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 Senior Vice President for Academics/Interim Provost and the Vice President for Clinical 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: