Legal and Ethical Issues



Chapter 13

Legal and Ethical Issues

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Ethics

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

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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

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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

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Belmont Report Principles

Respect for persons

Beneficence

Justice

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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.

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Beneficence

Acts of kindness or charity that go beyond duty

Obligations derived from beneficence:

Do no harm

Prevent harm

Prevent evil

Promote good

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Justice

Treat people fairly.

Share burdens and benefits of research fairly.

Distinguish procedural justice from distributive (society as a whole) justice.

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Principles Applied

Beneficence: sound research design, competent investigators, favorable risk-benefit ratio

Respect: informed consent, respect for privacy

Justice: equitable selection of subjects

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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

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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

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Informed Consent

What it is:

Ongoing process of communications and mutual understanding

Shared responsibility for protection

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Informed Consent

What it is not:

Piece of paper

One moment in time

Legal contract

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Elements of the Informed Consent Form

If the study involves research:

Purpose of research

Expected duration for subject

Description of procedures

Identification of experimental procedures

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Elements of the Informed Consent Form

Reasonably foreseeable risks or discomforts

How can risks be minimized?

Reasonably foreseeable benefits for subjects or others

How can benefits be maximized?

What alternative procedures or treatments are available?

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Elements of the Informed Consent Form

Payment: total or prorated

Who has access to records

Probability of random assignment

Special qualifications for investigator

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Institutional Review Boards (IRBs)

Review research projects and ensure that ethical standards are met in relation to the protection of the rights of subjects

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Elements of the
Informed Consent Form

Consents that involve an intervention:

May involve unforeseeable risks

Situations where researcher can terminate subject’s participation

Any additional costs

Consequences and procedures for subject’s early withdrawal

Revelation of new findings

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Elements of the Informed Consent Form

Confidentiality

Compensation for research-related injury

Who can answer questions

About study and research-related injuries

About subject’s rights

Participation is always voluntary

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IRB Role

Assess for “fair” recruitment

Evaluate inclusion and exclusion criteria

Determine investigator-subject relationship

Establish role of IRB in study

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Definition of Human Subject

A living individual about whom an investigator conducting research obtains:

Data through intervention or interaction with the individual

OR

Identifiable private information

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IRB Role

Review consent for

Autonomy

Protection

Risk and benefit

Review consent forms for clarity and process

Additional protections

Assessing risk and benefit

Assessing consent forms and process

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Recruitment

Plans and materials must be reviewed by IRB

Public service announcement or ads must also be reviewed

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Approval Categories

Exempt: low risk, nonvulnerable, not sensitive, short duration (six categories [e.g., educational])

Expedited review: minimal risk (no substantive increase beyond risks of ordinary life), nonvulnerable, nonsensitive topic (nine categories [e.g., chart review, questionnaires])

Full board review

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Full Board Review

All members participate and review

All members participate in discussion and make comments

Decision is rendered by a majority of assembled quorum

No member has a conflict of interest

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Comprehension

Not valid unless subject understands

Responsibility for understanding rests with researcher, who must consider:

Nature of population

Type of information

Circumstance and timing

Language and culture

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Approval Criteria

Risks minimized

Risks balanced by benefit

Subject selection equitable

Procedures for obtaining informed consent

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Approval Criteria

Procedures for consent documentation

Data monitoring provisions

Privacy and confidentiality measures

Safeguards for vulnerable subjects

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Risk Assessment

Probability of harm occurring as a result of participation

Quantified by probability and magnitude

Types: social, legal, physical, economic, psychological

May apply to individual or society

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Benefit Assessment

Valued or desired outcome, an advantage

Quantified by probability or magnitude

Types: medical, psychological, kinship

May apply to individual or society

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Special Considerations

Vulnerable subjects

Children

Prisoners

Mentally disabled persons

Economically disadvantaged

Educationally disadvantaged

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Special Considerations

Vulnerable subjects

Subtle vulnerabilities: language, culture, pregnancy, students, employees, chemical use, health status

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Assurance of Anonymity and Confidentiality

The right to privacy is also protected through individually identifiable health information (IIHI)

IIHI must be de-identified under Health Insurance Portability and Accountability (HIPAA) Privacy Rule.

Data are part of a limited data set, and
data use agreement with the researcher
is in place.

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Health Insurance Portability and Accountability Act of 1996 (HIPAA)

Describes federal standards to protect patients’ medical records and other health information

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Protecting Basic Human Rights of Vulnerable Groups

Research with children-assent

Research with pregnant woman, fetuses, and neonates

Research with prisoners

Research with the elderly

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Appraising the Evidence: Legal and Ethical Aspects of a Research Study

Was the study approved by an IRB or other agency?

Was informed consent obtained from all subjects? How was it obtained?

Were the subjects protected from physical or emotional harm?

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Appraising the Evidence: Legal and Ethical Issues of a Research Study

Were the subjects informed about the purpose of the study?

Were the subjects informed about potential risks?

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Appraising the Evidence: Legal and Ethical Issues of a Research Study

Were benefits maximized and risks minimized?

Was the privacy of subjects safeguarded?

How have data been kept anonymous or confidential?

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Appraising the Evidence: Legal and Ethical Issues of a Research Study

Were subjects coerced or unduly influenced?

Did they have the right to refuse or withdraw without penalty?

Were vulnerable subjects used?

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Appraising the Evidence: Legal and Ethical Issues of a Research Study

Were subjects coerced or unduly influenced?

Did they have the right to refuse or withdraw without penalty?

Were vulnerable subjects used?

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Who is legally and ethically responsible to protect study subjects from physical or mental harm or discomfort?

The researcher

The research team

The nurse

The caregiver

All of the above

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ANSWER: E

RATIONALE: Researchers and caregivers (including nurses) of research subjects must take every precaution to protect people being studied from physical or mental harm or discomfort.

Unethical research studies have taken place in the United States as recently as:

the 1890s

the 1940s

the 1970s

the 1990s

None of the above

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ANSWER: D

RATIONALE: Despite the supposed safeguards provided by federal guidelines, some of the most atrocious, and hence memorable, examples of unethical research studies took place in the United States as recently as the 1990s. The example given is the UCLA Schizophrenia Medication Study.

At what grade level should informed consent be written?

Third grade

Sixth grade

Eighth grade

Twelfth grade

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ANSWER: C

RATIONALE: The language of the consent form must be understandable. For example, the reading level should be no greater than eighth grade for adults, and the use of technical research language should be avoided.

At what age can children give sole consent to research?

6 years

14 years

18 years old

21 years old

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ANSWER: B

RATIONALE: In terms of the work by Piaget regarding cognitive ability, children at age 6 and older can participate in giving assent. Children at age 14 years and older, although not legally authorized to give sole consent unless they are emancipated minors, can make such decisions as capably as adults. But this decision should be decided by the internal review board, or IRB.

Which term refers to subjects’ identity not being identifiable or linked to their individual response even by the researcher?

Anonymity

Confidentiality

HIPPA

Privacy

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ANSWER: A

RATIONALE: Anonymity refers to the subject’s identify not being identifiable or linked to their individual response even by the researcher. Confidentiality means that individual identities of subjects will not be linked to the information they provide and will not be publicly divulge. Privacy means that the patients information will not be shared with others and HIPPA is the legal guidelines followed for patient information.


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