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Clinical Research Support

Office for Human Research Studies (OHRS)

External Regulatory Guidance

1) Resource Links

  • CTC Guidance  
  • Office of Research Integrity
  • New FAQs on the Review Process for Human Gene Transfer Trials Posted on OBA Web Site - OBA has developed a set of Frequently Asked Questions (FAQs) about the process by which OBA and its Recombinant DNA Advisory Committee review human gene transfer protocols. These FAQs were developed in response to the many queries that OBA receives and may be of interest to OBA_NEWS subscribers. In particular, they may be a useful educational tool for gene transfer investigators, institutional administrators, and others who wish to learn more about the process and its requirements. 

2) Federal Agencies Guidelines and Regulations

3) Forms for Federal Agencies

4) Ethical Principles of Human Subjects Protection

  •  The Belmont Report 
  • IRB Guidebook  
    Provides help for IRB members and researchers in understanding the regulations and standards that govern research with human subjects and outlines issues to consider in designing and reviewing research proposals.
  • The Nuremberg Code
    A 10 point code of human experimentation ethics developed during the military war crimes trial.
  • Declaration of Helsinki  
    The World Medical Association's ethical principles for medical research involving human subjects.
  • ICH Consolidated Guidance
    Web site for International Conference on Harmonization (ICH) guidance for ethical and quality standards for research involving humans (also see FDA link for E6 Good Clinical Practice below)

5) Certificates of Confidentiality