Reading Reflection Nursing Research

Reading Reflection Nursing Research

Chapter 12

Research Ethics

Research Ethics

Research ethics addresses the rights of people who participate in research studies and the related responsibilities of those who conduct the research

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Examples of Events that Support Need for Ethics Guidelines

Tuskegee Syphilis Study

Experimental measles vaccine

Alcohol use in Native Americans

Gelsinger case

Painted mice

Centenarian study

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Principles of Ethical Conduct in Research

Respect of person

Treat individuals as autonomous agents

Protect individuals with limited ability to make decisions for themselves

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Principles of Ethical Conduct in Research

Beneficence and nonmaleficence sets an obligation to do no harm and to maximize possible benefits

Justice is defined in relation to research as “fairness in distribution,” which is an opportunity to participate but to impose a burden of inequality

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Training

In most cases, there are both local and federal requirements for training in the ethical conduct of research

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Training

During basic training the following topics are covered for researchers:

Historical perspective

Principles of ethical research conduct

Compliance procedures

Informed consent procedures

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Training

During basic training the following topics are covered for researchers:

Risks associated with participation in research

Vulnerable populations

Special situations and populations

FDA regulations

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Training

During basic training the following topics are covered for researchers:

Health Insurance Portability and Accountability Act (HIPAA) requirements

Conflicts of interest

IRB membership

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Responsible Conduct of Research Training

An additional level of research ethics that are required when applying for federal grant support are:

Research misconduct

Data management

Conflict of interest

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Responsible Conduct of Research Training

An additional level of research ethics that are required when applying for federal grant support are:

Collaborative science

Responsible authorship

Mentoring

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Responsible Conduct of Research Training

An additional level of research ethics that are required when applying for federal grant support are:

Peer review

Lab animals

Human subjects

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Institutional Review Boards (IRBs) Membership

Federal guidelines for memberships of IRBs include the following:

At least five members

Expertise and experience related to studies reviewed

Diverse membership

At least one scientist and one nonscientist

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Institutional Review Boards (IRBs) Membership

Federal guidelines for memberships of IRBs include the following:

At least one member that is not affiliated with the parent organization

Members with sensitivity to community attitudes

May not consist entirely of members of one profession

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Application for IRB Approval

Basic information: title, funding, investigators, and training

Characteristics of proposed sample

Investigator experience, professional licenses, and any sanctions or problems related to ethical conduct of research in the past

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Application for IRB Approval

Conflicts of interest

Use of investigational drugs, devices, or recombinant DNA

Environmental concerns, boating safety, use of radioactive and other hazardous materials

Research sites

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Application for IRB Approval

Participant safety

Data safety monitoring board (DSMBs)

Participant privacy, confidentiality, and anonymity

Consent and recruitment procedures

Incentives

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Basic Elements of Informed Consent

There are eight basic elements of informed consent:

Purpose of the research

Possible risks and discomforts

Possible benefits

Alternative procedures or treatment

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Basic Elements of Informed Consent

There are eight basic elements of informed consent:

Procedures to maintain confidentiality

Any compensation for injury

Contact information for members of research team

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Basic Elements of Informed Consent

There are eight basic elements of informed consent:

Statement saying participation is voluntary, refusal to participate will result in any penalty or loss of benefits, and that the participant may withdraw at any time without penalty or loss of benefit

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When Consent Can Be Waived

An IRB may provide waivers of consent for certain types of research:

If secondary data can be completely deidentified

Observation of public behavior

Research on normal educational practices

Quality improvement projects

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Ongoing Consent

Consenting activities are not completed when a signature on the consent form has been completed

Ensure consent process is complete

Remind participant of research context at every encounter

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Issues Related to Ethical Research Conduct

Use of deception

Limits to confidentiality

Translating and understanding consents

Balancing protection and participation

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Issues Related to Ethical Research Conduct

Vulnerable populations

Pregnant women, fetuses, and neonates

Children

Prisoners

Illness and crisis effects

Victims of intimate partner violence

Cognitively impaired

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Issues Related to Ethical Research Conduct

Certificates of confidentiality may be issued by the National Institute of Health to protect the data from forced disclosures

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Institutional Animal Care and Use Committees (IACUCs)

Members include at least one veterinarian

Review studies involving animals

Adhere to federal guidelines for animal research

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The Three Rs

Replacement is using animal tissue rather than live animal where possible

Reduction is using the least number of animals necessary

Refinement is decreasing any pain and distress as much as possible

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Application for Approval for IACUCs

An application for approval of a study using an animal includes:

Investigator qualifications

Procedures that will involve the animals

How pain and discomfort will be minimized

Assurance that the study does not duplicate previous studies, unless necessary

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Application for Approval for IACUCs

An application for approval of a study using an animal includes:

Animal living conditions and veterinary care

Surgical procedures: justification and infection control

Euthanasia procedures

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