Research Compliance Assurance
The Research Compliance Assurance ensures that all institutional research programs as well as their employees comply with the rules and regulations of the national and international regulatory agencies (including those of MOPH, MOE, GLP, GMP, HIPAA, OHRP, OSHA). It requires that all institutional policies and procedures are being followed and that the performance of the institute meets the organization’s Standards of Conduct through the following committees:
a- Institutional Review Board (IRB)
The Institutional Review Board (IRB) is responsible for assuring the ethical protection of the rights and welfare of human subjects from research risks. The IRB assures that all human research conducted under the auspices of QBRI are ethically and methodologically sound, as required under public law and most importantly, as expected - by public trust. The IRB is a highly professional committee that reviews and approves human research protocols of various disciplines and all related processes and documents to ensure that the rights and welfare of human subjects are protected above all other considerations. The IRB has the authority to approve, require modifications, or disapprove all research activities that fall within their jurisdiction in conformity with all ethical foundations for the protection of human subjects. The IRB functions independently, to protect its ethical mission without compromise and without any perception of conflict of interest or undue influence of power.
To comply with Qatari regulations concerning research involving human subjects, the QBRI Institutional Review Board has the assurance of: the Ministry of Public Health (MOPH) and the Wide Federal Assurance (WFA) of the Office for Human Research Protections (OHRP) of the US Department of Health and Human Services (DHHS).
IRB members include scientists, physicians, ethicists, psychologists, and individuals with expertise in allied disciplines. More specifically, the QBRI Institutional Review Board is committed to the following ethical requirements:
- Social Values
- Scientific Merit
- Respect for People
- Respect for Vulnerable Persons
- Privacy and Confidentiality
- Collaborative Partnerships
- Ethical Review
- Professional Competence
b- Institutional Biosafety Committee (IBC)
Institutional Biosafety Committee (IBC) is the cornerstone of the institutional oversight of all biomedical research programs that involve infectious agents, animal use, recombinant or synthetic nucleic acid and genetically modified materials to recombinant DNA & genetically modified organisms. QBRI’s IBC has the registration and approval of the Ministry of Public Health (MOPH) and consists of three constituent elements:
- Identification of each laboratory biosafety level criteria and containments requirements
- Biosecurity - the management of risks associated with facilities and operations
- Animal research safety programs
- Biological Risk Assessment
- Occupational health and immunoprophylaxis plans
- Waste management & Emergency planning
The IBC aims to review and approve recombinant DNA research protocols conducted at, or sponsored by QBRI for compliance with the International Biosafety Guidelines. The IBC is also responsible for tailoring the biosafety programs according to the level of risk assessed, carry out the inspection of institutional facilities, maintain a register of approved projects that are periodically reviewed to ensure compliance with the containment facilities (laboratories, animal houses), including personnel working on genetic manipulation in facilities, ensure all persons dealing with GMOs are adequately trained and that a record of trained personnel is maintained.
Adopting emergency plans covering accidental spills and personnel contamination resulting from recombinant DNA research is one of the most important roles of the IBC.
The Institutional Biosafety Committee is comprised of selected professionals in biosafety & medical research, those who have experience and expertise in recombinant DNA technology, and the capability to assess the safety of recombinant DNA research and to identify any potential risk to public health or the environment and QBRI Biosafety officer.