Appendix A: Letter To Ministers Of Health – To Accompany Template For Research Regulation: Dr. Derrick Aarons

APPENDIX A Letter To Ministers Of Health – To Accompany Template For Research Regulation: Dr. Derrick Aarons

Dear Minister: RE: REGULATION TO PROTECT RESEARCH PARTICIPANTS IN YOUR COUNTRY

CARPHA hereby invites you to commence the enactment of Regulations to protect research participants in your country. The legal regulation of research as well as research ethics are important because the human subjects of research may be harmed. Further, not all risks can be predicted in advance, hence laws should be written to ensure compensation from research harms. The history of modern research is replete with scandals and abuses of research participants. Whilst the world knows about the research abuses that occurred in the Nazi experiments during World War II where the intended outcome of very many experiments was the death of the victims (e.g. plutonium injected into hospitalized patients to study bio-distribution of radioactive material in the human body; cereal with tracer doses of radioactive isotopes fed to boys in a school for the mentally handicapped), there have been less well-known experiments all over the globe in which subjects were harmed.

Some include live cancer cells injected into elderly patients, carcinoma-in-situ in the cervix being allowed to run its course for observation without any treatment intervention, and mentally retarded institutionalized children being injected with hepatitis virus to study immunity. More recently in one of our Caribbean countries, there was a research proposal which sought to use human faeces to produce gas, as a sustainable initiative. However, only vulnerable persons from a certain area of the society would have been targeted for their faeces! Due to the trusting nature of many of the Caribbean’s research-naïve inhabitants, research protection for these persons should be enshrined in the law of the country. The Caribbean basin now hosts a large number of offshore medical schools, colleges, and local institutions that require research be done by enrolled students and tutors. Further, Caribbean countries have very limited resources and their inhabitants are vulnerable to exploitation by overseas sponsors of research and researchers who are very aware of minimally functioning ethics review committees and policies, and the varying literacy levels among inhabitants in many of our countries. Some Caribbean countries have Research Ethics Committees to evaluate research proposals and protect potential participants from harm, but such committees do not have the backing of specific law addressing research in the country. Nearly all developed countries have such laws to protect their inhabitants in research. CARPHA hopes that our Caribbean member states will similarly move to protect all inhabitants through appropriate legislation similar to that suggested by the attached Template for Research Regulation. Sincerely, Derrick Aarons MD, PhD, Ethicist The Caribbean Public Health Agency (CARPHA)