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
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 - 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)
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.
- US DHHS Office of Human Research Protections (OHRP)
Protects the rights, welfare, and well-being of subjects involved in research conducted or supported by the DHHS and helps ensure that such research is carried out in accordance with the regulations described at The Code of Federal Regulations (CFR) Title 45 Part 46 (below).
- US DHHS Regulations Regarding Protection of Human Subjects
CFR Title 45 Part 46 deals with the protection of human subjects in research.
- US DHHS Regulations Regarding Objectivity in Research
CFR Title 42 Part 50 promotes objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research funded under PHS grants or cooperative agreements will be biased by any conflicting financial interest of an investigator.
- United States Food and Drug Administration (FDA)
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
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
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.
- 21 CFR 50 - Regarding protection of human subjects
- 21 CFR 56 ï¿½Regarding 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
US FDA regulations of special interest:
- United States National Institutes of Health (NIH)
The primary US federal agency for conducting and supporting medical research, the NIH provides leadership and financial support to researchers in the US and throughout the world.
- US NIH Office of Laboratory Animal Welfare (OLAW)
Provides guidance and interpretation of the Public Health Service (PHS) Policy to ensure the humane care and use of animals in PHS-supported research, testing, and training.
- US NIH Office of Biotechnology Activities (OBA) Information Regarding Recombinant DNA and Gene Transfer
Promotes science, safety, and ethics in biotechnology through advancement of knowledge, enhancement of public understanding, and development of sound public policies.
- US NIH Stem Cell Information
Provides information on stem cells, healthcare, research and policy, cell line availability, and funding.
- World Health Organization (WHO)
The directing and coordinating authority for health within the United Nations system. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries, and monitoring and assessing health trends.
- Clinical Trials Registrations
- US NIH & FDA Registry
A web based data entry system for registering clinical trials that are approved by a human subject review board (or equivalent) and conform to the regulations of the appropriate national health authorities.
- World Health Organization (WHO) Registry Network
Provides prospective trial registries with a forum to exchange information and work together to establish best practice for clinical trial registration.
- International Committee of Medical Journal Editors (ICMJE)
Published the Uniform Requirements for Manuscripts Submitted to Biomedical Journals. A number of journals require adherence to these requirements. ICMJE member journals follow the ICMJE clinical trials registration policy.