Regulation and Ethics Review of Research

Research involving human participants needs, in principle, to be reviewed by a capable Research Ethics Committee (REC) – also called an Institutional Review Board (IRB).  The ethical review of research protocols before research studies are started has become an essential requirement of good research in all but a very few countries.
 
In the case of 'international collaborative health research' involving researchers and funding from high income countries to conduct research for health in low and middle income countries this is especially important and ethical review is often complex. In addition, research is becoming increasingly international and takes place in more than one country at the same time.
 
Capable RECs/IRBs and - where appropriate - national ethics committees, high quality ethics guidelines that adapt international guidelines to local conditions, and effective management of or 'standard operating procedures' for RECs/IRBs will all facilitate the conduct of ethical research and will minimise the risks and maximise the benefits of research for health – especially in low and middle income countries.
 
This section of HRWeb provides crucial contact information for ethics reviews of health research in countries. The information is being provided partly by COHRED but increasingly by Research Ethics Committees themselves under an agreement with HRWeb.

 

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  SOP 1
SOP 1  - (doc, 91 Kb)
 Brochure d'information aux chercheurs
Document montrant les procedures de soumission de protocoles au CNERS  - (pdf, 2960.7 Kb)
 Calendar of RNEC Mtngs 2011
Calendar of RNEC Mtngs 2011  - (docx, 39.92 Kb)
 CIRE depliant-Flyer
Une Vision et un outil au service du d√©veloppement durable de la R√©gion des pays des Grands Lacs Africains.  - (pdf, 73.06 Kb)
 Consent Template
Consent Template  - (doc, 30 Kb)
 Constituting an IRB Guideline
Constituting an IRB Guideline  - (doc, 122 Kb)
 FHS IRB review cycle deadlines (2014)
 (docx, 12.85 Kb)
 Form No 3. Application form for Ethics Approval
 (doc, 143 Kb)
 Form No 3. Application form for Ethics Approval
 (doc, 143 Kb)
 Form No 4. Checklist for Application
 (doc, 54 Kb)
 Form No. 5-Letter of Clearance from Biostatistician
 (doc, 29.5 Kb)
 Form No. 6- Application for Protocol Amendment Form
 (doc, 69 Kb)
 Form No. 7- Serious Adverse Events Reporting Form
 (doc, 33 Kb)
 Form No. 8-Project Update and Closure Form
 (doc, 40 Kb)
 Forn No 9. Ethical review Fee Schedule
 (doc, 30.5 Kb)
 General outline
General outline for a study protocol:  - (docx, 12.96 Kb)
 Gu√≠as Operativas - CEISH -Hospital San Jos√© - FUCS
Bogot√°, 2009  - (pdf, 497.86 Kb)
 Guideline for submission of a proposal, 2013 version
Details guidelines for submission of a proposal to the REC Lesotho. Developed in 2011 and updated in 2013.  - (doc, 177.5 Kb)
 Guidelines
Guidelines for submission of a research proposal are described.  - (doc, 177.5 Kb)
 Guidelines
Steps for submission of a health research proposal are described.  - (doc, 177.5 Kb)
 Guidelines
Steps for submission of a health research proposal are described.  - (doc, 177.5 Kb)
 Guidelines
The steps for submission of a health research proposal are described. Published in 2011 and updated in 2013.  - (pdf, 737.99 Kb)
 Guidelines for Protocol Submission
Guidelines for Protocol Submission  - (docx, 20.35 Kb)
 Guidelines for submission
Describe the guidelines for submission of a health research proposal to the National Health Research Ethics committee.  - (doc, 177.5 Kb)
 Guidelines for submission of a proposal
Describe the requirements for submission of a health research proposal to the National Health Research Ethics Committee.  - (doc, 177.5 Kb)
 Guidelines for submission of a research proposal
Describe the guidelines for submission of a health research proposal to the Research Ethics Committee Lesotho. Developed in 2011 and updated in 2013.  - (doc, 177.5 Kb)
 Guidelines for Submission to School of medicine Research Ethics Committee
Submission Guidelines  - (doc, 60 Kb)
 Information on Ethical Clearance for the Conduct of Research in the Ghana Health Service
 (pdf, 123.98 Kb)
 Informed Consent template
Informed Consent template  - (doc, 28.5 Kb)
 INSTITUTIONAL RESEARCH AND ETHICS COMMITTEE (IREC) REVIEW CONTINUING REVIEW
IREC REVIEW CONTINUING REVIEW   - (doc, 154.5 Kb)
 List of REC Members
List of REC Members  - (doc, 66.5 Kb)
 National Health Research Policy
Background, guidelines, vision and challenges of health research in Lesotho are described. Published in 2008.  - (pdf, 310.92 Kb)
 National Health Research Policy
Current status, challenges, vision of health research in Lesotho are described.  - (doc, 315.5 Kb)
 National Health Research Policy
Describe the policy guidelines, challenges and vision for health research in Lesotho; published in 2008.  - (doc, 315.5 Kb)
 National Health Research Policy
Describe the policy guidelines, challenges and vision of health research in Lesotho.  - (doc, 315.5 Kb)
 National Health Research Policy
Published in 2008. Describes about the background, vision, challenges and guidelines for health research in Lesotho.  - (pdf, 310.92 Kb)
 National Health Research Policy
The document is about the National Policy on Health Research in Lesotho. It describes the current situation, policy guidelines and vision on health research. Developed in 2008.  - (doc, 315.5 Kb)
 National Health Research Policy, Lesotho
Background, vision and guiding policy for Health Research in Lesotho, developed in 2007 and updated in 2008.  - (pdf, 310.92 Kb)
 National Health Research Policy, Lesotho
Describe current situation , challenges and vision of health research in Lesotho. Developed in 2008.  - (doc, 315.5 Kb)
 NHRP
Hea.lth Research Policy developed in 2008  - (doc, 315.5 Kb)
 Procedures for applying for review
 (doc, 27 Kb)
 Procedures for subm
 (doc, 36 Kb)
 Reglement Interieur
R√®glement Interieur adopt√© le 13 Janvier 2011  - (doc, 0 Kb)
 Reglement Interieur AMENDE 2011
 (doc, 0 Kb)
 REQUIREMENTS FOR SUBMISSION OF NEW PROTOCOLS FOR REVIEW
 (pdf, 46.77 Kb)
 REQUISITOS DE SOLICITUD PARA LA EVALUACI√ďN BIO√ČTICA DE LOS PROTOCOLOS DE INVESTIGACI√ďN BIOM√ČDICA.
Requisitos minimos de presentacion de un protocolo  - (doc, 28 Kb)
 Research Ethics Application form/ Kenyatta National Hospital/University of Nairobi
Research Ethics Application form  - (pdf, 57.57 Kb)
 Research Ethics Clearance System
Process of reviewing and approving a research proposal is described.  - (doc, 121 Kb)
 Reviewing Final Report SOP
Reviewing Final Report SOP  - (doc, 77 Kb)
 Revised TASO Research Requirements
Revised TASO Research Requirements  - (pdf, 31.85 Kb)
 SOMREC SOP 10
SOMREC SOP 10  - (doc, 83.5 Kb)
 SOMREC SOP 11
SOMREC SOP 11  - (doc, 124 Kb)
 SOMREC SOP 12
SOMREC SOP 12  - (doc, 106.5 Kb)
 SOMREC SOP 13
SOMREC SOP 13  - (doc, 58 Kb)
 SOMREC SOP 14
SOMREC SOP 14  - (doc, 83.5 Kb)
 SOMREC SOP 2
SOMREC SOP 2  - (doc, 82.5 Kb)
 SOMREC SOP 3
SOMREC SOP 3  - (doc, 78.5 Kb)
 SOMREC SOP 4
SOMREC SOP 4  - (doc, 93 Kb)
 SOMREC SOP 5
SOMREC SOP 5  - (doc, 127 Kb)
 SOMREC SOP 5
SOMREC SOP 6  - (doc, 105 Kb)
 SOMREC SOP 7
SOMREC SOP 7  - (doc, 124 Kb)
 SOMREC SOP 8
SOMREC SOP 8  - (doc, 95 Kb)
 SOMREC SOP 9
SOMREC SOP 9  - (doc, 100 Kb)
 SOP No. 8: SUBMITING AN APPLICATION FOR ETHICS CLEARANCE
 (doc, 36 Kb)
 SOP No. 8: SUBMITING AN APPLICATION FOR ETHICS CLEARANCE
 (doc, 36 Kb)
 SOP's
SOP's from RNEC  - (doc, 0 Kb)
 Standard Operating Procedures
Describe the routine administrative and review process of the Research Ethics Committee.  - (doc, 1124 Kb)
 Standard Operating Procedures
Routine operating system of the Health Research Ethics Committee. Developed in 2011 and modified in 2013.  - (doc, 1124 Kb)
 Standard Operating Procedures
The routine procedures of the National Health Research Ethics Committee are described.  - (doc, 1124 Kb)
 Standard Operating Procedures
The routine procedures of the Research Ethics Committee Lesotho. Developed in 2011 and updated in 2013.  - (doc, 1124 Kb)
 Testing Document for RHInnO
Protocol  - (docx, 9.79 Kb)
 UFS Research Ethics Application Form
UFS Research Ethics Application Form  - (doc, 647 Kb)
 UFS Undergraduate Ethics Approval Application Form
UFS Undergraduate Ethics Approval Application Form  - (doc, 512.5 Kb)
 ZIREC SOPs and Mission Statement
ZIREC SOPs and Mission Statement  - (doc, 36.5 Kb)

 

 Brochure de l'investigateur
Document qui d√©crit la composition du dossier, les √©tapes de d√©pot, et les engagements du soumissionnaire  - (pdf, 1083.78 Kb)
 CERB
Document  - (pdf, 48.3 Kb)
 First African Conference for Administrators of Research Ethics Committees (AAREC) Report
Efforts to strengthen the capacity of research ethics committees in Africa have, to date, targeted research ethics committee (RECs) chairs and members, without a focus on the research ethics committee administrators (RECAs), who manage the RECs and are responsible for facilitating the review process, supporting capacity strengthening, and developing norms and standards for best practice in ethics review. To bridge this gap, the first African conference for Administrators of Research Ethics Committees (AAREC) was organized by MARC.  - (pdf, 2020.8 Kb)
 Mana Tangata
 (pdf, 78.65 Kb)
 Mana Tangata
Investigacion en poblaciones vulnerables  - (pdf, 78.65 Kb)
 Testing for RHInno
Publication  - (docx, 9.79 Kb)
 Testing for RHInno
Publication  - (pdf, 80.71 Kb)
 Health Canada's CHVI Regulatory Capacity Building Newsletter
Health Canada HIV Vaccine Initiative Regulatory Capacity building network Newsletter  - (pdf, 143.64 Kb)
 Mapping African ethical Review committee activity onto capacity needs: the MARC initiative and HRWeb's interactive database of RECs in Africa
Mapping African ethical Review committee activity onto capacityneeds  - (pdf, 359.7 Kb)
 MARC Canada Meeting Report
MARC Canada Meeting Report  - (pdf, 405.67 Kb)
 The South African Journal of Bioethics and Law
The South African Journal of Bioethics and Law (SAJBL) (2012 Vol. 5 No. 2) has been published. 
 Health Canada's CHVI Regulatory Capacity Building Newsletter
Health Canada HIV Vaccine Initiative Regulatory Capacity building network Newsletter  - (pdf, 143.64 Kb)
 Mapping African ethical Review committee activity onto capacity needs: the MARC initiative and HRWeb's interactive database of RECs in Africa
Mapping African ethical Review committee activity onto capacityneeds  - (pdf, 359.7 Kb)
 MARC Canada Meeting Report
MARC Canada Meeting Report  - (pdf, 405.67 Kb)
 The South African Journal of Bioethics and Law
The South African Journal of Bioethics and Law (SAJBL) (2012 Vol. 5 No. 2) has been published.