air force issued addendum to the department of...

Department of Defense Human Research Protection Program

AIR FORCE ISSUED DEPARTMENT OF DEFENSE (DOD) ADDENDUM TO THE DEPARTMENT OF HEALTH AND HUMAN SERVICES (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

Name University of Louisville DHHS FWA Number FWA00002211 Description of the Institution

University of Louisville (all Schools and Colleges) University of Louisville Hospital

Kosair Childrens Hospital J Graham Brown Cancer Center

(IRB for faculty practicing in) Jewish Hospital amp 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 Institutions 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

bull Title 32 Code of Federal Regulations Part 219 (32 CFR 219) Department of Defense Regulations Protection of Human Subjects

bull 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 321602

bull Title 21 Code of Federal Regulations 50 56 312 and 812 Food and Drug Administration (FDA) Regulations

bull DoD Directive (DoDD) 321602 Protection of Human Subjects and Adherence to Ethical Standards in DoD-supported Research

bull Title 10 United States Code Section 980 (10 USC 980) Limitation on Use of Humans as Experimental Subjects

bull DoDD 32107 Research Integrity and Misconduct bull DoD Instruction (DoDI) 620002 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 219101(d))

Department of the Army bull AR 70-25 Use of Volunteers as Subjects of Research 25 January 1990 bull AR 40-38 Clinical Investigation Program 1 September 1989 bull 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 bull SECNAVINST 390039D of 6 November 2006

Department of the Air Force bull Air Force Instruction 40-402 Protection of Human Subjects in Research

Office of the Secretary of Defense for Personnel and Readiness bull HA Policy 05-003


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 institutions 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

bull Conduct initial and continuing research ethics education for personnel who are engaged in human subject research (eg who review approve oversee or manage research)

bull Document determination by a designated Institutional Official (other than investigators) whether research meets criteria for exemption

bull Ensure new research and substantive scientific amendments to approved research shall undergo scientific review and that the review is considered by the IRB

bull Ensure additional protections for military research subjects to minimize undue influence bull Explain to subjects any provisions for medical care for research-related injury bull Report unanticipated problems adverse events research-related injury and suspensions or

terminations of research bull Appoint a Medical Monitor when necessary bull Safeguard for research conducted with international populations bull Protect pregnant women prisoners and children bull Comply with DoD limitations on research where consent by legally authorized representatives is

proposed bull Comply with DoD limitation on exceptions from informed consent (eg 10 USC 98045 CFR 46

and 21 CFR 50) bull Comply with limitations on dual compensation for US military personnel bull Follow DoD requirements for additional review for DoD-sponsored survey research or survey

research within DoD bull Address and report allegations of non-compliance with human research protections bull Address and report allegations of research misconduct bull Follow procedures for addressing financial and other conflicts of interest bull Prohibit research with prisoners of war (POW) bull Comply with all provisions for research with human subjects using investigational test articles

(drugs device and biologics) bull Follow recordkeeping requirements bull Support oversight by the sponsoring DoD Component (which may include DoD Component

review of the research and site visits)


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 DoDshysupported 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 DHHS IRB Registration Number (8 digits) 1Biomedical IRB 00000251 2SociaiBehavioraiEducation (SBE) IRB 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 DoDshysponsor 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 IRB Name or Number DHHSIRB

Registration Number (8 digits)

Name of the Institution Providing the IRB

DoD Assurance Number of the Institution

DHHS FWA Number of the Institution

1 None 2 3 4 5 6

If applicable


Part6 INSTITUTIONAL AGREEMENT

A Official Legally Authorized to Represent the FWA Institution (ie signed the FWA)

Acting in an authorized capacity on behalf of this institution and with an understanding of the institutions responsibilities under its FWA and this Addendum I assure protections for human subjects as specified above

Datetbull

Name William M Pierce PhD Telephone number 502-852-8373 FAX number 502-85~-837 _ o1

RankGrade Email address iAJflJpieJ ot~Jow~VJifemiddot~ 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 institutions Biomedical IRB and with an understanding of the IRBs responsibilities under the institutions FWA and this Addendum I assure protections for human subjects as specified above

~ Name Laura Clark MD Institutional Title Anesthesiologist Institution University of Louisville

Name(s) or Number of IRB Biomedical IRB Mailing Address MedCenter One Suite 200

501 E Broadway Louisville KY 40202

Telephone number 502-852-5188 FAX number 502-852-2164 Email address llclar02louisvilleedu

UotL DoD Addendum to DHHS FWA 2012-01-03 5

Acting in an authorized capacity on behalf of this institutions SBE IRB and with an understanding of the IRBs responsibilities under the institutions FWA and this Addendum I assure protections for human

szt= sed~ t Yj -zshy1

Signature D~te

Name Peter M Quesada PhD Telephone number 502-852-5188 Institutional Title Professor FAX number 502-852-2164 Institution University of Louisville Email address pmques01 louisvilleedu Name(s) or Number of IRB BiomedicaiiRB Mailing Address MedCenter One Suite 200


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 Telephone number 502-852-6956 RankGrade FAX number 502-852-2164 Institutional Title Interim Director HSPP Email address rhhigg01 louisvilleedu Mailing Address MedCenter One Suite 200



Table 3 Institutional Review Board (IRB) Membership List

Name of IRB Biomedical IRB A (1) Effective Date of Membership List 07012011

DoD IRB (if applicable) DHHS IRB (if applicable)00000251

Institution Name University of Louisville DoD Assurance Number

RankTitle Last Name First Name

11RB Chair Clark Laura Assoc Professor

Votina (Primarv) Members - including Vice Chairs

2Geriatric Nurse Barrer Sharon

3 Physician Member-NHI Carreon Leah

4 Asst Professor Coram Rita

5 Assoc Professor Dryden Gerald

6Professor Flynn Michael

7 Professor Emeritus Gall Stanley

BVice Chair Clinical Goldman Julie Assoc Professor

9Vice Chair Professor Groff Diller Emeritus

10 Asst Professor Hanson Stephen

11 Professor Quesada Peter

12Vice Chair Comm Mbr Martinez Serae

13 Community Member Moll John

14 Asst Professor Radmacher Paula 15 Community Member Stenger Robert

16 Professor Sullivan Janice 17 Vice Chair Community Walker Frank Member

18 Pharmacy Director Whalen Cathy

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Gend Earned er Degrees (MF)

F MD

F ADAS

F MDMSc

F MD

M MD

M MD

M MD

F MD

M MD

M PhD

M PhD

M MDJD

M CPA

F PhD

M JD

F MD

M MD

F PharmD

Professional Expertise Affilia Name of Institution for Experience (indicate ted Non-affiliated Members Non- Scientist by NS) (YIN)

Anesthesiology (PS) y

FamilyGeriat Med (OS) y

Orthopedic Surgery (PS) N Norton Healthcare

Medicine-Cardiology(PS) y

Medicine-GI (PS) y

Suraerv-Oncology (PS) y

OBGYN (PS) y

Surgery-Pediatric ENT y (PS)

Surgery-Otolaryngology y (PS)

BioethicsPhilosophy y (NS)

Mech Engineering y

Surgery-ENT (PS) y

Accountant (NS) N Unemployed

Pediatrics-MPH (OS) y

Law Professor (NS) N Retired

Peds-Critical Care (PS) y

Pediatrics (PS) N L-MARC Research

Drug policyresearch y (OS)

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DoD Addendum to DHHS FWA 2012-0I-03doc 7

Alternates for Voting Members (Alternate for Member namenumber)

1Assoc Professor Abou-Chebl Alex M MD Neurology (PS) y 1 3456789 12 1617

2 Asst Professor Alshaher Motaz M MD Mad-Cardiology (PS) y 1 3456789 12 1617

3Research Manager Beatty Karen s F ADAS GCRC (OS) y 2111418

4 Professor Berkenbosch John M MD Peds-Critical Care (PS) y 1 3456 7 89 12 1617

5 Professor Binkley Catherine J F DDS Oral Surgery (OS) y 2 11 14 18 PhD MSPH

6 Professor Birks Emma J F PhD Mad-Cardiology y 1 3456 7 89 12 1617 MRCP MBBS

7 Adj_ Asst Professor Carter Mary B F MDPhD Medical Educator (PS) y 1 3456789 121617

8 Professor Casanova Manuel F M MD Psychiatry (SSPS) y 1 3456789 12 1617

9 Professor Civelek Cahid A M MD Diag Radiology (PS) y 1 3456789 12 16 7

10 Professor Term Coldwell Douglas M M MD Diag Radiology (PS) y 1 3456789 12 1617

11 Retired Prison Warden Deuth Doris w F BAMA Community Mbr (NS) N 10 1315

12 Asst Professor Karkare Shefali F MD Neurology (PS) y 1 3456789 121617

13 Community Member Kaufman Christina L F PhD Community Mbr (OS) N 2 11 14 18

14 Community Member Leitsch Patricia K F PhD EdHuman Dev (NS) N 101315

15 Professor Maloney Thomas s M PhD Philosophy (NS) y 10 1315

16 Asst Professor Redman Rebecca F MD Med-Oncology (PSl y 1 3456789 12 1617

17 Professor Emeritus Redinger Richard N M MD Medici ne-G I y 1 3456789 12 1617

18 Research Coordinator Trachtenberg Laura S --shy

F MA Surgery (OS) y 2 11 14 18

DoD Addendum to DHHS FWA 2012-0l-03doc 8


Name of IRB Social Behavioral Education IRB B (2) Effective Date of Membership List 07012011




11RB Chair Quesada Peter

Assoc Professor

Voting (Primary) Members - including Vice Chairs

2 Assoc Dean Andris Melissa

3 Community Member Berndt Leander

4 Asst Professor Collins-Camargo Crystal

5 Community Member Deuth Doris

6Law Professor Hall Timoth_y


8 Community Member Leitsch Patricia

9 Professor Maloney Thomas

10 Community Member Munoz Marco

11 Assoc Professor Newton Tamara

12 Asst Professor Ridner s 13 Doctoral Student Schapmire Tara

-

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s s

K

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M PhD

F PhD

M MDiv

F PhD

F BAMA

M JD

M PhD

F PhD

M PhD

M EdD

F PhD

M PhD

F BSW

MSSW


Mech Engineering (OS) y

Sociology (SS) y

Retired Armed Srvcs N None-Retired Chaplain

Social Work (SS) y

Retired Prison Warden N Retired (NS)

School of Law (OS) y


Retired Educator (NS) N Retired

Philosophy (NS) y

Educational Analyst (OS) N Jefferson Co Public Schools

Psychology (SS) y

Nursin_g (OS) y

Social Work (SS) y

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DoD Addendum to DHHS FWA 2012-0l-03 doc 9

Alternates for Voting Members (Alternate for Member namenumber) I

1 Nursing Supervisor Berger Jill T F RNMA Nursing (OS) N Alt for 6 10 12 I

Norton Healthcare

2Professor Cunningham Michael R M PhD PsychologyCommunicashy y 1248 1113 I

tions (SS)

3Doctoral Student Clark Rebecca A F MSSW Social Work _iSS)_ y 1248 1113 I

4 Doctoral student Cumberland Denise F BAMA Education (SS1 y 1 2 4 8 11 13

5 Professor Negrey Cynthia L F PhD Sociology_(SS1 y 1 24 8 1113

6 Assoc Professor Smigielski Elizabeth M F MSLS Library Sciences (NS) y 5 7 8 9

7Practicum student Wooldridge Donald T M BA Counseling Psychology y 1 2 4 8 11 1 13 (SS)

10 DoD Addendum to DHHS FWA 2012-0l-03doc

Part 2 DOD REQUIREMENTS

In addition to the requirements identified in the Institutions 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

bull Title 32 Code of Federal Regulations Part 219 (32 CFR 219) Department of Defense Regulations Protection of Human Subjects

bull 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 321602

bull Title 21 Code of Federal Regulations 50 56 312 and 812 Food and Drug Administration (FDA) Regulations

bull DoD Directive (DoDD) 321602 Protection of Human Subjects and Adherence to Ethical Standards in DoD-supported Research

bull Title 10 United States Code Section 980 (10 USC 980) Limitation on Use of Humans as Experimental Subjects

bull DoDD 32107 Research Integrity and Misconduct bull DoD Instruction (DoDI) 620002 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 219101(d))

Department of the Army bull AR 70-25 Use of Volunteers as Subjects of Research 25 January 1990 bull AR 40-38 Clinical Investigation Program 1 September 1989 bull 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 bull SECNAVINST 390039D of 6 November 2006

Department of the Air Force bull Air Force Instruction 40-402 Protection of Human Subjects in Research

Office of the Secretary of Defense for Personnel and Readiness bull HA Policy 05-003



























1 None 2 3 4 5 6

If applicable





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