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 Institutional Review Board SB#1 (WFU Reynolda Campus)
 
WFUHS Board #1
 
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WFUHS Board #5
 
WFUHS Board #6
 
WFUHS Board #7
 
WFUHS Board #8
 

Institutional Policies and Procedures (HRPP)

 2018 Common Rule Standard Operating Procedures
Created Date:  1/19/2019 11:52 PM
Type:  (.pdf file)
 
Common Rule - Does it apply to my study? ( 2019)
Created Date:  2/6/2019 3:33 PM
Type:  (.pdf file)
 
Compliance in the Conduct of Human Research SOP 9-13-18.pdf
Created Date:  10/5/2018 1:54 PM
Type:  (.pdf file)
 
Conflict of Interest (1).pdf
Created Date:  10/5/2018 1:20 PM
Type:  (.pdf file)
 
Data Ownership Policy.pdf
Created Date:  10/5/2018 1:22 PM
Type:  (.pdf file)
 
External Audits of Human Subjects Research.pdf
Created Date:  10/5/2018 1:21 PM
Type:  (.pdf file)
 
Institutional Conflicts of Interest in Research and Clinical Care.pdf
Created Date:  10/5/2018 1:21 PM
Type:  (.pdf file)
 
Institutional Oversight of Human Research.pdf
Created Date:  10/5/2018 1:25 PM
Type:  (.pdf file)
 
Intake Review and Approval of Industry-Sponsored Human Subjects Research.pdf
Created Date:  10/5/2018 1:20 PM
Type:  (.pdf file)
 
Internal Post-approval Monitoring of Human Subjects Research.pdf
Created Date:  10/5/2018 1:23 PM
Type:  (.pdf file)
 
Investigational FDA Conditionally Approved Medical Devices Policy.pdf
Created Date:  10/5/2018 1:22 PM
Type:  (.pdf file)
 
IRB-HRPP POLICIES AND PROCEDURES revised date for WF.12MAR20.pdf
Created Date:  10/30/2019 12:39 PM
Type:  (.pdf file)
 
Policy on Quality Conduct of Clinical Research.pdf
Created Date:  10/5/2018 1:25 PM
Type:  (.pdf file)
 
Policy on Research Integrity 2017.pdf
Created Date:  10/5/2018 1:24 PM
Type:  (.pdf file)
 
Retention and Destruction of Human Subjects Research Data and Records.pdf
Created Date:  10/5/2018 1:24 PM
Type:  (.pdf file)
 
Sponsor Monitoring of Human Subjects Research.pdf
Created Date:  10/5/2018 1:23 PM
Type:  (.pdf file)
 
Standard Operating Procedure on Registration of Clinical Trials in clinicaltrials.gov.pdf
Created Date:  10/5/2018 1:22 PM
Type:  (.pdf file)
 
Statement of IRB Compliance(WFUHS.pdf
Created Date:  10/5/2018 1:26 PM
Type:  (.pdf file)
 
WFUHS Guidance Document- External IRB and WF Facilitated Review
Created Date:  3/19/2019 12:34 PM
Type:  (.docx file)
 

FWA Assurance Links for:
Wake Forest University Health Sciences 
Wake Forest University (Reynolda Campus) 
      

Human Subject Protection Certification
Certification Listing in eIRB 
CITI Program in the Protection of Human Research Subjects 
ICH-GCP Training 
      

Resources

The following websites are resources for individuals who work with human subjects. These sites will provide you with an understanding of the Federal Regulations for Human Subjects Research as well as an ethical background for practicing research.
45 CFR 46 (The Common Rule) 
Belmont Report 
FDA Information Sheets 
Human Subjects Research Decision Charts 
Office for Human Research Protection (OHRP) 
      

Information Security

Information Security Resources

Information Security Documents

 WFUHS eIRB Security and Data Management Statement.pdf
 

Information Security Links
WFUBMC Information Security (internal access)