1. Ethical Concerns in Research
Ethical standards providing direction for conducting research
Researchers must consider the ethical principles and regulations that guide research activities

2. Basis of Ethics in Research
Integrity of scientific method is founded on the professional conduct of the researcher
Dishonest, fraudulent or unethical researches can circumvent the scientific method
Without moral principles, protective measures and a system of ethical standards that oblige researchers to follow certain rules, scientific misconduct and dishonestly will occur
Existence of ethical standarsd does not guarantee ethical behavior

3. Examples - Unethical Behavior
Nazi “Medical” Experiments
The “Doctors Trial” - Nuremberg War Crime Trials (Gang of 23)
Medical experiments on prisoners, inmates, “others” without consent [cruelties, tortures, other inhuman acts]
Examples - Freezing; Malaria; high altitude; underwater; starvation; sound; mental
Nuremberg Code (1947)- Set of principles governing ethical conduct of research with humans

4. Tuskegee Syphilis Study
Examples - Unethical Behavior
Tuskegee Syphilis Study
* USPH study in Macon County, AL to investigate the long-term effects of untreated syphilis
* African Americans recruited to participate to death [not told of purpose of study, that they had disease; no treatment offered (not available at time of study, but came available 8 yr later); offered illegal inducements; doctors and army told not to treat under any circumstances.
* Study continued for 40 yr; in 1972 it was stopped because of newspaper article.
* US government agreed to out-of-court settlement

5. Ethics
Concerned with human behavior from a perspective of right or wrong.
Ethical statements are developed to “prescribe behaviors (directives) telling us what we ought to do in situations” [define our values in terms of acceptable behaviors]
Ethics vary from one person to another, from one group to another and from one culture to another
How, then, can be define normative ethics that apply to all?
Situational ethics v Normative ethics - What to do?

6. Ethics Debate <http://www.wma.net/e/policy/17-c_e.html>
Governments and organizations embrace normative standards, knowing it will not prevent unethical behavior, but without guiding principles responsible conduct will be jeopardized and knowledge devalued.
(1947) Nuremberg Code - first attempt to develop ethical standards for conducting research on humans
(1964) Declaration of Helsinki - World Medical Assoc Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects - Revised 1975, 1983, 1989, 2000
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7. Nuremberg Code Voluntary human consent is essential
Experimental results should results in good for society
Anticipated results should justify the experiment
Avoid all unnecessary physical and mental suffering
No experiment if there is a chance of death/disability
Minimize risk of subjects
Proper preparations and facilities to protect subjects
Experiments conducted only by qualified persons
Subjects can withdraw at anytime
Terminate experiment if results are known or with best judgement

8. USA National Research Act
National commission for the protection of human subjects - formulated ethical principles and guidelines for conducting research with humans - The Belmont Report
Respect for persons - proclaiming respect for individuals as autonomous agents with self-determination
Beneficence - obligating researchers to protect persons from harm and to maximize possible benefits and minimize harms
Justice - protect selection of subjects

9. 2000 - DHHS Office of Human Research Protection
DHHS “Common Rule”
Code of Federal Regulations
“… all research involving human subjects be reviewed by an Institutional Review Board (IRB)
DHHS Office of Human Research Protection
Guidelines on human subjects protection “protected by law”

10. Informed Consent First provision of Nuremberg Code:
“voluntary consent of human subject is absolutely essential”
Subjects are made fully aware of nature and purpose of research
Consent is voluntarily given
Persons involved have the legal capacity to give consent
Responsibility for obtaining consent rests with the researcher

11. Informed Consent
Explain purpose of research and expected duration of participation; description of procedures
Description of any risks or discomforts to subject
Description of benefits to subjects
Disclosure of appropriate alternative treatments if any exist
Describe protection of confidentiality of personal records
If there is risk, describe precautions and treatments available

12. Research Involving Children, Prisoners or Pregnant Women
Special protection of “vulnerable subjects” in terms of consent and disclosure

13. Privacy and Confidentiality
Privacy - capacity of individuals to control when and under what conditions others will have access to their behaviors, beliefs and values (control we have over information about ourselves)
Confidentiality - ability to link information or data to a person’s identity (pertains to how personal information that is disclosed may be used)
Researcher responsible for insuring confidentiality of personal information
* Obtain anonymous information * Limit data access
* Code data without names, etc * Report only means
* Substitute surrogate names * Use computerized data ID
* Do not release individual data

14. Research With Animals
1985- U.S. Govt. Principles for the Utilization and Care of Vertebrate Animals Used in Testing
“Guidelines relating to the transportation, care, and use of animals in way that are judged to be scientifically, technically, and humanely appropriate”

15. Disclosure of Research Findings
Accurate and honest disclosure of research findings is part of ethical obligations of researchers
“inaccuracies, deception, fraud undermine the scientific process”

16. Scientific Misconduct
Fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. It does include honest error or honest differences in interpretations of judgments of data.
Possible Penalties: letters of reprimand, salary freeze, reduciton in professional rank, prohibition form obtaining outside grants, fines, dismissal from job, legal action --- students - receive a failing grade, probation, suspended, expelled

17. How to avoid plagiarism: <www.writing.nwu/tips/plag.html>
“presentation of the ideas or works of others as your own without giving proper credit”
How to avoid plagiarism: <

18. Authorship * Issue of order of authorship
* Financial support declaration (sponsored research)
“who owns the data?”
“who controls release of research findings?”
“who controls subsequent research studies?”