What are the quality and safety standards that the World Health Organization (WHO) polio research abides by, and must these be applied to external research supported by the Polio Research Committee (PRC)?
All research funded by WHO and involving human participants is subject to clearance by the WHO Research Ethics Review Committee, as well as approval by a local institutional review board. The clinical trials also require approval by national regulatory agencies. That therefore includes any research supported by the PRC. In addition to this, all the polio clinical trials sponsored by WHO are designed and implemented in compliance with Good Clinical Practice (GCP) standards, as per the 1996 International Conference on Harmonisation (ICH). Lastly, an independent Data and Safety Monitoring Board was established to ensure the scientific and ethical integrity of the polio clinical trials funded and sponsored by WHO.
What are the principal review criteria by the Polio Research Committee (PRC) on submitted research proposals?
The PRC requests each proposal to include information relating to:
1) research question/objectives
2) qualification of investigators and collaborators
3) budget request
4) study design and methodology.
Key to a successful application is to ensure the completeness of research proposals, following the submission guidelines. Incomplete proposals cannot be considered for approval by the PRC. Any anticipated challenges, with proposed solutions, should be elucidated. Proposals requesting significant funding (i.e. >US$ 100 000) should include detailed, divided budgets presented by phases of the proposed research activity. Involving research collaborators with relevant experience in the field of the proposed research activity is advantageous. The PRC encourages proposals meeting identified unmet research needs.
Polio eradication requires the eventual cessation of OPV use in routine immunization programmes. Otherwise, the continued reintroduction of the attenuated polioviruses of OPV into a polio-free world will result in polio cases due to vaccine-associated paralytic polio (VAPP), and polio outbreaks due to circulating vaccine-derived polioviruses (cVDPVs). The cVDPVs could re-seed the world with poliovirus, and thus negate the achievement of eradication. Thus, OPV cessation is the cornerstone to secure polio eradication.
The role of IPV following OPV cessation is still being evaluated. At a minimum, IPV will be needed in all countries that elect to retain poliovirus stocks. For countries which are not retaining poliovirus after eradication, but perceive the long-term poliovirus risks warrant continued routine immunization, IPV will be the only option with which to do this. Recognizing that current costs of IPV are substantially higher than OPV, the Global Polio Eradication Initiative is evaluating a range of approaches to establish affordable options for IPV use, to achieve immunity at a cost similar to that achieved through OPV.
Unlike OPV, IPV confers very little immunity in the intestinal tract. When a person immunized with IPV is infected with wild poliovirus or a cVDPV, virus can still multiply inside the intestines and be shed in the stool, risking continued circulation. For this reason, OPV is the vaccine of choice wherever a polio outbreak needs to be stopped.