Encyclopedia of Psychology and Law

come from participation. The Nuremberg Code fur-

ther states that experiments should only be conducted

by scientifically qualified persons, that the results

should yield fruitful results for the good of society,

that all harm to the participant should be avoided, and

that the participant may end the experiment at any

time. The Nuremberg Code was expanded when the

World Medical Association adopted the Declaration

of Helsinki in 1964. The Code established indepen-

dent ethical review committees to oversee all experi-

mental procedures, which set the stage for the later

development of institutional review boards (IRBs).

Although the Nuremburg Code helped to identify

basic ethical principles of research, there were still

instances in which egregious ethical breaches contin-

ued. The Tuskegee Syphilis Study, which began in

1932 and ultimately ended in 1972, was a research

study in which medically ill patients were not offered

effective medical treatment, which became available

during the course of the research. In 1972, the uneth-

ical manner of the research project was made public

and this ultimately led to the 1974 Research Act. The

National Research Act was signed into law, thereby

creating the National Commission for the Protection

of Human Subjects of Biomedical and Behavioral

Research. The charge of the commission was to iden-

tify the basic ethical principles that should underlie

research involving human subjects and to develop

guidelines that should be followed in accordance with

the described principles. The 1979 Belmont Report

emerged as a product of this work group and man-

dated that all researchers gain approval from an IRB

before proceeding with any type of experimentation.

Principles of Beneficence,

Justice, and Respect

The Belmont Report specified the three basic ethical

principles governing scientific research. These include

respect for persons, beneficence, and justice. Respect

for persons specifies that individuals should be treated

as autonomous persons, and those whose decision

making is compromised should be given special pro-

tections and safeguards. Furthermore, participants

must enter into a research setting voluntarily and with

adequate information. Beneficence is applied in the

research setting in that persons are entitled to partici-

pation that is free from harm and that maximizes pos-

sible benefits and minimizes possible harm. The

principle of justice dictates that individuals should be

treated fairly and equally in the research setting,

according to their need, effort, contribution, and merit,

and that all persons must share the responsibility of

research.

The three principles of the Belmont Report are

translated into informed consent by maintaining that

persons are participating of their own free will and that

the benefits to the person outweigh the risks. The

Belmont Report served as the basis for the Code of

Federal Regulations, which was approved in 1978. In

addition, in 1993, the International Ethical Guidelines

for Biomedical Research Involving Human Subjects

were developed. In 2005, the Department of Health

and Human Services released a revised edition of the

Federal Code of Regulations on the Protection of

Human Subjects. Title 45, part 46 of the U.S. Code of

Federal Regulations upholds the application of the

Belmont Report principles and is now generally

accepted as the uniform policy for the protection of

research participants. Outlined are specific definitions

and statements as they apply to both federally and non-

federally funded research projects.

Requirements of Informed Consent

The theory of informed consent to research is that

a research participant is both voluntary and fully

informed about the nature and consequences of an

experimental situation before giving consent to partici-

pate. There are three essential elements to the doctrine

of informed consent: voluntariness, information, and

competency. The first element is that the person volun-

tarily consents to the procedure, in that the individual

chooses freely to participate. To be voluntary, the per-

son must consent without the presence of coercion,

fraud, or duress, which may hinder the person’s deci-

sion-making ability. Stanley and Guido further elabo-

rate that when an individual is consenting to participate

in psychological research, one must consider the envi-

ronment to ensure that the participant’s voluntary status

is not compromised by the setting (e.g., prison, hospi-

tal, school).

Second, an individual must be fully informed of

the proposed research setting to which he or she is

consenting. The disclosure of information, which is

provided in a formal informed consent document to

the research participant, should include a description

of the proposed procedures, its purpose, duration of

the research procedure, the risks and benefits of par-

ticipation, alternatives to participation, and the volun-

tariness of participation. Other issues that should be

disclosed are that the individual has the opportunity to

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