Module 3: Informed Consent and Human Subject Research

Case of Henrietta Lacks (HeLa)

The Case of Henrietta Lacks (HeLa) refers to the ethical controversy surrounding the non-consensual use of cancer cells taken from Henrietta Lacks in 1951, which led to significant advancements in medical research. Her cells, known as HeLa cells, became vital for scientific breakthroughs, raising important questions about consent and the rights of patients.

Was the case of Henrietta Lacks (HeLa) legal at the time?

The case of Henrietta Lacks involved the unauthorized use of her cancer cells for research, raising ethical questions about consent and ownership of biological materials, which were not adequately addressed by law at the time.

Alder Hey Children's Hospital scandal

-gave organs to a pharmaceutical company for financial donations

-The organs were collected from babies/children who died at the hospital between 1988-1996 without consent of their parents or guardians.

Human Tissue Act (UK)

-1961 Act assumed consent unless explicit objection was made by patients or their families.

-There was no clear definition of what consituted tissue

-Cadavers: authorize post-mortem examinations and retain body parts for diagnostic purposes

-2004 it changed

What qualifies as human subject research?

-if the information from the interviews is collected with the intent to contribute to generalizable knowledge (i.e., published or presented research)

-if the interviews involve identifiable private information or are about the person's behavior, health, or personal experience.

-if you are interacting with the individuals to obtain data.

Before Nuremberg

Research required self experimentation such as during research for Yellow fever conducted by Jesse W. Lazear who was tasked with investigating the cause and transmission of yellow fever in Havana, Cuba