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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