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

Copyright © 2008 Wolters Kluwer Health | Lippincott Williams & Wilkins

Chapter 7

Generating Research Evidence Ethically


Ethical Dilemma in Conducting Research

•A situation in which the rights of study participants are in direct conflict with requirements for a rigorous study


Code of Ethics

•Nuremberg Code •Declaration of Helsinki •Belmont Report •Codes for professional disciplines (e.g.,

by the American Nurses’ Association, American Psychological Association)


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


Potential Benefits and Risks of Research to Participants


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)


Ethical Principles from the Belmont Report (cont’d)

3. Principle of Justice • Right to fair treatment • Right to privacy (confidentiality,

anonymity)


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


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


Content of Informed Consent (cont’d)

•Sponsorship of the study •Participant selection •Potential risks and benefits •Treatment alternatives


Content of Informed Consent (cont’d)

•Confidentiality pledge •Voluntary nature of participation •Participant’s right to withdraw or

withhold information •Information on contacting researcher


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