Dr Agatha Nkiru David

Consultant Paediatrician/Chief Research Fellow

Head, Clinical Trial Research Group

Nigerian Institute of Medical Research

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Background

Research in the National Health Act

NIMR and Health Research

Conclusion

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The National Health Bill was signed into law by the

National Assembly on October 31, 2014

The NH Act is aimed at:

(1) establishing a framework for the regulation,

development and management of a national

health system

(2) Setting standards for rendering healthcare

services in Nigeria

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The Objectives of the Act are to: I. Achieve universal health coverage (UHC) and meet

MDG targets

II. Eliminate quacks from the health delivery system

III. Provide funds for basic health needs of Nigerians

IV. Provide health insurance for certain class of people

who are deprived

V. Reduction of medical tourism

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In the NH Act, the Health system is to be funded by: ◦ Federal Govt Annual Grant of not less than 1% of its

consolidated Revenue Fund(CRF) ◦ Grants from international donors

The funds to be managed by: ◦ The National Primary Healthcare Development Agency–

45% ◦ The National Health Insurance Scheme (50%) ◦ The Federal Ministry of Health (5%)

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The Act provides for the establishment of a National Health Research Committee:

MEMBERSHIP: Not more than 13 members and

To be appointed by the minister on recommendation of health research institutions and related bodies in Nigeria

reflect federal character

Chairman must be an acknowledged and renowned health researcher

Secretary shall be the Director of Health Planning in the Federal Ministry of health

◦ The Chairman of the Committee:

Shall have a maximum of 2 three-year terms

Shall Vacate office through resignation, permanent incapacitation or death 6

To promote health research by public and private health authorities

To ensure that health research agenda and resources focus on priority health problems

To develop and advise the minister on the application and implementation of an integrated strategy for health research

To collate and document information on the research activities of health establishments 7

Research on living persons must:

◦ be conducted in accordance with guidelines from relevant

authorities

◦ be after written informed consent

◦ If on minors:

Only when in the best interest of the minor

Only as prescribed by the NHREC

With the written informed consent of the parent or

guardian 8

Membership:

◦ Not more than 15 persons

To include:

Medical doctor, lawyer, pharmacist, nurse, representative of

Christian or Islamic faith, community health worker,

researcher in medical field, medical laboratory scientist,

health record officer, researcher in medical laboratory

science field, physiotherapist, and radiographer

3 other persons of proven integrity including a woman

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Conditions for Membership:

◦to serve maximum of 2 three-year terms

◦Vacate office by resignation or if requested

by the Minister to do so

the vacated office to be filled by the

Minister in accordance with

recommendations in the Act 10

Determine guidelines to be followed by health

research ethics committees (HRECs):

◦Set standards for conducting research on

humans and animals including clinical trials

◦Determine the extent of health research to

be carried out by health authorities

◦Adjudicate on complaints on HRECs

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◦Register and audit accounts of HRECs

◦Refer ethical or professional violation by

healthcare provider to relevant authority

◦Recommend appropriate disciplinary action

for violation of research guidelines, standards

and norms

◦Advise the Federal and state ministries of health

on ethical issues concerning research on health

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Any institution where health research is carried out must

establish or have access to a HREC registered with NHREC

HRECs shall:

◦ Review research protocols to ensure that it will

promote health, prevent/provide cure for disease and

disability

◦ Grant approval for research proposals that meet ethical

standards

◦ Perform other functions as may be assigned by the

Minister 13

Established by Act in 1977

Mandate: Research for National Health and Development

Structured in 2011 into 9 Research Groups to actualize its mandate:

1. Clinical Trials

2. Emergency Preparedness and Response

3. Health Systems

4. HIV/TB

5. Immunology and Vaccinology

6. Malaria

7. Maternal and Child Health

8. Neglected Tropical Diseases

9. Non-Communicable Diseases

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Research from the institute has impacted significantly the life of Nigerians:

◦ Generic ARVs were as efficacious and safe as the branded

ARVs, bringing ART to hundreds of thousands of Nigerians

◦ High quality research in Malaria and its vector control

◦ Maternal, adolescent and child health issues especially

determining the strains of HPV in Nigerian HIV infected and

uninfected women; and survey on alcohol use in pregnancy in

Nigeria

◦ Evaluating research capacity at various levels of the health

system in Nigeria

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State-of-the-Art and certified laboratories:

1. Human Virology Laboratory: a national reference

laboratory for HIV

2. TB Laboratory: a biosafety level 3 (BSL 3) and national

reference laboratory for TB

3. Clinical Diagnostic Laboratory: for general laboratory

services and patient care

4. Research Laboratories in all the research divisions of

the institute including molecular biology laboratory

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NIMR has a properly constituted and effective

and Internationally certified Health Research

Ethics Committee, the Institutional Review

board (IRB).

Has reviewed hundreds of health research

proposals and approved many from within and

outside Nigeria.

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Provides opportunity for Industrial Training (IT) as part of

Students Industrial Work Experience Scheme (SIWES) for health

science students from various universities and Polytechnics

across the nation

Organizes training for various cadres of Healthcare workers on

HIV/TB and Integrated Management of Adult and Adolescent &

Childhood Illness (IMAI IMCI)

Organizes Training workshops on malaria diagnostics and

Molecular Biology Techniques

Training courses on Grants and proposal writing and monitoring

and evaluation

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Annual Scientific conference for the dissemination

of health research findings from the institute and

beyond

Usually features a distinguished lecture from a

seasoned health researcher

Many national and international speakers on topical

health issues

Increasing number of articles Published in Peer-

review Journal of high impact.

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NIMR is ready to become a centre for the collation

of health research findings in Nigeria

NIMR is ready to Publish Nigeria’s weekly (or

monthly) morbidity and mortality report

NIMR is ready to undertake cutting edge research

especially in the area of clinical trials and also

translational Research to improve the health of the

Nigerian people

But only if funding level is substantially improved 20

NIMR will continue to build on the existing capacity through capacity building, equipment procurement and infrastructural upgrade for researchers and non-researchers to effectively contribute to quality health research in Nigeria using the National Health Act as the guide

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I thank you all

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