Protecting Human Participants

Background

A series of unethical research practices with regards to human subjects led to the creation of the current rules.

1. The Tuskegee Syphilis Study (1932–1972)
   • Conducted by the U.S. Public Health Service on  400 African American men with syphilis.
   • They were intentionally misinformed, treatment was never administered, and the men were never given adequate treatment for their disease.
   • Optional: See the Centers for Disease Control website for its history and more information: http://www.cdc.gov/tuskegee/timeline.htm.
2. The Nazi war crimes that were revealed at the Nuremberg trials (1945–1946)
   • Medical experiments were conducted on thousands of prisoners without their consent that resulted in disfigurement, permanent disability, or death.
   • Many physicians who conducted the experiments were found guilty at the Nuremberg Trials.
3. The Willowbrook Study (1963–1966)
   •  Conducted at the New York institution for mentally handicapped children.
   • Children were deliberately infected with hepatitis virus to test vaccines.

In response to these unethical practices and others, the following rules were developed.

These rules cumulatively determined the way research in social and biological (medical) sciences are conducted today. The most recent and comprehensive of these cumulative rules is the “Common Rule” of the U.S. Federal Government (see details at http://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html).

 

The following table summarizes the overall development of the rules in a chronological order.

Table 2.1. Ethical Rule Development

Rule	Year	Content
The Nuremberg Code	1947	Ten principles of ethical research were adopted.
The Declaration of Helsinki	1964	Principles adopted: Minimize risks, obtain informed consent, and protect personal integrity of participants.
The National Research Act	1974	Codified the principles for protecting human participants, created IRB.
The Belmont Report	1979	Formulated the three current principles: respect for persons, beneficence, and justice.
The Federal Common Rule	1991	Required IRB reviews for all federally funded research projects; most comprehensive principles to this date

Table 2.1. Ethical Rule Development

Note: Read the O’Sullivan et al., book and Michelle Stickler, The Ethics of Human Participant Research (PSU ORP Slides), for more details.

In this lesson we will talk about The Belmont Report and the Federal Common Rule of 1991 in detail as they are more relevant for social science and public administration research.