Principles

of Human Research
Ethics
Dr. Jonathan D. Moreno
Coursera: Neuroethics
 THE BELMONT REPORT
National Commission for the Protection of
Human Subjects of Biomedical and
Behavioral Research 1979

A. Boundaries between research and practice

B. Ethical principles underlying the conduct of
research:
Respect for persons
Beneficence
Justice
 Respect for Persons
Individuals should be treated as autonomous
agents (capable of self-determination)
Persons with diminished autonomy deserve
protection
Application: Informed consent

 Benecence
Do no harm
Maximize possible benefits and minimize
possible harms
Application: Risk/Benefit assessment
 Jus>ce
Fairness in the distribution of the benefits and
burdens of research (distributive justice)
Application:
Fair procedures and outcomes in the selection of
subjects
Protection of vulnerable subjects
Equitable health care system?
 45CFR.46 Protec>on of Human
Subjects
PHS policy (1966)
National Research Act (1974)
DHEW regulations (1981)
Part A is the Common Rule for 17 Federal
agencies (1991)
Parts B,C,D for vulnerable populations
International Ethical Guidelines for Biomedical
Research Involving Human Subjects

CIOMS/ WHO 2002
Effective application of the Helsinki principles
to developing countries
Proposed guidelines 1982, Guidelines for
ethical review of epidemiological studies 1991,
and revised International guidelines 1993,
currently undergoing revision
International Ethical Guidelines for Biomedical
Research Involving Human Subjects

15 Guidelines with extensive commentary
Informed consent
Research involving children, persons with
mental or behavioral disorders, prisoners,
subjects in underdeveloped communities,
pregnant women
Externally sponsored research
International Ethical Guidelines for Biomedical
Research Involving Human Subjects

Responsiveness to the health needs and
priorities of the community
Reasonable availability
Rights of subjects to compensation for
research injury
 ICH Harmonised Tripar>te Guideline-
GCP, 1996
Objective: to provide a unified standard for the
European Union, Japan, and the U.S.for
mutual acceptance of clinical data by
regulatory authorities
GCPan international ethical and scientific
quality standard for designing, conducting,
recording, and reporting trials that involve the
participation of human subjects
 ICH-Guideline for Good Clinical
Prac>ce

Compliance with this standard provides

public assurance that the rights, safety, and
well-being of trial subjects are protected,
consistent with the principles that have their
origin in the Declaration of Helsinki, and that
the clinical data are credible
 European Union Clinical Trials
Direc>ve, 2001
Risk assessment, ethics committee review,
protection of personal data
Persons incapable of giving legal consent only
included when grounds for expecting direct
benefit, outweighing the risks
Children should be protected but medicinal
products likely to be of value should be tested
 European Union Clinical Trials
Direc>ve, 2001
Others incapable of giving consent should only
be involved when grounds for assuming that
direct benefits outweigh risks
Written consent by legal representative in
cooperation with treating doctor
Participant must consent to scrutiny of
personal information