2-Research ethics (2).pptx

educational

1. ETHICS IN RESEARCH

2. Introduction Required for human and animal research Unethical research e.g. Nazi medical experiments of 1930s and 40s[harm and no voluntary participation), between 1932 and 1972, the Tuskegee Syphilis Study [ withholding treatment] Code of ethics developed in response to human rights violations during research Nursing and medicine have developed own ethics eg I CN Code of Ethics for Nurses

3. Helsinki declaration World Medical Association (WMA) DECLARATION OF HELSINKI – ETHICAL PRINCIPLES FOR MEDICAL RESEARCH INVOLVING HUMAN PARTICIPANTS Versions from June 1964-October 2024 Basic ethical principles: Autonomy, Dignity, Respect, Justice, Privacy, confidentiality Some General Principles Health and well being of patients/participants Safeguard patient/participant rights Medical research is subject to ethical standards that ensure respect for patients and protect their health and rights

4. Some General Principles[continued] Main purpose of medical research involving human participants is individual and public health. However, this purpose can never take precedence over the rights and interests of individual research participants Even in emergencies, uphold the ethical principles in human research Consider Country the ethical, legal and regulatory norms and standards The responsibility for the protection of research participants must always rest with physicians or other researchers and never with the research participants, even though they have given consent.

5. Specific ethical considerations The Right to freedom from harm and discomfort : Including physical, social, financial, emotional, spiritual harm/discomforts. Anticipate and be explicit of these and put strategies to minimize them The right to protection from exploitation. This emergences especially where there is power asymmetries e.g. nurse VS patient, employer VS employee, research with vulnerable participants The right to self-determination: Deals with issues of informed and voluntary participation, freedom from coercion, use of incentives The right to full disclosure: Full study description, harm/benefits disclosure. Consent is based on self-determination and full disclosure. The right to fair treatment: concerns discrimination, burden/benefits of research, nonprejuducial treatment. The right to privacy: information confidentiality, identity pr

6. Risks, Burdens, and Benefits Medical interventions often involve risks and burdens Harm: Benefit ratio considered Current study approved by ethics board following assessment of risk and burden Benefits: incentive used cautiously

7. Strategies for protecting participants Potential benefits/risks assessment I nformed consent. Implied consent and process consent are subtypes of consent Observing confidentiality: anonymity and promise of confidentiality Debriefings and Referrals Consider level of vulnerability External r eviews by institutional review boards/committees

8. Implied consent refers to a type of consent that is not expressly stated but is inferred from a person's actions, facts, or circumstances. It is commonly used in healthcare, research, and legal settings when it is reasonable to assume that a person has agreed to something based on their behavior or the situation. Examples of Implied Consent: In Healthcare: A patient extends their arm for a blood draw without saying anything . This action implies they consent to the procedure. An unconscious patient brought to the emergency room receives life-saving treatment. It's assumed they would consent if they were conscious—this is emergency implied consent.

9. In Law Enforcement (some jurisdictions): By obtaining a driver’s license, a person is considered to have given implied consent to submit to alcohol or drug testing if suspected of impaired driving.

10. Process consent is the continuous negotiation of consent throughout the duration of a relationship, project, or treatment. It recognizes that consent is not a one-time event but an ongoing dialogue that must be revisited regularly. Key Principles of Process Consent: Ongoing : Consent is revisited at multiple points, especially after significant changes (e.g., in procedures, risks, or participant understanding). Dynamic : It responds to the changing needs, experiences, and emotions of the participant. Participant-Centered : Ensures that the individual continues to fully understand and voluntarily agree to participate or receive treatment. Respectful : Prioritizes autonomy, allowing participants to withdraw or renegotiate consent at any point.

11. Ethical dilemmas in research Conduct of rigorous research can conflict with application of ethical principles resulting into ethical dilemmas for researchers What ethical principles and dilemmas are involved in these e xamples? Does a new medication reduce forgetfulness in Alzheimer's disease? How well do nurses apply the nursing process in their clinical practice? What is the lived experience of informal carers of palliative care patients?

12. Critical thinking questions What are the ethical dilemmas and solutions associated with full disclosure and confidentiality? e.g. Observing participant behaviour while they are aware Studying illegal/immoral behaviour e.g. drug abuse, prostitution, sexual activity Subpoenas versus certificate of confidentiality Is participants’ deception and concealment[covert data collection] justifiable? Using a table map each of the specific ethical considerations into the basic ethical principles How do research ethical issues with animals differ from humans? How do research ethics observations in quantitative and qualitative research different?

13. Is participants’ deception and concealment[covert data collection] justifiable? It can sometimes be justified, but only under strict conditions , and must align with established ethical guidelines such as those by the Belmont Report, Declaration of Helsinki, or institutional ethics review boards. When it may be justifiable : 1. Scientific Value: The research must address a significant question that cannot be answered without deception or covert data collection. 2. Lack of Alternatives: There are no viable non-deceptive methods to obtain the needed data.

14. 3. Minimal Risk : The procedure must not cause harm, distress, or significant discomfort to participants. 4. Debriefing Afterwards: Participants must be fully informed of the deception as soon as possible after the study, and given the opportunity to withdraw their data. 5. Ethical Review Approval: An independent ethics committee must review and approve the deception.

15. When it is not justifiable : If it violates the dignity, autonomy, or well-being of participants. If it involves vulnerable populations without extra safeguards . If participants would have likely refused participation had they known the truth. If harm, psychological distress, or legal consequences may result.

16. Example: A study observing how people behave in public spaces without their knowledge (e.g., watching if people pick up litter) may be considered ethical if: It's in a public area (where there’s no reasonable expectation of privacy), The observation is non-intrusive, The data are anonymized, and There is later debriefing if applicable.

17. Deception and concealment can be justifiable— but only under stringent ethical controls. Researchers must weigh the scientific benefits against the potential ethical harms, always respecting participants' rights as much as possible.

18. Ethical Principle Specific Ethical Consideration Explanation 1.Respect for Persons Informed Consent Participants must voluntarily agree to participate, understanding all relevant information about the study. Right to Withdraw Participants must be free to leave the study at any time without penalty. Deception/Concealment (requires debriefing) May only be used when justified; respect for autonomy demands later disclosure and consent to use collected data. Privacy and Confidentiality Protecting personal information shows respect for individuals’ control over their data. 2.Beneficence Risk-Benefit Assessment The study must minimize harm and maximize potential benefits to participants or society. Minimizing Harm Ensuring psychological, physical, and social harm is as low as possible.

19. Monitoring for Adverse Effects Researchers should observe participants during the study to identify and mitigate any unforeseen negative outcomes. Justice Fair Participant Selection Ensuring that the benefits and burdens of research are equitably distributed across different groups in society. Avoiding Exploitation of Vulnerable Populations Extra protections must be provided for children, the elderly, or socioeconomically disadvantaged individuals. Equitable Access to Benefits No group should unfairly receive the risks of research without access to its potential benefits.

20. Quantitative vs. Qualitative Research Ethics Ethical Aspec t Quantitative Research Qualitative Research Nature of Interaction Often limited or structured; minimal direct contact with participants Close, ongoing, and often personal interaction with participants Informed Consent Standardized and typically obtained once at the start More process-oriented ; may require ongoing or evolving consent Privacy & Confidentiality Focus on anonymized data and secure databases Must handle sensitive personal narratives carefully and respectfully

21. Risk of Harm Often low if surveys or experiments are non-invasive Higher potential for emotional or social harm due to sensitive topics Deception Sometimes used in experiments; requires debriefing afterward Rarely used; honesty and trust are essential Participant Role Seen more as subjects who provide data Seen as co-creators or collaborators in generating meaning Data Collection Structured tools like surveys or instruments Open-ended methods like interviews or observations Data Interpretation Often statistical; less chance of researcher bias if done properly Subject to interpretive bias ; must guard against misrepresentation Ethical Review Process Focus on risk level, consent forms, and instrument validation Greater emphasis on contextual sensitivity , reflexivity, and confidentiality

22. Kenya Research Ethics Ecosystem Government bodies protect participants by enacting laws eg Kenya National Commission for Science ,Technology and Innovation(NACOSTI) formed National Scientific and Ethics Committee (NSEC) in 2021 NSEC offers guidelines and create accreditation standards for Institutional Ethics Review Committees (IERC) NSEC is committed to enabling and supporting ethical research in Kenya through protecting rights, safety, dignity and wellbeing of research participants. NACOSTI also provide Research License with ethical approval from IERC as one of requirements

23. READING ASSIGNEMENT Methods of anonymization Pseudonymization Data swapping Generalization Data masking Data perturbation

24. 1.Pseudonymization Pseudonymization is a data de-identification technique where identifiable fields within a data record are replaced with artificial identifiers or "pseudonyms." How it works: Names, ID numbers, or emails are replaced with codes or fake values. A key or mapping file exists that can reverse the process, but it is kept secure and separate. Use case: Research where identity must be protected but data may need to be linked later. GDPR considers this a privacy-enhancing measure, not full anonymization.

25. 2. Data Swapping (Permutation) Definition: Data swapping involves rearranging attribute values within a dataset to break the direct link between individuals and their data without changing overall statistics. How it works: Two or more records exchange values of sensitive attributes (like age, income) randomly.

26. Example (Before Swapping): Name Age Salary Alice 30 $40K Bob 45 $70K After Swapping: Name Age Salary Alice 45 $40K Bob 30 $70K

27. 3. Generalization 📌 Definition: Generalization reduces the specificity of data by replacing exact values with broader categories , making it less likely to identify individuals. ✅ How it works: Precise information is replaced with more general descriptions. 📊 Example: Date of Birth "1990-06-12" → Year of Birth "1990" Age 27 → "20–30" Location “Kasarani, Nairobi” → “Nairobi County”

28. 4. Data Masking 📌 Definition: Data masking is the process of hiding original data with modified or obscured values, typically used in non-production environments (e.g., training or testing databases). ✅ How it works: Characters or digits are replaced with random values or symbols. Real data is inaccessible to unauthorized users. 📊 Example: Name Credit Card Number Sarah 4520---1123

29. 5. Data Perturbation 📌 Definition: Data perturbation involves modifying data slightly by adding random noise or errors to prevent exact identification while retaining statistical usefulness. ✅ How it works: Numeric data is changed by a small, random value. Ensures that the aggregate statistics (e.g., mean, variance) are preserved. Example: Original salary: $50,000 Perturbed salary: $49,800 or $50,200

30. Method Key Idea Can Be Reversed? Use Case Pseudonymization Replace identifiers with codes Yes (with key) Research needing re-identification Data Swapping Swap values between records No Statistics, census data Generalization Replace precise values with broader ones No Data anonymization in research Data Masking Hide data with fake/obscured values No Software testing, training Data Perturbation Add noise to data No Privacy-preserving data analysis