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Ethics lecture for beginners in research.pptx
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- 3. What are Ethics? Rules for distinguishing between right & wrong Norms for conduct that distinguish between acceptable and unacceptable behavior Ethical norms are so ubiquitous that u may think of them like common sense Ethical norms are broader & more informal than laws
- 5. Background Post SecondWorld War (1939-45) German doctors accused of conducting experiments on humans without their consent and exposing them to grave risk of death or permanent impairment. Doctors’ Trial- United States authorities held in their occupation zone in Nuremberg, Germany. Doctors were accused of having been involved in Nazi human experimentation and mass murder under the guise of euthanasia
- 6. The firstInternational Statement on the ethics of medical research using human subjects namely, the Nuremberg Code was formulated in 1947 In 1964 at Helsinki, the World Medical Association formulated general principles and specific guidelines on use of human subjects in medical research, known as the Helsinki Declaration, which was revised from time to time A notable change from the Nuremberg Code was a relaxation of the conditions of consent, which was 'absolutely essential' under Nuremberg. Now doctors were asked to obtain consent 'if at all possible' and research was allowed without consent where a proxy consent, such as a legal guardian, was available We follow ICMR code on Ethical guidelines
- 7. Principles of Ethics Respect for Autonomy Beneficence- to do good Non-maleficence- do no harm Justice
- 8. Institutional Ethics Committees The system of prior ethical review of medical research employs to protect the rights and welfare of human participants, ensuring the legal and ethical application of codes of practice of medical research conduct Aims to safeguard the welfare, dignity, and safety of the participants, ensures that ethically approved research is conducted in line with the approved protocol, and pro-motes public confidence in the conduct of human research
- 9. Functions of IEC Prior review of human research proposals, scrutinizing the ethical standards for research conduct in legal framework Observations to the investigators, to modify there search proposal to meet the required ethical standards Decision to approve or reject the research proposal Monitoring the conduct of approved research proposals, ensuring that their conduct continues to conform to the approved protocol Resolution, or referral for resolution, of complaints in relation to the conduct of approved research projects or the conduct of the ethical review of those projects Premature termination and/or suspension of the conduct of a research proposal whenever it becomes evident that continuing conduct will expose participants to greater levels of risk than those approved Accountability and quality assurance by reporting to the relevant institution about its performance
- 10. Composition of IEC Multidisciplinary Multisectorial- social workers, legal advisors, lay persons
- 11. Key Issues inResearch Ethics Informed Consent Patient information sheet Confidentiality Privacy Privileged information Respect & Responsibility
- 12. Informed Consent 3elements-Voluntarism, Information disclosure, Decision- making capacity It refers to an ethical and legal doctrine based on the understanding that all interventions (diagnostic, therapeutic, preventive, or related to scientific studies) in the medical field should only be performed after a participant has been informed about the purpose, nature, consequences, and risks of the intervention and has freely consented to it Waiver- considered by IEC
- 13. Informed Consent Vulnerablepopulations (i.e. prisoners, children, pregnant women, etc.) must receive extra protections In writing, consent document must be written in language easily understood by the participant, it must minimize the possibility of coercion or undue influence, and the subject must be given sufficient time to consider participation Info to be provided in IC: Purpose of study Expectations from participant Responsibility of the investigators Risks & Benefits of intervention/method Alternatives Options to withdraw
- 15. Vulnerable Participants Lacksability to fully consent to participate Minors, Pregnant women, Prisoners, PWD, sex workers, illiterate person, students, women in some settings Can still participate- additional safeguards
- 16. Patient information sheet Title of the research project Invitation to participate in the research Identity of research teams Purpose and significance of research Time commitments Procedures to be followed Benefits expected Risks involved, availability of medicalT/t for such injury/risk Costs and compensation Termination of participation, indication voluntary contribution and alternatives Anonymity and confidentiality Contact details of IEC Chairman- appeal against violation of rights For Genetic & HIV testing- counseling Storage of samples Commercialization- benefit sharing Publications
- 17. Patient & DataSafety Protection of rights, safety and well being of the participants Risk-benefit analysis
- 18. Participant protection Followethical standards Confidentiality- Nondisclosure of certain information except to another authorized person Patient identifiers should not be published
- 19. Confidentiality Nondisclosure ofcertain information except to another authorized person. The concept of confidentiality applies that the information a person reveals to a professional is private and has limits on how and when it can be disclosed to a third party Parameters: Human rights, confidentiality in young persons, domestic violence, true anonymisation of data, validity of consent for disclosure, cancer and genetic registers, fertility, involuntary disclosure, and safeguards
- 20. Confidentiality Parameters NOT breachof confidentiality if anonymity maintained Conventional X-rays Images taken from pathology slides Laparoscopic images of the inside of abdominal cavity Images of internal organs Ultrasound images
- 21. Confidentiality To maintainthe subject confidentiality, the researcher should collect only the data that is really required, should collect anonymous data, store name and data separately by using identification numbers instead of names, use password to protect the data files, and secure the office and computer.
- 22. Privacy Privacy isthe quality of being secluded from the presence or view of others. Privacy in research refers to the right of an individual to make decisions concerning how much information about their physical status, health, social network, and thoughts and feelings will be shared with investigators
- 23. Privileged communication Itincludes conversations within the context of a protected relationship, such as that between doctor and patient, a therapist and client, An attorney and client, a husband and wife, or a priest and penitent; Under common law, privilege involves a number of rules excluding evidence that would be adverse to a fundamental principle or relationship if it were disclosed
- 24. Respect and Responsibility Respect in research refers to respect for people and respect for truth. People have the right to dignity and privacy Responsibility- informed consent, avoiding deception, rewards and incentives, privacy, and disclosure. Maintaining the reputation of educational research by adhering to the highest standards of quality research. When publishing the research, investigators should disclose any competing or financial interests
- 25. Conclusion Ethics ofmedical research on human subjects must be clinically justified and scientifically sound. Informed consent is a mandatory component of any clinical research. Investigators are obligated to design research protocols that establish standards of scientific integrity, safeguard ethical and legislative issues of the human subjects, and follow the protocols for prospective review by independent research ethics committees
- 26. Research misconduct Currently,majority of the research misconduct and irregularities are related to studies funded by the pharmaceutical industry and strongly linked with the financial interests of this industry. Technical faults in the research design, wrong recruitment process, insufficient sample size, and weak statistical analysis of the data often lead to non-publishable research. Another form of research misconduct is the procedural irregularities by misinterpreting the trial data, attempting to draw favorable conclusions than those warranted by the available data
- 27. What is Plagiarism? •Using other peoples’ ideas and words without clearly acknowledging the source of that information. • It's plagiarism whether you use – a whole document – a paragraph – a single sentence – a distinctive phrase – a specialized term – specific data – a graphic element of any kind 13:28:34 Source: http://www.english.vt.edu/~IDLE/plagiarism/plagiarism2.html
- 28. 13:28:35 Tips for AvoidingPlagiarism 1 Use your own ideas. 2 Use the ideas of others sparingly. 3 Include complete citation in note taking 4 Read cross references fully 5 Carefully select action verbs to express your opinion. 6 Use different colours.
Editor's Notes
- #2 M-Personal interaction E-Professional interaction- concrete conduct by members of the community L-societal interactions governed by law of the land. Applicable to stranger as well. binding to all sectors of the community
- #5 War conditions related, Trying drugs & vaccines, Racial inferiority- induce diseases
- #27 Latin-plagiarus- kidnapper
- #28 As it is your thesis, it should be your ideas that should be the focus. Only to support or reinforce your own argument. and do not assume from the paper’s abstract. Say ‘red’ for other’s version and ‘green’ for your version.