Introduction to Research

1. Introduction to Research Dr Adedeji O. Adekanye MBBS, FWACS(Urol), Dip.(Health Res. Ethics) Director, CHAR & Program Coordinator, Residency Training Urology Unit, Department of Surgery, Federal Medical Centre, Bida. Nigeria. E-mail: tokiade@yahoo.com

2. What is research • 45 CFR 46 defines it as “a systematic investigation designed to develop or contribute to generalizable knowledge” • 2 components • Systematic investigation • Intent is to develop or contribute to generalizable knowledge

3. What is not research • Medical practice, particularly innovative therapy (or non-validated practice) – an activity designed solely for the benefit of the patient but in which the ability of the activity to result in the desired result is to some degree not proven • Medical practice for the benefit of others, e.g. vaccination, - the goal of the intervention is to benefit a well defined group of people in a predictable way

4. What is not research • Public health practice e.g., monitoring of diseases, monitoring of programs • Quality assessment or improvement • Outcome analysis • Resource utilization review • Investigational or off-label use of products

5. Research steps • Research idea • Literature review • Planning • Materials and methods • Data collection and collation • Data input and analysis • Interpretation of data • Research outcome(s) – Publication and actions

6. Contemporary Health Challenges • Infections, whether emerging or existing, communicable or otherwise • Social, political, economic and environmental determinants of health • Health policy and systems for better performance • Health improvements for social and economic development • etc

7. There remains a substantial need for research to create new knowledge and technologies and to translate these into effective interventions that will enable people to be healthy … everywhere.

8. “Health research” and “research for health” The spectrum of health research includes: Biomedical research Public health research Health policy and systems research Environmental health research Social sciences and behavioural research Operational research Health research as part of general “science and technology” research

9. “Health research” and “research for health” • However, considering the definition of health, it is evident that the range of research needed to “protect and promote health and reduce disease” is even broader than this. • Indeed, it is more appropriate to speak about “research for health” than about “health research” to recognize that the fields of interest span the relationships between health and, among many others, social, economic, political, legal, agricultural and environmental factors

10. “Health research” and “research for health” • It is also apparent that neither “research for health” nor “health research” is necessarily a public sector task. • Both private for-profit and non-governmental, non-profit organizations have made research contributions to health, health equity and development

11. Health Research Systems (HRS) • The concept of health research systems attempts to provide a framework for the understanding and guidance of the overall research efforts in nations and societies. • In its broadest sense, health research systems include all efforts that are directly linked to and have an effect on the way in which research is done and how it impacts on health

12. Health Research Systems (HRS) • the media (which translate research findings into publicly understandable language); • the community (specifically, organized civil society); • development and business sectors (for future action); • the health system (who should implement findings?) • the policy-makers (whose responsibility it will be to ensure the implementation of health services)

13. Such a health research system is complex, not under the control of any one agency or office, and often not well defined

14. National Health Research Systems (NHRS) • COHRED attempted a first definition of NHRS by proposing four generic functions to the International Conference on Health Research for Development in 2000 (modified to 5) • Stewardship and governance • Financing • Capacity building • Knowledge generation or translation • Knowledge utilization

15. Countries Investing in Health • Early Investors – Cuba, India, Korea, South Africa • Recent Investors – Brazil, Chile, China, Thailand • Development without investment in health research is – apparently – not possible. Where are we in this spectrum?

16. What makes a research ethical • Current problems in research ethics • Use of placebo • Phase 1 drug research • International research ethics • Community engagement and protection of communities • Involvement of children and vulnerable groups • Tensions and contradictions exist among the different guidelines • Emphasizes the need for a coherent and systematic framework that includes all relevant ethical considerations

17. Seven requirements • Guide • Ethical development • Evaluation of clinical studies by investigators, IRB members, funders and others • Several national and international guidelines • Written in response to crises and therefore tend to focus on preventing new ones

18. 1. Value • Evaluation of a treatment, intervention, or theory that will improve health and well-being or increase knowledge • Justification • Responsible use of scarce resources • Avoidance of exploitation • Scientific knowledge; citizen’s understanding of social priorities

19. Examples of non-valuable research • Clinical research with non-generalizable results • Trifling hypothesis • Substantial or total overlap with proven results • Results can never be disseminated • Implementation of result is impractical, even if effective

20. 2. Scientific validity • Research must be conducted in a methodologically rigorous manner • Clear objective • Designed according to accepted principles, methods and reliable practices • Have sufficient power • Plausible data analysis • Justification • Responsible use of scarce resources • Avoidance of exploitation

21. Invalid research • Biased samples, questions, or statistical methods • Under-powered studies • Neglects critical end points • Could not possibly enroll enough subjects • Careless, sloppy conduct of research • Absence of a null hypothesis or clinical equipoise

22. 3. Fair subject selection • Scientific goals, not vulnerability, privilege, convenience, etc. should guide subject selection • Groups should also not be unnecessarily excluded from the opportunity to participate in research • Remember that subject selection can affect risks and benefits of a study • Groups who bear the burden should enjoy the benefits of research endeavors • Justification • Equals should be treated similarly • Fair distribution of social cooperative efforts

23. Unfair subject selection • Avoid convenient samples when the scientific question does not justify it • Avoid subjects with compromised ability to protect themselves • Subjects who qualify but are at substantial risk of being harmed or experiencing more harm should be avoided • Groups who would be excluded from the benefits of a research should not have to bear the burden

24. 4. Favorable risk benefit ratio • 3 conditions need to be fulfilled consistent with the scientific aims of the study and relevant standards of clinical practice • Potential risks to individuals are minimized • Potential benefits to individuals are enhanced • Potential benefits to individuals or society outweigh the risk • What about research that promises no benefit to participants

25. Unfavorable risk benefit analyses • Non-health related potential benefits, e.g. payments, or adjunctive health benefits otherwise just increasing these may tilt the scale

26. 5. Independent review • Investigators have multiple and often conflicting interests which can distort judgment • Reassures society 6. Informed consent 7. Respect for enrolled and potential subjects

27. Importance of these requirements • Universality • Expertise • Clinical investigators must be skilled in research methods, statistical tests, outcome measures, etc. but must also be able to affirm, appreciate and implement ethical requirements • Ethical boards should consist of people with training in science, statistics, ethics, law and citizens who know social values, priorities, vulnerability and concerns of potential subjects

28. New trends in research • ICT and research Softwares • Nano-technology • Other (scientific) technologies

29. References CarelIJsselmuiden and Stephen Matlin Why Health Research? 2006 Research for Health: Policy Briefings A series jointly published by Council on Health Research for Development and Global Forum for Health Research to promote rational decision-making in health research for development Ezekiel J. Emanuel, David Wendler, Christine Grady What Makes Clinical Research Ethical? JAMA. 2000;283:2701-2711