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:
• 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 Should Evolve with Society, Ethics, and Advocacy.
Each milestone happened because people demanded greater fairness, accountability, and stronger protections.
Now it's time to ensure informed consent keeps pace with the research environment it was designed to support.
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 (45 CFR 46)
Codified federal regulations establishing IRB oversight and informed consent requirements across the U.S. 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.
2023 - FDA Informed Consent Guidance Update
FDA replaced its 1998 informed consent guidance with an updated document intended to clarify existing requirements and incorporate more recent regulatory changes. While the guidance modernized and consolidated previous recommendations, it did not introduce any new significant participant protections or address many emerging issues affecting research participants.
The Evolution of Participant Protections
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 over decades as a result of research abuses, public scandals, regulatory reform, and participant advocacy.
This history matters, because it shows us how far we’ve come, and why more change is still needed.
Current FDA Informed Consent Guidance (2023)
The FDA's current guidance document for informed consent in clinical investigations. This document replaced the agency's 1998 guidance and provides recommendations for IRBs, investigators, and sponsors regarding informed consent requirements.
HVA Perspective:
While the FDA's 2023 guidance updated and consolidated prior informed consent recommendations, many issues affecting modern research participants remain largely unaddressed.
• Participant tracking system disclosures and oversight
• Demographic inclusion and exclusion transparency
• Drug screening and confirmatory testing protections
• Compensation protections and study cancellation policies
• Administrative exclusion decisions
• Site-level participant support pathways
• Independent participant advocacy resources
• IRB reporting, confidentiality, and participant rights disclosures
HVA believes these areas warrant additional transparency, participant protections, and informed consent modernization.
Important Note:
These issues represent real, documented concerns affecting healthy volunteers throughout clinical research. HVA has developed additional participant protection and informed consent reform recommendations addressing many of these concerns. For more information, please visit the page below
History shows informed consent evolves when people speak up.
Join HVA to make sure healthy volunteers are not left behind
Where HVA Steps In..
While the informed consent process was originally created to help protect research participants, many of the concerns healthy volunteers experience today involve issues that are not always clearly addressed within current informed consent materials.
HVA believes informed consent should evolve alongside modern clinical research practices and provide participants with clearer information regarding:
GREATER TRANSPARENCY REGARDING INCLUSION AND EXCLUSION PRACTICES
Participants should receive clearer explanations regarding significant demographic eligibility restrictions and the scientific, medical, or safety rationale underlying those decisions.
GREATER TRANSPARENCY REGARDING PARTICIPANT TRACKING SYSTEMS AND SCREENING RESTRICTIONS
Participants should understand how participant tracking systems operate, what information may be collected or shared, how screening restrictions may affect future participation opportunities, and what reporting or review options are available when concerns arise.
MODERNIZED DRUG SCREENING STANDARDS AND PARTICIPANT PROTECTIONS
Participants should receive clearer disclosure regarding drug screening practices, the limitations of preliminary testing, confirmatory testing options, and the potential consequences associated with positive or unconfirmed results.
GREATER TRANSPARENCY AND FAIRNESS REGARDING PARTICIPANT COMPENSATION PROTECTIONS
Participants should clearly understand compensation policies involving study cancellation, delayed admission decisions, participant dismissal, early release, travel reimbursement, and other situations that may affect expected compensation.
CLEARER SITE-LEVEL ADMINISTRATIVE REVIEW AND PARTICIPANT RESOLUTION PROCESSES
Participants should have access to clearly identified site-level support and administrative review pathways capable of addressing communication concerns, inaccurate information, compensation questions, scheduling conflicts, and other participant-related issues before outside escalation becomes necessary.
INDEPENDENT PARTICIPANT ADVOCACY AND SUPPORT PATHWAYS
Participants should have access to independent advocacy and support resources capable of providing guidance, reporting assistance, confidentiality protections, and participant support when site-level pathways are unavailable, ineffective, or inappropriate.
CLEARER IRB ROLE, REPORTING, AND CONFIDENTIALITY DISCLOSURES
Participants should receive clearer explanations regarding the role of IRBs, available reporting options, confidentiality protections, anonymous reporting pathways, and the types of concerns IRBs are intended to address.
As clinical research continues to evolve, HVA believes informed consent materials should evolve as well. Greater transparency, communication, participant understanding, and clearly defined support pathways can help strengthen participant protections while improving trust, accountability, and the overall integrity of the clinical research process.
Why This Matters Now
Healthy volunteers are essential to clinical research- not just test subjects.
When otherwise qualified individuals are excluded due to age, sex, or BMI without clear scientific justification, the entire research ecosystem is affected. Studies are delayed, volunteers lose income opportunities, and trust in the system erodes.
Clinical research should rely on evidence based eligibility criteria. Age, BMI, or sex alone should not be used as grounds for exclusion in the absence of scientific rationale just as diagnostics and treatments do not rely on these factors as stand-alone eligibility criteria.
The next chapter is clear:
Healthy volunteers must be included and respected.
“Science Needs Us All…Healthy At Any Age”
Join the movement for fairness, transparency, and respect.