Office of the Coordinator
Activities (UR-CRA)
of
Research
Doc5 Ethics Operational Guidelines and Procedures
1. General Information
a) All University of Rwanda (UR) researchers (including affiliates) are obliged to comply with the
highest standards of professional conduct.
b) All research conducted by UR staff and students involving human participants and the use of living
vertebrate animal subjects must be referred for review to the College Research Screening and Ethics
Clearance Committee (RSEC-C), composed of one representative from each School and chaired by
the College Director of Research and Postgraduate Studies. Applications are made by filling Form2:
Ethical Research Approval Form. The form can be downloaded from the UR website.
c) All researches involving external researchers shall be reviewed by the UR wide Research Screening
and Ethics Clearance Committee (UR-RSECC), composed of College Directors of Research, one
professorial representative from each college and is chaired by the UR Coordinator of Research
Activities (UR-CRA). Also in this case, applications are made by filling Form2.
d) Applications will be submitted to the Chairperson of either the College or the UR Research Screening
and Ethics Clearance Committee as appropriate. The committee will process the ethics review and
will grant an ethics clearance letter or will refer the application to the Ethics Committee of the
College of Medicine and Health Sciences all cases involving testing (both invasive and non-invasive,
involving drugs and not involving drugs), and medical and non-medical treatment or intervention. All
cases involving wildlife or protected areas will be referred to the National Ethics Committee.
e) Letters of Ethics Clearances by the College Committees will be copied to the UR-CRA for updating
the database and reporting.
f) Ethics clearance for UR affiliates will be done by UR-RSECC except for all cases involving, animals,
wildlife, protected areas, testing (both invasive and non-invasive, involving drugs and not involving
drugs), and medical and non-medical treatment or intervention which will be done by the National
Ethics Committee as stipulated in the Rwanda Law (see “Ministerial Instructions No 003/2010” of 9th
December 2010 regulating Research Activities in Rwanda available on the MINEDUC link:
http://www.mineduc.gov.rw/spip.php?article66).
g) The responsibility for seeking compliance with the basic ethical principles and procedures should rest
with the Principal Investigator who should clearly indicate in his/her research proposal if it is
necessary to seek ethical clearance or not.
h) In addition, to ensure that all human research participants at UR are well protected, for all projects
which involve any data collection from human subjects, one Co-researcher from UR should seek
ethical approval from UR.
2. Who Should Apply for Ethical Review and Clearance
Staff undertaking research projects which involve human participants in research investigations with a
potential for invading human privacy, such as written questionnaires, telephone surveys, interviews,
observations, video- and audio-taping, case study of focus groups, secondary use of data (not for a
directly related purpose when the data were collected), deception, testing (both invasive and non-invasive,
involving drugs and not involving drugs), and medical and non-medical treatment or intervention.
Ethical review and clearance is required for all research and consultancy undertaken by university staff
and students, including theses, dissertations, and undergraduate final projects. The review will normally
be undertaken and clearance given by the supervisor or principal researcher; signed clearance forms
should be lodged with the College Research Office and may be inspected by them.
The following kinds of research should always be referred to the College Ethics committee for review and
clearance:
 All research on live animals other than non-intrusive observational studies in the wild.
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
3.
a)
b)
c)
All research involving children under the age of 16, people diagnosed as suffering from a serious
physical or mental disease or handicap, people who have undergone what would generally be
regarded as traumatic experiences related to the area of research now or in the past, or people who
would be judged by any reasonable person to be especially vulnerable.
 All experiments or clinical trials carried out on human subjects.
 Any research that involves a power relationship such as teacher/pupil, doctor/patient,
employer/employee etc.
 All research employing covert methods or where informed consent cannot or will not be sought,
except for research on ‘public situations’ such as the behaviour of crowds or groups of people in
circumstances where the researcher has a right to be present.
 Any research where the identity of the subjects/informants/participants cannot be concealed,
unless they are specifically to be make aware of this and provide their signed consent.
 Any other research, whatever the methods employed, which might reasonably be judged at risk of
causing harm, distress or discomfort to people or groups (including social stigmatization/penalty,
commercial disadvantage or environmental damage or degradation).
Awareness of Ethical Principles and Informed Consent
Ethical principles: The Principal Investigators should be aware of the basic ethical principles
underpinning research involving human participants, e.g. as expounded in the Belmont Report (see
webpage http://www.hku.hk/rss/HREC.htm ).
Informed Consent: Respect for persons requires that subjects, to the degree that they are capable, be
given the opportunity to choose what shall or shall not happen to them; the informed consent process
is the instrument to provide this opportunity. Researchers must accordingly obtain appropriate
informed consent, and shall:
- give the research participant sufficient information about the study and how the
study may affect the subject;
- deliver the information in a comprehensible manner, using a language readily
understandable by the research participant; and
- assure the voluntary capacity of the participant by providing sufficient opportunity
to consider whether or not to participate, and minimizing the possibility of
coercion, undue influence, or harassment.
Informed Consent Process: The process of obtaining informed consent has two components:
- providing the person who is being recruited to become the research participant in
the research with the information necessary to give informed consent by means
such as an Information Sheet, and obtaining the consent to participate in the
research; and
- Documenting that informed consent has been obtained by means of an Informed
Consent Form (see SECTION C of Form 2).
It is possible that clearance will be given to projects where informed consent is not or cannot be sought,
but the proposer(s) will need to demonstrate that (a) the situation is such that asking for consent is
impossible, or that seeking consent would make the research impossible, and (b) that the project would
make a substantial and significant contribution to knowledge, policy or practice and (c) that the good that
accrues form this contribution substantially outweighs any potential harm to research subjects/informants.
4. Privacy and Confidentiality of data
a) Privacy: researchers must maintain the confidentiality of data related to individual research
participants. Except by public observation, researcher should clearly indicate the purpose of the
collection of data and the method to ensure the confidentiality of collected data. Researchers must
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also avoid any personal identifiers such as individual names and addresses in their research reports
which could lead to the human participants being identified.
b) Security: participants should be assured that the information collected will not be publicly disclosed
in a way that specific person can be identified, and that every precautions will be taken in relation to
the storage, use and disposition of data, for example, locking up raw data. Measures should be taken
to ensure the integrity, prudence and competence of persons having access to data. e.g., only the
research team will be given access to process or transmit data, and such data can be kept for up to five
years after the publication of research results and should be disposed of thereafter. Data without
personal identifiers can be kept indefinitely. For audio/video-taped data involving sensitive topics,
consent should be sought from participants on the method and duration of data storage.
5. Procedures to be followed when applying for Ethical Review by UR Ethics Committee
a) Deadlines: Research proposals submitted by staff members and Research students (i.e. MPhil and
PhD) will be scrutinized by the College RSEC-C while those by UR affiliates will scrutinized by the
UR-RSECC. The committees shall meet monthly, a calendar shall be issued and published on the UR
websites in June, with provision for emergence meetings if need arises. Deadline for the receipt of the
applications is generally 7 days before the scheduled meeting date.
i. Clearance by supervisors or principal researchers. Copy sent to College Research Office, who
will be free to look at them and tell the participants if further clearance is needed.
ii. Screening by the Chair of College RSEC-C (or Chair of UR-RSECC) to deal with the obvious
ones – ones where the precedent is already known or the issues are entirely trivial.
iii. Consideration of the rest by the full Committee.
b) Documents to be completed: A filled and signed hard copy of From 2 including the filled and signed
Informed Consent.
6. The Outcome of the Review
a) Approved applications: The Chair of the College or UR Committee will notify the applicant of the
result of application submitted for review within three weeks of receipt of his/her application. A letter
of approval will be issued to the Principal Investigator. The approval letter is issued with
comments/concerns to be satisfactorily addressed.
b) If Approval is not given: The Committee will specify its comments/ recommendations to the Principal
Investigators for applications which are not approved.
c) Reconsideration of decision: The Committee will further consider the resubmitted proposals
according to the Committee’s recommendations.
d) Appeals: All applicants have a right to appeal, and to refer cases with doubts or problems for further
review to the UR or College Research and Postgraduate Studies Committee. These committees will
form small committees of experts to do the further review.
7. Progress Monitoring
The Principal Investigators of all active research projects are required to report to the UR or College
Committee (whichever is appropriate) any amendments, new information on the project and any researchrelated incidents, such as physical or emotional harm to the participant during the research process or
breaches of confidentiality. Principal Investigators are also required to submit, as appropriate, an annual
progress/final completion report.
8. How to Maintain Ethical Standard in Research
a) Each College shall organise Training Workshops on ethical principles and procedures at the start of
each academic year or as and when appropriate.
b) Each research project shall include a budget for monitoring missions by UR supervisors
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