Department of Defense Human Research Protection Program

Transcription

1 Department of Defense Human Research Protection Program AR ORCE SSUED DEPARTENT O DEENSE (DOD) ADDENDU TO THE DEPARTENT O HEALTH AND HUAN SERVCE'S (DHHS) EDERALWDE ASSURANCE (WA) OR THE PROTECTON O HUAN SUBJECTS This Addendum is for non-dod nstitutions that alread have an WA approved b DHHS and will be engaged in DoD-supported human subject research. A. Purpose of DoD Addendum Part 1 NSTTUTON NORATON [ ] New [ X] Renewal for DoD Addendum Number: B. nstitution nformation Name: Universit of Louisville DHHS WA Number: WA Description of the nstitution: Universit of Louisville (all Schools and Colleges) Universit of Louisville Hospital Kosair Children's Hospital J. Graham Brown Cancer Center (RB for facult practicing in) Jewish Hospital & St ars Healthcare Norton Healthcare, nc. The nstitutional Review Boards (RBs) at the Universit of Louisville review all Universit affiliated human subjects research, regardless of funding. The RB chair or vice-chair makes the determination of exemption from RB review. C. Scope This Addendum applies to all DoD-supported human research protocols performed b this institution, unless specified below. D. Effective Date This Addendum is effective as of the date the approval document is signed b the DoD Component Designated Official and expires on the date listed in the approval document. UofL DoD Addendum to DHHS WA

2 Part 2 DOD REQUREENTS n addition to the requirements identified in the nstitution's WA, this institution assures it shall compl 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 ederal Regulations Part 219 (32 CR 219), Department of Defense Regulations, "Protection of Human Subjects" Title 45 Code of ederal Regulations Part 46, (45 CR 46) Department of Health and Human Services Regulations, "Protection of Human Subjects," Subparts 8, C, and D as made applicable b DoDD Title 21 Code of ederal Regulations 50, 56, 312, and 812, ood and Drug Administration (DA) Regulations DoD Directive (DoDD) , "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 , "Research ntegrit and isconduct" DoD nstruction (DoD) , "Application of ood and Drug Administration (DA) Rules to Department of Defense orce Health Protection Programs" Part 3 DOD COPONENT REQUREENTS The institution assures it shall also compl with DoD Component requirements for the research protocol(s) sponsored b that DoD Component. The requirements for each DoD Component are listed below. DoD Components ma require that other research, not specificall identified b 32 CR 219, also compl with the terms of this Addendum (32 CR (d)). Department of the Arm AR Use of Volunteers as Subjects of Research, 25 Januar 1990 AR 40-38, Clinical nvestigation Program, 1 September 1989 AR 40-7, Use of nvestigational Drugs in Humans and the Use of Schedule Controlled Drug Substances, 4 Januar 1991 Department of the Nav SECNAVNST D of 6 November 2006 Department of the Air orce Air orce nstruction , Protection of Human Subjects in Research Office of the Secretar of Defense for Personnel and Readiness HA Polic UofL DoD Addendum to DHHS WA

3 Part4 NSTTUTON RESPONSBLTES 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 WA. A select list of responsibilities of the nstitutional Official, RB, and nvestigators 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 RB 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 b a designated nstitutional 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 b the RB Ensure additional protections for militar research subjects to minimize undue influence Explain to subjects an provisions for medical care for research-related injur Report unanticipated problems, adverse events, research-related injur, and suspensions or terminations of research Appoint a edical onitor when necessar Safeguard for research conducted with international populations Protect pregnant women, prisoners, and children Compl with DoD limitations on research where consent b legall authorized representatives is proposed Compl with DoD limitation on exceptions from informed consent (e.g., 10 USC 980,45 CR 46, and 21 CR 50) Compl with limitations on dual compensation for U.S. militar personnel ollow DoD requirements for additional review for DoD-sponsored surve research or surve research within DoD Address and report allegations of non-compliance with human research protections Address and report allegations of research misconduct ollow procedures for addressing financial and other conflicts of interest Prohibit research with prisoners of war (POW) Compl with all provisions for research with human subjects using investigational test articles (drugs, device, and biologics) ollow recordkeeping requirements Support oversight b the sponsoring DoD Component (which ma include DoD Component review of the research and site visits) UofL DoD Addendum to DHHS WA

4 PartS DESGNATON O RB(S) THAT WLL REVEW DOD-SUPPORTED RESEARCH All of the RBs supporting the institution do not need to be listed in Tables 1 and 2. List onl those RBs that will review DoD-supported research. A. RB(s) that are Part of this nstitution n Table 1, identif each RB that is organizationall part of this institution and can review DoDsupported research under this Addendum to the WA (the RBs should also be listed on the WA). or each RB listed in Table 1, the RB Chair must sign this Addendum in Part 6. When requested b the DoD-sponsor, attach the membership list for each RB listed (in accordance with 45 CR 46); see Table 3 for an example. Table 1. RB(s) within the nstitution RB Name or Number DHHS RB Registration Number (8 digits) 1.Biomedical RB Sociai/Behaviorai/Education (SBE) RB B. RB(s) that are not Part of this nstitution n Table 2, identif each RB that is not associated with this institution and can review DoD-supported research under this Addendum to the WA. or each RB listed in Table 2, attach the DoD nstitutional Agreement for RB Review (or an equivalent agreement). When requested b the DoDsponsor, attach the membership list for each RB listed (in accordance with 45 CR 46); see Table 3 for an example. Table 2. RB(s) not part of this nstitution RB Name or Number DHHSRB Registration Number (8 digits)* Name of the nstitution Providing the RB 1. None * f applicable. DoD Assurance Number of the nstitution* DHHS WA Number of the nstitution* UofL DoD Addendum to DHHS WA

5 Part6 NSTTUTONAL AGREEENT A. Official Legall Authorized to Represent the WA nstitution (i.e., signed the WA) Acting in an authorized capacit on behalf of this institution and with an understanding of the institution's responsibilities under it's WA and this Addendum, assure protections for human subjects as specified above. Datet Name: William. Pierce, Ph.D. Telephone number: AX number: ~-837? _ o1 Rank/Grade: address: iajfl'jpiej' ot..~jow~vjife. ~ u_, nstitutional Title: Executive VP for Research and nnovation ailing Address: Office of the Executive Vice President for Research Universit of Louisville Jouett Hall 2301 South Third Street Louisville, KY B. Chair(s) of the RB(s) that are part of the nstitution and listed in Table 1 Acting in an authorized capacit on behalf of this institution's Biomedical RB and with an understanding of the RB's responsibilities under the institution's WA and this Addendum, assure protections for human subjects as specified above. ~ Name: Laura Clark, D nstitutional Title: Anesthesiologist nstitution: Universit of Louisville Telephone number: AX number: address: llclar02@louisville.edu Name(s) or Number of RB: Biomedical RB ailing Address: edcenter One, Suite E. Broadwa Louisville, KY UotL DoD Addendum to DHHS WA

6 Acting in an authorized capacit on behalf of this institution's SBE RB and with an understanding of the RB's responsibilities under the institution's WA and this Addendum, assure protections for human s:zt= s;;ed~ t/ Yj;-z Signature: D~te: Name: Peter. Quesada, Ph.D. Telephone number: nstitutional Title: Professor AX number: nstitution: Universit of Louisville address: Name(s) or Number of RB: BiomedicaiiRB ailing Address: edcenter One, Suite E. Broadwa Louisville, KY Note: f there are multiple RBs listed in Table 1, each Chair should sign this Addendum and provide the information in this section. f a Chair presides over multiple RBs listed in Table 1, provide the name and number of each RB in this section. C. Primar Contact - Human Research Protection of the WA nstitution Name: Rebecca H. Higgins, BS, CP Telephone number: Rank/Grade: AX number: nstitutional Title: nterim Director, HSPP address: ailing Address: edcenter One, Suite E. Broadwa Louisville, KY UofL DoD Addendum to DHHS WA

7 Table 3. nstitutional Review Board (RB) embership List Name of RB: Biomedical RB A (#1) Effective Date of embership List: 07/01/2011 DoD RB #(if applicable): DHHS RB #(if applicable): nstitution Name: Universit of Louisville DoD Assurance Number: Rank/Title Last Name irst Name 1.1RB Chair Clark Laura Assoc Professor Votina (Primarv) embers - including Vice Chairs 2.Geriatric Nurse Barrer Sharon 3. Phsician ember-nh Carreon Leah 4. Asst Professor Coram Rita 5. Assoc Professor Drden Gerald 6.Professor lnn ichael 7. Professor Emeritus Gall Stanle B.Vice Chair/ Clinical Goldman Julie Assoc Professor 9.Vice Chair/ Professor Groff Diller Emeritus 10. Asst Professor Hanson Stephen 11. Professor Quesada Peter 12.Vice Chair/ Comm br. artinez Serae 13. Communit ember oll John 14. Asst Professor Radmacher Paula 15. Communit ember Stenger Robert 16. Professor Sullivan Janice 17. Vice Chair/ Communit Walker rank ember 18. Pharmac Director Whalen Cath D L w B A L B s A G L E A R Gend er (/) Earned Degrees.D. ADAS D,Sc D D D D D D D,JD CPA J.D. D D PharmD Professional Expertise/ Affilia Name of nstitution for Experience (indicate ted Non-affiliated embers Non- Scientist b NS) (YN) Anesthesiolog (PS) amil/geriat ed (OS) Orthopedic Surger (PS) N Norton Healthcare edicine-cardiolog(ps) edicine-g (PS) Suraerv-Oncolog (PS) OB/GYN (PS) Surger-Pediatric ENT (PS) Surger-Otolarngolog (PS) Bioethics/Philosoph (NS) ech. Engineering Surger-ENT (PS) Accountant (NS) N Unemploed Pediatrics-PH (OS) Law Professor (NS) N Retired Peds-Critical Care (PS) Pediatrics (PS) N L-ARC Research Drug polic/research (OS) i 7 DoD Addendum to DHHS WA doc

8 Alternates for Voting embers (Alternate for ember name/number) 1.Assoc Professor Abou-Chebl Alex D Neurolog (PS) 1,3,4,5,6,7,8,9, 12, 16,17 2. Asst Professor Alshaher otaz D ad-cardiolog (PS) 1,3,4,5,6,7,8,9, 12, 16,17 3.Research anager Beatt Karen s ADAS GCRC (OS) 2,11,14,18 4. Professor Berkenbosch John D Peds-Critical Care (PS) 1,3,4,5,6, 7,8,9, 12, 16,17 5. Professor Binkle Catherine J DDS, Oral Surger (OS) 2, 11, 14, 18, SPH 6. Professor Birks Emma J., ad-cardiolog 1,3,4,5,6, 7,8,9, 12, 16,17 RCP, BBS 7. Adj_ Asst Professor Carter ar B D/ edical Educator (PS) 1,3,4,5,6,7,8,9, 12,16,17 8. Professor Casanova anuel D Pschiatr (SS/PS) 1,3,4,5,6,7,8,9, 12, 16,17 9. Professor Civelek Cahid A D Diag Radiolog (PS) 1,3,4,5,6,7,8,9, 12, 16, Professor, Term Coldwell Douglas D Diag Radiolog (PS) 1,3,4,5,6,7,8,9, 12, 16, Retired Prison Warden Deuth Doris w BA,A Communit br (NS) N 10, 13, Asst Professor Karkare Shefali D Neurolog (PS) 1,3,4,5,6,7,8,9, 12,16, Communit ember Kaufman Christina L Communit br (OS) N 2, 11, 14, Communit ember Leitsch Patricia K Ed/Human Dev (NS) N Professor alone Thomas s Philosoph (NS) 10, 13, Asst Professor Redman Rebecca D ed-oncolog (PSl 1,3,4,5,6,7,8,9 12, 16, Professor Emeritus Redinger Richard N D edici ne-g 1,3,4,5,6,7,8,9, 12, 16, Research Coordinator -- Trachtenberg Laura S. A Surger (OS) 2, 11, 14, 18 8 DoD Addendum to DHHS WA l-03.doc

9 Table 3. nstitutional Review Board (RB) embership List Name of RB: Social Behavioral Education RB B (#2) Effective Date of embership List: 07/01/2011 DoD RB #(if applicable) : DHHS RB #(if applicable): nstitution Name: Universit of Louisville DoD Assurance Number: Rank/Title Last Name irst Name 1.1RB Chair Quesada Peter Assoc Professor Voting (Primar) embers - including Vice Chairs 2. Assoc Dean Andris elissa 3. Communit ember Berndt Leander 4. Asst Professor Collins-Camargo Crstal 5. Communit ember Deuth Doris 6.Law Professor Hall Timoth_ 7. Asst Professor Hanson Stephen 8. Communit ember Leitsch Patricia 9. Professor alone Thomas 10. Communit ember unoz arco 11. Assoc Professor Newton Tamara 12. Asst Professor Ridner s 13. Doctoral Student Schapmire Tara - E E w s s K s - L L J Gend er (/) Earned Degrees Div BA,A JD EdD BSW, SSW Professional Expertise/ Affilia Name of nstitution for Experience (indicate ted Non-affiliated embers Non- Scientist b NS) (YN) ech Engineering (OS) Sociolog (SS) Retired Armed Srvcs N None-Retired Chaplain Social Work (SS) Retired Prison Warden N Retired (NS) School of Law (OS) Bioethics/Philosoph (NS) Retired Educator (NS) N Retired Philosoph (NS) Educational Analst (OS) N Jefferson Co Public Schools Pscholog (SS) Nursin_g (OS) Social Work (SS) 9 DoD Addendum to DHHS WA l-03.doc

10 Alternates for Voting embers (Alternate for ember name/number) 1. Nursing Supervisor, Berger Jill T RN,A Nursing (OS) N Alt for: 6, 10, 12 Norton Healthcare ' 2.Professor Cunningham ichael R Pscholog/Communica 1,2,4,8, 11,13 tions (SS) 3.Doctoral Student Clark Rebecca A SSW Social Work _iss)_ 1,2,4,8, 11,13 ' 4. Doctoral student Cumberland Denise BA,A Education (SS1 1, 2, 4, 8, 11, Professor Negre Cnthia L Ph.D. Sociolog_(SS1 1, 2,4, 8, 11,13 6. Assoc Professor Smigielski Elizabeth SLS Librar Sciences (NS) 5, 7, 8, 9 7.Practicum student Wooldridge Donald T BA Counseling Pscholog 1, 2, 4, 8, (SS) 10 DoD Addendum to DHHS WA l-03.doc