Top 8 Clinical trial ethical requirements you should not miss!
“Clinical trials” is the medical research that determines the safety and efficacy of medication, devices and diagnostic products which involves participation of human subjects. Therefore, clinical research must be conducted in a reliable manner with the ethics of clinical practice.
The best example which reiterates to following guidelines is the infamous Tuskegee study that happened in 1932. The study was called the “Tuskegee Study of Untreated Syphilis in the Negro Male.”
Collaborative partnership
Collaborative partnership for clinical trials to be ethical include involvement of the community in designing, coordinating and overseeing research. This can be achieved by including Community advisory boards, Patient advocates on scientific advisory boards and adapting the research results in the health care systems.
The researchers in the Tuskegee study started the experiment with the objective to simply observe the natural progression of syphilis within a community. The subjects were unaware and they received no treatment. It was ethically abusive as no one was aware of the study outside the researcher team.
Social Value
Social value means performing clinical research which includes improvement of health of the participants and the community the research is conducted. Improvement of health care can be achieved by conducting Evidence based studies, multinational studies for diversity research and improving the existing medication and procedures.
When the Tuskegee study started there was no treatment available for the disease. The subjects received placebos as treatment which led to deaths, went blind or insane or experienced other severe health problems due to their untreated syphilis. Also, the researchers convinced local physicians not to treat the participants, and instead research was done at the Tuskegee Institute.
Scientific validity
Scientific validity includes study conducted with professional manner that is practically feasible and produces valid and consistent data with unbiased endpoints. Also using scientific methods to evaluate the effectiveness and safety of treatments or other interventions.
After 15 years of study, by the year 1947 penicillin was available as safe and reliable treatment for syphilis but the subjects in Tuskegee study were not aware and never treated with the available medicine.
Fair subject selection
Fair subject selection includes the enrolment of subjects with a targeted population without vulnerable or convenient groups (children in foundling hospital, poor and needy). The subject enrolment depends on the protocol inclusion-exclusion criteria. Also Excluding a particular group of population for higher risk and with scientific purpose is part of fair selection.
Only African American men were enrolled in the study. Most of the men were poor and illiterate sharecroppers from the county. Fair subject selection can be expressed as; subjects should be selected on the basis of scientific importance, not based on convenience, vulnerability or bias.
Favorable risk-benefit ratio
It will be unethical to conduct clinical trials without a Favorable risk-benefit ratio as it will be against social value. The risk-benefit ratio is evaluated by identifying (physical, psychological, economic, social risks), assessing, minimizing risks and enhancing benefits to individual participants.
Placebos such as aspirin and mineral supplements were given to subjects as a result syphilis was untreated and led to deaths of subjects and spread of disease to family of the subject. The same treatment continued regardless of the fact that penicillin became the recommended treatment for syphilis in 1947, some 15 years into the study.
Independent review
Independent review is important for the security of the trial subject. It is responsible for the protection of rights, safety, and well-being of all subjects. Also, it minimizes the investigators conflicts of interest. Independent review also assures society it will not benefit from abuse of subjects.
The research was not reviewed for rights or safety or wellbeing of the subjects in fact the objective was to simply observe the natural progression of syphilis within a community. So, no treatment was provided in spite of the availability of alternate treatment.
Informed consent
Informed consent is the subject’s volunteer confirmation for the participation in the clinical trial.
Every informed consent process comprises the four elements
- Competence of the subject
- Disclosure of information to the subject
- Understanding or comprehension by the subject
- Voluntariness of the decision.
In Tuskegee study the subjects were never informed that they are part of the study and all the subjects were poor and illiterate sharecroppers. They were not enrolled voluntarily as they were told they will get free medical exams, free meals, and burial insurance along with the treatment.
Respect for human subjects
Respect for the human subjects is predominant after the process of signed informed consent. It is essential to monitor subject welfare and protect confidentiality along with providing new information and what was learned from the research.
There were no choices given to the participants to quit the study when penicillin became available as a treatment and cure for syphilis. The subjects were unaware that they were part of research and were not given any treatment at all that makes Tuskegee study ethically unjustified study. President Bill Clinton issued a formal presidential apology for the study.
Above list gives you an wholesome idea of how these guidelines can be useful to conduct your clinical trials. The Tuskegee study emphasizes the disaster you can bring in in your trials by ignoring these guidelines. The most important part is to follow these guidelines in an order they are listed above in a manner consistent with the standard of clinical practice.
All 8 requirements are necessary, essential and universal everywhere regardless of your geographical location to make clinical research ethical. They should be adapted to the local health, economic, cultural and technological circumstances.
