The History of Informed Consent
Why consent matters, how protections were built, and what still needs to change.
Connecting History to Today
The history of the Informed Consent Form (ICF) shows how protections were added step by step — to prevent abuse, to ensure participants were informed, and to guarantee respect. Yet history also teaches us that informed consent is not finished; it evolves through advocacy and accountability.
Today, one of the most glaring issues facing healthy volunteers is age-based exclusion. Many studies arbitrarily exclude individuals over 40, 50, or 60 — not for medical reasons, but because it is simpler for sponsors to design and for clinics to manage. These exclusions shut out capable, willing participants with no scientific justification.
This matters because:
• Research slows when fewer volunteers can participate.
• Older adults lose opportunities to contribute and benefit financially.
• Clinical trials should treat participants based on health, not age.
• Excluding qualified volunteers undermines fairness and trust in science.
The ICF is not fixed in stone — it evolves with society, ethics, and advocacy. Each milestone happened because people demanded fairness. Now it’s time for the next step.
Timeline of Key Milestones in Informed Consent
1947 – Nuremberg Code
Declared that voluntary consent is absolutely essential after Nazi medical experiments revealed horrific abuses.
1964 – Declaration of Helsinki
Required participants to be informed of risks and benefits; participant well-being must always come before science.
1966 – Henry Beecher’s Article
Exposed 22 unethical U.S. studies in the New England Journal of Medicine, raising global awareness.
1972 – Tuskegee Syphilis Study Exposed
Journalists revealed Black men were denied treatment for decades. Public outrage led directly to reforms.
1974 – National Research Act / Belmont Report (1979)
Established core principles: Respect for Persons, Beneficence, and Justice.
1981 – U.S. Federal Regulations
Required ICFs to cover study purpose, risks, benefits, alternatives, confidentiality, and voluntariness.
1991 – The Common Rule
Standardized protections across 15 U.S. federal agencies.
1990s – Expanding Protections
Added rights around compensation for injury, withdrawal, and clearer confidentiality.
2000s – Privacy & Genetics
ICFs updated for genetic testing, biobanking, and HIPAA privacy laws.
2018 – Revised Common Rule
Added a plain-language “Key Information” section to make consent easier to understand.
When clinical research began, participants had almost no protections.
Consent was often assumed, not documented, and risks were rarely explained.
The Informed Consent Form (ICF) we know today was built step by step — often after abuse, scandal, or strong advocacy.
This history matters, because it shows us how far we’ve come, and why more change is still needed.
History shows informed consent evolves when people speak up. Join HVA to make sure healthy volunteers are not left behind
Where HVA Steps In
1. Fair Compensation for Canceled Studies
Volunteers often lose time and money when studies are canceled last-minute. HVA advocates for every ICF to include a sponsor’s obligation to compensate participants fairly if a study is canceled after acceptance.
2. Scientific Justification for Eligibility Restrictions
Many healthy, able-bodied volunteers are unfairly excluded due to arbitrary age, gender, or ethnicity restrictions. HVA is fighting for clear scientific justification in ICFs. If restrictions exist without science-based reasoning, they should be disclosed as sponsor preference, not medical necessity.
Why This Matters Now
Healthy volunteers are essential partners, not test subjects. Yet when qualified individuals are denied due to age, the entire research ecosystem suffers. Studies get delayed, volunteers are denied income opportunities, and trust in the system erodes. Clinical research should never discriminate on age alone — diagnostics and treatments never do.
History shows consent protections grow when people speak up. The next chapter is clear: healthy volunteers must be included and respected.
Join the movement for fairness, transparency, and respect.