1. - Social and Scientific Values - Social and Scientific Values - Scientific Validity - Scientific Validity - Fair Subject Selection - Fair Subject Selection - Favorable Risk-Benefit Ratio - Favorable Risk-Benefit Ratio - Informed Consent - Respect for Enrolled Subjects - Informed Consent - Respect for Enrolled Subjects - Independent Review - Independent Review - Community Perspective - Community Perspective “What Makes Clinical Research Ethical ?” “What Makes Clinical Research Ethical ?” Guidelines for Research Ethics القيم الاجتماعية والعلمية الصلاحية العلمية العدل فى اختيار الأشخاص محل البحث تغليب المنافع على المخاطر الموافقة المستنيرة احترام الأشخاص محل البحث المراجعة المستقلة منظور المجتمع Prof. Dr. Wafaa E. Abdel-Aal National Research Centre, Cairo, Egypt

2. Social Value To be ethical clinical research must lead to improvements in health or advancement in generalizable knowledge It is not justifiable to expose subjects to risks of a study if it lacks social value

3. Research must be conducted with an appropriate methodology to ensure that the results will answer the original research questions Invalid research: underpowered studies studies with inappropriate endpoints or statistical tests studies that cannot enroll sufficient subjects Scientific Validity

4. Selection of subjects is equitable Convenient (vulnerable) groups should not be targeted. CIOMS #13 – Vulnerable persons are those who are relatively (or absolutely) incapable of protecting their own interests. – More formally, they may have insufficient power, intelligence, education, resources, strength, or other needed attributes to protect their own interests Equitable Selection of Subjects

5. Risks are identified Risks are minimized Potential benefits enhanced Risks are reasonable to potential benefits to subject and society Favorable Risk-Benefit Ratio

6. Physical Psychological Social Legal Economic Community What are the types of harm?

7. Favorable Risk-Benefit Analysis POTENTIAL BENEFITS Participants + Society RISK OF HARMS Participants

8. Analysis of Risks and Benefits Risk Level Minimal Above Minimal Too RISKY Heba Kassem, Alexandria University

9. Informed consent الموافقة المستنيرة

10. Informed consent ensures that individuals themselves decide: – whether to enroll in research and – whether research fits with their own values, interests, and goals. Research on individuals who cannot decide requires surrogate consent – children and mentally impaired Informed Consent

11. informationVoluntary Decision- Making Capacity Understanding and Appreciation Cognitive Abilities Expression of a Choice The CIOMS Guidelines have defined informed consent as consent given by a competent individual who:

12. Respecting enrolled subjects includes: ‣ Permitting withdrawal ‣ Protecting confidentiality ‣ Monitoring welfare throughout the study Respect for Enrolled Subjects The ethical requirements of research do not end with a signed consent document.

13. Independent Review Research Ethics Committees

14. REC Purpose and Function “...contribute to safeguarding the dignity, rights, safety, and well-being of all actual or potential research participants.” WHO Guidelines

15. Why Research Ethics and RECs? Obtain External Funding Publish International Journals Enhance Global Health Protect human rights Protect human welfare Minimize harms Ensure Justice Public Trust

16. Research Ethics Committees  The role of the Research Ethics Committee (REC) as an independent “agent” protecting human research participants is well described in key international guidelines. ◦ Declaration of Helsinki ◦ CIOMS Regulations WHO: Operational Guidelines for Ethics Committees that Review Biomedical Research

17. What are Barriers? Perceptions that RECs hinder research Decisions – Approve – Require Modifications – Deferred – Disapprove Less than 5% of protocols were disapproved

18. “A collaborative approach to research that equitably involves all partners in the research process to enhance the understanding of community needs and make more likely the enabling of action for social change” What is Community-Based Participatory Research? Community/social change focus

19. Growing realization that “traditional” research approaches have failed to solve complex health problems. Address locally identified needs. Renewed focus on the social, political, and economic behaviors that influence health behavior. Enhance potential for social change Motivation for Community Input

20. Build trust/acceptance of research/respect – Voice for study participants and community – Share research results with community Allow for community role in development of research agenda and specific studies – Encourage recruitment (trial participation) – Enhances Informed Consent Bridges cultural gaps between researchers and communities Why Community? Overall Goals

21. - Social and Scientific Values - Social and Scientific Values - Scientific Validity - Scientific Validity - Fair Subject Selection - Fair Subject Selection - Favorable Risk-Benefit Ratio - Favorable Risk-Benefit Ratio - Informed Consent - Respect for Enrolled Subjects - Informed Consent - Respect for Enrolled Subjects - Independent Review - Independent Review - Community Perspective - Community Perspective “What Makes Clinical Research Ethical ?” “What Makes Clinical Research Ethical ?” Guidelines for Research Ethics القيم الاجتماعية والعلمية الصلاحية العلمية العدل فى اختيار الأشخاص محل البحث تغليب المنافع على المخاطر الموافقة المستنيرة احترام الأشخاص محل البحث المراجعة المستقلة منظور المجتمع Prof. Dr. Wafaa E. Abdel-Aal National Research Centre, Cairo, Egypt