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 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:
Tel/Mobile:
Email:
Collaborating Institution(s) and contact person
1.
2.
Etc.
All co-investigators (local and foreign)
  Name: Qualification Institution/Department
1.
2.
Etc.
Purpose of Research
(Check X in the relevant boxes - click on the check box)
Not for degree purposes
Postgraduate: degree/diploma (state which)
Name of degree/diploma
Details of the proposed Research
Starting and ending dates
Research site in Tanzania

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Research site outside Tanzania (if any)
Budget (Tsh or $)
Source of funds/sponsor
Nature of Research
(Check X in the relevant boxes - click on checkbox)
Respective study Prospective study
Longitudinal study Cross-sectional study
Audit Review of records
Behavioural study Anthropological or socialogical study
Development and/or Testing of education material/methods Observational study
Quantitative methods to be used Qualitative methods to be used
Mixed methods to be used Other (describe)
Describe further if necessary
Will this study involve the taking of blood and/or any other biological samples?: Yes No NA
Will this study involve shipment of biological samples outside Tanzania?:
If Yes, Please attach Material Transfer Agreement
Yes No NA
Will this study involve data sharing/transfer outside Tanzania?:
If Yes, Please attach Data sharing/transfer agreement
Yes No NA
Is this an externally sponsored research?:
If Yes, Please attach ethics approval letter from foreign ethics committee
Yes No NA
Have you applied for ethics approval from the NIMR National Ethics Committee?
Please attach if applicable.
Yes No NA
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.
State the total duration of the project, and where it will be undertaken in Tanzania (and also in other countries if appropriate).
Provide evidence (such as commitment/endorsement letter) to show that local government officaials in the region(s)/disctrict(s) where the proposed research will be conducted have been informed about this study. IF THIS HAS NOT BEEN DONE, describe how you plan to achieve this BEFORE the study starts.

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Specify the number of the study participants, with scientific justification for sample size, age, gender
Specify recruitment methods, inclusions and exclusions criteria and study end points
Specify data collection procedures, including interviews and sample collection, involving human participants 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)
If samples will be taken overseas, are there samples which will be left in Tanzania? Describe procedures to be used in their shipping, storage and when they will be destroyed. Indicate which institution or laboratory samples will be analyzed. Please note that before samples are shipped out of Tanzania, a MTA clearance is required.
Is the technology required for analysis of the samples available in Tanzania? Yes No NA
If YES, please explain why are samples being taken outside the country
Would local scientist(s) be involved in sample analysis? Yes No NA
If YES, describe her/his involvement, and if NOT please explain what are the strategies of technology transfer
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.
Describe the potential risks, discomfort, distress or hazards that 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 the 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 Participant Information Sheet (Check X in the relevant boxes - double click on 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 during the consent process
Consent will be only verbal
Consent will be only written
Consent will be written or verbal (depending on participant’s literacy)
Informed consent is not necessary

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State why not:
Request waiver for consent due to the nature of study
Please state why :
If a Questionnaire or Interview is to be used in the research, it must be attached.
Is it attached? If not, the application cannot be considered. Yes No
Assent / Guardian form must be attached.
Age range of patients/participants/controls:
If under 18 years, from whom will consent be obtained?
Please state any other thing that you think could be useful in the evaluation process





Please submit the completed protocol to :

The Secretariat

CUHAS/BMC Joint Ethics & Review Committee
Telephone: +255 28 2500881
Fax: +255 28 2502678