AUA Policy on Research Ethics and IRB (http://policies.aua.am/policy/107)

The Institutional Review Board (IRB) of the American University of Armenia (AUA) is registered with the National Institute of Health, the United States Department of Health and Human Services: http://www.hhs.gov/ohrp/assurances/irb/index.html. The IRB functions under the guidance of the Office for Human Research Protection (OHRP), which provides regulatory oversight and clarifications on ethical issues in biomedical and social-behavioral research.

AUA maintains two Institutional Review Boards: IRB #1 chaired by Sarah H. Kagan, PhD, RN reviews and approves non-clinical studies and IRB #2 chaired by Hripsime Martirosyan, MD, MPH reviews and approves clinical studies. Dr. Sarah H. Kagan is the Senior Officer of AUA IRBs.

All investigators applying for review and approval must show proof of current patient oriented research (POR) training that conforms to the standards for ethical practice and research conduct. The AUA IRB on-line POR course is available without charge at: http://chsrd.aua.am/irb/eng/ .

Only AUA faculty, staff and students are eligible to submit applications for review. Application forms are available at:

            IRB#1: Non Clinical Application

            IRB#2: Clinical Application Form

AUA IRB does not accept applications from investigators not affiliated with AUA, pharmaceutical companies or investigators conducting pharmaceutical, medical device or other clinical trials.

To learn about the AUA IRB application process or to submit an application please write to the Human Protections Administrator at: AUAIRB@aua.am.

AUA IRB membership appointments are based on the requirements of the Code of Federal Regulations (CFR) 46.107 (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.107).

Senior Officer of AUA IRB, in consultation with the AUA School of Public Health Dean and the AUA Human Protections Administrator, is responsible for making recommendations for AUA IRB membership. All IRB members can also recommend new candidates for the IRB membership to the Senior Officer. AUA President, the AUA IRB Signatory Official, makes the final appointment of IRB members based on the recommendations from the Senior Officer of AUA IRB. Information on current IRB members is available at: IRB Membership.

The IRB chair can supplement the IRB review by inviting experts for the research projects that require specific expertise or are out of the usual scope of research submitted for the review. However, invited exerts will not have a right to vote. The IRB Chair or a member of IRB designated by the Chair can review applications that qualify for expedited review and issue an approval letter.

IRB members and invited experts should declare conflict of interest with the proposed research under IRB review and recuse from the review process. Conflict of interest is defined as being the principal investigator, co-investigator or immediate family member of those and participating in the research design and conduct.

Additional resources:

  1. AUA Training Course On Research Ethics: “Human Participant Protections”

http://chsrd.aua.am/irb/

  1. The OHRP Human Subjects Assurance Training Module (relevant for the IRB personnel)

http://ohrp-ed.od.nih.gov/CBTs/Assurance/login.asp

  1. The OHRP IRB Guidebook

http://www.hhs.gov/ohrp/archive/irb/irb_guidebook.htm

  1. The OHRP educational resources

http://www.hhs.gov/ohrp/education/index.html

  1. Belmont report

http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html

  1. The HHS Regulations at 45 CFR part 46

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

  1. The NIH Office of Extramural Research, Protecting Human Research Participants training

https://phrp.nihtraining.com/users/login.php