The Ministry of Health of the Nevis Island Administration issues the following statement in relation to the renal screening project undertaken by the Caribbean Education and Health Foundation (CHEF) in conjunction with the Nevis Renal Society.
The proposal was first received in Nevis in January 2014 by the office of the Permanent Secretary. It was authored by the founder of CHEF.
While the project proposal was welcomed in principle, there were several concerns that required clarification and resolution prior to final approval.
Recognizing that the author is not a health professional, the Ministry of Health sought to assist him by pointing out the areas for clarification and resolution. They were identified during a meeting between the PS, the CMO in the Federal Ministry of Health, Dr. Patrick Martin, and Medical Officer of Public Health on Nevis, Dr. Judy Nisbett. This meeting followed an initial meeting with the relevant senior managers of the Ministry of Health.
While clarification was received with regard to some of the other areas of concern, up to today,two fundamental matters have not been addressed by CHEF and its partners. They are:
1: Ethics Approval: This is a basic requirement for activities where human beings are tested. During the ethics approval process, a proposal is closely scrutinized for its scientific and technical rigor. Overall, it is designed to uphold and protect human rights, and to prevent harm and exploitation. Since the CHEF proposal came from outside the Federation, and since CHEF is based in the USA, CHEF was required to obtain ethics approval from a credible agency in the USA then submit it to the Ministry of Health for review. This has not been done.
2: Data Ownership: The CHEF renal screening project involves collecting samples from human beings and testing them. It is an international norm that test results or test data are owned by the country. The country then determines who gets access to the data, how it is to be used, if it is to be published and where. In correspondence to the Ministry, CHEF stated that it alone will own the data after a request for clarification was made on February 7th. In response, the Nevis Ministry of Health regarded CHEF’s arrogation of data ownership as a violation of the country’s data sovereignty. This matter has not being resolved.
The public is further informed that another research project is ongoing studying the human papilloma virus which causes cervical cancer. This study is sponsored by the Pan American Health Organization (PAHO). It received the approval of the Ministry of Health following the submission on a study proposal. The PAHO study is ethics approved and the data will be owned by the country.
All research proposals, studies, surveys and screenings proposed to the Nevis Ministry of Healthare forwarded to the Office of the CMO for evaluation and approval. The CMO advised that final approval of the CHEF renal screening project be withheld until the matters related to ethics approval and data ownership were addressed to the satisfaction of the Ministry.
CHEF and the Nevis Renal Society are aware of the requirements to conduct research studies and screening projects in Nevis. A member of the NRS has conducted other research in Nevis with the full backing of the Ministry of Health. Therefore, the Nevis Ministry of Health is disappointed that usual and expected cooperation and coordination have not taken place. Rather, CHEF and the NRS are acting in complete defiance of the authority of the Nevis Ministry of Health.
Residents of Nevis are advised that renal screening project currently undertaken by CHEF in conjunction with the Nevis Renal Society has not been approved. The screening tests being doneare not new; they are routinely done in the Federation. The Nevis Ministry of Health is putting more resources into improving the Alexandra Hospital laboratory so that more and better services can be provided to residents.
The Ministry will continue to work assiduously to uphold and protect ethics, human rights, the standards of data ownership and its governmental authority.
As it seeks to improve the health situation in Nevis, the Ministry of Health is willing and prepared to work with any person or group provided that all national requirements are satisfied.