Institutional Review Board | ��Ӱֱ��

Federal Wide Assurance

The ��Ӱֱ�� Institutional Review Board (IRB) operates under a Federal Wide Assurance with the Department of Health and Human Services to protect human research participants.

The identification number of the ��Ӱֱ�� IRB FWA is FWA 00002516.

Please refer to the FWA for current expiration date.

Institutional Authority

The ��Ӱֱ�� IRB operates under the authority of the ��Ӱֱ�� Board of Directors, and is the primary IRB of record for ��Ӱֱ�� research. ��Ӱֱ�� research encompasses all laboratory based, translational and clinical research conducted at ��Ӱֱ�� utilizing ��Ӱֱ�� facilities/equipment, patients or staff, unless ��Ӱֱ�� is determined not to be engaged in the research, per Research policy Institutional Engagement in Research. Any investigation involving human participants at ��Ӱֱ��, utilizing ��Ӱֱ�� facilities, patients or staff (including retrospective studies of specimens or medical records) requires prior review and approval by the IRB. This includes but is not limited to:

Clinical research conducted at ��Ӱֱ�� facilities.
Outcomes studies where data collection is taking place in the private practice, but surgical procedure being assessed took place at ��Ӱֱ��.
Studies based on a medical, clinical or other record or report which is initiated at ��Ӱֱ��.
Registry studies where data is being collected in the private practice, but the intervention took place at ��Ӱֱ��.
The investigator or key personnel are ��Ӱֱ�� employees, residents or fellows.

Systematic investigations, including research development, testing and evaluation involving human participants or identifiable information for the purpose of increasing generalized knowledge, will be considered research and require review by the IRB.

The IRB has the authority to approve, require modifications in, or disapprove all research activities involving human subjects.

The purpose of the IRB review is to assure, both in the Initial and Continuing Review, that appropriate steps are taken to protect the rights and welfare of human research participants.

The ��Ӱֱ�� IRB serves as ��Ӱֱ��’s local IRB. When research meets certain criteria, ��Ӱֱ�� researchers may select either ��Ӱֱ��’s IRB or a ��Ӱֱ��-approved, AAHRPP (Association for the Accreditation of Human Research Protection Programs) accredited external IRB. Currently approved external IRBs are Chesapeake IRB (CIRB), Western IRB (WIRB), Quorum, SMART IRB, and the National Cancer Institute Central Institutional Review.

Meetings of the Committee

The IRB meets twice a month, on the 1st Thursday and 3rd Friday, to review and make determinations regarding new project submissions, Annual or Continuing Review of projects, Protocol Amendments, Unanticipated Problems and Protocol Deviation Reports.