Department of Defense Human Research Protection Program AIR FORCE ISSUED DEPARTMENT OF DEFENSE (DOD) ADDENDUM TO THE DEPARTMENT OF HEALTH AND HUMAN SERVICE'S (DHHS) FEDERALWIDE ASSURANCE (FWA) FOR THE PROTECTION OF HUMAN SUBJECTS This Addendum is for non-DoD Institutions that already have an FWA approved by DHHS and will be
engaged in DoD-supported human subject research.
Part 1 INSTITUTION INFORMATION A. Purpose of DoD Addendum
[ ] New
[ X] Renewal for DoD Addendum Number: F50309
B. Institution Information
University of Louisville Name:
DHHS FWA Number:
FWA00002211 Description of the Institution: University of Louisville (all Schools and Colleges) University of Louisville Hospital Kosair Children's Hospital J. Graham Brown Cancer Center
(IRB for faculty practicing in)
Jewish Hospital & St Marys Healthcare
Norton Healthcare, Inc.
The Institutional Review Boards (IRBs) at the University of Louisville review all University affiliated
human subjects research, regardless of funding. The IRB chair or vice-chair makes the determination
of exemption from IRB review.
C. Scope
This Addendum applies to all DoD-supported human research protocols performed by this institution,
unless specified below.
D. Effective Date
This Addendum is effective as of the date the approval document is signed by the DoD Component
Designated Official and expires on the date listed in the approval document.
UofL DoD Addendum to DHHS FWA 2012-01-03
1
Part 2 DOD REQUIREMENTS In addition to the requirements identified in the Institution's FWA, this institution assures it shall comply
with the following laws, regulations, and guidance when conducting, reviewing, approving , overseeing,
supporting, or managing DoD-supported research with human subjects:
• Title 32 Code of Federal Regulations Part 219 (32 CFR 219), Department of Defense Regulations, "Protection of Human Subjects" • Title 45 Code of Federal Regulations Part 46, (45 CFR 46) Department of Health and Human
Services Regulations, "Protection of Human Subjects," Subparts 8, C, and D as made applicable
by DoDD 3216.02
• Title 21 Code of Federal Regulations 50, 56, 312, and 812, Food and Drug Administration (FDA)
Regulations
• DoD Directive (DoDD) 3216.02, "Protection of Human Subjects and Adherence to Ethical
Standards in DoD-supported Research"
• Title 10 United States Code Section 980 (10 USC 980), "Limitation on Use of Humans as
Experimental Subjects"
• DoDD 3210.7, "Research Integrity and Misconduct"
• DoD Instruction (DoDI) 6200.02, "Application of Food and Drug Administration (FDA) Rules to
Department of Defense Force Health Protection Programs"
Part 3 DOD COMPONENT REQUIREMENTS The institution assures it shall also comply with DoD Component requirements for the research
protocol(s) sponsored by that DoD Component. The requirements for each DoD Component are
listed below. DoD Components may require that other research, not specifically identified by 32 CFR
219, also comply with the terms of this Addendum (32 CFR 219.101(d)).
Department of the Army
• AR 70-25 Use of Volunteers as Subjects of Research, 25 January 1990
• AR 40-38, Clinical Investigation Program, 1 September 1989
• AR 40-7, Use of Investigational Drugs in Humans and the Use of Schedule I Controlled Drug
Substances, 4 January 1991
Department of the Navy
• SECNAVINST 3900.39D of 6 November 2006
Department of the Air Force
• Air Force Instruction 40-402, Protection of Human Subjects in Research
Office of the Secretary of Defense for Personnel and Readiness
• HA Policy 05-003
UofL DoD Addendum to DHHS FWA 2012-01-03
2
Part4 INSTITUTION RESPONSIBILITIES The complete list of requirements for compliance is provided above in Part 2, DoD Requirements; Part 3,
DoD Component Requirements; and in the institution's FWA. A select list of responsibilities of the
Institutional Official, IRB, and Investigators are identified below. This partial list is taken from the
regulations and guidance listed in Parts 2 and 3. The institution should communicate with the DoD
organization supporting the research to ensure the institution and their IRB are in compliance.
• Conduct initial and continuing research ethics education for personnel who are engaged in
human subject research (e.g., who review, approve, oversee, or manage research)
• Document determination by a designated Institutional Official (other than investigators) whether
research meets criteria for exemption
• Ensure new research and substantive scientific amendments to approved research shall undergo
scientific review and that the review is considered by the IRB
• Ensure additional protections for military research subjects to minimize undue influence
• Explain to subjects any provisions for medical care for research-related injury
• Report unanticipated problems, adverse events, research-related injury, and suspensions or
terminations of research
• Appoint a Medical Monitor when necessary
• Safeguard for research conducted with international populations
• Protect pregnant women, prisoners, and children
• Comply with DoD limitations on research where consent by legally authorized representatives is
proposed
• Comply with DoD limitation on exceptions from informed consent (e.g., 10 USC 980,45 CFR 46,
and 21 CFR 50)
• Comply with limitations on dual compensation for U.S. military personnel
• Follow DoD requirements for additional review for DoD-sponsored survey research or survey
research within DoD
• Address and report allegations of non-compliance with human research protections
• Address and report allegations of research misconduct
• Follow procedures for addressing financial and other conflicts of interest
• Prohibit research with prisoners of war (POW)
• Comply with all provisions for research with human subjects using investigational test articles
(drugs, device, and biologics)
• Follow recordkeeping requirements
• Support oversight by the sponsoring DoD Component (which may include DoD Component
review of the research and site visits)
UofL DoD Addendum to DHHS FWA 2012-01-03
3
PartS
DESIGNATION OF IRB(S) THAT WILL REVIEW DOD-SUPPORTED RESEARCH
All of the IRBs supporting the institution do not need to be listed in Tables 1 and 2. List only those
IRBs that will review DoD-supported research.
A. IRB(s) that are Part of this Institution
In Table 1, identify each IRB that is organizationally part of this institution and can review DoD­
supported research under this Addendum to the FWA (the IRBs should also be listed on the FWA).
For each IRB listed in Table 1, the IRB Chair must sign this Addendum in Part 6. When requested by
the DoD-sponsor, attach the membership list for each IRB listed (in accordance with 45 CFR 46); see
Table 3 for an example.
Table 1. IRB(s) within the Institution
IRB Name or Number
1.Biomedical IRB
2.Sociai/Behaviorai/Education (SBE) IRB
DHHS IRB Registration Number (8 digits)
00000251
00000252
3.
4.
B. IRB(s) that are not Part of this Institution
In Table 2, identify each IRB that is not associated with this institution and can review DoD-supported
research under this Addendum to the FWA. For each IRB listed in Table 2, attach the DoD
Institutional Agreement for IRB Review (or an equivalent agreement). When requested by the DoD­
sponsor, attach the membership list for each IRB listed (in accordance with 45 CFR 46); see Table 3
for an example.
Table 2. IRB(s) not part of this Institution
DHHSIRB
Name of the
IRB Name or Number
Registration Institution
Providing
Number
(8 digits)*
the IRB
DoD
Assurance
Number of
the
Institution*
DHHS FWA
Number of the
Institution*
1. None
2.
3.
4.
5.
6.
* If applicable.
UofL DoD Addendum to DHHS FWA 2012-01-03
4
Part6 INSTITUTIONAL AGREEMENT A. Official Legally Authorized to Represent the FWA Institution (i.e., signed the FWA)
Acting in an authorized capacity on behalf of this institution and with an understanding of the institution's
responsibilities under it's FWA and this Addendum, I assure protections for human subjects as specified
above.
Datet•
Name: William M. Pierce, Ph.D.
Rank/Grade:
Telephone number: 502-852-8373
FAX number: 502-85~-837?
_
o1
Email address: iAJfl'JpieJ' ot..~Jow~VJife.·~ u_,
Institutional Title: Executive VP for Research and Innovation
Mailing Address: Office of the Executive Vice President for Research
University of Louisville
Jouett Hall
2301 South Third Street
Louisville, KY 40292
B. Chair(s) of the IRB(s) that are part of the Institution and listed in Table 1
Acting in an authorized capacity on behalf of this institution's Biomedical IRB and with an understanding
of the IRB's responsibilities under the institution's FWA and this Addendum, I assure protections for
human subjects as specified above.
~
Name: Laura Clark, MD
Institutional Title: Anesthesiologist
Institution: University of Louisville
Telephone number: 502-852-5188
FAX number: 502-852-2164
Email address: llclar02@louisville.edu
Name(s) or Number of IRB: Biomedical IRB
Mailing Address: MedCenter One, Suite 200
501 E. Broadway
Louisville, KY. 40202
UotL DoD Addendum to DHHS FWA 2012-01-03
5
Acting in an authorized capacity on behalf of this institution's SBE IRB and with an understanding of the
IRB's responsibilities under the institution's FWA and this Addendum, I assure protections for human
s:zt= s;;ed~
t/ Yj;-z­
Signature:
D~te:
Name: Peter M. Quesada, Ph.D.
Institutional Title: Professor
Institution: University of Louisville
Name(s) or Number of IRB: BiomedicaiiRB
Mailing Address: MedCenter One, Suite 200
501 E. Broadway Louisville, KY. 40202 Telephone number: 502-852-5188
FAX number: 502-852-2164
Email address: pmques01 @louisville.edu
1
Note: If there are multiple IRBs listed in Table 1, each Chair should sign this Addendum and provide
the information in this section. If a Chair presides over multiple IRBs listed in Table 1, provide the
name and number of each IRB in this section.
C. Primary Contact - Human Research Protection of the FWA Institution
Name: Rebecca H. Higgins, BS, CIP
Rank/Grade:
Institutional Title: Interim Director, HSPP
Mailing Address: MedCenter One, Suite 200
501 E. Broadway
Louisville, KY. 40202
Telephone number: 502-852-6956
FAX number: 502-852-2164
Email address: rhhigg01 @louisville.edu
UofL DoD Addendum to DHHS FWA 2012-01-03
6
Table 3. Institutional Review Board (IRB) Membership List
Effective Date of Membership List: 07/01/2011
DHHS IRB #(if applicable):00000251
DoD Assurance Number:
Name of IRB: Biomedical IRB A (#1)
DoD IRB #(if applicable):
Institution Name:
University of Louisville
Rank/Title
1.1RB Chair
Assoc Professor
Last Name
Clark
First Name
Laura
M
I
D
Gend
er
(M/F)
Earned
Degrees
M.D.
F
Professional Expertise/
Experience (indicate
Non- Scientist by NS)
Affilia
ted
(YIN)
Anesthesiology (PS)
y
Name of Institution for
Non-affiliated Members
I
I
I
I
I
Votina (Primarv) Members - including Vice Chairs
2.Geriatric Nurse
3. Physician Member-NHI
4. Asst Professor
I
Barrer
Carreon
5. Assoc Professor
Coram
Dryden
6.Professor
Flynn
7. Professor Emeritus
B.Vice Chair/ Clinical
Assoc Professor
Sharon
L
F
ADAS
Leah
y
F
MD,MSc
Rita
Family/Geriat Med (OS)
Orthopedic Surgery (PS)
y
y
y
y
y
y
F
MD
Medicine-Cardiology(PS)
N
Gerald
w
M
MD
Medicine-GI (PS)
B
M
Gall
Michael
Stanley
A
M
MD
MD
Suraerv-Oncology (PS)
OB/GYN (PS)
Goldman
Julie
L
F
MD
Surgery-Pediatric ENT
(PS)
9.Vice Chair/ Professor
Emeritus
Groff
Diller
B
M
MD
Surgery-Otolaryngology
(PS)
y
10. Asst Professor
Hanson
Stephen
s
M
PhD
Bioethics/Philosophy
(NS)
y
11. Professor
Quesada
Peter
M
M
PhD
Mech. Engineering
12.Vice Chair/ Comm Mbr.
Martinez
Serae
A
M
MD,JD
Surgery-ENT (PS)
y
y
13. Community Member
Moll
John
M
CPA
Accountant (NS)
N
F
PhD
Pediatrics-MPH (OS)
y
M
J.D.
Law Professor (NS)
N
MD
Peds-Critical Care (PS)
y
A
F
M
MD
Pediatrics (PS)
N
R
F
PharmD
Drug policy/research
(OS)
y
14. Asst Professor
Radmacher
Paula
15. Community Member
Stenger
Robert
G
L
16. Professor
17. Vice Chair/ Community
Member
18. Pharmacy Director
Sullivan
Janice
E
Walker
Frank
Whalen
Cathy
7
Norton Healthcare
I
i
Unemployed
Retired
L-MARC Research
DoD Addendum to DHHS FWA 2012-0I-03.doc
Alternates for Voting Members (Alternate for Member name/number)
2,11,14,18
Oral Surgery (OS)
y
y
y
y
y
PhD,
MRCP,
MBBS
Mad-Cardiology
y
1 ,3,4,5,6, 7 ,8,9, 12, 16,17
F
MD/PhD
Medical Educator (PS)
1,3,4,5,6,7,8,9, 12,16,17
F
M
MD
Psychiatry (SS/PS)
Cahid
A
M
MD
Diag Radiology (PS)
Coldwell
Douglas
M
M
MD
Diag Radiology (PS)
y
y
y
y
Deuth
Doris
w F
BA,MA
Community Mbr (NS)
N
10, 13,15
MD
Neurology (PS)
y
1,3,4,5,6,7,8,9, 12,16,17
PhD
Community Mbr (OS)
N
2, 11, 14, 18
PhD
Ed/Human Dev (NS)
N
10.13.15
y
y
y
y
10, 13,15
1.Assoc Professor
Abou-Chebl
Alex
M
MD
Neurology (PS)
2. Asst Professor
Alshaher
Motaz
M
MD
Mad-Cardiology (PS)
3.Research Manager
Beatty
Karen
F
ADAS
GCRC (OS)
4. Professor
Berkenbosch
John
M
MD
Peds-Critical Care (PS)
5. Professor
Binkley
Catherine
J
F
DDS,
PhD,
MSPH
6. Professor
Birks
Emma
J.
F
7. Adj_ Asst Professor
Carter
Mary
B
8. Professor
Casanova
Manuel
9. Professor
Civelek
10. Professor, Term
11 . Retired Prison Warden
s
12. Asst Professor
Karkare
Shefali
13. Community Member
Kaufman
Christina
L
14. Community Member
Leitsch
Patricia
K
s
15. Professor
Maloney
Thomas
16. Asst Professor
Redman
Rebecca
17. Professor Emeritus
Redinger
Richard
18. Research Coordinator
Trachtenberg
Laura
- - ­
F
F
F
M
PhD
Philosophy (NS)
F
MD
Med-Oncology (PSl
N
M
MD
Medici ne-G I
S.
F
MA
Surgery (OS)
8
1,3,4,5,6,7,8,9, 12, 16,17
1,3,4,5,6,7,8,9, 12, 16,17
1,3,4,5,6, 7 ,8,9, 12, 16,17
2, 11, 14, 18
1,3,4,5,6,7,8,9, 12, 16,17
1,3,4,5,6,7,8,9, 12, 16, 7
1,3,4,5,6,7,8,9, 12, 16,17
1,3,4,5,6,7,8,9 12, 16,17
1,3,4,5,6,7,8,9, 12, 16,17
2, 11, 14, 18
DoD Addendum to DHHS FWA 2012-0l-03.doc
Table 3. Institutional Review Board (IRB) Membership List
Name of IRB: Social Behavioral Education IRB B (#2)
DoD IRB #(if applicable) :
Institution Name:
University of Louisville
Effective Date of Membership List: 07/01/2011
DHHS IRB #(if applicable):00000252
DoD Assurance Number:
Rank/Title
Last Name
First Name
M
I
Gend
er
(M/F)
Earned
Degrees
Professional Expertise/
Experience (indicate
Non- Scientist by NS)
Affilia
ted
(YIN)
1.1RB Chair
Quesada
Peter
M
M
PhD
Mech Engineering (OS)
y
Name of Institution for
Non-affiliated Members
I
Assoc Professor
I
Voting (Primary) Members - including Vice Chairs
F
PhD
Sociology (SS)
y
M
MDiv
Retired Armed Srvcs
Chaplain
N
E
F
PhD
Social Work (SS)
y
Doris
w
F
BA,MA
Retired Prison Warden
(NS)
N
Hall
Timoth_y
M
JD
School of Law (OS)
7. Asst Professor
Hanson
Stephen
s
s
M
PhD
Bioethics/Philosophy
(NS)
y
y
8. Community Member
Leitsch
Patricia
K
F
PhD
9. Professor
Maloney
Thomas
s
M
PhD
Retired Educator (NS)
Philosophy (NS)
y
10. Community Member
Munoz
Marco
M
EdD
Educational Analyst (OS)
N
11 . Assoc Professor
Newton
Tamara
L
F
PhD
Psychology (SS)
12. Asst Professor
Ridner
s
L
M
PhD
Nursin_g (OS)
13. Doctoral Student
Schapmire
Tara
J
F
BSW,
MSSW
Social Work (SS)
y
y
y
2. Assoc Dean
Andris
Melissa
3. Community Member
Berndt
Leander
4. Asst Professor
Collins-Camargo
Crystal
5. Community Member
Deuth
6.Law Professor
-
E
-
9
N
I
None-Retired
Retired
Retired
Jefferson Co Public
Schools
DoD Addendum to DHHS FWA 2012-0l-03 .doc
I
Alternates for Voting Members (Alternate for Member name/number)
1. Nursing Supervisor,
Berger
Jill
T F
Norton Healthcare
2.Professor
Cunningham
Michael
R M
3.Doctoral Student
Clark
Rebecca
4. Doctoral student
5. Professor
Cumberland
Negrey
Denise
Cynthia
L
6. Assoc Professor
Smigielski
Elizabeth
M
F
F
F
F
7.Practicum student
Wooldridge
Donald
T
M
A
'
RN,MA
Nursing (OS)
N
Alt for: 6, 10, 12
PhD
Psychology/Communica­
tions (SS)
y
1,2,4,8, 11,13
MSSW
Social Work _iSS)_
1,2,4,8, 11,13
BA,MA
Education (SS1
Ph.D.
Sociology_(SS1
Library Sciences (NS)
BA
y
y
y
y
y
MSLS
10
Counseling Psychology
(SS)
1, 2, 4, 8, 11, 13
1, 2,4, 8, 11,13
5, 7, 8, 9
1, 2, 4, 8, 11 13
1
DoD Addendum to DHHS FWA 2012-0l-03.doc
I
I
I
'