1. Copyright © 2008 Wolters Kluwer Health | Lippincott Williams & Wilkins Chapter 7 Generating Research Evidence Ethically

2. Copyright © 2008 Wolters Kluwer Health | Lippincott Williams & Wilkins Ethical Dilemma in Conducting Research A situation in which the rights of study participants are in direct conflict with requirements for a rigorous study

3. Copyright © 2008 Wolters Kluwer Health | Lippincott Williams & Wilkins Code of Ethics Nuremberg Code Declaration of Helsinki Belmont Report Codes for professional disciplines (e.g., by the American Nurses’ Association, American Psychological Association )

4. Copyright © 2008 Wolters Kluwer Health | Lippincott Williams & Wilkins Ethical Principles from the Belmont Report 1. Principle of Beneficence: Above all, do no harm Freedom from harm Freedom from exploitation Maximizing benefits to participants and society Maintaining an appropriate risk/ benefit ratio

5. Copyright © 2008 Wolters Kluwer Health | Lippincott Williams & Wilkins Potential Benefits and Risks of Research to Participants

6. Copyright © 2008 Wolters Kluwer Health | Lippincott Williams & Wilkins Ethical Principles from the Belmont Report (cont’d) 2. Principle of Respect for Human Dignity Right to self-determination (absence of coercion) Right to full disclosure (absence of deception or concealment)

7. Copyright © 2008 Wolters Kluwer Health | Lippincott Williams & Wilkins Ethical Principles from the Belmont Report (cont’d) 3. Principle of Justice Right to fair treatment Right to privacy (confidentiality, anonymity)

8. Copyright © 2008 Wolters Kluwer Health | Lippincott Williams & Wilkins Informed Consent Informed consent means that participants: have adequate information about the research can comprehend that information have free choice in deciding whether to participate in or withdraw from the study

9. Copyright © 2008 Wolters Kluwer Health | Lippincott Williams & Wilkins Content of Informed Consent—What Must Be Communicated? Status as a study participant Study goals Type of data to be collected and procedures to be used Nature of participant’s commitment

10. Copyright © 2008 Wolters Kluwer Health | Lippincott Williams & Wilkins Content of Informed Consent (cont’d) Sponsorship of the study Participant selection Potential risks and benefits Treatment alternatives

11. Copyright © 2008 Wolters Kluwer Health | Lippincott Williams & Wilkins Content of Informed Consent (cont’d) Confidentiality pledge Voluntary nature of participation Participant’s right to withdraw or withhold information Information on contacting researcher

12. Copyright © 2008 Wolters Kluwer Health | Lippincott Williams & Wilkins Vulnerable Subjects Children Mentally or emotionally disabled people Severely ill or physically disabled people Terminally ill people Institutionalized people Pregnant women