Universal Regulations

Should we have universal standards to regulate medical technologies? Universal regulations provide the opportunity to increase accountability for large medical device and biotechnology companies and help protect vulnerable populations. However, universal regulations also pose an issue for countries that do not possess the infrastructure to enforce strict controls. Watch the video below to learn more about the pros and cons of universal regulations.

Self-Assessment Questions:

Click here to test your understanding on Universal Regulations.

Discussion Questions:

1. Refer to the Nuremberg code and the Belmont Report to best propose a solution or pathway countries and companies can take in enacting universal regulations while ensuring an invisible health barrier is not created.
2. Read the Pfizer Trovan Testing case review. What ethical principles were violated? What in terms of experimental design could have been done to prevent this?
3. Consider the current fast-tracking of COVID-19 vaccines and the large amount of undergoing clinical trials to make this possible, as well as the Sinopharm Vaccine Phase ½ data. Suggest three universal regulations bioengineers may consider when designing and eventually testing new medications (e.g. vaccines) on human subjects.

Continue Reading:

• Xia et al (2020). Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial. Lancet Infect Dis, 21: 39–51. doi: https://doi.org/10.1016/S1473-3099(20)30831-8
  • This article investigates the efficiency and immunogenicity of the preliminary Sinopharm Vaccine (Phase 1/2 trial).
• Rabi Abdullahi v. Pfizer, Inc (2009). Docket Nos: 05-4863-cv (L), 05-6768-cv (CON). Click here to read.
  • This is a case review on the ethicality of Pfizer’s Trovan testing in Nigeria; non-consenting human subjects.
• Larson et al (2011). Addressing the vaccine confidence gap. Lancet. 378(9760): 526-535. Click here to read.
  • This article analyzes the vaccine confidence gap, socioeconomic marginalization, and historical experiences (e.g. Trovan).

About the Creator:

This video was created by a student in the Rice Bioengineering Class of 2023 (used with permission).