Donna B. Konradi, DNS, RN, CNE GERO 586 Understanding the Ethics of Research.

Donna B. Konradi, DNS, RN, CNE

GERO 586

Understanding the Ethics of Research


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


TerminologyProvide Examples of the Following Anonymity versus

confidentiality Consent

Informed Implied Assent Process consent Consent form


TerminologyProvide Examples of the Following Risk/benefit ratio Minimal risk


Principle of Beneficence Freedom from harm Freedom for exploitation Risk/benefit ratios

High anticipated benefit may balance high risks


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


Respect for Human DignityRespect

Covert data collection (concealment) Deception

Informed Consent


Principle of Justice Fair treatment (even if choose not to

participate) Right to privacy

Anonymity Confidentiality


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


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


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


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


Vulnerable Groups1. Children2. Mentally or

emotionally disabled3. Physically disabled4. Institutionalized5. Pregnant women


Levels of IRB Review

Exempt Expedited Full Review


Institutional Review Board (IRB) Who serves? Functions

Protection of rights and welfare Voluntary informed consent Benefits exceed risks


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?


Ethical Issues Related to Research Scientific misconduct in the conduct of

research Use of animals in research


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?


Critiquing the Ethical Aspects of a Study Deception? Full disclosure? Protection of

participants’ privacy? IRB review and

approval?

Donna B. Konradi, DNS, RN, CNE GERO 586 Understanding the Ethics of Research.

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