COLLEGE OF MEDICINE AND HEALTH SCIENCES

CMHS Institutional Review Board (IRB)

CMHS IRB PROTOCOL SUBMISSION REQUIREMENTS

(PI should be UR staff; or formerly affiliated non-UR researchers or non-UR students).

NB: Ethical Clearance is valid for 12 months only.

1. Covering letter
2. Full protocol (Refer to: http://www.rnecrwanda.org/images/pdfs/OUTLINE_for_a_study_protocol.pdf)
3. Summary of the protocol on special form (Appendix 1, and on IRB website in MS Word)
4. Letter of recommendation from the school /department (for students)
5. 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)
6. Informed consent/assent form should include telephone numbers of Chairperson of the CMHS IRB
(0788 490 522) and of the Deputy Chairperson (0783 340 040)
7. Study documents in English/French and Kinyarwanda e.g. patient recruitment materials, case report
forms, questionnaire, interview schedule, other data capture sheets;
8. Draft materials transfer agreement (if applicable, in case you expect to transfer samples outside the
country) (Refer to: http://www.rnecrwanda.org/images/pdfs/standard_Operating_procedures_SOPs.pdf, Appendix 6, page 76)
9. Curriculum vitae (CVs) of investigators to also include email address, phone contacts, affiliation,
academic background, research publications and research projects undertaken;
10. Certificate of attendance of research ethics training within the last 2 years
Examples of online courses:
i. Protection of Human Research Participants: https://phrp.nihtraining.com/
ii. Research ethics training: http://www.fhi360.org/sites/all/libraries/webpages/fhi-retc2/index.html
11. Study budget
12. Progress report and the previous ethical clearance (for amendment of protocol or renewal of ethical
clearance);
13. Receipt of payment of submission fee, also applicable to protocol amendment or renewal of ethical
clearance. Fee rates are as follows:
i. MSc. projects: USD 300
ii. All other projects including PhD: USD 500
iii. There is no fee for undergraduate protocol submission.
Bank Account:
All fee payments in US Dollars related to CMHS IRB activities should be made to the following
account:
Name of Bank: BANK OF KIGALI
Account Name: UR-COLLEGE OF MEDICINE AND HEALTH SCIENCES
Account Number: 00094 -00651934-37
Swift Code: BKIGRWRW

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14. Students without funded research projects can write a letter endorsed by their supervisors to request
for a fee waiver.
NB:
i. Ethical Clearance granted by the CMHS IRB can be submitted without fee to RNEC to get RNEC
approval, in case a situation so demands, without need for further protocol review.

ii. 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 UR. Foreign researchers formerly affiliated to UR shall
get such letters from the Deputy Vice Chancellor, in charge of Academic Affairs and Research (DVC-
AR).

Schedule of IRB meetings and deadlines for submission of protocols can be accessed at:
(http://www.cmhs.ur.ac.rw/fileadmin/templates/downloads/IRB/CMHS_IRB_2017_Meeting_Calendar.pdf).

Please submit protocols in electronic form at least 2 weeks before scheduled IRB meeting date to CMHS
IRB secretariat on this email address: researchcenter@ur.ac.rw

For more information you may contact: sundayfrax@gmail.com, Tel: +250 (0)7885-63311

Prof Kato J NJUNWA

Chairperson
Institutional Review Board
College of Medicine and Health Sciences

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 COLLEGE OF MEDICINE AND HEALTH SCIENCES INSTITUTIONAL REVIEW BOARD (IRB)

APPENDIX 1: PROTOCOL SUMMARY FORM

SECTION A: Project Information

Project title:

Investigator:

Student No.

Co-Investigators (if applicable):

Supervisor/s: (if applicable)

Contact details of Phone Fax E-mail

Investigator:

Degree enrolled in (if

applicable):
Project location:

Project duration:

SECTION B: Ethical Review Application (To be filled by Applicant (s))

Please answer all of the following questions

1. Who are the research participants and how will they be recruited?
1.1.
etc

2. Provide a brief summary of the project:

3. Outline the research plan:
4. How will informed consent and assent (where applicable) be obtained from participants?
5. Provide details of procedures for establishing confidentiality and protecting privacy of participants.
6. Provide details of data collection, security and storage
7. Give details of whether and/or how feedback will be available to participants:
8. Does the project involve any of the following procedures?
a) The possibility of physical or psychological injury, stress and/or discomfort? (If YES, give details
b) Participant involvement by any “vulnerable groups.” (If YES, give details)
c) Does the project involve any other disciplines and/or Ethics Committees? (If YES, please state which
and what approval has already been obtained - attach documentation.)
d) Will payments to participants be made? (If YES, state amount and whether payment is for out-of-
pocket expenses, or a fee.)
e) Will the project receive financial support?
(i) If YES, specify the nature and source of the support
(ii) If YES, have any restrictions been imposed upon the conduct of the research? (If YES, specify
the nature of the restrictions)
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 f) Will any restrictions be placed on the publication of results? (If YES, please state the nature of the
restrictions)
g) Are there any other points you wish to make in justification of the proposed study?

h) Please complete the items on the checklist shown below. (Write either YES or NO in
the box following each item) YES/NO
i. Have you completed all the questions on this form that are applicable to your
project?
ii. Have you attached a covering letter?

iii. Have you attached the full protocol?

iv. Have you attached a letter of recommendation from the school /department (for
students)?
v. Have you attached an informed consent form and Assent form (for children
between 7-20 years, if applicable) in both English and Kinyarwanda (see below)?
vi. Have you attached a sample questionnaire or interview schedule, data capture
sheets for lab work (if applicable) in English and Kinyarwanda?
vii. Have you attached a draft materials transfer agreement (if applicable, in case you
expect to transfer samples outside the country)?
viii. Have you attached the Curriculum vitae (CVs) of all investigators to also include
email address, phone contacts, affiliation, academic background, research
publications and research projects undertaken?
ix. Have you attached Certificate of research ethics training and/or GCP (Good
Clinical Practice)/RCR (Responsible Conduct of Research) course from the
Principal Investigators?
x. Have you attached the budget?

xi. Have you attached the progress report and the previous ethical clearance (for
amendment of protocol or renewal of ethical clearance)?
xii. Have you attached receipt of payment of submission fee (also applicable to
protocol amendment or renewal of ethical clearance)?

Signature of Proposer (PI):___________________ Date: ________/___________/ ____________

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