Research Ethics
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This document discusses key principles of research ethics including guidelines for authorship, the Nuremberg Code, Declaration of Helsinki, Belmont Report, and Philippine laws and guidelines. Ethical research requires voluntary informed consent, favorable risk-benefit ratio, scientific validity, fair subject selection, and independent review. Research ethics aims to protect human subjects and ensure scientific integrity by applying principles like respect for persons, beneficence, and justice.
Research Ethics
- 1. RESEARCH ETHICS Helen V. Madamba, MD MPH-TM
- 2. Ethical Guidelines on Authorship and Publication Who is an author? 1. Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND 2. Drafting the work or revising it critically for important intellectual content; AND 3. Final approval of the version to be published; AND 4. Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. http://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html
- 3. RESEARCH ETHICS Research ethics is the application of ethical principles to provide guidance in the responsible conduct of scientific research.
- 4. Nuremberg Code 10-point guideline developed as a result of subsequent Nuremburg trials, the Doctors Trial of 1946-1947, that prosecuted 23 German Nazi physicians who carried out torturous experiments on concentration camp prisoners.
- 5. Nuremberg Code 1. Voluntary human consent is essential. 2. Experimental results should result in good for society. 3. Anticipated results should justify the experiment. 4. Avoid all necessary physical and mental suffering 5. No experiment if there is a chance of death/disability 6. Minimize risk of subjects 7. Proper preparations and facilities to protect subjects 8. Experiments conducted only by qualified persons 9. Subjects can withdraw at anytime 10. Terminate experiment if results are known or with best judgment. https://history.nih.gov/research/downloads/nuremberg.pdf
- 6. Declaration of Helsinki 1964 • a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA) • the cornerstone document on human research ethics. https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
- 7. Belmont Report 1979 • Guidelines issued by the US National Commission for the Protection of Human Services of Biomedical and Behavioral Researc in 1979 in response to the Tuskegee syphilis experiments performed from 1932 to 1972. • Three main principles: • Respect for persons: participants know about and consent to research • Beneficence: do no harm, maximize benefits, minimize risks • Justice: fair distribution of costs/benefits to all potential participants https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html
- 8. Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization developed the International Ethical Guidelines for Biomedical Research Involving Human Subjects with the intent to apply the provisions in the Declaration of Helsinki in developing countries. https://cioms.ch/
- 9. DOST Administrative Order 001-2007 • Requires the review of all health researches involving human subjects/participants • Establish research ethics committees that will evaluate and monitor researches involving human subjects/participants • In accordance with National Ethical Guidelines for Health Research http://www.ethics.healthresearch.ph/index.php/orders-and-memorandums/ 10-orders-and-memos/219-dost-administrative-order-001-series-of-2007
- 10. Republic Act 10532 http://www.ethics.healthresearch.ph/index.php/orders-and-memorandums/ 10-orders-and-memos/219-dost-administrative-order-001-series-of-2007 An act institutionalizing the Philippine National Health Research System
- 11. Medical research is subject to ethical standards that promote and ensure respect for all human subjects and protect their health and rights. Declaration of Helsinki
- 12. 1. Social or scientific value 2. Scientific validity 3. Fair subject selection 4. Favorable risk-benefit ratio 5. Independent review 6. Informed consent 7. Respect for potential and enrolled subjects https://www.ncbi.nlm.nih.gov/pubmed/10819955
- 13. Social or scientific value • Responsible use of limited resources – clinical, manpower, financial • Avoidance of exploitation of human participants • Address and help resolve a health issue which is relevant to the subject population and community • Justifications are stated in the significance of the study • Publication of results in scientific journals or presentation in scientific meetings • To teach and train the next generation of researchers to learn the scientific method DR Benavides. Clinical Practice Guidelines for Ethics Review in POGS Research Handbook: The Essentials.
- 15. Scientific validity • For a research to be ethically sound, it must be technically sound Declaration of Helsinki, Principle 21: Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation. DR Benavides. Clinical Practice Guidelines for Ethics Review in POGS Research Handbook: The Essentials.
- 16. Scientific validity • A research must be conducted in a methodologically rigorous manner and contain the following elements: 1. Clear scientific objective 2. Research design based on accepted principles 3. Reproducible and feasible methodology 4. Sufficient power and sufficient number of subjects to definitely test the objective 5. Plausible data analysis plan DR Benavides. Clinical Practice Guidelines for Ethics Review in POGS Research Handbook: The Essentials.
- 17. Fair subject selection JUSTICE – there is an ideal distribution of risks and benefits when recruiting participants in clinical trials • Scientific objective should be the basis for selection of study sites and subject population • Clear description of the inclusion and exclusion criteria • Probability sampling • Higher probability of risk and severity of harm that should be the reasons why certain groups are to be excluded DR Benavides. Clinical Practice Guidelines for Ethics Review in POGS Research Handbook: The Essentials.
- 18. Favorable risk-benefit ratio • Benefit is defined as a valued or desired outcome: an advantage. • Risk is the probability of harm or injury occurring as a result of participation in the study DR Benavides. Clinical Practice Guidelines for Ethics Review in POGS Research Handbook: The Essentials.
- 19. Favorable risk-benefit ratio • Risk justified only if consistent with scientific aims of the study, and the relevant standards of clinical practice, three conditions are fulfilled: 1. The potential risks to individual subjects are minimized 2. The potential benefits to individual subjects are enhanced 3. The potential benefits to individual subjects and society are proportionate to or outweigh the risks DR Benavides. Clinical Practice Guidelines for Ethics Review in POGS Research Handbook: The Essentials.
- 20. Favorable risk-benefit ratio • Declaration of Helsinki, Principle 16: Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects. DR Benavides. Clinical Practice Guidelines for Ethics Review in POGS Research Handbook: The Essentials.
- 22. Favorable risk-benefit ratio Risk- benefit assessment can be achieved using these steps 1. Identifying and minimizing risks 2. Enhancement of potential benefits 3. Weighing in and comparing the risks and potential benefits of the clinical research interventions to individual subjects DR Benavides. Clinical Practice Guidelines for Ethics Review in POGS Research Handbook: The Essentials.
- 23. Independent review • Declaration of Helsinki, Principle 23 The research protocol must be submitted for consideration, comment, guidance and approval to the concerned research ethics committee before the study begins. This committee must be transparent in its functioning, must be independent of the researcher, the sponsor and any other undue influence and must be duly qualified. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards. DR Benavides. Clinical Practice Guidelines for Ethics Review in POGS Research Handbook: The Essentials.
- 24. Informed consent • Respect for persons is based on the fundamental ethical principle of AUTONOMY, which states that each person has the right to self- determination, the right of a competent person to decide and choose what is in his/her best interest. • Process by which a person voluntarily confirms his or her willingness to participate in a particular trial, after having been adequately informed of all aspects of the trial that are relevant to the decision to enroll or to continue participation. DR Benavides. Clinical Practice Guidelines for Ethics Review in POGS Research Handbook: The Essentials.
- 26. Respect for potential and enrolled subjects • Participants must be treated with respect throughout and even after the participation in the study 1. Respect for privacy and confidentiality 2. Permitting withdrawal 3. Providing new information 4. Monitoring welfare 5. Informing subjects of results of clinical research DR Benavides. Clinical Practice Guidelines for Ethics Review in POGS Research Handbook: The Essentials.
- 30. RESEARCH ETHICS Helen V. Madamba, MD MPH-TM