Human Research Protection Program
The Institutional Review Board (IRB) is the research oversite committee charged with ensuring that human subjects research is conducted in compliance with the application federal, state, and institutional policies and procedures. “The IRB shall be sufficiently qualified through the experience and expertise of its members (professional competence), and the diversity of its members, including race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.” 45 CFR 46.107
Following appointment to membership on the IRB and prior to serving as expedited reviewers or acting as a voting member at a convened committee meeting, IRB members and alternate members receive the following training:
- Web based training modules for IRB Members available through the U.S. Department of Health and Human Services Human Research Protection Foundational Training | HHS.gov or Collaborative Institutional Training Initiative (CITI). This certification must be renewed every three (3) years.
- The IRB staff will offer an orientation session for each new member to include instruction on use of the electronic IRB submission system and to educate first-time reviewers on expedited applicability criteria and categories, criteria for IRB approval, and general responsibilities as an expedited reviewer and voting committee member.
EAMC IRB staff offer the following continuing education opportunities to current members of the IRB.
EAMC IRB staff disseminate materials containing ethical and regulatory guidance for the review of protocols involving a specialized area, (i.e., gene therapy or tissue banking) or selected vulnerable subject populations (i.e., prisoners) to each IRB member.
The EAMC IRB staff maintains e-mail distribution lists which are used on an ongoing basis to send IRB members a variety of materials such as copies of pertinent articles, regulatory updates, web references to resource materials or government reports, or communication about a specific protocol review. IRB members who do not have e-mail receive paper copies of this material.
Upon request or as appropriate, EAMC IRB staff presents training on selected topics at IRB meetings or IRB in-service programs. EAMC IRB staff may invite specialists in a specific area to address the IRB as needed. EAMC IRB staff subscribes to and makes available, applicable webinar presentations.
Links for resources to supplement IRB member training:
Belmont Report
Nuremberg Code
Code of Federal Regulations
FDA
OHRP Educational Videos
Investigational New Drugs