Chapter005

Copyright © 2010 Wolters Kluwer Health | Lippincott Williams & Wilkins

Chapter 5

Ethics in Research


Codes of Ethics

• Nuremberg Code

• Declaration of Helsinki

• Belmont Report and subsequent government-imposed codes

• Codes for professional disciplines (e.g., by the American Nurses’ Association)


Ethical Dilemmas

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


Ethical Principles: The Belmont Report

• Beneficence

• Respect for Human Dignity

• Justice


Beneficence

• Principle of Beneficence: Above all, do no harm

• Right to protection from harm and discomfort

–Beneficence—maximize good

–Nonmaleficence—minimize harm

• Right to protection from exploitation


Question

Is the following statement True or False?

• The Nuremberg Code was one of the first established sets of ethical standards.


Answer

• True

– One of the first international efforts to establish ethical standards was the Nuremberg Code.


• Principle of Respect for Human Dignity

– Right to self-determination (absence of coercion)

– Right to full disclosure (absence of deception or concealment)

Respect for Human Dignity


• Principle of Justice

– Right to fair treatment

– Right to privacy (confidentiality, anonymity)

Justice


• Risk-benefit assessments

• Informed consent

• Confidentiality procedures

• Debriefings and referrals

• Special treatment of vulnerable groups

• Institutional Review Boards and external reviews

Procedures for Protecting Study Participants


Potential Benefits To Study Participants• Access to a potentially helpful intervention that

might otherwise be unavailable

• Comfort in ability to discuss situation with a friendly, objective person

• Increased self-knowledge (via introspection or direct interaction with researchers)

• Escape from normal routine

• Satisfaction that information could help others with similar problems or conditions

• Direct monetary or material gains through stipends or other incentives


Potential Risks To Study Participants• Physical harm, discomfort, fatigue, or boredom

• Psychological distress resulting from self-disclosure, introspection, fear of the unknown, discomfort with strangers, anger or embarrassment at the type of questions being asked

• Social risks, such as the risk of stigma, adverse effects on personal relationships, loss of status

• Loss of privacy

• Loss of time

• Monetary costs (e.g., for transportation, time lost from work)


Question

The principle of justice ensures a research subject’s right to which of the following?

a. Self-determination

b. Full disclosure

c. Protection from harm

d. Privacy


Answer

d. Privacy

• The principle of justice ensures a research subject’s right to privacy and fair treatment. The right to self-determination and full disclosure are ensured by the principle of respect for human dignity. The right to protection from harm is ensured by the principle of beneficence.


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


Informed Consent (cont.)

• Typical documentation: A consent form

– Implied consent (e.g., for self-administered questionnaires)

– Process consent (renegotiated over time, qualitative studies)


Confidentiality Procedures

• Anonymity—Even researcher is unable to link participants to their data

• Confidentiality Pledge—A promise to safeguard data and identifying information from others

• Certificate of Confidentiality—A certificate obtained to prevent forced disclosure of confidential information to authorities


Vulnerable Subjects

• Vulnerable subjects are study participants who require special protections.

– Some (e.g., children) cannot make a truly informed decision about voluntary participation.

– Others (e.g., pregnant women) are at higher-than-average risk.


Groups Considered Vulnerable

• Children

• Mentally/emotionally disabled people

• Severely ill or physically disabled people

• Terminally ill people

• Institutionalized people

• Pregnant women


External Review

• Ethical aspects of a study are increasingly likely to be reviewed before permission is granted to conduct a study.

– Human subjects committees

– Institutional Review Boards (IRBs)

– Research Ethics Boards (REBs—in Canada)


Question

Is the following statement True or False?

• Children require special protection when they are involved in a research study.


Answer

• True

– Children, because of their inability to make a truly informed decision about voluntary participation in a research study, are considered vulnerable and thus require special protection.


Other Ethical Issues

• Ethical use of animal subjects

• Research misconduct

– Plagiarism

– Fabrication of results

– Falsification of data


End of Presentation

Chapter005

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