ESRC Review Process

a) What is the process of submitting my protocol to Amref ESRC for approval?

The Amref Ethics and Scientific Review Committee (ESRC) reviews soft copies of protocol documents which the investigator submits through the Amref Health Africa website (www.amref.org). The application package that contains guidelines, application forms, templates (consent form and CV templates) and bank details for payment can be accessed on the same website.

b) What documents do I need to submit?

When applying for scientific and ethical approval, the following documents must be uploaded on Amref ESRC platform ;

• Complete Protocol developed using the Amref ESRC format
• Filled and signed application form
• Cover letter from institution
• Study tools- Questionnaires, interview guides
• Ethics certificates of all the investigators preferably NIH and FHI
• Payment receipt

c) How many copies of the proposal should I submit?

Only one copy of all documents is required. The protocol, study tools and consent forms must be submitted as Word documents and not PDF.

d) What are the ESRC review processes?

• Once you submit your protocol you will receive an automatic email acknowledging receipt of the protocol.
• The ESRC Secretariat then reviews the application to ensure that all the relevant documents are provided, and the protocol and other documents follow the ESRC format.
• The initial review comments are shared with the principal investigator by email.
• Once the investigators have addressed the comments and submitted the revised protocol, the protocol is then sent back to the reviewers. This process can take one week.
• The protocol is then submitted to the reviewers for their reports. At least two (2) reviewers review each protocol.
• The protocol is then discussed in the monthly ESRC meetings and a decision is made on whether the protocol is accepted as is, whether major or minor revisions are recommended, or whether the protocol is rejected,
• Comments raised are then combined into a review letter which is shared with the principal investigator.
• The investigators then revise the protocol and submit a response letter and revised protocol, highlighting the changes made based on the comments raised.
• The protocol is then further reviewed and approved if all comments are adequately addressed.

e) Do you receive hard copies of the proposal?

No. All protocols must be uploaded on the Amref ESRC portal platform.

f) What is the cost of approval?

There are two types of reviews: normal reviews and expedited reviews. The principal investigator needs to advise the Secretariat on what type of review in requested. Expedited reviews cost 1000 USD and take three weeks for an approval. Normal reviews cost 500 USD and take 6−8 weeks for an approval. Students’ rates vary. Local students pay 50 USD and international students pay 100 USD. Internal protocols (protocols from Amref projects) cost 100 USD. Amendments and Renewals cost 500 USD. The fee for amendments and renewal is waivered for students.

g) How long does it take to get an approval from the ESRC?

Normal reviews take 6-8 weeks and expedited reviews take 3 weeks.

h) Where are you located?

We are located at the Amref Health Africa Kenya Country Office next to Wilson Airport opposite Lang’ata Primary School on Lang’ata Road, Nairobi County.

i) What is the mode of payment for approval?

Payments are made by bank deposit using the bank details below. Kindly quote ESRC X218 when filling the bank slip or wire transfer details. For wire transfer, ensure your organization caters for the transfer charges. Once you have paid, share the original bank slip with the secretariat through ESRC email to facilitate issuance of official Amref Receipt to the cashier at the Finance Department. Attach the official Amref Receipt to your application.
Account Name : AMREF
Bank Name : Standard Chartered Bank
Account No. : 0108003408900
Branch : Upper Hill
Swift Code : SCBLKENXXXX
Currency : Kenya shillings (Confirm the exchange rate with secretariat)
OR
Account Name : AMREF
Bank Name : Standard Chartered Bank
Account No. : 8708003408900
Branch : Upper Hill
Swift Code : SCBLKENXXXX
Currency : US Dollars

Prior to making payment of the ESRC review fee, ensure you first reach out to the secretariat (esrc.kenya@amref.org) and request for an invoice. For internal (Amref) protocols, request for an inter ledger invoice and share cost center. The following details should be provided when requesting for an invoice:

1. Title of the study
2. Type of review
• Expedited Review or normal review for new protocols
• Renewal only
• Amendment only
• Both renewal and amendment
3. Name of the PI
4. Contact details of the PI (Telephone number and email address) Name of the organization

j) Can one pay via mpesa?

No. Payments are made through wire transfer or directly deposit to the bank account

k) What kind of proposals do you approve?

We review and approve all proposals that have a health component and involve human subjects

l) Who are the reviewers?

The reviewers are committee members with expertise in various disciplines including health, environmental sciences, statistics, epidemiology and research. The committee members also include two (2) lay persons and one (1) legal officer.

m) Can I get a hard copy of the approval letter?

Yes. Hard copies of approval letters are available on request. However, the Secretariat always shares the soft copy of the signed approval letter after approval is granted.

n) How can I reach you?

You can reach us via email and telephone through the ESRC Secretariat. Our email address is ESRC.kenya @amref.org; mobile number +254 795 746777; landline +254 20 699 4000.

o) Do I need approval from NACOSTI before submitting my protocol to Amref ESRC?

You need to first obtain an approval letter from ESRC before submitting your protocol to NACOSTI to obtain your research permit.

p) How do I renew ethical approval if my approval has expired?

The protocol approval is for one year. A request of renewal of approval must be submitted to ESRC at least 60 days prior to expiry of the approval period. You are required to fill the Application Form and submit a progress report. In addition, a cover letter with a justification of extension must be provided together with proof of payment.

q) What procedure do I follow if I want to make changes to my proposal after I have received approval?

Any changes to the protocol after it has been approved must be submitted to ESRC for further approval. The principal investigator must submit a filled update form, a cover letter from institution highlighting the changes made. In cases of change in investigators, a letter from the principal investigator explaining why the investigator is no longer part of the study must be submitted together with a letter from the outgoing investigator consenting to exit the study.

r) How do I report adverse events?

All adverse events must be reported within 24 hours after occurrence, using adverse events reporting template.

s) How often does the ESRC meet?

The ESRC ideally meets once per month, on every last Thursday of the month. Any changes in the dates is often communicated. All protocols should be submitted to the secretariat 2 weeks before the meeting to allow ample time for review.

t) Do I need to submit a copy of my report after the study?

Yes. An executive summary report must be submitted within 90 days after completion of the study. This information forms part of the database that can be consulted when processing related research studies, to minimize duplication.