The Vector Control Division Research and Ethics Committee works to oversee
The Vector Control Division–Research and Ethics Review Committee (VCD-REC) was established in 2003. It is an REC that has been functioning under the supervision of Uganda National Council of Science and Technology (UNCST). The purpose of the REC is reviewing health research so as to contribute in safeguarding the dignity, rights, safety, and well being of all actual or potential research participants. The principles of “respect for the dignity of persons” require that each person should be treated as an independent entity, capable of making decisions about themselves and their personal aspirations. The VCD-REC has always tried to ensure that the principle of “justice” is observed. Although the goals of research are important, it unethical to allow it to override the health well being and care of research participants.
The need for the VCDREC arose out of volume of research in the specialised areas of vector borne diseases namely Lymphatic Filariasis, Onchocerciasis, Bilharzia, (Soil Transmitted Helminths) STH, sleeping sickness, etc. This has over the years grown to encompass Neglected Tropical Disease. Having realised the serious need for sound knowledge and practice regarding Ethical review for research proposals/protocols including clinical trials, members sought specialized training in the following areas: overall Ethics Review progress with dates and duration; a) HAT platform and Kenya Medical Research institute (KEMRI) attendance of certification , b) Dennis Bilharziasis Laboratory (DBL) certification attendance and certification , c) Clinical monitors- HAT platform and KEMRI, d) Administration of REC by HAT platform and KEMRI; e) UNCST Annual General meeting with CDP on Research
The REC had a direct outcome of these trainings and the CDP have benefited from valuable literature materials which now form treasured references. Because of the tremendous experience gained and due to continuing demand from both local and international prominent researchers, VCD-REC has been championing the lead in the process of Research proposals/protocols in the area of vector borne diseases, Neglected tropical Diseases, Neglected Zoonotic diseases and public health in general in Uganda. For information on research and collaboration related to NTDs in Uganda
Key personnel for the Committee are:
- Dr. Abbas Kakembo, Chair Vector Control Division Research & Ethics Committee
- Mr. Tom Lakwo, Vice chair Vector Control Division Research & Ethics Committee
- Mr. Moses Adriko, Secretary Vector Control Division Research & Ethics Committee
The required information for a PI to submit research protocols on NTDs are:
- Requirements for Initial review of SOPs at VCDREC Meeting at Vector Control Division
- A submission form VCD-REC (Research Proposal submission form) has to be filled in by the principal investigator and signed by the supervisor if the PI.
- The investigator submits 4 hard copies of the proposal and attaches the submission form to the front of each copy of the proposal.
- Send a soft copies of the submissions to firstname.lastname@example.org.
- Insert a version number and Version date on the protocol, consent forms and data collection tools. This is essential for version control and monitoring document use. Include page numbers on the proposal as well for easy review.
- The investigator pays $300 or equivalent to VCDREC and given receipt and $300 to the UNCST after clearance from VCDREC the receipt when submitting the proposals.
- Proposal should be submitted two weeks before the date of the meeting (preferably the early weeks of the month); meetings are usually held every 3rd week of the month, so for one to be considered for this meeting they should submit before the 5th of every month, the mode of operation is first come first serve basis.
- All research activities should include a local Investigator (Ugandan) to be part of the study. A written approval from the home institution must be submitted with the VCDREC application for International students and they should also have Ugandan Supervisor on the proposal.
- Please VCD-REC format for writing proposal must be followed for ease of review.
NB: complete submission should entail the following accordingly: Submission Requirements for Initial Review (Checklist)
- CVs of the Investigators on the study is required
- VCD-REC/UNCST Research Proposal submission form, appropriately signed.
- Research Protocol, Investigator brochure, or device specifications (where applicable)
- Questionnaires & assessment instruments, plus copies of these documents translated to the appropriate local language.
- Proposed informed consent document(s); plus copies of these documents translated to the appropriate local language, “thumbprint” should be provided for illiterate participants. (CONTACTS FOR THE VCDREC CHAIRPERSON SHOULD BE INCLUDED IN THE CONSENT FORM I.E
- Dr. Abbas Kakembo email@example.com, or
- ADMINISTRATOR, Ms. Mbabazi Fausta, firstname.lastname@example.org, or
- Secretary Mr. Adriko Moses, email@example.com, for participants to contact him in case they have any questions concerning their rights while they participate in the study and this should be clearly stated in the consent form)
- Proposed subject instruction); plus copies of these documents translated to the appropriate local language of the proposal research site (s).
- Any other supporting material, such as advertisements for recruitment of Research participants.
- A description of the consenting process or a copy of the investigative site’s Standard Operating Procedures for obtaining informed consent.
- You need to be physically available for presentation on the day of the meeting, use the power point template.
- Requirements when responding to VCD-REC Comments
Usually after review by the REC, the Research team will receive comments and or suggestions that require them to address or respond to before approval is granted.
This is how you should go about it:
- A cover letter addressed to the REC Chair providing itemized responses to VCDREC comments and guidance for the changes made to the protocol if any
- (02) copies of the revised protocol with track changes
- A clean copy of the revised protocol.
- Requirements for continuing Review
Approvals from the VCDREC, atleast for one year, and therefore Principal Investigators are required to request for renewal of approval 02 months before the date of expiry, if the study is ongoing.
- Investigators are required to submit the Continuation or Termination of Approved Protocol form to the VCDREC before the expiration date of the study.
- VCDREC template for continuing review should be followed.
- A cover letter addressed to the chairman of the REC requesting for renewal of approval should be submitted to the VCDREC.
- Previously approved protocol (02) copies should be submitted together with the request.
- The Investigator pays US$100 to accounts Officer and brings the Photocopy of the receipt when submitting the documents.
- Requirements for Amendment of the protocol
An amendment refers to any made to the previously approved proposal, and any change/ amendment requires VCDREC approval before implementation even the change of a question in a questionnaire or change in title would require VCDREC review, as long as the change is being made to the protocol that has already been approved.
- A cover letter requesting for approval of the amendment and a description of the changes proposed indicating the rationale.
- Submit 03 copies of the previously approved protocol, study instruments and consent forms.
- 03 copies of the amended protocol, study instruments and consent forms with track changes (highlighting proposed changes) should also be submitted
- The Investigator pays US$300 to accounts Officer and brings the photocopy of the receipt when submitting the documents
- Requirements for Expedited Review of a Protocol
An expedited review, refers to review of a proposal in the quickest way possible, there’s no requirement for a meeting, the chairman can either review the submitted proposal or assign it to any other designated VCDREC reviewer (s), the P.I should expect to get IRB comments within a week which they have to respond to before approval is granted. However not all studies can fit the criteria for expedited review, the VCDREC chairman and Administrator have to review the proposal in line with the VCDREC SOPs to determine if it fits the criteria for expedited review, therefore the PI should only pay VCDREC fees before confirming that their proposal has been reviewed.
List of requirements:
- A cover letter addressed to the VCDREC Chairman requesting for expedited review, explaining why you think the study qualifies for expedited review.
- A submission form should be attached to (04) copies of the proposal to be submitted for review.
- The Investigator should wait to hear from the Committee confirming to them if their study qualifies for expedited review, (the Investigator can be notified within two days)
- The Investigator pays US$350 to the Bank Accounts of VCDREC and brings the Photocopy of the receipt to the REC Administrator.
- Requirements for Exemption from VCDREC Review
Requests for exemption are also reviewed expeditiously and only apply to proposals which don’t involve human subjects, studies that only employ document review and many other specifications in the SOP.
- Cross check with VCDREC administrator to see if the SOP guidelines provides for exemption of their study.
- Drafts a cover letter addressed to VCDREC Chairman requesting for exemption from VCDREC Review basing on the SOPs they’ve reviewed.
- Investigator submits 3 Copies of the proposal and fills in Page 66 extracted from the HDREC SOPs and submits it as well.
- This kind of review is charged US$100 which should to the VCDREC administrator and brings the Photocopy of the receipt to the REC Administrator.