TOPIC 2 gp 2 on national and international Guidelines and DeCLARATIONS[1].pptx

Bioethics in research

1. National and International Guidelines and Declarations on Bioethic Group TWO

2. Group Members Prince George Acquah Jnr- PG4588324 Nana Yaw Wireko-Ampong - PG4585924 Che Eyen Larissa Audrey- PG4585724 Benedicta Adade Mawunyo - PG4586924 Hukportie Albert Elikplim - PG4589224 Joseph Kwabena Akwei - PG4587024 Richard Dogbatse - PG4587224 2

3. What are Guidelines and Declarations? An ethical guideline is a set of principles or recommendations designed to direct the moral behaviour or decision-making in specific contexts, often flexible and adaptable to various situations. A declaration is a formal, public statement or proclamation that asserts a position, belief, or commitment, often with moral or ethical weight. They differ in purpose , scope , enforceability and format. 3

4. What are Guidelines and Declarations? 4 Parameter Guidelines Declarations Purpose offer practical direction state ideals or commitments Scope are specific and contextual universal or broad Enforceability Non-binding but influencial non-binding but normative Format detailed and procedural Concise, formal and declarative

5. Evolution of Guidelines and Declarations 5 Edward Jenner James Lind Guiseppe Sanarelli Nazi Germany WWII

6. Why are Guidelines and Declarations Important? To protect study subjects. To maintain the quality and credibility of scientific work and public health interventions. To foster public trust. To ensure that research contributes positively to society. 6

7. Timelines of major Guidelines and Declarations 7

8. Specific Guidelines and Declarations

9. The Nuremberg Code (1947) Emphasises on Ten ethical principles laid the groundwork for modern research ethics: Voluntary Consent Fruitful Results for Society Scientific Foundation Avoid Unnecessary Suffering No Risk of Death or Disability Risk-Benefit Balance Proper Preparation and Facilities Qualified Personnel Right to Withdraw Termination by Researchers 9

10. The Belmont Report (1979) Outlines ethical principles and guidelines for research involving human subjects: Respect for persons. Beneficence Justice These principles have influenced ethical guidelines globally, including the Common Rule in the U.S . 10

11. Universal Declaration on Bioethics and Human Rights (2005) Emphasises on: Human dignity and rights. Consent and privacy. Equity and justice: Solidarity and social responsibility: Cultural diversity This declaration serves as a framework for countries to develop national bioethics policies and establish bioethics committees. 11

12. Declaration of Helsinki (1964, amended periodically) Adopted by the World Medical Association, this declaration provides ethical guidelines for medical researchers, emphasizing: The necessity of ethical review by independent committees. The requirement of informed consent. The obligation to ensure scientific and social value in research. It serves as a cornerstone for ethical medical research globally. 12

13. CIOMS International Ethical Guidelines (1982, 1993, 2002) These guidelines, developed by the Council for International Organizations of Medical Sciences, provide detailed ethical standards for biomedical research, including: Requirements for ethical review and informed consent. Guidance on research involving vulnerable populations. Recommendations for international collaboration and data sharing. They are widely used in international research ethics. 13

14. U.S. Common Rule The Federal Policy for the Protection of Human Subjects, known as the Common Rule, sets forth regulations for research involving human subjects in the U.S., including: Requirements for Institutional Review Boards (IRBs). Standards for informed consent. Additional protections for vulnerable populations such as children, prisoners, and pregnant women. These regulations are foundational for ethical research practices in the U.S. 14

15. Indian Council of Medical Research (ICMR) National Ethical Guidelines (2017) Emphasises on: Compensation for research-related injuries. Privacy and confidentiality. Distributive justice. 15

16. Ethical Guidelines in Ghana lacks a centralized national bioethics policy or regulatory authority. Localised guidelines that draw heavily on international standards like the Declaration of Helsinki and CIOMS but are contextualized for Ghana’s health research environment. 16

17. REFERENCES Department of Health, South Africa. (2015). Ethics in health research: Principles, processes and structures (2nd ed.) . https://www.health.gov.za/ Ghana FDA. (2020). Guidelines for conduct of clinical trials in Ghana . https://www.fdaghana.gov.gh/ Ghana Health Service. (2020). Standard Operating Procedures for Ethical Review Committee . https://www.ghs.gov.gh/ethics/ Ghooi RB. (2011) The Nuremberg Code-A critique. Perspect Clin Res. ;2:72–6. [PMC free article] [PubMed] ICMR. (2017). National ethical guidelines for biomedical and health research involving human participants . Indian Council of Medical Research. https://ethics.ncdirindia.org/ ICH. (2016). ICH harmonised guideline: Integrated addendum to ICH E6(R1): Guideline for good clinical practice E6(R2) . International Council for Harmonisation . https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf 17

18. REFERENCES Continued… National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont Report . https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/ Shuster E. (1997) Fifty years later: he significance of the Nuremberg Code. N Engl J Med;337:1436–40. [PubMed] U.S. Department of Health and Human Services. (2018). 45 CFR 46 – Protection of human subjects (Common Rule) . https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/ UNESCO. (2005). Universal declaration on bioethics and human rights . https://unesdoc.unesco.org/ark:/48223/pf0000146180 U.S. Government. (1949). Trials of war criminals before the Nuremberg military tribunals under control council law no. 10, Vol. 2 . U.S. Government Printing Office. World Medical Association. (2013). WMA Declaration of Helsinki – Ethical principles for medical research involving human subjects . JAMA, 310(20), 2191–2194. https://doi.org/10.1001/jama.2013.281053 18

19. THANK YOU 19