A GUIDE TO RESEARCH ETHICS - Health Sciences

1 A GUIDE TO RESEARCH ETHICS UNIVERSITY OF MINNESOTA CENTER FOR BIOETHICS 20032 TABLE OF CONTENTS BACKGROUND AND DEFINITION .. Page 3 RESEARCH ETHICS ISSUES Authorship .. Page 8 Plagiarism .. Page 11 Peer review .. Page 15 Conflicts of interest .. Page 19 Data management .. Page 22 RESEARCH misconduct .. Page 27 RESEARCH with animals .. Page 31 RESEARCH with human subjects .. Page 35 GLOSSARY OF CLINICAL TRIAL TERMS .. Page 43 REFERENCES .. Page 51 3 Photo of the Nuremberg Palace of Justice Photo by: Thomas J.

2 Dodd Papers, Dodd RESEARCH Center, University Libraries, University of ConnecticutRESEARCH ETHICS : BACKGROUND AND DEFINITION DEFINITION RESEARCH ETHICS provides guidelines for the responsible conduct of biomedical RESEARCH . In addition, RESEARCH ETHICS educates and monitors scientists conducting RESEARCH to ensure a high ethical standard. BRIEF HISTORY The birth of modern RESEARCH ETHICS began with a desire to protect human subjects involved in RESEARCH projects. The first attempt to craft regulations began during the Doctors Trial of 1946-1947.

3 The Doctors Trial was a segment of the Nuremberg Trials for Nazi war criminals (see photo*). In the Doctors Trial, 23 German Nazi physicians were accused of conducting abhorrent and torturous experiments with concentration camp inmates. The accused physicians tortured, brutalized, crippled, and murdered thousands of victims in the name of RESEARCH . Some of their experiments involved gathering scientific information about the limits of the human body by exposing victims to extreme temperatures and altitudes.

4 The most gruesome and destructive experiments tested how quickly a human could be euthanatized in order to carry out the Nazi racial purification policies most efficiently. To prosecute the accused Nazi doctors for the atrocities they committed, a list of ethical guidelines for the conduct of RESEARCH the Nuremberg Code were developed. * Thomas J. Dodd Papers website. Accessed 2/05/03. 4 The Nuremberg Code consisted of ten basic ethical principles that the accused The 10 guidelines were as follows: 1.

5 RESEARCH participants must voluntarily consent to RESEARCH participation 2. RESEARCH aims should contribute to the good of society 3. RESEARCH must be based on sound theory and prior animal testing 4. RESEARCH must avoid unnecessary physical and mental suffering 5. No RESEARCH projects can go forward where serious injury and/or death are potential outcomes 6. The degree of risk taken with RESEARCH participants cannot exceed anticipated benefits of results 7. Proper environment and protection for participants is necessary 8.

6 Experiments can be conducted only by scientifically qualified persons 9. Human subjects must be allowed to discontinue their participation at any time 10. Scientists must be prepared to terminate the experiment if there is cause to believe that continuation will be harmful or result in injury or death The Nuremberg guidelines paved the way for the next major initiative designed to promote responsible RESEARCH with human subjects, the Helsinki Declaration. The Helsinki Declaration was developed by the World Medical Association and has been revised and updated periodically since 1964, with the last update occurring in The document lays out basic ethical principles for conducting biomedical RESEARCH and specifies guidelines for RESEARCH conducted either by a physician, in conjunction with medical care, or within a clinical setting.

7 The Helsinki Declaration contains all the basic ethical elements specified in the Nuremberg Code but then advances further guidelines specifically designed to address 5 the unique vulnerabilities of human subjects solicited to participate in clinical RESEARCH projects. The unique principles developed within the Helsinki Declaration include: The necessity of using an independent investigator to review potential RESEARCH projects Employing a medically qualified person to supervise the RESEARCH and assume responsibility for the Health and welfare of human subjects The importance of preserving the accuracy of RESEARCH results Suggestions on how to obtain informed consent from RESEARCH participants Rules concerning RESEARCH with children and mentally incompetent persons Evaluating and using experimental treatments on patients

8 The importance of determining which medical situations and conditions are appropriate and safe for RESEARCH Following the Helsinki Declaration, the next set of RESEARCH ETHICS guidelines came out in the Belmont Report of 1979 from the National Commission for the Protection of Human Subjects of Biomedical and Behavioral RESEARCH . The report outlines: 1. The ethical principles for RESEARCH with human subjects 2. Boundaries between medical practice and RESEARCH 3. The concepts of respect for persons, beneficence, and justice 4.

9 Applications of these principles in informed consent (respect for persons), assessing risks and benefits (beneficence), and subject selection (justice)3 The Nuremberg, Helsinki, and Belmont guidelines provided the foundation of more ethically uniform RESEARCH to which stringent rules and consequences for violation were attached. Governmental laws and regulations concerning the responsible conduct of RESEARCH have since been developed for RESEARCH that involves both human and animal 6 subjects. The Animal Welfare Act provides guidelines and regulations for RESEARCH with animals.

10 It goes into detail about sale, licensure, facilities, transport, and other care instructions. For RESEARCH with human subjects Title 45, Part 46 from the Code of Federal Regulations (45 CFR 46): The Protection of Human Subjects Regulations outlines the purpose and policies of Institutional Review Board (IRB) oversight and approval, informed consent, and protections and policies for RESEARCH with children, pregnant women, fetuses, prisoners, and mentally incompetent individuals. Currently, the focus of RESEARCH ETHICS lies in the education of researchers regarding the ethical principles behind regulations as well as the oversight and review of current and potential RESEARCH projects.