News:  December 2009:  New IRB Policy Revisions (Policy 13 Informed Consent  and Policy 15 Vulnerable Populations) Click here to see summary of revisions.

New to the IRB process? Click   to get started!

Investigators using MSHA facilities or patients, click here  for new guidelines.

Click here for IRB contact information.

HUMAN SUBJECTS TRAINING

Click here for instructions for CITI training.

Click here to access CITI

IRB SCHEDULES

ETSU Campus IRB Meeting Schedule and Submission Deadline NEW SUBMISSION GUIDELINES FOR FULL CAMPUS STUDIES- 36 copies are no longer required!  Submit the original packet, 2 paper copies of the entire packet, and 1 electronic copy of the entire packet on a CD.    

ETSU/VA Medical Campus IRB Meeting Schedule and Submission Deadline NEW SUBMISSION GUIDELINES FOR FULL MEDICAL STUDIES- 36 copies are no longer required!  Submit the original packet, 2 paper copies of the entire packet, and 1 electronic copy of the entire packet on a CD.  For clinical trials,  also include 3 paper copies of the sponsor protocol and investigator brochure but these items do not have to be included on the CD.  

IRB NEWSLETTERS

IRB Review January 2010 Policy Revisions
IRB Review December 2009 Policy Revisions
IRB Review September 2009 New ICD Template with HIPAA language
IRB Review June 2009 Policy Revisions
IRB Review Vol 4 Number 6 (October/November 2008) Policy Revisions
IRB Review Vol 4 Number 5 (June/July 2008) AAHRPP
IRB Review Vol 4 Number 4 (April/May 2008) IRB Policy Revisions
IRB Review Vol 4 Number 3 (March 2008) IRB Policy Revisions
IRB Review Vol 4 Number 2 (February 2008) Non-compliance
IRB Review Vol 4  Number 1 (January 2008) Payment, Recruitment
IRB Review Vol 3 Number 4 (December 2007) Research Involving Children
IRB Review Vol 3 Number 3 (September 2007) IRB Policy Revisions
IRB Review Vol 3 Number 2 (July 2007) VA Research Data Security and Privacy
IRB Review Vol 3 Number 1   (April 2007) Revised 2/08 How to complete a narrative
IRB Review Vol 2 Number 8  (August 2006) Definition of human subjects research and submission checklist
IRB Review Vol 2 Number 7  (July 2006) The review process
IRB Review Vol 2 Number 6 (June 2006) After approval overview
IRB Review Vol 2 Number 5 (May 2006) Drugs and Devices
IRB Review Vol 2 Number 4 (April 2006 ) Conflict of Interest
IRB Review Vol 2 Number 3 (March 2006) VA submissions
IRB Review Vol 2 Number 2 (February 2006) Vulnerable Populations- Pregnant Women, Neonates
IRB Review Vol 2 Number 1 (January 2006) Informed Consent
IRB Review Vol 1 Number 2 (December 2005) Approval Criteria
IRB Review Vol 1 Number 1 (November 2005) AAHRPP

 

Need more information?

Data and Safety Monitoring Plans

Click here for presentation explaining data safety monitoring plans.

Click here for sample plan.

Informed Consent Documents

Click here for checklist to determine whether your informed consent has all the required elements.

Narrative Completion

Click here for presentation explaining the narrative questions and their relation to approval criteria.

Privacy and Confidentiality

Click here for presentation explaining the difference between privacy and confidentiality.

Unanticipated Problems Involving Risks to Subjects or Others (UPIRTSO) Reporting

 Click here for UPIRTSO brochure.

Waivers

Click here for presentation of waivers.

Click here for sample letter for an anonymous survey study applying for a waiver for requirement of written documentation of informed consent. 

 

 

 

 

 

 

 




Last updated on  January 21, 2010

Home Page   /   E-mail webmaster
© ETSU 2005