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 www.nimr.or.tz

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 www.nimr.or.tz

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 www.nimr.or.tz

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 www.nimr.or.tz

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 www.nimr.or.tz

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 www.nimr.or.tz

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 www.nimr.or.tz

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 www.nimr.or.tz

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 www.nimr.or.tz

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 www.nimr.or.tz

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 www.nimr.or.tz

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 www.nimr.or.tz

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 www.nimr.or.tz

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 www.nimr.or.tz

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 www.nimr.or.tz

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 www.nimr.or.tz

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 www.nimr.or.tz

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 www.nimr.or.tz

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

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