National Commission For Science, Technology And Innovation

NATIONAL COMMISSION FOR SCIENCE,TECHNOLOGY AND INNOVATIONwww.nacosti.go.ke

Introduction The National Commission for Science, Technologyand Innovation (NACOSTI), is established by theScience, Technology and Innovation (ST&I) Act,2013. NACOSTI is the successor the National Council forScience and Technology (NCST) which wasestablished by the Science and Technology Act,Cap 250 of the Laws of Kenya in 1977www.nacosti.go.ke

Mandate of NACOSTITo REGULATE and ASSURE QUALITY in Science, Technologyand Innovation sector and ADVICE Government on mattersrelated thereto.The Act also gives powers and guiding principles to theNACOSTI in the discharge of its functions.www.nacosti.go.ke

FunctionsAmong Others: Set the priorities in research, science and technology inKenya in relation to the economic and social policies of theGovernment, and the country’s international commitments Register and Accredit research institutions in Kenya Approve all scientific research in Kenya Assure relevance and quality of ST&I programs inresearch institutes.www.nacosti.go.ke

Functions Cont.d Coordinate, monitor and evaluate, as appropriate, activitiesrelated to scientific research and technology development Promote and encourage private sector involvement inscientific research and innovation development. Develop and Enforce Codes, Guidelines and Regulationsin accordance with the policy determined under ST&I Act. Undertake or cause to be undertaken, regular inspections,monitoring and evaluation of research institutions to ensurecompliance with set standards and guidelines.www.nacosti.go.ke

Research Misconduct- DefinitionsGenerally research misconduct is defined as fabrication,falsification, or plagiarism in proposing, performing, orreviewing research, or in reporting research results.Fabrication: making up data or results and recording orreporting them.Falsification: manipulating research materials, equipment, orprocesses, or changing or omitting data or results such thatthe research is not accurately represented in the researchrecord.www.nacosti.go.ke

Research Misconduct- DefinitionsPlagiarism: the appropriation of another person’s ideas,processes, results, or words without giving appropriate credit.However, research misconduct does not include “honest error”or differences of opinion.Research misconduct is committed intentionally or recklesslywww.nacosti.go.ke

Other forms of Research Misconduct Violation of laws or research regulations or policies Misuse of confidential information from peer reviews Failure to declare Conflict of interest Misrepresentation of qualifications/credentials Unethical authorship Violation of research subjects, materials etc. Unauthorized transfer of materials from the countrywww.nacosti.go.ke

Who has the Responsibility of Research Misconduct? NACOSTI has the overall mandate of regulation of researchin Kenya Research institutions/organization which include universitiesbear the primary responsibility of detection and preventionof research misconduct since this is where research takesplace. General public Research participants/subjects has a responsibility toreportingwww.nacosti.go.ke

Legal Framework for Research Misconduct?Constitution 2010ArticleElements31. Privacy Every person has the right to privacy,which includes: the right not to haveinformation related to their family orprivate affairs revealed32 Freedom of A person shall not be compelled to act, orConscience, Religion,engage in any act, that is contrary to theBelieve and opinionperson's belief or religion.33. Freedom of Every person has the right to freedom ofexpressionexpression, which includes academicfreedom and freedom of scientificresearch.www.nacosti.go.ke

Legal Framework for Research Misconduct?Constitution 2010ArticleElements40. Protection of right The State shall support, promote andto propertyprotect the intellectual propertyrights of the people of Kenya42. Environment53. Children Environment protection for thebenefit of present and futuregenerations through legislative andother measures Every child has the right to beprotected from abuse, harmfulcultural practices, hazardous orexploitative laborwww.nacosti.go.ke

Some Provisions of ST&I Act-Licensing of ResearchSectionProvisions12 (1) Requirement for No person shall undertake research in Kenyalicence to undertakewithout obtaining a research license issuedresearchunder the ST&I Act.Section 12 (3) Any person undertaking or intending toundertake research in science andtechnology in the country, or who accesses,handles, or transfers any material ortechnology or moves it within, from or into thecountry, shall apply to the Commission for thegrant of a licence in accordance with ST&IActSection 14 Procedures, This requires a person issued with a license tostandards, ethics andadhere to such procedures, standards, codewww.nacosti.go.ke

OffencesProvisionsSection(1) Any person who—Section accesses, handles, transacts, transfers or moves any15specified technology or any material necessary forOffencesscientific research within, into or from Kenya without alicence issued under this Act; or contravenes the provisions of section 12,commits an offence and shall, in addition to any otherpenalty which may be provided for in this Act or anyother written law, be liable on conviction to a fine notexceeding five million shillings or to imprisonment fora term not exceeding four years, or both.www.nacosti.go.ke

OffencesSectionProvisionsSection 15Offences2)The Court convicting a person undersubsection (1) may in addition to any penaltyimposed thereunder, order the confiscation ofthe materials in respect of which the offence iscommitted, and may bar the person soconvicted from undertaking any furtherresearch in the country or transferring ormoving any substance or material in or out ofthe country.www.nacosti.go.ke

Offences Cont.dSectionSection 15(3)ProvisionsFor the avoidance of doubt, the technologies or materialsimported into or exported out of Kenya and declaredunder—(a) the Industrial Property Act (Cap. 509);(b) the Seeds and Plant Varieties Act (Cap. 326);(c) the Wildlife Conservation and Management Act,2013;(d) the Customs and Excise Act (Cap. 472);(e) the Biosafety Act (Cap. 321A);or any other written law shall be deemed to betechnologies or materials to which this sectionapplies.www.nacosti.go.ke

Registration of Research InstitutionsSectionProvisionsSection 16(1) Provides for the establishment and grant of CertificateEstablishmenof Registration to research Institutionst of researchinstitutionsSection 16 Provides that the institute established:(3)(a) shall have corporate personality;(b) Should specify the duties, powers and functions;(c) Specify the manner in which the institute shall begoverned; and(d) such other matters with respect to the conduct andmanagement of the institute, as the CS may find itnecessary or desirable to provide for.www.nacosti.go.ke

Registration of Research InstitutionsSectionProvisionsSection 17 and18provides for application and grant ofCertificate of Registration to establishedresearch Institutionwww.nacosti.go.ke

Offences Cont.dSectionSection 21 (1)Offence toestablish oroperate researchinstitutes withoutauthoritySection 21 (2)ProvisionsProvides that “any person who establishes or operatesa research institute without obtaining a Certificate ofRegistration commits an offence under this Act andshall be liable on conviction to a fine not exceedingone million shillings or to imprisonment for a term ofnot exceeding than two years or to both.”Any property, equipment, material or other facilitiesused in a research institution in contravention of thisAct shall be liable to be confiscated by theCommission and disposed of in the manner deemedappropriate by the Commissionwww.nacosti.go.ke

RegulationsSectionProvisionsSection 45(1)Empowers the Cabinet Secretary to make Regulations forthe better carrying out of the provisions of the Act.45 (2)Regulations shall prescribe: (a) standards, guidelines and codes to ensure and maintainstandards and ethics in research;(b) the forms to be used in connection with the issuance oflicenses under the Act;(c) the manner and form of the registers to be kept; and(d) any other matter for the better carrying into effect ofthe provisions of the Act.www.nacosti.go.ke

ST&I Regulations, 2014The following are the Regulations under the Act: LEGAL NOTICE No. 106: Registration and Accreditation ofResearch Institutions Regulations, 2014 LEGAL NOTICE No. 107: Relevance and Quality Assurancein Research Regulations, 2014 LEGAL NOTICE No. 108: Research Licensing Regulations,2014www.nacosti.go.ke

National Bioethics CommitteeMandate of National Bioethics Committee The National Bioethics Committee (NBC) is established asan advisory committee in accordance with the provisionsof sections 9 and 27 of ST&I Act. It is multidisciplinary and draws membership from thevarious institutions across the country. The core mandate of the committee is to ensure thehighest ethical (professional, moral, social, cultural andlegal) standard are maintained in research.www.nacosti.go.ke

NBC- CompositionNBC was first established in Kenya in 2009. The committee ismade up of 11 members constituted as follows:i. Experts from different scientific disciplesii. Lawyeriii. Lay person There is gender and regional balances The tenure of each Committee is three (3) years andmembers could be reappointed Current Committee will serve for the period 2018-2021www.nacosti.go.ke

NBC- functionsThe Committee’s functions are to: Ensure that the highest ethical (professional, moral, social,cultural and legal) standards are maintained in research; Consider and review accreditation applications for ethicscommittees in Kenya; Advise on Bioethical policy issues Prepare guidelines on bioethics Create and enhance awareness on bioethical issues ofpublic concernwww.nacosti.go.ke

NBC- functions Cont.d Provide a forum for consultation and informed debate onbioethical issues of public concern; Review of protocols referred to the committee; and Promote training of Institutional Ethics ReviewCommittees.www.nacosti.go.ke

NBC- key Achievements In total NBC has recommended accredited twenty eight (29)Institutional Ethics Review Committees (IERCs). Ensures compliance of the Accredited IERCs through review ofannual reports and M&E It reviewed and resolved several matters referred to it by theCommission.www.nacosti.go.ke

NBC- Key AchievementsThe committee has prepared a set of guidelines and otherdocuments to be used in the country; Material Transfer Agreement (MTA) Guidelines Guidelines for Ethical Conduct of Biomedical ResearchInvolving Human Subjects in Kenya National Guidelines for the Care and Use of Animals inResearch and Education in Kenya Curriculum for training IERC members. A tool for Monitoring and Evaluation for IERCs Guidelines for accreditation of IERCswww.nacosti.go.ke

Institutional Ethics ReviewCommittees NACOSTI has delegated the task of reviewing researchproposals for ethical clearance to IERCs. This is to ensurethat research conducted in the country observes highstandards research ethics. 29 IERCs have been accredited by NACOSTI in hospitals,research institutions and universities. The number of IERCs is expected to increase given theincrease in the number of registered research institutionsand Universities.www.nacosti.go.ke

The Role of IERCs Review ethical concerns and clear research protocols with aview to safeguard the dignity, rights, safety and well beingof all actual and potential research participants; Monitor the research study; document procedures and prepare annual reports; and Examine compliance with all regulatory requirements,applicable guidelines and laws.www.nacosti.go.ke

Observations- Challenges Inadequate mechanisms for protection of whistleblowers forresearch misconductwww.nacosti.go.ke