RESEARCH ETHICS

ETHICS

refers to the rules of conduct recognized in certain associations or departments of human life ( Simpson, 2004). these are moral principles that govern a person’s behavior.

RESEARCH ETHICS

refers to the rules of conduct recognized in certain associations or departments of human life ( Simpson, 2004)

Research Ethics

concerned with the responsibility of the researchers to be honest and respectful to all individuals who are involved in research study the conduct of research should NOT inflict harm on researcher as well as research subjects

Ethical guidelines

developed consistent with the rules and norms of human behavior based on Christian Morality and Ethics.

The Universal Declaration of Human Rights

no one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment.

NUREMBERG CODE

was developed in 1949 borne out of the Nuremberg trials. done primarily due to sadistic treatment of subjects by Nazi experimenters. rules were formulated to guide investigators in their conduct of research

NUREMBERG CODE

1949

DECLARATION OF HELSINKI

adopted by the World Medical Association in 1964 main contribution was the introduction of the distinction between therapeutic and non therapeutic research.

DECLARATION OF HELSINKI

1964

CIOMS GUIDELINES ( Council for International Organization in Medical Science)

formally known as the International Ethical Guidelines for Biomedical Research Involving Human Subjects it is a set of 21 ethical principles and guidelines regarding human experimentation created in 1933 it address the issues on informed consent, external review, recruitment of participants

CIOMS GUIDELINES

1933

CIOMS GUIDELINES

a set of 21 principles

BELMONT REPORT

July 12, 1974, National Research Act was signed into law thereby creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

BELMONT REPORT

July 12, 1974

National Research Act

was signed into law thereby creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

BELMONT REPORT CONSIDERATIONS

boundaries between biomedical & behavioral research assessment of risk benefit criteria for the respondents guidelines in selection of human subjects informed consent

CODE OF ETHICS FOR NURSES

the code served as the standard for nurses’ performance worldwide since it was first adopted in 1953

CODE OF ETHICS FOR NURSES

1953

INFORMED CONSENT

participants must be fully informed about the nature of research, its purpose and potential risks and benefits. must have the power of free choice to voluntary consent or decline in case of children, an assent form should be obtained.

BENEFICENCE AND NONMALEFICENCE

this means “to do good” and “to do no harm”

Beneficence and non maleficence

CONSIDERATIONS: freedom from any physical & psychological harm freedom from exploitation

RESPECT FOR HUMAN DIGNITY

rights of all involved in the study must be protected and respected. it includes: right to self-determination right to full disclosure right to remain anonymous or right to confidentiality of personal information

JUSTICE AND FAIRNESS

participants deserve fair and equitable treatment before, during, and after the study period. CONSIDERATIONS: right to fair treatment anonymity and confidentiality right to intellectual property

Nazi Experiments

~ World War II (1939–1945), Nazi doctors and scientists conducted inhumane medical experiments in Germany.

~ 23 Nazi physicians and administrators were indicted at the Nuremberg Doctors’ Trial (1946–1947, Germany)

~focused on survival, military advantage, and racial ideologies, immense suffering, permanent injuries, and death

~ Led to the creation of the Nuremberg Code (1949), the basis of modern medical ethics and human research protections

Tuskegee syphilis study

notorious and unethical medical experiment conducted by

the U.S. Public Health Service between 1932–1972

~Involved 600 Black men (399 with syphilis, 201 without) from Macon County, Alabama.

Henderson Act (1943)

requiring syphilis treatment

Monster study

a speech experiment conducted in 1939 at the University of Iowa

It involved 22 orphan children, divided into groups receiving either positive or negative speech therapy

NAZI EXPERIMENTS

1946–1947

23

Nazi physicians and administrators

TUSKEGEE STUDY

600 Black men (399 with syphilis, 201 without)

TUSKEGEE STUDY

1932–1972

MONSTER STUDY

1939