IRB Policies

Click here for the full policy in pdf format.

Purpose
The Institutional Review Board (IRB) must approve the use of all investigational drugs and devices for experimental use at WakeMed.  The IRB shall determine whether research proposals are compatible with institutional commitments and confirm all applicable laws, regulations and standards of professional conduct, practice and community attitude.  The IRB shall:
 
a) review and have the authority to approve, require modification in, or disapprove all research proposals for reasons including but not limited to subject risk, adequacy of the design, such as hypothesis, methodology, consent form, ethical considerations, budget, and principal investigator.

b) evaluate on a continual basis, in collaboration with hospital administration, the safety and effectiveness of ongoing IRB approved research, at intervals appropriate to the degree of risk involved but not less than once per year.  As appropriate, Class III device studies may be reviewed semi-annually; see Procedure 105, Significant Risk and Non-Significant Risk Devices. If an IRB study is reviewed sooner then the annual renewal date, the earlier date will become the new annual renewal date. 

c) suspend and, if appropriate, terminate approval of clinical research not being conducted in accordance with the determinations of the IRB, or when there is unexpected serious harm to subjects. 

d) refer to the Credentials Committee regarding privileges for the practitioner involved, as appropriate.

e) establish policies, standards and guidelines for clinical research conducted within WakeMed.

Training and Education
Administrative Fees
Significant and Non-Significant Risk Device Studies Review Process (word document or pdf)
Conflict of Interest (word document or pdf)
IRB Submissions (pdf document)
Safety Reporting (pdf document)