Research Ethics Committee (REC)
To offer independent ethical and scientific review of proposed and continuing studies by UVRI staff and partners with the aim of protecting human participants’ rights and welfare. Established in 1992, the UVRI REC;-
- Conducts initial and continuing review of research studies
- Classifies studies according to risk to participants (high and low risk studies)
- Carries out monitoring visits to ensure compliance with scientific and ethical requirements
- Is accredited by the Uganda National Council for Science and Technology (UNCST)
- Follows the UNCST National Guidelines for Research Involving human participants
- UVRI REC has a secretariat which is fully equipped with office equipment. The office is fully operational managed by the REC Administrative Secretary and a part-time Regulatory officer. With the existence of the secretariat, Principal Investigators (PIs) are always reminded to submit progress reports on time and records on each protocol are properly filed.
- There are 13 members on the committee from different disciplines (Medical, Laboratory, Basic sciences, Biostatistics, Social and Behavioral Sciences, Community representative) and programs at UVRI.
- All consent forms to be used in the field by researchers are date stamped by REC. Researchers are now using only stamped copies of consent forms. This was done to avoid any changes on the consent forms without approval from REC.
- REC holds monthly meetings to review new protocols, major amendments, progress reports, Adverse Events, protocol violations and protocol deviations.
- The secretariat has better communication facilities; telephone, email and the internet services. The Administrative Secretary is able to communicate to all members and Principal Investigators in a timely manner.
- The Secretariat has a filing system for all protocols, accessed by only REC members. The files are numbered and only identified by the REC Administrative secretary who manages and electronic filing system
- Currently study teams and REC use an electronic system (RHInnO, ref below) for submitting and reviewing new protocols
New Protocol Submission and review criteria
The following are required for a protocol to be accepted for review;-
- Signed cover letter
- Signature page for all applicants (protocol team)
- Filled UVRI REC application form
- Full/detailed study protocol with version and date
- Data collection forms (if applicable)
- Consent forms/information sheet-translated (if applicable)
- All Applicants’ CVs
- Approval letters/clearance from collaborating RECs (if applicable)
- Letter of approval from the school/uniuversity (for students’ projects)
- Application has a UVRI affiliation
- Material Transfer Agreement (if sample shipment is proposed)
- Investigator Brochures (if applicable)
- Recent certificate of GCP training (for clinical trials)
- Study Budget
- Proof of payment
- Where hard copies are submitted need 14 copies to the REC secretariat
- Review of research protocols is done on a monthly basis (on the Second last Thursday of the month) The UVRI REC reviews research protocols within 60 days from the date of submission of the research protocol. Requests for annual renewals are submitted 60 days prior to the REC expiry date. Initial reviews and amendments should be submitted two weeks prior to the REC scheduled meeting. The outcome is communicated within 14 days from the date of the meeting. Investigators should allow 30-60 days to receive a response from the UVRI REC.
Levels of review for research protocols
There are four levels of review conducted by the UVRI REC;
- Exempt from REC review: for research that presents less than minimal risk to the study participants and may include educational tests, surveys, interviews can be exempted from full REC review. Please note that it’s only the REC not the researcher that can make the judgement as to whether research is exempt.
- Expedited review: This is performed for proposals that involve interviewing of non-confidential nature, not likely to harm the status or interests of the participants or not likely to harm the sensibilities of the people involved, those that involves collection of small amounts of blood samples & minor modification/amendments among others.
- Speedy review: Speedy reviews are very necessary especially when the review slots are full and the protocol team has to wait for another full month.
- Full board review: Research proposals involving greater than minimal risk to participants including vulnerable populations receive a full board review which requires the REC to convene under a quorum and may require adjustments consistent with protecting the rights of human participants.
The RHInnO Ethics Platform (electronic submission and review platform)
- RHInnO Ethics enables administrators, researchers and reviewers to comprehensively manage the entire review cycle, including protocol submission, reviewing protocols, approval and follow-up through an online platform.
- The current version, RHinno Ethics 2.2, is an ideal, cloud-based software solutions for effective and efficient management of all research ethics administration. RHinno Ethics 2.2 has improved on the quality or the review process, speeding up multi-centre reviews, and added to the continuous learning of research ethics committee members, reviewers and researchers.
RHInnO Overall Efficiencies
- Avoids Delays in Communication
- Avoid Loss of Submissions
- Improves Cost Effectiveness
Administrators Interface enables;
- Setting review and meeting dates.
- Inviting reviewers.
- Screening Applications.
- Assigning protocols to reviewers.
- Monitoring process of review.
- Able to access online guidelines.
- Issuing approval letters/certificates.
- Registration in the system
- Initiation and submission of protocols
- Receiving of alerts on review progress and any REC communication
- Responding to comments from REC reviews
- Able to access online guidelines
- Accepting/declining submissions
- Able to access online guidelines
- Reviewing of assigned protocols
- Submitting the completed reviews online
- It’s a low band width platform which can be accessed from any device that accesses internet (Phone, IPad, laptop & Desk top)
- It’s a cloud based system
- Its secure
- The platform can be adjusted to suit clients’ needs
- Has some features which can be changed by the REC Admin.
Feedback from users
- Full board review 300$
- Speedy/Expedited review 450$
- Students 100$
- Continuing review 200$
For more information, please contact;
The REC secretariat
Uganda Virus Research Institute
P.O Box, 49 Entebbe