Resources and References

The following resources and references provide valuable information on research regulations and ethics:

  • Qatar Supreme Council of Health Guidelines, Regulations and Policies for Research Involving Human Subjects
    The Qatar Supreme Council of Health guidelines, regulations and policies apply to all human subjects research conducted, supported or otherwise subject to regulation by any department of research or research organization in Qatar. This includes research conducted or supported in collaboration with a non-Qatari institution.
  • The Belmont Report Popup
    The Belmont Report summarizes the basic ethical principles identified by The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
    • The Belmont Report The Belmont Report - Arabic Version - Arabic Version
      Translation funded by Weill Cornell Medical College in Qatar
      Arabic Language Translator: Professor Hussam Alkhateeb, Qatar National Council for Culture, Arts & Heritage
  • United States Department of Health and Human Services (DHHS) Popup
    The principal US government agency for protecting the health of all Americans and providing essential human services. Department activities include oversight of health and social science research.
  • United States Food and Drug Administration (FDA) Popup
    Responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the US national food supply, cosmetics, and products that emit radiation.
    • US FDA Institutional Review Board (IRB) Information Sheets Popup
      These provide recommendations for IRBs, clinical investigators, and sponsors to help them fulfill their responsibilities to protect human subjects participating in FDA-regulated research.
    • US FDA Regulations - Code of Federal Regulations Title 21 Popup
      Title 21 of the CFR database details FDA regulations concerning food, drugs, devices and biologics. This includes regulations governing experimental drugs and devices, and their pre-market approval. The CFR Title 21 database is fully searchable.

    • US FDA regulations of special interest:
      • 21 CFR 50 - Regarding protection of human subjects
      • 21 CFR 56 �Regarding institutional review boards
      • 21 CFR 312 - Regarding investigational new drug applications
      • 21 CFR 812 - Regarding investigational device exemptions
      • 21 CFR 312.120 - Regarding foreign clinical studies not conducted under an IND

Last modified on Thursday, 01-Aug-2013 10:21:08 AST