1. National Institute for Medical Research
Understanding the Consequences and Impact of Scientific Misconduct and Research Irregularities at National Level
Joyce Ikingura, BSc, MPH,
Assistant Secretary, NatHREC, National Institute for Medical Research
MUHAS DMRET
Scientific Integrity in Research Workshop,
08-09 March 2017
National Institute for Medical Research

2. National Institute for Medical Research www.nimr.or.tz
Outline
Regulation of Health Research In Tanzania
Legal and Ethical framework in Tanzania
NIMR Act, and NIMR Act amendment
Guidelines to conduct Health Research in Tanzania
Researcher’s obligations
Research ethics committee’s obligations
Examples of irregularities –Misconducts
Consequences and impact of research irregularities
Actions to correct research irregularities
National Institute for Medical Research

3. Regulation of Health Research In Tanzania
There are 3 institutions established by Law to jointly regulate health research
National Institute for Medical Research (NIMR)
Tanzania Commission for Science and Technology(COSTECH): Research Permit, Research clearance, renewals
Tanzania Food and Drugs Authority (TFDA) Clinical trial certificate
Ministry of Health, Community Development, Gender, Elderly & Children (overall)
National Institute for Medical Research

4. Laws in the Ethical Framework
NIMR Legal basis (NIMR Act 1979 and its amendment in 1997). Ethical Clearance (national), Amendment, Renewal, Permission to publish, Deviations, SAEs, Misconducts
COSTECH Act : ( Tanzania Commission for Science and Technology Act, Cap. 226): Research Permit, Research clearance, Researcher registration, renewal,
TFDA Act: (Tanzania Food, Drugs and Cosmetics Act, 2003) Clinical Trials Certificate
Institutional ethical clearance, (universities, research institutes, hospitals
National Institute for Medical Research

5. National Institute for Medical Research www.nimr.or.tz
NIMR Mandates
Mandate to carry out and promote the carrying out of medical research designed to alleviate disease among the people of Tanzania
To monitor, control and coordinate medical research carried out within Tanzania, and to evaluate the findings of that research
To establish a system of registration of , to register the findings of medical research carried out within Tanzania, and promote the practical application…
National Institute for Medical Research

6. National Institute for Medical Research www.nimr.or.tz
Regulations
Will be adapted for implementation in this country.
10 regulations
Regulation 2: a researcher PI before implementing research should at their own cost shall submit a fully developed proposal
Regulation 3 relevant expertise, collaborating institutions including the funding agency
Regulation 4 Charging a fee by NIMR to process national ethical clearance
Regulation 5&6 Institutions in URT, hosting HR, may apply to NIMR to be mandated to review for institutional clearances
Mandate is to researchers hosted by the institution
National Institute for Medical Research

7. Guidelines to conduct Health Research in Tanzania
Researcher’s Capacity: Qualification, Experience, host institution, research facilities, team
Ethical Clearances
National
Institutional
Supportive documents from the proposed study sites,
Health research proposal with all elements of the MRCC proposal format
National Institute for Medical Research

8. Guidelines/Regulations for Clinical trials
Well prepared Clinical trial protocol, Reputable PI, sponsor, DSMB
Tanzanian Host Institutional capacity
Institutional Research mandate, experience
Institutional Financial capacity, laboratory facilities
Tanzanian Clinical trialist capacity and team local investigator
Collaborative memorandum MoUs
Capacity building component- team, lab, plans after the study
Insurance of clinical trial participants
Study site benefits
National Institute for Medical Research

9. Researcher’s obligations
Progress report is submitted to the Ministry of Health and the National Institute for Medical Research, Regional and District Medical Officers after every six months.
Permission to publish the results is obtained from National Institute for Medical Research.
Copies of final publications are made available to the Ministry of Health & Social Welfare and the National Institute for Medical Research.
Any researcher, who contravenes or fails to comply with these conditions, shall be guilty of an offence and shall be liable on conviction to a fine. NIMR Act No. 23 of 1979, PART III Section 10(2).
Sites:
National Institute for Medical Research

10. Researchers obligations cont.
To apply for ethical clearance (national, institutional) To conducts research as per approved proposal, methodology, use of approved ICF, budget, research team, sites. Maintain trust with participants, community, Follow up on those requiring special attention, Maintain good relations with the research collaborators and institutions, with any updates
National Institute for Medical Research

11. RECs responsibilities
Follow using SOPs
Ethical review
Follow up on the conduct of approved research, active, passive
ensure any change is seen and approved by the REC
Ensure renewal is done before expiry
Handle all reported misconducts as per SOPs
Resolve misconduct with objectivity
National Institute for Medical Research

12. What are Irregularities
Irregularities would occur in case the research activity is done contrary to the regulations that govern health research in the country
Institutional level: the institution host research contrary to country regulations on hr
Individual level: S/He engages in research, and or collaborators without following set out regulations, guidelines and procedures
Not seeking proper authorizations from legally mandated institutions.
National Institute for Medical Research

13. Examples: Conduct health research before seeking
Come in the country by visitor’s visa, local arrangement with contacts, collects data, samples and leave. (Mosquito researcher)
Irregularities:
Smuggling research data, or material
Unlawfully doing research in the country without permission
analyze data as one party,
Writing the manuscript,
Publish without seeking permission from NIMR
National Institute for Medical Research

14. National Institute for Medical Research www.nimr.or.tz
What is Regular: right
Research is conducted after seeking approval from all bodies involved in the approval process.
Permission to publish should be sought
After permission the manuscript may be submitted to the journal for publication
Data, samples are regulated by legal documents prepared in collaboration with the Government, through a mechanism set out by NatHREC, MTAs, DTAs, templates to be filled before any is transferred
DTAs, MTAs filling as per guidelines both parties, MRCC approval
National Institute for Medical Research

15. Conditions of national ethical approval
Progress report is submitted to the Ministry of Health and the National Institute for Medical Research, Regional and District Medical Officers after every six months.
Permission to publish the results is obtained from National Institute for Medical Research.
Copies of final publications are made available to the Ministry of Health & Social Welfare and the National Institute for Medical Research.
Any researcher, who contravenes or fails to comply with these conditions, shall be guilty of an offence and shall be liable on conviction to a fine. NIMR Act No. 23 of 1979, PART III Section 10(2).
Sites:
National Institute for Medical Research

16. After approval do not comply with set conditions of approval
Irregularities
Failure to engage local host institution and local investigator- Collaborator in the conduct, reporting, of research project’s activities
Failure to respect agreed authorship rules
Failure to renew ethical clearances yearly while the project is ongoing
Failure to seek amendment approval for any changes on the study proposal
National Institute for Medical Research

17. National Institute for Medical Research www.nimr.or.tz
Irregularities cont.
Making changes of the investigators without permission of those removed from the study
Engaging unqualified personnel in the conduct of research for example using a project driver to conduct interviews on participants
National Institute for Medical Research

18. Consequences and Impacts of irregularities
When you are a seasoned senior scientist or starting out your career you are very much aware of the importance of ethical conduct Being a victim of misconduct is a sensitive and challenging situation. At individual level: your stand in the scientific community is questionable As an Institution: your research team reputation falls down, and will take time for you to regain Trust is lost, and will be costly to earn it again.
National Institute for Medical Research

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Consequences cont.
Diplomatic relations are put in tension, and even countries involved in the misconduct and related violations.
National Institute for Medical Research

20. National Institute for Medical Research www.nimr.or.tz
References
NIMR Act COSTECH Act National ethical Guidelines on ethics in Tanzania Nathrec SOPs
National Institute for Medical Research