The Importance of Ethics and the Protection of Subjects By Westley R The Importance of Ethics and the Protection of Subjects By Westley R. Meredith A Brief History of the Protection of Subjects The Belmont Reports Three Principles How to Avoiding Personal Ethical Conflicts as an Investigator

A brief history Prior to 1906, there were no regulations regarding the use of human subjects in research It was not until 1948 that this issue was touched upon in research, when the Nuremburg Code was established Tuskegee Syphilis Study (1932-1972)- 400 African American males were denied treatment for syphilis, even after the discovery of a cure in penicillin in the 1950s Following the Tuskegee Syphilis Study, the National Research Act (1974) was passed Established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research From the commission came The Belmont Report, the foundational document for the ethics of human subjects research in the United States Obtained from the University of Nevada, Las Vegas

The Belmont Report’s Three Principles Respect for Persons Informed Consent Beneficence Assessment of Risks and Benefits Justice Selection of Subjects

Respect for Persons (Autonomy) "Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy." Obtained from the Belmont Report

Application: Informed Consent Purpose of the research Procedures involved in the research Alternatives available should a subject decide not to participate in the research All foreseeable risks and discomforts to the subject. These include not only physical injury but also possible psychological, social, or economic harm, discomfort, or inconvenience Benefits of the research to society and possibly to the individual human subject Length of time the subject is expected to participate Payment for participation (if applicable) Person to contact for answers to questions or in the event of a research-related injury or emergency Statement that participation is voluntary and that refusal to participate will not result in any consequences or any loss of benefits that the person is otherwise entitled to receive Subjects' right to confidentiality and right to withdraw from the study at any time without any consequences Obtained from Citi Training Program

Beneficence "Persons are [to be] treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being." Two Obligations: Do No Harm Maximize Possible benefits and minimize possible harm Assessment of Risks and Benefits Ensure all possible risks to subject are explored Ensure possible benefits outweigh the possible risks Information obtained from Citi Training Program

Justice The burdens and benefits of the research must be evenly distributed Selection of subjects “The selection of research subjects needs to be scrutinized to determine whether some classes are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied.” In terms student subjects: “Students have the right to be free from any coercion or bias that might result when a researcher is also evaluating them in a course. Therefore, the person recruiting the subjects should be someone other than an instructor of the students. This is to reduce any perception of coercion and to reduce the possibility of bias by the person evaluating the students resulting from knowing who is or isn't participating in the research project.” Information obtained from Citi Training Program & The Belmont Report

Avoiding Ethical Conflict Negotiating an agreement with the partner institution Why is the project being conducted? What are the potential uses for the data? Determine data access and ownership Avoid Role Conflicts Understand your role. Ensure ethical standards are met Tell the Truth/avoid research misconduct Obtained from Upcraft and Schuh

Research Misconduct “Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, reviewing, or in reporting research results.” Fabrication- making up data or results and recording or reporting them Falsification- manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record Plagiarism- the appropriation of another person's ideas, processes, results, or words without giving appropriate credit *Note: Research misconduct does not include honest error Obtained from the Citi Training Program

Summary Review Ethics with subjects Respect the autonomy of the subjects Obtain informed consent with full information given Respect the subjects Protect the confidentiality of the subject Make sure to do no harm to your subjects Never coerce your subject into participation in your research Ethics with self Ask questions!!!!!! Avoid conflict of interests Avoid participation in research misconduct at all levels

References History of research ethics. The Office of Research Integrity - Human Subjects Research, University of Nevada, Las Vegas, Las Vegas, Nevada. Retrieved from <http://research.unlv.edu/ORI-HSR/history-ethics.htm> Research misconduct (2010). The Citi Training Program, Retrieved from <https://www.citiprogram.org/members/learnersII/moduletext.asp?strKeyID=E1510 F0B-EA33-4AEC-8643-C0768F7BDAD9-11491427&module=1495> Upcraft , M. L., & Schuh, J. H. (1996). Assessment in student affairs. (pp. 290-314). San Francisco: Jossey-Bass. U.S. Department of Health and Human Services, Office of the Secretary. (1979). The belmont report. Retrieved from website: <http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html>