Institutional Review Board ETSU Campus

Reports to:

ETSU President

Charge:

Review all proposals involving research on human subjects submitted by faculty, staff and students from the Colleges of Arts and Sciences, Business and Technology, Clinical and Rehabilitative Health Sciences, Education, Nursing, and Public  Health, other institutions operating under contractual agreement with ETSU, as well as the School of Continuing Studies and from the Quillen College of Medicine at East Tennessee State University and the ETSU College of Pharmacy as warranted by content of the study and requested by either the principal investigator or the Chair of the ETSU/VA Medical 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 to the Office for Human Research Protections (OHRP), and to other federal, state, or private agencies as applicable.

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

Ensure compliance with the institution's Federalwide Assurance on file with OHRP.

Monitor ongoing research to ensure subject safety and quality improvement through regular and on-going site audits of approved ETSU Campus IRB research records and sites to confirm compliance with federal and institutional mandates and with protocols as approved by the convened IRB.

Ensure that each individual involved in human subjects research in the University's Colleges of Arts and Sciences, Business and Technology, Clinical and Rehabilitative Health Sciences, Education, Nursing, and Public Health, the School of Continuing Studies, and other Colleges or institutions operating under contractual agreement with ETSU has taken an IRB approved course, as appropriate,  in the ethical conduct of research involving human subjects and in regard for the privacy and confidentiality of protected health information and has passed a post-course assessment of her/his knowledge of the material presented in the course(s) prior to submitting a proposal for IRB review.

Ensure that each individual involved in human subject research, as indicated above, maintains compliance education in the ethical conduct of research involving human subjects following initial certification.  Should certification (initial or re-certification) expire (lapse), the investigator will have to re-take the course in its entirety.  The IRB, and/or its administration, the Office for the Protection of Human Research Subjects (OPHRS), shall require written documentation of initial certification, or re-certification, as appropriate, prior to receiving any proposal for IRB review.

Frequency of Meetings:

The Board meets every other month.

Selection:

Members are nominated by the Provost/Vice President for Academic Affairs and the Vice President of Health Affairs.

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 and the Vice President for Health Affairs.  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

Status

Membership  Structure

Name

Area of Representation

Length of Term

Voting

Chair

Mr. Chris Ayres

Kinesiology, Leisure and Sports Sciences

2014

Nine (9)  Faculty Representatives: One each from the Colleges of Business & Technology, Clinical & Rehabilitative Health Sciences, Nursing, and Public Health; one representing the humanities; one representing the social sciences within the College of Arts & Sciences; one representing the area of human development; one representing the areas of curriculum and instruction and educational leadership within the College of Education, and one representing Faculty Senate.

Dr. Fred Mackara

Business &  Technology

2016

Dr. Kurt Loess

Faculty Senate

2014

Dr. Vijaya Guntupalli

Clinical & Rehabilitative Health Sciences

2014

Dr. Florence Weierbach

Nursing

2015

TO BE NAMED

Public Health

2016

Dr. Daryl Carter

Humanities

2016

Dr. Stacey Williams, Vice Chair

Social Sciences in College of Arts & Science

2016

Dr.Jill Stinson

Psychology (Human Development and Learning)

2014

Dr. Rosalind Gann

Curriculum & Instruction

2014

Two Staff

Ms. Kristine Ann Harper Bowers

Rural Health

2016

Dr. Janet Keener

Office of Information Technology

2016

Two representatives from the local community

Ms. Karen Dorr

Community

2014

Mr. Vincent Dial, Pastor

Community

2014

To be named

Community

2016

One prisoner advocate

Dr. Wanda Sue Chafin

Northeast State Correctional Center

2015

One individual holding the MD degree

Merry Miller, MD

Psychiatry

2016

Non-Voting/ Ex-officio

University Counsel

Mr. Ed Kelly

University Counsel

Indefinite

OPHRS Representative

Ms. Janine Olive

OPHRS

Indefinite

IRB Coordinators

Ms. Hazel Robinson

OPHRS

Indefinite

Ms. Amber Anderson

OPHRS

Indefinite

IRB Information Research Technician

Ms. Theresia Cannon

OPHRS

Indefinite

Alternates

Dr.Craig Wassinger Physical Therapy 2014

Dr. Joseph Sobol

Curriculum & Instruction

2014

TO BE NAMED

 

2014

Dr. Patti Vanhook

Nursing

2014

Dr. Joel Hillhouse

Public Health

2016

Dr. Karin Bartoszuk

Graduate School

2014

 

Updated: 11 January 2014