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Statement Regarding Herpes Vaccine Trial

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Commentary

Dr-P-MartinThis statement is in response to a number of inquiries about a herpes vaccine trial that recently made the news.

 

It is reported that several persons travelled to the Federation between April and August 2016, as part

of the said trial.

 

I was active as Chief Medical Officer (CMO) from 1st October, 2004, to 16th June, 2016.  During the period, no vaccine trial in the Federation came to my attention.

 

The following is submitted for general information:

 

1.       Research for health is universally regarded as an essential public health function.  New medicines, vaccines and devices are intended to improve health.  They are developed via thorough proven practices.  Trials for new vaccines and medicines are major research undertakings, which warrant strict attention to international best practices in research ethics

and scientific methodologies.

 

2.       St. Kitts and Nevis is a member of the international community of nations.  It is party to the United Nations-approved frameworks for assessing the merits of research and other investigations that involve human subjects.

 

3.       Research procedures are known to the Ministries of Health (federal and local).  The focal point is the Office of the Chief Medical Officer - the most senior functionary in relation to scientific and technical matters of health.  Responsibility for examining and approving submitted proposals is vested in the CMO who is so empowered under the Public Health Act

subject to the ultimate authority of the Minister.

 

4.       All aspects of research activities must meet the highest international standards in relation to ethics, scientific rigor and technical soundness.  The review mechanism is commonly called an Institutional Review Board (IRB) or similar terminology.

 

5.       IRB approval is required for all investigations involving human subjects such as

 

a.       Investigations into disease and injury causes, risk factors, and

trends

 

b.      Studies to identify effective polices, programs, services and practices

 

c.       Trials to find new medicines, vaccines and devices, and

 

d.      Health screenings e.g. kidney function tests, HIV testing, prostate

health, blood pressure levels, etc.

 

6.       Over the years, depending on the complexity of the research, IRB

functions have been carried out as follows

 

e.      By the CMO,

 

f.        By a task force of competent persons in the Federation convened by the CMO, or

 

g.       By the IRBs of partner institutions.

 

7.       In 2014, government drafted legislation to establish a formal IRB. This was a direct response to increased interest in carrying out health research in the Federation including stem cell research.

 

8.       All persons seeking to carry out research involving human subjects (resident or non-resident) must submit proposals in writing and receive approval in writing from the CMO prior to the start of the research activity.

 

9.       Proposals for research and other investigations that either bypassed the Office of the CMO or were not sanctioned by the Office of the CMO must be regarded as being unethical and fake.

 

Other Information

 

10.   Realizing the value of conducting and participating in research, the subject area “Research for Health” is listed as a priority area of the 2008 - 2012 St. Kitts and Nevis National Strategic Plan for Health.

 

11.   In March 2008, the first policy position on research was developed by the Office of the CMO.  There have been two revisions so that by March 2014, version 3 was submitted by the CMO to the PS for administrative endorsement as a prelude to final ministerial fiat.

 

12.   The research policy instrument was used to evaluate and decide on approximately twenty (20) research proposals received over the years from institutions and individuals at home and abroad.

 

13.   The list of institutional research partners includes PAHO, CARPHA, Ross University and the University of Virginia at Charlottesville.   In 2014, CARPHA established an ethics unit to, among the things, support its member countries, such as St. Kitts and Nevis, to conduct robust IRD functions.  The CARPHA unit has been instrumental in providing training and

in reviewing in-depth research proposals whose complexity exceed local

competencies.

 

-- 

Patrick Martin MD

Pediatrician & Physician Executive

Basseterre, St. Kitts & Nevis

 

I am not a saint, unless you think of a saint as a sinner who keeps on trying. - Nelson Mandela



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