Conclusions and recommendations
A national harmonized ethics review system is recommended to ensure a high-quality response during both public health emergencies (PHE) and throughout normal times. Ethics review should ensure efficiency, competence, and rigor to protect research participants, and to support researchers, hospitals, and communities in their efforts to respond to the PHE, while also providing public confidence in the safety and value of the science undertaken by researchers and their institutions. Develop harmonized ethics review
- Develop (co create) comprehensive guidance for ethics review that are reflective of the needs of the ethics review system of Pakistan to enable harmonized ethics review
- Strengthen governance structure by provision of sufficient resources
- Develop synergies and line of communication between IRBs/RECs and NBC-REC and the Drug Regulatory Authority Pakistan (DRAP) Optimal Training Recommendation
- Develop plan on how to optimize training opportunities as per need.
- Research institutes must (be made accountable to) develop Human Research Programs and commit to provide support and training to its researchers in addition to IRBs. Ethics review during PHEs
- Develop guidance for ethics review during PHEs. Governments through its national level competent bodies and health, research, and ethics institutions, and WHO Regional Offices should support the development of collaborative systems, to support rapid and responsive review during emergencies.
These systems should be context sensitive and may need to include means of accessing needed additional ethical expertise, increased workload management, special training relevant to PHE, mechanisms for communications between NBC, IRBs/ECs, and drug regulatory where possible as well as multicounty consultations, as appropriate.
