CUHAS/BMC JOINT ETHICS & REVIEW COMMITTEE

FORM NO. 1: APPLICATION FORM FOR ETHICAL CLEARANCE

For Official use only

Application No	Date Received:
Name, date and signature of the BMC/ CUHAS E&R Committee Member receiving the application	Name:
	Signature:	Date:

---

Instructions. All applications for ethics approval should be submitted using this form. The Principal Investigator is required to ensure the information provided is accurate and will sign on this form to indicate that he/she approves the content. The information provided in this form is expected to be complete and adequate for reviewers to make a decision on the final disposition of the proposal. The Application Form must be TYPED. Handwritten forms are not acceptable. Responses should be typed in the blank space/field after each question. All forms to be handed in must be complete in full and relevant signatures must be provided. Should this not be done, the evaluation process will not commence. The form shall be handed to the Ethics & Review Secretariat with one copy of the full proposal and the receipt for the payment of the clearance fee.

Title of Proposal/ Project
Name of the Principal Investigator (PI)
Nationality of the PI
Current qualifications of the PI
Position/ Academic title
Institution/ Department/ Unit
Signature of the PI
If Research student: Name, Signature and approval of Supervisor (include approval letter	Name:	Signature

Contact details for correspondence (include the name of contact if different from the PI)	Physical:
	Postal Address:
	Tel/ Mobile Phone:
	Email Address:

Collaborating Institution(s) and contact person	1:
	2:

All co-investigators (local and foreign)	Name	Qualification	Institution/ Department
1
2
3
4
5

Purpose of Research (Check V in the relevant boxes-click on the check box)

Not For Degree purposes      :For Degree purposes      :For Masters purposes      :For PhD purposes

Abstractof the proposed Research
Starting and Ending dates	Starting	Ending
Research site in Tanzania
Research site outside Tanzania (if any)
Budget (Tshs or $)
Source of funds/sponsor

Nature of Research (Click X in the relevant boxes

Describe further if necessary

Will this study involve the taking of blood and/or any other biological samples?		YES NO N/A
Will this study involve shipment of biological samples outside Tanzania? If Yes, Please attach Material Transfer Agreement from NIMR		YES NO N/A
Will this study involve data sharing/transfer outside Tanzania? If Yes, Please attach Data sharing/transfer agreement from NIMR		YES NO N/A
If this an externally sponsored research? If Yes, Please attach ethics approval letter from foreign ethics committee		YES NO N/A
Have you applied for ethics approval from the NIMR National Ethics Committee? Please attach if applicable		YES NO N/A

Provide the scientific background, study design and objectives and hypotheses. Max 300 words
State the intended value of the project or rationale. Why is it important to conduct this study in Tanzania? Provide relevant references as appropriate. Max 200 words
IF THIS HAS NOT BEEN DONE, describe how you plan to achieve this BEFORE the study starts. LETTER OF PERMISSION WILL BE SOUGHT FROM Purpose of Research (Check V in the relevant boxes-click on the check box) City      Regional Authorities      Council(s) Authorities      District / Medical Officers Others.....
Specify the number of study participants, with scientific justification for sample size, age, gender
Specify data collection procedure with brief details of actual methods. Attach copies of questionnaires and other data collection tools in English and Swahili (if applicable) 400 words
If applicable, specify procedures to be used to process, store and test biological samples (e.g. blood, genital swabs, urine, etc)
Is the technology required for analysis of the samples available in Tanzania? If YES, please explain why are samples being taken outside the county	YES NO N/A
Would local scientist(s) be involved in sample analysis? If YES, describe her/his involvement, and if NOT please explain what are the strategies of technology transfer	YES NO N/A
Specify data management procedures and methods to be used during data analysis
If data will be taken overseas, please describe why are being taken outside the country. Please note that before data are taken out of Tanzania, a DSA is required from NIMR
Describe the potential risks, discomfort, distress or hazards the research participants may be exposed to (these may be physical, biological and/or psychological). What precautions will be taken to reduce risks and ensure participant's safety?
Describe potential benefits for participants and the population where they come from. Are there direct benefits for the people of Tanzania and/or other countries?
Specify how confidentiality of the study participants and data collected will be maintained.

Requirements for Participants Information Sheet (Check v in the relevant boxes - click on the check box)

Participant information leaflet is attached. (for written and verbal consent)		YES	NO
Informed Consent Form is attached. (For written consent)		YES	NO
Describe steps to be taken to minimise coercion/undue influence during the consent process
Describe how you are going to assess the comprehension of the information provided the consent process	Consent will be only written Information sheet will be read to the participant
If a Questionnaire or Interview is to be used in the research, it must be attached. Is it attached? If not, the applicant cannot be considered.		YES	NO
Age range of patients/participants/controls:
If under 18 years, from whom will consent be obtained?	Parent      Guardian
Please state any other thing that you think could be useful in the evaluation process.

FEES FOR ETHICAL CLEARANCE FROM THE CUHAS/ BUGANDO

NO	CATEGORY	Fee USD	Fee Tsh
1	Proposal from Tanzanian Institutions and / or on local collaborators		200000
2	Proposal with foreign collaborators	200
3	Proposal from Tanzania students (MMED, MPH, MSc)		100,000
4	Proposal for Tanzania students (PhD)		200,000
5	Proposal from foreign students (Masters)	100
6	Proposal from foreign students (PhD)	200
7	Amendments of a proposal		60,000
8	Application for renewal of ethical clearance		120,000
9	Application for amendment of ethical clearance (foreigners or collaboration with foreigners)	50
10	Application for renewal of ethical clearance (foreigners or collaboration with foreigners)	100

PROCEDURE FOR PAYMENT:

1. Pay to CUHAS account no. 02J1054045500 (USD Account) and 01J1054045501 (Tshs Account) at CRDB Bank.
2. Bring the deposit slip to the cashier's office.
3. Get an official receipt.
4. Present the receipt, together with the application form for ethical clearance and a copy of your proposal to the Research & Innovations Administration Office (Mr .G. Luena) to proceed with the Ethics & Review process.

	Copyright (c) 2003-2021. Developed by Directorate of Information Systems. Catholic University of Health and Allied Sciences (CUHAS-Bugando) Application form for ethical clearance - Version 2 - June 2021

Please submit the completed protocol to :	The Secretariat CUHAS/BMC Joint Ethics & Review Committee Telephone: +255 28 298 3384 Email: cuhas.ethical.app@gmail.com Fax: +255 28 298 3386

PRINT FORM