the rights of people
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
