TBRI-REC


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 2015.
  • 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.

Structure


  • TBRI-REC is multidisciplinary and multisectoral in composition involving 19 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)

  • Prof. Ahmed El-Baz (Vice President of TBRI for Clinical & Field Affairs and Professor of Urology, TBRI)
  • Mr. Ahmed El-Mahdy (Legal Consultant, TBRI)
  • Sheikh. Ahmed Torky. General Director of Training Department, Ministry of Awqaf and Member of the Supreme Council for Islamic Affairs
  • Prof. Ashraf Heidar (Professor of General Surgery, Faculty of Medicine, Cairo University)
  •  Prof. Ayat Atef (Undersecretary for Endemic Diseases Ministry of Health and Population )
  • Prof. Azza Saleh (Head of Central Directorate for Research & Health Development and Moderator of ENREC, Ministry of Health and Population and Professor of Clinical Chemistry, TBRI)
  • Mrs. Bothaina Abdel Hameed (Journalist, El-Gomhoria )
  • Prof. Hanan El-Baz (Professor of Immunology, TBRI)
  • Prof. Hussein Ezzat (Professor of General Surgery, TBRI)
  • Prof. Iris Nesseim (Professor of Clinical Chemistry, TBRI)

 

  • Prof. Maha Abd El-Bar (Professor of Anesthesia, TBRI)
  • Prof. Manal Diab (Professor of Medical Microbiology, TBRI)
  • Dr. Mohamed Salah (Veterinarian)
  • Prof. Neamat Moussa (Professor of Parasitology, TBRI)
  • Prof. Sameh Fakhry (Professor of Hepatogastroenterology, TBRI)
  • Prof. Samira Saleh (Professor of Pharmacology, Faculty of Pharmacy, Cairo University)
  • Major/Tarek Abdel Azim (Head of Warrak District)    
  • Prof. Wafaa Abd El-Aal (Professor of Pathology, NRC)

Function


  • 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.

 

Required documents


  • 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.

111111111111111     1     1     1         1

 

1     1

Approval


  • 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.