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: tokiade@yahoo.com

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