R E S P E C T B E N E F IC E N CE JU S T IC E

H R P P IS B A S E D O N T H E S E P R IN C IP L E S :

East Tennessee State University

Full Accreditation

• Association for the Accreditation of Human Research Protection Programs (AAHRPP)

Two IRBs

• ETSU IRB• Serves the

academic campus• Reviews non-

medical research• Expertise in social

and behavioral research

• ETSU/VA IRB • Serves the QCOM,

the James H. Quillen VAMC, and is the IRB of Record for Mountain States Health Alliance

• Expertise in the medical sciences and clinical research

IRB Functions

• 1) determine and certify that all research projects conducted by ETSU or by the VAMC, or by physicians, faculty, staff, or students of either institution, or for any institution for whom these services are provided by contractual agreement, conform to the regulations and policies set forth by the DHHS, Office for Human Research Protection (OHRP), the FDA, and other federal entities regarding the health, welfare, safety, rights, and privileges of human subjects; and

• 2) assist the investigator in complying with federal and state regulations.

• No research that involves human subjects may be undertaken at East Tennessee State University or the James H. Quillen Veterans Affairs Medical Center, or other non-affiliated site(s) using either IRB, without the prior approval of the IRB.

Frequent Questions

What activities are subject to the purview of the IRB?

• Activities that meet the definition of “research” and “human subjects” as defined in DHHS regulations, or meet the definition of “research” and involve “human subjects” as defined in FDA regulations are subject to the ETSU or ETSU/VA IRB’s jurisdiction.

Who decides whether an activity is human subjects

research?

• Activities that constitute human subject research are determined by the ETSU and ETSU/VA IRB. The IRBs delegate this decision to the IRB Chair or Vice Chair.

• The IRB has the sole authority to make a final determination of whether a proposed activity is human research according to DHHS or FDA regulatory definitions.

• Unless you are familiar enough with these regulations to be certain that the activity does not represent human research, the activity should be brought forward to the IRB for a determination.

• Submission of a completed Form 129 (available on IRB website. (www.etsu.edu/irb) is required in order to make the determination of whether a proposed activity is human research. Written responses to the Form 129 will be made by the Chair or Vice Chair within one week of inquiry.

What authorities does the IRB have?

IRB Authority

• The IRB has the authority to:

• Approve, modify (to secure approval), or disapprove all human subjects research subject to its purview

IRB Authority

• The IRB has the authority to:

• Suspend or terminate research not conducted in accordance with all applicable regulations and policies, or that has been associated with unexpected serious harm to research subjects

IRB Authority

• The IRB has the authority to:

• Observe, or have a third party observe, the consent process

IRB Authority

• The IRB has the authority to:

• Observe, or have a third party observe, the conduct of the research

IRB Authority

• The ETSU/VA IRB has the authority to:

Serve as the Privacy Board for ETSU

• Research that has been approved by the IRB may be subject to further review and approval or disapproval by officials of the University (and when applicable, the VA).

• However, no office of any of the participating institutions may approve a research activity that has been disapproved by the IRB.

What IRB training is required for study staff?

CITI www.citiprogram.org

Four learner groups have been established through the CITIprogram to provide education applicable to the specific knowledge and skills required for different types of research.

--VA Biomedical --VA Social-Behavioral --non-VA Biomedical --non-VA Social-Behavioral

Instructions and link to CITI available on web-site, www.etsu.edu/irb

How do I submit an application for IRB review?

All submission forms, guidelines, and deadlines are on-line at

www.etsu.edu/irb

Call the IRB at 439-6053 with any questions.

What resources are available?

www.etsu.edu/irb

1. IRB Policies and Procedures with clickable index 2. Investigator Handbook with clickable index3. Monthly IRB Review newsletter4. Graduate Brochure (for graduate students and

advisors)5. After Approval Brochure6. On-line reference library

And the best resource--

Call the IRB at 439-6053.

We’ll be glad to assist you.