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Faculty: Regulatory Issues

Resources to help you become oriented to and familiar with Duke Medicine.

Research - Regulatory Issues

Regulatory Issues

IRB ethics training is mandatory for anyone conducting human research, including investigators and all study staff. Find up-to-date requirements and instructions at: http://medschool.duke.edu/research/hsp-certification

 Note:  VA education requirements will be accepted for Duke faculty in lieu of other modules

All investigators and study personnel will receive reminders when their IRB credentialing update is due, at 30 and 7-days prior to termination date.

The IRB will check the status of each key personnel member and if delinquent or within the 30-day window, it will send an email to the individual and the PI.

Duke Medicine/DUHS IRB

The link above provides basic information and policies governing clinical/human research within the School of Medicine and Health System. 

 All Duke/DUHS IRB submissions are done online through the e-IRB (https://eirb.mc.duke.edu) Website.  The eIRB Website has manuals, forms, and other useful information for submitting a protocol for review.

Once you complete the Duke Human Subjects Protection training an eIRB account will be created for you in one to two days.

Does your project require IRB review?  You can use the Checklist for Exemption of Relief from Further IRB Oversight to assess whether your project involving human subjects is subject to IRB review.

 Duke Office of Clinical Research  (DOCR) http://docr.som.duke.edu/

 Certain types of clinical research (i.e. clinical trials) are subject to the rules and regulations of Clinical Research Units (CRU) groups, The School of Medicine Clinical Research Units (CRUs) are the organizational and functional structures that provide support for clinical research in which a Duke Medicine department, center/institute, CSU or school serves as the investigative sites for the research.  If you are conducting such research, please visit the DOCR website for more information.

 Animal Research

 Before animals are ordered or used, you will need an animal use application, and you will need to complete online compliance training.

The Animal Care and Use Website has information on protocol development as well as other useful resources.

 The Duke animal program applications, forms, reports, or questions  can be emailed to the Duke Institutional Animal Care and Use Committee (IACUC) at Email address:  IACUC@DUKE.EDU

 Questions?  Contact information is available here:  http://vetmed.duhs.duke.edu/ProgramContacts.html

Compliance

 Duke expects all researchers to comply with federal and state regulations governing the conduct of research and the receipt of federal grant funds.  The Office of Research Administration and the Duke Office of Clinical Research are also available to answer questions and assist you with other grant compliance issues.

Clinical Trials Registration  -- the Duke Office of Clinical Research provides instructions and assistance for meeting this requirement

NIH Public Access Policy -- Library staff have created instructions for becoming and staying in compliance with this policy and can assist you with questions or problems -- 919.660.1100 or medical-librarian@duke.edu.