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 Terminology Provide Examples of the Following Anonymity versus confidentiality Consent Informed Implied Assent Process consent Consent form

Donna B. Konradi, DNS, RN, CNE Terminology Provide 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 Dignity Self-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 Dignity Respect 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 Consent 1. 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 Consent 4. 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 Consent 6. 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 Consent 8. 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 Groups 1. Children 2. Mentally or emotionally disabled 3. Physically disabled 4. Institutionalized 5. 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?