Protecting Human Subjects in Research: Not To IRB(e) Taken Lightly

On this week's episode of the podcast, we discuss protections in place for human research subjects. To start the conversation, we discuss some infamous examples of past injustices conducted in the name of "research" and the regulations they prompted as a result. We highlight four cases: the Holocaust experiments, the Tuskegee Syphilis Study, the work of James Marion Sims, and the case of Henrietta Lacks.
We spend some time detailing historical documents and regulations that were developed to protect human subjects that came out of these horrific historical blunders and atrocities. Next, we discuss in detail what "informed consent" means, the rigorous regulatory process for any research involving humans, and the modern-day Institutional Review Board (IRB). We recognize that there continues to exist distrust of science and the medical establishment, particularly among populations of color, and our hope is that this episode sets the stage for future conversations that are needed to address this complex issue.

PLEASE NOTE: The discussion and information provided in this podcast are for general educational, scientific, and informational purposes only and are not intended as, and should not be treated as, medical or other professional advice for any particular individual or individuals.  Every person and medical issue is different, and diagnosis and treatment requires consideration of specific facts often unique to the individual.  As such, the information contained in this podcast should not be used as a substitute for consultation with and/or treatment by a doctor or other medical professional.  If you are experiencing any medical issue or have any medical concern, you should consult with a doctor or other medical professional. 

Further, due to the inherent limitations of a podcast such as this as well as ongoing scientific developments, we do not guarantee the completeness or accuracy of the information or analysis provided in this podcast, although, of course we always endeavor to provide comprehensive information and analysis. In no event may Unbiased Science or any of the participants in this podcast be held liable to the listener or anyone else for any decision allegedly made or action allegedly taken or not taken allegedly in reliance on the discussion or information in this podcast or for any damages allegedly resulting from such reliance.

RESOURCES

• Protecting Human Research Subjects: The Past Defines the Future

• Beyond Nazi War Crimes Experiments: The Voluntary Consent Requirement of the Nuremberg Code at 70

• NOVA Online: Holocaust on Trial

• The Tuskegee Timeline

• Historical Origins of the Tuskegee Experiment: The Dilemma of Public Health in the United States

• HeLa Publication Brews Bioethical Storm

• Deal Done Over HeLa Cell Line

• Henrietta Lacks: Science Must Right A Historical Wrong

• The Office for Human Research Protections (OHRP) History

• Medical Ethics of J. Marion Sims

• Medical Ethics of J. Marion Sims: Alternative Perspective

• FDA IRB Frequently Asked Questions

• The Historical, Ethical, and Legal Background of Human-Subjects Research

• How to Obtain Informed Consent

• Research Participants Need for Autonomy

• Protecting Human Research Subjects: The Past Defines the Future