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MEDICAL CAMPUS
Human Research Protections Program

East Tennessee State University/
James H. Quillen Veterans Affairs Medical Center

INSTITUTIONAL REVIEW BOARD
STANDING COMMITTEE

CHARGE:
Review all proposals involving research on human subjects submitted by faculty, staff, and students from the James H. Quillen College of Medicine and the James H. Quillen Veterans Affairs Medical Center, and from other Colleges or institutions operating under contractual agreement with ETSU where warranted by the content of the study and requested by either the principal investigator or chair of the ETSU Campus IRB.  This responsibility includes considering the level of risk to the individuals involved as it relates to the overall benefit of the protocol as presented, determining that participants have been given “informed consent,” and resolving that the proposed research is consistent with the moral and ethical precepts of the institution.

Act as the certifying agency for the proposals it approves for East Tennessee State University and for the James H. Quillen Veterans Affairs Medical Center to the Office for Human Research Protections (OHRP), and to the Food and Drug Administration (FDA), in addition to other federal, state, or private agencies.

Ensure institutional compliance with federal, state, and local regulations and ordinances pertaining to the use of human subjects for the protocols it has approved.

Ensure compliance with the ETSU and the Federalwide Assurance (FWA) on file with OHRP.

Ensure quality improvement through regular and on-going site audits of approved Medical IRB research records and sites to confirm compliance with federal and institutional mandates and with protocols as approved by the convened Medical IRB.

Ensure that each individual involved in human subjects research in the James H. Quillen College of Medicine, the James H. Quillen Veterans Affairs Medical Center, and other Colleges or institutions operating under contractual agreement with ETSU  has taken an IRB approved course in *Good Clinical Practices, the ethical conduct of research involving human subjects and the privacy and confidentiality of protected health information, and has passed a post-course assessment(s) of her/his knowledge of the material presented in the course(s) prior to submitting a proposal for review.

FREQUENCY OF MEETINGS: The Board meets at least monthly.

REPORTS TO: ETSU President / VA Driector as established in the Memorandum of Understanding (MOU)

VOTING:

Six Faculty Representatives
Three Faculty Representatives with greater than half-time VA appointments
Four Staff Representatives
Two Staff Representatives with VA appointments
Two representatives from the local community
One representative from a VA service organization
One representative from the Tennessee Department of Corrections

NON-VOTING and EX-OFFICIO:
Assistant to the President for Legal Affairs
Research & Sponsored Programs Representative
Administrative Officer of the VAMC Research & Development Committee
Chair, VA Research & Development Committee
IRB Coordinator
IRB Secretary
Director of Pharmacy, Johnson City Medical Center Hospital (MSHA)

SELECTION:
Members are nominated by the Provost/Vice President of Academic Affairs, Vice President for Health Affairs/Dean of Medicine, and by the Associate Chief of Staff for Research from the Veterans Affairs Medical Center Office of Research and Development.

Among the voting members the following constituencies must be represented: men and women, behavioral and social scientists, non-scientists, an ethicist, and at least one member who is not affiliated with the institution or related to an affiliated member.

ALTERNATES:
A pool of alternates may be selected by the Board upon the approval of the Provost/Vice President for Academic Affairs, Vice President for Health Affairs/Dean of Medicine, and by the VAMC Director.  They have full voting authority (in the absence of the regular member) and are designated to replace regular members at meetings to which the latter cannot attend.  Alternates are appointed for three year terms, as are regular members, and are encouraged to attend the meetings so as to gain from their experience in serving on the IRB.  Alternates may be recommended by the Chair, with concurrence of the regular membership, for election to vacant, unexpired terms and full three year terms for which they qualify on the regular committee.  The Board meets at least monthly.

INSTITUTIONAL REVIEW BOARD MEMBERSHIP 2002-2006:
VOTING:

Faculty Representatives

Chair Kenneth Olive, M.D., Internal Medicine, 2004
Box 70565

David Chi, Ph.D., Internal Medicine, 2004
Box 70622

William Finger, Ph.D., Psychology Service, 2006
VAMC 116B2, Mountain Home, TN 37684

Ronald Hamdy, M.D., Geriatrics / Gerontology, 2004
VAMC 11E, Mountain Home, TN 37684

Pat Moynihan, M.D., Surgery, 2004
Box 70575

Peter Panus, Ph.D., Physical Therapy, 2004
Box 70624

Priscilla Ramsey, Ph.D., Nursing, 2006
Box 70629

Thomas Roy, M.D., Pulmonary Medicine, 2004
VAMC 111B, Mountain Home, TN 37684

Gary Kukulka, M.D., Family Medicine, 2006
Box 70621
 

Staff Representatives
Ms. Michelle Hurley, Ronald McNair Program, 2006
Box 70597

Vice Chair Colleen Noe, Ph.D., VA Audiology, 2006
VAMC 126, Mountain Home, TN 37684

Mr. Joe Smith, University Relations, 2004
Box 70717

Ms. Janine Richardson, R.N., VA Cardiology, 2006
VAMC 111C, Mountain Home, TN 37684

Kaggal V. Umakantha, M.D., Chief, VA Physical Medicine and Rehab, 2005
VAMC 117, Mountain Home, TN 37684
 

Community Representatives
Pastor Ann Burns, Cornerstone Church, 2006
120 Cornerstone Drive, Johnson City, TN 37601

Ms. Jennifer Long, 2005
671 Summit Drive, Jonesborough, TN 37658
 

VA Service Organization Representative
Ms. Jane Harris, VA Service Organization (American Red Cross), 2004
501 S. Wilcox Ave., Kingsport, TN 37664
 

International Programs
Ms. Maria Costa, Associate Director, International Programs, 2005
Box 70668
 

Alternate Members
Judaun Alison, M.D., Surgery, 2004
Box 70575

Loren Bennett, O.D., Chief, Optometry, 2004
VAMC 112, Mountain Home, TN 37684

Myra Elder, Ph.D., VA Psychology Service, 2004
VAMC 116B2, Mountain Home, TN 37684

Kendra Weaver, Ph.D., VA Psychology Service, 2005
VAMC 116B2, Mountain Home, TN 37684

Mr. Clarence Kiser, American Legion, Veteran Affairs Service Organization, 2004
1106 Knob Creek Road, Johnson City, TN 37604

Ms. Holly Melendez, Family Medicine, 2006
Box 70621

Ms. Janice Frazier, Clinical Research Coordinator, ETSU Cancer Center, 2005
JCMC, 400 N. State of Frankllin Road, Johnson City, TN 37604
 

NON-VOTING AND EX-OFFICIO

Mr. Edward J. Kelly, Legal Affairs (ex-officio), Indefinite
Box 70285

Ms. Pat Myrick, HRPP Compliance Manger, Office of Research & Sponsored Programs, Indefinite
Box 70565

Ms. Linda Quade, Administrative Officer, VA R & D, Indefinite
VA 151, Mountain Home, TN 37684

Ms. Sharron Livingston, IRB Secretary, Office of Research and Sponsored Programs, Indefinite
Box 70565

Ms. Catherine Shuttle, IRB Coordinator, Office of Research and Sponsored Programs, Indefinite
Box 70565

Chair, VA Research & Development Committee, Indefinite
VA 151, Mountain Home, TN 37684

Bettie Wilson, PharmD, (JCMC) Director of Pharmacy, Indefinite
JCMC, 400 N. State of Franklin Road, Johnson City, TN 37604

Mr. Jerry Hayes, Northeast Correctional Center, Indefinite
P. O. Box 5000, Mountain City, TN 37683-5000

*ETSU is an affiliate institution of the James H. Quillen Veterans Affairs Medical Center at Mountain Home, TN.  Current compliance education requirements for VA researchers or for other researchers conducting VA-approved research may be found at http://www.etsu.edu/irb/EDCLASSREQ.doc.