Research Ethics Committee

Abdalla Farahat 2021 October 9 441 Views

  • TBRI-REC
  • Structure
  • Function
  • Required documents
  • Approval

TBRI Research Ethics Committee (TBRI-REC)

TBRI-REC was established 2002, to clear proposals on biomedical research involving human subjects.

    • Currently the committee is responsible for Ethics reviewing of health-related research on humans as well as all aspects of animal care and use.
    • To acquaint researchers about TBRI- REC, a leaflet/brochure in English and Arabic has been prepared and circulated involving: Why to have RE Committee approval; REC Objective and an idea about Helsinki declaration.                     

Recognition

    • FWA recognition (No. 00010609) was achieved 2006 and was renewed in 2020.
    • TBRI-REC is also a registered by the Ministry of Health and Population (Registration no. 2017122301).

Goal

    • Promote high ethical standards in research for health and scientific merit of research.

Responsibilities

    • Protect potential participants in the research, taking into account potential risks and benefits for the community in which the research will be carried out.
    • Ensure human use of animals and avoid them unnecessary suffering.

TBRI-REC is multidisciplinary and multisectoral in composition involving 15 members (11 females/ 8 males) of medical and non-medical backgrounds and also scientific and non-scientific members (those representing the community e.g. Religious people, Journalist, Lawyer and the president of Warrak district where TBRI resides)

List of REC members:

  • Chairperson: Prof. Sanaa Botros  (Professor of Pharmacology, TBRI)
  • Moderator: Dr. Walaa El-Maadawy (Researcher of Pharmacology, TBRI)

Members (arranged in alphabetical order) :

  • Mr. Ahmed El-Mahdy (Judge and Legal Consultant of TBRI)
  • Prof. Ahmed Abdel Salam (Professor of Clinical Pharmacology, Ain Shams University)
  • Prof. Ahmed Abdel Aziz (Professor of General Surgery, TBRI)
  • Dr. Ashraf Ameen (Director of office for control of Schistosomiasis control and intestinal parasites, Ministry of Health and Population )
  • Mrs. Bothaina Abdel Hameed (Journalist, El-Gomhoria )
  • Prof. Hanan El-Baz (Professor of Immunology, TBRI)
  • Mr. Osama Mohamed (Head of Warrak District)
  • Prof. Manal Diab (Professor of Medical Microbiology, TBRI)
  • Dr. Mohamed Beder (Member of the Supreme Council for Islamic Affairs, Ministry of Awqaf)
  • Prof. Reeham Botros (Professor of Anesthesia, TBRI)
  • The committee meets monthly and examines from 7-10 proposals/meeting.
  • All research studies are subject to examination by technical reviewers with a presentation from the PI for any further clarification.
  • Expedited reviewing can be conducted by chair of REC with moderator in special conditions (e.g: archival samples, in vitro studies, etc…)
  • To ensure fair judgment and to make things easy for the reviewers, SOPs were developed after studying different international agencies procedures, 5 levels of judgment were adopted according to the WHO: Approval, approval after modifications, deferment and disapproval.
  • For easy reviewing a check list for both human and experimental research have been developed.
  • Request of approval
  • Research protocol (Article/Thesis/Project) fulfilling all items in the template provided “to ensure sound proven scientific methodology  that satisfies ethical and scientific standards”
  • For Researches on humans; a copy from the informed consent (using the supplied template) in simple language, clarifying the details of the research to be conducted, also the benefits and risks, measures to ensure the safety and respect of the research participants.

Required documents :

  • REC approval is for six months to one year, to be renewed provided the progress report presented to the committee is accepted.
  • Final approval is provided by the end of study provided all informed consents were delivered.

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