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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 the 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 the 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. The NIEHS IRB is part of the Human Subject Protection Program of the NIH.


Institutional Review Board Contacts

David B. Resnik, JD, Ph.D. (http://www.niehs.nih.govhttp://www.niehs.nih.gov/research/resources/bioethics/bioethicist.cfm)
Bioethicist and NIEHS IRB Chair
P.O. Box 12233, Mail Drop CU 03
Research Triangle Park, North Carolina 27709
Tel (919) 541-5658
Fax (919) 541-9854
resnikd@niehs.nih.gov
Joan P. Packenham, Ph.D. (http://www.niehs.nih.gov/research/clinical/join/ohrc/index.cfm)
NIEHS IRB Vice-Chair
Director, OHRC
DIR CRP OCR CD
Director, Office of Human Research Compliance
Clinical Research Unit, Room 110
Tel (919) 541-0766
Fax (919) 541-9854
packenhm@niehs.nih.gov
Craig Wladyka, MPA, RHIA, CIP (http://www.niehs.nih.govhttp://www.niehs.nih.gov/research/clinical/join/ohrc/index.cfm)
IRB Protocol Coordinator
DIR CRP OCR CD
IRB Protocol Coordinator, Office of Human Research Compliance
Clinical Research Unit, Room 120
Tel (919) 541-3822
Fax (919) 541-9854
cwladyka@niehs.nih.gov
Jane M. Lambert, CIP (http://www.niehs.nih.govhttp://www.niehs.nih.gov/research/clinical/join/ohrc/index.cfm)
IRB Administrator
DIR CRP OCR CD
NIEHS IRB Administrator, Office of Human Research Compliance
Clinical Research Unit, Room 115
Tel (919) 541-5047
Fax (919) 541-9854
lambert@niehs.nih.gov
Edith M. Lee, MPA (http://www.niehs.nih.govhttp://www.niehs.nih.gov/research/clinical/join/ohrc/index.cfm)
OHRC Protocol Specialist
DIR CRP OCR CD
NIEHS Protocol Specialist, Office of Human Research Compliance
Clinical Research Unit, Room 122
Tel (919) 541-3852
Fax (919) 541-9854
leeem@niehs.nih.gov

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