TANZANIA COMMISSION FOR SCIENCE AND TECHNOLOGY (COSTECH) NATIONAL RESEARCH REGISTRATION AND CLEARANCE GUIDELINES 2018 TANZANIA COMMISSION FOR SCIENCE AND TECHNOLOGY (COSTECH) NATIONAL RESEARCH REGISTRATION AND CLEARANCE GUIDELINES 2018 ISBN: 978-9987-9485-2-9 TABLE OF CONTENTS 1.0 INTRODUCTION 4 1.1 BACKGROUND AND CONTEXT 4 1.2 COSTECH’S MISSION STATEMENT 4 1.3 MANDATES, ROLES AND FUNCTIONS 4 1.4 OBJECTIVES 5 2.0 RESEARCH CATEGORIES 6 3.0 DOCUMENTS REQUIRED FOR RESEARCH CLEARANCE 7 4.0 REQUIREMENTS FOR RESEARCH CLEARANCE 8 5.0 PROCESSING NEW APPLICATIONS 10 6.0 SUBMISSION OF RENEWAL APPLICATIONS 10 7.0 PROCESSING RENEWAL APPLICATIONS 11 8.0 DECISIONS OF THE NRRC 11 9.0 MONITORING AND EVALUATION 12 10.0 TERMINATION OF RESEARCH 12 11.0 FAILURE TO REGISTER A RESEARCH TO COSTECH 13 12.0 DISPUTE SETTLEMENT 13 13.0 AFFILIATION TO LOCAL INSTITUTIONS 13 14.0 AMENDMENTS TO THE GUIDELINES 13 APPENDIX 1: APPLICATION FORMS 14 APPENDIX 2: TANZANIAN RESEARCH AND ACADEMIC INSTITUTIONS 18 2 ABBREVIATIONS AND ACRONYMS Tanzania Commission for Science COSTECH and Technology DTA Data Transfer Agreement M&E Monitoring & Evaluation M.Sc Master’s of Science MTA Material Transfer Agreement NGO Non Governmental Organization National Institute of Medical NIMR Research The National Research NRRC Registration Committee PhD Doctor of Philosophy PI Principal Investigator Tanzania Wildlife Research TAWIRI Institute Tanzania Food and Drug TFDA Authority TZ Tanzania 3 1.0 INTRODUCTION 1.1 BACKGROUND AND CONTEXT The Tanzania Commission for Science and Technology (COSTECH) is a public institution established by the Act of Parliament No. 7 of 1986. COSTECH was successor to UTAFITI which had been in existence since 1972. The Commission is under the Ministry responsible for Science and Technology and is the principal advisory organ to the Government on all matters relating to VFLHQWLÀFUHVHDUFKLQQRYDWLRQDQGWHFKQRORJ\GHYHORSPHQWDQGWUDQVIHU Given our experience in the last 30 years in relation to the registration of UHVHDUFKSURMHFWV&267(&+KDVVHHQWKHQHHGIRUVWUHQJWKHQLQJJXLGHOLQHV which provide guidance on the processes for registration and clearance of all research activities conducted within Tanzania mainland. The guidelines shall be DSSOLFDEOHWRDOOLQGLYLGXDOVDQGLQVWLWXWLRQVRUJDQL]DWLRQVFRQGXFWLQJUHVHDUFK as mandated in the Commission for Science and Technology Act No. 7 of 1986 (revised) described in part II section 5 caption 2 (b) and (c).1 These include DOO KLJKHU OHDUQLQJ UHVHDUFK DQG GHYHORSPHQW LQVWLWXWLRQV ZKLFK DUH XQGHU JRYHUQPHQW PLQLVWULHV GHSDUWPHQWV DJHQFLHV SULYDWH FRPSDQLHVHQWHUSULVHV QRQJRYHUQPHQWDODQGLQWHUJRYHUQPHQWDORUJDQL]DWLRQVLQWHUQDWLRQDODJHQFLHV and community based organizations. These guidelines will also be useful for professional bodies to incorporate into their codes of conduct in their efforts to advance professionalism through embracing research. Researchers intending to undertake research in Zanzibar are required to seek permission from the Second 9LFH3UHVLGHQWV2IÀFH=DQ]LEDU 1.2 COSTECH’S MISSION STATEMENT To foster a knowledge-based economy through the promotion and coordination RI UHVHDUFK WHFKQRORJ\ GHYHORSPHQW DQG LQQRYDWLRQ IRU VXVWDLQDEOH development in Tanzania. 1.3 MANDATES, ROLES AND FUNCTIONS The principal roles and responsibilities of the Commission as provided in the &267(&+$FW1RRI &DSUHY LQFOXGH i. WRSUHSDUHDQGUHYLHZWKHQDWLRQDOVFLHQFHWHFKQRORJ\DQGLQQRYDWLRQ SURJUDPPHVLQFOXGLQJGLVVHPLQDWLRQDQGWUDQVIHURI WHFKQRORJ\ ii. WRPRQLWRUDQGFRRUGLQDWHDFWLYLWLHVUHODWLQJWRVFLHQWLÀFUHVHDUFK technology development and innovation of all persons or bodies FRQFHUQHGZLWKVXFKDFWLYLWLHV 1 Tanzania Commission for Science and Technology Act of 1986 (revised) 4 iii. WR DFTXLUH VWRUH DQG GLVVHPLQDWH VFLHQWLÀF DQG WHFKQRORJ\ LQIRUPDWLRQDQGIRUWKDWSXUSRVHWRKROGRUVSRQVRUFRQIHUHQFHV V\PSRVLDPHHWLQJVVHPLQDUVRUZRUNVKRSVSXEOLVKDQ\QHZVSDSHU MRXUQDO RU SHULRGLFDO RU GR DQ\ RWKHU DFW RU WKLQJ GHVLJQHG WR SURPRWHLQWHUHVWLQVFLHQFHWHFKQRORJ\DQGLQQRYDWLRQ iv. to advise the Government on matters such as priority areas for VFLHQWLÀF UHVHDUFK DOORFDWLRQ DQG XWLOL]DWLRQ RI UHVHDUFK DQG LQQRYDWLRQ IXQGV DFFRUGLQJ WR SULRULWLHV VFLHQWLÀF UHVHDUFK DQG UHJLRQDO DQG LQWHUQDWLRQDO FRRSHUDWLRQ LQ VFLHQWLÀF UHVHDUFK LQQRYDWLRQDQGWHFKQRORJ\GHYHORSPHQWDQGWUDQVIHUDQGPDWWHUV relating to the training and recruitment of research personnel. ,QH[HFXWLQJLWVUROHVDQGIXQFWLRQVRQPRQLWRULQJDQGFRRUGLQDWLRQRIUHVHDUFK the Commission has set up various national advisory committees. One of WKHVHLVWKH1DWLRQDO5HVHDUFK5HJLVWUDWLRQ&RPPLWWHH 155& ZKLFKDVVLVWV COSTECH in maintaining a with a commitment to facilitate innovative and high quality research in the country. The NRCC thus receives and reviews research SURSRVDOVIRUWKHLUVFLHQWLÀFPHULWVDIHW\VXLWDELOLW\DQGHWKLFDODSSURSULDWHQHVV :KHQWKHVHDUHGHHPHGVDWLVIDFWRU\WKH15&&LVVXHVUHVHDUFKSHUPLWVWKDW DOORZRQHWRFRQGXFWUHVHDUFKLQWKHFRXQWU\DQGE\GRLQJVRWKHDSSURYHG research proposal is duly registered in the country’s research database. 7KHVHJXLGHOLQHVHVWDEOLVKWKHNH\SURFHVVHVSURFHGXUHVSUDFWLFHVDQGPLQLPXP UHTXLUHPHQWV QHFHVVDU\ IRU UHVHDUFK DSSURYDO UHJLVWUDWLRQ DQG FRQGXFW RI research in Tanzania. The mandatory requirements in the guidelines represent DXVHIXOLQVWUXPHQWIRUUHVHDUFKHUV ERWK7DQ]DQLDQQDWLRQDOVDQGIRUHLJQ DQG RWKHUVWDNHKROGHUVLQFOXGLQJUHVHDUFKIXQGHUVUHVHDUFKRUJDQL]DWLRQVUHVHDUFK HWKLFVFRPPLWWHHV1*2VDQGUHVHDUFKVXEMHFWV 1.4 OBJECTIVES The overall objective of the guidelines is to document all research activities to HQDEOHFRRUGLQDWLRQSURPRWLRQDQGSULRULWL]LQJRI UHVHDUFKDVZHOODVWKHXVH RI UHVHDUFKUHVXOWVIRUVXVWDLQDEOHGHYHORSPHQWLQ7DQ]DQLD 7KHVSHFLÀFREMHFWLYHVDUHWR i. ensure that research conduct in Tanzania is of the required VWDQGDUGVZKLFKREVHUYHQDWLRQDOUXOHVDQGUHJXODWLRQV ii. GRFXPHQWDQGUHJLVWHUGLYHUVHUHVHDUFKDFWLYLWLHVLQ7DQ]DQLD iii. secure results of research undertaken in Tanzania and promote its XWLOL]DWLRQLQSROLF\DQGSUDFWLFH 5 iv. VDIHJXDUG WKH GLJQLW\ULJKWV VDIHW\ DQG ZHOOEHLQJ RI DOO VWXG\ VXEMHFWVDQGÁRUDIDXQD v. UHGXFHV\VWHPLFULVNVLPSRVHGWKURXJKWKHUHVHDUFKXQGHUWDNLQJ and vi. provide research permits for all research undertaken. 2.0 RESEARCH CATEGORIES )RU WKH SXUSRVHV RI WKHVH WKHVH JXLGHOLQHV UHVHDUFK VKDOO EH XQGHUVWRRG DV ´DQ\W\SHRI V\VWHPDWLFLQYHVWLJDWLRQWHVWLQJRUHYDOXDWLRQGHVLJQHGWRGHYHORS RUFRQWULEXWHWRDERG\RI NQRZOHGJHµ,WLQFOXGHVUHVHDUFKLQDOOVHFWRUVVXFK DVLQGXVWU\PHGLFLQHDJULFXOWXUHKXPDQLWLHVDQGVRFLDOVFLHQFHVQDWXUDODQG SK\VLFDO VFLHQFHV DV ZHOO DV H[SHULPHQWDO GHYHORSPHQW ZRUN OHDGLQJ WR QHZ GHVLJQV SURGXFWV RU SURFHVVHV IRU WKH RYHUDOO LPSURYHPHQW RI WKH KXPDQ condition. 7KUHHFDWHJRULHVRI UHVHDUFKDUHLGHQWLÀHGRQWKHEDVLVRI WKHLUGXUDWLRQ A. Short-term research for accredited undergraduate and Masters’ degrees (lasting one year or less) %5HVHDUFKODVWLQJXSWRWKUHH\HDUVDQG C. Long-term research lasting more than three years. The following requirements apply for each of the research categories during the registration process. A. 6KRUWWHUP5HVHDUFK a. ,WPD\LQYROYHRQO\RQHSHUVRQ b. ,WVKRXOGEHIRU8QGHUJUDGXDWHRU0DVWHUV·GHJUHHV c. ,WVKRXOGEHIRUDPD[LPXPRI RQH\HDU d. ,Q FDVH RI IRUHLJQ DSSOLFDQWV WKH UHVHDUFKHU VKRXOG DIÀOLDWH with a recognized local tertiary education institution and/or a research institution with relevant expertise. B. 0HGLXPWHUPUHVHDUFKODVWLQJEHWZHHQRQHDQGWKUHH\HDUV i. It should preferably address topics/themes from the current national research priority areas.2 ii. ,Q WKH FDVH RI IRUHLJQ DSSOLFDQWV WKH\ VKRXOG DIÀOLDWH ZLWK D research institution or tertiary education institution in Tanzania 2 Refer to the National Research Priorities. 6 and involve local research collaborator(s) through their respective institutions. iii. ,W VKRXOG WUDLQ PHQWRU RU VXSSRUW DW OHDVW RQH 7DQ]DQLDQ DW Master’s Degree level. C. /RQJWHUPUHVHDUFKODVWLQJEH\RQGWKUHH\HDUV i. It should preferably address topics/themes from the current national research priority areas. ii. It should include a capacity-building component to support UHVLGHQWVDW0DVWHUV3K'DQGSRVWGRFWRUDOOHYHOV iii. ,Q WKH FDVH RI IRUHLJQ DSSOLFDQWV WKH\ VKRXOG DIÀOLDWH ZLWK a recognized local research institution or tertiary education institution and involve local research collaborators. One of these would preferably be a co-PI (co-Principal Investigator) with relevant expertise. 3.0 DOCUMENTS REQUIRED FOR RESEARCH CLEARANCE All applications and attachments must be submitted to the Director General RI &267(&+ WKURXJK DQ RQOLQH V\VWHP DYDLODEOH DW ZZZFRVWHFKRUW] RU HPDLOHGWRUFOHDUDQFH#FRVWHFKRUW]DWOHDVWWKUHHPRQWKVEHIRUHWKHLQWHQGHG commencement of research in Tanzania. Application forms and templates of the required supporting documents are available on the COSTECH website at www.costech.or.tz. The research clearance application forms must be DFFRPSDQLHGE\WKHIROORZLQJGRFXPHQWV a) 'HWDLOHGFXUULFXODYLWDHRIDOOUHVHDUFKHUVLQYROYHGLQWKHSURMHFW b) $ IXOO UHVHDUFK SURSRVDO LQGLFDWLQJ LPSRUWDQW VHFWLRQV VXPPDU\ V\QRSVLV LQWURGXFWLRQ SUREOHP VWDWHPHQW REMHFWLYHV DQG VLJQLÀFDQFH RI WKH UHVHDUFK K\SRWKHVHV RU UHVHDUFK TXHVWLRQV WKHRUHWLFDOIUDPHZRUNGHWDLOHGPHWKRGRORJLHVDQGWLPHIUDPH c) 7KHVSRQVRU·VFRYHULQJOHWWHU3 d) )RUIRUHLJQDSSOLFDQWVVFLHQWLÀFDQGUHVHDUFKHWKLFVDSSURYDOIURP DQDSSURSULDWHLQVWLWXWLRQDODXWKRULW\LQWKH3,·VFRXQWU\RI UHVLGHQFH e) Research ethical clearance (where applicable) from subject matter DXWKRULWLHVLQ7DQ]DQLDVXFKDV i. the National Institute of Medical Research (NIMR) for UHVHDUFKLQPHGLFDOSXEOLFKHDOWKDQGRUKXPDQKHDOWK 36SRQVRULVDSHUVRQRUERG\SURYLGLQJSULPDU\¿QDQFLDODQGRUPDWHULDOVXSSRUWIRUWKHSURMHFW 7 ii. the Tanzania Food and Drugs Authority (TFDA) for FOLQLFDOWULDOV iii. the Tanzania