The mandate of the Amref ESRC includes:

• Approval: Reviewing and approving research involving human subjects conducted in Kenya by Amref Health Africa and other local and international organizations.
• Monitoring: Monitoring approved research studies.
• Mentorship and capacity building: Providing ethical guidance to researchers to strengthen the quality of research ethics based on quality of protocols submitted.
• Knowledge generation and dissemination: Adding to research ethics knowledge by presenting in local and international conferences and manuscript development.

Yes. The Amref ESRC is accredited by NACOSTI and operates under its guidelines, as well as international ethics standards such as the Declaration of Helsinki and CIOMS guidelines. IMPORTANT: You need to first obtain an approval letter from ESRC before submitting your protocol to NACOSTI to obtain your research permit.

Amref ESRC is regulated by the following bodies:

1. National Commission for Science, Technology and Innovation (NACOSTI): Registration number NCST/NBC/AC/0912 - ESRC is accredited by NACOSTI to review and approve research involving human participants.

2. The Office for Human Research Protections (OHRP): International registration by OHRP gives ESRC a global recognition and the ability to approve federally funded research from international organizations:

• Federal wide assurance (FWA) number: FWA000018713
• The International Review Board Organizations (IORG) number: IORG0007315

Researchers affiliated with Amref Health Africa or external researchers conducting studies in collaboration with Amref or within Kenya, including students, can submit protocols for review.

Protocols are submitted electronically via the ESRC online submission portal. You must first create an account and follow the protocol submission workflow.

The ESRC processes the following types of reviews:

• Expedited Review
• Normal Review
• Clinical Trials
• Renewals
• Amendments
• Renewals and Amendments
• Shipment of biological samples

Required documents include:

• Completed ESRC Application Form with relevant signatures
• Completed research protocol
• Completed tools, e.g. questionnaires, in-depth interview guides, FGD guides, data extraction sheets, case report forms, diary cards etc
• Complete consent and/or assent forms with the necessary translations/Request for waiver of informed consent
• Material to be used (including advertisements) for the recruitment of potential research subjects
• Protection of Human Research Participants certificates from all investigators. Recommended courses:

- Training and Resources in Research Ethics Evaluation (TRREE) Module 1 (FREE)

- Global Health Training Centre Research Ethics Online Course (FREE)

- NIH Research Ethics Course

- Collaborative Institutional Training Initiative (CITI)

• CVs of all Investigators in ESRC format (updated, signed and dated)
• Donor budget and approval
• Signed Data confidentiality agreement forms for all investigators
• An approval letter from the local and/or county authorities, and/or government departments, where applicable
• Approval from other institutional review boards where applicable
• Approval from the university department or other responsible person (for students only)
• Scanned copy of the ESRC review fee receipt

For clinical trials, additional requirements include:

• Cover letter
• Duly signed application form
• Master protocol and site-specific addendum
• Informed consent/assent forms with the necessary translations
• Participant/patient materials (study guides, questionnaires, posters, flyers, talking points etc.)
• Investigator's brochure (Product information, batch release certificate, certificate of analysis)
• Good clinical practice certificates for all study staff
• Valid research ethics certificates of all investigators
• Details of the Data Safety Monitoring Board including the charter, composition and meeting schedule
• Valid indemnity covers for the investigator(s) valid for the entire period of the study
• Valid insurance certificate for the participants valid for the entire period of the study
• A copy of current practice licenses or certificates
• Laboratory accreditation certificate
• Workload forms for the investigators
• Evidence of contractual agreement between sponsor and principal Investigator
• Signed declaration by the sponsor or principal investigator that the study will be carried out according to the protocol and applicable laws, regulations and GCP requirements
• Declarations by the principal investigator and sponsor on conflict of interest
• Adequate information and data from previous studies and phases to support the current study
• Proof of ethical approval from other involved countries for multi-country studies
• Detailed statistical analysis plan
• Assessment of comprehension script
• Proof of registration of the clinical trial-Registration reference number
• Investigational Product Dossier

The review process takes approximately 3–4 weeks for expedited reviews and 5–6 weeks for normal reviews.

Expedited Review:

• Turnaround time: 3 weeks
• Shared with 3 reviewers
• Cost: USD 1,000
• Feedback is shared with investigators as soon as it is fully reviewed and does not have to wait to be discussed in the monthly meeting

Normal Review:

• Turnaround time: 6 weeks
• Shared with 2 reviewers
• Cost: USD 500
• Must be discussed during an ESRC meeting before any comments or feedback are shared with the investigators

Once the protocol is submitted through the system:

• Preliminary Review: The Secretariat screens for completeness and adherence to guidelines. Feedback is hence given to investigators whose submissions do not meet the required standards, for them to align
• Assigning reviewers: Once secretariat reviews the revised submission and deems it fit to undergo the review process, the protocol is assigned to reviewers based on the following criteria: Expertise of reviewer, type of protocol, Thematic area of the protocol
• Review by reviewers: Reviewers evaluate scientific and ethical merit
• Review comments: Through a review letter, comments will be shared requiring clarification or revision
• Approval: Once revised and clear, the ESRC will approve the study and issue an official 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.

Yes. After logging into your account on the platform, you can view the status of your protocol submission under "My Protocols."

Reviewer comments are shared via the portal through an official review letter. Investigators are expected to respond through the system and re-upload revised documents, including a point-to-point response letter.

Yes. Investigators may formally appeal by submitting a letter to the Secretariat, detailing the grounds for the appeal and providing supporting documentation, and also request for a meeting with the ESRC to justify themselves.

The ESRC conducts its meetings every last Wednesday of the month apart from December, which meeting is held in a yearly workshop early in the month. All protocols should be submitted to the secretariat 2 weeks before the meeting to allow ample time for review.

Currently, the module for renewals and amendments submission is under development. Please submit this request on email.

To request a protocol amendment, the following documents must be submitted:

• Cover letter stating all the amendments to the protocol, with justifications
• Revised protocol with all changes highlighted
• Revised study tools, where appropriate
• Completed Update Form
• Progress report – if any data has been analyzed, include preliminary findings. Any publications or abstracts of conference presentations should be attached
• Any other relevant documents

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.

Yes. All approvals are valid for one year. Submit a request for renewal at least two months (60 days) before expiry.

To request an annual renewal, the following documents must be submitted:

• Cover letter requesting for annual renewal
• Approved protocol
• Approval letter
• Update Form
• Progress report – if any data has been analyzed, include preliminary findings. Any publications or abstracts of conference presentations should be attached
• Proof of payment of review fee (500USD)
• Any other relevant documents

Depending on the nature of your protocol, you will often be expected to submit the following reports:

• Progress reports during submissions of renewals and amendments
• Closeout report upon study completion
• Adverse Event/Serious Adverse Event reports/SUSARs
• Protocol deviations or violations reports (if any)
• Pregnancy occurrence

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

For review and approval of material transfer requests, the following documents should be submitted to ESRC for review:

• A cover letter requesting for shipment of specimens indicating the type(s) of materials, volumes and quantities to be shipped, to where they will be shipped, and a clear justification for shipment
• Filled and signed export request form provided by the ESRC
• A completed MTA signed by the person requesting the export and the recipient institution
• Approved protocol: the justification for shipment of specimens must have been provided in the approved protocol
• Approved written informed consent forms (ICFs) that include the need for shipment of specimens, and storage of specimens for possible future use and research
• If shipment is being requested for further testing, the application must be accompanied by a list of tests that will be performed, and accreditation certificates of the laboratories that will be performing these specific tests

Yes. The ESRC offers regular capacity-building workshops and short courses in research ethics for investigators, students, and institutions. Kindly submit your request through the secretariat.

Yes. Principal Investigators must provide certificates of recent research ethics training (completed within the last 3 years).

Recommended courses include:

• Training and Resources in Research Ethics Evaluation (TRREE) Module 1 - Introduction to Research Ethics (FREE)
• Global Health Training Centre Research Ethics Online Course (FREE)
• NIH Research Ethics Course
• Collaborative Institutional Training Initiative (CITI)

Review fees are:

• Expedited Review: USD 1,000
• Normal Review: USD 500
• Renewals: USD 500

Payment Process: 1. Request an invoice through the platform first 2. Make payment via bank deposit using the bank details below. Quote "ESRC X218" when filling the bank slip or wire transfer details. For wire transfer, ensure your organization caters for the transfer charges. Kenya Shillings Account: Account Name: AMREF Bank Name: Standard Chartered Bank Account No.: 0108003408900 Branch: Upper Hill Swift Code: SCBLKENXXXX US Dollars Account: Account Name: AMREF Bank Name: Standard Chartered Bank Account No.: 8708003408900 Branch: Upper Hill Swift Code: SCBLKENXXXX 3. Share the original bank slip with the secretariat through ESRC email to facilitate issuance of official Amref Receipt 4. Attach the official Amref Receipt to your application Payments can also be made via M-Pesa. Ensure you upload valid proof of payment (remittance advice from the bank with details of the Amref account number where payment has been made, amount paid, date paid and the name of the organization/person who has paid).

When requesting an invoice, provide:

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

For internal (Amref) protocols, request for an inter ledger invoice and share cost center.

Request for an invoice using the portal first to request for an invoice before making payment.

• The invoice will be sent to you via email in 1-2 business days.

Click on "Forgot Password" on the login page to receive instructions via email on how to reset your password.

Contact the ESRC Secretariat via phone +254795746777 or email esrc.kenya@amref.org with details of the issue.

Yes. Once logged in, go to "My Profile" to update your personal and professional details.

After approval, you must:

• Conduct research in accordance with approved protocol
• Obtain further approval in case of any amendments
• Obtain necessary approvals as per regulatory bodies
• Report any adverse events promptly
• Maintain participant confidentiality and data protection

Yes. Approval can be suspended or withdrawn if the study is found non-compliant with ethical standards, poses unforeseen risks, or fails to submit required reports.

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.