Protection of Human Research Subjects

Theresia YiallourouNora Leonardi

Ulrike Kettenberger

November 19th 2010

Goals and Principles of Research in Humans

„Research in humans differs from other research in that the

subject has decision-making power and must be treated with

respect. The long history, even in the name of science of one

group of humans exploiting another has made it necessary to

establish elaborate rules and procedures to protect human

participants in research.“

Korenman, Teaching the Responsible Conduct of Research in Humans, 1994

Codes and Regulations

• 1947: Nuremberg Code– First international Code of research

ethics• 1964: Declaration of Helsinki– First international agreement

recommending ethical standards for clinical research

• 1979: Belmont Report– Ethical principles and guidelines for

the protection of human subjects in research (US)

3 Fundamental Principles of Research Ethics

Respect for persons

JusticeBeneficence

1 - Respect for Persons

Each individual:• Is unique and free• Has the right and capacity to decide• Has value and dignity• Has the right to informed consent

2 - Beneficence

Researchers must:• Protect physical, mental and social well-

being• Retain the community perspective• Maximize possible benefits and minimize

possible harms

3 - Justice

Researchers must:• Ensure a fair distribution of risks

and benefits• Conduct equitable recruitment of

research participants• Provide special protection for

vulnerable groups

Questions for You to Think About

• Was this study ethical?

• In what ways were the 3 fundamental principles of research

ethics respected/violated?

The Tuskegee Study of Untreated Syphilis in the Negro Male (1932-1972)

• The PHS examines the progression of untreated syphilis in African-Americans:– Subject group: 616 African-American men

(412 diagnosed with syphilis and 204 controls)

• True nature of the study never explained to patients

• Dr. I. Schatz first medical professional to formally object to the study on moral grounds in 1965

• Only in 1972 Investigations and revelations of journalist J. Heller brought study to immediate end

The Willowbrook Case – Deliberate Infection of Mentally Retarded Children with Hepatitis (1963-66)

• Willowbrook State School in Staten Island: institution for mentally retarded children

• Regular outbreaks of hepatitis due to horrible hygienic conditions –> creation of a medical study to understand the natural history of infectious hepatitis and to test the effects of gamma globulin in preventing or combating the disease

• Deliberate infection of some new residents (children) by feeding them infected feces or giving injections

• Parents were unable to admit their child to Willowbrook without agreeing to the study

CIA medics accused of ‘interrogation research’ on detainees - June 2010

• Human-rights advocacy group alleges CIA medics conducted human research on prisoners in US custody:– Waterboarding practices– Simultaneous vs sequential application of

interrogation techniques– Effects of sleep deprivation

• Relies on previously classified data (heavily redacted documents)

• No evidence lawfulness of monitoring assessed by Office of Legal Counsel

• Lacks actual data

http://phrtorturepapers.org/; Wadman, Nature 2010

http://phrp.nihtraining.com

3 Fundamental Principles - Summary

• Respect for persons Recognition of personal autonomy and dignity, special protection of those with diminished autonomy

• Beneficence Protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm

• Justice Fair distribution of benefits and burdens of research