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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: [email protected]. What is research. - PowerPoint PPT Presentation
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Introduction to Research
Dr Adedeji O. AdekanyeMBBS, FWACS(Urol), Dip.(Health Res. Ethics)Director, CHAR & Program Coordinator,
Residency Training
Urology Unit, Department of Surgery, Federal Medical Centre, Bida. Nigeria.
E-mail: [email protected]
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
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
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
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
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
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.
“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
“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
“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
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
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)
Such a health research system is complex, not under the control of any one agency or office, and often not well defined
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)
1. Stewardship and governance
2. Financing
3. Capacity building
4. Knowledge generation or translation
5. Knowledge utilization
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?
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
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
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
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
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
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
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
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
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
Unfavorable risk benefit analyses
Non-health related potential benefits, e.g. payments, or adjunctive health benefits otherwise just increasing these may tilt the scale
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
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
New trends in research
ICT and research
Softwares Nano-technology Other (scientific) technologies
ReferencesCarel IJsselmuiden 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