The National Health Research Ethics Committee, Nigeria, has approved the use of an experimental Ebola drug, Zmapp, for treatment of patients infected with the virus. The committee, which composed research scientists, is a national body under the Federal Ministry of Health.
The endorsement is contained in a statement issued to newsmen by Prof. Clement Adebamowo, Chairman of the committee on Wednesday in Abuja.
The decision by the committee is coming on the heels of Tuesday’s approval by the World Health Organisation (WHO) on the use of Zmapp for treatment of Ebola patients.
“It is ethical to use these treatments in the current situation without first submitting an application to National, State or Institutional Health Research Ethics Committee for prior review and approval.
“In addition, the Committee waives the current requirement that international shipment of any biological samples out of Nigeria should be preceded by the establishment of a Materials Transfer Agreement.
“This waiver is to promote rapid international response to this global emergency,’’ the statement said.
In the statement, the Nigerian National Code for Health Research Ethics emphasised that all innovative and non-validated treatments should be carefully and adequately documented.
According to the statement, the documentation can form the basis for clinical trials of the efficacy and side effects of the treatment according to established scientific principles.
In the statement, the ethics committee enjoined all agencies, development partners and research scientists to follow the guideline for the rapid resolution of the current emergency.
“The guideline will contribute to preparedness in case of future occurrences and contribution to scientific knowledge.
“It must be noted that all Phase O and Phase I Clinical Trials that may subsequently be designed for treatment of this infection can be approved only by the National Health Research Ethics Committee,’’ it said. Source
No comments:
Post a Comment