1. Chapter 10 Research in the Schools: Ethical-Legal Issues Jacob, Decker, & Hartshorne 1

2. Historical Context Nazi Medical Experiments - Nazis conducted inhumane medical experiments, with Jews and other ethnic minorities used as human sacrifices to science. Tuskegee Study - A group of African- American men suffering from syphilis were left untreated, despite the availability of penicillin, in order to study the natural course of the disease. 2

3. Historical Context Willowbrook - Investigators seeking a cure for hepatitis intentionally injected the disease virus into hundreds of children with mentally retardation at Willowbrook State School. U.S. Department of Energy Secret Radiation Experiments - Many of the experimental subjects suffered harmful consequences as a result of exposure to radioactive substances. Subjects included pregnant women, infants, terminally ill patients, poor people, and other vulnerable groups. 3

4. Legal and Ethical Guidelines for the Conduct of Research with Human Subjects The Nuremberg Code The National Research Act of 1974 – Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects (1974) – Federal Regulations for the protection of human research participants issued through the Department of Health and Human Services (HHS; 45 C.F.R. Subtitle A, Part 46) Food and Drug Administration Regulations and Policies Ethical Codes (e.g., NASP-PPE IV. 5) 4

5. The Belmont Report – Three Principles Respect for persons—the obligation to respect the autonomy of individuals and protect individuals with diminished autonomy, Beneficence—the obligation to do no harm, to maximize possible benefits and minimize possible harm, and 5

6. Three Broad Principles (Cont.) Justice—the obligation to ensure that all persons share equally in the burdens and benefits of research. 6

7. HHS Regulations & Research in Public Schools The National Research Act regulations apply to researchers affiliated with universities/institutions that receive federal research funds. Common Rule extends to HHS regulation of human subjects research to projects funded by the U.S. Department of Education. PPRA is only protection of student and family privacy rights specific to the elementary and secondary public school setting. 7

8. HHS Federal Regulations Institutional Review Board for Research Involving Human Subjects (IRB) policies apply to all research involving the use of human subjects conducted by university faculty, staff, or students, if the university receives any federal research funds. 8

9. Human Subjects Human subjects are identified as individuals whose physiologic or behavioral characteristics and responses are the object of study in a research project. Under federal regulations, human subjects are defined as: living individuals(s) about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information. 9

10. Purpose of IRB Review Safeguard the rights and welfare of research participants. Maintain the public trust in science and research. Protect the university/institution from loss of federal funds. Protect the university and the researcher from liability. 10

11. Six Types of Risk Physical Emotional Social Legal Economic Dignitary 11

12. Specific Research Risks pain or physical injury exposure to stressful procedures and possible emotional discomfort or harm invasion of privacy loss of community standing or embarrassment exposure to criminal prosecution loss of employment or potential monetary gain denial of potentially beneficial treatment violations of confidentiality 12

13. Informed Consent Consent Must be Knowingly Given: The investigator informs the participant of all aspects of the research that may be expected to influence willingness to participate Consent Must be “Competent”: The individual giving consent must be legally competent to do so (must be age of majority), otherwise parent permission and child assent are required. Consent Must be Voluntary: must respect individual’s freedom to choose to participate in research or not, as well as to discontinue participation at any time. Must attract consent without coercion or endue enticement or influence. 13

14. Minimal Risk Research In accordance with HHS regulations, some types of minimal risk research do not require the informed consent of the research participants. Minimal risk research generally means that the study poses little likelihood of invasion of privacy, exposure to stress, or psychological, physical, social, legal, or economic harm as a result of participation in the study. 14

15. Scientific Misconduct Reporting research findings in a biased or misleading way. Fabricating or falsifying data. Plagiarism. Taking credit for work that is not your own. 15

16. Plagiarism “Occurs when the words, ideas, or contributions others are appropriated in writing or speech without proper citation or acknowledgement” (McGue, 2000, p. 83). Self-plagiarism is an oxymoron. You may re-use your own words and ideas but you must cite where they were previously published and obtain copyright permission to re-use a significant portion of previously published material. 16

17. Authorship Doctoral students are first author if their dissertation is published. In other situations, authorship should be decided based on the relative scientific contribution of the individuals involved. 17