JOINT STATEMENT ON THE INTEGRITY OF VACCINE TRIALS AND THE INCLUSION OF BLACK, INDIGENOUS AND PEOPLE OF COLOR (BIPOC)
By Drs. Wayne A. I. Frederick, David M. Carlisle, Valerie Montgomery Rice and James Hildreth
We, as representatives of the four historically Black medical schools in our nation, are committed to the inclusion of Black, Indigenous and people of color (BIPOC) as we engage in research initiatives focused on the novel coronavirus, SARS CoV-2. The virus, COVID-19, disproportionately impacts the number of infections, complications, and deaths in our communities. Our research efforts will be governed by the basic principles of respect of persons, beneficence, and justice.
Respect for persons demands that our communities enter into research voluntarily and with adequate information. Beneficence ensures that our communities will recognize the benefits and risks that may result from the improvement of knowledge through their participation in research. And finally, justice will be achieved by ensuring that no person is denied participation in research without good reason, nor will anyone be unduly burdened by their participation.
Our decisions to recommend participation in clinical studies, including vaccine trials, will always be informed by rigorous science carried out under international rules governing safe and ethical conduct of research. Our approach will be unbiased nor influenced by financial or non-financial conflicts. We will rely on peer-reviewed, transparent science is an important component in protecting the welfare of persons who volunteer to participate in clinical studies.
Specifically, we stand together to:
- Protect the members of our communities by maintaining the highest standard of integrity and respect which have always been, and will remain as cornerstones of our engagement;
- Listen to our communities and address concerns and fears surrounding research related to COVID-19- including clinical trials, vaccine candidate trials, and therapeutic and diagnostic research- by providing accurate information based on scientific evidence;
- Ensure that the manner and context in which information regarding participation in research is conveyed is culturally and linguistically appropriate;
- Confirm that individuals enter into research voluntarily, and agreement to participate in research constitutes a valid consent;
- Uphold, no matter what, the fundamental guiding ‘Hippocratic’ maxim ‘to do no harm’; and lastly
- Promote equity as it relates to access to opportunities to improve the quality of health and wellness, ensuring that each community we engage gets what they need, when they need it, and in the amount that they need.
These fundamental principles are inherent to each of us as individual medical schools, and collectively we pledge to use our unified voice to advocate for all who consider and those who participate in COVID-related clinical and translational research.