1. Chapter 5 Ethical Concerns in Research

2. Historical Perspective on Ethics Nazi Experimentation in WWII –“medical experiments” –Nuremberg War Crime Trials –Nuremberg Code – basic principles to govern research involving human subjects Tuskegee Syphilis Study –PHS project related to untreated syphilis –Highlights deception and informed consent Human radiation experiments

3. Ethical Standards for the Protection of Research Participants Nuremberg Code (1947) – first set of guidelines Helsinki Declaration (1964) – medical research Belmont Report (1979) – fundamental document for current federal regulations in US Common Rule (1991) – 45 C.F.R. 46 –Federal rules that govern research involving human participants in the US Institutional Review Boards (IRB)

4. Basic Principles of Belmont Report Respect for persons –Proclaims individuals capable of self-determination; thus voluntary consent is essential Beneficence –Obligates researchers to maximize potential benefits and minimize possible harm Justice –Requires the benefits and burdens of research be fairly distributed

5. Informed Consent Arguably the most important ethical standard Refers to telling research participants about all aspects of the research that might reasonably influence their decision to participate Four important elements 1.Subjects are fully aware of nature and purpose of research project 2.Consent is voluntarily given 3.Person has legal capacity to give consent 4.Responsibility for obtaining consent rests with researcher

6. Protecting Vulnerable Subjects Particular precautions must be taken to protect the welfare of subjects that might be considered especially vulnerable or at risk for some reason The following types of subjects might be considered to be vulnerable: children, handicapped, cardiac rehab patients, welfare recipients, prisoners, pregnant women, patients in a mental hospital, etc.

7. Privacy & Confidentiality Privacy – refers to the capacity of individuals to control when and under what conditions others have access to their behaviors, beliefs, and values Confidentiality – refers to treating subject information or responses in a manner so that it is not linked to any specific individual who participated in a study – single-subject research requires particular caution Normally addressed through informed consent

8. Institutional Review Boards IRBs established by federal mandate to assure compliance with governmental regulations IRBs have authority to approve, require modifications, or disapprove research IRB approval required before any aspect of the research involving human subjects may commence

9. Categories of IRB Review Exempt from review Expedited review Full review Dependent upon amount of risk present

10. Criteria for IRB Approval  Risks to subjects are minimized  Risks to subjects are reasonable in relation to anticipated benefits  Selection of subjects is equitable in relation to the purpose of the research and its setting  Informed consent will be sought from each prospective subject or their legal representative  Informed consent will be appropriately documented  Provisions for monitoring data collected to ensure safety of subjects  Provisions to protect privacy of subjects and to maintain confidentiality of data

11. Disclosure of Results Research investigations normally result in some disclosure of the results of the study (e.g., paper, published article, presentation) The preeminent ethical obligation in this regard is not to disclose inaccurate, deceptive, or fraudulent research results To do so undermines the very nature of the scientific process! Proper establishment of authorship.

12. Scientific Misconduct According to the U.S. Public Health Service... –“Misconduct” means 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

13. Ethical Obligations in Research Researcher is responsible for his/her subjects Researcher is responsible for his/her own actions and those of any research aides Subjects must provide informed consent Researcher protects subjects from harm, danger, and discomfort Maintain anonymity and confidentiality Subjects should not be coerced Researcher has responsibility after the investigation is complete to safeguard subject data Honest disclosure of results