**Office of Research Oversight (ORO)\
Institutional Review Board (IRB) Checklist**

**April 14, 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 (if any) with
    relevant organization chart(s)

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

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

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

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

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 HUMAN RESEARCH PROTECTION PROGRAM CHECKLIST and
THE ORO RESEARCH AND DEVELOPMENT COMMITTEE CHECKLIST for items related
to the IRB.

VA Facility:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Reviewer:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_Review Date:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

+------------------------+---+---+---+---+-------+-------+------+------------+
| ## **OFFICE OF RESE    |   |   |   |   |       |       |      |            |
| ARCH OVERSIGHT (ORO)** |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       |       |      |            |
| ## **                  |   |   |   |   |       |       |      |            |
| INSTITUTIONAL REVIEW B |   |   |   |   |       |       |      |            |
| OARD (IRB) 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. INSTITUTIONAL     | * | * | * | * | **R   | **    | **   | **Notes**  |
| REVIEW BOARD (IRB)**   | * | * | * | * | EGS** | VHA** | AAHR |            |
|                        | Y | N | I | N |       |       | PP** |            |
|                        | * | * | P | A |       |       |      |            |
|                        | * | * | * | * |       |       |      |            |
|                        |   |   | * | * |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 1\. IRB membership     |   |   |   |   | 38    | VHA   | I    |            |
| consists of:           |   |   |   |   | CFR   | Han   | .1.D |            |
|                        |   |   |   |   | 1     | dbook |      |            |
| \(a\) Minimum of five  |   |   |   |   | 6.107 | 12    | II   |            |
| members.               |   |   |   |   |       | 00.5, | .1.E |            |
|                        |   |   |   |   | 21    | 6.b.  |      |            |
|                        |   |   |   |   | CFR   | -6.f. | II   |            |
|                        |   |   |   |   | 5     |       | .3.A |            |
|                        |   |   |   |   | 6.107 | 12    |      |            |
|                        |   |   |   |   |       | 00.5, |      |            |
|                        |   |   |   |   |       | 6.i.  |      |            |
|                        |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       | 1     |      |            |
|                        |   |   |   |   |       | 200.1 |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(b\) At least one     |   |   |   |   |       |       |      |            |
| member whose primary   |   |   |   |   |       |       |      |            |
| concern is in the      |   |   |   |   |       |       |      |            |
| scientific area.       |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(c\) At least one     |   |   |   |   |       |       |      |            |
| member whose primary   |   |   |   |   |       |       |      |            |
| concern is in the      |   |   |   |   |       |       |      |            |
| non-scientific area.   |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(d\) At least one     |   |   |   |   |       |       |      |            |
| member who is not      |   |   |   |   |       |       |      |            |
| otherwise affiliated   |   |   |   |   |       |       |      |            |
| with the institution   |   |   |   |   |       |       |      |            |
| and who is not part of |   |   |   |   |       |       |      |            |
| the immediate family   |   |   |   |   |       |       |      |            |
| of a person who is     |   |   |   |   |       |       |      |            |
| affiliated with the    |   |   |   |   |       |       |      |            |
| institution.           |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(e\) Does not consist |   |   |   |   |       |       |      |            |
| of entirely men or     |   |   |   |   |       |       |      |            |
| women.                 |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(f\) Does not consist |   |   |   |   |       |       |      |            |
| entirely of members of |   |   |   |   |       |       |      |            |
| one profession.        |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 2\. If IRB regularly   |   |   |   |   |       |       |      | Note:      |
| reviews research that  |   |   |   |   |       |       |      | Vulnerable |
| involves a vulnerable  |   |   |   |   |       |       |      | subjects   |
| category of subjects,  |   |   |   |   |       |       |      | include    |
| inclusion of one or    |   |   |   |   |       |       |      | children,  |
| more individuals who   |   |   |   |   |       |       |      | prisoners, |
| are knowledgeable      |   |   |   |   |       |       |      | pregnant   |
| about and experienced  |   |   |   |   |       |       |      | women,     |
| in working with those  |   |   |   |   |       |       |      | h          |
| subjects.              |   |   |   |   |       |       |      | andicapped |
|                        |   |   |   |   |       |       |      | or         |
|                        |   |   |   |   |       |       |      | mentally   |
|                        |   |   |   |   |       |       |      | disabled   |
|                        |   |   |   |   |       |       |      | persons.   |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 3\. At least one       |   |   |   |   |       |       |      |            |
| member is also a       |   |   |   |   |       |       |      |            |
| member of, or liaison  |   |   |   |   |       |       |      |            |
| to, the R&DC.          |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+

+------------------------+---+---+---+---+-------+-------+------+------------+
| 4\. ACOS/R&D serves    |   |   |   |   | (see  | (see  | (see |            |
| only as a non-voting   |   |   |   |   | a     | a     | ab   |            |
| member.                |   |   |   |   | bove) | bove) | ove) |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 5\. AO/R&D serves only |   |   |   |   |       |       |      |            |
| as a non-voting        |   |   |   |   |       |       |      |            |
| member.                |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 6\. RCO serves only as |   |   |   |   |       |       |      |            |
| a non-voting member.   |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 7\. If the IRB is      |   |   |   |   |       | VHA   |      |            |
| operated by an         |   |   |   |   |       | Han   |      |            |
| academic affiliate of  |   |   |   |   |       | dbook |      |            |
| the VA facility,       |   |   |   |   |       | 12    |      |            |
| members include two or |   |   |   |   |       | 00.5, |      |            |
| more VA employees as   |   |   |   |   |       | 5.a.( |      |            |
| voting members .       |   |   |   |   |       | 3)(a) |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 8\. IRB records        |   |   |   |   |       | VHA   |      |            |
| contain a resume or CV |   |   |   |   |       | Han   |      |            |
| for each member.       |   |   |   |   |       | dbook |      |            |
|                        |   |   |   |   |       | 12    |      |            |
|                        |   |   |   |   |       | 00.5, |      |            |
|                        |   |   |   |   |       | 7.    |      |            |
|                        |   |   |   |   |       | i.(5) |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 9\. IRB records        |   |   |   |   | 38    |       |      |            |
| include a membership   |   |   |   |   | CFR   |       |      |            |
| roster that identified |   |   |   |   | 16    |       |      |            |
| each member by:        |   |   |   |   | .115( |       |      |            |
|                        |   |   |   |   | a)(5) |       |      |            |
| \(a\) Name.            |   |   |   |   | 38    |       |      |            |
|                        |   |   |   |   | CFR   |       |      |            |
|                        |   |   |   |   | 16    |       |      |            |
|                        |   |   |   |   | .103( |       |      |            |
|                        |   |   |   |   | b)(3) |       |      |            |
|                        |   |   |   |   |       |       |      |            |
|                        |   |   |   |   | 21    |       |      |            |
|                        |   |   |   |   | CFR   |       |      |            |
|                        |   |   |   |   | 56    |       |      |            |
|                        |   |   |   |   | .115( |       |      |            |
|                        |   |   |   |   | a)(5) |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(b\) Earned degrees.  |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(c\) Representative   |   |   |   |   |       |       |      |            |
| Capacity               |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       |       |      |            |
| (1) Affi               |   |   |   |   |       |       |      |            |
| liated/non-affiliated. |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| > \(2\) Status as      |   |   |   |   |       |       |      |            |
| > scientist            |   |   |   |   |       |       |      |            |
| >                      |   |   |   |   |       |       |      |            |
|  (physician-scientist, |   |   |   |   |       |       |      |            |
| > other scientist,     |   |   |   |   |       |       |      |            |
| > non-scientist, or    |   |   |   |   |       |       |      |            |
| > social behavioral    |   |   |   |   |       |       |      |            |
| > scientist).          |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(d\) Indications of   |   |   |   |   |       |       |      |            |
| experience such as     |   |   |   |   |       |       |      |            |
| board certifications,  |   |   |   |   |       |       |      |            |
| licenses, etc.,        |   |   |   |   |       |       |      |            |
| sufficient to describe |   |   |   |   |       |       |      |            |
| each members chief     |   |   |   |   |       |       |      |            |
| anticipated            |   |   |   |   |       |       |      |            |
| contribution to IRB    |   |   |   |   |       |       |      |            |
| deliberations.         |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(e\) Any employment   |   |   |   |   |       |       |      |            |
| or other relationship  |   |   |   |   |       |       |      |            |
| between each member    |   |   |   |   |       |       |      |            |
| and the institution.   |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(f\) Voting vs        |   |   |   |   |       |       |      |            |
| alternate status.      |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(g\) IRB Chair.       |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+

+------------------------+---+---+---+---+-------+-------+------+------------+
| **B. WRITTEN IRB       | * | * | * | * | **R   | **    | **   | **Notes**  |
| PROCEDURES**           | * | * | * | * | EGS** | VHA** | AAHR |            |
|                        | Y | N | I | N |       |       | PP** |            |
|                        | * | * | P | A |       |       |      |            |
|                        | * | * | * | * |       |       |      |            |
|                        |   |   | * | * |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| **Written procedures   |   |   |   |   |       | VHA   | I    | FDA Info   |
| describe the           |   |   |   |   |       | Han   | .1.A | Sheets     |
| following:**           |   |   |   |   |       | dbook | & C  |            |
|                        |   |   |   |   |       | 12    |      |            |
| 1\. IRB authority and  |   |   |   |   |       | 00.1, | I.   |            |
| jurisdiction are       |   |   |   |   |       | 11.f. | 3.A. |            |
| defined in writing and |   |   |   |   |       |       |      |            |
| include:               |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| > \(a\) Requiring      |   |   |   |   |       |       |      |            |
| > progress reports     |   |   |   |   |       |       |      |            |
| > from investigators.  |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| > \(b\) Overseeing     |   |   |   |   |       |       |      |            |
| > conduct of research. |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| > \(c\) Suspending or  |   |   |   |   | 38    |       |      |            |
| > terminating approval |   |   |   |   | CFR   |       |      |            |
| > of research.         |   |   |   |   | 1     |       |      |            |
|                        |   |   |   |   | 6.113 |       |      |            |
|                        |   |   |   |   |       |       |      |            |
|                        |   |   |   |   | 21    |       |      |            |
|                        |   |   |   |   | CFR   |       |      |            |
|                        |   |   |   |   | 5     |       |      |            |
|                        |   |   |   |   | 6.113 |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| > \(d\) Placing        |   |   |   |   |       |       |      |            |
| > restrictions on a    |   |   |   |   |       |       |      |            |
| > study.               |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 2\. IRB membership and |   |   |   |   |       |       | I    |            |
| related procedures are |   |   |   |   |       |       | .3.A |            |
| defined in writing and |   |   |   |   |       |       |      |            |
| include:               |   |   |   |   |       |       | I    |            |
|                        |   |   |   |   |       |       | .4.A |            |
|                        |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       |       | II   |            |
|                        |   |   |   |   |       |       | .1.D |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(a\) Appointment and  |   |   |   |   |       | VHA   |      |            |
| function of alternate  |   |   |   |   |       | Han   |      |            |
| members.               |   |   |   |   |       | dbook |      |            |
|                        |   |   |   |   |       | 12    |      |            |
|                        |   |   |   |   |       | 00.5, |      |            |
|                        |   |   |   |   |       | 6.j.  |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(b\) Ensuring that    |   |   |   |   |       | VHA   |      |            |
| initial and continuing |   |   |   |   |       | Han   |      |            |
| education requirements |   |   |   |   |       | dbook |      |            |
| for the IRB Chair, IRB |   |   |   |   |       | 12    |      |            |
| members, and IRB       |   |   |   |   |       | 00.5, |      |            |
| alternate members have |   |   |   |   |       | 7.d   |      |            |
| been met.              |   |   |   |   |       | .(10) |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 3\. IRB administration |   |   |   |   |       |       | I    |            |
| and operation:         |   |   |   |   |       |       | .3.A |            |
|                        |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       |       | II.2 |            |
|                        |   |   |   |   |       |       | .A - |            |
|                        |   |   |   |   |       |       | J    |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(a\) Scheduling and   |   |   |   |   |       |       |      |            |
| calling meetings.      |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(b\) Initial review.  |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(c\) Continuing       |   |   |   |   |       |       |      |            |
| review.                |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(d\) Review of        |   |   |   |   |       |       |      |            |
| changes and            |   |   |   |   |       |       |      |            |
| amendments.            |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(e\) Review of        |   |   |   |   |       |       |      |            |
| reports of             |   |   |   |   |       |       |      |            |
| unanticipated problems |   |   |   |   |       |       |      |            |
| involving risks to     |   |   |   |   |       |       |      |            |
| subjects or others.    |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(f\) Review of        |   |   |   |   |       |       |      |            |
| reports of serious and |   |   |   |   |       |       |      |            |
| continuing             |   |   |   |   |       |       |      |            |
| noncompliance.         |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+

+------------------------+---+---+---+---+-------+-------+------+------------+
| 4\. Use by the IRB of  |   |   |   |   |       |       | I.3. | OHRP       |
| primary reviewer       |   |   |   |   |       |       |      | Guidance   |
| systems for:           |   |   |   |   |       |       | II   |            |
|                        |   |   |   |   |       |       | .2.A |            |
| \(a\) Initial review.  |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       |       | II   |            |
|                        |   |   |   |   |       |       | .2.C |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| > \(b\) Continuing     |   |   |   |   |       |       | I    | OHRP       |
| > review.              |   |   |   |   |       |       | .3.A | Guidance   |
|                        |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       |       | II   |            |
|                        |   |   |   |   |       |       | .2.A |            |
|                        |   |   |   |   |       |       | & D  |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| > \(c\) Review of      |   |   |   |   |       |       | I    | OHRP       |
| > changes and          |   |   |   |   |       |       | .3.A | Guidance   |
| > amendments.          |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       |       | II   |            |
|                        |   |   |   |   |       |       | .2.A |            |
|                        |   |   |   |   |       |       | & E  |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 5\. The timing of      |   |   |   |   |       |       | I    | OHRP       |
| document distribution  |   |   |   |   |       |       | .3.A | Guidance   |
| prior to IRB meetings. |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 6\. A list of          |   |   |   |   |       |       | I    | OHRP       |
| materials to be        |   |   |   |   |       |       | .3.A | Guidance   |
| distributed for        |   |   |   |   |       |       |      |            |
| initial review,        |   |   |   |   |       |       | II   |            |
| appropriate to the     |   |   |   |   |       |       | .2.A |            |
| review system used:    |   |   |   |   |       |       | & C  |            |
|                        |   |   |   |   |       |       |      |            |
| \(a\) If all members   |   |   |   |   |       |       |      |            |
| review all materials,  |   |   |   |   |       |       |      |            |
| these must be          |   |   |   |   |       |       |      |            |
| provided: protocol,    |   |   |   |   |       |       |      |            |
| consent document,      |   |   |   |   |       |       |      |            |
| grant application,     |   |   |   |   |       |       |      |            |
| investigator's         |   |   |   |   |       |       |      |            |
| brochure, any          |   |   |   |   |       |       |      |            |
| application/progress   |   |   |   |   |       |       |      |            |
| report forms used,     |   |   |   |   |       |       |      |            |
| advertising/recruiting |   |   |   |   |       |       |      |            |
| materials, survey and  |   |   |   |   |       |       |      |            |
| questionnaire          |   |   |   |   |       |       |      |            |
| instruments; OR        |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       |       |      |            |
| > \(b\) If a primary   |   |   |   |   |       |       |      |            |
| > reviewer system is   |   |   |   |   |       |       |      |            |
| > used, the primary    |   |   |   |   |       |       |      |            |
| > reviewer receives    |   |   |   |   |       |       |      |            |
| > the materials listed |   |   |   |   |       |       |      |            |
| > above, and other     |   |   |   |   |       |       |      |            |
| > members receive a    |   |   |   |   |       |       |      |            |
| > substantive summary  |   |   |   |   |       |       |      |            |
| > of the research, the |   |   |   |   |       |       |      |            |
| > informed consent     |   |   |   |   |       |       |      |            |
| > document, and        |   |   |   |   |       |       |      |            |
| >                      |   |   |   |   |       |       |      |            |
| advertising/recruiting |   |   |   |   |       |       |      |            |
| > materials.           |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 7\. A list of          |   |   |   |   |       |       | I    | OHRP       |
| materials to be        |   |   |   |   |       |       | .3.A | Guidance   |
| distributed for        |   |   |   |   |       |       |      |            |
| continuing review,     |   |   |   |   |       |       | II   |            |
| appropriate to the     |   |   |   |   |       |       | .2.A |            |
| review system used:    |   |   |   |   |       |       | & D  |            |
|                        |   |   |   |   |       |       |      |            |
| \(a\) All IRB members  |   |   |   |   |       |       |      |            |
| receive protocol       |   |   |   |   |       |       |      |            |
| summary and a status   |   |   |   |   |       |       |      |            |
| report on the progress |   |   |   |   |       |       |      |            |
| of the research, a     |   |   |   |   |       |       |      |            |
| copy of the current    |   |   |   |   |       |       |      |            |
| informed consent       |   |   |   |   |       |       |      |            |
| document and any newly |   |   |   |   |       |       |      |            |
| proposed consent       |   |   |   |   |       |       |      |            |
| document.; OR          |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       |       |      |            |
| \(b\) At least one     |   |   |   |   |       |       |      |            |
| member of the IRB      |   |   |   |   |       |       |      |            |
| (i.e., a primary       |   |   |   |   |       |       |      |            |
| reviewer) receives a   |   |   |   |   |       |       |      |            |
| copy of the complete   |   |   |   |   |       |       |      |            |
| protocol including any |   |   |   |   |       |       |      |            |
| modifications          |   |   |   |   |       |       |      |            |
| previously approved by |   |   |   |   |       |       |      |            |
| the IRB.               |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 8\. Details of any     |   |   |   |   |       |       | I    | OHRP       |
| process (e.g.          |   |   |   |   |       |       | .3.A | Guidance   |
| subcommittee           |   |   |   |   |       |       |      |            |
| procedure) that may be |   |   |   |   |       |       | II   |            |
| used to supplement the |   |   |   |   |       |       | .2.A |            |
| IRB's initial review,  |   |   |   |   |       |       |      |            |
| continuing review,     |   |   |   |   |       |       | II   |            |
| review of protocol     |   |   |   |   |       |       | .2.E |            |
| changes, and/or        |   |   |   |   |       |       |      |            |
| reports of             |   |   |   |   |       |       |      |            |
| unanticipated problems |   |   |   |   |       |       |      |            |
| involving risks to     |   |   |   |   |       |       |      |            |
| subjects or others or  |   |   |   |   |       |       |      |            |
| of serious or          |   |   |   |   |       |       |      |            |
| continuing             |   |   |   |   |       |       |      |            |
| noncompliance.         |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+

+------------------------+---+---+---+---+-------+-------+------+------------+
| 9\. The range of       |   |   |   |   |       |       | I    | OHRP       |
| possible actions taken |   |   |   |   |       |       | .3.A | Guidance   |
| by the IRB for         |   |   |   |   |       |       |      |            |
| protocols undergoing:  |   |   |   |   |       |       | II   |            |
|                        |   |   |   |   |       |       | .2.A |            |
| > \(a\) Initial        |   |   |   |   |       |       | & C  |            |
| > review.              |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(b\) Continuing       |   |   |   |   |       |       | I    | OHRP       |
| review.                |   |   |   |   |       |       | .3.A | Guidance   |
|                        |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       |       | II   |            |
|                        |   |   |   |   |       |       | .2.A |            |
|                        |   |   |   |   |       |       | & D  |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(c\) Review of        |   |   |   |   |       |       | I    | OHRP       |
| protocol changes.      |   |   |   |   |       |       | .3.A | Guidance   |
|                        |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       |       | II   |            |
|                        |   |   |   |   |       |       | .2.A |            |
|                        |   |   |   |   |       |       | & E  |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(d\) Review of        |   |   |   |   |       |       |      | OHRP       |
| reports of             |   |   |   |   |       |       |      | Guidance   |
| unanticipated problems |   |   |   |   |       |       |      |            |
| involving risks to     |   |   |   |   |       |       |      |            |
| subjects or others.    |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(e\) Review of        |   |   |   |   |       |       |      | OHRP       |
| serious or continuing  |   |   |   |   |       |       |      | Guidance   |
| noncompliance.         |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 10\. Details for       |   |   |   |   | 38    | VHA   | I    |            |
| reporting, in writing, |   |   |   |   | CFR   | Han   | .1.D |            |
| IRB findings and       |   |   |   |   | 16.10 | dbook |      |            |
| actions to:            |   |   |   |   | 3(b)( | 12    | I    |            |
|                        |   |   |   |   | 4)(i) | 00.5, | .2.A |            |
| \(a\) Principal        |   |   |   |   |       | 7.    | & B  |            |
| Investigator.          |   |   |   |   | 21    | d.(1) |      |            |
|                        |   |   |   |   | CFR   |       | I    |            |
|                        |   |   |   |   | 56    |       | .3.A |            |
|                        |   |   |   |   | .108( |       | & I  |            |
|                        |   |   |   |   | a)(1) |       |      |            |
|                        |   |   |   |   |       |       | II   |            |
|                        |   |   |   |   |       |       | .2.A |            |
|                        |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       |       | II   |            |
|                        |   |   |   |   |       |       | .4.D |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(b\) Institution.     |   |   |   |   | 38    |       |      |            |
|                        |   |   |   |   | CFR   |       |      |            |
|                        |   |   |   |   | 16.10 |       |      |            |
|                        |   |   |   |   | 3(b)( |       |      |            |
|                        |   |   |   |   | 4)(i) |       |      |            |
|                        |   |   |   |   |       |       |      |            |
|                        |   |   |   |   | 21    |       |      |            |
|                        |   |   |   |   | CFR   |       |      |            |
|                        |   |   |   |   | 56    |       |      |            |
|                        |   |   |   |   | .108( |       |      |            |
|                        |   |   |   |   | a)(1) |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(c\) R&D Committee.   |   |   |   |   |       | VHA   |      |            |
|                        |   |   |   |   |       | Han   |      |            |
|                        |   |   |   |   |       | dbook |      |            |
|                        |   |   |   |   |       | 12    |      |            |
|                        |   |   |   |   |       | 00.5, |      |            |
|                        |   |   |   |   |       | 7.    |      |            |
|                        |   |   |   |   |       | d.(1) |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(d\) Institutional    |   |   |   |   |       |       |      | OHRP       |
| officials, including   |   |   |   |   |       |       |      | Guidance   |
| details of which       |   |   |   |   |       |       |      |            |
| institutional          |   |   |   |   |       |       |      |            |
| office(s) or           |   |   |   |   |       |       |      |            |
| official(s) are        |   |   |   |   |       |       |      |            |
| notified and how       |   |   |   |   |       |       |      |            |
| notification to each   |   |   |   |   |       |       |      |            |
| is accomplished.       |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 11\. Details for       |   |   |   |   |       |       |      | FDA Info   |
| communications from    |   |   |   |   |       |       |      | Sheets     |
| the IRB to the         |   |   |   |   |       |       |      |            |
| investigator for       |   |   |   |   |       |       |      |            |
| additional             |   |   |   |   |       |       |      |            |
| information.           |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 12\. Details for       |   |   |   |   |       |       |      | OHRP       |
| reviewing and acting   |   |   |   |   |       |       |      | Guidance   |
| upon investigator's    |   |   |   |   |       |       |      |            |
| responses to           |   |   |   |   |       |       |      |            |
| communications from    |   |   |   |   |       |       |      |            |
| the IRB.               |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 13\. Details for       |   |   |   |   | 38    |       | I    | OHRP       |
| reporting to the IRB,  |   |   |   |   | CFR   |       | .1.D | suggests   |
| institutional          |   |   |   |   | 16.10 |       |      | including  |
| officials, ORO, OHRP   |   |   |   |   | 3(b)( |       | I    | which      |
| and FDA, as            |   |   |   |   | 5)(i) |       | .3.J | office or  |
| appropriate:           |   |   |   |   |       |       |      | ins        |
|                        |   |   |   |   | 21    |       |      | titutional |
| \(a\) Unanticipated    |   |   |   |   | CFR   |       |      | official   |
| research related       |   |   |   |   | 56    |       |      | is         |
| problems involving     |   |   |   |   | .108( |       |      | r          |
| risks to subjects or   |   |   |   |   | b)(1) |       |      | esponsible |
| others.                |   |   |   |   |       |       |      | for        |
|                        |   |   |   |   |       |       |      | reporting  |
|                        |   |   |   |   |       |       |      | and the    |
|                        |   |   |   |   |       |       |      | time frame |
|                        |   |   |   |   |       |       |      | for        |
|                        |   |   |   |   |       |       |      | reporting. |
+------------------------+---+---+---+---+-------+-------+------+------------+

+------------------------+---+---+---+---+-------+-------+------+------------+
| \(b\) Serious or       |   |   |   |   | 38    | VHA   | I    |            |
| continuing             |   |   |   |   | CFR   | Han   | .3.I |            |
| noncompliance.         |   |   |   |   | 16.10 | dbook |      |            |
|                        |   |   |   |   | 3(b)( | 12    |      |            |
|                        |   |   |   |   | 5)(i) | 00.5, |      |            |
|                        |   |   |   |   |       | 7.d.  |      |            |
|                        |   |   |   |   | 21    | (5)   |      |            |
|                        |   |   |   |   | CFR   |       |      |            |
|                        |   |   |   |   | 56    |       |      |            |
|                        |   |   |   |   | .108( |       |      |            |
|                        |   |   |   |   | b)(2) |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(c\) Suspension or    |   |   |   |   | 38    |       | I    |            |
| termination.           |   |   |   |   | CFR   |       | .3.A |            |
|                        |   |   |   |   | 6.103 |       |      |            |
|                        |   |   |   |   | (b)(5 |       | II   |            |
|                        |   |   |   |   | )(II) |       | .4.D |            |
|                        |   |   |   |   |       |       |      |            |
|                        |   |   |   |   | 21    |       |      |            |
|                        |   |   |   |   | CFR   |       |      |            |
|                        |   |   |   |   | 56    |       |      |            |
|                        |   |   |   |   | .108( |       |      |            |
|                        |   |   |   |   | b)(3) |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 14\. Details for       |   |   |   |   |       |       | #    |            |
| reporting to the       |   |   |   |   |       |       | # II |            |
| medical center         |   |   |   |   |       |       | .4.D |            |
| director and VACO any  |   |   |   |   |       |       |      |            |
| AEs that cause harm or |   |   |   |   |       |       |      |            |
| risk of harm to human  |   |   |   |   |       |       |      |            |
| subjects or groups.    |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 15\. Details for       |   |   |   |   |       | VHA   | ##   |            |
| reporting:             |   |   |   |   |       | Han   |      |            |
|                        |   |   |   |   |       | dbook |      |            |
| \(a\) Any AE as        |   |   |   |   |       | 12    |      |            |
| required by VA and     |   |   |   |   |       | 00.5, |      |            |
| Federal policy and     |   |   |   |   |       | 7.d.  |      |            |
| regulations.           |   |   |   |   |       | (6)   |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(b\) To the Privacy   |   |   |   |   |       | VHA   | I.   |            |
| Officer any            |   |   |   |   |       | Han   | 3.A, |            |
| unauthorized use,      |   |   |   |   |       | dbook | I, J |            |
| loss, or disclosure of |   |   |   |   |       | 12    |      |            |
| individually           |   |   |   |   |       | 00.5, |      |            |
| identifiable patient   |   |   |   |   |       | 7.d.  |      |            |
| information.           |   |   |   |   |       | (12)  |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(c\) Violations of VA |   |   |   |   |       | VHA   | I    |            |
| information security   |   |   |   |   |       | Han   | .3.A |            |
| requirements to the    |   |   |   |   |       | dbook |      |            |
| appropriate VHA        |   |   |   |   |       | 12    |      |            |
| Information Security   |   |   |   |   |       | 00.5, |      |            |
| official               |   |   |   |   |       | 7.d.  |      |            |
|                        |   |   |   |   |       | (13)  |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(d\) Non-compliance   |   |   |   |   |       | VHA   | *    |            |
| by study personnel.    |   |   |   |   |       | Han   | *I.3 |            |
|                        |   |   |   |   |       | dbook | .A** |            |
|                        |   |   |   |   |       | 12    |      |            |
|                        |   |   |   |   |       | 00.5, |      |            |
|                        |   |   |   |   |       | 7.d.  |      |            |
|                        |   |   |   |   |       | (4)   |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 16\. Details for:      |   |   |   |   |       | VHA   | I.   |            |
|                        |   |   |   |   |       | Han   | 3.A, |            |
| \(a\) Conducting       |   |   |   |   |       | dbook | I, L |            |
| audits of protocols    |   |   |   |   |       | 12    |      |            |
| and other IRB          |   |   |   |   |       | 00.5, |      |            |
| activities.            |   |   |   |   |       | 7.d.  |      |            |
|                        |   |   |   |   |       | (9)   |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(b\) Observing the    |   |   |   |   |       | VHA   | I    |            |
| informed consent       |   |   |   |   |       | Han   | .3.A |            |
| process when the IRB   |   |   |   |   |       | dbook |      |            |
| determines it to be    |   |   |   |   |       | 12    | II   |            |
| appropriate.           |   |   |   |   |       | 00.5, | .7.G |            |
|                        |   |   |   |   |       | 7.d.  |      |            |
|                        |   |   |   |   |       | (8)   |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(c\) Termination      |   |   |   |   |       | VHA   | ## I |            |
| and/or suspension of   |   |   |   |   |       | Han   | .3.A |            |
| IRB approval.          |   |   |   |   |       | dbook |      |            |
|                        |   |   |   |   |       | 12    | #    |            |
|                        |   |   |   |   |       | 00.5, | # II |            |
|                        |   |   |   |   |       | 7.d.  | .4.D |            |
|                        |   |   |   |   |       | (7)   |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| > \(d\) The            |   |   |   |   |       |       | ## I | FDA Info   |
| > investigator to      |   |   |   |   |       |       | .3.A | Sheets     |
| > request changes in   |   |   |   |   |       |       |      |            |
| > study after          |   |   |   |   |       |       | #    |            |
| > initiation.          |   |   |   |   |       |       | # II |            |
|                        |   |   |   |   |       |       | .2.A |            |
|                        |   |   |   |   |       |       |  & D |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| > \(e\) The            |   |   |   |   |       |       | ## I |            |
| > investigator to      |   |   |   |   |       |       | .3.J |            |
| > report unexpected    |   |   |   |   |       |       |      |            |
| > adverse events       |   |   |   |   |       |       | #    |            |
| > (NOTE: FDA           |   |   |   |   |       |       | # II |            |
| > definition of UAE).  |   |   |   |   |       |       | .2,  |            |
|                        |   |   |   |   |       |       | B, D |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(f\) The investigator |   |   |   |   |       |       | I    |            |
| to provide progress    |   |   |   |   |       |       | .3.A |            |
| reports to the IRB.    |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       |       | II   |            |
|                        |   |   |   |   |       |       | .2.D |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(g\) Ensuring prompt  |   |   |   |   | 38    | VHA   |      | OHRP       |
| reporting by the PI to |   |   |   |   | CFR   | Han   |      | Guidance   |
| the IRB of (proposed)  |   |   |   |   | 16    | dbook |      |            |
| changes in research    |   |   |   |   | .103( | 12    |      |            |
| activities.            |   |   |   |   | b)(4) | 00.5, |      |            |
|                        |   |   |   |   | (IIi) | 7.    |      |            |
|                        |   |   |   |   |       | d.(3) |      |            |
|                        |   |   |   |   | 21    |       |      |            |
|                        |   |   |   |   | CFR   |       |      |            |
|                        |   |   |   |   | 56    |       |      |            |
|                        |   |   |   |   | .108( |       |      |            |
|                        |   |   |   |   | a)(3) |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(h\) Ensuring that    |   |   |   |   | 38    | VHA   | I    |            |
| changes or amendments  |   |   |   |   | CFR   | Han   | .3.A |            |
| in approved research   |   |   |   |   | 16    | dbook |      |            |
| are not initiated      |   |   |   |   | .103( | 12    | II   |            |
| without IRB review and |   |   |   |   | b)(4) | 00.5, | .2.D |            |
| approval except to     |   |   |   |   |       | 7.d   |      |            |
| eliminate apparent     |   |   |   |   | 21    | (3)   |      |            |
| immediate hazards.     |   |   |   |   | CFR   |       |      |            |
|                        |   |   |   |   | 56    |       |      |            |
|                        |   |   |   |   | .108( |       |      |            |
|                        |   |   |   |   | a)(4) |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(i\) Reporting        |   |   |   |   | 38    |       | I    | OHRP       |
| unanticipated problems |   |   |   |   | CFR   |       | .3.A | Guidance   |
| involving risks to     |   |   |   |   | 16.10 |       |      | suggests   |
| subjects or others to  |   |   |   |   | 3(b)( |       | II   | that the   |
| the IRB, including     |   |   |   |   | 5)(i) |       | .2.D | time       |
| time frames.           |   |   |   |   |       |       |      | frames be  |
|                        |   |   |   |   | 21    |       |      | included.  |
|                        |   |   |   |   | CFR   |       |      |            |
|                        |   |   |   |   | 56    |       |      |            |
|                        |   |   |   |   | .108( |       |      |            |
|                        |   |   |   |   | b)(2) |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(j\) Notifying and    |   |   |   |   | 21    |       | I    | FDA Info   |
| reporting to the IRB   |   |   |   |   | CFR   |       | .5.C | Sheets     |
| within 5 days of       |   |   |   |   | 56.1  |       |      |            |
| Emergency Use of       |   |   |   |   | 04(c) |       |      |            |
| investigational drugs  |   |   |   |   |       |       |      |            |
| or devices without IRB |   |   |   |   |       |       |      |            |
| review.                |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(j\) Notifying and    |   |   |   |   | 21    |       | II   |            |
| reporting to the IRB   |   |   |   |   | CFR   |       | .7.F |            |
| within 5 days of       |   |   |   |   | 50.23 |       |      |            |
| Emergency Use of       |   |   |   |   |       |       |      |            |
| investigational drugs  |   |   |   |   |       |       |      |            |
| or devices without     |   |   |   |   |       |       |      |            |
| informed consent.      |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(k\) A statement      |   |   |   |   | 21    |       | II   |            |
| specifying that VA     |   |   |   |   | CFR   |       | .7.F |            |
| does not permit the    |   |   |   |   | 50.24 |       |      |            |
| conduct of "planned    |   |   |   |   |       |       |      |            |
| emergency research     |   |   |   |   |       |       |      |            |
| without informed       |   |   |   |   |       |       |      |            |
| consent" per 21 CFR    |   |   |   |   |       |       |      |            |
| 50.54.                 |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 17\. A description of  |   |   |   |   |       |       | ## I | OHRP       |
| which institutional    |   |   |   |   |       |       | .1.A | Guidance   |
| office(s) or           |   |   |   |   |       |       |      |            |
| official(s) is         |   |   |   |   |       |       |      |            |
| responsible for        |   |   |   |   |       |       |      |            |
| further review and     |   |   |   |   |       |       |      |            |
| approval or            |   |   |   |   |       |       |      |            |
| disapproval of         |   |   |   |   |       |       |      |            |
| research that is       |   |   |   |   |       |       |      |            |
| approved by the IRB.   |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 18\. Initial review of |   |   |   |   | 38    | VHA   | I    | OHRP       |
| proposed research      |   |   |   |   | CFR   | Han   | .3.A | Guidance   |
| including procedures   |   |   |   |   | 1     | dbook |      | suggests   |
| for determining which  |   |   |   |   | 6.103 | 12    | II   | including  |
| projects require       |   |   |   |   | (b)(4 | 00.5, | .2.A | specific   |
| review more often than |   |   |   |   | )(II) | 7.d.  |      | criteria   |
| annually.              |   |   |   |   |       | (2)   |      | for IRB to |
|                        |   |   |   |   | 21    |       |      | make these |
|                        |   |   |   |   | CFR   |       |      | deter      |
|                        |   |   |   |   | 56    |       |      | minations. |
|                        |   |   |   |   | .108( |       |      |            |
|                        |   |   |   |   | a)(2) |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 19\. Expedited review  |   |   |   |   | 38    | VHA   | I    |            |
| including:             |   |   |   |   | CFR   | Han   | .3.A |            |
|                        |   |   |   |   | 16.1  | dbook |      |            |
| \(a\) A method to      |   |   |   |   | 10(c) | 12    |      |            |
| advise members of      |   |   |   |   |       | 00.5, |      |            |
| research proposals     |   |   |   |   | 21    | 7.d.  |      |            |
| approved by expedited  |   |   |   |   | CFR   | (11)  |      |            |
| review.                |   |   |   |   | 56.1  |       |      |            |
|                        |   |   |   |   | 10(c) |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(b\) Approval of      |   |   |   |   |       |       | II   | OHRP       |
| minor modifications to |   |   |   |   |       |       | .2.B | Guidance   |
| ongoing studies.       |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(c\) A description of |   |   |   |   |       |       | ##   | OHRP       |
| how expedited reviews  |   |   |   |   |       |       |      | Guidance   |
| are conducted at both  |   |   |   |   |       |       |      |            |
| initial and continuing |   |   |   |   |       |       |      |            |
| review including       |   |   |   |   |       |       |      |            |
| documentation of       |   |   |   |   |       |       |      |            |
| specific permissible   |   |   |   |   |       |       |      |            |
| category and           |   |   |   |   |       |       |      |            |
| documentation of the   |   |   |   |   |       |       |      |            |
| review and action      |   |   |   |   |       |       |      |            |
| taken by the           |   |   |   |   |       |       |      |            |
| designated reviewer.   |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 20\. Review of exempt  |   |   |   |   |       |       | I    | OHRP       |
| research including:    |   |   |   |   |       |       | .3.C | Guidance   |
|                        |   |   |   |   |       |       | & D  |            |
| \(a\) Procedures for   |   |   |   |   |       |       |      |            |
| the IRB Chair (or IRB  |   |   |   |   |       |       |      |            |
| member designated by   |   |   |   |   |       |       |      |            |
| the Chair) to approve  |   |   |   |   |       |       |      |            |
| exemption of a         |   |   |   |   |       |       |      |            |
| proposed research      |   |   |   |   |       |       |      |            |
| activity from the      |   |   |   |   |       |       |      |            |
| human subjects         |   |   |   |   |       |       |      |            |
| regulations.           |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(b\) Procedures for   |   |   |   |   |       | VHA   |      |            |
| notifying IRB and R&D  |   |   |   |   |       | Han   |      |            |
| Committee of decisions |   |   |   |   |       | dbook |      |            |
| about exemptions, and  |   |   |   |   |       | 12    |      |            |
| for documenting such   |   |   |   |   |       | 00.5, |      |            |
| exemptions in IRB      |   |   |   |   |       | 7.d   |      |            |
| records, including     |   |   |   |   |       | .(11) |      |            |
| documentation of the   |   |   |   |   |       |       |      |            |
| specific category      |   |   |   |   |       |       |      |            |
| justifying the         |   |   |   |   |       |       |      |            |
| exemption              |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 21\. Continuing        |   |   |   |   | 38    | VHA   | I    | OHRP       |
| review, including      |   |   |   |   | CFR   | Han   | .1.D | Guidance   |
| procedures for         |   |   |   |   | 1     | dbook |      | suggests   |
| determining from       |   |   |   |   | 6.103 | 12    | I    | including  |
| sources other than the |   |   |   |   | (b)(4 | 00.5, | .3.I | specific   |
| investigator that no   |   |   |   |   | )(II) | 7.    | & J  | criteria   |
| material changes have  |   |   |   |   |       | d.(2) |      | for IRB to |
| occurred since         |   |   |   |   | 21    |       | II   | make this  |
| previous IRB review.   |   |   |   |   | CFR   |       | .2.A | dete       |
|                        |   |   |   |   | 56    |       |      | rmination. |
|                        |   |   |   |   | .108( |       |      |            |
|                        |   |   |   |   | a)(2) |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 22\. Review of         |   |   |   |   |       | VHA   | II   |            |
| research conducted in  |   |   |   |   |       | Dire  | .2.A |            |
| international settings |   |   |   |   |       | ctive |      |            |
| (i.e., outside the     |   |   |   |   |       | 200   |      |            |
| United States),        |   |   |   |   |       | 5-050 |      |            |
| including prospective  |   |   |   |   |       |       |      |            |
| approval of the        |   |   |   |   |       |       |      |            |
| CRADO).                |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 23\. Review to ensure  |   |   |   |   | #     | VHA   |      |            |
| that all               |   |   |   |   |       | Han   |      |            |
| investigators:         |   |   |   |   |       | dbook |      |            |
|                        |   |   |   |   |       | 12    |      |            |
| \(a\) Function         |   |   |   |   |       | 00.1, |      |            |
| strictly in accordance |   |   |   |   |       | 5.a,  |      |            |
| with their             |   |   |   |   |       | &     |      |            |
| VA-authorized          |   |   |   |   |       | 5.e.  |      |            |
| credentials,           |   |   |   |   |       |       |      |            |
| privileges, and scopes |   |   |   |   |       | VHA   |      |            |
| of practice when       |   |   |   |   |       | Han   |      |            |
| involved in research.  |   |   |   |   |       | dbook |      |            |
|                        |   |   |   |   |       | 12    |      |            |
|                        |   |   |   |   |       | 00.5, |      |            |
|                        |   |   |   |   |       | 3.n., |      |            |
|                        |   |   |   |   |       | 10    |      |            |
|                        |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       | ORD   |      |            |
|                        |   |   |   |   |       | Gui   |      |            |
|                        |   |   |   |   |       | dance |      |            |
|                        |   |   |   |   |       |       |      |            |
|                        |   |   |   |   |       | May   |      |            |
|                        |   |   |   |   |       | 10,   |      |            |
|                        |   |   |   |   |       | 2007  |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(b\) Are 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.              |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 24\. Review to ensure  |   |   |   |   | #     | C     |      |            |
| that all protocols and |   |   |   |   |       | RADO/ |      |            |
| investigators:         |   |   |   |   |       | D     |      |            |
|                        |   |   |   |   |       | USHOM |      |            |
| \(a\) Comply with all  |   |   |   |   |       | Memos |      |            |
| VA and VHA             |   |   |   |   |       | 06.12 |      |            |
| requirements for use,  |   |   |   |   |       | .2006 |      |            |
| disclosure, storage,   |   |   |   |   |       |       |      |            |
| transfer, and security |   |   |   |   |       | &     |      |            |
| of research            |   |   |   |   |       | 02.06 |      |            |
| information.           |   |   |   |   |       | .2007 |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(b\) Comply with VHA  |   |   |   |   | #     | C     |      |            |
| requirements for       |   |   |   |   |       | RADO/ |      |            |
| research recruiting    |   |   |   |   |       | USH   |      |            |
| contacts with          |   |   |   |   |       | Memo  |      |            |
| veterans.              |   |   |   |   |       | 07.10 |      |            |
|                        |   |   |   |   |       | .2006 |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 25\. The Medical       |   |   |   |   | #     | VHA   |      |            |
| Center Director        |   |   |   |   |       | Dire  |      |            |
| appoints the facility  |   |   |   |   |       | ctive |      |            |
| Information Security   |   |   |   |   |       | 2007  |      |            |
| Officer (ISO) to the   |   |   |   |   |       | -040, |      |            |
| IRB or R&D Committee,  |   |   |   |   |       | 4.    |      |            |
| at least as a          |   |   |   |   |       | b.(3) |      |            |
| non-voting member, and |   |   |   |   |       | and   |      |            |
| the facility's         |   |   |   |   |       | 4.    |      |            |
| policies and SOPs      |   |   |   |   |       | b.(4) |      |            |
| incorporate these      |   |   |   |   |       |       |      |            |
| requirements.          |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 26\. Review of each    |   |   |   |   | #     |       |      |            |
| protocol by the ISO to |   |   |   |   |       |       |      |            |
| ensure compliance with |   |   |   |   |       |       |      |            |
| all VA and VHA         |   |   |   |   |       |       |      |            |
| requirements for use,  |   |   |   |   |       |       |      |            |
| disclosure, storage,   |   |   |   |   |       |       |      |            |
| transfer, and security |   |   |   |   |       |       |      |            |
| of research            |   |   |   |   |       |       |      |            |
| information.           |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 27\. Appointment of    |   |   |   |   | #     |       |      |            |
| the facility Privacy   |   |   |   |   |       |       |      |            |
| Officer to the IRB, at |   |   |   |   |       |       |      |            |
| least as a non-voting  |   |   |   |   |       |       |      |            |
| member.                |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 28\. Review of each    |   |   |   |   | #     |       |      |            |
| protocol by the        |   |   |   |   |       |       |      |            |
| facility Privacy       |   |   |   |   |       |       |      |            |
| Office to ensure       |   |   |   |   |       |       |      |            |
| compliance with all VA |   |   |   |   |       |       |      |            |
| and VHA privacy        |   |   |   |   |       |       |      |            |
| requirements.          |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 29\. Determining the   |   |   |   |   | #     | VHA   |      |            |
| conditions when an     |   |   |   |   |       | Han   |      |            |
| electronic warning     |   |   |   |   |       | dbook |      |            |
| flag must be placed in |   |   |   |   |       | 190   |      |            |
| the subject's          |   |   |   |   |       | 7.01, |      |            |
| Computerized Patient   |   |   |   |   |       | 6.t   |      |            |
| Record System (CPRS)   |   |   |   |   |       | .(10) |      |            |
| VA Health Record.      |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+

+------------------------+---+---+---+---+-------+-------+------+------------+
| **C. IRB PROJECT       | * | * | * | * | **R   | **    | **   | **Notes**  |
| FILES**                | * | * | * | * | EGS** | VHA** | AAHR |            |
|                        | Y | N | I | N |       |       | PP** |            |
|                        | * | * | P | A |       |       |      |            |
|                        | * | * | * | * |       |       |      |            |
|                        |   |   | * | * |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| **IRB Project Files    |   |   |   |   | 38    | VHA   | I    | OHRP       |
| include**:             |   |   |   |   | CFR   | Han   | .2.D | Guidance   |
|                        |   |   |   |   | 16    | dbook |      |            |
| 1\. Study protocol     |   |   |   |   | .115( | 1     | II.  | FDA Info   |
| with abstract.         |   |   |   |   | a)(1) | 200.5 | 3.A, | Sheets     |
|                        |   |   |   |   |       | 7.    | B, C |            |
|                        |   |   |   |   | 38    | i.(1) |      |            |
|                        |   |   |   |   | CFR   |       | III  |            |
|                        |   |   |   |   | 1     |       | .2.B |            |
|                        |   |   |   |   | 6.111 |       |      |            |
|                        |   |   |   |   |       |       |      |            |
|                        |   |   |   |   | 21    |       |      |            |
|                        |   |   |   |   | CFR   |       |      |            |
|                        |   |   |   |   | 56    |       |      |            |
|                        |   |   |   |   | .115( |       |      |            |
|                        |   |   |   |   | a)(1) |       |      |            |
|                        |   |   |   |   |       |       |      |            |
|                        |   |   |   |   | 21    |       |      |            |
|                        |   |   |   |   | CFR   |       |      |            |
|                        |   |   |   |   | 5     |       |      |            |
|                        |   |   |   |   | 6.111 |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 2\. Grant application  |   |   |   |   | 38    |       |      | OHRP       |
| (for federally funded  |   |   |   |   | CFR   |       |      | Common     |
| research).             |   |   |   |   | 16.1  |       |      | Findings   |
|                        |   |   |   |   | 03(f) |       |      |            |
|                        |   |   |   |   |       |       |      |            |
|                        |   |   |   |   | 21    |       |      |            |
|                        |   |   |   |   | CFR   |       |      |            |
|                        |   |   |   |   | 56.   |       |      |            |
|                        |   |   |   |   | 1     |       |      |            |
|                        |   |   |   |   | 03(f) |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 3\. Clinical           |   |   |   |   |       | VHA   |      | FDA Info   |
| Investigator's         |   |   |   |   |       | Han   |      | Sheets     |
| brochure.              |   |   |   |   |       | dbook |      |            |
|                        |   |   |   |   |       | 12    |      |            |
|                        |   |   |   |   |       | 00.5, |      |            |
|                        |   |   |   |   |       | 7.    |      |            |
|                        |   |   |   |   |       | i.(1) |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 4\. Study advertising  |   |   |   |   |       | VHA   |      | FDA Info   |
| material.              |   |   |   |   |       | Han   |      | Sheets     |
|                        |   |   |   |   |       | dbook |      |            |
|                        |   |   |   |   |       | 12    |      |            |
|                        |   |   |   |   |       | 00.5, |      |            |
|                        |   |   |   |   |       | 7.    |      |            |
|                        |   |   |   |   |       | i.(1) |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 5\. Approved informed  |   |   |   |   | 38    | VHA   |      |            |
| consent (VA Form       |   |   |   |   | CFR   | Han   |      |            |
| 10-1086).              |   |   |   |   | 16    | dbook |      |            |
|                        |   |   |   |   | .115( | 12    |      |            |
|                        |   |   |   |   | a)(1) | 00.5, |      |            |
|                        |   |   |   |   |       | 7.    |      |            |
|                        |   |   |   |   | 21    | i.(1) |      |            |
|                        |   |   |   |   | CFR   |       |      |            |
|                        |   |   |   |   | 56    | VHA   |      |            |
|                        |   |   |   |   | .115( | Han   |      |            |
|                        |   |   |   |   | a)(1) | dbook |      |            |
|                        |   |   |   |   |       | 12    |      |            |
|                        |   |   |   |   |       | 00.5, |      |            |
|                        |   |   |   |   |       | App   |      |            |
|                        |   |   |   |   |       | C,    |      |            |
|                        |   |   |   |   |       | 3.b   |      |            |
|                        |   |   |   |   |       | .(1). |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 6\. Copy of            |   |   |   |   |       | M-2,  |      |            |
| Investigational Drug   |   |   |   |   |       | Part  |      |            |
| Information Record VA  |   |   |   |   |       | VII,  |      |            |
| Form 10-9012.          |   |   |   |   |       | Ch    |      |            |
|                        |   |   |   |   |       | 6.07  |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 7\. Copy of Report of  |   |   |   |   |       | M-2,  |      |            |
| Subcommittee on Human  |   |   |   |   |       | Part  |      |            |
| Studies VA Form        |   |   |   |   |       | VII,  |      |            |
| 10-1223.               |   |   |   |   |       | Ch    |      |            |
|                        |   |   |   |   |       | 6.07  |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 8\. Records of         |   |   |   |   | 38    | VHA   |      | OHRP       |
| continuing review      |   |   |   |   | CFR   | Han   |      | Guidance   |
| activities showing:    |   |   |   |   | 16    | dbook |      |            |
|                        |   |   |   |   | .115( | 12    |      |            |
| \(a\) Brief summary of |   |   |   |   | a)(3) | 00.5, |      |            |
| the research           |   |   |   |   |       | 7.g.( |      |            |
| methodology and        |   |   |   |   | 21    | 1)(a) |      |            |
| procedures.            |   |   |   |   | CFR   |       |      |            |
|                        |   |   |   |   | 56    |       |      |            |
|                        |   |   |   |   | .115( |       |      |            |
|                        |   |   |   |   | a)(3) |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| \(b\) Number of        |   |   |   |   |       | VHA   |      |            |
| subjects entered and   |   |   |   |   |       | Han   |      |            |
| withdrawn (including   |   |   |   |   |       | dbook |      |            |
| the reasons 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 |   |   |   |   |       | dbook |      |            |
|     the protocol.      |   |   |   |   |       | 12    |      |            |
|                        |   |   |   |   |       | 00.5, |      |            |
|                        |   |   |   |   |       | 7.g.( |      |            |
|                        |   |   |   |   |       | 1)(c) |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+

+-------------------------+---+---+---+---+-------+-------+------+------------+
| (d) Number of subjects  |   |   |   |   |       | VHA   | (see |            |
|     considered as       |   |   |   |   |       | Han   | ab   |            |
|     members of specific |   |   |   |   |       | dbook | ove) |            |
|     vulnerable          |   |   |   |   |       | 12    |      |            |
|     populations.        |   |   |   |   |       | 00.5, |      |            |
|                         |   |   |   |   |       | 7.g.( |      |            |
|                         |   |   |   |   |       | 1)(d) |      |            |
+-------------------------+---+---+---+---+-------+-------+------+------------+
| (e) A copy of the       |   |   |   |   |       | VHA   |      |            |
|     proposal and all    |   |   |   |   |       | Han   |      |            |
|     approved            |   |   |   |   |       | dbook |      |            |
|     amendments.         |   |   |   |   |       | 12    |      |            |
|                         |   |   |   |   |       | 00.5, |      |            |
|                         |   |   |   |   |       | 7.g.( |      |            |
|                         |   |   |   |   |       | 1)(e) |      |            |
+-------------------------+---+---+---+---+-------+-------+------+------------+
| (f) A copy of the       |   |   |   |   |       | VHA   |      |            |
|     current approved    |   |   |   |   |       | Han   |      |            |
|     informed consent .  |   |   |   |   |       | dbook |      |            |
|                         |   |   |   |   |       | 12    |      |            |
|                         |   |   |   |   |       | 00.5, |      |            |
|                         |   |   |   |   |       | 7.g.( |      |            |
|                         |   |   |   |   |       | 1)(f) |      |            |
+-------------------------+---+---+---+---+-------+-------+------+------------+
| (g) A copy of the       |   |   |   |   |       | VHA   |      |            |
|     current HIPAA       |   |   |   |   |       | Han   |      |            |
|     Authorization       |   |   |   |   |       | dbook |      |            |
|     document, if        |   |   |   |   |       | 12    |      |            |
|     separate from the   |   |   |   |   |       | 00.5, |      |            |
|     informed consent.   |   |   |   |   |       | 7.g.( |      |            |
|                         |   |   |   |   |       | 1)(g) |      |            |
+-------------------------+---+---+---+---+-------+-------+------+------------+
| (h) Information that    |   |   |   |   |       | VHA   |      |            |
|     may impact on the   |   |   |   |   |       | Han   |      |            |
|     risk benefit ratio  |   |   |   |   |       | dbook |      |            |
|     such as a summary   |   |   |   |   |       | 12    |      |            |
|     of adverse events   |   |   |   |   |       | 00.5, |      |            |
|     and any             |   |   |   |   |       | 7.g.( |      |            |
|     unanticipated       |   |   |   |   |       | 1)(h) |      |            |
|     problems involving  |   |   |   |   |       |       |      |            |
|     risks to subjects   |   |   |   |   |       |       |      |            |
|     or others, and      |   |   |   |   |       |       |      |            |
|     complaints about    |   |   |   |   |       |       |      |            |
|     the research.       |   |   |   |   |       |       |      |            |
+-------------------------+---+---+---+---+-------+-------+------+------------+
| (i) Research findings   |   |   |   |   |       | VHA   |      |            |
|     to date, if         |   |   |   |   |       | Han   |      |            |
|     available.          |   |   |   |   |       | dbook |      |            |
|                         |   |   |   |   |       | 12    |      |            |
|                         |   |   |   |   |       | 00.5, |      |            |
|                         |   |   |   |   |       | 7.g.( |      |            |
|                         |   |   |   |   |       | 1)(i) |      |            |
+-------------------------+---+---+---+---+-------+-------+------+------------+
| (j) A summary of the    |   |   |   |   |       | VHA   |      |            |
|     DSMB or DMC         |   |   |   |   |       | Han   |      |            |
|     meetings (if        |   |   |   |   |       | dbook |      |            |
|     applicable) or      |   |   |   |   |       | 12    |      |            |
|     findings based on   |   |   |   |   |       | 00.5, |      |            |
|     information         |   |   |   |   |       | 7.g.( |      |            |
|     collected by the    |   |   |   |   |       | 1)(j) |      |            |
|     data and safety     |   |   |   |   |       |       |      |            |
|     monitoring plan     |   |   |   |   |       |       |      |            |
|     submitted in the    |   |   |   |   |       |       |      |            |
|     initial proposal.   |   |   |   |   |       |       |      |            |
+-------------------------+---+---+---+---+-------+-------+------+------------+
| (k) Assurance that all  |   |   |   |   |       | VHA   |      |            |
|     SAEs and UAEs have  |   |   |   |   |       | Han   |      |            |
|     been reported.      |   |   |   |   |       | dbook |      |            |
|                         |   |   |   |   |       | 12    |      |            |
|                         |   |   |   |   |       | 00.5, |      |            |
|                         |   |   |   |   |       | 7.g.( |      |            |
|                         |   |   |   |   |       | 1)(k) |      |            |
+-------------------------+---+---+---+---+-------+-------+------+------------+
| \(l\) New scientific    |   |   |   |   |       | VHA   |      |            |
| findings in the         |   |   |   |   |       | Han   |      |            |
| literature, or other    |   |   |   |   |       | dbook |      |            |
| relevant finds, that    |   |   |   |   |       | 12    |      |            |
| may impact on the       |   |   |   |   |       | 00.5, |      |            |
| research.               |   |   |   |   |       | 7.g.( |      |            |
|                         |   |   |   |   |       | 1)(l) |      |            |
+-------------------------+---+---+---+---+-------+-------+------+------------+
| 9\. Requests to change  |   |   |   |   | 38    | VHA   |      |            |
| and/or amend protocol   |   |   |   |   | CFR   | Han   |      |            |
| after study initiation  |   |   |   |   | 16    | dbook |      |            |
| and IRB actions on      |   |   |   |   | .103( | 12    |      |            |
| each.                   |   |   |   |   | b)(4) | 00.5, |      |            |
|                         |   |   |   |   | (iii) | 7.i   |      |            |
|                         |   |   |   |   |       | .(1). |      |            |
|                         |   |   |   |   | 21    |       |      |            |
|                         |   |   |   |   | CFR   |       |      |            |
|                         |   |   |   |   | 56    |       |      |            |
|                         |   |   |   |   | .108( |       |      |            |
|                         |   |   |   |   | a)(3) |       |      |            |
+-------------------------+---+---+---+---+-------+-------+------+------------+
| 10\. Reports of         |   |   |   |   | 38    | VHA   |      |            |
| unexpected and serious  |   |   |   |   | CFR   | Han   |      |            |
| adverse events, as well |   |   |   |   | 16    | dbook |      |            |
| as injuries to          |   |   |   |   | .115( | 12    |      |            |
| subjects.               |   |   |   |   | a)(1) | 00.5, |      |            |
|                         |   |   |   |   |       | 7.    |      |            |
|                         |   |   |   |   | 38    | i.(1) |      |            |
|                         |   |   |   |   | CFR   |       |      |            |
|                         |   |   |   |   | 16    |       |      |            |
|                         |   |   |   |   | .103( |       |      |            |
|                         |   |   |   |   | b)(5) |       |      |            |
|                         |   |   |   |   |       |       |      |            |
|                         |   |   |   |   | 21    |       |      |            |
|                         |   |   |   |   | CFR   |       |      |            |
|                         |   |   |   |   | 56    |       |      |            |
|                         |   |   |   |   | .115( |       |      |            |
|                         |   |   |   |   | a)(1) |       |      |            |
|                         |   |   |   |   |       |       |      |            |
|                         |   |   |   |   | 21    |       |      |            |
|                         |   |   |   |   | CFR   |       |      |            |
|                         |   |   |   |   | 56    |       |      |            |
|                         |   |   |   |   | .108( |       |      |            |
|                         |   |   |   |   | a)(3) |       |      |            |
+-------------------------+---+---+---+---+-------+-------+------+------------+
| 11\. Final report.      |   |   |   |   | 21    |       |      | FDA Info   |
|                         |   |   |   |   | CFR   |       |      | Sheets     |
|                         |   |   |   |   | 5     |       |      |            |
|                         |   |   |   |   | 6.108 |       |      |            |
|                         |   |   |   |   | (     |       |      |            |
|                         |   |   |   |   | a)(3) |       |      |            |
+-------------------------+---+---+---+---+-------+-------+------+------------+
| 12\. All written        |   |   |   |   | 38    |       |      |            |
| communications          |   |   |   |   | CFR   |       |      |            |
| regarding the study to  |   |   |   |   | 16    |       |      |            |
| and from the PI and IRB |   |   |   |   | .115( |       |      |            |
| including approval      |   |   |   |   | a)(4) |       |      |            |
| letters.                |   |   |   |   |       |       |      |            |
|                         |   |   |   |   | 21    |       |      |            |
|                         |   |   |   |   | CFR   |       |      |            |
|                         |   |   |   |   | 56    |       |      |            |
|                         |   |   |   |   | .115( |       |      |            |
|                         |   |   |   |   | a)(4) |       |      |            |
+-------------------------+---+---+---+---+-------+-------+------+------------+

+------------------------+---+---+---+---+-------+-------+------+------------+
| 13\. Approved HIPAA    |   |   |   |   |       | VHA   | (see |            |
| Authorization document |   |   |   |   |       | Han   | ab   |            |
| if separate from       |   |   |   |   |       | dbook | ove) |            |
| informed consent.      |   |   |   |   |       | 12    |      |            |
|                        |   |   |   |   |       | 00.5, |      |            |
|                        |   |   |   |   |       | 7.    |      |            |
|                        |   |   |   |   |       | i.(1) |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 14\. Documentation of  |   |   |   |   |       |       |      |            |
| protocol violations.   |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 15\. Documentation of  |   |   |   |   |       |       |      |            |
| non-compliance with    |   |   |   |   |       |       |      |            |
| the applicable         |   |   |   |   |       |       |      |            |
| regulations.           |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 16\. Progress reports  |   |   |   |   | 38    |       |      |            |
| submitted by the       |   |   |   |   | CFR   |       |      |            |
| investigator.          |   |   |   |   | 16    |       |      |            |
|                        |   |   |   |   | .115( |       |      |            |
|                        |   |   |   |   | a)(1) |       |      |            |
|                        |   |   |   |   |       |       |      |            |
|                        |   |   |   |   | 21    |       |      |            |
|                        |   |   |   |   | CFR   |       |      |            |
|                        |   |   |   |   | 56    |       |      |            |
|                        |   |   |   |   | .115( |       |      |            |
|                        |   |   |   |   | a)(1) |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 17\. Statements of     |   |   |   |   | 38    | VHA   |      |            |
| significant new        |   |   |   |   | CFR   | Han   |      |            |
| findings provided to   |   |   |   |   | 16    | dbook |      |            |
| the subjects.          |   |   |   |   | .115( | 12    |      |            |
|                        |   |   |   |   | a)(7) | 00.5, |      |            |
|                        |   |   |   |   |       | 7.    |      |            |
|                        |   |   |   |   | 21    | i.(6) |      |            |
|                        |   |   |   |   | CFR   |       |      |            |
|                        |   |   |   |   | 56    |       |      |            |
|                        |   |   |   |   | .115( |       |      |            |
|                        |   |   |   |   | a)(7) |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 18\. Institutionally   |   |   |   |   |       |       |      | FDA Info   |
| developed protocol     |   |   |   |   |       |       |      | Sheets     |
| summary forms or other |   |   |   |   |       |       |      |            |
| forms.                 |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 19\. Copy of the       |   |   |   |   | 21    |       |      | FDA Info   |
| sponsor\'s risk        |   |   |   |   | CFR   |       |      | Sheets     |
| assessment and         |   |   |   |   | 812.  |       |      |            |
| rationale used in      |   |   |   |   | 150(b |       |      |            |
| making its risk        |   |   |   |   | )(10) |       |      |            |
| determination for      |   |   |   |   |       |       |      |            |
| investigational        |   |   |   |   |       |       |      |            |
| devices.               |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 20\. For review of     |   |   |   |   |       | VHA   |      |            |
| exempt research, IRB   |   |   |   |   |       | Han   |      |            |
| records document that  |   |   |   |   |       | dbook |      |            |
| reviewer is either the |   |   |   |   |       | 12    |      |            |
| IRB Chair or           |   |   |   |   |       | 00.5, |      |            |
| designated IRB member. |   |   |   |   |       | 8.b.  |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 21\. For review of     |   |   |   |   |       | VHA   |      | OHRP       |
| exempt research, IRB   |   |   |   |   |       | Han   |      | Guidance   |
| records contain a      |   |   |   |   |       | dbook |      |            |
| statement explaining   |   |   |   |   |       | 12    |      |            |
| under which category   |   |   |   |   |       | 00.5, |      |            |
| listed in the          |   |   |   |   |       | 8.b.  |      |            |
| regulations the study  |   |   |   |   |       |       |      |            |
| qualifies as exempt.   |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
|                        |   |   |   |   |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| **D. MINUTES OF IRB    | * | * | * | * | **R   | **    | **   | **Notes**  |
| MEETINGS**             | * | * | * | * | EGS** | VHA** | AAHR |            |
|                        | Y | N | I | N |       |       | PP** |            |
|                        | * | * | P | A |       |       |      |            |
|                        | * | * | * | * |       |       |      |            |
|                        |   |   | * | * |       |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 1\. Date and time      |   |   |   |   |       |       |      | Typically  |
| meeting starts and     |   |   |   |   |       |       |      | included   |
| ends.                  |   |   |   |   |       |       |      | but not    |
|                        |   |   |   |   |       |       |      | required   |
|                        |   |   |   |   |       |       |      | by         |
|                        |   |   |   |   |       |       |      | regulation |
|                        |   |   |   |   |       |       |      | or policy. |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 2\. Presence and       |   |   |   |   | 38    | VHA   | II   |            |
| absence of IRB members |   |   |   |   | CFR   | Han   | .3.A |            |
| is recorded to show    |   |   |   |   | 16.1  | dbook |      |            |
| that quorum including  |   |   |   |   | 08(b) | 12    | II   |            |
| one member whose       |   |   |   |   |       | 00.5, | .3.C |            |
| primary concern is     |   |   |   |   | 38    | 7     |      |            |
| non-scientific and     |   |   |   |   | CFR   | .i.(2 |      |            |
| those participating by |   |   |   |   | 16    | ).(a) |      |            |
| teleconference.        |   |   |   |   | .115( |       |      |            |
|                        |   |   |   |   | a)(2) | VHA   |      |            |
|                        |   |   |   |   |       | Han   |      |            |
|                        |   |   |   |   | 21    | dbook |      |            |
|                        |   |   |   |   | CFR   | 12    |      |            |
|                        |   |   |   |   | 5     | 00.5, |      |            |
|                        |   |   |   |   | 6.108 | 7     |      |            |
|                        |   |   |   |   | (c)   | .i.(2 |      |            |
|                        |   |   |   |   |       | ).(b) |      |            |
|                        |   |   |   |   | 21    |       |      |            |
|                        |   |   |   |   | CFR   |       |      |            |
|                        |   |   |   |   | 56    |       |      |            |
|                        |   |   |   |   | .115( |       |      |            |
|                        |   |   |   |   | a)(2) |       |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 3\. If the research    |   |   |   |   |       | VHA   |      |            |
| involves a product     |   |   |   |   |       | Han   |      |            |
| regulated by the FDA,  |   |   |   |   |       | dbook |      |            |
| presence of a licensed |   |   |   |   |       | 12    |      |            |
| physician.             |   |   |   |   |       | 20.5, |      |            |
|                        |   |   |   |   |       | 7.    |      |            |
|                        |   |   |   |   |       | f.(1) |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+
| 4\. Indicate for which |   |   |   |   |       | VHA   |      |            |
| member any alternate   |   |   |   |   |       | Han   |      |            |
| IRB member is present. |   |   |   |   |       | dbook |      |            |
|                        |   |   |   |   |       | 12    |      |            |
|                        |   |   |   |   |       | 00.5, |      |            |
|                        |   |   |   |   |       | 7.i.( |      |            |
|                        |   |   |   |   |       | 2)(c) |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+

+------------------------+---+---+---+---+--------+-------+------+------------+
| > 5\. Members with a   |   |   |   |   | 38 CFR | VHA   | II   | OHRP       |
| > conflict of interest |   |   |   |   | 16.    | Han   | .3.A | Guidance   |
| > are absent from      |   |   |   |   | 107(e) | dbook |      |            |
| > discussion and vote. |   |   |   |   |        | 12    | II   |            |
|                        |   |   |   |   | 21 CFR | 00.5, | .3.C |            |
|                        |   |   |   |   | 56.    | 7.i.( |      |            |
|                        |   |   |   |   | 107(e) | 2)(g) |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| > 6\. Actions taken by |   |   |   |   | 38 CFR | VHA   |      | OHRP       |
| > the IRB, including   |   |   |   |   | 16.115 | Han   |      | Guidance   |
| > deferral of projects |   |   |   |   | (a)(2) | dbook |      |            |
| > when substantive     |   |   |   |   |        | 12    |      |            |
| > issues remain        |   |   |   |   | 21 CFR | 00.5, |      |            |
| > unresolved.          |   |   |   |   | 56.115 | 7.i.( |      |            |
|                        |   |   |   |   | (a)(2) | 2)(d) |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| > 7\. Voting record    |   |   |   |   | 38 CFR | VHA   |      | OHRP       |
| > indicates votes for, |   |   |   |   | 16.115 | Han   |      | Guidance   |
| > against and          |   |   |   |   | (a)(2) | dbook |      |            |
| > abstention.          |   |   |   |   |        | 12    |      |            |
|                        |   |   |   |   | 21 CFR | 00.5, |      |            |
|                        |   |   |   |   | 56.115 | 7.i.( |      |            |
|                        |   |   |   |   | (a)(2) | 2)(f) |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| > 8\. A clear synopsis |   |   |   |   | 38 CFR | VHA   |      | OHRP       |
| > (summary) of the     |   |   |   |   | 16.115 | Han   |      | Guidance   |
| > discussion of        |   |   |   |   | (a)(2) | dbook |      |            |
| > controverted matters |   |   |   |   |        | 12    |      |            |
| > and their            |   |   |   |   | 21 CFR | 00,5, |      |            |
| > resolution.          |   |   |   |   | 56.115 | 7.i.( |      |            |
|                        |   |   |   |   | (a)(2) | 2)(i) |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| > 9\. Basis for        |   |   |   |   | 38 CFR |       |      |            |
| > requiring changes or |   |   |   |   | 16.115 |       |      |            |
| > disapproving         |   |   |   |   | (a)(2) |       |      |            |
| > research.            |   |   |   |   |        |       |      |            |
|                        |   |   |   |   | 21 CFR |       |      |            |
|                        |   |   |   |   | 56.115 |       |      |            |
|                        |   |   |   |   | (a)(2) |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| > 10\. Documentation   |   |   |   |   |        | VHA   |      |            |
| > indicating the       |   |   |   |   |        | Han   |      |            |
| > approval of a waiver |   |   |   |   |        | dbook |      |            |
| > or alteration of the |   |   |   |   |        | 12    |      |            |
| > HIPAA authorization. |   |   |   |   |        | 00.5, |      |            |
|                        |   |   |   |   |        | 7.i.( |      |            |
|                        |   |   |   |   |        | 2)(m) |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| > 11\. IRB minutes for |   |   |   |   | 38 CFR |       | II   | OHRP       |
| > INITIAL REVIEW       |   |   |   |   | 16.111 |       | .3.A | Guidance   |
| > (specific findings   |   |   |   |   | (a)(1) |       | & C  |            |
| > may be documented in |   |   |   |   |        |       |      |            |
| > IRB minutes or in    |   |   |   |   | 21 CFR |       | II   |            |
| > protocol file):      |   |   |   |   | 56.111 |       | .4.A |            |
|                        |   |   |   |   | (a)(1) |       | & B  |            |
| (a) Risks to subjects  |   |   |   |   |        |       |      |            |
|     are minimized.     |   |   |   |   |        |       | II   |            |
|                        |   |   |   |   |        |       | .5.A |            |
|                        |   |   |   |   |        |       | & B  |            |
|                        |   |   |   |   |        |       |      |            |
|                        |   |   |   |   |        |       | II   |            |
|                        |   |   |   |   |        |       | .6.A |            |
|                        |   |   |   |   |        |       | & B  |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| (b) Risks to subjects  |   |   |   |   | 38 CFR |       |      |            |
| are reasonable in      |   |   |   |   | 16.111 |       |      |            |
| relation to benefits.  |   |   |   |   | (a)(2) |       |      |            |
|                        |   |   |   |   |        |       |      |            |
|                        |   |   |   |   | 21 CFR |       |      |            |
|                        |   |   |   |   | 56.111 |       |      |            |
|                        |   |   |   |   | (a)(2) |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(c\) Selection of     |   |   |   |   | 38 CFR |       |      |            |
| subjects is equitable. |   |   |   |   | 16.111 |       |      |            |
|                        |   |   |   |   | (a)(3) |       |      |            |
|                        |   |   |   |   |        |       |      |            |
|                        |   |   |   |   | 21 CFR |       |      |            |
|                        |   |   |   |   | 56.111 |       |      |            |
|                        |   |   |   |   | (a)(3) |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(d\) Informed consent |   |   |   |   | 38 CFR |       |      |            |
| will be sought from    |   |   |   |   | 16.111 |       |      |            |
| each prospective       |   |   |   |   | (a)(4) |       |      |            |
| subject or LAR (see    |   |   |   |   |        |       |      |            |
| waiver of informed     |   |   |   |   | 21 CFR |       |      |            |
| consent for            |   |   |   |   | 56.111 |       |      |            |
| exception).            |   |   |   |   | (a)(4) |       |      |            |
|                        |   |   |   |   |        |       |      |            |
|                        |   |   |   |   | 38 CFR |       |      |            |
|                        |   |   |   |   | 16.116 |       |      |            |
|                        |   |   |   |   |        |       |      |            |
|                        |   |   |   |   | 45 CFR |       |      |            |
|                        |   |   |   |   | 46.116 |       |      |            |
|                        |   |   |   |   |        |       |      |            |
|                        |   |   |   |   | 21 CFR |       |      |            |
|                        |   |   |   |   | 56.116 |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(e\) Informed consent |   |   |   |   | 38 CFR |       |      |            |
| will be properly       |   |   |   |   | 16.111 |       |      |            |
| documented (see waiver |   |   |   |   | (a)(5) |       |      |            |
| of documentation of    |   |   |   |   |        |       |      |            |
| informed consent for   |   |   |   |   | 21 CFR |       |      |            |
| exception).            |   |   |   |   | 56.111 |       |      |            |
|                        |   |   |   |   | (a)(5) |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| #####  (f) If the s    |   |   |   |   | 21 CFR | (see  | (see |            |
| hort form consent docu |   |   |   |   | 50.27  | a     | ab   |            |
| ment is used is used,  |   |   |   |   | (b)    | bove) | ove) |            |
|                        |   |   |   |   | (2)    |       |      |            |
| #####                  |   |   |   |   |        |       |      |            |
|  i. review conducted o |   |   |   |   |        |       |      |            |
| f the short form, and  |   |   |   |   |        |       |      |            |
|                        |   |   |   |   |        |       |      |            |
| ##### ii. review condu |   |   |   |   |        |       |      |            |
| cted of the written su |   |   |   |   |        |       |      |            |
| mmary of what is to be |   |   |   |   |        |       |      |            |
|  said to the subject . |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(g\) When             |   |   |   |   | 38 CFR |       |      |            |
| appropriate, the       |   |   |   |   | 16.111 |       |      |            |
| research plan makes    |   |   |   |   | (a)(6) |       |      |            |
| adequate provision for |   |   |   |   |        |       |      |            |
| monitoring the data    |   |   |   |   | 21 CFR |       |      |            |
| collected to ensure    |   |   |   |   | 56.111 |       |      |            |
| the safety of          |   |   |   |   | (a)(6) |       |      |            |
| subjects.              |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(h\) When             |   |   |   |   | 38 CFR |       |      | OHRP       |
| appropriate, there are |   |   |   |   | 16.111 |       |      | Guidance   |
| adequate provisions to |   |   |   |   | (a)(7) |       |      |            |
| protect the privacy of |   |   |   |   |        |       |      |            |
| subjects and to        |   |   |   |   | 21 CFR |       |      |            |
| maintain the           |   |   |   |   | 56.111 |       |      |            |
| confidentiality of     |   |   |   |   | (a)(7) |       |      |            |
| data.                  |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| (i) Assessment of risk |   |   |   |   |        | VHA   |      | OHRP       |
|     and frequency of   |   |   |   |   |        | Han   |      | Guidance   |
|     continuing review. |   |   |   |   |        | dbook |      |            |
|                        |   |   |   |   |        | 12    |      |            |
|                        |   |   |   |   |        | 00.5, |      |            |
|                        |   |   |   |   |        | 7.i.( |      |            |
|                        |   |   |   |   |        | 2)(k) |      |            |
|                        |   |   |   |   |        |       |      |            |
|                        |   |   |   |   |        | 12    |      |            |
|                        |   |   |   |   |        | 00.5, |      |            |
|                        |   |   |   |   |        | 7.i.( |      |            |
|                        |   |   |   |   |        | 2)(l) |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| **12.** IRB minutes    |   |   |   |   | 38 CFR |       | II   | OHRP       |
| for EXPEDITED REVIEW   |   |   |   |   | 16.    |       | .3.A | Guidance   |
| **(specific f**indings |   |   |   |   | 110(b) |       | & C  |            |
| may be documented in   |   |   |   |   |        |       |      |            |
| IRB minutes or         |   |   |   |   | 21 CFR |       |      |            |
| protocol file):        |   |   |   |   | 56.    |       |      |            |
|                        |   |   |   |   | 110(b) |       |      |            |
| (a) Reviewer is either |   |   |   |   |        |       |      |            |
|     the IRB chair or   |   |   |   |   |        |       |      |            |
|     an experienced     |   |   |   |   |        |       |      |            |
|     delegated IRB      |   |   |   |   |        |       |      |            |
|     member.            |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| (b) Study is minimal   |   |   |   |   |        |       |      |            |
|     risk .             |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| (c) The specific       |   |   |   |   |        |       |      |            |
|     category which     |   |   |   |   |        |       |      |            |
|     qualifies the      |   |   |   |   |        |       |      |            |
|     review for the     |   |   |   |   |        |       |      |            |
|     expedited          |   |   |   |   |        |       |      |            |
|     procedure.         |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| (d) Protocol specific  |   |   |   |   |        |       |      |            |
|     information        |   |   |   |   |        |       |      |            |
|     justifying the     |   |   |   |   |        |       |      |            |
|     action.            |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| (e) IRB members have   |   |   |   |   | 38 CFR |       |      |            |
|     been advised of    |   |   |   |   | 16.    |       |      |            |
|     the expedited      |   |   |   |   | 110(c) |       |      |            |
|     review approved    |   |   |   |   |        |       |      |            |
|     research.          |   |   |   |   | 21 CFR |       |      |            |
|                        |   |   |   |   | 56.    |       |      |            |
|                        |   |   |   |   | 110(c) |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| 13\. IRB minutes for   |   |   |   |   | 38 CFR |       | II   | OHRP       |
| CONTINUING REVIEW      |   |   |   |   | 16.111 |       | .3.A | Guidance   |
| document findings,     |   |   |   |   | (a)(1) |       | & C  |            |
| including:             |   |   |   |   |        |       |      | FDA Info   |
|                        |   |   |   |   | 21 CFR |       | II.  | Sheets     |
| (a) Risks to subjects  |   |   |   |   | 56.111 |       | 4.A, |            |
|     are minimized.     |   |   |   |   | (a)(1) |       | B, D |            |
|                        |   |   |   |   |        |       |      |            |
|                        |   |   |   |   |        |       | II   |            |
|                        |   |   |   |   |        |       | .5.A |            |
|                        |   |   |   |   |        |       | & B  |            |
|                        |   |   |   |   |        |       |      |            |
|                        |   |   |   |   |        |       | II   |            |
|                        |   |   |   |   |        |       | .6.A |            |
|                        |   |   |   |   |        |       | & B  |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(b\) Risks to         |   |   |   |   | 38 CFR |       |      |            |
| subjects are           |   |   |   |   | 16.111 |       |      |            |
| reasonable in relation |   |   |   |   | (a)(2) |       |      |            |
| to any benefits.       |   |   |   |   |        |       |      |            |
|                        |   |   |   |   | 21 CFR |       |      |            |
|                        |   |   |   |   | 56.111 |       |      |            |
|                        |   |   |   |   | (a)(2) |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(c\) Selection of     |   |   |   |   | 38 CFR |       |      |            |
| subjects is equitable. |   |   |   |   | 16.111 |       |      |            |
|                        |   |   |   |   | (a)(3) |       |      |            |
|                        |   |   |   |   |        |       |      |            |
|                        |   |   |   |   | 21 CFR |       |      |            |
|                        |   |   |   |   | 56.111 |       |      |            |
|                        |   |   |   |   | (a)(3) |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+

+------------------------+---+---+---+---+--------+-------+------+------------+
| \(d\) Informed consent |   |   |   |   | 38 CFR | (see  | (See |            |
| will be sought from    |   |   |   |   | 16.111 | a     | ab   |            |
| each prospective       |   |   |   |   | (a)(4) | bove) | ove) |            |
| subject or LAR (see    |   |   |   |   |        |       |      |            |
| waiver of informed     |   |   |   |   | 21 CFR |       |      |            |
| consent for            |   |   |   |   | 56.111 |       |      |            |
| exception).            |   |   |   |   | (a)(4) |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(e\) Informed consent |   |   |   |   | 38 CFR |       |      |            |
| will be properly       |   |   |   |   | 16,111 |       |      |            |
| documented (see waiver |   |   |   |   | (a)(5) |       |      |            |
| of documentation of    |   |   |   |   |        |       |      |            |
| informed consent for   |   |   |   |   | 21 CFR |       |      |            |
| exception).            |   |   |   |   | 56.111 |       |      |            |
|                        |   |   |   |   | (a)(5) |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(f\) When             |   |   |   |   | 38 CFR |       |      |            |
| appropriate, the       |   |   |   |   | 16.111 |       |      |            |
| research plan makes    |   |   |   |   | (a)(6) |       |      |            |
| adequate provision for |   |   |   |   |        |       |      |            |
| monitoring the data    |   |   |   |   | 21 CFR |       |      |            |
| collected to ensure    |   |   |   |   | 56.111 |       |      |            |
| the safety of          |   |   |   |   | (a)(6) |       |      |            |
| subjects.              |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(g\) When             |   |   |   |   | 38 CFR |       |      |            |
| appropriate, there are |   |   |   |   | 16.111 |       |      |            |
| adequate provisions to |   |   |   |   | (a)(7) |       |      |            |
| protect the privacy of |   |   |   |   |        |       |      |            |
| subjects and to        |   |   |   |   | 21 CFR |       |      |            |
| maintain the           |   |   |   |   | 56.111 |       |      |            |
| confidentiality of     |   |   |   |   | (a)(7) |       |      |            |
| data.                  |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(h\) Assessment of    |   |   |   |   |        |       |      |            |
| risk and frequency of  |   |   |   |   |        |       |      |            |
| continuing review.     |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| 14\. IRB minutes       |   |   |   |   |        |       | II   |            |
| reflect written        |   |   |   |   |        |       | .3.A |            |
| policies for           |   |   |   |   |        |       | & C  |            |
| documenting review of  |   |   |   |   |        |       |      |            |
| ADVERSE EVENTS.        |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| 15 IRB minutes reflect |   |   |   |   |        |       |      |            |
| written policies for   |   |   |   |   |        |       |      |            |
| documenting review of  |   |   |   |   |        |       |      |            |
| unanticipated problems |   |   |   |   |        |       |      |            |
| involving risks to     |   |   |   |   |        |       |      |            |
| subjects or others.    |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| 16\. IRB minutes       |   |   |   |   | 38 CFR |       | II   |            |
| include reasons for    |   |   |   |   | 16.113 |       | .4.D |            |
| suspensions or         |   |   |   |   |        |       |      |            |
| terminations of        |   |   |   |   | 21 CFR |       |      |            |
| research.              |   |   |   |   | 56.113 |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| 17\. IRB minutes       |   |   |   |   | 38 CFR |       | II   | Note: FDA  |
| document specific      |   |   |   |   | 16.116 |       | .3.A | does not   |
| determinations         |   |   |   |   | (d)(1) |       |      | allow for  |
| regarding waiver of    |   |   |   |   |        |       | II   | the IRB to |
| informed consent or    |   |   |   |   |        |       | .3.C | determine  |
| alteration of the      |   |   |   |   |        |       |      | that       |
| elements of informed   |   |   |   |   |        |       | II   | waiver of  |
| consent, including:    |   |   |   |   |        |       | .7.E | informed   |
|                        |   |   |   |   |        |       |      | consent is |
| \(a\) Study specific   |   |   |   |   |        |       |      | ap         |
| information to show    |   |   |   |   |        |       |      | propriate. |
| that the research      |   |   |   |   |        |       |      |            |
| involves no more than  |   |   |   |   |        |       |      |            |
| minimal risk.          |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(b\) Study specific   |   |   |   |   | 38 CFR |       |      |            |
| information to show    |   |   |   |   | 16.116 |       |      |            |
| that that the waiver   |   |   |   |   | (d)(2) |       |      |            |
| or alteration will not |   |   |   |   |        |       |      |            |
| adversely effect the   |   |   |   |   |        |       |      |            |
| rights and welfare of  |   |   |   |   |        |       |      |            |
| the subjects.          |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(c\) Study specific   |   |   |   |   | 38 CFR |       |      |            |
| information to show    |   |   |   |   | 16.116 |       |      |            |
| that the research      |   |   |   |   | (d)(3) |       |      |            |
| could not practicably  |   |   |   |   |        |       |      |            |
| be carried out without |   |   |   |   |        |       |      |            |
| the waiver.            |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(d\) Study specific   |   |   |   |   | 38 CFR |       |      |            |
| information to show    |   |   |   |   | 16.116 |       |      |            |
| that, whenever         |   |   |   |   | (d)(4) |       |      |            |
| appropriate, the       |   |   |   |   |        |       |      |            |
| subjects will be       |   |   |   |   |        |       |      |            |
| provided with          |   |   |   |   |        |       |      |            |
| additional pertinent   |   |   |   |   |        |       |      |            |
| information after      |   |   |   |   |        |       |      |            |
| participation.         |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+

+------------------------+---+---+---+---+--------+-------+------+------------+
| > 18\. IRB minutes     |   |   |   |   | 38 CFR |       | II   | OHRP       |
| > document specific    |   |   |   |   | 16.117 |       | .3.A | Guidance   |
| > determinations       |   |   |   |   | (c)(1) |       |      |            |
| > regarding waiver of  |   |   |   |   |        |       | II   | Note: FDA  |
| > DOCUMENTATION OF     |   |   |   |   |        |       | .3.C | does not   |
| > INFORMED CONSENT,    |   |   |   |   |        |       |      | allow for  |
| > including:           |   |   |   |   |        |       | II   | the IRB to |
| >                      |   |   |   |   |        |       | .7.E | determine  |
| > \(a\) Study specific |   |   |   |   |        |       |      | that       |
| > information to show  |   |   |   |   |        |       |      | waiver of  |
| > that the only record |   |   |   |   |        |       |      | doc        |
| > linking the subject  |   |   |   |   |        |       |      | umentation |
| > and the research     |   |   |   |   |        |       |      | of         |
| > would be the consent |   |   |   |   |        |       |      | informed   |
| > document and the     |   |   |   |   |        |       |      | consent is |
| > principal risk would |   |   |   |   |        |       |      | ap         |
| > be potential harm    |   |   |   |   |        |       |      | propriate. |
| > from a breach of     |   |   |   |   |        |       |      |            |
| > confidentiality; OR  |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| > \(b\) Study specific |   |   |   |   | 38 CFR | VHA   |      |            |
| > information to show  |   |   |   |   | 16.117 | Han   |      |            |
| > that the research    |   |   |   |   | (c)(1) | dbook |      |            |
| > presents no more     |   |   |   |   |        | 12    |      |            |
| > than minimal risk of |   |   |   |   |        | 00.5, |      |            |
| > harm to subjects and |   |   |   |   |        | App   |      |            |
| > involves no          |   |   |   |   |        | C,    |      |            |
| > procedures for which |   |   |   |   |        | 3.f.  |      |            |
| > written consent is   |   |   |   |   |        |       |      |            |
| > normally required    |   |   |   |   |        |       |      |            |
| > outside of the       |   |   |   |   |        |       |      |            |
| > research context.    |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| > 19\. IRB minutes     |   |   |   |   | 45 CFR | VHA   | II   |            |
| > document specific    |   |   |   |   | 1      | Han   | .6.A |            |
| > determinations       |   |   |   |   | 64.512 | dbook |      |            |
| > regarding waiver or  |   |   |   |   | (i)(2) | 12    | II   |            |
| > alteration of HIPAA  |   |   |   |   |        | 00.5, | .6.B |            |
| > AUTHORIZATION,       |   |   |   |   |        | App.  |      |            |
| > including:           |   |   |   |   |        | E, 2. |      |            |
| >                      |   |   |   |   |        |       |      |            |
| > \(a\) The findings   |   |   |   |   |        |       |      |            |
| > on which the IRB's   |   |   |   |   |        |       |      |            |
| > decision is based.   |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(b\) Identification   |   |   |   |   |        |       |      |            |
| of the IRB.            |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(c\) Date of IRB      |   |   |   |   |        |       |      |            |
| approval of waiver of  |   |   |   |   |        |       |      |            |
| authorization.         |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(d\) Statement that   |   |   |   |   |        |       |      |            |
| the alteration or      |   |   |   |   |        |       |      |            |
| waiver of              |   |   |   |   |        |       |      |            |
| authorization          |   |   |   |   |        |       |      |            |
| satisfies the          |   |   |   |   |        |       |      |            |
| following criteria:    |   |   |   |   |        |       |      |            |
|                        |   |   |   |   |        |       |      |            |
| > \(i\) The use or     |   |   |   |   |        |       |      |            |
| > disclosure involves  |   |   |   |   |        |       |      |            |
| > no more than a       |   |   |   |   |        |       |      |            |
| > minimal risk to      |   |   |   |   |        |       |      |            |
| > individuals' privacy |   |   |   |   |        |       |      |            |
| > based, at least, on  |   |   |   |   |        |       |      |            |
| > an adequate:         |   |   |   |   |        |       |      |            |
|                        |   |   |   |   |        |       |      |            |
| -   Plan to protect    |   |   |   |   |        |       |      |            |
|     identifiers from   |   |   |   |   |        |       |      |            |
|     improper use or    |   |   |   |   |        |       |      |            |
|     disclosure.        |   |   |   |   |        |       |      |            |
|                        |   |   |   |   |        |       |      |            |
| -   Plan to destroy    |   |   |   |   |        |       |      |            |
|     the identifiers at |   |   |   |   |        |       |      |            |
|     the earliest       |   |   |   |   |        |       |      |            |
|     opportunity        |   |   |   |   |        |       |      |            |
|     consistent with    |   |   |   |   |        |       |      |            |
|     the research,      |   |   |   |   |        |       |      |            |
|     unless there is a  |   |   |   |   |        |       |      |            |
|     health or research |   |   |   |   |        |       |      |            |
|     justification for  |   |   |   |   |        |       |      |            |
|     retaining the      |   |   |   |   |        |       |      |            |
|     identifiers, or    |   |   |   |   |        |       |      |            |
|     for other research |   |   |   |   |        |       |      |            |
|     for which the use  |   |   |   |   |        |       |      |            |
|     or disclosure of   |   |   |   |   |        |       |      |            |
|     the requested      |   |   |   |   |        |       |      |            |
|     information would  |   |   |   |   |        |       |      |            |
|     be permitted by    |   |   |   |   |        |       |      |            |
|     the Privacy Rule.  |   |   |   |   |        |       |      |            |
|                        |   |   |   |   |        |       |      |            |
| ```{=html}             |   |   |   |   |        |       |      |            |
| <!-- -->               |   |   |   |   |        |       |      |            |
| ```                    |   |   |   |   |        |       |      |            |
| -   Witten assurance   |   |   |   |   |        |       |      |            |
|     that the requested |   |   |   |   |        |       |      |            |
|     information will   |   |   |   |   |        |       |      |            |
|     not be reused or   |   |   |   |   |        |       |      |            |
|     disclosed to any   |   |   |   |   |        |       |      |            |
|     other person or    |   |   |   |   |        |       |      |            |
|     entity, except as  |   |   |   |   |        |       |      |            |
|     required by law,   |   |   |   |   |        |       |      |            |
|     for authorized     |   |   |   |   |        |       |      |            |
|     oversight of the   |   |   |   |   |        |       |      |            |
|     research study, or |   |   |   |   |        |       |      |            |
|     for other research |   |   |   |   |        |       |      |            |
|     for which the use  |   |   |   |   |        |       |      |            |
|     or disclosure of   |   |   |   |   |        |       |      |            |
|     the information    |   |   |   |   |        |       |      |            |
|     would be permitted |   |   |   |   |        |       |      |            |
|     by the Privacy     |   |   |   |   |        |       |      |            |
|     Rule.              |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(ii\) The research    |   |   |   |   |        |       |      |            |
| could not practicably  |   |   |   |   |        |       |      |            |
| be conducted without   |   |   |   |   |        |       |      |            |
| the waiver or          |   |   |   |   |        |       |      |            |
| alteration.            |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(iii\) The research   |   |   |   |   |        |       |      |            |
| could not practicably  |   |   |   |   |        |       |      |            |
| be conducted without   |   |   |   |   |        |       |      |            |
| access to and use of   |   |   |   |   |        |       |      |            |
| the requested          |   |   |   |   |        |       |      |            |
| information.           |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(e\) A brief          |   |   |   |   | (see   | (see  | (see |            |
| description of the     |   |   |   |   | above) | a     | ab   |            |
| Protected Health       |   |   |   |   |        | bove) | ove) |            |
| Information (PHI) for  |   |   |   |   |        |       |      |            |
| which the IRB has      |   |   |   |   |        |       |      |            |
| determined use or      |   |   |   |   |        |       |      |            |
| disclosure to be       |   |   |   |   |        |       |      |            |
| necessary.             |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(f\) Identification   |   |   |   |   |        |       |      |            |
| of the review          |   |   |   |   |        |       |      |            |
| procedure used to      |   |   |   |   |        |       |      |            |
| approve the waiver of  |   |   |   |   |        |       |      |            |
| authorization (full    |   |   |   |   |        |       |      |            |
| committee or           |   |   |   |   |        |       |      |            |
| expedited).            |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(g\) Signatures of    |   |   |   |   |        |       |      |            |
| the Chair of the IRB,  |   |   |   |   |        |       |      |            |
| or member designated   |   |   |   |   |        |       |      |            |
| by the Chair, to       |   |   |   |   |        |       |      |            |
| approve the waiver of  |   |   |   |   |        |       |      |            |
| authorization          |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| 20\. For review of     |   |   |   |   | 21 CFR |       | I    | FDA Info   |
| INVESTIGATIONAL        |   |   |   |   | 81     |       | .5.A | Sheets     |
| DEVICES, IRB minutes   |   |   |   |   | 2.2(b) |       |      |            |
| document:              |   |   |   |   |        |       |      |            |
|                        |   |   |   |   |        |       |      |            |
| \(a\) Receipt of       |   |   |   |   |        |       |      |            |
| information from the   |   |   |   |   |        |       |      |            |
| Sponsor regarding the  |   |   |   |   |        |       |      |            |
| rationale for a        |   |   |   |   |        |       |      |            |
| NON-SIGNIFICANT RISK   |   |   |   |   |        |       |      |            |
| (NSR) determination.   |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(b\) The IRB SR vs    |   |   |   |   |        |       |      |            |
| NSR determination.     |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| 21\. For review of     |   |   |   |   |        | VHA   |      | \*\*\*     |
| TISSUE BANKING:        |   |   |   |   |        | Dire  |      | NOTE:      |
| Compliance with        |   |   |   |   |        | ctive |      | Remains    |
| current VHA policy.    |   |   |   |   |        | 2000  |      | ORD        |
| \*\*\*                 |   |   |   |   |        | -043: |      | Interim    |
|                        |   |   |   |   |        | Ba    |      | policy     |
|                        |   |   |   |   |        | nking |      | until      |
|                        |   |   |   |   |        | of    |      | Handbook   |
|                        |   |   |   |   |        | Human |      | on tissue  |
|                        |   |   |   |   |        | Res   |      | banking is |
|                        |   |   |   |   |        | earch |      | issued.    |
|                        |   |   |   |   |        | Subj  |      |            |
|                        |   |   |   |   |        | ects' |      |            |
|                        |   |   |   |   |        | Spec  |      |            |
|                        |   |   |   |   |        | imens |      |            |
|                        |   |   |   |   |        | (11/  |      |            |
|                        |   |   |   |   |        | 6/00) |      |            |
|                        |   |   |   |   |        | \     |      |            |
|                        |   |   |   |   |        | *\*\* |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+

+------------------------+---+---+---+---+--------+-------+------+------------+
| **E. IRB MINUTES:      | * | * | * | * | **     | **    | **   | **Notes**  |
| VULNERABLE**           | * | * | * | * | REGS** | VHA** | AAHR |            |
|                        | Y | N | I | N |        |       | PP** |            |
| **SUBJECT              | * | * | P | A |        |       |      |            |
| POPULATIONS**          | * | * | * | * |        |       |      |            |
|                        |   |   | * | * |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| **1. ALL VULNERABLE    |   |   |   |   |        | VHA   | II   |            |
| POPULATIONS.**         |   |   |   |   |        | Han   | .1.D |            |
|                        |   |   |   |   |        | dbook |      |            |
|                        |   |   |   |   |        | 12    | II   |            |
|                        |   |   |   |   |        | 00.5, | .3.C |            |
|                        |   |   |   |   |        | App D |      |            |
|                        |   |   |   |   |        |       | II   |            |
|                        |   |   |   |   |        |       | .4.C |            |
|                        |   |   |   |   |        |       |      |            |
|                        |   |   |   |   |        |       | II   |            |
|                        |   |   |   |   |        |       | .7.A |            |
|                        |   |   |   |   |        |       | & B  |            |
|                        |   |   |   |   |        |       |      |            |
|                        |   |   |   |   |        |       | III  |            |
|                        |   |   |   |   |        |       | .1.F |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| a\. Documentation of   |   |   |   |   | 38 CFR | VHA   |      | OHRP       |
| review of additional   |   |   |   |   | 16.    | Han   |      | Guidance   |
| safeguards to protect  |   |   |   |   | 111(b) | dbook |      |            |
| vulnerable populations |   |   |   |   |        | 12    |      |            |
| if entered as study    |   |   |   |   | 21 CFR | 00.5, |      |            |
| subjects when not      |   |   |   |   | 56.    | 7.i.( |      |            |
| otherwise documented   |   |   |   |   | 111(b) | 2)(j) |      |            |
| in IRB records.        |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| b\. IRB has            |   |   |   |   | 38 CFR |       |      |            |
| appropriate expertise  |   |   |   |   | 16.    |       |      |            |
| and an the expert is   |   |   |   |   | 107(a) |       |      |            |
| present or at least    |   |   |   |   |        |       |      |            |
| participated in the    |   |   |   |   |        |       |      |            |
| review.                |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+

+------------------------+---+---+---+---+--------+-------+------+------------+
| **2. SURROGATE CONSENT |   |   |   |   |        |       | II   |            |
| for research involving |   |   |   |   |        |       | .4.C |            |
| Incompetent            |   |   |   |   |        |       |      |            |
| Individuals and        |   |   |   |   |        |       | II   |            |
| Individuals with       |   |   |   |   |        |       | .5.A |            |
| Impaired Decision      |   |   |   |   |        |       |      |            |
| Making Capacity.**     |   |   |   |   |        |       | II   |            |
|                        |   |   |   |   |        |       | .7.B |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| a\. IRB Review of      |   |   |   |   |        |       |      |            |
| Research That Involves |   |   |   |   |        |       |      |            |
| Persons With Impaired  |   |   |   |   |        |       |      |            |
| Decision Making        |   |   |   |   |        |       |      |            |
| Capacity.              |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(1\) IRB Membership   |   |   |   |   | 38 CFR | VHA   |      |            |
| must include at least  |   |   |   |   | 16.107 | Han   |      |            |
| one member who is an   |   |   |   |   | (a)    | dbook |      |            |
| expert in the area of  |   |   |   |   |        | 12    |      |            |
| the research - Ad hoc  |   |   |   |   | 21 CFR | 00.5, |      |            |
| member is acceptable.  |   |   |   |   | 56.17  | App.  |      |            |
|                        |   |   |   |   | (a)    | D.    |      |            |
|                        |   |   |   |   |        | 6.(b) |      |            |
|                        |   |   |   |   | 45 CFR | (1) - |      |            |
|                        |   |   |   |   | 46.107 | (2)   |      |            |
|                        |   |   |   |   | (a)    |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| > \(2\) Documentation  |   |   |   |   |        | VHA   |      |            |
| > of the following     |   |   |   |   |        | Han   |      |            |
| > criteria:            |   |   |   |   |        | dbook |      |            |
|                        |   |   |   |   |        | 12    |      |            |
| \(a\) Only incompetent |   |   |   |   |        | 00.5, |      |            |
| persons or persons     |   |   |   |   |        | App.  |      |            |
| with impaired          |   |   |   |   |        | D.    |      |            |
| decision-making        |   |   |   |   |        | 6.(c) |      |            |
| capacity are suitable  |   |   |   |   |        | (1) - |      |            |
| to be subjects in      |   |   |   |   |        | (3)   |      |            |
| research studies that  |   |   |   |   |        |       |      |            |
| involve persons with   |   |   |   |   |        |       |      |            |
| impaired               |   |   |   |   |        |       |      |            |
| decision-making        |   |   |   |   |        |       |      |            |
| capability.            |   |   |   |   |        |       |      |            |
|                        |   |   |   |   |        |       |      |            |
| \(b\) The proposed     |   |   |   |   |        |       |      |            |
| research entails no    |   |   |   |   |        |       |      |            |
| significant risks,     |   |   |   |   |        |       |      |            |
| tangible or            |   |   |   |   |        |       |      |            |
| intangible, or if the  |   |   |   |   |        |       |      |            |
| research presents some |   |   |   |   |        |       |      |            |
| probability of harm,   |   |   |   |   |        |       |      |            |
| there must be at least |   |   |   |   |        |       |      |            |
| a greater possibility  |   |   |   |   |        |       |      |            |
| of direct benefit to   |   |   |   |   |        |       |      |            |
| the participant.       |   |   |   |   |        |       |      |            |
|                        |   |   |   |   |        |       |      |            |
| \(c\) Procedures have  |   |   |   |   |        |       |      |            |
| been devised to ensure |   |   |   |   |        |       |      |            |
| that the participants' |   |   |   |   |        |       |      |            |
| representatives are    |   |   |   |   |        |       |      |            |
| well informed          |   |   |   |   |        |       |      |            |
| regarding their role   |   |   |   |   |        |       |      |            |
| and obligations to     |   |   |   |   |        |       |      |            |
| protect incompetent    |   |   |   |   |        |       |      |            |
| subjects or person     |   |   |   |   |        |       |      |            |
| with impaired decision |   |   |   |   |        |       |      |            |
| making capacity.       |   |   |   |   |        |       |      |            |
|                        |   |   |   |   |        |       |      |            |
| \(i\) Health care      |   |   |   |   |        |       |      |            |
| agents (appointed      |   |   |   |   |        |       |      |            |
| under Durable Power of |   |   |   |   |        |       |      |            |
| Attorney for Health    |   |   |   |   |        |       |      |            |
| Care (DPAHC)) and      |   |   |   |   |        |       |      |            |
| next-of-kin, or        |   |   |   |   |        |       |      |            |
| guardians, must be     |   |   |   |   |        |       |      |            |
| given descriptions of  |   |   |   |   |        |       |      |            |
| both proposed research |   |   |   |   |        |       |      |            |
| studies and the        |   |   |   |   |        |       |      |            |
| obligations of the     |   |   |   |   |        |       |      |            |
| person's               |   |   |   |   |        |       |      |            |
| representatives.       |   |   |   |   |        |       |      |            |
|                        |   |   |   |   |        |       |      |            |
| \(ii\) They must be    |   |   |   |   |        |       |      |            |
| told that their        |   |   |   |   |        |       |      |            |
| obligation is to try   |   |   |   |   |        |       |      |            |
| to determine what the  |   |   |   |   |        |       |      |            |
| subject would do if    |   |   |   |   |        |       |      |            |
| competent, or if the   |   |   |   |   |        |       |      |            |
| subject\'s wishes      |   |   |   |   |        |       |      |            |
| cannot be determined,  |   |   |   |   |        |       |      |            |
| what they think is in  |   |   |   |   |        |       |      |            |
| the incompetent        |   |   |   |   |        |       |      |            |
| person\'s best         |   |   |   |   |        |       |      |            |
| interest.              |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(3\) For subjects     |   |   |   |   |        | VHA   |      |            |
| with fluctuating       |   |   |   |   |        | 12    |      |            |
| decision making        |   |   |   |   |        | 00.5, |      |            |
| capacity or those with |   |   |   |   |        | App.  |      |            |
| decreasing capacity to |   |   |   |   |        | D,    |      |            |
| give consent, a        |   |   |   |   |        | 6.e.  |      |            |
| re-consenting process  |   |   |   |   |        |       |      |            |
| with surrogate consent |   |   |   |   |        |       |      |            |
| is included in the     |   |   |   |   |        |       |      |            |
| protocol.              |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(4\) Even if a        |   |   |   |   |        | VHA   |      |            |
| legally authorized     |   |   |   |   |        | 12    |      |            |
| representative         |   |   |   |   |        | 00.5, |      |            |
| approves participation |   |   |   |   |        | App.  |      |            |
| in a research protocol |   |   |   |   |        | D,    |      |            |
| for an incompetent     |   |   |   |   |        | 6.f.  |      |            |
| individual, if the     |   |   |   |   |        |       |      |            |
| incompetent individual |   |   |   |   |        |       |      |            |
| resists participating, |   |   |   |   |        |       |      |            |
| he/she cannot be       |   |   |   |   |        |       |      |            |
| forced or coerced to   |   |   |   |   |        |       |      |            |
| participate.           |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+

+------------------------+---+---+---+---+--------+-------+------+------------+
| b\. Surrogate Consent  |   |   |   |   |        |       |      |            |
| Process:               |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(1\) Consent may be   |   |   |   |   |        | VHA   | (see | NOTE: This |
| obtained from: a       |   |   |   |   |        | Han   | ab   | list       |
| health care agent      |   |   |   |   |        | dbook | ove) | contains   |
| appointed by the       |   |   |   |   |        | 12    |      | the only   |
| person in a DPAHC or   |   |   |   |   |        | 00.5, |      | surrogate  |
| similar document       |   |   |   |   |        | 11.   |      | entities   |
| court-appointed        |   |   |   |   |        | a.2.  |      | who are    |
| guardians of the       |   |   |   |   |        |       |      | allowed to |
| person, or from        |   |   |   |   |        |       |      | provide    |
| next-of-kin in the     |   |   |   |   |        |       |      | consent    |
| following order of     |   |   |   |   |        |       |      | for        |
| priority, unless       |   |   |   |   |        |       |      | research   |
| otherwise specified by |   |   |   |   |        |       |      | purposes.  |
| applicable state law:  |   |   |   |   |        |       |      |            |
| spouse, adult child    |   |   |   |   |        |       |      |            |
| (18 years or older),   |   |   |   |   |        |       |      |            |
| parent, adult sibling  |   |   |   |   |        |       |      |            |
| (18 years of age or    |   |   |   |   |        |       |      |            |
| older), grandparent,   |   |   |   |   |        |       |      |            |
| or adult grandchild    |   |   |   |   |        |       |      |            |
| (18 years of age or    |   |   |   |   |        |       |      |            |
| older).                |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(2\) Prior to         |   |   |   |   |        | VHA   |      | Subjects   |
| presentation, is there |   |   |   |   |        | Han   |      | may have   |
| evidence that capacity |   |   |   |   |        | dbook |      | impaired   |
| to consent has been    |   |   |   |   |        | 12    |      | decis      |
| assessed?              |   |   |   |   |        | 00.5, |      | ion-making |
|                        |   |   |   |   |        | 11.   |      | capacity,  |
| There is a signed and  |   |   |   |   |        | a.    |      | not        |
| dated progress note    |   |   |   |   |        | VHA   |      | limited to |
| indicating:            |   |   |   |   |        | Han   |      | neu        |
|                        |   |   |   |   |        | dbook |      | rological, |
| \(a\) The              |   |   |   |   |        | 1     |      | ps         |
| practitioner, in       |   |   |   |   |        | 200.5 |      | ychiatric, |
| consultation with the  |   |   |   |   |        | , 11. |      | or         |
| Chief of Staff has     |   |   |   |   |        | b.    |      | substance  |
| determined, after      |   |   |   |   |        |       |      | abuse      |
| appropriate medical    |   |   |   |   |        |       |      | problems,  |
| evaluation that the    |   |   |   |   |        |       |      | e.g. great |
| prospective subject    |   |   |   |   |        |       |      | stress or  |
| lacks decision-making  |   |   |   |   |        |       |      | a person   |
| capacity and is        |   |   |   |   |        |       |      | in shock.  |
| unlikely to regain it  |   |   |   |   |        |       |      |            |
| within a reasonable    |   |   |   |   |        |       |      |            |
| amount of time.        |   |   |   |   |        |       |      |            |
|                        |   |   |   |   |        |       |      |            |
| \(b\) The medical      |   |   |   |   |        |       |      |            |
| evaluation has         |   |   |   |   |        |       |      |            |
| included consultation  |   |   |   |   |        |       |      |            |
| with a psychiatrist or |   |   |   |   |        |       |      |            |
| licensed psychologist  |   |   |   |   |        |       |      |            |
| when the determination |   |   |   |   |        |       |      |            |
| that the prospective   |   |   |   |   |        |       |      |            |
| research subject lacks |   |   |   |   |        |       |      |            |
| decision-making        |   |   |   |   |        |       |      |            |
| capacity based on a    |   |   |   |   |        |       |      |            |
| diagnosis of mental    |   |   |   |   |        |       |      |            |
| illness.               |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| > \(3\) Presentation:  |   |   |   |   |        | VHA   |      | Applicable |
| >                      |   |   |   |   |        | Han   |      | to both    |
| > \(a\) Legally        |   |   |   |   |        | dbook |      | the        |
| > authorized           |   |   |   |   |        | 12    |      | regular    |
| > representative is    |   |   |   |   |        | 00.5, |      | consent    |
| > documented in        |   |   |   |   |        | 11    |      | process    |
| > medical record       |   |   |   |   |        | (3)   |      | and the    |
| > (progress note or    |   |   |   |   |        |       |      | short      |
| > copy of legally      |   |   |   |   |        |       |      | process.   |
| > recognized document) |   |   |   |   |        |       |      |            |
| > if applicable.       |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| > \(b\) If the person  |   |   |   |   |        | VHA   |      |            |
| > obtaining the        |   |   |   |   |        | Han   |      |            |
| > informed consent is  |   |   |   |   |        | dbook |      |            |
| > not the PI, is the   |   |   |   |   |        | 12    |      |            |
| > person: formally     |   |   |   |   |        | 00.5, |      |            |
| > designated by the    |   |   |   |   |        | 7.(   |      |            |
| > Investigator         |   |   |   |   |        | a)(5) |      |            |
| > properly trained?    |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| > \(c\) How does the   |   |   |   |   | 21 CFR | VHA   |      | ########   |
| > person obtaining     |   |   |   |   | 50     | Han   |      |            |
| > informed consent     |   |   |   |   | .27(a) | dbook |      |            |
| > present the IRB      |   |   |   |   | &      | 12    |      |            |
| > approved informed    |   |   |   |   | (b)(1) | 00.5, |      |            |
| > consent document to  |   |   |   |   |        | App.  |      |            |
| > the legally          |   |   |   |   | 38 CFR | C     |      |            |
| > authorized           |   |   |   |   | 16.    |       |      |            |
| > representative for   |   |   |   |   | 117(a) |       |      |            |
| > review?              |   |   |   |   | &      |       |      |            |
| >                      |   |   |   |   | (b)(1) |       |      |            |
| > i\. Informed consent |   |   |   |   |        |       |      |            |
| > document is provided |   |   |   |   |        |       |      |            |
| > to the subject\'s    |   |   |   |   |        |       |      |            |
| > legally authorized   |   |   |   |   |        |       |      |            |
| > representative;      |   |   |   |   |        |       |      |            |
| >                      |   |   |   |   |        |       |      |            |
| > [OR]{.underline}     |   |   |   |   |        |       |      |            |
| >                      |   |   |   |   |        |       |      |            |
| > ii\. The legally     |   |   |   |   |        |       |      |            |
| > authorized           |   |   |   |   |        |       |      |            |
| > representative is    |   |   |   |   |        |       |      |            |
| > given adequate       |   |   |   |   |        |       |      |            |
| > opportunity to read  |   |   |   |   |        |       |      |            |
| > the informed consent |   |   |   |   |        |       |      |            |
| > document.            |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+

+------------------------+---+---+---+---+--------+-------+------+------------+
| \(d\) The person       |   |   |   |   | 21 CFR |       | (see | FDA Info   |
| obtaining the consent  |   |   |   |   | 50.27  |       | ab   | Sheets     |
| describes the research |   |   |   |   | (b)(2) |       | ove) |            |
| to the legally         |   |   |   |   |        |       |      |            |
| authorized             |   |   |   |   |        |       |      |            |
| representative.        |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(e\) The person       |   |   |   |   |        | VHA   |      |            |
| obtaining the informed |   |   |   |   |        | Han   |      |            |
| consent encourages the |   |   |   |   |        | dbook |      |            |
| legally authorized     |   |   |   |   |        | 12    |      |            |
| representative to ask  |   |   |   |   |        | 00.5, |      |            |
| questions.             |   |   |   |   |        | App.  |      |            |
|                        |   |   |   |   |        | C, 2. |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(f\) Disclosures      |   |   |   |   |        | VHA   |      |            |
| required by VHA        |   |   |   |   |        | Han   |      |            |
| Handbook 1200.5 must   |   |   |   |   |        | dbook |      |            |
| be made by the         |   |   |   |   |        | 12    |      |            |
| investigator to the    |   |   |   |   |        | 00.5, |      |            |
| subject's surrogates   |   |   |   |   |        | 11.   |      |            |
|                        |   |   |   |   |        | b.    |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(g\) If feasible, the |   |   |   |   |        | VHA   |      |            |
| practitioner must      |   |   |   |   |        | Han   |      |            |
| explain the proposed   |   |   |   |   |        | dbook |      |            |
| research to the        |   |   |   |   |        | 12    |      |            |
| prospective research   |   |   |   |   |        | 00.5, |      |            |
| subject even when the  |   |   |   |   |        | 11.   |      |            |
| surrogate gives        |   |   |   |   |        | b.    |      |            |
| consent.               |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(h\) Under no         |   |   |   |   |        | VHA   |      |            |
| circumstances may a    |   |   |   |   |        | Han   |      |            |
| subject be forced or   |   |   |   |   |        | dbook |      |            |
| coerced to participate |   |   |   |   |        | 12    |      |            |
| in a research study.   |   |   |   |   |        | 00.5, |      |            |
|                        |   |   |   |   |        | 11.   |      |            |
|                        |   |   |   |   |        | b.    |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(i\) Has the legally  |   |   |   |   | 21 CFR | [Per  |      | Must be    |
| authorized             |   |   |   |   | 50.27  | VA    |      | done at    |
| representative~~)~~    |   |   |   |   |        | 10-1  |      | affiliate  |
| signed and dated the   |   |   |   |   |        | 086]( |      | also for   |
| informed consent       |   |   |   |   |        | ../co |      | VA         |
| document?              |   |   |   |   |        | nsent |      | subjects   |
|                        |   |   |   |   |        | .doc) |      | returning  |
| \(j\) In the presence  |   |   |   |   |        |       |      | to VA.     |
| of a witness?          |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(k\) Was a copy of    |   |   |   |   | [21    | VHA   |      |            |
| the fully executed     |   |   |   |   | CFR    | Han   |      |            |
| informed consent       |   |   |   |   | 50.    | dbook |      |            |
| document given to the  |   |   |   |   | 27(a)] | 1     |      |            |
| legally authorized     |   |   |   |   | (../21 | 200.5 |      |            |
| representative?        |   |   |   |   | CFR50. | App C |      |            |
|                        |   |   |   |   | htm#fd | 3b(3) |      |            |
|                        |   |   |   |   | a21cfr |       |      |            |
|                        |   |   |   |   | 5027a) |       |      |            |
|                        |   |   |   |   |        |       |      |            |
|                        |   |   |   |   | [38    |       |      |            |
|                        |   |   |   |   | CFR    |       |      |            |
|                        |   |   |   |   | 16     |       |      |            |
|                        |   |   |   |   | .117(a |       |      |            |
|                        |   |   |   |   | )](../ |       |      |            |
|                        |   |   |   |   | 38CFR1 |       |      |            |
|                        |   |   |   |   | 6.htm# |       |      |            |
|                        |   |   |   |   | a117a) |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| c\. Informed consent   |   |   |   |   |        | VHA   |      |            |
| processes (including   |   |   |   |   |        | Han   |      |            |
| informed consent       |   |   |   |   |        | dbook |      |            |
| documents) clearly     |   |   |   |   |        | 12    |      |            |
| differentiate between  |   |   |   |   |        | 00.5, |      |            |
| individualized         |   |   |   |   |        | App.  |      |            |
| treatment and research |   |   |   |   |        | C,    |      |            |
| and between clinicians |   |   |   |   |        | 2.(   |      |            |
| and clinical           |   |   |   |   |        | 3),(5 |      |            |
| investigators.         |   |   |   |   |        | ),(6) |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| d\. IRBs are required  |   |   |   |   | [38    | VHA   | #    | ########   |
| to consider including  |   |   |   |   | CFR    | Han   | #### |            |
| one or more members    |   |   |   |   | 16     | dbook | ###  |            |
| knowledgeable about    |   |   |   |   | .107(a | 12    |      |            |
| and experienced in     |   |   |   |   | )](../ | 00.5, |      |            |
| working with these     |   |   |   |   | 38CFR1 | App.  |      |            |
| subjects.              |   |   |   |   | 6.htm# | D,    |      |            |
|                        |   |   |   |   | a107a) | 6.b.  |      |            |
|                        |   |   |   |   |        | (1) - |      |            |
|                        |   |   |   |   | [21    | (2)   |      |            |
|                        |   |   |   |   | CFR    |       |      |            |
|                        |   |   |   |   | 56.10  |       |      |            |
|                        |   |   |   |   | 7(a)]( |       |      |            |
|                        |   |   |   |   | ../21C |       |      |            |
|                        |   |   |   |   | FR56.h |       |      |            |
|                        |   |   |   |   | tm#fda |       |      |            |
|                        |   |   |   |   | 21cfr5 |       |      |            |
|                        |   |   |   |   | 6107a) |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| e\. Key factor in      |   |   |   |   |        | VHA   | #    | ########   |
| subjects'              |   |   |   |   |        | Han   | #### |            |
| decision-making is     |   |   |   |   |        | dbook | ###  |            |
| their appreciation of  |   |   |   |   |        | 12    |      |            |
| how the risks,         |   |   |   |   |        | 00.5, |      |            |
| benefits, and          |   |   |   |   |        | App.  |      |            |
| alternatives to        |   |   |   |   |        | D,    |      |            |
| participation in the   |   |   |   |   |        | 6.    |      |            |
| study apply to them    |   |   |   |   |        | c.(2) |      |            |
| personally.            |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| > \(1\) Researchers    |   |   |   |   |        |       |      | NIH Points |
| > should consider      |   |   |   |   |        |       |      | to         |
| > timing of assessment |   |   |   |   |        |       |      | consider   |
| > of a subject\'s      |   |   |   |   |        |       |      |            |
| > capacity to avoid    |   |   |   |   |        |       |      |            |
| > periods of           |   |   |   |   |        |       |      |            |
| > heightened           |   |   |   |   |        |       |      |            |
| > vulnerability when   |   |   |   |   |        |       |      |            |
| > the subject may not  |   |   |   |   |        |       |      |            |
| > be able to provide a |   |   |   |   |        |       |      |            |
| > valid informed       |   |   |   |   |        |       |      |            |
| > consent.             |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+

+------------------------+---+---+---+---+--------+-------+------+------------+
| \(2\) As impairment    |   |   |   |   |        |       | (see |            |
| increases, along with  |   |   |   |   |        |       | ab   |            |
| risks and discomforts, |   |   |   |   |        |       | ove) |            |
| safeguards should      |   |   |   |   |        |       |      |            |
| increase accordingly.  |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| \(3\) Additional       |   |   |   |   |        | ####  |      | NIH Points |
| safeguards include:    |   |   |   |   |        | ####  |      | to         |
| use of an independent  |   |   |   |   |        |       |      | Consider   |
| monitor, use of a      |   |   |   |   |        |       |      |            |
| surrogate, use of      |   |   |   |   |        |       |      |            |
| assent in additional   |   |   |   |   |        |       |      |            |
| to surrogate, use of   |   |   |   |   |        |       |      |            |
| an advance directive,  |   |   |   |   |        |       |      |            |
| use of                 |   |   |   |   |        |       |      |            |
| inf                    |   |   |   |   |        |       |      |            |
| ormational/educational |   |   |   |   |        |       |      |            |
| techniques, or use of  |   |   |   |   |        |       |      |            |
| waiting periods.       |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| f\. Criteria and a     |   |   |   |   |        |       | #    | ########   |
| procedure for          |   |   |   |   |        |       | #### |            |
| determining the        |   |   |   |   |        |       | ###  |            |
| prospective subject\'s |   |   |   |   |        |       |      |            |
| ability to consent     |   |   |   |   |        |       |      |            |
| should be part of the  |   |   |   |   |        |       |      |            |
| approved protocol, and |   |   |   |   |        |       |      |            |
| the results of the     |   |   |   |   |        |       |      |            |
| prescribed procedure   |   |   |   |   |        |       |      |            |
| should be documented.  |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| **3. PRISONERS.**      |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| a\. IRB verifies that  |   |   |   |   |        | VHA   |      | OHRP       |
| waiver was obtained    |   |   |   |   |        | Han   |      | Guidance   |
| from the Chief         |   |   |   |   |        | dbook |      |            |
| Research and           |   |   |   |   |        | 12    |      |            |
| Development Officer    |   |   |   |   |        | 00.5, |      |            |
| (CRADO) or makes       |   |   |   |   |        | App.  |      |            |
| contingent approval on |   |   |   |   |        | D. 5. |      |            |
| obtaining waiver.      |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| b\. A majority of the  |   |   |   |   | 45 CFR |       |      |            |
| IRB (exclusive of      |   |   |   |   | 46.    |       |      |            |
| prisoner members) has  |   |   |   |   | 304(a) |       |      |            |
| no association with    |   |   |   |   |        |       |      |            |
| the prison involved.   |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| c\. At least one       |   |   |   |   | 45 CFR |       |      |            |
| member of the IRB is a |   |   |   |   | 46.    |       |      |            |
| prisoner or prisoner   |   |   |   |   | 304(b) |       |      |            |
| representative with    |   |   |   |   |        |       |      |            |
| appropriate background |   |   |   |   |        |       |      |            |
| and experience to      |   |   |   |   |        |       |      |            |
| serve in that capacity |   |   |   |   |        |       |      |            |
| (can be ad-hoc         |   |   |   |   |        |       |      |            |
| member).               |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| d\. This IRB member    |   |   |   |   |        |       |      |            |
| must be clearly listed |   |   |   |   |        |       |      |            |
| in the minutes as a    |   |   |   |   |        |       |      |            |
| prisoner or a prisoner |   |   |   |   |        |       |      |            |
| representative.        |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| e\. Study-specific     |   |   |   |   | 45 CFR |       |      |            |
| information to show    |   |   |   |   | 46.305 |       |      |            |
| that the research      |   |   |   |   | (a)(1) |       |      |            |
| reviewed represents    |   |   |   |   |        |       |      |            |
| one of the categories  |   |   |   |   |        |       |      |            |
| of research            |   |   |   |   |        |       |      |            |
| permissible under 45   |   |   |   |   |        |       |      |            |
| CFR 46.306(a)(2) and   |   |   |   |   |        |       |      |            |
| the specific category  |   |   |   |   |        |       |      |            |
| is documented.         |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| f\. Study-specific     |   |   |   |   | 45 CFR |       |      |            |
| information to show    |   |   |   |   | 46.305 |       |      |            |
| that any possible      |   |   |   |   | (a)(2) |       |      |            |
| advantages to accruing |   |   |   |   |        |       |      |            |
| the prisoner through   |   |   |   |   |        |       |      |            |
| his or her             |   |   |   |   |        |       |      |            |
| participation in the   |   |   |   |   |        |       |      |            |
| research, when         |   |   |   |   |        |       |      |            |
| compared to the        |   |   |   |   |        |       |      |            |
| general living         |   |   |   |   |        |       |      |            |
| conditions, medical    |   |   |   |   |        |       |      |            |
| care, quality of food, |   |   |   |   |        |       |      |            |
| amenities and          |   |   |   |   |        |       |      |            |
| opportunity for        |   |   |   |   |        |       |      |            |
| earnings in the        |   |   |   |   |        |       |      |            |
| prison, are not of     |   |   |   |   |        |       |      |            |
| such a magnitude that  |   |   |   |   |        |       |      |            |
| his or her ability to  |   |   |   |   |        |       |      |            |
| weigh the risks of the |   |   |   |   |        |       |      |            |
| research against the   |   |   |   |   |        |       |      |            |
| value of such          |   |   |   |   |        |       |      |            |
| advantages in the      |   |   |   |   |        |       |      |            |
| limited choice         |   |   |   |   |        |       |      |            |
| environment of the     |   |   |   |   |        |       |      |            |
| prison is impaired.    |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+

+------------------------+---+---+---+---+--------+-------+------+------------+
| g\. Study-specific     |   |   |   |   | 45 CFR |       | (see | OHRP       |
| information to show    |   |   |   |   | 46.305 |       | ab   | Guidance   |
| that the risks         |   |   |   |   | (a)(3) |       | ove) |            |
| involved in the        |   |   |   |   |        |       |      |            |
| research are           |   |   |   |   |        |       |      |            |
| commensurate with the  |   |   |   |   |        |       |      |            |
| risks that would be    |   |   |   |   |        |       |      |            |
| accepted by            |   |   |   |   |        |       |      |            |
| non-prisoner           |   |   |   |   |        |       |      |            |
| volunteers.            |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| h\. Study-specific     |   |   |   |   | 45 CFR |       |      |            |
| information to show    |   |   |   |   | 46.305 |       |      |            |
| that procedures for    |   |   |   |   | (a)(4) |       |      |            |
| the selection of       |   |   |   |   |        |       |      |            |
| subjects within the    |   |   |   |   |        |       |      |            |
| prison are fair to all |   |   |   |   |        |       |      |            |
| prisoners and immune   |   |   |   |   |        |       |      |            |
| from arbitrary         |   |   |   |   |        |       |      |            |
| intervention by prison |   |   |   |   |        |       |      |            |
| authorities or         |   |   |   |   |        |       |      |            |
| prisoners (see         |   |   |   |   |        |       |      |            |
| regulation for         |   |   |   |   |        |       |      |            |
| exception).            |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| i\. Study-specific     |   |   |   |   | 45 CFR |       |      |            |
| information to show    |   |   |   |   | 46.305 |       |      |            |
| that the information   |   |   |   |   | (a)(5) |       |      |            |
| is presented in a      |   |   |   |   |        |       |      |            |
| language which is      |   |   |   |   |        |       |      |            |
| understandable to the  |   |   |   |   |        |       |      |            |
| subject population.    |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| j\. Study-specific     |   |   |   |   | 45 CFR |       |      |            |
| information to show    |   |   |   |   | 46.305 |       |      |            |
| that adequate          |   |   |   |   | (a)(6) |       |      |            |
| assurances exists that |   |   |   |   |        |       |      |            |
| parole boards will not |   |   |   |   |        |       |      |            |
| take into account a    |   |   |   |   |        |       |      |            |
| prisoner\'s            |   |   |   |   |        |       |      |            |
| participation in the   |   |   |   |   |        |       |      |            |
| research in making     |   |   |   |   |        |       |      |            |
| decisions regarding    |   |   |   |   |        |       |      |            |
| parole, and each       |   |   |   |   |        |       |      |            |
| prisoner is clearly    |   |   |   |   |        |       |      |            |
| informed in advance    |   |   |   |   |        |       |      |            |
| that participation in  |   |   |   |   |        |       |      |            |
| the research will have |   |   |   |   |        |       |      |            |
| no effect on his or    |   |   |   |   |        |       |      |            |
| her parole.            |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| k\. Study-specific     |   |   |   |   | 45 CFR |       |      |            |
| information to show    |   |   |   |   | 46.305 |       |      |            |
| that where the IRB     |   |   |   |   | (a)(7) |       |      |            |
| finds there may be     |   |   |   |   |        |       |      |            |
| need for follow-up     |   |   |   |   |        |       |      |            |
| examination or care of |   |   |   |   |        |       |      |            |
| participants after the |   |   |   |   |        |       |      |            |
| end of their           |   |   |   |   |        |       |      |            |
| participation,         |   |   |   |   |        |       |      |            |
| adequate provision has |   |   |   |   |        |       |      |            |
| been made for such     |   |   |   |   |        |       |      |            |
| examination or care,   |   |   |   |   |        |       |      |            |
| taking into account    |   |   |   |   |        |       |      |            |
| the varying lengths of |   |   |   |   |        |       |      |            |
| individual prisoner\'s |   |   |   |   |        |       |      |            |
| sentences, and for     |   |   |   |   |        |       |      |            |
| informing participants |   |   |   |   |        |       |      |            |
| of this fact.          |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| l\. The IRB certifies  |   |   |   |   | 45 CFR |       |      |            |
| to the Secretary of    |   |   |   |   | 46.305 |       |      |            |
| HHS (OHRP), that the   |   |   |   |   | (c)    |       |      |            |
| IRB has fulfilled the  |   |   |   |   |        |       |      |            |
| duties of 45CFR46,     |   |   |   |   |        |       |      |            |
| Subpart C.             |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| **4. CHILDREN.**       |   |   |   |   | 45 CFR | VHA   |      | Six        |
|                        |   |   |   |   | 46     | Dire  |      | separate   |
|                        |   |   |   |   | S      | ctive |      | sections   |
|                        |   |   |   |   | ubpart | 200   |      | of the     |
|                        |   |   |   |   | D      | 1-028 |      | r          |
|                        |   |   |   |   |        |       |      | egulations |
|                        |   |   |   |   |        | VHA   |      | on         |
|                        |   |   |   |   |        | Han   |      | children   |
|                        |   |   |   |   |        | dbook |      | require    |
|                        |   |   |   |   |        | 12    |      | protoco    |
|                        |   |   |   |   |        | 00.5, |      | l-specific |
|                        |   |   |   |   |        | App.  |      | docu       |
|                        |   |   |   |   |        | D.7.  |      | mentation. |
+------------------------+---+---+---+---+--------+-------+------+------------+
| a\. Waiver to conduct  |   |   |   |   |        |       |      |            |
| research with children |   |   |   |   |        |       |      |            |
| in the VA granted by   |   |   |   |   |        |       |      |            |
| the CRADO.             |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+
| b\. Prior to the       |   |   |   |   |        |       |      |            |
| granting of the        |   |   |   |   |        |       |      |            |
| waiver, the following  |   |   |   |   |        |       |      |            |
| criteria are met:      |   |   |   |   |        |       |      |            |
|                        |   |   |   |   |        |       |      |            |
| \(1\) Certification    |   |   |   |   |        |       |      |            |
| that the IRB has       |   |   |   |   |        |       |      |            |
| determined the study   |   |   |   |   |        |       |      |            |
| to be of no greater    |   |   |   |   |        |       |      |            |
| than minimal risk and  |   |   |   |   |        |       |      |            |
| has approved the       |   |   |   |   |        |       |      |            |
| study.                 |   |   |   |   |        |       |      |            |
+------------------------+---+---+---+---+--------+-------+------+------------+

  ------------------------- -- -- -- -- --------- ---------- -------- -------------
  \(2\) The IRB reviewing                         (see       (see     
  the study must have                             above)     above)   
  appropriate membership to                                           
  represent children's'                                               
  interests and pediatric                                             
  expertise.                                                          

  \(3\) The IRB reviewing                                             
  the study must have                                                 
  specific policies and                                               
  procedures regarding                                                
  children in research.                                               

  \(4\) The medical center                                            
  Director must certify                                               
  that the facility is able                                           
  to respond to pediatric                                             
  emergencies.                                                        

  \(5\) If a contractor                                               
  and/or a non-VA employee                                            
  conducts the research,                                              
  the facility must make                                              
  certain that the                                                    
  individual, or entity                                               
  performing the research,                                            
  has procured appropriate                                            
  liability insurance.                                                

  \(6\) If the waiver is                                              
  granted, the research                                               
  must be in accordance                                               
  with applicable Federal                                             
  regulations pertaining to                                           
  children as research                                                
  subjects (see 45 CFR Part                                           
  46, Subpart D).                                                     

  \(7\) IRB determined that             45 CFR                        
  adequate provisions are               Part 46,                      
  made for soliciting the               Subpart                       
  assent of the children,               D, 46.408                     
  when in the judgment of               (a) and                       
  the IRB the children are              (e)                           
  capable of providing                                                
  assent.                                                             

  \(8\) When the IRB                    45 CFR                        
  determines that assent is             Part 46,                      
  required, it shall also               Subpart                       
  determine whether and how             D, 46.408                     
  assent must be                        (a) and                       
  documented.                           (e)                           

  \(9\) IRB determined that             45 CFR                        
  adequate provisions are               Part 46,                      
  made for soliciting the               Subpart                       
  permission of each                    D, 46.408                     
  child\'s parents or                   (b)                           
  guardian.                                                           

  \(10\) IRB may waive                  45 CFR                        
  requirement for parental              Part 46,                      
  permission under certain              Subpart                       
  circumstances.                        D, 46.408                     
                                        (c)                           

  **5. PREGNANT WOMEN AND                         VHA                 OHRP Guidance
  FETUSES.**                                      Handbook            
                                                  1200.5,             
                                                  App. D.4            

  a\. For research                                                    
  involving participation                                             
  of pregnant women where                                             
  pregnant women are the                                              
  focus of the research.                                              
  Research focusing solely                                            
  on the fetus is not                                                 
  allowed in the VA..                                                 
  ------------------------- -- -- -- -- --------- ---------- -------- -------------

  ------------------------- -- -- -- -- --------- --------------- -------- -------------
  b\. Study-specific                    45 CFR    VHA Handbook    (see     OHRP Guidance
  information to show that              46. 204   1200.5, App. D, above)   
  where scientifically                            4.d.(1)(a)               
  appropriate, preclinical                                                 
  studies, including                                                       
  studies on pregnant                                                      
  animals, and clinical                                                    
  studies, including                                                       
  studies on nonpregnant                                                   
  women, have been                                                         
  conducted and provide                                                    
  data for assessing                                                       
  potential risks to                                                       
  pregnant women and                                                       
  fetuses.                                                                 

  b\. Study-specific                              VHA Handbook             
  information to show that                        1200.5, App. D,          
  the purpose of the                              4.d.(1)(b)               
  activity is to meet the                                                  
  health needs of the                                                      
  mother or the particular                                                 
  fetus and the risk to the                                                
  fetus is minimal.                                                        

  c\. Study-specific                                                       
  information to show that                                                 
  any risk is the least                                                    
  possible for achieving                                                   
  the objectives of the                                                    
  research.                                                                

  d\. Study-specific                              VHA Handbook             
  information to show that                        1200.5, App. D,          
  if the purpose of the                           4.d.(1)(c)               
  activity is to meet the                                                  
  health needs of the                                                      
  mother, consent is                                                       
  obtained per informed                                                    
  consent provision in the                                                 
  regulations.                                                             

  e\. Study-specific                              VHA Handbook             
  information to show that                        1200.5, App. D,          
  if the research hold out                        4.d.(1)(c)1-4            
  the prospect of direct                                                   
  benefit solely to the                                                    
  fetus then the consent of                                                
  the pregnant woman and                                                   
  the father is obtained in                                                
  accord with informed                                                     
  consent provisions in the                                                
  regulations, except that                                                 
  the father\'s consent                                                    
  need not be obtained if                                                  
  he is unable to consent                                                  
  because of                                                               
  inavailability,                                                          
  incompetence, or                                                         
  temporary incapacity or                                                  
  pregnancy resulted from                                                  
  rape or incest .                                                         

  f\. Study-specific                              VHA Handbook             
  information showing no                          1200.5, App. D,          
  inducements, monetary or                        4.d.(1)(c)(2)            
  otherwise, will be                                                       
  offered to terminate                                                     
  pregnancy.                                                               

  g\. Study-specific                              VHA Handbook             
  information to show that                        1200.5, App. D,          
  individuals engaged in                          4.d.(1)(c)1.             
  the research will have no                                                
  part in any decisions as                                                 
  to the timing, method or                                                 
  procedures used to                                                       
  terminate pregnancy.                                                     

  h\. Study-specific                              VHA Handbook             
  information to show that                        1200.5, App. D,          
  individuals engaged in                          4.d.(1)(c)2              
  the research will have no                                                
  part in determining the                                                  
  viability of a neonate.                                                  

  i\. Study-specific                                                       
  information to show that                                                 
  adequate provision has                                                   
  been made to monitor the                                                 
  risks to the subject and                                                 
  the fetus.                                                               

  j\. Study-specific                              VHA Handbook             
  information to show that                        1200.5, App. D,          
  adequate consideration                          4.c.(3)                  
  has been given to the                                                    
  manner in which potential                                                
  subjects are going to be                                                 
  selected, and that                                                       
  adequate provision has                                                   
  been made to monitor the                                                 
  informed consent process.                                                
  ------------------------- -- -- -- -- --------- --------------- -------- -------------

+------------------------+---+---+---+---+-------+-------+------+------------+
| 24\. All researchers   |   |   |   |   | #     | VHA   | (see |            |
| acknowledge and        |   |   |   |   |       | Han   | ab   |            |
| fulfill their          |   |   |   |   |       | dbook | ove) |            |
| 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/ |      |            |
| researcher contacts    |   |   |   |   |       | USH   |      |            |
| with veterans.         |   |   |   |   |       | Memo  |      |            |
|                        |   |   |   |   |       | 07.10 |      |            |
|                        |   |   |   |   |       | .2007 |      |            |
+------------------------+---+---+---+---+-------+-------+------+------------+

+-----------------------------------------------------------------------+
| **SEE SEPARATE ORO HUMAN RESEARCH PROTECTION PROBRAM (HRPP) 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