By Osero Shadrack via Fb
Let me write a curt discussion on this topic that’s ever talked about. Clinical trials of new vaccines. Colloquially called human tests. Please take this as a technical advice from a competent person. One of my classes as a development policy student at MIT has been how to conduct research.
All arrays of research. From economic, health, agriculture and educational spectrum. Professor Esther Duflo, was the lead at my classes. With a mix of other professors, drawn from Harvard, Yale and Columbia Universities. With many other research groups and institutions like the the Abdul Latif Jameel Poverty Action Lab, housed at MIT department of Economics and our KEMRI.
Back to my topic.
Doing a test for a new vaccine or medical drug takes a lot of many technical and regulatory steps to complete. We call this “Randomized Control Trials”, or RCTs. To complete one cycle of an RCT, could take between 8-15 years. Kenya has been and is still a host to many RCTs. Notable one is on the economic aspects of kids nutrition in Busia County and their projected school success. Let me not delve further on it’s details.
At the moment, globally, we’ve had slightly above 700 RCTs experiments. These are all done to derive evidence based public policy guidelines. They all follow a similar protocol to conduct.
With the Corona Virus outbreak, scientists across the globe are at a rush to get a vaccine. And this will need a minimum of 12-18 months to conduct a condensed version of an RCT, aimed to prove the drug’s efficacy and security.
Back then before legal standards were formulated, especially during the times of the two world wars, autocratic nations conducted experiments to citizenry covertly. The Nazi Germany for example did lots of medical trials at concentration camps. In the US, medical trials were done using prisoners in Pennsylvania.
Today, we do have Shylocks or people who are paid to be used as laboratory rats in the US. A person can house 10 different medical trials at ago, with good money paid.
What altered the course is the Tuskegee Syphilis Experiment, a surreptitious program done by the US government over a period of 40 years between 1932 and 1972.
Basically, the US government conducted a research on blacks at the State of Alabama without their consent. This is where the problem elicits, with many people questions as to why the French and British medical scientists want to use Africans and Kenyans as lab rats.
Now, the so called developed nations have stringent research regulations and ethical standards, that are blurred when we cross over to Kenya. These laws are derived from the Tuskegee Syphilis Experiment aftermaths. They are called the “Belmont Principles”, on which I doubt if Kenya has adopted and domesticated these said laws.
The Belmont Report was a document drafted and is one of the leading works concerning ethics and health care research. It allows for the protection of participants in clinical trials and research studies.
The three fundamental ethical principles for using any human subjects for research were then outlined as follows.
1.Respect for persons: protecting the autonomy of all people and treating them with courtesy and respect and allowing for informed consent. Researchers must be truthful and conduct no deception;
2. Beneficence: The philosophy of “Do no harm” while maximizing benefits for the research project and minimizing risks to the research subjects; and
3. Justice: ensuring reasonable, non-exploitative, and well-considered procedures are administered fairly — the fair distribution of costs and benefits to potential research participants — and equally.
These principles remain the basis for the United States Department of Health and Human Services (HHS) human subject protection regulations.
Today, the Belmont Report continues as an essential reference for institutional review boards (IRBs) that review HHS-conducted or -supported human subjects research proposals involving human subjects, in order to ensure that the research meets the ethical foundations of the regulations.
Applications of these principles to conduct research requires careful consideration of i) informed consent, ii) risks benefit assessment, and iii)selection of subjects of research.
Outlined by Jennifer Sims in her article “A brief review of the Belmont Report”, she states 7 things nurses, as primary caregivers for individuals participating in a study, must do to ensure the rights of the participant is met.
-Ensure the study is approved by an IRB.
-Get informed consent from the patient.
-Ensure that the patient understands the full extent of the experiment, and if not, will contact the study coordinator.
-Ensure the patient wasn’t coerced into doing the experiment by means of threatening or bullying.
-Be careful of other effects of the clinical trial that were not mentioned, and report it to the proper study coordinator.
-Support the privacy of the patient’s identity, their motivation to join or refuse the experiment.
-Ensure that all patients at least get the minimal care needed for their condition.
-Researchers must share the findings of their procedures regardless of them being good or bad results.
-Also in the case someone did not want to participate in research but would like treatment they cannot be turned away and must be treated with the same standard care.
The problem is; will your fellow Kenyans manning the KEMRI protect you from these trials. Or “money” will be talking. I know equivalent example from Pakistan, where the Chinese government has been provided a go ahead to to test its Corona Virus candidate vaccine.