Donna B. Konradi, DNS, RN, CNE
GERO 586
Understanding the Ethics of Research
Donna B. Konradi, DNS, RN, CNE
Important Topics Terminology Historical background Codes of Ethics Principles articulated
in the Belmont Report Beneficence Respect for human
dignity Justice
Vulnerable groups Institutional Review
Boards Research Literature
Donna B. Konradi, DNS, RN, CNE
TerminologyProvide Examples of the Following Anonymity versus
confidentiality Consent
Informed Implied Assent Process consent Consent form
Donna B. Konradi, DNS, RN, CNE
TerminologyProvide Examples of the Following Risk/benefit ratio Minimal risk
Donna B. Konradi, DNS, RN, CNE
Principle of Beneficence Freedom from harm Freedom for exploitation Risk/benefit ratios
High anticipated benefit may balance high risks
Donna B. Konradi, DNS, RN, CNE
Respect for Human DignitySelf-determination (autonomy)
Coercion Stipends
Full Disclosure Nature of the study Right to refuse participation Researcher’s responsibilities Risks and benefits associated with participation
Donna B. Konradi, DNS, RN, CNE
Respect for Human DignityRespect
Covert data collection (concealment) Deception
Informed Consent
Donna B. Konradi, DNS, RN, CNE
Principle of Justice Fair treatment (even if choose not to
participate) Right to privacy
Anonymity Confidentiality
Donna B. Konradi, DNS, RN, CNE
8 Elements of Informed Consent1. Statement that the study involves research, an
explanation of the purposes of the research, the duration of the participant’s participation, description of research procedures, and identification of experimental procedures
2. Description of foreseeable risks or discomforts to the participant
3. Description of any benefits to the participants or any others that may be expected from the research
Donna B. Konradi, DNS, RN, CNE
8 Elements of Informed Consent4. Disclosure of
appropriate alternative procedures or courses of treatment
5. Statement describing the extent, if any that confidentiality will be maintained
Donna B. Konradi, DNS, RN, CNE
8 Elements of Informed Consent6. Explanation about any compensation or medical
treatments that may be available if injury occurs, what they may be and where to get further information
7. Explanation of who to contact for answers to questions about the research, research participant’s rights, or whom to contact in the case of a research related injury or adverse effect
Donna B. Konradi, DNS, RN, CNE
8 Elements of Informed Consent8. Statement that participation is voluntary,
that refusal to participate involves no penalty or loss of benefits, that the subject may discontinue participation at any time without penalty or loss of benefits
Donna B. Konradi, DNS, RN, CNE
Vulnerable Groups1. Children2. Mentally or
emotionally disabled3. Physically disabled4. Institutionalized5. Pregnant women
Donna B. Konradi, DNS, RN, CNE
Levels of IRB Review
Exempt Expedited Full Review
Donna B. Konradi, DNS, RN, CNE
Institutional Review Board (IRB) Who serves? Functions
Protection of rights and welfare Voluntary informed consent Benefits exceed risks
Donna B. Konradi, DNS, RN, CNE
Institutional Review Board (IRB) Is the research justified based on current data? Are the steps in the protocol clearly identified? Do the benefits of participation outweigh the
risks of participation? Are participants clearly and completely
informed? Is it likely that this study will contribute in a
meaningful way to the state of the science? Will participants be placed at undue risk?
Donna B. Konradi, DNS, RN, CNE
Ethical Issues Related to Research Scientific misconduct in the conduct of
research Use of animals in research
Donna B. Konradi, DNS, RN, CNE
Critiquing the Ethical Aspects of a Study Harm, discomfort or
psychological distress?
Benefits versus costs (or risks)?
Coercion or undue influence?
Use of vulnerable populations?
Donna B. Konradi, DNS, RN, CNE
Critiquing the Ethical Aspects of a Study Deception? Full disclosure? Protection of
participants’ privacy? IRB review and
approval?
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