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Office of Human Research Compliance

Clinical Research

Related Links

South Atlantic National Research Conference Presentations (http://www.niehs.nih.gov/news/events/pastmtg/2012/sanc-presentations/index.cfm)
Conference explores best practices of community-engaged research (http://www.niehs.nih.gov/news/newsletter/2012/4/spotlight-SANCmeeting/index.htm)
Institutional Review Board (http://www.niehs.nih.gov/about/boards/irb/index.cfm)
IRB Members (http://www.niehs.nih.gov/about/boards/irb/members/index.cfm)
Managing Clinical Protocols That Safeguard Human Subjects (http://www.niehs.nih.gov/news/newsletter/2010/july/index.cfm)
NIEHS Bioethics
NIH Clinical Research Trials and You

The overall mission of the Office of Human Research Compliance (OHRC) is to manage a comprehensive Human Research Protection Program at the National Institute of Environmental Health Sciences (NIEHS).

The OHRC accomplishes its mission by providing professional advice and leadership to NIEHS in the protection of human subjects participating in research through:

Maintaining compliance by providing clarification and guidance in interpreting the Federal Regulations for the protection of human subjects, 45CFR46 and 21CFR50 & 56; NIH and NIEHS policies and guidance; and state regulations and guidance.
Providing guidance to PIs during protocol development.
Managing the administration of the Pre-IRB Process.
Managing the daily administration of the NIEHS Institutional Review Board (IRB).
Establishing educational and training programs with the goal of creating a culture of respect for and awareness of the rights and welfare of human research participants at NIEHS and its affiliated sites.
Maintaining a Quality Assurance and Improvement Program to audit, monitor and continually improve the quality of its human research protections.
Implementing and maintaining electronic resources and management systems for the NIEHS OHRC.
Giving guidance and serving as the NIEHS central point of contact during the AAHRPP accreditation process. After accreditation has been achieved, the OHRC will develop guidelines and internal processes to maintain accreditation.

For information contact the Office of Human Research Compliance at:
Telephone: (919) 541-3852
FAX: (919) 541-3845
E-mail: NIEHS-OfficeofHRC@niehs.nih.gov

Components

OHRC Staff

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: Tel (919) 541-0766
Fax (919) 541-9854
packenhm@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: Tel (919) 541-5047
Fax (919) 541-9854
lambert@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: Tel (919) 541-3822
Fax (919) 541-9854
cwladyka@niehs.nih.gov

Edith M. Lee, MPA (http://www.niehs.nih.govhttp://www.niehs.nih.gov/research/clinical/join/ohrc/index.cfm) IRB Protocol Specialist DIR CRP OCR CD: Tel (919) 541-3852
Fax (919) 541-9854
leeem@niehs.nih.gov

Lynnelle Fowler-McDonald Technical IRTA: Tel (919) 541-9844
lynnelle.fowlermcdonald@niehs.nih.gov

Terry Lewis, MPA Program Specialist: Tel (919) 541-7817
lewis8@niehs.nih.gov

Christine Philiput, Ph.D. AAHRPP Accreditation & Quality Assurance Specialist