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

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Presentation transcript:

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

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

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 )

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

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

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)

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)

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

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

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

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

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

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