Office of Human Research Compliance

Clinical Research

CULTURE OF PROTECTING HUMAN SUBJECTS: Regulatory Compliance, Guidance During Protocol Development, Pre-IRB Management, IRB Management, Education & Training, Quality Assurance & Improvement Program, Website & Management System, AAHRPP Accreditation Program

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

The goals of this office are 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.

The OHRC provides professional advice and leadership to NIEHS in the protection of human subjects participating in research. This is accomplished by training and educating investigators to establish an atmosphere within their research programs which creates a culture of respect for and awareness of the rights and welfare of human research participants at NIEHS and its affiliated sites. In addition, OHRC promotes awareness to Investigators that research participants are partners in their research program and therefore should be fully informed of all procedures and the risks and benefits associated with participating in the research study.

Reference Guides

• NIEHS Non-Epidemiology Branch Reference Guide (http://www.niehs.nih.gov/research/clinical/join/ohrc/docs/non-eb-preirb-reference-guide.pdf)   (909 KB)
• NIEHS IRB Reference Guide (http://www.niehs.nih.gov/research/clinical/join/ohrc/docs/irb-reference-guide.pdf)   (668 KB)

OHRC Saff

To contact this office please send all inquiries to: E-mail address: NIEHS-OfficeofHRC@niehs.nih.gov; Telephone Number (919) 541-3852

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