IREC ref no.

IREC use only
IREC APPLICATION FORM

This form is to be submitted to ILRIResearchcompliance@cgiar.org along with any relevant documentation after completing all sections and all endorsements (see Annex for instructions).
POINTS TO NOTE:
	This form is valid, unchanged, for one year. 
	If minor changes are required then the IREC MINOR AMENDMENT FORM (see website for form - www.ilri.org/ethicscommittee) should be completed and sent to the IREC committee for consideration.
	If renewal of approval is required then the IREC RENEWAL OF APPROVAL FORM (see website for form - www.ilri.org/ethicscommittee) should be completed and sent to the IREC committee for consideration.
	The committee requires the form to be submitted to the IREC committee at least 6 weeks before the start of the research activity to enable sufficient time for it to be approved.
	The ILRI IREC committee follows international standards for research ethics and follows the principles of research ethics (autonomy, beneficence, non - maleficence and justice).  

Approval Type Requested:	X the box which applies. Note that ‘Conditional’ applications should be followed up by ‘Final’ applications at project activity planning stage	
Conditional (e.g. project proposal stage)		Final (e.g. project activity planning stage)		
If previous conditional approval received give the IREC ref. number		
Approval for a whole project		Approval for an activity within a project		
If an activity within a project, give the title of the project		

1. Title of research project & activity:	Overall project title & research activity to which this form refers (Max. 30 words)	

2. Team, location & grant code under which research activity falls:	e.g. BT02 NBO WEL004	

3. Principal Investigator (PI):
(Person ultimately responsible for this research activity)		Home Tel.
Mobile Tel.		
4. ILRI staff responsible & role: 		
5. Names or description of others involved in conducting the research: 	

6. Overall objectives of this research activity:	(Provide numbered list)	

	

7. Regulatory Requirements / Guidelines: 	Are you in compliance with local regulatory requirements (give details & info. on any approvals required)	

8. Anticipated benefits: 	1.	Anticipated benefits to research participants and their community
2.	Anticipated benefits to other communities	

	

9a. Anticipated risks and their management	1.	Anticipated risks to research participants
2.	Anticipated risks to personnel involved in conducting the research
3.	Anticipated risks to animals, environmental sustainability, economy or development
4.	Procedures taken to minimise & manage these risks	

	
9b. Care and protection of research participants	Regarding ‘risks to research participant’ in Section 10, Detail here:
1.	Any medical care or treatments to be provided
2.	Any rewards and compensations for research participants
3.	Provisions for compensation/indemnity in case of adverse effects	

10. Research activity details / protocol	1.	Study type / design (incl. use of ‘counterfactuals’, if relevant & site selection) 
2.	Justification for number of participants (e.g. power / sample size calc.)
3.	Plans for data management & analysis 
Attach to application any relevant documentation (e.g. study, sampling, or data management protocols)	

	

11. Recruitment & involvement of research participants and informed consent	1.	Means of recruitment (incl. inclusion & exclusion criteria, withdrawal criteria) 
2.	Means by which full information about the research activity will be conveyed to communities / participants
3.	Details of the informed consent process (attach to application relevant forms)	

	

12. Protection of privacy & confidentiality	Detail the following:
1.	Measures taken to ensure privacy (during data collection & after)
2.	Who will have access to data & in what form, plan to anonymise the data etc.	

	

13. Feedback to communities & participants	How will research results be made available to research participants and the communities (detail for each type of results – e.g. survey, sample results)	

	

14. Proposed (future) commencement date:		Duration:		

15. Details on site facilities, equipment & skills of technical staff	Explain the various technical facilities required / in place for the research (e.g. labs, field stations) & the skills and any relevant training required e.g. medical qualifications for human sampling, training of enumerators for household surveys etc.)	

	

16. Instruments	List relevant research instruments attached: e.g. consent form, questionnaire, interview guide, protocols – study, sampling, data management.	

		

17. Other ILRI approvals required?:	1. Research activities involving animals require an IACUC form (this also covers the Ethical issues relating to research on animals)
2. Research activities involving biohazardous substances must be approved by the IBC	
	Required? (X if yes)	Reference (if already received)	
Institutional Animal Care & Use Committee (IACUC)			
Institute Biosafety Committee (IBC)			

18. Endorsements:	Main signatures in the order below signify that all necessary obligations/requirements have been satisfied.	
Signature of Principal Investigator *: 		Date: 		
Signature of Program Leader :		Date		
Signature of DDG-R (IS or BioS) :		Date:		

* I certify that the any revision to this protocol will be forwarded to the IREC for review using the IREC amendment form and revised protocol will not be implemented until IREC approval has been obtained.

IREC USE ONLY

Date received by IREC:		Received by:		
Application number:		

IREC review actions:	(Reference can be to an e-mail, description of actions or edited version of form)	
Reference:	Requested by (name):	Action (what / by whom):	

			

IREC FINAL APPROVAL:	
Signature:		IREC position:		Date:		

ANNEX

The sign-off procedure is as follows 

N.B. This process / chain should be indicated by FORWARDING e-mails through the process

Principal Investigator (PI): This is be the person (researcher) who takes responsibility for ensuring that the experiment runs as stated in the protocol - and that animals are cared for as they should be. The PI should be the person who is touch with the field staff and can answer and explain all questions about the way the protocol is implemented and why. They will be based wherever the experiment is taking place.

Program Leader: This is the person who is directly responsible for the research project under which the PI is working and is likely to be the supervisor of the PI. In some cases PI and program leader will be the same person.

Deputy Director General Research - Integrated Sciences / BioSciences: DDG under which the Program, project and PI falls.

Approval of Scientific Merit (PL & DDG Approval Required):
The IREC assumes that the proposed research has been reviewed and approved on the basis of scientific merit by the relevant PL & DDG, evidenced by their signed-off or his/her designee (in the “Endorsements” section).