3. Ethics Committee (EC)/Institutional Review Board (IRB)

3.1 Provide a list of documents needed to be submitted for EC/IRB review and approval including the number of copies and/or translations as relevant.

The Dubai Scientific Research Ethics Committee (DSREC) acts as the Central Ethics Committee for the Emirate of Dubai. It takes the final decision on health research proposal requests after reviewing them thoroughly during periodic meetings. DSREC recognizes the establishment of Local Ethics Committees within the academic institution or private, government, or semi-government health institution or research center falling under the jurisdiction of the Emirate of Dubai.

Any research planned at DHA-licensed facilities WITHOUT the review or approval of the Local Ethics Committee must directly be submitted to the DSREC for review and approval.

Who can apply?

Researchers either health professionals or health university/college students who wish to obtain ethical approval on the research planned at the research sites that fall under the jurisdiction of the Emirate of Dubai.

Submission Procedure

Submit the following documents to (Email DSREC@dha.gov.ae):

Note: If the attachments size exceeds 120 MB, applicants must notify the DSREC via email at: DSREC@dha.gov.ae; they will share a secured link to upload the required documents.

1. Cover letter on headed paper (Addressed by Principal Investigator to DSREC):

• Please specify the role of each investigator in the study.  
• Index all documents submitted, with version if applicable.

2. DSREC Application Form (Click here), duly signed and dated:

• All questions mentioned in the form must be answered. In case NOT APPLICABLE, mention NA.
• If there is more than one site involved in the study, the Principal Investigator (PI) must obtain the administrative site approval from the Head Of Department (HOD) from each study site.
• If the study involves 3 or more than 3 sites, the applicant is to contact the DSREC for more information on the submission procedure.
• If the PI is the Head of Department, please obtain an administrative site approval from a higher authority.
• If research is planned at a wider scale in the Emirate of Dubai (at sites such as all governmental hospitals and/or all private hospitals which are under the jurisdiction of DHA and/or public places in Dubai and/or on the whole population (Emiratis/residents), then an administrative site approval from Head of Medical Research Section of DHA’s Medical Education and Research Department, must be obtained.

3. Study proposal/Synopsis

4. Patient/ Participant Information Sheet and Informed Consent Form (Click here), If applicable:

• Informed consent forms must be submitted in both Arabic and English.
• The attached template may be used as guidance to consider all of the required information for patient/participant enlightenment during the recruitment process.
• The attached template may be used and customized according to study requirements.

5. Questionnaires: If applicable, to be submitted in both English and Arabic.

6. Confidentiality Agreement Patient Information (Click here) to be signed by Principal Investigator and Co-Investigators.

7. Resume of Principal Investigator and Co-Investigators

8. Source of funding, if applicable (please submit supporting documents along with funding requirements).

9. Device Form (Click here), if applicable

10. Clinical Trial Undertaking Letter (Click here), applicable for Clinical Trials only.

11. All relevant enclosures such as Data Collection Tool/Case Report form/proforma/follow-up cards, etc.

Local Ethics Committees: According to Art. 34 of the “Guidelines for Conducting Clinical Trials with Investigational Products and Medical Devices”:

“Article 34. Scope of activities and responsibilities 

The Local Ethics Committee shall give an opinion for all clinical trials with interventional and non-interventional design when this is requested by the relevant Central Ethics Committee and when it is involving only one investigational site."

3.2 Time required for EC/IRB review and approval process and turnaround time if any query is raised during the review process.

Section 8.8 of the DSREC ”Submission of New Applications and Opinions to DSREC” states the following:

Applications for ethical review are required to be submitted 14 days prior to DSREC's scheduled regular meetings (frequency of meetings specified in Section 3.5 below).

The DSREC will report in writing to the principal investigator, advising whether the application has received ethical approval (including any conditions of approval), or whether further information, clarification, or modification might still be needed. This will occur within 7 working days of the meeting unless otherwise notified.

If the requested information is not received from the applicant within three months or two meetings (whichever occurs sooner), the project will be dismissed, and the applicant will be required to re-submit the project at a later date.

3.3 Does EC/IRB have any fast-track or expedited review process?

No. There is no fast track or expedited DSREC review process specified.

3.4 Does EC/IRB need to be registered and/or accredited/approved by RA/CA?

No. The DSREC is part of the Dubai Health Authority, which is also the regulatory authority for the Emirate of Dubai.

3.5 How frequently do EC/IRB meet?

The DSREC meets every six to eight weeks, except in July and August.

3.6 Is any additional approval required apart from the EC/IRB (e.g. scientific committee, subject matter expert committee, etc.)?

Not that we have been able to establish.

3.7 Please describe the process of the EC/IRB submission for clinical trial approval.

See Section 3.1 above. 

3.8 What is the relevant EC/IRB fee in local currency/USD? (e.g., is the fee different for notification/approval, initial submission, amendment, study with IMPD and study without IMPD, investigator site addition, etc.)?

The fees payable to the DSREC are as follows:

Dubai Scientific Research Ethics Committee 

Annex to the Administrative Decision No Administration Decision No. (07) of 2012 In respect of Medical Research Committee

3.9 Does EC/IRB accept checks or can payment be made electronically? Please provide details on (1) A/C number; (2) A/C Name; (3) Sort Code; (4) Swift Code; (5) Bank address, etc. Where can remittance advice notices be sent?

Payment may be made online, or in cash, in person.

BANK DETAILS

DUBAI SCIENTIFIC RESEARCH ETHICS COMMITTEE 

Bank Name Dubai Islamic Bank

Account Name DUBAI HEALTH AUTHORITY ‐ MEDICAL EDUCATION

Branch Main ‐ Dubai

Account No 001700005099749

IBAN. AE040240001700005099749

SWIFT Code DUIBAEAD

Payment Procedure

• Payment is accepted through bank transfer to Dubai Health Authority’s Bank Account. For details, please click here.
• Please send the transfer proof (receipt) to DSREC@dha.gov.ae, then payment will be confirmed with the Finance Dept team who will then share the payment voucher.
• An additional AED 20 will be charged as Knowledge and Innovation fees.

3.10 Is there any guidance tool available for making electronic applications? If yes, provide the link and/or step-by-step instructions.

Currently, clinical trial applications are submitted via email.

The DSREC has published some guidance on “Submission of New Applications and Opinions to the DSREC”.

3.11 Does EC/IRB require any mock screens/screenshots of participant-facing material on the app? If yes, do these need to be submitted in the local language?

Yes. The DSREC has not issued any guidance on the use of eConsent. The DSREC has advised that approval of eConsent is taken on a case-by-case basis.

It is advisable that the Sponsor planning to use eConsent in Dubai discuss it with the DSREC prior to submission. The DSREC will then advise what additional documentation (i.e. screenshots) is required or not.  

3.12 Does the EC/IRB have any template or specific element requirements on ICF and/or other participant-facing materials?

Yes, the DSREC has an ICF template available.

3.13 Is there any guidance tool on participant compensation including clinical study-related injury per local requirements?

There is no specific guidance on participant compensation. Details of insurance compensation and any expenses (travel, loss of earnings) should be indicated within the Patient Information Sheet. 

The DSREC ICF template available (see Section 3.12 above) contains language provisions to indicate such details.

It will be up to the DSREC to evaluate any compensation given to study participants.

3.14 Are there any specific local safety reporting requirements for clinical studies?

Please refer to Section 2.15.

3.15 Does the EC/IRB require any periodic study reporting?

Please refer to Section 2.16.