Important IRB Links

Office of Human Research Protections (OHRP)
Formerly the Office for Protection from Research Risks (OPRR). OHRP has primary responsibility for developing, monitoring and overseeing compliance with Health and Human Service (HHS) regulations for the protection of human subjects in research conducted or supported by any component of the Department of Health and Human Services, including the NIH; see also:

 

• Federal Wide Assurances
• DHHS Regulations
• Guidance Documents
  

FDA - the main menu of the Food and Drug Administration; see also: 

 

• Center for Drug Evaluation and Research (CDER) --
  • CDER Home
  • Regulatory Guidance 
  • IND - Guidance on the preparation of an investigator-held Investigational New Drug (IND) Application. 
  
  
• Center for Devices and Radiological Health (CDRH) --
  • CDRH Home
  • Device Advice
  • IDE - Guidance on how to obtain an investigational device exemption (IDE).
  
  
• Center for Biologics Evaluation and Research (CBER) --
  • CBER Home
  • Guidance and Guidelines
  
  
• Clinical Trials & GCP --
  • Clinical Trials Home
  • Guidance and Information Sheets
  
  
• FDA Regulations
  

• Guidance for Institutional Review Boards and Clinical Investigators - Compilation of current FDA Guidance documents for IRBs, including investigator responsibilities. Includes information on both drug and device studies. 

President's Council on Bioethics - Advises the President on bioethical issues that may emerge as a consequence of advances in biomedical science and technology. In connection with its advisory role, the mission of the Council includes the following functions: to undertake fundamental inquiry into the human and moral significance of developments in biomedical and behavioral science and technology; to explore specific ethical and policy questions related to these developments; to provide a forum for a national discussion of bioethical issues; to facilitate a greater understanding of bioethical issues; and to explore possibilities for useful international collaboration on bioethical issues. 

Ethical, Legal, and Social Implications (ELSI) of Human Genetics Research. Part of the Human Genome Project (HGP), the ELSI Program seeks to identify, analyze and addres the ethical, legal and social implications of human genetics research at the same time that the basic scientific issues are being studied.

 

Public Responsibility in Medicine and Research/The Applied Research Ethics National Association ( PRIM&R/ARENA) - Advancing strong research programs and the consistent application of ethical precepts in both medicine and research.

 

Clinical Trials:

• CenterWatch - a private organization posting information on ongoing private sector clinical trials. 
• ClinicalTrials.gov - the NIH's directory of (mostly) publically-funded clinical trial

The IRB Discussion Forum - (previously known as "MCWIRB") promotes the discussion of ethical, regulatory and policy concerns with human subjects research.

 

AAHRPP - The Association for the Accreditation of Human Research Protection Programs, Inc., (AAHRPP) works to protect the rights and welfare of research participants and promote scientifically meritorious and ethically sound research by fostering and advancing the ethical and professional conduct of persons and organizations that engage in research with human participants. AAHRPP achieves its mission by using an accreditation process based on self-assessment, peer review, and education.

 

Research at Pennsylvania Hospital. Information about special requirements regarding nursing review at PAH can be found at their web page.