Doc5 Ethics Operational Guidelines and Procedures

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:

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.

1. 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.
• 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).

1. Awareness of Ethical Principles and Informed Consent

a)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

b)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.

c)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.

1. 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 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.

1. 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.

1. 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.

1. 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 research-related 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.

1. 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

Approved on 18 February 2014Page 1