Essay about Chapter 13

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Chapter 13
Legal and Ethical Issues

Copyright © 2014, 2010, 2006, 2002, 1998, 1994, 1990, 1986 by Mosby, an imprint of Elsevier Inc.

Ethics


The theory or discipline dealing with principles of moral values and moral conduct

Copyright © 2014, 2010, 2006, 2002, 1998, 1994, 1990, 1986 by Mosby, an imprint of Elsevier Inc.

2

Past Ethical Dilemmas in Research





Nazi experiments
Nuremberg Code and its definitions of the terms “voluntary,” “legal capacity,” “sufficient understanding,” and “enlightened decision”
Declaration of Helsinki, 1964

Copyright © 2014, 2010, 2006, 2002, 1998, 1994, 1990, 1986 by Mosby, an imprint of Elsevier Inc.

3

U.S. Federal Guidelines




In 1973, the Department of Health, Education, and Welfare published the first set of proposed regulations on the protection of human subjects, identifying basic ethical principles that underlie the conduct of human research National Research Act, passed in 1974
(Public Law 93-348), created the National
Commission for the Protection of Human
Subjects of Biomedical and Behavioral
Research
Copyright © 2014, 2010, 2006, 2002, 1998, 1994, 1990, 1986 by Mosby, an imprint of Elsevier Inc.

4

Federal Regulations and Policy




Office of Human Research Protection
(OHRP)
45 CFR 46-DHHS Policy for Protection of
Human Research Subjects (Subparts A, B, C,
D)

Copyright © 2014, 2010, 2006, 2002, 1998, 1994, 1990, 1986 by Mosby, an imprint of Elsevier Inc.

5

Belmont Report Principles




Respect for persons
Beneficence
Justice

Copyright © 2014, 2010, 2006, 2002, 1998, 1994, 1990, 1986 by Mosby, an imprint of Elsevier Inc.

6

Respect





Treat individuals as autonomous agents.
Do not use a person as a means to an end.
Allow people to choose for themselves.
Give extra protection to those with limited autonomy. Copyright © 2014, 2010, 2006, 2002, 1998, 1994, 1990, 1986 by Mosby, an imprint of Elsevier Inc.

7

Beneficence




Acts of kindness or charity that go beyond duty Obligations derived from beneficence:





Do no harm
Prevent harm
Prevent evil
Promote good

Copyright © 2014, 2010, 2006, 2002, 1998, 1994, 1990, 1986 by Mosby, an imprint of Elsevier Inc.

8

Justice




Treat people fairly.
Share burdens and benefits of research fairly.
Distinguish procedural justice from distributive (society as a whole) justice.

Copyright © 2014, 2010, 2006, 2002, 1998, 1994, 1990, 1986 by Mosby, an imprint of Elsevier Inc.

9

Principles Applied






Beneficence: sound research design, competent investigators, favorable riskbenefit ratio
Respect: informed consent, respect for privacy Justice: equitable selection of subjects

Copyright © 2014, 2010, 2006, 2002, 1998, 1994, 1990, 1986 by Mosby, an imprint of Elsevier Inc.

10

DHHS Recommendations 1981


General requirements for informed consent





Documentation of informed consent
IRB review of research proposals
Exempt and expedited review procedures for certain kinds of research
Criteria for IRB approval of research

Copyright © 2014, 2010, 2006, 2002, 1998, 1994, 1990, 1986 by Mosby, an imprint of Elsevier Inc.

11

Protection of Human Rights






Right to self-determination
Right to privacy and dignity
Right to anonymity and confidentiality
Right to fair treatment
Right to protection from discomfort and harm

Copyright © 2014, 2010, 2006, 2002, 1998, 1994, 1990, 1986 by Mosby, an imprint of Elsevier Inc.

12

Informed Consent


What it is:



Ongoing process of communications and mutual understanding Shared responsibility for protection

Copyright © 2014, 2010, 2006, 2002, 1998, 1994, 1990, 1986 by Mosby, an imprint of Elsevier Inc.

13

Informed Consent


What it is not:




Piece of paper
One moment in time
Legal contract

Copyright © 2014, 2010, 2006, 2002, 1998, 1994, 1990, 1986 by Mosby, an imprint of Elsevier Inc.

14

Elements of the Informed Consent
Form


If the study involves research:





Purpose of research
Expected duration for subject
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