145(a |       |      |            |
|                        |   |   |   |   | )-(c) |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 20\. Investigators     |   |   |   |   | # 21  |       |      |            |
| fulfill all            |   |   |   |   |  CFR  |       |      |            |
| requirements and       |   |   |   |   | 812.1 |       |      |            |
| maintain required      |   |   |   |   | 40(5) |       |      |            |
| documentation for      |   |   |   |   |       |       |      |            |
| control of             |   |   |   |   |       |       |      |            |
| investigational        |   |   |   |   |       |       |      |            |
| articles:              |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       |       |      |            |
| \(a\) (DEVICE) Any     |   |   |   |   |       |       |      |            |
| other records that FDA |   |   |   |   |       |       |      |            |
| requires to be         |   |   |   |   |       |       |      |            |
| maintained by          |   |   |   |   |       |       |      |            |
| regulation or by       |   |   |   |   |       |       |      |            |
| specific requirement   |   |   |   |   |       |       |      |            |
| for a category of      |   |   |   |   |       |       |      |            |
| investigations or a    |   |   |   |   |       |       |      |            |
| particular             |   |   |   |   |       |       |      |            |
| investigation.         |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(b\) (DRUG)           |   |   |   |   |       |       |      |            |
| Investigational Drug   |   |   |   |   |       |       |      |            |
| Information Record (VA |   |   |   |   |       |       |      |            |
| Form 10-9012) or       |   |   |   |   |       |       |      |            |
| superseding forms.     |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| ######  (c) Copy sen   |   |   |   |   |       | VHA   |      | #          |
| t to Pharmacy Service. |   |   |   |   |       | Han   |      |            |
|                        |   |   |   |   |       | dbook |      |            |
|                        |   |   |   |   |       | 12    |      |            |
|                        |   |   |   |   |       | 00.5, |      |            |
|                        |   |   |   |   |       | 14.c. |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(d\) Records of       |   |   |   |   | # 21  |       |      |            |
| drug/device            |   |   |   |   |  CFR  |       |      |            |
| disposition (dates,    |   |   |   |   | 312.6 |       |      |            |
| quantity, batch        |   |   |   |   | 2 (a) |       |      |            |
| number, use by         |   |   |   |   |       |       |      |            |
| subjects, etc.).       |   |   |   |   | # 21  |       |      |            |
|                        |   |   |   |   | CFR 8 |       |      |            |
|                        |   |   |   |   | 12.14 |       |      |            |
|                        |   |   |   |   | 0 (a) |       |      |            |
|                        |   |   |   |   | (2)(i |       |      |            |
|                        |   |   |   |   | -iii) |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(e\) Documentation of |   |   |   |   | # 21  |       |      |            |
| unused drug/device     |   |   |   |   |  CFR  |       |      |            |
| being returned to the  |   |   |   |   | 312.6 |       |      |            |
| sponsor or disposed of |   |   |   |   | 2 (a) |       |      |            |
| after the completion   |   |   |   |   |       |       |      |            |
| of the study.          |   |   |   |   | # 21  |       |      |            |
|                        |   |   |   |   | CFR 8 |       |      |            |
|                        |   |   |   |   | 12.11 |       |      |            |
|                        |   |   |   |   | 0 (e) |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(f\) (DRUG) If the    |   |   |   |   | # 21  |       |      |            |
| investigational drug   |   |   |   |   | CFR 3 |       |      |            |
| is a controlled        |   |   |   |   | 12.69 |       |      |            |
| substance, it is       |   |   |   |   |       |       |      |            |
| stored in a securely   |   |   |   |   |       |       |      |            |
| locked, substantially  |   |   |   |   |       |       |      |            |
| constructed cabinet,   |   |   |   |   |       |       |      |            |
| or other securely      |   |   |   |   |       |       |      |            |
| locked, substantially  |   |   |   |   |       |       |      |            |
| constructed enclosure, |   |   |   |   |       |       |      |            |
| with limited access to |   |   |   |   |       |       |      |            |
| prevent theft or       |   |   |   |   |       |       |      |            |
| diversion of the       |   |   |   |   |       |       |      |            |
| substance into illegal |   |   |   |   |       |       |      |            |
| channels of            |   |   |   |   |       |       |      |            |
| distribution.          |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 21\. Principal         |   |   |   |   | #     | VHA   |      |            |
| Investigators (PIs)    |   |   |   |   |       | Han   |      |            |
| fulfill all            |   |   |   |   |       | dbook |      |            |
| requirements related   |   |   |   |   |       | 12    |      |            |
| to use, disclosure,    |   |   |   |   |       | 00.1, |      |            |
| storage, transfer, and |   |   |   |   |       | 5.e.  |      |            |
| security of research   |   |   |   |   |       |       |      |            |
| information, including |   |   |   |   |       | CRADO |      |            |
| current requirements   |   |   |   |   |       | /     |      |            |
| for protocol-specific  |   |   |   |   |       | D     |      |            |
| Certification of       |   |   |   |   |       | USHOM |      |            |
| Security Requirements. |   |   |   |   |       | Memos |      |            |
|                        |   |   |   |   |       | 0     |      |            |
|                        |   |   |   |   |       | 6.12. |      |            |
|                        |   |   |   |   |       | 2006, |      |            |
|                        |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       | 02.06 |      |            |
|                        |   |   |   |   |       | &     |      |            |
|                        |   |   |   |   |       | 04.11 |      |            |
|                        |   |   |   |   |       | .2007 |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 22\. The ACOS/R and    |   |   |   |   | #     | CRADO |      |            |
| Facility Director      |   |   |   |   |       | /     |      |            |
| fulfill all            |   |   |   |   |       | D     |      |            |
| requirements related   |   |   |   |   |       | USHOM |      |            |
| to use, disclosure,    |   |   |   |   |       | Memo  |      |            |
| storage, transfer, and |   |   |   |   |       | 02.06 |      |            |
| security of research   |   |   |   |   |       | .2007 |      |            |
| information, including |   |   |   |   |       | &     |      |            |
| current requirements   |   |   |   |   |       | 04.11 |      |            |
| for protocol-specific  |   |   |   |   |       | .2007 |      |            |
| Certification of       |   |   |   |   |       |       |      |            |
| Security Requirements  |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 23\. Principal         |   |   |   |   | #     | VHA   | (see |            |
| Investigators (PIs)    |   |   |   |   |       | Han   | ab   |            |
| acknowledge and        |   |   |   |   |       | dbook | ove) |            |
| fulfill their          |   |   |   |   |       | 12    |      |            |
| responsibilities for   |   |   |   |   |       | 00.1, |      |            |
| conduct of the         |   |   |   |   |       | 5.a,  |      |            |
| research and for       |   |   |   |   |       | &     |      |            |
| leadership and         |   |   |   |   |       | 5.e.  |      |            |
| supervision of the     |   |   |   |   |       |       |      |            |
| research team,         |   |   |   |   |       | VHA   |      |            |
| including ensuring     |   |   |   |   |       | Han   |      |            |
| that:                  |   |   |   |   |       | dbook |      |            |
|                        |   |   |   |   |       | 12    |      |            |
| \(a\) All members of   |   |   |   |   |       | 00.5, |      |            |
| the research team      |   |   |   |   |       | 3.n., |      |            |
| function strictly in   |   |   |   |   |       | 3.t., |      |            |
| accordance with their  |   |   |   |   |       | 10    |      |            |
| VA-authorized          |   |   |   |   |       |       |      |            |
| credentials,           |   |   |   |   |       | ORD   |      |            |
| privileges, and scopes |   |   |   |   |       | Gui   |      |            |
| of practice when       |   |   |   |   |       | dance |      |            |
| involved in research.  |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       | May   |      |            |
|                        |   |   |   |   |       | 10,   |      |            |
|                        |   |   |   |   |       | 2007  |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(b\) All members of   |   |   |   |   | #     |       |      |            |
| the research team are  |   |   |   |   |       |       |      |            |
| fully qualified to     |   |   |   |   |       |       |      |            |
| perform their research |   |   |   |   |       |       |      |            |
| duties by virtue of    |   |   |   |   |       |       |      |            |
| their education,       |   |   |   |   |       |       |      |            |
| experience, and        |   |   |   |   |       |       |      |            |
| protocol-specific      |   |   |   |   |       |       |      |            |
| training.              |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(c\) All members of   |   |   |   |   | #     | CRADO |      |            |
| the research team      |   |   |   |   |       | /     |      |            |
| comply with all VA and |   |   |   |   |       | D     |      |            |
| VHA requirements for   |   |   |   |   |       | USHOM |      |            |
| use, disclosure,       |   |   |   |   |       | Memos |      |            |
| storage, transfer, and |   |   |   |   |       | 06.12 |      |            |
| security of research   |   |   |   |   |       | .2006 |      |            |
| information.           |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       | &     |      |            |
|                        |   |   |   |   |       | 02.06 |      |            |
|                        |   |   |   |   |       | .2007 |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(d\) All members of   |   |   |   |   | #     | C     |      |            |
| the research team      |   |   |   |   |       | RADO/ |      |            |
| comply with VHA        |   |   |   |   |       | USH   |      |            |
| requirements for       |   |   |   |   |       | Memo  |      |            |
| researcher contacts    |   |   |   |   |       | 07.10 |      |            |
| with veterans          |   |   |   |   |       | .2007 |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 24\. All researchers   |   |   |   |   | #     | VHA   |      |            |
| acknowledge and        |   |   |   |   |       | Han   |      |            |
| fulfill their          |   |   |   |   |       | dbook |      |            |
| responsibilities to:   |   |   |   |   |       | 12    |      |            |
|                        |   |   |   |   |       | 00.1, |      |            |
| \(a\) Function         |   |   |   |   |       | 5.a,  |      |            |
| strictly in accordance |   |   |   |   |       | &     |      |            |
| with their             |   |   |   |   |       | 5.e.  |      |            |
| VA-authorized          |   |   |   |   |       |       |      |            |
| credentials,           |   |   |   |   |       | VHA   |      |            |
| privileges, and scopes |   |   |   |   |       | Han   |      |            |
| of practice when       |   |   |   |   |       | dbook |      |            |
| involved in research.  |   |   |   |   |       | 12    |      |            |
|                        |   |   |   |   |       | 00.5, |      |            |
|                        |   |   |   |   |       | 3.n., |      |            |
|                        |   |   |   |   |       | 10    |      |            |
|                        |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       | ORD   |      |            |
|                        |   |   |   |   |       | Gui   |      |            |
|                        |   |   |   |   |       | dance |      |            |
|                        |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       | May   |      |            |
|                        |   |   |   |   |       | 10,   |      |            |
|                        |   |   |   |   |       | 2007  |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(b\) Be fully         |   |   |   |   | #     | VHA   |      |            |
| qualified to perform   |   |   |   |   |       | Han   |      |            |
| their research duties  |   |   |   |   |       | dbook |      |            |
| by virtue of their     |   |   |   |   |       | 12    |      |            |
| education, experience, |   |   |   |   |       | 00.1, |      |            |
| and protocol-specific  |   |   |   |   |       | 5.a.  |      |            |
| training.              |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(c\) Comply with all  |   |   |   |   | #     | CRADO |      |            |
| VA and VHA             |   |   |   |   |       | /     |      |            |
| requirements for use,  |   |   |   |   |       | D     |      |            |
| disclosure, storage,   |   |   |   |   |       | USHOM |      |            |
| transfer, and security |   |   |   |   |       | Memos |      |            |
| of research            |   |   |   |   |       | 06.12 |      |            |
| information.           |   |   |   |   |       | .2006 |      |            |
|                        |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       | &     |      |            |
|                        |   |   |   |   |       | 02.06 |      |            |
|                        |   |   |   |   |       | .2007 |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(d\) Comply with VHA  |   |   |   |   | #     | C     |      |            |
| requirements for       |   |   |   |   |       | RADO/ |      |            |
| research recruiting    |   |   |   |   |       | USH   |      |            |
| contacts with          |   |   |   |   |       | Memo  |      |            |
| veterans.              |   |   |   |   |       | 07.10 |      |            |
|                        |   |   |   |   |       | .2006 |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 25\. Investigators     |   |   |   |   | #     | VHA   |      |            |
| create or update VA    |   |   |   |   |       | Han   |      |            |
| Health Record:         |   |   |   |   |       | dbook |      |            |
|                        |   |   |   |   |       | 190   |      |            |
| \(a\) For all research |   |   |   |   |       | 7.01, |      |            |
| subjects admitted as   |   |   |   |   |       | 6.    |      |            |
| in-patients, treated   |   |   |   |   |       | t.(8) |      |            |
| as outpatients, or for |   |   |   |   |       |       |      |            |
| whom research          |   |   |   |   |       |       |      |            |
| procedures or          |   |   |   |   |       |       |      |            |
| interventions are used |   |   |   |   |       |       |      |            |
| in their medical care. |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(b\) When the         |   |   |   |   | #     |       |      |            |
| research requires use  |   |   |   |   |       |       |      |            |
| of any clinical        |   |   |   |   |       |       |      |            |
| resources such as      |   |   |   |   |       |       |      |            |
| radiology, cardiology  |   |   |   |   |       |       |      |            |
| (e.g., EKG, stress     |   |   |   |   |       |       |      |            |
| test etc.), clinical   |   |   |   |   |       |       |      |            |
| laboratory, and        |   |   |   |   |       |       |      |            |
| pharmacy.              |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(c\) The research     |   |   |   |   | #     | (see  | (see |            |
| intervention may lead  |   |   |   |   |       | a     | ab   |            |
| to physical or         |   |   |   |   |       | bove) | ove) |            |
| psychological adverse  |   |   |   |   |       |       |      |            |
| events.                |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 28\. Investigators     |   |   |   |   | #     | VHA   |      |            |
| place the following    |   |   |   |   |       | Han   |      |            |
| information in the VA  |   |   |   |   |       | dbook |      |            |
| Health record for      |   |   |   |   |       | 190   |      |            |
| research subjects:     |   |   |   |   |       | 7.01, |      |            |
|                        |   |   |   |   |       | 6.    |      |            |
| \(a\) Informed consent |   |   |   |   |       | t.(9) |      |            |
| document and HIPPA     |   |   |   |   |       |       |      |            |
| authorization.         |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(b\) Copy of the      |   |   |   |   | #     |       |      |            |
| initial enrollment     |   |   |   |   |       |       |      |            |
| progress note and      |   |   |   |   |       |       |      |            |
| other applicable       |   |   |   |   |       |       |      |            |
| progress notes.        |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(c\) Information on   |   |   |   |   | #     |       |      |            |
| all research           |   |   |   |   |       |       |      |            |
| interventions and      |   |   |   |   |       |       |      |            |
| potential risks,       |   |   |   |   |       |       |      |            |
| including risks of     |   |   |   |   |       |       |      |            |
| drugs administered     |   |   |   |   |       |       |      |            |
| because of the         |   |   |   |   |       |       |      |            |
| research               |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(d\) VA Form10-9012,  |   |   |   |   | #     |       |      |            |
| Investigational Drug   |   |   |   |   |       |       |      |            |
| Information Record,    |   |   |   |   |       |       |      |            |
| where applicable.      |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(e\) A copy of any    |   |   |   |   | #     |       |      |            |
| research results that  |   |   |   |   |       |       |      |            |
| are used for medical   |   |   |   |   |       |       |      |            |
| care.                  |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+

<table>
<colgroup>
<col style="width: 34%" />
<col style="width: 2%" />
<col style="width: 0%" />
<col style="width: 2%" />
<col style="width: 0%" />
<col style="width: 2%" />
<col style="width: 3%" />
<col style="width: 12%" />
<col style="width: 0%" />
<col style="width: 11%" />
<col style="width: 10%" />
<col style="width: 19%" />
</colgroup>
<tbody>
<tr class="odd">
<td><strong>E. INFORMED CONSENT</strong></td>
<td><strong>Y</strong></td>
<td colspan="2"><strong>N</strong></td>
<td colspan="2"><strong>IP</strong></td>
<td><strong>NA</strong></td>
<td><strong>Regs</strong></td>
<td colspan="2"><strong>VHA</strong></td>
<td><strong>AAHRPP</strong></td>
<td><strong>NOTES</strong></td>
</tr>
<tr class="even">
<td>1. Consent is prepared on VA Form 10-1086, VA Informed Consent
Document (either paper or electronic).</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="2">VHA Handbook 1200.5, 7.a.(4)(a) &amp; App C 1.d.</td>
<td><p>II.7. A - F</p>
<p>III.1.F</p></td>
<td>Note: Use of 10-1086 implies signature and date by subject, witness
and person obtaining informed consent.</td>
</tr>
<tr class="odd">
<td>2. Each page of the 10-1086 contains a stamp that indicates the date
of the most recent IRB approval of the document and the expiration
date.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="2">VHA Handbook 1200.5, 7.a.(4)(a)</td>
<td></td>
<td>NOTE: OHRP recommends that the expiration date be included, VHA
requires that the approval date is present.</td>
</tr>
<tr class="even">
<td>3. If the consent form is amended during the protocol approval
period, the form must bear the approval date of the amendment rather
than the date of the approved protocol.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>4. Consent is in a language understandable to the subject or the
representative.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td><p>38 CFR 16. 116</p>
<p>21 CFR 50. 20</p></td>
<td colspan="2">VHA Handbook 1200.5, App C, 1.b.</td>
<td></td>
<td>FDA Info Sheets</td>
</tr>
<tr class="even">
<td>5. Consent does not include any exculpatory language through which
the subject or the representative is made to waive or 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 for liability
from negligence.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td><p>38 CFR 16. 116</p>
<p>21 CFR 50. 20</p></td>
<td colspan="2">VHA Handbook 1200.5, App C, 1.c.</td>
<td></td>
<td>FDA Info Sheets</td>
</tr>
<tr class="odd">
<td><p>6. Contains signature lines for:</p>
<p>(a) Subject or subject’s legally authorized representative.</p></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td><p>38 CFR 16.117</p>
<p>21 CFR 50.27</p></td>
<td colspan="2">VHA Handbook 1200.5, App C, 3.a.(1)</td>
<td>(see above)</td>
<td></td>
</tr>
<tr class="even">
<td>(b) Person obtaining the informed consent.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="2">VHA Handbook 1200.5, App C, 3.a.(3)</td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>(c) Witness to the signature.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="2">VHA Handbook 1200.5, App C, 3.a.(2)</td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td><p>7. Unless formally waived and documented in IRB meeting minutes,
contains the basic elements of informed consent:</p>
<p>(a) Name of Study.</p></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="2">VHA Handbook 1200.5, App C, 2. a. (1)</td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>(b) Name of Principal Investigator (PI).</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="2">VHA Handbook 1200.5, App C, 2.a.(2)</td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>(c) A statement that the study involves research.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td><p>38 CFR 16.116 (a)(1)</p>
<p>21 CFR 50.25 (a)(1)</p></td>
<td colspan="2">VHA Handbook 1200.5, App C, 2.a.(3)</td>
<td></td>
<td>FDA Info Sheets</td>
</tr>
<tr class="odd">
<td>(d) Explanation of the purpose of the research.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td><p>38 CFR 16.116 (a)(1)</p>
<p>21 CFR 50.25 (a)(1)</p></td>
<td colspan="2">VHA Handbook 1200.5, App C, 2.a.(4)</td>
<td></td>
<td>FDA Info Sheets</td>
</tr>
<tr class="even">
<td>(e) Expected duration of the subject's participation.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td><p>38 CFR 16.116 (a)(1)</p>
<p>21 CFR 50.25 (a)(1)</p></td>
<td colspan="2">VHA Handbook 1200.5, App C, 2.a.(4)</td>
<td></td>
<td>FDA Info Sheets</td>
</tr>
<tr class="odd">
<td>(f) Description of procedures to be followed and identification of
those being done for research purposes.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td><p>38 CFR 16.116 (a)(1)</p>
<p>21 CFR 50.25 (a)(1)</p>
<p>38 CFR 17.32 (g)(3)</p></td>
<td colspan="2"><p>VHA Handbook 1200.5, App C 2.a.(5)</p>
<p>FDA Info Sheets</p></td>
<td></td>
<td>NOTE: VHA is more restrictive than the federal regulations.</td>
</tr>
<tr class="even">
<td>(g) Identification of any procedures which are experimental.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td><p>38 CFR 16.116 (a)(1)</p>
<p>21 CFR 50.25 (a)(1)</p></td>
<td colspan="2">VHA Handbook 1200.5, App C 2.a.(6)</td>
<td></td>
<td>FDA Info Sheets</td>
</tr>
<tr class="odd">
<td>(h) Description of reasonably foreseeable risks or discomforts to
the subject including for example, privacy risks (legal, employment and
social).</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td><p>38 CFR 16.116 (a)(2)</p>
<p>21 CFR 50.25 (a)(2)</p></td>
<td colspan="2">VHA Handbook 1200.5, App C 2.a.(7)</td>
<td></td>
<td>NOTE: VHA is more prescriptive about types of risks than FDA.</td>
</tr>
<tr class="even">
<td>(i) Description of any benefits to the subject or others that may
reasonably be expected from the research.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td><blockquote>
<p>38 CFR 16.116 (a)(3)</p>
<p>21CFR 50.25 (a)(3)</p>
</blockquote></td>
<td colspan="2"><blockquote>
<p>VHA Handbook 1200.5, App C 2.a.(8)</p>
</blockquote></td>
<td>(see above)</td>
<td>FDA Info Sheets</td>
</tr>
<tr class="odd">
<td>(i) Disclosure of appropriate alternative procedures or courses of
treatment that might be advantageous to the subject.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td><blockquote>
<p>38 CRF 16.116 (a)(4)</p>
<p>21 CFR 50.25 (a)(4)</p>
</blockquote></td>
<td colspan="2"><blockquote>
<p>VHA Handbook 1200.5, App C 2.a.(9)</p>
</blockquote></td>
<td></td>
<td>FDA Info Sheets</td>
</tr>
<tr class="even">
<td>(k) A statement describing the extent, if any, to which
confidentiality of records identifying t he subject will be
maintained.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td><p>38 CFR 16.116 (a)(5)</p>
<p>21 CFR 50.25 (a)(5)</p></td>
<td colspan="2">VHA Handbook 1200.5, App C, 2.a.(10)</td>
<td></td>
<td>FDA Info Sheets</td>
</tr>
<tr class="odd">
<td>(l) For FDA-regulated research, a statement that the FDA may inspect
the records that include a subject’s individual medical record.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td>21 CFR 50.25 (a)(5)</td>
<td colspan="2">VHA Handbook 1200.5, App C, 2.a.(10)</td>
<td></td>
<td>FDA Info Sheets. Required only for research regulated by FDA.</td>
</tr>
<tr class="even">
<td>(m) Explanation of whom to contact for questions about the research.
NOTE for Items (m) thru (o), at least one contact must be someone other
than a member of the research team.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td><p>38 CFR 16.116 (a)(7)</p>
<p>21 CFR 50.25 (a)(7)</p></td>
<td colspan="2">VHA Handbook 1200.5, App C, 2.a.(12)</td>
<td></td>
<td>FDA Info Sheets</td>
</tr>
<tr class="odd">
<td>(n) Explanation of whom to contact for questions about research
subject’s rights. NOTE for Items (m) thru (o), at least one contact must
be someone other than a member of the research team.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td><p><a href="../38CFR16.htm#a116a7">38 CFR 16.116 (a)(7)</a></p>
<p>21 CFR 50.25 (a)(7)</p></td>
<td colspan="2">VHA Handbook 1200.5, App C, 2.a.(12)</td>
<td></td>
<td>FDA Info Sheets</td>
</tr>
<tr class="even">
<td>(o) Explanation of whom to contact for a research-related injury to
the subject. NOTE for Items (m) thru (o), at least one contact must be
someone other than a member of the research team.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td><p>38 CFR 16.116 (a)(7)</p>
<p>21 CFR 50.25 (a)(7)</p></td>
<td colspan="2">VHA Handbook 1200.5, App C, 2.a.(12)</td>
<td></td>
<td>FDA Info Sheets</td>
</tr>
<tr class="odd">
<td>(p) A statement as to whether any compensation is available if
injury occurs, and if so what it consists of or where further
information can be obtained. (Required for greater than minimal risk
research only.)</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td><p>38 CFR 16.116 (a)(6)</p>
<p>21 CFR 50.25 (a)(6))</p></td>
<td colspan="2">VHA Handbook 1200.5, App C, 2.a.(11) &amp; (11)(a)</td>
<td></td>
<td>FDA Info Sheets</td>
</tr>
<tr class="even">
<td>(q) A statement that the VA will provide necessary medical treatment
to a research subject injured by participation in a research project
approved by a VA R&amp;D Committee and conducted under the supervision
of one or more VA employees and what it consists of or where further
information can be obtained.*</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td><p>38 CFR</p>
<p>16.116 (a)(6),</p>
<p>17.85 &amp; 17.92</p>
<p>21 CFR 50.25 (a)(6)</p></td>
<td colspan="2"><p>VHA Handbook 1200.5, App C,</p>
<p>2. a.(11) &amp; (11)(a)</p></td>
<td></td>
<td>* NOTE: 38 CFR 17.85 and 17.92 require that subjects receive
treatment</td>
</tr>
<tr class="odd">
<td>(r) A statement that participation is voluntary.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td><p>38 CFR 16.116 (a)(8)</p>
<p>21 CFR 50.25 (a)(8)</p></td>
<td colspan="2">VHA Handbook 1200.5, App C 2. a. (13)</td>
<td></td>
<td>FDA Info Sheets</td>
</tr>
<tr class="even">
<td>(s) A statement that refusal to participate will involve no penalty
or loss of benefits to which the subject is otherwise entitled.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td><p><a href="../38CFR16.htm#a116a8">38 CFR 16.116 (a)(8)</a></p>
<p>21 CFR 50.25 (a)(8)</p></td>
<td colspan="2">VHA Handbook 1200.5, App C 2. a. (13)</td>
<td>(see above)</td>
<td>FDA Info Sheets</td>
</tr>
<tr class="odd">
<td>(t) A statement that the subject may discontinue participation at
any time without penalty or loss of benefits to which the subject is
otherwise entitled.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td><p><a href="../38CFR16.htm#a116a8">38 CFR 16.116 (a)(8)</a></p>
<p>21 CFR 50.25 (a)(8)</p></td>
<td colspan="2">VHA Handbook 1200.5, App C 2. a. (13)</td>
<td></td>
<td>FDA Info Sheets</td>
</tr>
<tr class="even">
<td>(u) A statement that a veteran-subject will not be required to pay
for care received as a subject in a VA research project.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="2">VHA Handbook 1200.5, App C 2.a.(14) (a),(b),(c)</td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>8. Suggested Wording Regarding Co-payments for Certain Veterans:
“Some veterans are required to pay co-payments for medical care and
services provided by VA. These co-payments requirements will continue to
apply to medical care and services provided by VA that are not part of
this study.”</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="2">VHA Handbook 1200.5, App C 2.a.(14) (a),(b)</td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td><p>9. Additional Elements of Consent (when appropriate):</p>
<p>(a) A statement that the particular treatment or procedure may
involve risks to subject (or to the embryo or fetus, if subject is or
may become pregnant) which is currently unforeseeable.</p></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td><p>38 CFR 16.116 (b)(1)</p>
<p>21 CFR 50.25 (b) (1)</p></td>
<td colspan="2">Handbook 1200.5, App C 2. b. (1)</td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>(b) Anticipated circumstances under which the subjects participation
may be terminated by the investigator without regard to the subject’s
consent.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td><p>38 CFR 16.116 (b)(2)</p>
<p>21 CFR 50.25 (b)(2)</p></td>
<td colspan="2">VHA Handbook 1200.5, App C 2.b. (2)</td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>(c) Additional costs to the subject that may result from
participation in the research.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td><p>38 CFR 16.116 (b)(3)</p>
<p>21 CFR 50.25 (b)(3)</p></td>
<td colspan="2">VHA Handbook 1200.5, App C 2.b. (3)</td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>(d) The consequences of a subject’s decision to withdraw from the
research and procedures for orderly termination of subject
participation.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td><p>38 CFR 16.116 (b)(4)</p>
<p>21 CFR 50.25 (b)(4)</p></td>
<td colspan="2">VHA Handbook 1200.5, App C, 2.b.(4)</td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>(e) A statement that significant new findings developed during the
course of the research that may relate to the subject's willingness to
continue participation, will be provided to subject.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td><p>38 CFR 16.116 (b)(5)</p>
<p>21 CFR 50.25 (b)(5)</p></td>
<td colspan="2">VHA Handbook 1200.5, App C 2.b.(5)</td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>(f) A statement of the approximate number of subjects involved in
the study.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td><p>38 CFR 16.116 (b)(6)</p>
<p>21 CFR 50.25 (b) (6)</p></td>
<td colspan="2">VHA Handbook 1200.5, App C 2. b. (6)</td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td><p>(g) The IRB may require that information, in addition to that
specifically mentioned in CFR be given to the subjects when in the IRB’s
judgment the information would meaningfully add to the protection of the
rights and welfare of subjects:</p>
<p>(1) Identification of the sponsor of the study.</p>
<p>(2) If the specimens obtained could be part of, or lead to the
development of a commercially valuable product.</p></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td><p>38 CFR 16.109 (b)</p>
<p>21 CFR 56.109 (b)</p></td>
<td colspan="2">VHA Handbook 1200.5, App C 2.(b)(7)</td>
<td>(see above)</td>
<td></td>
</tr>
<tr class="odd">
<td>(h) A statement regarding any payment the subject is to receive and
how payment will be made.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="2">VHA Handbook 1200.5, App C 2.b. (8)</td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>(i) When applicable, a statement that the FDA, OHRP or GAO may
inspect the records.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="2">VHA Handbook 1200.5, App C 2.a. (10)</td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td><p>10. Banked Specimens: If the research involves banked specimens
the informed consent must also state:</p>
<p>(a) If the specimen will be used for future research and allow the
subject the choice of how the specimen will be used (any research,
research by the PI or other researchers, genetic analysis, research
related to a specific area, etc.).</p></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="2">VHA 2001 Memo &amp; VHA Dir 2000-043: Banking of Human
Research Subjects’ Specimens CRADO, 4.d.(1)</td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>(b) If research results of reuse of the specimen will be conveyed to
the subject.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="2">See above 4.d.(2)</td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>(c) If the subject will be re-contacted after the original study is
completed.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="2">See above. 4.d.(3)</td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>(d) If the subject requests, the specimen and all links to the
clinical data will be destroyed.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="2">See above 4.d.(4)</td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>11. Financial Conflict of Interest. IRBs should take steps to ensure
that potential research subjects are apprised of the source of funding
for the study and payment arrangements for Investigators during the
consent process and in the Consent Form, whenever that information is
considered to be material to the potential subjects’ decision-making
process.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td>OHRP Guidance on Financial Relationships in Clinical Research: Issue
5.2.</td>
</tr>
<tr class="even">
<td>12. Language other than English. If the investigator anticipates
that the consent interviews will be conducted in a language other than
English, an approved translated informed consent is available.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td><p>OHRP Guidance</p>
<p>FDA Info Sheets</p></td>
</tr>
<tr class="odd">
<td>13. Assent of Minors. If the IRB requires written documentation of
assent, the form used to obtain assent complies with the IRB’s
determinations.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td>45 CFR 46. 408 (e)</td>
<td colspan="2"></td>
<td>(see above)</td>
<td></td>
</tr>
<tr class="even">
<td><p>14. Specified Conditions. If the research involves disclosure of
information relating to diagnosis, prognosis or treatment of any or all
of the following diseases, a written statement to this effect is
included:</p>
<p>(a) HIV.</p></td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td>38 CFR 7332 (a)(1)</td>
<td colspan="2"><p>VHA Handbook 1200.5, 7.a.(7)</p>
<p>VHA Directive 2002-048</p></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>(b) Drug abuse.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>(c) Alcoholism or alcohol abuse.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>(d) Sickle cell anemia.</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>15. When permitted, surrogate consent may ONLY be obtained from a
health care agent under a Durable Power of Attorney for Health Care; a
court appointed guardian; or next of kin in the following order (unless
otherwise specified under state law): spouse, adult child, parent, adult
sibling, grandparent, or adult grandchild.</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td>VHA Handbook 1200.5, 11</td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>16. Surrogate consent may be requested and accepted ONLY when the
prospective research participant is incompetent or has impaired
decision-making capacity, as determined and documented in the subject’s
medical record with a signed and dated progress note, as follows:</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>(a) The practitioner, in consultation with the chief of service, or
COS, may determine after appropriate medical evaluation that the
prospective subject lacks decision-making capacity and is unlikely to
regain it within a reasonable period of time.</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>(b) Consultation with a psychiatrist or licensed psychologist must
be obtained when the determination that the subject lacks
decision-making capacity is based on mental illness.</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>(c) If feasible, the practitioner must explain the research to the
subject even when the surrogate gives consent. No subject be forced or
coerced to participate in a research study.</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>(d) All required disclosures must be made to the surrogate.</td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
</tr>
</tbody>
</table>

+------------------------+---+---+---+---+--------+-------+------+------------+
| **F. HIPAA PRIVACY     | * | * | * | * | **     | **    | **   | **NOTES**  |
| RULE AUTHORIZATIONS**  | * | * | * | * | Regs** | VHA** | AAHR |            |
|                        | Y | N | I | N |        |       | PP** |            |
|                        | * | * | P | A |        |       |      |            |
|                        | * | * | * | * |        |       |      |            |
|                        |   |   | * | * |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| The HIPAA              |   |   |   |   | 45 CFR | VHA   | II.6 | \*\*\* The |
| authorization is       |   |   |   |   | Parts  | Han   | .A - | HIPAA      |
| written in plain       |   |   |   |   | 1      | dbook | B    | aut        |
| language and includes  |   |   |   |   | 64.508 | 12    |      | horization |
| the following items:   |   |   |   |   | (c)    | 00.5, |      | can be a   |
| \*\*\*                 |   |   |   |   |        | 7.a.( |      | separate   |
|                        |   |   |   |   |        | 4)(b) |      | document   |
|                        |   |   |   |   |        |       |      | or         |
|                        |   |   |   |   |        |       |      | in         |
|                        |   |   |   |   |        |       |      | corporated |
|                        |   |   |   |   |        |       |      | into the   |
|                        |   |   |   |   |        |       |      | informed   |
|                        |   |   |   |   |        |       |      | consent    |
|                        |   |   |   |   |        |       |      | document.  |
+------------------------+---+---+---+---+--------+-------+------+------------+
| 1\. The identity of    |   |   |   |   |        | VHA   |      |            |
| the individual to whom |   |   |   |   |        | Han   |      |            |
| the information        |   |   |   |   |        | dbook |      |            |
| pertains (i.e., name   |   |   |   |   |        | 16    |      |            |
| and social security    |   |   |   |   |        | 05.1, |      |            |
| number).               |   |   |   |   |        | 14.   |      |            |
|                        |   |   |   |   |        | b.(   |      |            |
|                        |   |   |   |   |        | 1)(a) |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| 2\. A description of   |   |   |   |   |        | VHA   |      |            |
| the information to be  |   |   |   |   |        | Han   |      |            |
| used or disclosed that |   |   |   |   |        | dbook |      |            |
| identifies the         |   |   |   |   |        | 16    |      |            |
| information in a       |   |   |   |   |        | 05.1, |      |            |
| specific and           |   |   |   |   |        | 14.   |      |            |
| meaningful fashion. If |   |   |   |   |        | b.(   |      |            |
| HIV, sickle cell       |   |   |   |   |        | 1)(b) |      |            |
| anemia, drug and/or    |   |   |   |   |        |       |      |            |
| alcohol abuse          |   |   |   |   |        |       |      |            |
| treatment information  |   |   |   |   |        |       |      |            |
| is to be disclosed     |   |   |   |   |        |       |      |            |
| this information must  |   |   |   |   |        |       |      |            |
| be specifically        |   |   |   |   |        |       |      |            |
| identified in the      |   |   |   |   |        |       |      |            |
| description.           |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| 3\. The name or other  |   |   |   |   |        | VHA   |      |            |
| specific               |   |   |   |   |        | Han   |      |            |
| identification of the  |   |   |   |   |        | dbook |      |            |
| person(s), class of    |   |   |   |   |        | 16    |      |            |
| persons or office      |   |   |   |   |        | 05.1, |      |            |
| designation(s)         |   |   |   |   |        | 14.   |      |            |
| authorized to make the |   |   |   |   |        | b.(   |      |            |
| requested use or       |   |   |   |   |        | 1)(c) |      |            |
| disclosure.            |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| 4\. The name or other  |   |   |   |   |        | VHA   |      |            |
| specific               |   |   |   |   |        | Han   |      |            |
| identification of the  |   |   |   |   |        | dbook |      |            |
| person(s), class of    |   |   |   |   |        | 16    |      |            |
| persons, or office     |   |   |   |   |        | 05.1, |      |            |
| designation(s) to whom |   |   |   |   |        | 14.   |      |            |
| the agency may make    |   |   |   |   |        | b.(   |      |            |
| the requested use or   |   |   |   |   |        | 1)(d) |      |            |
| disclosure.            |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| 5\. A description of   |   |   |   |   |        | VHA   |      |            |
| each purpose of the    |   |   |   |   |        | Han   |      |            |
| requested use or       |   |   |   |   |        | dbook |      |            |
| disclosure. The        |   |   |   |   |        | 16    |      |            |
| statement "at the      |   |   |   |   |        | 05.1, |      |            |
| request of the         |   |   |   |   |        | 14.   |      |            |
| individual" is         |   |   |   |   |        | b.(   |      |            |
| sufficient when an     |   |   |   |   |        | 1)(e) |      |            |
| individual initiates   |   |   |   |   |        |       |      |            |
| the authorization and  |   |   |   |   |        |       |      |            |
| does not, or elects    |   |   |   |   |        |       |      |            |
| not to, provide a      |   |   |   |   |        |       |      |            |
| statement of the       |   |   |   |   |        |       |      |            |
| purpose.               |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| 6\. An expiration date |   |   |   |   |        | VHA   |      |            |
| or event that relates  |   |   |   |   |        | Han   |      |            |
| to the individual or   |   |   |   |   |        | dbook |      |            |
| the purpose of the use |   |   |   |   |        | 16    |      |            |
| or disclosure.         |   |   |   |   |        | 05.1, |      |            |
| Examples of            |   |   |   |   |        | 14.   |      |            |
| appropriate expiration |   |   |   |   |        | b.(   |      |            |
| date language are as   |   |   |   |   |        | 1)(f) |      |            |
| follows:               |   |   |   |   |        |       |      |            |
|                        |   |   |   |   |        |       |      |            |
| \(a\) The statement    |   |   |   |   |        |       |      |            |
| "end of the research   |   |   |   |   |        |       |      |            |
| study" or similar      |   |   |   |   |        |       |      |            |
| language is sufficient |   |   |   |   |        |       |      |            |
| if the authorization   |   |   |   |   |        |       |      |            |
| is for use or          |   |   |   |   |        |       |      |            |
| disclosure of          |   |   |   |   |        |       |      |            |
| ind                    |   |   |   |   |        |       |      |            |
| ividually-identifiable |   |   |   |   |        |       |      |            |
| health information for |   |   |   |   |        |       |      |            |
| research.              |   |   |   |   |        |       |      |            |
|                        |   |   |   |   |        |       |      |            |
| \(b\) The statement    |   |   |   |   |        |       |      |            |
| "none" or similar      |   |   |   |   |        |       |      |            |
| language is sufficient |   |   |   |   |        |       |      |            |
| if the authorization   |   |   |   |   |        |       |      |            |
| is for the agency to   |   |   |   |   |        |       |      |            |
| use or disclose        |   |   |   |   |        |       |      |            |
| ind                    |   |   |   |   |        |       |      |            |
| ividually-identifiable |   |   |   |   |        |       |      |            |
| health information,    |   |   |   |   |        |       |      |            |
| including for the      |   |   |   |   |        |       |      |            |
| creation and           |   |   |   |   |        |       |      |            |
| maintenance of a       |   |   |   |   |        |       |      |            |
| research database or   |   |   |   |   |        |       |      |            |
| research repository.   |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| 7\. The signature of   |   |   |   |   |        | VHA   |      |            |
| the individual, or     |   |   |   |   |        | Han   |      |            |
| someone with the       |   |   |   |   |        | dbook |      |            |
| authority to act on    |   |   |   |   |        | 16    |      |            |
| behalf of the          |   |   |   |   |        | 05.1, |      |            |
| individual, and date   |   |   |   |   |        | 14.   |      |            |
| signed.                |   |   |   |   |        | b.(   |      |            |
|                        |   |   |   |   |        | 1)(g) |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| 8\. A statement that   |   |   |   |   |        | VHA   | (see |            |
| the individual has the |   |   |   |   |        | Han   | ab   |            |
| right to revoke the    |   |   |   |   |        | dbook | ove) |            |
| authorization in       |   |   |   |   |        | 16    |      |            |
| writing except to the  |   |   |   |   |        | 05.1, |      |            |
| extent that VHA has    |   |   |   |   |        | 14.   |      |            |
| already acted in       |   |   |   |   |        | b.(   |      |            |
| reliance on it, and a  |   |   |   |   |        | 1)(h) |      |            |
| description of how the |   |   |   |   |        |       |      |            |
| individual may revoke  |   |   |   |   |        |       |      |            |
| the authorization      |   |   |   |   |        |       |      |            |
| (e.g., to whom the     |   |   |   |   |        |       |      |            |
| revocation is          |   |   |   |   |        |       |      |            |
| provided). For a use   |   |   |   |   |        |       |      |            |
| or disclosure of       |   |   |   |   |        |       |      |            |
| individually           |   |   |   |   |        |       |      |            |
| identifiable health    |   |   |   |   |        |       |      |            |
| information related to |   |   |   |   |        |       |      |            |
| research the statement |   |   |   |   |        |       |      |            |
| "end of the research   |   |   |   |   |        |       |      |            |
| study," "none," or     |   |   |   |   |        |       |      |            |
| similar language is    |   |   |   |   |        |       |      |            |
| sufficient.            |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| 9\. A statement that   |   |   |   |   | (see   | VHA   |      |            |
| VHA may not condition  |   |   |   |   | above) | Han   |      |            |
| treatment, payment,    |   |   |   |   |        | dbook |      |            |
| enrollment, or         |   |   |   |   |        | 16    |      |            |
| eligibility for        |   |   |   |   |        | 05.1, |      |            |
| benefits based on the  |   |   |   |   |        | 14.   |      |            |
| individual completing  |   |   |   |   |        | b.    |      |            |
| an authorization.      |   |   |   |   |        | (1)   |      |            |
|                        |   |   |   |   |        | (i)   |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| 10\. A statement that  |   |   |   |   |        | VHA   |      |            |
| individually           |   |   |   |   |        | Han   |      |            |
| identifiable health    |   |   |   |   |        | dbook |      |            |
| information disclosed  |   |   |   |   |        | 16    |      |            |
| pursuant to the        |   |   |   |   |        | 05.1, |      |            |
| authorization may no   |   |   |   |   |        | 14.   |      |            |
| longer be protected by |   |   |   |   |        | b.    |      |            |
| Federal laws or        |   |   |   |   |        | (1)   |      |            |
| regulations and may be |   |   |   |   |        | (j)   |      |            |
| subject to             |   |   |   |   |        |       |      |            |
| re-disclosure by the   |   |   |   |   |        |       |      |            |
| recipient.             |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+

+------------------------+---+---+---+---+--------+-------+------+------------+
| **G. PHARMACY          | * | * | * | * | **     | **    | **   | **NOTES**  |
| RESPONSIBILITIES**     | * | * | * | * | Regs** | VHA** | AAHR |            |
|                        | Y | N | I | N |        |       | PP** |            |
|                        | * | * | P | A |        |       |      |            |
|                        | * | * | * | * |        |       |      |            |
|                        |   |   | * | * |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| 1.  For each study     |   |   |   |   |        | VHA   | I    |            |
|     involving          |   |   |   |   |        | Han   | .2.D |            |
|     investigational    |   |   |   |   |        | dbook |      |            |
|     drugs, the         |   |   |   |   |        | 12    | I.   |            |
|     pharmacy receives  |   |   |   |   |        | 00.5, | 5.A, |            |
|     from the PI:       |   |   |   |   |        | 14.c  | B, C |            |
|                        |   |   |   |   |        |       |      |            |
| \(a\) VA Form 10-1223, |   |   |   |   |        |       |      |            |
| Report of Subcommittee |   |   |   |   |        |       |      |            |
| on Human Studies.      |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(b\) VA Form 10-9012, |   |   |   |   |        |       |      |            |
| Investigational Drug   |   |   |   |   |        |       |      |            |
| Information Record.    |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(c\) A signed copy of |   |   |   |   |        |       |      |            |
| VA Form 10-1086        |   |   |   |   |        |       |      |            |
| documenting each       |   |   |   |   |        |       |      |            |
| subject's consent to   |   |   |   |   |        |       |      |            |
| participate in the     |   |   |   |   |        |       |      |            |
| study.                 |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| 2\. Prior to R&D       |   |   |   |   |        | VHA   |      |            |
| Committee (R&DC)       |   |   |   |   |        | Han   |      |            |
| approval of each study |   |   |   |   |        | dbook |      |            |
| involving              |   |   |   |   |        | 110   |      |            |
| investigation drugs,   |   |   |   |   |        | 8.04, |      |            |
| the Chief of Pharmacy  |   |   |   |   |        | 4.    |      |            |
| Service or Manager of  |   |   |   |   |        | a.(3) |      |            |
| Research Service       |   |   |   |   |        |       |      |            |
| Investigational        |   |   |   |   |        |       |      |            |
| Pharmacy (RSIP)        |   |   |   |   |        |       |      |            |
| documents the adequacy |   |   |   |   |        |       |      |            |
| of pharmacy resources  |   |   |   |   |        |       |      |            |
| or provisions for      |   |   |   |   |        |       |      |            |
| reimbursement needed   |   |   |   |   |        |       |      |            |
| for the study.         |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| 3\. Medications        |   |   |   |   |        | VHA   |      |            |
| approved for an        |   |   |   |   |        | Han   |      |            |
| investigational study  |   |   |   |   |        | dbook |      |            |
| are identified in the  |   |   |   |   |        | 110   |      |            |
| drug file as a study   |   |   |   |   |        | 8.04, |      |            |
| medication. If the     |   |   |   |   |        | 4.    |      |            |
| medication is already  |   |   |   |   |        | a.(9) |      |            |
| listed as a formulary  |   |   |   |   |        |       |      |            |
| agent, a second entry  |   |   |   |   |        |       |      |            |
| in the drug file       |   |   |   |   |        |       |      |            |
| identifies the         |   |   |   |   |        |       |      |            |
| medication as a study  |   |   |   |   |        |       |      |            |
| medication or supply.  |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| 4\. Pharmacy Service   |   |   |   |   |        | VHA   | (see |            |
| or RSIP verifies that  |   |   |   |   |        | Han   | ab   |            |
| all investigational    |   |   |   |   |        | dbook | ove) |            |
| studies have initial   |   |   |   |   |        | 110   |      |            |
| approval and funding   |   |   |   |   |        | 8.04, |      |            |
| prior to ordering,     |   |   |   |   |        | 5.a.  |      |            |
| receipt, or dispensing |   |   |   |   |        |       |      |            |
| of investigational     |   |   |   |   |        |       |      |            |
| drugs.                 |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| 5\. Pharmacy Service   |   |   |   |   |        |       |      |            |
| or RSIP maintains the  |   |   |   |   |        |       |      |            |
| following              |   |   |   |   |        |       |      |            |
| documentation of       |   |   |   |   |        |       |      |            |
| approval for each      |   |   |   |   |        |       |      |            |
| investigational study: |   |   |   |   |        |       |      |            |
|                        |   |   |   |   |        |       |      |            |
| \(a\) Minutes or       |   |   |   |   |        |       |      |            |
| approval letter signed |   |   |   |   |        |       |      |            |
| by R&D Chair.          |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(b\) Minutes,         |   |   |   |   |        |       |      |            |
| approval letter signed |   |   |   |   |        |       |      |            |
| by the IRB Chair, or   |   |   |   |   |        |       |      |            |
| VA Form 10-1223        |   |   |   |   |        |       |      |            |
| approved by the IRB or |   |   |   |   |        |       |      |            |
| the R&D Committee.     |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(c\) A copy of VA     |   |   |   |   |        |       |      |            |
| Form 9012,             |   |   |   |   |        |       |      |            |
| Investigational Drug   |   |   |   |   |        |       |      |            |
| Record when            |   |   |   |   |        |       |      |            |
| appropriate.           |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(d\) A copy of the    |   |   |   |   |        |       |      |            |
| approved protocol.     |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| 6\. Investigational    |   |   |   |   |        | VHA   |      |            |
| drugs are:             |   |   |   |   |        | Han   |      |            |
|                        |   |   |   |   |        | dbook |      |            |
| \(a\) Secured in the   |   |   |   |   |        | 110   |      |            |
| pharmacy.              |   |   |   |   |        | 8.04, |      |            |
|                        |   |   |   |   |        | 5.d.  |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(b\) Stored           |   |   |   |   |        |       |      |            |
| separately from        |   |   |   |   |        |       |      |            |
| non-investigational    |   |   |   |   |        |       |      |            |
| drugs (although        |   |   |   |   |        |       |      |            |
| storage does not       |   |   |   |   |        |       |      |            |
| require a separate     |   |   |   |   |        |       |      |            |
| locked area).          |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(c\) Clearly          |   |   |   |   |        |       |      |            |
| identified.            |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| 7\. Consideration has  |   |   |   |   |        | VHA   |      |            |
| been given to          |   |   |   |   |        | Han   |      |            |
| including a pharmacy   |   |   |   |   |        | dbook |      |            |
| representative on the  |   |   |   |   |        | 110   |      |            |
| R&D Committee and/or a |   |   |   |   |        | 8.04, |      |            |
| formal mechanism has   |   |   |   |   |        | 5.e.  |      |            |
| been established to    |   |   |   |   |        |       |      |            |
| inform Pharmacy        |   |   |   |   |        | 12    |      |            |
| Service or RSIP of     |   |   |   |   |        | 00.1, |      |            |
| approved drug          |   |   |   |   |        | 6.b.( |      |            |
| research.              |   |   |   |   |        | 3)(e) |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| 8\. Pharmacy Service   |   |   |   |   |        |       |      |            |
| or RSIP are            |   |   |   |   |        |       |      |            |
| represented on the IRB |   |   |   |   |        |       |      |            |
| as a voting or         |   |   |   |   |        |       |      |            |
| non-voting member.     |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| 9\. Pharmacy Service   |   |   |   |   |        | VHA   |      |            |
| or RSIP maintains a    |   |   |   |   |        | Han   |      |            |
| file of all studies    |   |   |   |   |        | dbook |      |            |
| involving drugs        |   |   |   |   |        | 110   |      |            |
| including:             |   |   |   |   |        | 8.04, |      |            |
|                        |   |   |   |   |        | 6.b.  |      |            |
| \(a\) IRB and R&DC     |   |   |   |   |        |       |      |            |
| approvals.             |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(b\) Any              |   |   |   |   |        |       |      |            |
| sponsor-related        |   |   |   |   |        |       |      |            |
| correspondence to the  |   |   |   |   |        |       |      |            |
| site investigator      |   |   |   |   |        |       |      |            |
| specific to the        |   |   |   |   |        |       |      |            |
| investigational        |   |   |   |   |        |       |      |            |
| drug(s).               |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(c\) All              |   |   |   |   |        |       |      |            |
| correspondence from    |   |   |   |   |        |       |      |            |
| the FDA and other      |   |   |   |   |        |       |      |            |
| involved authorities   |   |   |   |   |        |       |      |            |
| specific to the        |   |   |   |   |        |       |      |            |
| investigational        |   |   |   |   |        |       |      |            |
| drug(s).               |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| 10\. Regardless of     |   |   |   |   |        | VHA   |      | Note: Does |
| source, all            |   |   |   |   |        | Han   |      | not        |
| investigational drugs  |   |   |   |   |        | dbook |      | include    |
| are delivered to       |   |   |   |   |        | 110   |      | inves      |
| Pharmacy Service or    |   |   |   |   |        | 8.04, |      | tigational |
| RSIP for receipt,      |   |   |   |   |        | 7.a.  |      | drugs      |
| storage, security,     |   |   |   |   |        |       |      | mailed     |
| dispensing,            |   |   |   |   |        |       |      | directly   |
| distribution, and      |   |   |   |   |        |       |      | to subject |
| disposition.           |   |   |   |   |        |       |      | through    |
|                        |   |   |   |   |        |       |      | c          |
|                        |   |   |   |   |        |       |      | entralized |
|                        |   |   |   |   |        |       |      | dispensing |
|                        |   |   |   |   |        |       |      | protocols. |
+------------------------+---+---+---+---+--------+-------+------+------------+
| 11\. Distribution of   |   |   |   |   |        | VHA   | (see | Note: Does |
| investigational drugs  |   |   |   |   |        | Han   | ab   | not        |
| to other locations     |   |   |   |   |        | dbook | ove) | include    |
| occurs from the main   |   |   |   |   |        | 110   |      | inves      |
| pharmacy.              |   |   |   |   |        | 8.04, |      | tigational |
|                        |   |   |   |   |        | 7.a.  |      | drugs      |
|                        |   |   |   |   |        |       |      | mailed     |
|                        |   |   |   |   |        |       |      | directly   |
|                        |   |   |   |   |        |       |      | to subject |
|                        |   |   |   |   |        |       |      | through    |
|                        |   |   |   |   |        |       |      | c          |
|                        |   |   |   |   |        |       |      | entralized |
|                        |   |   |   |   |        |       |      | dispensing |
|                        |   |   |   |   |        |       |      | protocols. |
+------------------------+---+---+---+---+--------+-------+------+------------+
| 12\. Any delegation to |   |   |   |   |        | VHA   |      |            |
| the PI by Pharmacy     |   |   |   |   |        | Han   |      |            |
| Service or RSIP of     |   |   |   |   |        | dbook |      |            |
| investigational drug   |   |   |   |   |        | 110   |      |            |
| custody for storage    |   |   |   |   |        | 8.04, |      |            |
| outside the pharmacy   |   |   |   |   |        | 6.a.  |      |            |
| must:                  |   |   |   |   |        |       |      |            |
|                        |   |   |   |   |        |       |      |            |
| \(a\) Be in writing,   |   |   |   |   |        |       |      |            |
| signed by the PI, and  |   |   |   |   |        |       |      |            |
| maintained in the      |   |   |   |   |        |       |      |            |
| pharmacy.              |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(b\) Identify the     |   |   |   |   |        |       |      |            |
| location of the drug   |   |   |   |   |        |       |      |            |
| and the name of the    |   |   |   |   |        |       |      |            |
| investigator           |   |   |   |   |        |       |      |            |
| responsible for        |   |   |   |   |        |       |      |            |
| storage and            |   |   |   |   |        |       |      |            |
| dispensing.            |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(c\) Include the      |   |   |   |   |        |       |      |            |
| requirement to         |   |   |   |   |        |       |      |            |
| maintain a real-time   |   |   |   |   |        |       |      |            |
| documentation log of   |   |   |   |   |        |       |      |            |
| all drugs dispensed.   |   |   |   |   |        |       |      |            |
| See item G.14. below.  |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| 13\. Any               |   |   |   |   |        | VHA   |      |            |
| investigational drugs  |   |   |   |   |        | Han   |      |            |
| obtained from other    |   |   |   |   |        | dbook |      |            |
| facilities or PIs must |   |   |   |   |        | 110   |      |            |
| have an approved       |   |   |   |   |        | 8.04, |      |            |
| Letter of              |   |   |   |   |        | 7.c.  |      |            |
| Understanding (LOU)    |   |   |   |   |        |       |      |            |
| except as permitted    |   |   |   |   |        |       |      |            |
| under a treatment IND  |   |   |   |   |        |       |      |            |
| or emergency use.      |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| 14\. An automated or   |   |   |   |   |        | VHA   |      |            |
| written investigation  |   |   |   |   |        | Han   |      |            |
| drug log, authorized   |   |   |   |   |        | dbook |      |            |
| by the facility or     |   |   |   |   |        | 110   |      |            |
| study sponsor, must be |   |   |   |   |        | 8.04, |      |            |
| maintained and         |   |   |   |   |        | 8.e.  |      |            |
| include:               |   |   |   |   |        |       |      |            |
|                        |   |   |   |   |        |       |      |            |
| \(a\) Name of the      |   |   |   |   |        |       |      |            |
| drug, dosage, form,    |   |   |   |   |        |       |      |            |
| and strength.          |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(b\) Manufacturer or  |   |   |   |   |        |       |      |            |
| other source.          |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(c\) Date of receipt  |   |   |   |   |        |       |      |            |
| of drug.               |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(d\) Quantity         |   |   |   |   |        |       |      |            |
| received.              |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(e\) Expiration,      |   |   |   |   |        |       |      |            |
| retest, or repass      |   |   |   |   |        |       |      |            |
| date.                  |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(f\) Control, lot     |   |   |   |   |        |       |      |            |
| number, or other       |   |   |   |   |        |       |      |            |
| identification number. |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(g\) Name of site     |   |   |   |   |        |       |      |            |
| investigator.          |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(h\) Protocol name or |   |   |   |   |        |       |      |            |
| number.                |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(i\) Identifier for   |   |   |   |   |        |       |      |            |
| subjects receiving the |   |   |   |   |        |       |      |            |
| drug.                  |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(j\) Quantity         |   |   |   |   |        |       |      |            |
| dispensed.             |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(k\) Balance of drug  |   |   |   |   |        |       |      |            |
| available (where       |   |   |   |   |        |       |      |            |
| applicable).           |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(l\) Recorder's       |   |   |   |   |        |       |      |            |
| initials.              |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(m\) Subject serial   |   |   |   |   |        |       |      |            |
| number.                |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+

+------------------------+---+---+---+---+--------+-------+------+------------+
| \(n\) A final entry    |   |   |   |   |        | VHA   | (see | NOTE: Not  |
| when drug therapy for  |   |   |   |   |        | Han   | ab   | required   |
| the study is ended at  |   |   |   |   |        | dbook | ove) | when       |
| the site, including    |   |   |   |   |        | 110   |      | documented |
| date of termination of |   |   |   |   |        | 8.04, |      | by the     |
| the use of the drug,   |   |   |   |   |        | 8.e.  |      | sponsor    |
| quantity remaining,    |   |   |   |   |        |       |      | that       |
| action taken to        |   |   |   |   |        |       |      | expiration |
| dispose of drug        |   |   |   |   |        |       |      | dare and   |
| remaining, and         |   |   |   |   |        |       |      | control    |
| individual responsible |   |   |   |   |        |       |      | number are |
| for drug destruction   |   |   |   |   |        |       |      | monitored  |
| or return.             |   |   |   |   |        |       |      | centrally. |
+------------------------+---+---+---+---+--------+-------+------+------------+
| 15\. In addition to    |   |   |   |   |        | VHA   |      |            |
| the storage and        |   |   |   |   |        | Han   |      |            |
| accountability         |   |   |   |   |        | dbook |      |            |
| requirements for their |   |   |   |   |        | 110   |      |            |
| use in routine patient |   |   |   |   |        | 8.04, |      |            |
| care, the following    |   |   |   |   |        | 8.e.  |      |            |
| are required for use   |   |   |   |   |        |       |      |            |
| of controlled          |   |   |   |   |        |       |      |            |
| substances as study    |   |   |   |   |        |       |      |            |
| drugs:                 |   |   |   |   |        |       |      |            |
|                        |   |   |   |   |        |       |      |            |
| \(a\) Controlled       |   |   |   |   |        |       |      |            |
| substance inventories. |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(b\) All controlled   |   |   |   |   |        |       |      |            |
| substance dispensing.  |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(c\) Controlled       |   |   |   |   |        |       |      |            |
| substances returned    |   |   |   |   |        |       |      |            |
| (including drawn but   |   |   |   |   |        |       |      |            |
| not used).             |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(d\) All controlled   |   |   |   |   |        |       |      |            |
| substance              |   |   |   |   |        |       |      |            |
| reconciliation.        |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(e\) Controlled       |   |   |   |   |        |       |      |            |
| substances wasted.     |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(f\) Controlled       |   |   |   |   |        |       |      |            |
| substance use          |   |   |   |   |        |       |      |            |
| categorized by         |   |   |   |   |        |       |      |            |
| investigator and/or    |   |   |   |   |        |       |      |            |
| prescribing            |   |   |   |   |        |       |      |            |
| individual.            |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+

+-----------------------+---+---+---+---+--------+-------+------+------------+
| **H. ADDITIONAL       | * | * | * | * | **     | **    | **   | **NOTES**  |
| AAHRPP REQUIREMENTS** | * | * | * | * | Regs** | VHA** | AAHR |            |
|                       | Y | N | I | N |        |       | PP** |            |
|                       | * | * | P | A |        |       |      |            |
|                       | * | * | * | * |        |       |      |            |
|                       |   |   | * | * |        |       |      |            |
+-----------------------+---+---+---+---+--------+-------+------+------------+
| 1\. The Facility has  |   |   |   |   |        |       | I    |            |
| a written plan for    |   |   |   |   |        |       | .1.A |            |
| its HRPP appropriate  |   |   |   |   |        |       |      |            |
| for the volume and    |   |   |   |   |        |       |      |            |
| nature of its human   |   |   |   |   |        |       |      |            |
| research.             |   |   |   |   |        |       |      |            |
+-----------------------+---+---+---+---+--------+-------+------+------------+
| 2\. The Facility has  |   |   |   |   |        |       | I    |            |
| and follows written   |   |   |   |   |        |       | .3.G |            |
| policies and          |   |   |   |   |        |       |      |            |
| procedures to         |   |   |   |   |        |       |      |            |
| identify, manage, and |   |   |   |   |        |       |      |            |
| minimize individual   |   |   |   |   |        |       |      |            |
| conflicts of interest |   |   |   |   |        |       |      |            |
| of investigators, and |   |   |   |   |        |       |      |            |
| works with the IRB    |   |   |   |   |        |       |      |            |
| regarding conflicts   |   |   |   |   |        |       |      |            |
| of interest, when     |   |   |   |   |        |       |      |            |
| appropriate.          |   |   |   |   |        |       |      |            |
+-----------------------+---+---+---+---+--------+-------+------+------------+
| 3\. The Facility is   |   |   |   |   |        |       | I    |            |
| developing written    |   |   |   |   |        |       | .3.H |            |
| policies and          |   |   |   |   |        |       |      |            |
| procedures for        |   |   |   |   |        |       |      |            |
| recognizing and       |   |   |   |   |        |       |      |            |
| managing              |   |   |   |   |        |       |      |            |
| institutional         |   |   |   |   |        |       |      |            |
| conflicts of          |   |   |   |   |        |       |      |            |
| interest.             |   |   |   |   |        |       |      |            |
+-----------------------+---+---+---+---+--------+-------+------+------------+
| 4\. The Facility has  |   |   |   |   |        |       | I    |            |
| and follows written   |   |   |   |   |        |       | .3.I |            |
| policies and          |   |   |   |   |        |       |      |            |
| procedures for        |   |   |   |   |        |       |      |            |
| investigating         |   |   |   |   |        |       |      |            |
| allegations and       |   |   |   |   |        |       |      |            |
| addressing findings   |   |   |   |   |        |       |      |            |
| of non-compliance     |   |   |   |   |        |       |      |            |
| with HRPP             |   |   |   |   |        |       |      |            |
| requirements.         |   |   |   |   |        |       |      |            |
+-----------------------+---+---+---+---+--------+-------+------+------------+
| 5\. The Facility      |   |   |   |   |        |       | I    |            |
| provides resources to |   |   |   |   |        |       | .2.A |            |
| the HRPP sufficient   |   |   |   |   |        |       |      |            |
| for conducting the    |   |   |   |   |        |       |      |            |
| activities under its  |   |   |   |   |        |       |      |            |
| jurisdiction.         |   |   |   |   |        |       |      |            |
+-----------------------+---+---+---+---+--------+-------+------+------------+
| 6\. The Facility      |   |   |   |   |        |       | I    |            |
| provides resources    |   |   |   |   |        |       | .2.C |            |
| that are necessary    |   |   |   |   |        |       |      |            |
| for human research    |   |   |   |   |        |       |      |            |
| protection, care of   |   |   |   |   |        |       |      |            |
| research              |   |   |   |   |        |       |      |            |
| participants, and     |   |   |   |   |        |       |      |            |
| safety during the     |   |   |   |   |        |       |      |            |
| conduct of the        |   |   |   |   |        |       |      |            |
| research.             |   |   |   |   |        |       |      |            |
+-----------------------+---+---+---+---+--------+-------+------+------------+
| 7\. The Facility      |   |   |   |   |        |       | I    |            |
| provides for          |   |   |   |   |        |       | .2.D |            |
| communication and     |   |   |   |   |        |       |      |            |
| interaction for its   |   |   |   |   |        |       |      |            |
| units involved in the |   |   |   |   |        |       |      |            |
| conduct of human      |   |   |   |   |        |       |      |            |
| research.             |   |   |   |   |        |       |      |            |
+-----------------------+---+---+---+---+--------+-------+------+------------+
| 8\. The Facility has  |   |   |   |   |        |       | I    |            |
| and follows written   |   |   |   |   |        |       | .3.B |            |
| policies and          |   |   |   |   |        |       |      |            |
| procedures that allow |   |   |   |   |        |       |      |            |
| the IRB to function   |   |   |   |   |        |       |      |            |
| independently in its  |   |   |   |   |        |       |      |            |
| role in protecting    |   |   |   |   |        |       |      |            |
| research              |   |   |   |   |        |       |      |            |
| participants.         |   |   |   |   |        |       |      |            |
+-----------------------+---+---+---+---+--------+-------+------+------------+
| 9\. The Facility has  |   |   |   |   |        |       | I    |            |
| and follows written   |   |   |   |   |        |       | .3.C |            |
| policies and          |   |   |   |   |        |       |      |            |
| procedures for        |   |   |   |   |        |       |      |            |
| determining when      |   |   |   |   |        |       |      |            |
| studies meet the      |   |   |   |   |        |       |      |            |
| regulatory            |   |   |   |   |        |       |      |            |
| definitions of human  |   |   |   |   |        |       |      |            |
| research.             |   |   |   |   |        |       |      |            |
+-----------------------+---+---+---+---+--------+-------+------+------------+
| 10\. The Facility has |   |   |   |   |        |       | I    |            |
| and follows written   |   |   |   |   |        |       | .3.E |            |
| policies and          |   |   |   |   |        |       |      |            |
| procedures for        |   |   |   |   |        |       |      |            |
| addressing protection |   |   |   |   |        |       |      |            |
| of participants in    |   |   |   |   |        |       |      |            |
| research exempt from  |   |   |   |   |        |       |      |            |
| applicable federal    |   |   |   |   |        |       |      |            |
| regulations           |   |   |   |   |        |       |      |            |
+-----------------------+---+---+---+---+--------+-------+------+------------+
| 11\. The Facility has |   |   |   |   |        |       | I    |            |
| and follows written   |   |   |   |   |        |       | .3.J |            |
| policies and          |   |   |   |   |        |       |      |            |
| procedures for        |   |   |   |   |        |       |      |            |
| addressing            |   |   |   |   |        |       |      |            |
| unanticipated         |   |   |   |   |        |       |      |            |
| problems involving    |   |   |   |   |        |       |      |            |
| risks to research     |   |   |   |   |        |       |      |            |
| participants or       |   |   |   |   |        |       |      |            |
| others.               |   |   |   |   |        |       |      |            |
+-----------------------+---+---+---+---+--------+-------+------+------------+
| 12\. The Facility     |   |   |   |   |        |       | I    |            |
| implements a plan to  |   |   |   |   |        |       | .3.L |            |
| measure and improve   |   |   |   |   |        |       |      |            |
| Human Research        |   |   |   |   |        |       |      |            |
| Protection Program    |   |   |   |   |        |       |      |            |
| effectiveness,        |   |   |   |   |        |       |      |            |
| quality, and          |   |   |   |   |        |       |      |            |
| compliance with       |   |   |   |   |        |       |      |            |
| organizational        |   |   |   |   |        |       |      |            |
| policies and          |   |   |   |   |        |       |      |            |
| procedures and        |   |   |   |   |        |       |      |            |
| applicable federal,   |   |   |   |   |        |       |      |            |
| state, and local      |   |   |   |   |        |       |      |            |
| laws.                 |   |   |   |   |        |       |      |            |
+-----------------------+---+---+---+---+--------+-------+------+------------+
| 13\. The Facility has |   |   |   |   |        |       | I    |            |
| and follows written   |   |   |   |   |        |       | .3.M |            |
| policies and          |   |   |   |   |        |       |      |            |
| procedures so that    |   |   |   |   |        |       |      |            |
| investigators may     |   |   |   |   |        |       |      |            |
| bring forward         |   |   |   |   |        |       |      |            |
| concerns or           |   |   |   |   |        |       |      |            |
| suggestions regarding |   |   |   |   |        |       |      |            |
| the HRPP, including   |   |   |   |   |        |       |      |            |
| the IRB.              |   |   |   |   |        |       |      |            |
+-----------------------+---+---+---+---+--------+-------+------+------------+
| 14\. The Facility     |   |   |   |   |        |       | I.   |            |
| secures assurances    |   |   |   |   |        |       | 5.A. |            |
| from the sponsor that |   |   |   |   |        |       |      |            |
| the manufacture and   |   |   |   |   |        |       |      |            |
| formulation of        |   |   |   |   |        |       |      |            |
| investigational or    |   |   |   |   |        |       |      |            |
| unlicensed test       |   |   |   |   |        |       |      |            |
| articles conform to   |   |   |   |   |        |       |      |            |
| federal regulations.  |   |   |   |   |        |       |      |            |
+-----------------------+---+---+---+---+--------+-------+------+------------+
| 15\. The Facility has |   |   |   |   | 21 CFR |       | I    |            |
| and follows written   |   |   |   |   | 56.    |       | .5.C |            |
| policies and          |   |   |   |   | 104(c) |       |      |            |
| procedures for        |   |   |   |   |        |       |      |            |
| compliance with       |   |   |   |   |        |       |      |            |
| federal regulations   |   |   |   |   |        |       |      |            |
| for emergency use of  |   |   |   |   |        |       |      |            |
| an investigational or |   |   |   |   |        |       |      |            |
| unlicensed test       |   |   |   |   |        |       |      |            |
| article               |   |   |   |   |        |       |      |            |
|                       |   |   |   |   |        |       |      |            |
| \(a\) without IRB     |   |   |   |   |        |       |      |            |
| review;               |   |   |   |   |        |       |      |            |
+-----------------------+---+---+---+---+--------+-------+------+------------+
| \(b\) without         |   |   |   |   | 21 CFR |       | II   |            |
| informed consent in   |   |   |   |   | 50.23  |       | .7.B |            |
| an unplanned          |   |   |   |   |        |       |      |            |
| situation.            |   |   |   |   |        |       |      |            |
+-----------------------+---+---+---+---+--------+-------+------+------------+
| \(c\) without         |   |   |   |   | 21 CFR |       |      |            |
| informed consent in a |   |   |   |   | 50.24  |       |      |            |
| planned situation.    |   |   |   |   |        |       |      |            |
+-----------------------+---+---+---+---+--------+-------+------+------------+

  ------------------------ -- -- -- -- -------- -------- -------- -------------
  16\. The Research Review                               II.8.A   
  Unit has and follows                                            
  policies and procedures                                         
  for communication among                                         
  IRBs, when appropriate,                                         
  for research conducted                                          
  at multiple sites (e.g.,                                        
  multi-site clinical                                             
  trials, epidemiology                                            
  studies, or educational                                         
  surveys).                                                       

  17\. The Research Review                               II.8.B   
  Unit has and follows                                            
  policies and procedures                                         
  for management of                                               
  information obtained in                                         
  multi-site research that                                        
  may be relevant to the                                          
  protection of research                                          
  participants, such as                                           
  reporting of unexpected                                         
  problems or interim                                             
  results.                                                        

  18\. The Facility has a                                IV.1.A   
  written agreement with                                          
  the sponsor that The                                            
  Facility protect                                                
  research participants.                                          

  19\. The Facility has a                                IV.1.B   
  written agreement with                                          
  the sponsor that                                                
  addresses medical care                                          
  for research                                                    
  participants with a                                             
  research-related injury.                                        

  20\. In studies where                                  IV.2.A   
  sponsors bear                                                   
  responsibility for                                              
  monitoring of the                                               
  research, the Facility                                          
  has a written plan with                                         
  the sponsor that the                                            
  sponsor promptly reports                                        
  to the Facility findings                                        
  that could affect the                                           
  safety of participants                                          
  or their willingness to                                         
  continue participation,                                         
  influence the conduct of                                        
  the study, or alter the                                         
  IRB's approval to                                               
  continue the study.                                             

  21\. Before initiating                                 IV.3.A   
  research, the Facility                                          
  has a written agreement                                         
  with the Sponsor about                                          
  plans for disseminating                                         
  findings from the                                               
  research and the roles                                          
  that investigators and                                          
  sponsors will play in                                           
  publication or                                                  
  disclosure of results.                                          

  22\. When participant                                  IV.3.B   
  safety or medical care                                          
  could be directly                                               
  affected by study                                               
  results, the Facility                                           
  addresses in the written                                        
  agreement with the                                              
  Sponsor how results will                                        
  be communicated to study                                        
  participants.                                                   

  23\. The Facility has                                  V.1.A    
  and follows written                                             
  policies and procedures                                         
  that require each                                               
  protocol to provide a                                           
  procedure for research                                          
  participants to ask                                             
  questions and voice                                             
  concerns or complaints                                          
  to the Investigator.                                            

  24\. The Facility has                                  V.1.B    
  and follows written                                             
  policies and procedures                                         
  that establish a safe,                                          
  confidential, and                                               
  reliable channel for                                            
  current, prospective, or                                        
  past research                                                   
  participants or their                                           
  representatives to                                              
  discuss problems,                                               
  concerns, and questions;                                        
  obtain information; or                                          
  offer input with an                                             
  informed individual                                             
  unaffiliated with the                                           
  specific research                                               
  protocol.                                                       

  25\. The Facility                                      V.2.A    
  conducts appropriate                                            
  activities (e.g.,                                               
  pamphlets, public                                               
  relations events, or                                            
  community speaking                                              
  engagements) to enhance                                         
  understanding of human                                          
  research by                                                     
  participants,                                                   
  prospective                                                     
  participants, or their                                          
  community.                                                      

  26\. The Facility                                      V.2.B    
  periodically evaluates                                          
  its outreach activities                                         
  and makes changes when                                          
  appropriate.                                                    
  ------------------------ -- -- -- -- -------- -------- -------- -------------

+-----------------------------------------------------------------------+
| **SEE SEPARATE ORO INSTITUTIONAL REVIEW BOARD (IRB) and**             |
|                                                                       |
| **RESEARCH AND DEVELOPMENT COMMITTEE (R&DC) CHECKLISTS FOR ADDITIONAL |
| REQUIREMENTS.**                                                       |
+-----------------------------------------------------------------------+

> AAHRPP Association for the Accreditation of Human Research Protection
> Programs
>
> AAMC Association of American Medical Colleges
>
> ACOS/R&D Associate Chief of Staff for Research and Development
>
> AE Adverse Event
>
> AO/R&D Administrative Officer for Research & Development
>
> CBOC Community Based Outpatient Clinic
>
> CFO Chief Financial Officer
>
> CFR Code of Federal Regulations
>
> CIO Chief Information Officer
>
> CLIA Clinical Laboratory Improvement Act
>
> CMOP Consolidated Mail Outpatient Pharmacy
>
> CMS Center for Medicare and Medicaid Services (DHHS)
>
> CoC Certificate of Confidentiality (DHHS)
>
> CQI Continuous Quality Improvement
>
> CRADO Chief Research and Development Officer (VHA)
>
> CSP Cooperative Studies Program (VHA)
>
> CSPCC Cooperative Studies Program Coordinating Center
>
> DCHV Domiciliary Care for Homeless Veterans
>
> DHHS Department of Health and Human Services
>
> DMC Data Monitoring Committee
>
> DME Durable Medical Equipment
>
> DOD Department of Defense
>
> DRG Diagnostic Related Groups
>
> DSMB Data and Safety Monitoring Board
>
> DUSHOM Deputy Under Secretary for Health for Operations and Management
> (VHA)
>
> EOC Environment of Care Committee
>
> FDA Food and Drug Administration (DHHS)
>
> FDAMA FDA Modernization Act of 1997 (Section 561 of the Federal Food,
> Drug & Cosmetic Act)
>
> FFP Falsification, Fabrication, and Plagiarism
>
> FMS Financial Management System
>
> FOIA Freedom of Information Act
>
> FR Federal Register
>
> FWA Federal-Wide Assurance (DHHS)
>
> GAO Government Accountability Office
>
> GCP Good Clinical Practice
>
> HDE Humanitarian Device Exemption
>
> HHS Health and Human Services
>
> HIPAA Health Insurance Portability and Accountability Act of 1996
>
> HRPP Human Research Protection Program
>
> HUD Humanitarian Use Device
>
> IBC Institutional Biosafety Committee
>
> IDE Investigational Device Exemption
>
> IND Investigational New Drug
>
> IRB Institutional Review Board
>
> IRM Information Resource Management
>
> LVA Leadership VA
>
> MOU Memorandum of Understanding
>
> NCI National Cancer Institute (NIH)
>
> NHGRI National Human Genome Research Institute (NIH)
>
> NIH National Institutes of Health (DHHS)
>
> NLB National Leadership Board (VHA)
>
> NSF National Science Foundation
>
> NSR Non-Significant Risk (Medical Device)
>
> OBA Office of Biotechnology Activities (NIH)
>
> OER Office of Extramural Research (NIIH)
>
> OHRP Office for Human Research Protections (DHHS)
>
> OIG Office of Inspector General
>
> OMB Office of Management and Budget
>
> OMI Office of the Medical Inspector (VHA)
>
> ORD Office of Research and Development (VHA)
>
> ORI Office of Research Integrity (DHHS)
>
> ORO Office of Research Oversight (VHA)
>
> PHS Public Health Service (DHHS)
>
> PI Principal Investigator
>
> PRIM&R Public Responsibility in Medicine and Research
>
> P&T Pharmacy & Therapeutics
>
> PTSD Post-Traumatic Stress Disorder
>
> PVA Paralyzed Veterans of America
>
> QA Quality Assurance
>
> R&DC Research and Development Committee (VHA)
>
> RAC Recombinant DNA Advisory Committee (NIH)
>
> RACO Research Assurance and Compliance Officer (VHA)
>
> RCO Research Compliance Officer (VHA)
>
> RDRC Radioactive Drug Research Committee
>
> RSC Radiation Safety Committee
>
> SAE Serious Adverse Event
>
> SOP Standard Operating Procedures
>
> SR Significant Risk
>
> VA Department of Veterans Affairs
>
> VAMC Department of Veterans Affairs Medical Center
>
> VHA Veterans Health Administration (VA)
>
> VISN Veterans Integrated Service Network
>
> WOC Without Compensation