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Patient Protections

Office of Human Research Compliance

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.
Components of the NIEHS Office of Human Research Compliance are Regulatory Compliance, Guidance During Protocol Development, Pre-IRB Management, IRB Management, Education & Training, Quality Assurance & Improvement Program, Website & Management System, AAHHRPP Accreditation Program, all comprising the Culture of Protecting Human Subjects

Certificates of Confidentiality

NIEHS is committed protecting the confidentiality of all clinical study participants. For more information on how to acquire a certificate, see the Certificates of Confidentiality page.

OHRC Staff

Joan P. Packenham
Joan P. Packenham, Ph.D.
Director, NIEHS Office of Human Research Compliance (OHRC)

Tel 919-541-0766
Fax 919-541-9854
packenhm@niehs.nih.gov
Jane Lambert
Jane M. Lambert
IRB Administrator

Tel 919-541-5047
Fax 919-541-9854
lambert@niehs.nih.gov
Edith Lee
Edith M. Lee, M.P.A.
OHRC Program Specialist

Tel 919-541-3852
Fax 919-541-9854
leeem@niehs.nih.gov
Lynae Thomas
Lynae T. Baker
Technical Intramural Research Training Award Fellow

Tel 919-541-9844
lynae.thomas@nih.gov
Craig Wladyka
Craig Wladyka, M.P.A.
IRB Protocol Coordinator

Tel 919-541-3822
Fax 919-541-3845
cwladyka@niehs.nih.gov
Not Pictured
Christine Philiput, Ph.D.
AAHRPP Accreditation & Quality Assurance Specialist


Submitting a Complaint to Office for Human Research Protections (OHRP), U.S. Department of Health and Human Services (HHS)

Complainants may submit allegations of noncompliance by e-mail, mail, or fax to OHRP's Director of the Division of Compliance Oversight, 1101 Wootton Parkway, Suite 200, Rockville, MD, 20852 (email ohrp@hhs.gov; fax (240) 453-6909). OHRP accepts complaints submitted anonymously, and asks complainants who identify themselves to OHRP whether OHRP may reveal their identity to the institution where the alleged noncompliance may have occurred.

If you have any questions, you may contact OHRP at (240) 453-6900 or visit the HHS OHRP web page for more information.