79C3C34C52B45572883A05D425EB0F82
Guidelines for Reseachers Intending to do Health Research in Rwanda
http://www.moh.gov.rw/fileadmin/templates/PHIS/Researchers-Guidelines.pdf
http://leaux.net/URLS/ConvertAPI Text Files/BE27ADD8B32130237B320AF7924F2C8A.en.txt
Examining the file media/Synopses/BE27ADD8B32130237B320AF7924F2C8A.html:
This file was generated: 2020-12-01 09:19:07
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / stateless persons
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p.000002: Table of Contents
p.000002: I. Introduction
p.000004: 4
p.000004: II. Definition of Research
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p.000004: III. Research with Existing Data
p.000005: 5
p.000005: IV. Note on Collaborations
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p.000005: V. Process to Begin a Research Project in Rwanda
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p.000006: A. Proposal Generation
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p.000006: B. Scientific Review
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p.000007: C. Ethical Review
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p.000008: D. Ministry of Health Registration
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p.000009: E. Ministry of Health Support to Research Teams
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p.000010: VI. Implementation of Approved Research
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p.000010: A. Capacity-Building
p.000010: 10
p.000010: B. Monitoring for Misconduct
p.000010: 10
p.000010: C. Availability, Use , and Publication of Data and Research Findings
p.000011: 11
p.000011: D. Renewal of Approval
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p.000012: VII. Provisions for the Transition Period
p.000012: 12
p.000012: VIII. Additional Resources
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p.000003: I. Introduction
p.000003: Research is widely acknowledged to play an important role in the socioeconomic development of a nation. Health research
p.000003: is particularly important because it allows for evidence-based decision-making that improves health outcomes. The
p.000003: Government of Rwanda has recently created the Health Sector Research Policy (HSRP), in order to outline a vision for
p.000003: effective and efficient health research in Rwanda.
p.000003: In accordance with the Ministry of Health’s (MoH) desire to facilitate health research in Rwanda, the guidelines
p.000003: presented here have been developed to aid investigators who want to do research with a primary aim of studying health
p.000003: in Rwanda. These guidelines are intended to clarify the processes, expectations, and benefits of doing health research
p.000003: in Rwanda. With the clarity afforded by the guidelines, it is the hope of the Ministry of Health that health research
p.000003: will be a smooth process for investigators, and that it will be a mutually beneficial endeavor for the investigators,
p.000003: the Government of Rwanda, and the communities.
p.000003:
p.000003: II. Definition of Research
p.000003: The Ministry of Health of the Government of Rwanda, defines health research as the following:
p.000003: “Any activity intended to increase the stock of knowledge relating to health that can be generalized and used to draw
p.000003: conclusions, devise new applications, and guide decision- making.”
p.000003: This definition includes a) basic scientific research relating to health, including investigation into fundamental
p.000003: scientific phenomena without a particular application in view; b) applied/operational research, which is generation of
p.000003: new knowledge with a specific practical aim; and c) experimental development, which is research intended to develop new
p.000003: or significantly alter and improve materials, products, systems and services. General-purpose data collection,
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Health / Drug Usage
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p.000010: to ensure maximum public benefit in Rwanda, as well as in the broader international research community. To that end,
p.000010: data and results from a study must be shared with the community in which the research was carried out and must be
p.000010: published in Rwanda. The publication in Rwanda may be done after the international one.
p.000010: The Ministry of Health will maintain a registry of both datasets and research reports. To this end, datasets, data
p.000010: documentation, and research reports must be shared with the National institution which the PI is coming from as a
p.000010: co-owner of the data and MoH data warehouse within three months of the conclusion of the data collection. This will
p.000010: facilitate future research utilizing data previously collected, and future research wishing to build off of previous
p.000010: work. Two years after the conclusion of data collection, the dataset can be shared by the National Institution with
p.000010: other researchers on written demand for secondary analysis. In case of negative answer from this institution a
p.000010: researcher can appeal to national research committee which will judge adequacy of the negative answer and take the
p.000010: final decision. In special circumstances, an MOU can be signed between the Ministry of Health and the research team or
p.000010: research institution, which will detail the ownership and use of data. Additionally, the investigator may send a formal
p.000010: request to keep data private beyond two years, with reasons detailed.
p.000010: Timely publication of results in peer-reviewed academic journals is highly encouraged. Peer review helps to maintain
p.000010: the quality of research in Rwanda, and publication ensures that the results of research in Rwanda are recognized
p.000010: internationally, and can be used to influence policy and future research around the globe. In the event that the PI is
p.000010: foreign, it is important the Rwandan collaborator be a co-PI on any publication, consistent with the guidelines for
p.000010: authorship addressed in the Roles and Responsibilities of Investigators
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p.000011: document. . For research done in Rwanda that is initiated by a foreign PI, it is encouraged that at least four
p.000011: Rwandans be collaborators.
p.000011: D. Renewal of Approval
p.000011: Researchers who wish to extend their periods of data collection must renew the approval for the projects. The PI is
p.000011: required to compile a report on the work already completed, and write a letter detailing the rationale and need behind
p.000011: extending the data collection. If the extension is within the same research methods, these materials should be
p.000011: submitted to the IRB or RNEC at least one month prior to the expiration of the original approval. The IRB or RNEC will
p.000011: respond within one month, and renewal may be approved for up to an additional one year, except in special
p.000011: circumstances. At this point, a “renewal of research” form should be submitted to the Ministry of Health. If the
p.000011: research methods for the extension differ from those originally approved, the request for an extension must be
p.000011: submitted to the SRC prior to the renewal approval by IRB or RNEC, and before final renewal is registered at the
p.000011: Ministry of Health. This more extensive renewal process may take up to two months, so researchers should therefore plan
p.000011: ahead accordingly so as not to have to suspend data collection.
p.000011:
p.000011: VII. Provisions for the Transition Period
p.000011: It is understood that many of the structures described above are not yet implemented, and that while they are being
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Health / HIV/AIDS
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p.000011: extending the data collection. If the extension is within the same research methods, these materials should be
p.000011: submitted to the IRB or RNEC at least one month prior to the expiration of the original approval. The IRB or RNEC will
p.000011: respond within one month, and renewal may be approved for up to an additional one year, except in special
p.000011: circumstances. At this point, a “renewal of research” form should be submitted to the Ministry of Health. If the
p.000011: research methods for the extension differ from those originally approved, the request for an extension must be
p.000011: submitted to the SRC prior to the renewal approval by IRB or RNEC, and before final renewal is registered at the
p.000011: Ministry of Health. This more extensive renewal process may take up to two months, so researchers should therefore plan
p.000011: ahead accordingly so as not to have to suspend data collection.
p.000011:
p.000011: VII. Provisions for the Transition Period
p.000011: It is understood that many of the structures described above are not yet implemented, and that while they are being
p.000011: created, it is important to have provisions in place to guide research. These provisions will be removed from this
p.000011: document when all structures exist. To that end, if SRCs and IRBs do exist for an institution, researchers affiliated
p.000011: with those institutions should follow the protocol described above. If they do not, or a researcher is not affiliated
p.000011: with an institution, the following procedures should be followed:
p.000011: 1. Scientific review will happen in 3 ways. For projects covering at least one whole province, proposals should be
p.000011: submitted to NISR for scientific review. Proposals treating HIV/AIDS, Non communicable diseases,Malaria, Mental health
p.000011: should be submitted to IHDPC . All other proposals should be submitted directly to the RNEC, which will provide
p.000011: scientific review.
p.000011:
p.000011:
p.000012: 12
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p.000012: 2. Ethical review will happen at the RNEC. Proposals should be submitted in accordance with the SOPs of the RNEC.
p.000012: 3. All proposals (approved by scientific and ethical review) will be addressed to the Honorable Minister of Health
p.000012: and submitted to the Ministry of Health Medical Education and Research Department. They will be registered and the PI
p.000012: will receive a letter of authorization from the Minister of Health to facilitate implementation of the research, as
p.000012: above.
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: VIII. Additional Resources
p.000012: 1. Health Sector Research Policy (HSRP), Ministry of Health website.
p.000012: 2. Standard Operating Procedures, Rwanda National Ethics Committee
p.000012:
p.000012: 3. Visa Instruction Manual, National Institute of Statistics of Rwanda
p.000012:
p.000012: 4.
p.000012: 5. Ministerial Instructions on Research, Ministry of Education
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Social / Access to Social Goods
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p.000008: • Voluntary participation;
p.000008: • Risk of harm, both to subjects and researchers;
p.000008:
p.000008: Assuming a favorable review, the research team will receive a letter from the IRB indicating that the proposal has been
p.000008: approved and should be submitted to the Ministry of Health for registration and administrative authorization for data
p.000008: collection. If the ethical review is not favorable, the research team will receive a letter detailing the problems
p.000008: that need to be addressed before the proposal will be approved.
p.000008: D. Ministry of Health Registration
p.000008: The Ministry of Health will serve as the central registry for all health research in Rwanda. After proposals have
p.000008: received both scientific and ethical approval, the complete proposals, both hard and soft copies, including the
p.000008: registration form and copies of the letters from the SRC and IRB, should be addressed to the Honorable Minister of
p.000008: Health and submitted to the Ministry of Health , Medical Education and Research Department in one package. Within one
p.000008: week of receiving the necessary documents, the Ministry of Health will issue a letter to the research team confirming
p.000008: their research registration and authorizing them to begin to implement the research. This letter will facilitate data
p.000008: collection and research implementation. The ministerial Instructions N° 003/2010 of 09/12/2010, regulating research
p.000008: activities in Rwanda recognizes national research entities such as MoH and its entities. Proposals for analysis of
p.000008: existing data can expect further communication from the Ministry of Health giving them access to the requested data,
p.000008: which is centralized in the Ministry of Health. At this point, researchers may begin to implement the project which has
p.000008: been approved.
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p.000009: E. Ministry of Health Support to Research Teams
p.000009: In addition to serving as the final registration center, the Ministry of Health will play several supporting roles to
p.000009: researchers. After registration, the Ministry of Health will provide additional authorization letters as needed to
p.000009: support ease of data collection in health facilities, villages, etc. They will also support the efforts of the research
p.000009: team to other government officials within the rule of law. Finally, they will provide access as needed to national
p.000009: level data sets to inform the study (HMIS, TracNet, etc.). These efforts are intended to facilitate and streamline
p.000009: the research process for research teams whose proposals have been approved.
p.000009:
p.000009: VI. Implementation of Approved Research
p.000009: Procedures for implementation of research will vary widely depending on the nature of the study, but some aspects are
p.000009: consistent across all types of research in the health sector.
p.000009: A. Capacity-Building
p.000009: Implementation of all proposals should include some aspect of capacity-building for Rwanda. This can take many shapes
p.000009: and forms, but it is crucial that the implementation phase of any project include the training of Rwandan personnel, or
p.000009: the improvements of Rwanda’s research facilities or infrastructure.
p.000009: B. Monitoring for Misconduct
p.000009: The Ministry of Health and its agencies reserve the right to monitor the implementation of approved proposals to ensure
p.000009: that the projects are being carried out in accordance with the approved protocols. It is first and foremost the
p.000009: responsibility of the researchers and their sponsors and sponsoring institutions to ensure that implementation occurs
p.000009: as described in the approved proposal. Researchers are additionally expected to submit quarterly reports to the ethics
p.000009: committee that approved the research. Further monitoring and inspection may be done by a body authorized by the
p.000009: Ministry of Health. Researchers found to be non- compliant with approved methodology will be subject to consequences,
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Social / Marital Status
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p.000003: or significantly alter and improve materials, products, systems and services. General-purpose data collection,
p.000003: including statistical surveys and censuses where health data are collected and the primary aim is studying health, are
p.000003: also considered research in the health sector.
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p.000004: Some activities are considered non-research in the health sector unless they are carried out for the purpose of
p.000004: assisting research and development. If not carried out for research- related purposes, these non-research activities do
p.000004: not fall under the jurisdiction of these guidelines. These activities include: standardization procedures, provision
p.000004: of specialized health care, program evaluations (excluding impact evaluations), outbreak investigation/surveillance,
p.000004: and routine software development.
p.000004:
p.000004: III. Research with Existing Data
p.000004: Two main types of research are covered by this document: the collection of new data, and additional analysis of
p.000004: existing data. Investigators wishing to conduct health research in Rwanda that requires original data collection are
p.000004: welcome, as new information will help Rwanda to make more informed policy decisions and will help improve health
p.000004: outcomes. This has traditionally been the main form of research in Rwanda.
p.000004: However, consistent with the principles outlined in the HSRP, the Ministry of Health of Rwanda is also committed to
p.000004: encouraging and facilitating the use of existing data to further knowledge about health in Rwanda. Doing so prevents
p.000004: duplication of work already completed, and thereby prevents waste of limited resources. Use of existing data also
p.000004: allows for meta-analyses, which may yield improved or more generalizeable knowledge than single studies.
p.000004: The process for carrying out research is largely the same for new data collection as for existing data analysis, and
p.000004: unless otherwise noted, the procedures and expectations outlined in the document apply to researchers wishing to carry
p.000004: out either type of research.
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p.000004: IV. Note on Collaborations
p.000004: For researchers coming from outside of Rwanda, it is requested to have a Rwandan collaborator involved at all stages of
p.000004: the work with a clear repartition of responsibilities. As such, foreign investigators are requested to partner with a
p.000004: Rwandan researcher who is working in the field of research topic. This will help to ensure relevancy of research
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p.000005: projects for Rwanda, facilitate the approval process (via the institutional affiliation(s) of the Rwandan collaborator
p.000005: or his/her knowledge of the review process), and will additionally help Rwanda build capacity for conducting research
p.000005: of its own. In these guidelines, references to “investigators” or “researchers” are used to refer to the collaboration
p.000005: of foreign and Rwandan investigators, if a foreign investigator is involved.
p.000005: If any samples, including biological materials and chemicals, are to be removed from Rwanda, it is required that the
p.000005: collaborators develop and sign a memorandum of understanding (MOU) or other material transfer agreement (MTA) prior to
p.000005: initiation of data collection. Such a document will prevent confusion later on, and will strengthen proposals for
p.000005: review by scientific and ethics committees .
p.000005:
p.000005: V. Process to Begin a Research Project in Rwanda
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Social / Property Ownership
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p.000005: This section outlines the steps to be taken in order to begin a research project in Rwanda. Researchers should allow
p.000005: three months from the first submission of the proposal to final approval, though in many cases, approval may be
p.000005: obtained much faster. Proposals will usually receive approval for up to one year, though in some cases where more time
p.000005: is clearly needed for the study, a longer approval period may be issued. Note: Rwandan students through the Master’s
p.000005: degree will receive approval solely from their institutions of learning according to the institutional standards, with
p.000005: authorization and registration at the institutional level but their research questions will be authorized by the MoH
p.000005: program in which they are related to and then approved by MoH to assure their effectiveness.
p.000005: A. Proposal Generation
p.000005: The first step in doing research in Rwanda is to generate a research proposal for review. Investigators will develop a
p.000005: research proposal of no more than 15 pages that contains the following:
p.000005: • Introduction with literature review and rationale behind research;
p.000005: • Clear description of research question to be addressed;
p.000005: • Specific objectives of research regarding the research question;
p.000005:
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p.000006: • Detailed protocol including risk assessment, informed consent procedures and methodology;
p.000006: • A clear link between the protocol and the ability to answer the research question addressed;
p.000006: • Information about the source of funding;
p.000006: • Evidence of ethical review at home institution (for foreign researchers);
p.000006: • Benefits for Rwanda or communities;
p.000006: • List of researchers and curriculum vitae of each researcher who will be involved in the research process, with
p.000006: declarations of conflicts of interest;
p.000006: • Clear dissemination strategy
p.000006:
p.000006:
p.000006: B. Scientific Review
p.000006: Scientific Review Committees (SRCs) will be established at institutions with health research in their mandates in
p.000006: order to provide scientific review for proposals. After the generation of a proposal, the proposal should be submitted
p.000006: to the scientific review committee (SRC) of the affiliated Rwandan institution, if one exists. If the researcher is not
p.000006: affiliated with an institution which has an SRC, the proposal should be submitted to the SRC of the institution which
p.000006: supervises the original institution, or to any existing SRC which is highly relevant for the research topic. If none of
p.000006: these alternatives fits a given case, the researcher should submit his/her research protocol to the national research
p.000006: committee to review the proposal in question as well as research project from out of Rwanda.
p.000006: The proposal should be submitted at least two weeks before the meeting of the SRC. Research protocols that require work
p.000006: or data collection nationally or for at least one whole province should be submitted to the National Institute of
p.000006: Statistics of Rwanda instead of another institutional SRC, pursuant to the Visa Instruction Manual found in the
p.000006: references. It is assumed that foreign researchers will also have proposals reviewed by their home institutions, but
p.000006: the additional review in Rwanda is required to ensure relevance to Rwanda.
p.000006:
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p.000007: In special cases where one given institution does not possess the scientific expertise required to review a certain
p.000007: proposal, the institution could seek external expertise. Additionally, for some projects initiated at the Ministry of
p.000007: Health or elsewhere, the Honorable Minister of Health can ask for assembly of an ad hoc SRC, either at one institution
p.000007: or comprising members from many institutions. All scientific review committees in Rwanda will use identical standards
p.000007: as defined by the Ministry of Health, consistent with international standards.
p.000007: The SRC will review the proposal in a timely manner for issues including but not limited to:
p.000007:
p.000007: • Qualifications of researchers;
p.000007: • Relevance of the project and benefit to Rwanda;
p.000007: • Appropriateness/ability of methodology to answer the study question;
p.000007: • Conformation of proposed project to the latest international standards for research;
p.000007: • Added value of knowledge after completion of the project, in Rwanda or in the world.
p.000007: If the proposal is approved, the research team will receive a letter to that effect, and indicating that the team may
p.000007: seek ethical approval. If the proposal is not approved, the SRC will send a letter containing the strengths and
p.000007: weaknesses of the proposal to allow for revision and resubmission. If the research is not relevant or out of standard
p.000007: it may be refused
p.000007: C. Ethical Review
p.000007: After receiving official confirmation of scientific approval, the proposal should be submitted with a copy of the
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Social / education
Searching for indicator education:
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p.000007: National Ethics Committee (RNEC) to ensure standardization. In especially sensitive cases, an institutional IRB may
p.000007: refer a
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p.000008:
p.000008: proposal to the RNEC for review. The ethics committees will review proposals including but not limited to the following
p.000008: issues:
p.000008: • Informed consent;
p.000008: • Confidentiality of patient information;
p.000008: • Voluntary participation;
p.000008: • Risk of harm, both to subjects and researchers;
p.000008:
p.000008: Assuming a favorable review, the research team will receive a letter from the IRB indicating that the proposal has been
p.000008: approved and should be submitted to the Ministry of Health for registration and administrative authorization for data
p.000008: collection. If the ethical review is not favorable, the research team will receive a letter detailing the problems
p.000008: that need to be addressed before the proposal will be approved.
p.000008: D. Ministry of Health Registration
p.000008: The Ministry of Health will serve as the central registry for all health research in Rwanda. After proposals have
p.000008: received both scientific and ethical approval, the complete proposals, both hard and soft copies, including the
p.000008: registration form and copies of the letters from the SRC and IRB, should be addressed to the Honorable Minister of
p.000008: Health and submitted to the Ministry of Health , Medical Education and Research Department in one package. Within one
p.000008: week of receiving the necessary documents, the Ministry of Health will issue a letter to the research team confirming
p.000008: their research registration and authorizing them to begin to implement the research. This letter will facilitate data
p.000008: collection and research implementation. The ministerial Instructions N° 003/2010 of 09/12/2010, regulating research
p.000008: activities in Rwanda recognizes national research entities such as MoH and its entities. Proposals for analysis of
p.000008: existing data can expect further communication from the Ministry of Health giving them access to the requested data,
p.000008: which is centralized in the Ministry of Health. At this point, researchers may begin to implement the project which has
p.000008: been approved.
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
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p.000009: E. Ministry of Health Support to Research Teams
p.000009: In addition to serving as the final registration center, the Ministry of Health will play several supporting roles to
p.000009: researchers. After registration, the Ministry of Health will provide additional authorization letters as needed to
p.000009: support ease of data collection in health facilities, villages, etc. They will also support the efforts of the research
p.000009: team to other government officials within the rule of law. Finally, they will provide access as needed to national
p.000009: level data sets to inform the study (HMIS, TracNet, etc.). These efforts are intended to facilitate and streamline
p.000009: the research process for research teams whose proposals have been approved.
p.000009:
p.000009: VI. Implementation of Approved Research
...
p.000011: submitted to the SRC prior to the renewal approval by IRB or RNEC, and before final renewal is registered at the
p.000011: Ministry of Health. This more extensive renewal process may take up to two months, so researchers should therefore plan
p.000011: ahead accordingly so as not to have to suspend data collection.
p.000011:
p.000011: VII. Provisions for the Transition Period
p.000011: It is understood that many of the structures described above are not yet implemented, and that while they are being
p.000011: created, it is important to have provisions in place to guide research. These provisions will be removed from this
p.000011: document when all structures exist. To that end, if SRCs and IRBs do exist for an institution, researchers affiliated
p.000011: with those institutions should follow the protocol described above. If they do not, or a researcher is not affiliated
p.000011: with an institution, the following procedures should be followed:
p.000011: 1. Scientific review will happen in 3 ways. For projects covering at least one whole province, proposals should be
p.000011: submitted to NISR for scientific review. Proposals treating HIV/AIDS, Non communicable diseases,Malaria, Mental health
p.000011: should be submitted to IHDPC . All other proposals should be submitted directly to the RNEC, which will provide
p.000011: scientific review.
p.000011:
p.000011:
p.000012: 12
p.000012:
p.000012: 2. Ethical review will happen at the RNEC. Proposals should be submitted in accordance with the SOPs of the RNEC.
p.000012: 3. All proposals (approved by scientific and ethical review) will be addressed to the Honorable Minister of Health
p.000012: and submitted to the Ministry of Health Medical Education and Research Department. They will be registered and the PI
p.000012: will receive a letter of authorization from the Minister of Health to facilitate implementation of the research, as
p.000012: above.
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: VIII. Additional Resources
p.000012: 1. Health Sector Research Policy (HSRP), Ministry of Health website.
p.000012: 2. Standard Operating Procedures, Rwanda National Ethics Committee
p.000012:
p.000012: 3. Visa Instruction Manual, National Institute of Statistics of Rwanda
p.000012:
p.000012: 4.
p.000012: 5. Ministerial Instructions on Research, Ministry of Education
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p.000003: I. Introduction
p.000003: Research is widely acknowledged to play an important role in the socioeconomic development of a nation. Health research
p.000003: is particularly important because it allows for evidence-based decision-making that improves health outcomes. The
p.000003: Government of Rwanda has recently created the Health Sector Research Policy (HSRP), in order to outline a vision for
p.000003: effective and efficient health research in Rwanda.
p.000003: In accordance with the Ministry of Health’s (MoH) desire to facilitate health research in Rwanda, the guidelines
p.000003: presented here have been developed to aid investigators who want to do research with a primary aim of studying health
p.000003: in Rwanda. These guidelines are intended to clarify the processes, expectations, and benefits of doing health research
p.000003: in Rwanda. With the clarity afforded by the guidelines, it is the hope of the Ministry of Health that health research
p.000003: will be a smooth process for investigators, and that it will be a mutually beneficial endeavor for the investigators,
p.000003: the Government of Rwanda, and the communities.
p.000003:
p.000003: II. Definition of Research
p.000003: The Ministry of Health of the Government of Rwanda, defines health research as the following:
p.000003: “Any activity intended to increase the stock of knowledge relating to health that can be generalized and used to draw
p.000003: conclusions, devise new applications, and guide decision- making.”
p.000003: This definition includes a) basic scientific research relating to health, including investigation into fundamental
p.000003: scientific phenomena without a particular application in view; b) applied/operational research, which is generation of
p.000003: new knowledge with a specific practical aim; and c) experimental development, which is research intended to develop new
p.000003: or significantly alter and improve materials, products, systems and services. General-purpose data collection,
p.000003: including statistical surveys and censuses where health data are collected and the primary aim is studying health, are
p.000003: also considered research in the health sector.
p.000003:
p.000004: 4
p.000004:
p.000004: Some activities are considered non-research in the health sector unless they are carried out for the purpose of
p.000004: assisting research and development. If not carried out for research- related purposes, these non-research activities do
p.000004: not fall under the jurisdiction of these guidelines. These activities include: standardization procedures, provision
p.000004: of specialized health care, program evaluations (excluding impact evaluations), outbreak investigation/surveillance,
p.000004: and routine software development.
p.000004:
p.000004: III. Research with Existing Data
p.000004: Two main types of research are covered by this document: the collection of new data, and additional analysis of
p.000004: existing data. Investigators wishing to conduct health research in Rwanda that requires original data collection are
p.000004: welcome, as new information will help Rwanda to make more informed policy decisions and will help improve health
p.000004: outcomes. This has traditionally been the main form of research in Rwanda.
p.000004: However, consistent with the principles outlined in the HSRP, the Ministry of Health of Rwanda is also committed to
p.000004: encouraging and facilitating the use of existing data to further knowledge about health in Rwanda. Doing so prevents
p.000004: duplication of work already completed, and thereby prevents waste of limited resources. Use of existing data also
p.000004: allows for meta-analyses, which may yield improved or more generalizeable knowledge than single studies.
p.000004: The process for carrying out research is largely the same for new data collection as for existing data analysis, and
p.000004: unless otherwise noted, the procedures and expectations outlined in the document apply to researchers wishing to carry
p.000004: out either type of research.
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: IV. Note on Collaborations
p.000004: For researchers coming from outside of Rwanda, it is requested to have a Rwandan collaborator involved at all stages of
p.000004: the work with a clear repartition of responsibilities. As such, foreign investigators are requested to partner with a
p.000004: Rwandan researcher who is working in the field of research topic. This will help to ensure relevancy of research
p.000004:
p.000005: 5
p.000005:
p.000005: projects for Rwanda, facilitate the approval process (via the institutional affiliation(s) of the Rwandan collaborator
p.000005: or his/her knowledge of the review process), and will additionally help Rwanda build capacity for conducting research
p.000005: of its own. In these guidelines, references to “investigators” or “researchers” are used to refer to the collaboration
p.000005: of foreign and Rwandan investigators, if a foreign investigator is involved.
p.000005: If any samples, including biological materials and chemicals, are to be removed from Rwanda, it is required that the
p.000005: collaborators develop and sign a memorandum of understanding (MOU) or other material transfer agreement (MTA) prior to
p.000005: initiation of data collection. Such a document will prevent confusion later on, and will strengthen proposals for
p.000005: review by scientific and ethics committees .
p.000005:
p.000005: V. Process to Begin a Research Project in Rwanda
p.000005: This section outlines the steps to be taken in order to begin a research project in Rwanda. Researchers should allow
p.000005: three months from the first submission of the proposal to final approval, though in many cases, approval may be
p.000005: obtained much faster. Proposals will usually receive approval for up to one year, though in some cases where more time
p.000005: is clearly needed for the study, a longer approval period may be issued. Note: Rwandan students through the Master’s
p.000005: degree will receive approval solely from their institutions of learning according to the institutional standards, with
p.000005: authorization and registration at the institutional level but their research questions will be authorized by the MoH
p.000005: program in which they are related to and then approved by MoH to assure their effectiveness.
p.000005: A. Proposal Generation
p.000005: The first step in doing research in Rwanda is to generate a research proposal for review. Investigators will develop a
p.000005: research proposal of no more than 15 pages that contains the following:
p.000005: • Introduction with literature review and rationale behind research;
p.000005: • Clear description of research question to be addressed;
p.000005: • Specific objectives of research regarding the research question;
p.000005:
p.000005:
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p.000006:
p.000006: • Detailed protocol including risk assessment, informed consent procedures and methodology;
p.000006: • A clear link between the protocol and the ability to answer the research question addressed;
p.000006: • Information about the source of funding;
p.000006: • Evidence of ethical review at home institution (for foreign researchers);
p.000006: • Benefits for Rwanda or communities;
p.000006: • List of researchers and curriculum vitae of each researcher who will be involved in the research process, with
p.000006: declarations of conflicts of interest;
p.000006: • Clear dissemination strategy
p.000006:
p.000006:
p.000006: B. Scientific Review
p.000006: Scientific Review Committees (SRCs) will be established at institutions with health research in their mandates in
p.000006: order to provide scientific review for proposals. After the generation of a proposal, the proposal should be submitted
p.000006: to the scientific review committee (SRC) of the affiliated Rwandan institution, if one exists. If the researcher is not
p.000006: affiliated with an institution which has an SRC, the proposal should be submitted to the SRC of the institution which
p.000006: supervises the original institution, or to any existing SRC which is highly relevant for the research topic. If none of
p.000006: these alternatives fits a given case, the researcher should submit his/her research protocol to the national research
p.000006: committee to review the proposal in question as well as research project from out of Rwanda.
p.000006: The proposal should be submitted at least two weeks before the meeting of the SRC. Research protocols that require work
p.000006: or data collection nationally or for at least one whole province should be submitted to the National Institute of
p.000006: Statistics of Rwanda instead of another institutional SRC, pursuant to the Visa Instruction Manual found in the
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| HIV | HIV/AIDS |
| access | Access to Social Goods |
| education | education |
| hiv/aids | HIV/AIDS |
| home | Property Ownership |
| influence | Drug Usage |
| nation | stateless persons |
| single | Marital Status |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| HIV | ['hiv/aids'] |
| hiv/aids | ['HIV'] |
Trigger Words
capacity
consent
ethics
harm
risk
sensitive
Applicable Type / Vulnerability / Indicator Overlay for this Input