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History of Ethics

Timeline

1947

Description: The Nuremberg Code was developed after World War II following the Nuremberg Trials.

Significance: A foundational document in medical research because it emphasizes informed consent and voluntary participation.

Nuremberg Code

Learn more: https://doi.org/10.1016/s1470-2045(07)70381-9

https://www.nationalww2museum.org/war/articles/nuremberg-and-tokyo-war-crimes-trials

1964

Declaration of Helsinki

Description: As medical research expanded, the Nuremberg Code was insufficient by itself. The document provided a broader ethical framework for clinical research.

Significance: It introduces new concepts of independent review and risk-benefit analysis, later influencing HIV vaccine trial research.

Learn more: https://www.jstor.org/stable/20507808

https://historyned.blog/2015/08/01/40-years-later-rethinking-the-helsinki-accords-and-human-rights/

1974

National Research Act

Description: A US law which was tasked with identifying ethical principles to guide research involving human participants, primarily in response to the controversy surrounding the Tuskegee Syphilis Study.

Significance: This act lead to the establishment of Institutional Review Boards (IRBs) to oversee research. IRB review for research is a critical safeguard in HIV vaccine trials, particularly to prevent exploitation of vulnerable populations.

https://www.npr.org/2021/02/16/967011614/in-tuskegee-painful-history-shadows-efforts-to-vaccinate-african-americans

Learn more: https://www.cdc.gov/tuskegee/about/effects-research.html

1979

Belmont Report

Description: The Belmont Report is a set of ethical principles and guidelines for research involving human subjects. Its primary purpose is to protect research participants and subjects. It was also developed as a result of the Tuskegee Syphilis Study.

Significance: The Belmont Report highlights three main principles: respect for persons and autonomy of individuals, beneficence and protecting subjects from harm, and justice and fairly distributing the benefits and burdens of research.

https://www.amazon.com/Belmont-Report-Principles-Guidelines-Protection/dp/B008KEVUWU

Learn more: https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html

1985

CIOMS Interational Ethical Guidelines

Description: Developed by the Council for International Organizations of Medical Sciences, these guidelines adapted the Declaration of Helsinki for research in developing countries.

Significance: CIOMS guidelines cover topics such as informed consent, confidentiality, and compensation for injury. They also address how to strengthen national and local ethical review. This is relevant for HIV vaccine research conducted globally.

https://www.ejprarediseases.org/cioms-glossary-of-ich-terms-and-definitions-now-available/

Learn more: https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf

1997

UNAIDS Guidance Document

Description: UNAIDS, with WHO, publishes ethical considerations specific to HIV vaccine trials, including community engagement, informed consent, and post-trial obligations.

Significance: This is the first major guideline addressing the unique ethical challenges of HIV vaccine research, such as risk for participants and benefits to communities involved in the trials.

https://healthpolicy-watch.news/selection-of-new-unaids-executive-director-raises-larger-questions-about-agencys-purpose-direction/

Learn more: https://www.unaids.org/sites/default/files/media_asset/ethical-considerations-hiv-prevention-trials_en.pdf

2000

Revisions to Helsinki

Description: The Declaration has undergone multiple revisions, notably in 2000, to clarify standards for research in low-resource settings.

Significance: It emphasizes that benefits of research should extend to communities involved, impacting HIV vaccine trials in countries heavily affected by HIV/AIDS.

https://www.theaspiringmedics.co.uk/post/medical-ethics-declaration-of-helsinkihttps://www.theaspiringmedics.co.uk/post/medical-ethics-declaration-of-helsinki

Learn more: https://pmc.ncbi.nlm.nih.gov/articles/PMC1884510

2002

Good Participatory Practices

Description: The Good Participatory Practice (GPP) Guidelines were developed to address ethical and practical challenges in conducting HIV biomedical research, particularly in communities heavily impacted by HIV/AIDS..

Significance: These guidelines are important because they help to ensure that the research outcome aligns with stakeholder priorities and that participants have a good experience. GPP guidelines were originally developed for HIV prevention clinical trials but are now used in research across many diseases.

Learn more: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-trial-of-covid-19-vaccines/good-participatory-practices

https://en.sputniknews.africa/20231208/africas-hiv-vaccine-trial-halted-ahead-of-schedule-due-to-ineffectiveness-report-reveals--1064019609.html

2017

U.S. Common Rule Revision

Description: The Revised Common Rule is a federal policy that governs federally funded research involving human subjects.

Significance: The revisions helped strengthen protections for study participants, reduce administrative burdens for researchers, and help people make better decisions about participating in clinical trials.

Learn more: https://research.unc.edu/compliance/training-communications/tutorials/common-rule-1/

https://www.aamc.org/news/5-things-you-need-know-about-revised-common-rule

How can we continue to ensure participants are protected by ethical codes?

How can YOU make a difference?

Revise ethical codes to address specific concerns instead of broad concerns