An institutional review board (IRB), also known as an independent ethics committee (IEC), is a type of committee that applies research ethics by reviewing the methods proposed for research to ensure that they are ethical. It is designated to approve (or reject), monitor, and review biomedical and behavioral research involving humans. It often conducts some form of risk-benefit analysis in an attempt to determine whether or not research should be completed. The purpose of the IRB is to assure that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study
The school of Medicine and Health Sciences (SMHS) Institutional Review Board (IRB) guidelines are centered on the Health Sector Research Policy and the Researchers’ guidelines for conducting research in Rwanda as set forward by the Ministry of Health, and the Rwanda National Ethics Committee (RNEC) Standard Operating Procedures (SOPs) found At http://www.rnecrwanda.org/images/pdfs/standard_Operating_procedures_SOPs.pdf.
Structure of the IRB
1. There is one IRB at the SMHS level that approves health research activities. This UG IRB will inform RNEC and the University of Gitwe (UG) of the decisions made (Figure 1);
2. The UG IRB is responsible for both scientific and ethical review thereby pre-empting the need for separate scientific review committees for staff and student.
3. Ethical Clearance granted by the UG IRB can be submitted without fee to RNEC to get RNEC approval, in case a situation so demands, without need for further protocol review.
4. There will be a sitting allowance for UG IRB members based on the number of meetings and not on the number of protocols reviewed. The amount payable will be determined and revised from time to time by UG IRB and approved by the University council.
Figure1. STRUCTURE OF IRB OF UG
A. Categories of protocols reviewed by the IRB of University of Gitwe
1. There are two (2) categories of proposal review
i. Expedited review (No more than Minimal Risk)
ii. Full Committee Review (Greater than Minimal Risk)
2. Students registered at University of Gitwe
i. Protocols will be submitted to the UG IRB for review
ii. MSc Students with funded projects will pay a submission fee of USD 300
iii. PhD students will pay USD 500.
iv. Students without funded research projects can write a letter endorsed by their supervisors to request for a fee waiver.
v. Undergraduate research protocols are not charged review fee.
3. Staff in the UG School of Medicine and Health Sciences, and other UG staff
i. Staffs who are Principal Investigators (PIs) of projects will submit protocols to the UG IRB
ii. Projects where staffs are co-investigators and collaborators will be submitted to RNEC, and UG IRB will be notified.
iii. A fee of USD 500 will be charged on all funded projects to the UG IRB
iv. Research proposal initiated by staff as PI from UG other than SMHS, will be approved by the UG IRB.
4. Projects with PIs external to the School and UG will be submitted to RNEC
5. Students who are not registered at SMHS or UG will submit protocols to RNEC
6. Students who are formally attached to UG-SMHS supervisors e.g. exchange students or fellowship students will submit protocols to UG IRB
7. Depending on the research project, there might be other approvals that need to be obtained (e.g. from the Ministry of Education for external students, National Institute of Statistics of Rwanda or, Rwanda Development Board).
8. To amend the protocol or renew the ethical clearance an application shall be submitted along with the previously given ethical clearance, and progress report to the UG IRB two weeks before the scheduled IRB meeting, with the same amount of submission fee for funded projects, of USD 300 or USD 500, as appropriate.
9. Ethical Clearance is valid for 12 months only.
NB: A letter of request for permission to conduct research in a selected study site is granted by the Dean of School where the staff/student belongs, in UG. Foreign researchers formerly affiliated to UG shall get such letters from the Deputy Vice Chancellor, in charge of Academic Affairs and Research (DVC-AR).
B. Proposal Submission Requirements:
i. Covering letter;
ii. Research protocol (Refer to: http://www.rnecrwanda.org/images/pdfs/OUTLINE_for_a_study_protocol.pdf);
iii. Summary of research protocol (See Annex 1)
iv. Letter of recommendation of protocol from the school/department (for students).
v. Informed consent form; or Parental/Guardian permission form and Assent form (if applicable), including Information Sheet, in English/French and Kinyarwanda (Refer to: (http://www.rnecrwanda.org/images/pdfs/standard_Operating_procedures_SOPs.pdf, page 49-75, as appropriate)
vi. Study documents in English/French and Kinyarwanda e.g. patient recruitment materials, case report forms, questionnaire, interview schedule, other data capture sheets;
vii. Draft Material Transfer Agreement (if Applicable) (Refer to: http://www.rnecrwanda.org/images/pdfs/standard_Operating_procedures_SOPs.pdf, Appendix 6, page 76)
viii. Curriculum vitae (CVs) of investigators to also include email address, phone contacts, affiliation, academic background, research publications and research projects undertaken; and
x. Certificate of research ethics training and/or GCP (Good Clinical Practice)/RCR (Responsible Conduct of Research) course from the Principal Investigators. Examples of online courses: a) Protection of Human Research Participants: https://phrp.nihtraining.com/ b) Research ethics training: http://www.fhi360.org/sites/all/libraries/webpages/fhi-retc2/index.html
xi. Progress report (for amendment of protocol or renewal of ethical clearance);
xii. Receipt of payment of submission fee (also applicable to protocol amendment or renewal of ethical clearance):
C. Bank Account.
All fee payments in RWF equivalent to the asked amount in US Dollars related to UG IRB activities should be made to the following
Account: Name of Bank: ……………………
Account Name: ………………………………
Account Number: …………………. ……….
Swift Code: ………………………………….
D. Schedule for submission:
The deadline for submission is 2 weeks before the scheduled date of IRB meeting, which takes place last Friday after two Months, according to the schedule accessible at: (http://www.smhs.uog.ac.rw/fileadmin/templates/downloads/IRB/SMHS_IRB_2017_Meeting_Calendar.pdf).
All protocols shall be submitted through the following e-mail address: firstname.lastname@example.org
To ensure good research conduct:
1. IRB members will undergo regular GCP and RCR training.
2. The UG Directorate of Research and Postgraduate Studies in collaboration with the UG IRB will ensure regular availability of the trainings.
Dr. Joseph Rwandema
Institutional Review Board