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Your Environment. Your Health.

Institutional Review Board

The mandate of the NIEHS Institutional Review Board (IRB) is to provide ethical and regulatory oversight of research that involves human subjects by:

  • Protecting the rights, welfare and well-being of human research participants, recruited to participate in research conducted or supported by NIEHS.
  • Ensuring compliance with relevant local, state and federal laws and regulations.
  • Ensuring compliance with NIEHS and NIH policies and regulations.
  • Employing the highest ethical standards for human research protections in all human subjects research by adhering to the ethical principles outlined in the Belmont report:
    • Respect for persons
      • Individuals should be treated as autonomous agents
      • Persons with diminished autonomy are entitled to protection
    • Beneficence
      • Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being
      • (1) Do no harm (2) maximize possible benefits and minimize possible harms
    • Justice
      • Fairness in distribution (select participants equitably)
      • Who ought to receive the benefits of research and bear its burdens?
  • Giving guidance to ensure sound research design, scientific integrity, and determining if the research contributes to generalizable knowledge and is worth exposing subjects to risk.

Human subject research conducted at NIH must meet high ethical and scientific standards. It must be designed, reviewed, approved, and implemented in accord with accepted ethical principles and the U.S. Department of Health and Human Services (45 CFR 46) and U.S. Food and Drug Administration (21 CFR 50 and 56) regulations for the protection of human subjects. NIEHS IRB is part of the Human Subject Protection Program of NIH.

Institutional Review Board Contacts

David B. Resnik, J.D., Ph.D.
Bioethicist and NIEHS IRB Chair
P.O. Box 12233
Mail Drop E1-06
Durham, N.C. 27709

Tel 984-287-4208
resnikd@niehs.nih.gov
Joan P. Packenham, Ph.D.
Director, NIEHS Office of Human Research Compliance (OHRC)
NIEHS IRB Vice-Chair
DIR CRP OCR CD
P.O. Box 12233
Mail Drop CU-02
Durham, N.C. 27709

Tel 984-287-4413
Fax 919-541-9854
packenhm@niehs.nih.gov
Craig Wladyka, M.P.A.
IRB Protocol Coordinator
P.O. Box 12233
Mail Drop CU-02
Durham, N.C. 27709

Tel 984-287-4425
cwladyka@niehs.nih.gov
Jane M. Lambert
Institutional Review Board Administrator
P.O. Box 12233
Mail Drop CU-02
Durham, N.C. 27709

Tel 984-287-4419
Fax 919-541-9854
lambert@niehs.nih.gov

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