26E7F511E9C44DFFD7F23D49E7875FB2
Uganda National Council for Science and Technology
https://leaux.net/URLS/General/Human_Subjects_Protection_Guidelines_July_2014.pdf
http://leaux.net/URLS/ConvertAPI Text Files/3606F8CE995F36E7FE39ED2B1599135D.en.txt
Examining the file media/Synopses/3606F8CE995F36E7FE39ED2B1599135D.html:
This file was generated: 2020-02-23 05:56:44
| 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 / Captive/Exiled Population
Searching for indicator displaced:
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p.000037: limited capacity or freedom to consent or decline consent. These include, but are not limited to,
p.000037: children, mature and emancipated minors, street children, prisoners, the homeless, refugees, adults
p.000037: staying on the street, internally displaced persons, substance abusers, handicapped (mentally and
p.000037: physically), armed forces, terminally ill and pregnant women. In some cases willingness to volunteer to
p.000037: participate in research is unduly influenced by expectation of benefits associated with their participation, or fear
p.000037: of retaliation from interested senior members of the hierarchy in case of refusal to participate.
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Political / Criminal Convictions
Searching for indicator prisoners:
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p.000037: protect their own interests. Individuals and groups conventionally considered vulnerable are those with
p.000037: limited capacity or freedom to consent or decline consent. These include, but are not limited to,
p.000037: children, mature and emancipated minors, street children, prisoners, the homeless, refugees, adults
p.000037: staying on the street, internally displaced persons, substance abusers, handicapped (mentally and
p.000037: physically), armed forces, terminally ill and pregnant women. In some cases willingness to volunteer to
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Political / Illegal Activity
Searching for indicator diminished:
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p.000037: action in those particular settings.
p.000037: These principles are briefly described as
p.000037: follows:
p.000037: a. Respect for persons incorporates at least two fundamental ethical considerations, namely: respect for
p.000037: autonomy, which requires that those who are capable of deliberation about their personal choices should be
p.000037: treated with respect for their capacity for self-determination; and protection of persons with
p.000037: impaired or diminished autonomy, which requires that those who are dependent or vulnerable be
p.000037: afforded security against harm or abuse.
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: b. Beneficence refers to the ethical obligation to maximize benefits and to minimize
p.000037: harms. That is to say, risks of harm by research should be reasonably justified by expected benefits,
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Political / Indigenous
Searching for indicator indigenous:
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p.000037: for providing feedback on the research results and outcomes of the research process. These plans should be shared with
p.000037: the RECs.
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p.000037: 34 UNCST
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p.000037: National Guidelines for Research involving Humans as Research Participants
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p.000037: 13.0 TRADITIONAL AND COMPLEMENTARY MEDICINE RESEARCH
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p.000037: Traditional and complementary medicine is the sum total of knowledge, skills, and practices based on the theories,
p.000037: beliefs, and experiences indigenous to different cultures, whether explicable or not, used in the maintenance
p.000037: of health as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness.
p.000037: Generally, traditional and complementary medicines research is subject to the same ethical standards as
p.000037: conventional research practices. The research should follow scientifically reliable
p.000037: procedures and observe the fundamental ethical principles of autonomy, beneficence and justice and
p.000037: the ethical review process outlined in these guidelines.
p.000037: Additional considerations are:
p.000037: a. Indigenous knowledge of the community should be recognized. There should
p.000037: be mechanisms to share equitably the benefits, which may arise out of the utilization of the
p.000037: knowledge in research. This may include support to the community to conserve their traditional knowledge and
p.000037: genetic resources.
p.000037: b. There should be considerations for protecting intellectual property or traditional knowledge
p.000037: in accordance with the relevant laws in Uganda.
p.000037: c. Research protocols should explain certain terminologies that may be unique to the indigenous languages of the
p.000037: community where the research is to be conducted.
p.000037: d. The study team involved in traditional and complementary medicine research shall include the
p.000037: traditional knowledge holder and trained scientists.
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p.000037: UNCST 35
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p.000037: National Guidelines for Research involving Humans as Research Participants
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p.000037: 14.0 PENALTIES FOR NON-COMPLIANCE
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p.000037: Non-compliance with these guidelines may be identified by any person, REC, UNCST, UNHRO, NDA and all
p.000037: other stakeholders. Non-compliance shall be documented wherever it is identified.
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Political / Political
Searching for indicator party:
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p.000037: testing to fulfill the objectives of the proposed research.
p.000037: All exchanges and transfers (including importation and exportation) of materials for research
p.000037: purposes shall require clearance from UNCST, except for exchange of human materials between organizations within
p.000037: the country. UNCST shall maintain a depositary of all MTAs. Applications for permission to exchange or
p.000037: transfer human materials for research purposes shall be made to UNCST. The application must be accompanied
p.000037: by a MTA.
p.000037: As a guide, the MTA shall include the following clauses:
p.000037: a. Parties
p.000037: The MTA must carefully list parties and their addresses. The MTA is signed only by authorized representatives of
p.000037: the party. Effective date of the MTA must be indicated.
p.000037: b. Description of materials
p.000037: The materials being transferred/ exchanged must be fully described, including a description
p.000037: of derivative products, if any. Quantities must be specified and appropriately packaged.
p.000037: c. Purpose and usage
p.000037: The recipient should fully describe the intended use of the materials. The recipient should also
p.000037: specify whether
p.000037: National Guidelines for Research involving Humans as Research Participants
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p.000037: the materials would be used for research purposes only or for commercial applications or both.
p.000037: d. User(s)
p.000037: Authorized users of the materials should be mentioned. The users cited must agree to abide by the terms and conditions
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p.000037: q. Liability
p.000037: The recipient or both the provider and recipient are accountable for any misuse or consequences of use of
p.000037: the material. Parties must agree on liability.
p.000037: r. Warranty
p.000037: The MTA should explain that the provider is giving the material “as is” and does not promise that material will perform
p.000037: in any specific way.
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p.000037: 30 UNCST
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p.000037: s. Amendment
p.000037: The MTA should have a clause which states that the MTA may be amended at any time by written mutual consent of
p.000037: the parties.
p.000037: t. Termination of MTA
p.000037: The MTA may be terminated by either party providing a written notice in an agreed time frame.
p.000037: Parties must, however, make provisions for benefit sharing of any accruing or anticipated future benefit at
p.000037: the point of termination.
p.000037: When preparing MTAs care should be taken not to contravene provisions of other existing agreements pertaining to the
p.000037: human material in question. If, for example, the human material is to be used together with a material
p.000037: governed by a separate MTA, care should be taken under such circumstances to avoid granting two or more
p.000037: parties conflicting rights to the same material or product.
p.000037: Usually before negotiating a MTA, parties correspond by mail to reach consensus on particular issues
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p.000037: ownership and use in accordance with the host organization’s data use and ownership policies. Ownership of data
p.000037: shall be clearly stated in the research protocol or collaborative research agreements, which shall be reviewed by
p.000037: the REC and registered with UNCST.
p.000037: 11.2 Data Sharing
p.000037: a. Collaborating research partners shall agree on appropriate data access and use rights before
p.000037: commencement of the study. Researchers shall have in place mechanisms for maintaining
p.000037: confidentiality of research participants and their communities.
p.000037: b. A collaborating research partner shall not transfer data to a third party without the written consent of the
p.000037: other partner.
p.000037: c. Local researchers shall have unrestricted access rights to data sets collected through a collaborative
p.000037: research project.
p.000037: d. Researchers shall ensure that research records from which the data has been obtained are available at
p.000037: the research site for at least five years after completion of the research project. Electronic records are
p.000037: acceptable.
p.000037: 11.3 Results Dissemination
p.000037: a. Researchers shall, as appropriate, make all reasonable efforts to share findings of research with
p.000037: the host organization, research participants, key stakeholders and communities in which research was done.
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Health / Cognitive Impairment
Searching for indicator impairment:
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p.000037: research project;
p.000037: National Guidelines for Research involving Humans as Research Participants
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p.000037: e. Not related: When injury is clearly due to another cause other than participation in a research project.
p.000037: Subject to applicable laws in Uganda, research participants shall be entitled to compensation
p.000037: when injury is classified as “Probably” or “Definitely” related to their participation in a research
p.000037: project. Sponsors shall ensure that research participants who suffer injury as a result of their participation in
p.000037: a research project are entitled to free medical treatment for such injury and to such financial or other assistance
p.000037: as would compensate them equitably for any resultant impairment, disability or handicap. Research
p.000037: participants shall not be asked to waive the right to compensation, and shall retain legal rights to seek
p.000037: monetary compensation for research related injuries including settlements out of court, in accordance with
p.000037: applicable laws in Uganda.
p.000037: The sponsor and researcher shall put in place a mechanism for compensating research related injury at the
p.000037: commencement of a study. The mechanism, which may include, inter alia, insurance and medical care, should be
p.000037: acceptable to the REC. The REC, research participant and/or researcher may initiate the compensation process. The
p.000037: REC, sponsor and researcher shall agree on an appropriate mechanism for arbitration.
p.000037: 6.6 Compensation for Participation in Research
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Searching for indicator impaired:
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p.000037: different moral weight in different settings, and their application may lead to different decisions or courses of
p.000037: action in those particular settings.
p.000037: These principles are briefly described as
p.000037: follows:
p.000037: a. Respect for persons incorporates at least two fundamental ethical considerations, namely: respect for
p.000037: autonomy, which requires that those who are capable of deliberation about their personal choices should be
p.000037: treated with respect for their capacity for self-determination; and protection of persons with
p.000037: impaired or diminished autonomy, which requires that those who are dependent or vulnerable be
p.000037: afforded security against harm or abuse.
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: b. Beneficence refers to the ethical obligation to maximize benefits and to minimize
p.000037: harms. That is to say, risks of harm by research should be reasonably justified by expected benefits,
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Health / Drug Dependence
Searching for indicator dependency:
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p.000037: incompetent to give consent.
p.000037: No provision of this subsection shall be construed as authorization to terminate a pregnancy
p.000037: where such termination would not otherwise be in conformity with current laws of Uganda relating to the
p.000037: termination of pregnancy.
p.000037: 5.8 Informed Consent by Mature and Emancipated Minors
p.000037: Mature minors are individuals 14-17 years of age who have drug or alcohol dependency or a sexually
p.000037: transmitted infection; while emancipated minors are individuals below the age of majority who are
p.000037: pregnant, married, have a child or cater for their own livelihood. Mature and emancipated minors may
p.000037: independently provide informed consent to participate in research if:
p.000037: a. In the view of the REC the research is not objectionable to parents or guardians (established by the
p.000037: REC with evidence from the community);
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Health / Drug Usage
Searching for indicator influence:
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p.000037: of their research. This is vital for achieving scientific goals and maximizing benefit to the community and
p.000037: society. Researchers should, therefore, adhere to sound scientific processes and appropriately weigh and
p.000037: address ethical issues in their study.
p.000037: d) Transparency
p.000037: Transparency about research includes ensuring that stakeholders receive open, honest, and
p.000037: understandable information about the objectives and processes of research. Transparency means ensuring
p.000037: that feedback from a broad range of stakeholders is acknowledged and addressed. It also includes ensuring
p.000037: that stakeholders are clear on their respective roles and responsibilities; the constituents, if any, they
p.000037: each represent; and the extent to which their input may influence research-related decisions.
p.000037: 12.3 Community Engagement Practices
p.000037: Researchers are encouraged to identify community stakeholders early enough during project conception and
p.000037: design. It is important
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p.000037: UNCST 33
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p.000037: National Guidelines for Research involving Humans as Research Participants
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p.000037: to consult with the identified stakeholders to get their input or participation in the research process. Such
p.000037: consultation involves obtaining prior agreement from community gatekeepers such as local chiefs, local
p.000037: administration officials or heads of organizations where research is to be undertaken.
p.000037: Such consultations with community stakeholders should be undertaken prior to seeking approvals from
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Searching for indicator drug:
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p.000031: 2.1 Research involving Humans as Research Participants 2
p.000031: 2.2 Rights and Welfare of Human Research Participants and
p.000031: their Communities 2
p.000031: 2.3 Principles of Research Ethics 2
p.000031: 3.0 Regulatory Oversight of Research 4
p.000031: 3.1 The Regulatory Process 4
p.000031: 3.2 Oversight by Uganda National Council for Science and Technology 4
p.000031: 3.3 Oversight by the National Drug Authority 5
p.000031: 3.4 Oversight by Uganda National Health Research Organization 5
p.000031: 3.5 Oversight by Research Ethics Committees 5
p.000031: 3.6 Oversight by Other Committees 6
p.000031: 3.6.1 Scientific Committees 6
p.000031: 3.6.2 Data and Safety Monitoring Boards 6
p.000031: 3.6.3 Community Advisory Boards 7
p.000031: 3.6.4 Institutional Biosafety Committees 8
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p.000037: Health Research Organisation, Dr. Stella Neema from Makerere University College of Humanities and Social
p.000037: Sciences, Dr. Joseph Ochieng from Makerere University School of Biomedical Sciences, Dr. Alex Opio from
p.000037: Ministry of Health, Dr. Pauline Byakika from Makerere University School of Medicine, Mr. Paul Kutyabami from
p.000037: Makerere University School of Health Sciences, Dr. Edward K. Mbidde from Uganda Virus Research Institute, Dr. Hannah
p.000037: Kibuuka from Makerere University-Walter Reed Project, Ms. Hellen Ndagije from National Drug Authority, and Dr.
p.000037: Julius Ecuru (Secretary) from UNCST. The hard work and relentless efforts by UNCST staff, especially Ms. Winfred
p.000037: Nazziwa Badanga and Ms. Leah Nawegulo Omongo, in servicing the Task force is very much appreciated. UNCST also thanks
p.000037: AVAC for co-funding meetings of the Task force. Finally, UNCST is thankful to all stakeholders for their inputs, which
p.000037: greatly enriched these guidelines.
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p.000037: iv UNCST
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p.000037: National Guidelines for Research involving Humans as Research Participants
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p.000037: Preface
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p.000037: Dr. Peter Ndemere
p.000037: Executive Secretary, UNCST
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p.000037: Professor Nelson K. Sewankambo
p.000037: Chair, Task Force
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p.000037: UNCST v
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p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037: Acronyms
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p.000037: ACREC Accreditation Committee for Research Ethics Committees in Uganda CAB Community Advisory Board
p.000037: CV Curriculum Vitae
p.000037: DSMB Data and Safety Monitoring Board IBC institutional Biosafety Committee MTA Material Transfer
p.000037: Agreement NDA National Drug Authority
p.000037: R&D Research and Development REC Research Ethics Committee S&T Science and Technology SAE
p.000037: Serious Adverse Event
p.000037: SC Scientific Committee
p.000037: SOP Standard Operating Procedures UCG Uganda Clinical Guidelines
p.000037: UNCST Uganda National Council for Science and Technology UNHROUganda National Health Research Organization
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p.000037: vi UNCST
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p.000037: 1.1 Introduction
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p.000037: inter-governmental and non-governmental organizations, and by individuals or groups, and (3)
p.000037: research conducted in a foreign country on human materials collected from Uganda.
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p.000037: UNCST 1
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p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037: 2.0 RIGHTS AND WELFARE OF RESEARCH PARTICIPANTS
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p.000037: 2.1 Research Involving Humans as Research Participants
p.000037: Research involving humans as research participants includes:
p.000037: a. Clinical investigations, that is, any experiment or study on one or more persons, which involves a
p.000037: test product/ article, whether a drug, treatment, procedure, or device;
p.000037: b. Social-behavioral studies, which involve interaction with or observation of people;
p.000037: c. Basic scientific research to study biology of persons or organs and specimens thereof;
p.000037: d. Systematic collection, storage and analysis of data on humans.
p.000037: 2.2 Rights and Welfare of Human Research Participants and their Communities
p.000037: Research should be conducted in a manner that does not violate rights and welfare of human research participants and
p.000037: their communities.
p.000037: 2.2.1 Human Research Participants have a right to, inter alia:
p.000037: a. Participate in research or not, or withdraw at any time without penalty;
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p.000037: 2.2.2 Research should aim at improving the welfare of research participants and their communities. This can be
p.000037: attained through:
p.000037: a. Ensuring adequate welfare for research participants, including compensation for inconveniences and time;
p.000037: b. Provision of health (ancillary) care beyond research related care;
p.000037: c. Provision of collateral1 benefits to
p.000037: research communities;
p.000037: d. Provision of good client care during study investigations and procedures;
p.000037: e. Taking measures to ensure easy access by the community to the test drug/ device, if proven
p.000037: beneficial.
p.000037: 2.3 Principles of Research Ethics
p.000037: In order to protect rights and welfare of human research participants, research should be conducted in
p.000037: accordance with four basic research ethics principles, namely: respect
p.000037: 1 These may include benefits that are related to but
p.000037: not directly linked to the research project.
p.000037:
p.000037:
p.000037: for persons, beneficence, non-maleficence and justice. It is generally observed that these principles guide the
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p.000037:
p.000037: 3.1 The Regulatory Process
p.000037: Oversight of research involving humans as research participants in Uganda is done first at the
p.000037: organizational level by Research Ethics Committees (RECs) and second at the national level by UNCST in collaboration
p.000037: with Uganda National Health Research Organization (UNHRO) for health research. UNCST liaises with the
p.000037: Research Secretariat in the office of the President on national security issues in respect of research conducted
p.000037: in Uganda. An additional requirement with regard to clinical trials is for the researcher to obtain a certificate from
p.000037: the National Drug Authority (NDA) in respect of a trial drug/device preferably prior to review of the
p.000037: research protocol (or proposal) by a REC and registration of the protocol with UNCST.
p.000037: The mandates of UNCST, UNHRO and NDA with respect to oversight of research are briefly mentioned below.
p.000037: 3.2 Oversight by Uganda National Council for Science and Technology
p.000037: UNCST is a semi-autonomous government agency established in 1990 (CAP 209 of the Laws of
p.000037: Uganda) to develop and implement strategies for integrating science and technology (S&T) into the
p.000037: national development process, provide advice to government of Uganda on policy matters necessary
p.000037: for advancing S&T and, oversee and coordinate research and development (R&D) in Uganda. Sections 4 and 5 of the
p.000037: UNCST Act (CAP 209) mandates UNCST to “act as
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p.000037: instruments such as questionnaires, and where applicable, informed consent documents.
p.000037: a clearinghouse for information on research
p.000037: and experimental development taking place
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p.000037: in scientific institutions, centres and other
p.000037: enterprises and on the potential applications
p.000037: 2 The registration is for oversight in accordance with the UNCST Act, and may involve additional
p.000037: review of a research proposal by specialized/ethics committees, task forces or expert review.
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p.000037: 4 UNCST
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p.000037: 3.3 Oversight by National Drug Authority
p.000037: NDA regulates safety, quality, efficacy, handling and use of drugs or drug related products and
p.000037: devices in research. Part IV, section 40 of the National Drug Policy and Authority Act (Chapter 206) states
p.000037: that, with respect to clinical trials: a) the authority may issue a certificate to any person for the purpose of
p.000037: carrying out clinical trials in respect of a drug that may be specified in the certificate, and b) no person may
p.000037: carry out any clinical trial in respect of any drug unless he or she is in possession of a certificate
p.000037: issued under subsection (1).
p.000037: It is the responsibility of each trial sponsor and/or researcher to obtain such authorization certificate for
p.000037: all experimental drugs/devices, irrespective of whether the drug/device has previously been licensed for use in
p.000037: humans or not. Researchers must file a copy of the NDA certificate authorizing the importation and/or use of the trial
p.000037: drug/device in Uganda with the relevant REC and UNCST. NDA shall also verify the continued use and eventual
p.000037: disposal of unused trial drug/device.
p.000037: The researcher shall, inter alia, provide the following information about the drug/device to NDA:
p.000037: a. Investigator’s brochure;
p.000037: b. A description of the drug/device (physical characteristics);
p.000037: c. Dosage form of the drug/device;
p.000037: d. Composition (complete formula);
p.000037: e. Active ingredients;
p.000037: f. Other ingredients (adjuncts, exipients,
p.000037: preservatives, colour, flavour etc);
p.000037: g. Pack size (weight or volume);
p.000037: h. Quality control processes done;
p.000037: National Guidelines for Research involving Humans as Research Participants
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p.000037: i. Certificate of analysis;
p.000037: j. Batch release certificate;
p.000037: k. Stability studies done on the drug/ device;
p.000037: l. Authorisation of the clinical trial from the country of origin;
p.000037: m. Good Manufacturing Practice certificate of plant from which drug/device was manufactured;
p.000037: n. Containers in which products is packaged;
p.000037: o. Labelling; and
p.000037: p. Relevant published literature on the drug/device.
p.000037: 3.4 Oversight by Uganda National Health Research Organization
p.000037: UNHRO is established by Act of Parliament to create a sustainable culture of health research by providing policy and
p.000037: ethical guidelines and national coordination of and regulation of health research. UNHRO is mandated
p.000037: under section 6(e) of the UNHRO Act “to register, renew and coordinate different types of health research in
p.000037: Uganda and promote multi-disciplinary and inter-sectoral research collaboration in a bid to establish
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p.000037: incompetent to give consent.
p.000037: No provision of this subsection shall be construed as authorization to terminate a pregnancy
p.000037: where such termination would not otherwise be in conformity with current laws of Uganda relating to the
p.000037: termination of pregnancy.
p.000037: 5.8 Informed Consent by Mature and Emancipated Minors
p.000037: Mature minors are individuals 14-17 years of age who have drug or alcohol dependency or a sexually
p.000037: transmitted infection; while emancipated minors are individuals below the age of majority who are
p.000037: pregnant, married, have a child or cater for their own livelihood. Mature and emancipated minors may
p.000037: independently provide informed consent to participate in research if:
p.000037: a. In the view of the REC the research is not objectionable to parents or guardians (established by the
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Searching for indicator substance:
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p.000037: limited capacity or freedom to consent or decline consent. These include, but are not limited to,
p.000037: children, mature and emancipated minors, street children, prisoners, the homeless, refugees, adults
p.000037: staying on the street, internally displaced persons, substance abusers, handicapped (mentally and
p.000037: physically), armed forces, terminally ill and pregnant women. In some cases willingness to volunteer to
p.000037: participate in research is unduly influenced by expectation of benefits associated with their participation, or fear
p.000037: of retaliation from interested senior members of the hierarchy in case of refusal to participate.
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p.000037: the daily lives or in the routine medical, dental, or psychological examination of healthy persons.
p.000037: Parent means the biological mother or father or adoptive mother or father of a child.
p.000037: Parental responsibility means all rights, duties, powers, responsibilities and authority which by law a parent
p.000037: of a child has in relation to the child.
p.000037: Permission means the agreement of the parent(s) or guardian(s) to the participation of their child or ward in
p.000037: the research project.
p.000037: Pharmaceutical product is any substance or combination of substances that has a therapeutic,
p.000037: prophylactic, or diagnostic use or is intended to modify physiological functions and is presented in a dosage form
p.000037: suitable for administration to humans.
p.000037: Pregnancy refers to the time period from confirmation of implantation through any of the presumptive signs
p.000037: of pregnancy including, for instance, missed menses or a medically accepted pregnancy test, until expulsion
p.000037: or extraction of the fetus.
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p.000037: Principal Investigator/Researcher is the main researcher overseeing or conducting a research
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Health / HIV/AIDS
Searching for indicator HIV:
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p.000037: research project.
p.000037: 12.2 Principles of Community Engagement
p.000037: The following principles4 are useful for effective community engagement:
p.000037: a) Respect
p.000037: Respect among stakeholders is key to communicating effectively, fostering trust, and developing
p.000037: partnerships to achieve shared goals. Respect is demonstrated when stakeholders communicate and act in
p.000037: ways that value and honour each other’s perspectives and realities. This respect includes respect for local
p.000037: values, cultures, and perspectives as well as respect for the scientific process.
p.000037:
p.000037: 4 Adapted from Good Participatory Practice Guidelines for Biomedical HIV Prevention Trials 2011
p.000037: b) Mutual understanding
p.000037: A common understanding about objectives and how to achieve them is essential to effective partnerships among
p.000037: stakeholders. Researchers should understand the norms, practices, and beliefs of relevant local cultures, and
p.000037: local social stances, as well as diverse community stakeholder perspectives, priorities, and research needs.
p.000037: This informs the design of the study so that it is culturally appropriate.
p.000037: c) Integrity
p.000037: Researchers should strive for the highest standards of scientific and ethical integrity in the conduct
p.000037: of their research. This is vital for achieving scientific goals and maximizing benefit to the community and
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Health / Health
Searching for indicator health:
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p.000031: their Communities 2
p.000031: 2.3 Principles of Research Ethics 2
p.000031: 3.0 Regulatory Oversight of Research 4
p.000031: 3.1 The Regulatory Process 4
p.000031: 3.2 Oversight by Uganda National Council for Science and Technology 4
p.000031: 3.3 Oversight by the National Drug Authority 5
p.000031: 3.4 Oversight by Uganda National Health Research Organization 5
p.000031: 3.5 Oversight by Research Ethics Committees 5
p.000031: 3.6 Oversight by Other Committees 6
p.000031: 3.6.1 Scientific Committees 6
p.000031: 3.6.2 Data and Safety Monitoring Boards 6
p.000031: 3.6.3 Community Advisory Boards 7
p.000031: 3.6.4 Institutional Biosafety Committees 8
p.000031: 4.0. Establishment and Functions of Research Ethics Committees 9
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p.000031: Glossary
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p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037:
p.000037: Acknowledgment
p.000037: Uganda National Council for Science and Technology (UNCST) is grateful for the contribution of its Task force in
p.000037: preparing these guidelines. Special thanks are to the following members of the Task force: Professor Nelson K.
p.000037: Sewankambo (Chair) from Makerere University College of Health Sciences, Professor David Guwatudde from Makerere
p.000037: University School of Public Health, Professor Charles Rwabukwali from Makerere University College of
p.000037: Humanities and Social Sciences, Mr. Richard Hasunira from Coalition for Health Promotion and Social
p.000037: Development Uganda, Dr. Philippa Musoke from Makerere University-Johns Hopkins University Research
p.000037: Collaboration, Dr. Frederick Nelson Nakwagala from Mulago Hospital, Dr. Sam Okware from Uganda National
p.000037: Health Research Organisation, Dr. Stella Neema from Makerere University College of Humanities and Social
p.000037: Sciences, Dr. Joseph Ochieng from Makerere University School of Biomedical Sciences, Dr. Alex Opio from
p.000037: Ministry of Health, Dr. Pauline Byakika from Makerere University School of Medicine, Mr. Paul Kutyabami from
p.000037: Makerere University School of Health Sciences, Dr. Edward K. Mbidde from Uganda Virus Research Institute, Dr. Hannah
p.000037: Kibuuka from Makerere University-Walter Reed Project, Ms. Hellen Ndagije from National Drug Authority, and Dr.
p.000037: Julius Ecuru (Secretary) from UNCST. The hard work and relentless efforts by UNCST staff, especially Ms. Winfred
p.000037: Nazziwa Badanga and Ms. Leah Nawegulo Omongo, in servicing the Task force is very much appreciated. UNCST also thanks
p.000037: AVAC for co-funding meetings of the Task force. Finally, UNCST is thankful to all stakeholders for their inputs, which
p.000037: greatly enriched these guidelines.
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p.000037: CV Curriculum Vitae
p.000037: DSMB Data and Safety Monitoring Board IBC institutional Biosafety Committee MTA Material Transfer
p.000037: Agreement NDA National Drug Authority
p.000037: R&D Research and Development REC Research Ethics Committee S&T Science and Technology SAE
p.000037: Serious Adverse Event
p.000037: SC Scientific Committee
p.000037: SOP Standard Operating Procedures UCG Uganda Clinical Guidelines
p.000037: UNCST Uganda National Council for Science and Technology UNHROUganda National Health Research Organization
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p.000037: vi UNCST
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p.000037:
p.000037: 1.1 Introduction
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: 1.0 GENERAL PROVISIONS
p.000037:
p.000037: Uganda has unique health, environmental, social and economic challenges, which attract both local and international
p.000037: research interests. The number of research projects involving humans as research participants in Uganda has
p.000037: more than quadrupled since 1990. This increasing quest for knowledge and the search for novel remedies to health,
p.000037: environmental, social and economic challenges is commendable, but could, if uncontrolled,
p.000037: involve exposing research participants to a spectrum of risks. These guidelines provide a national system or
p.000037: framework for harnessing the benefits of research while ensuring that rights, interests, values and welfare of
p.000037: research participants are protected.
p.000037: 1.2 Rationale
p.000037: Research is conducted for the benefit of society. It is important to have in place a system that
p.000037: promotes beneficial research and guards against unethical research. Research has inherent burdens, which
...
p.000037: c. Information about the research (it is important to ensure that information is communicated in
p.000037: understandable language, format and in a conducive environment at all stages of the research);
p.000037:
p.000037: 2 UNCST
p.000037: d. Protection against research related injuries, harm, exploitation, and any other forms of abuse;
p.000037: e. Privacy and confidentiality of their participation, during and after the research;
p.000037: f. The standard of health care that is established nationally;
p.000037: g. Treatment and management of research related injuries;
p.000037: h. Reimbursement for costs associated with their participation in the research.
p.000037: 2.2.2 Research should aim at improving the welfare of research participants and their communities. This can be
p.000037: attained through:
p.000037: a. Ensuring adequate welfare for research participants, including compensation for inconveniences and time;
p.000037: b. Provision of health (ancillary) care beyond research related care;
p.000037: c. Provision of collateral1 benefits to
p.000037: research communities;
p.000037: d. Provision of good client care during study investigations and procedures;
p.000037: e. Taking measures to ensure easy access by the community to the test drug/ device, if proven
p.000037: beneficial.
p.000037: 2.3 Principles of Research Ethics
p.000037: In order to protect rights and welfare of human research participants, research should be conducted in
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p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037: 3.0 REGULATORY OVERSIGHT OF RESEARCH
p.000037:
p.000037: 3.1 The Regulatory Process
p.000037: Oversight of research involving humans as research participants in Uganda is done first at the
p.000037: organizational level by Research Ethics Committees (RECs) and second at the national level by UNCST in collaboration
p.000037: with Uganda National Health Research Organization (UNHRO) for health research. UNCST liaises with the
p.000037: Research Secretariat in the office of the President on national security issues in respect of research conducted
p.000037: in Uganda. An additional requirement with regard to clinical trials is for the researcher to obtain a certificate from
p.000037: the National Drug Authority (NDA) in respect of a trial drug/device preferably prior to review of the
p.000037: research protocol (or proposal) by a REC and registration of the protocol with UNCST.
p.000037: The mandates of UNCST, UNHRO and NDA with respect to oversight of research are briefly mentioned below.
p.000037: 3.2 Oversight by Uganda National Council for Science and Technology
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p.000037: h. Quality control processes done;
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: i. Certificate of analysis;
p.000037: j. Batch release certificate;
p.000037: k. Stability studies done on the drug/ device;
p.000037: l. Authorisation of the clinical trial from the country of origin;
p.000037: m. Good Manufacturing Practice certificate of plant from which drug/device was manufactured;
p.000037: n. Containers in which products is packaged;
p.000037: o. Labelling; and
p.000037: p. Relevant published literature on the drug/device.
p.000037: 3.4 Oversight by Uganda National Health Research Organization
p.000037: UNHRO is established by Act of Parliament to create a sustainable culture of health research by providing policy and
p.000037: ethical guidelines and national coordination of and regulation of health research. UNHRO is mandated
p.000037: under section 6(e) of the UNHRO Act “to register, renew and coordinate different types of health research in
p.000037: Uganda and promote multi-disciplinary and inter-sectoral research collaboration in a bid to establish
p.000037: essential national health research, which is consistent with National Health Strategic Plan.” In
p.000037: executing this function, UNHRO collaborates with UNCST to register all research protocols related to health. This
p.000037: registration process is done centrally at UNCST.
p.000037: 3.5 Oversight by Research Ethics Committees
p.000037: RECs are established by organizations whose mandate includes carrying out research. Their primary function is to
p.000037: conduct initial and continuing review and approval of research projects, with the aim of protecting rights and
p.000037: UNCST 5
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p.000037: National Guidelines for Research involving Humans as Research Participants
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p.000037: welfare of human research participants. RECs operating in Uganda must be accredited by an Accreditation Committee for
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p.000037: or with potentially hazardous substances such as pathogens, radioactive material and applications
p.000037: of biotechnology, especially recombinant DNA techniques and processes.
p.000037: Specifically, IBCs shall:
p.000037: a. Notify the REC and UNCST of any research with potentially hazardous substances in their
p.000037: organizations;
p.000037: b. Conduct biosafety review of research proposals on potentially hazardous substances;
p.000037: c. Ensure provision of suitable and safe storage and disposal facilities for all materials
p.000037: involved in work with potentially hazardous substances;
p.000037: d. Ensure that all appropriate technical personnel of the organization have adequate training
p.000037: in biosafety;
p.000037: e. Establish a health-monitoring plan for all high-risk personnel involved in application, use and production of
p.000037: potentially hazardous substances.
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p.000037: 4.0. ESTABLISHMENT AND FUNCTIONS OF RESEARCH ETHICS COMMITTEES
p.000037:
p.000037: 4.1 Introduction
p.000037: RECs are established in or by an organization to conduct initial and continuing review of research projects
p.000037: with the primary goal of protecting rights and welfare of research participants. All organizations
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p.000037: is eligible for reappointment.
p.000037: i. A person may not serve as a member in more than two RECs concurrently.
p.000037: j. REC members must guard against any tendencies of unethical conduct on their own part, for example,
p.000037: they must protect the confidentiality of research projects, documents and discussions; a REC
p.000037: member shall not appropriate the submitted proposal for his or her own use; and REC members shall not compel
p.000037: researchers to submit to unnecessary repetition of review.
p.000037: k. RECs have a special responsibility to determine whether the objectives of a research project
p.000037: are responsive to the health needs and priorities of the proposed study population in particular and
p.000037: of Uganda in general. The ability to judge
p.000037:
p.000037:
p.000037:
p.000037: the ethical acceptability of various aspects of a research proposal requires a thorough understanding of a
p.000037: community’s customs and traditions. The REC, therefore, must have competent members or consulting persons
p.000037: with such understanding.
p.000037: 4. 4 Functions
p.000037: RECs act as independent reviewers of any proposed study on human research participants, to
p.000037: ensure ethical conduct of research, and that participant’s rights and welfare are not violated.
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p.000037: In order to approve research covered by these guidelines, the REC shall determine that all of the following basic
p.000037: ethical considerations are satisfied:
p.000037: a. The methods used are scientifically valid and practically feasible. The research project has a
p.000037: clear scientific objective, is designed using acceptable scientific
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p.000037: principles, methods and reliable practices; and, where applicable, has sufficient power to definitely test the study
p.000037: hypothesis.
p.000037: b. The research project demonstrates value in terms of new knowledge added and probably improvement in
p.000037: health care provision and general social wellbeing. There should be foreseeable benefits to the individuals and
p.000037: community that is going to be studied, and risks should be minimized.
p.000037: c. Risks to research participants are minimized by using procedures that are consistent with
p.000037: sound research design and which do not unnecessarily expose research participants to risk. Risks, if any, are
p.000037: reasonable in relation to anticipated benefits to the research participants, and the knowledge that will
p.000037: be gained. Risks may include psychological, mental, social, physical and economic harms. Benefits may include
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p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: j. The nature, form and extent of compensation for study participation, e.g. reimbursement for
p.000037: transport, time and meals.
p.000037: k. A brief description of sponsors of the research project and the organizational affiliation of the
p.000037: researchers.
p.000037: l. A statement that research participants will get feedback on findings and progress of the study, and that
p.000037: any new information that affects the study or data that has clinical relevance to research participants
p.000037: (including incidental findings) will be made available to research participants and/or their health
p.000037: care providers.
p.000037: m. Where necessary, provision for a witness at appropriate specific stages of the informed consent process, for
p.000037: example, in the case of illiterate, mentally incapacitated or physically handicapped research
p.000037: participants.
p.000037: n. A statement that the study has been approved by an accredited Ugandan based REC.
p.000037: 5.3.2 Any of the following shall
p.000037: be provided to the research participant, whenever appropriate, based on the nature and conduct of the study:
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p.000037: 5.7 Informed Consent by Pregnant Women
p.000037: For research involving pregnant women, informed consent should be obtained from both the mother and
p.000037: father of the embryos
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: and fetuses. However, the father’s consent shall not be required if (i) the purpose of the research is primarily
p.000037: to meet the health needs of the mother; (ii) the father’s identity and/or whereabouts are unknown; (iii) the
p.000037: father is not reasonably available; or iv) the pregnancy resulted from rape or incest and (v) the father is
p.000037: incompetent to give consent.
p.000037: No provision of this subsection shall be construed as authorization to terminate a pregnancy
p.000037: where such termination would not otherwise be in conformity with current laws of Uganda relating to the
p.000037: termination of pregnancy.
p.000037: 5.8 Informed Consent by Mature and Emancipated Minors
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p.000037: as participants; and a clear justification for not involving parents or guardians in the consent process.
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p.000037: 6.0 CARE FOR RESEARCH PARTICIPANTS
p.000037:
p.000037: 6.1 Care and Treatment for Research Participants
p.000037: A care package for research participants should be stated before initiation of a research project. Care
p.000037: and treatment for research participants should be provided with the ideal aim of providing the best proven
p.000037: intervention and, at the least, should be in accordance with the current Uganda Clinical Guidelines and other
p.000037: national health guidelines and standards. In the absence of these national health standards, the
p.000037: researcher, REC, sponsor, UNCST in collaboration with UNHRO and other regulatory bodies shall agree on the
p.000037: care and treatment package to be provided.
p.000037: The duration and sustainability of care and treatment for the research participant after the study should be
p.000037: negotiated before initiation of the study. Sponsors are encouraged, but not obliged, to provide care for
p.000037: concurrent illnesses not associated with the research project. However, researchers and sponsors are
p.000037: obliged to manage serious adverse events related to the study (including paying for associated costs thereof)
p.000037: until they are fully resolved or stabilized. Researchers should provide relevant follow up procedures
p.000037: for research participants for an appropriate period of time after the trial.
p.000037: 6.2 Care for Research Participants in Control Groups
p.000037: Research participants in a control group of a research project of a diagnostic, therapeutic, or preventive
p.000037: intervention should receive a proven intervention or as may be determined with reference to the applicable national
p.000037: health standards. Sponsors may, where possible, provide care and treatment beyond what is
p.000037: recommended in the national health guidelines taking into consideration sustainability issues.
p.000037: In certain circumstances, and as may be advised by a REC, a placebo or no intervention may be used in the
p.000037: control group where:
p.000037: a. Based on knowledge that is currently available, a proven intervention does not exist.
p.000037: b. Withholding a proven intervention would expose the research participant to at most a mild and temporary
p.000037: discomfort or delay in relief of symptoms.
p.000037: c. Use of a proven intervention as comparator would not yield scientifically reliable results and where use
p.000037: of a placebo or no intervention would not add any risk of serious or irreversible harm to the research
p.000037: participant.
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p.000037: m. Take, together with his/her research team, a recognized research ethics course or equivalent within
p.000037: three years prior to commencement of the study; and thereafter, have a refresher course at least once every three
p.000037: years. Student supervisors at training organizations are similarly encouraged to take basic research ethics
p.000037: courses.
p.000037: n. Be sufficiently qualified and competent to carry out the research project, and shall, where necessary,
p.000037: have the appropriate professional license to practice. Clinical trials shall be supervised by a competent
p.000037: and appropriately qualified physician or other health care professional.
p.000037: 7.2 Sponsor
p.000037: 7.2.1 The sponsor is responsible for providing all the necessary financial support for implementation of
p.000037: the research project, including post- research obligations. Specifically, the sponsor shall:
p.000037: a. Approve the final study report whether or not the research project has been completed.
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p.000037: b. Cause the timely reporting and management of adverse events.
p.000037: c. Be responsible for compensation or indemnity in the event of research-related injuries, disability, or
p.000037: death, in accordance with applicable Ugandan laws and regulations.
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p.000037: 8.2.1 Certain communities may also be vulnerable. Characteristics that constitute vulnerability in
p.000037: such communities include one or more of the following:
p.000037: a. Limited economic empowerment;
p.000037: b. Conflict and post-conflict situations;
p.000037: c. Inadequate protection of human rights;
p.000037: d. Discrimination on the basis of health status;
p.000037: e. Limited availability of health care and treatment options;
p.000037: f. Communities in acute disaster and disease epidemics;
p.000037: 8.2.2 In order to protect vulnerable communities, RECs should ensure that:
p.000037: a. Selection of communities is justified by
p.000037: the research goals;
p.000037: b. Research is responsive to needs and priorities of the community in which it is to be conducted;
p.000037: c. With respect to pregnant women and fetuses, appropriate studies on animals and non-pregnant
p.000037: individuals have been completed.
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p.000037: that disorder or condition;
p.000037: e. RECs may co-opt a person knowledgeable about and has experience working with the vulnerable group and individuals.
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p.000037: 9.0 MANAGEMENT OF SERIOUS ADVERSE EVENTS
p.000037:
p.000037: 9.1 Introduction
p.000037: The researcher shall identify, manage and promptly report serious adverse events to the REC. This shall not
p.000037: apply to events that are observed among participants who are in observational studies in which no
p.000037: health related intervention is being administered.
p.000037: 9.2 Defining Seriousness of Adverse
p.000037: Events and Unexpected Events
p.000037: 9.2.1 A serious adverse event is an event,
p.000037: which:
p.000037: a. Results in death;
p.000037: b. Is life threatening;
p.000037: c. Requires in patient hospitalization or prolongation of existing hospitalization;
p.000037: d. Results in significant and persistent
p.000037: incapacity;
p.000037: e. Is a congenital anomaly or birth defect;
p.000037: f. Is an important medical condition in the opinion of the investigator.
p.000037: 9.2.2 An unexpected event is an event:
p.000037: a. Which is previously unobserved or undocumented in humans under the health research
p.000037: intervention (or one substantially similar);
p.000037: b. Whose nature or severity is not consistent with information in the investigators brochure or other
p.000037: safety information known at the time;
p.000037: c. Which is observed with higher frequency or severity than previously documented.
p.000037: 9.2.3 Unexpectedness shall not include events that may reasonably be extrapolated from in vitro and animal studies.
p.000037: The relatedness of serious adverse events and unexpected events to an intervention can be graded as follows:
p.000037: Definitely: When the event is directly
p.000037: caused by the intervention.
p.000037: Probably: When the event is most likely
p.000037: explained by the research intervention but when definite proof of causality is not evident.
p.000037: Possible: When explanation for event
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p.000037: 13.0 TRADITIONAL AND COMPLEMENTARY MEDICINE RESEARCH
p.000037:
p.000037: Traditional and complementary medicine is the sum total of knowledge, skills, and practices based on the theories,
p.000037: beliefs, and experiences indigenous to different cultures, whether explicable or not, used in the maintenance
p.000037: of health as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness.
p.000037: Generally, traditional and complementary medicines research is subject to the same ethical standards as
p.000037: conventional research practices. The research should follow scientifically reliable
p.000037: procedures and observe the fundamental ethical principles of autonomy, beneficence and justice and
p.000037: the ethical review process outlined in these guidelines.
p.000037: Additional considerations are:
p.000037: a. Indigenous knowledge of the community should be recognized. There should
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p.000037: Prisoner means any individual who is involuntarily confined or detained in a penal institution. The term is
p.000037: intended to encompass individuals sentenced to such an institution under a criminal or civil provision or ruling,
p.000037: individuals detained in other facilities by virtue of statutes or commitment procedures, which provide
p.000037: alternatives to criminal prosecution or incarceration in a penal institution, and individuals
p.000037: detained pending a final disposition of their case.
p.000037: Research involving humans as research participants is defined as any study involving persons, and directed
p.000037: to the advancement of biomedical or other knowledge, that cannot be regarded as an element in
p.000037: established clinical management, public health or social practices and that involves either physical or
p.000037: psychological intervention or assessment, or generation, storage, and analysis of records containing
p.000037: biomedical or other information referable to identifiable individuals and communities. Research
p.000037: involving humans as research participants also includes research on any material obtained from a research
p.000037: participant, whether the participant is still living or has died.
p.000037: Research means any type of systematic investigation, testing and evaluation, designed to develop or
p.000037: contribute to generalizable knowledge.
p.000037:
p.000037: Research participant means a living individual about whom an investigator conducting
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Health / Mentally Disabled
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p.000037: researchers.
p.000037: l. A statement that research participants will get feedback on findings and progress of the study, and that
p.000037: any new information that affects the study or data that has clinical relevance to research participants
p.000037: (including incidental findings) will be made available to research participants and/or their health
p.000037: care providers.
p.000037: m. Where necessary, provision for a witness at appropriate specific stages of the informed consent process, for
p.000037: example, in the case of illiterate, mentally incapacitated or physically handicapped research
p.000037: participants.
p.000037: n. A statement that the study has been approved by an accredited Ugandan based REC.
p.000037: 5.3.2 Any of the following shall
p.000037: be provided to the research participant, whenever appropriate, based on the nature and conduct of the study:
p.000037: a. A statement that a particular treatment or procedure under study may involve risk to the research participant, or
p.000037: to the embryo or fetus if the research participant is or may become pregnant, and that the risk is currently
...
p.000037: children, mature and emancipated minors, street children, prisoners, the homeless, refugees, adults
p.000037: staying on the street, internally displaced persons, substance abusers, handicapped (mentally and
p.000037: physically), armed forces, terminally ill and pregnant women. In some cases willingness to volunteer to
p.000037: participate in research is unduly influenced by expectation of benefits associated with their participation, or fear
p.000037: of retaliation from interested senior members of the hierarchy in case of refusal to participate.
...
Searching for indicator disability:
(return to top)
p.000037: research project;
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: e. Not related: When injury is clearly due to another cause other than participation in a research project.
p.000037: Subject to applicable laws in Uganda, research participants shall be entitled to compensation
p.000037: when injury is classified as “Probably” or “Definitely” related to their participation in a research
p.000037: project. Sponsors shall ensure that research participants who suffer injury as a result of their participation in
p.000037: a research project are entitled to free medical treatment for such injury and to such financial or other assistance
p.000037: as would compensate them equitably for any resultant impairment, disability or handicap. Research
p.000037: participants shall not be asked to waive the right to compensation, and shall retain legal rights to seek
p.000037: monetary compensation for research related injuries including settlements out of court, in accordance with
p.000037: applicable laws in Uganda.
p.000037: The sponsor and researcher shall put in place a mechanism for compensating research related injury at the
p.000037: commencement of a study. The mechanism, which may include, inter alia, insurance and medical care, should be
p.000037: acceptable to the REC. The REC, research participant and/or researcher may initiate the compensation process. The
p.000037: REC, sponsor and researcher shall agree on an appropriate mechanism for arbitration.
p.000037: 6.6 Compensation for Participation in Research
...
p.000037: and appropriately qualified physician or other health care professional.
p.000037: 7.2 Sponsor
p.000037: 7.2.1 The sponsor is responsible for providing all the necessary financial support for implementation of
p.000037: the research project, including post- research obligations. Specifically, the sponsor shall:
p.000037: a. Approve the final study report whether or not the research project has been completed.
p.000037: UNCST 23
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: b. Cause the timely reporting and management of adverse events.
p.000037: c. Be responsible for compensation or indemnity in the event of research-related injuries, disability, or
p.000037: death, in accordance with applicable Ugandan laws and regulations.
p.000037: 7.2.2 For clinical trials involving investigational drugs and devices The sponsor shall:
p.000037: a. Provide the REC and all other regulatory authorities, a description and sample of the investigational or
p.000037: comparator drugs/ devices;
p.000037: b. Provide a dossier (research protocol and investigator’s Brochure);
p.000037: c. Ensure that the investigational product and any comparator products are of appropriate quality and are subject to
p.000037: quality assurance procedures;
p.000037: d. Promptly provide the investigator with any relevant new information that arises during the course
p.000037: of the trial, including information relating to product safety;
p.000037: e. Be responsible for the proper packaging and labeling of the investigational product(s) or medical device. The
...
p.000037: participant, whether the participant is still living or has died.
p.000037: Research means any type of systematic investigation, testing and evaluation, designed to develop or
p.000037: contribute to generalizable knowledge.
p.000037:
p.000037: Research participant means a living individual about whom an investigator conducting
p.000037: research obtains data through intervention or interaction with the individual or identifiable private
p.000037: information.
p.000037: Researcher means a person who engages in the methodical and systematic investigation of hypotheses with the
p.000037: goal of contributing to new knowledge.
p.000037: Serious adverse event is an adverse event associated with death, hospital admission, prolongation of a
p.000037: hospitalization, persistent or significant disability or incapacity, or otherwise life-threatening
p.000037: condition in connection with a clinical trial.
p.000037: Street children and orphans are persons who have not yet attained the legal age of majority
p.000037: under the applicable law and have no identifiable parent or guardian or have been abandoned by their
p.000037: parent(s) or guardian (s), are in wards of government or governmental entity, institution, organization,
p.000037: ministry, department, or subunit thereof, or are under the care of any governmental entity, institution,
p.000037: organization, ministry, department or subunit thereof.
...
Health / Mentally Incapacitated
Searching for indicator incapable:
(return to top)
p.000037: confidentiality;
p.000037: e. The research participant presents in an emergency situation and informed consent cannot be reasonably
p.000037: obtained from the individual or his/her representative.
p.000037: 5.6 Assent
p.000037: Assent to participate in research shall be obtained from all children eight (8) years of age and above, and from
p.000037: all persons incapable of self-determination. A child’s assent is obtained after parental/guardian’s
p.000037: consent. The child’s assent or dissent takes precedence over the parent’s or guardian’s consent. Assent for
p.000037: all other persons incapable of self- determination is obtained after consent from their representatives.
p.000037: 5.7 Informed Consent by Pregnant Women
p.000037: For research involving pregnant women, informed consent should be obtained from both the mother and
p.000037: father of the embryos
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
...
p.000037: organization’s research development goals. Such training should include regular courses in responsible
p.000037: conduct of research and research ethics;
p.000037: e. Take appropriate disciplinary action against researchers for non-compliance with these guidelines.
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: 24 UNCST
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: 8.0 VULNERABLE GROUPS AND INDIVIDUALS
p.000037:
p.000037: 8.1 Introduction
p.000037: Some groups or individuals are relatively (or absolutely) incapable of protecting their own interests. They
p.000037: may have insufficient power, intelligence, education, resources, strength, or other requisite attributes to
p.000037: protect their own interests. Individuals and groups conventionally considered vulnerable are those with
p.000037: limited capacity or freedom to consent or decline consent. These include, but are not limited to,
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.000037: expertise and diversity of its members, including consideration of gender, cultural
p.000037: backgrounds and sensitivity to social issues in the community in which research participants are drawn.
p.000037: b. Each REC shall include at least one member whose primary concerns are in scientific areas and at least
p.000037: one member whose primary concerns are in nonscientific areas.
p.000037: c. Each REC shall include at least one member who is not affiliated with the organization and who
p.000037: is not part of the immediate family of a person who is affiliated with the organization.
p.000037: d. Each REC shall include at least one lay3 person from the community.
p.000037: 3 “Lay person from the community” refers to an individual whose primary background is not in
p.000037: scientific research involving human participants, and who is capable of sharing his/her insights about the community
p.000037: from which participants are likely to be drawn.
p.000037: UNCST 9
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: e. No REC member may participate in the REC’s initial or continuing review of any project in which the member
p.000037: has a conflict of interest, except to provide information as may be requested by the REC.
...
Health / Physically Ill
Searching for indicator ill:
(return to top)
p.000037: children, mature and emancipated minors, street children, prisoners, the homeless, refugees, adults
p.000037: staying on the street, internally displaced persons, substance abusers, handicapped (mentally and
p.000037: physically), armed forces, terminally ill and pregnant women. In some cases willingness to volunteer to
p.000037: participate in research is unduly influenced by expectation of benefits associated with their participation, or fear
p.000037: of retaliation from interested senior members of the hierarchy in case of refusal to participate.
p.000037: Vulnerable groups and individuals need special considerations to ensure their protection.
...
Searching for indicator illness:
(return to top)
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: 34 UNCST
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: 13.0 TRADITIONAL AND COMPLEMENTARY MEDICINE RESEARCH
p.000037:
p.000037: Traditional and complementary medicine is the sum total of knowledge, skills, and practices based on the theories,
p.000037: beliefs, and experiences indigenous to different cultures, whether explicable or not, used in the maintenance
p.000037: of health as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness.
p.000037: Generally, traditional and complementary medicines research is subject to the same ethical standards as
p.000037: conventional research practices. The research should follow scientifically reliable
p.000037: procedures and observe the fundamental ethical principles of autonomy, beneficence and justice and
p.000037: the ethical review process outlined in these guidelines.
p.000037: Additional considerations are:
p.000037: a. Indigenous knowledge of the community should be recognized. There should
p.000037: be mechanisms to share equitably the benefits, which may arise out of the utilization of the
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.000031: 5.2 General Requirements for Informed Consent Process 16
p.000031: 5.3 Key Components of the Informed Consent Form 16
p.000031: 5.4 Documentation of Informed Consent Process 18
p.000031: 5.5 Waiver of Requirement for Informed Consent 18
p.000031: 5.6 Assent 19
p.000031: 5.7 Informed Consent by Pregnant Women 19
p.000031: 5.8 Informed Consent by Mature and Emancipated Minors 19
p.000031: 6.0 Care for Research Participants 20
p.000031: 6.1 Care and Treatment for Research Participants 20
p.000031: 6.2 Care for Research Participants in Control Groups 20
p.000031: 6.3 Care for Research Related Injuries 20
p.000031: 6.4 Referral of Research Participants 21
...
p.000037: participants.
p.000037: n. A statement that the study has been approved by an accredited Ugandan based REC.
p.000037: 5.3.2 Any of the following shall
p.000037: be provided to the research participant, whenever appropriate, based on the nature and conduct of the study:
p.000037: a. A statement that a particular treatment or procedure under study may involve risk to the research participant, or
p.000037: to the embryo or fetus if the research participant is or may become pregnant, and that the risk is currently
p.000037: unforeseeable.
p.000037: b. An explanation of circumstances under which the researcher may terminate the research
p.000037: participant’s participation, whether or not the research participant consents to such termination.
p.000037: UNCST 17
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: c. An explanation of any additional costs to the research participant that may result from his or her
p.000037: participation in the research project.
p.000037: d. A statement explaining the consequences of a research participant’s decision to withdraw from
p.000037: the research project. Research participants may withdraw at any time without further notice. However,
...
p.000037: consent. The child’s assent or dissent takes precedence over the parent’s or guardian’s consent. Assent for
p.000037: all other persons incapable of self- determination is obtained after consent from their representatives.
p.000037: 5.7 Informed Consent by Pregnant Women
p.000037: For research involving pregnant women, informed consent should be obtained from both the mother and
p.000037: father of the embryos
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: and fetuses. However, the father’s consent shall not be required if (i) the purpose of the research is primarily
p.000037: to meet the health needs of the mother; (ii) the father’s identity and/or whereabouts are unknown; (iii) the
p.000037: father is not reasonably available; or iv) the pregnancy resulted from rape or incest and (v) the father is
p.000037: incompetent to give consent.
...
p.000037: termination of pregnancy.
p.000037: 5.8 Informed Consent by Mature and Emancipated Minors
p.000037: Mature minors are individuals 14-17 years of age who have drug or alcohol dependency or a sexually
p.000037: transmitted infection; while emancipated minors are individuals below the age of majority who are
p.000037: pregnant, married, have a child or cater for their own livelihood. Mature and emancipated minors may
p.000037: independently provide informed consent to participate in research if:
p.000037: a. In the view of the REC the research is not objectionable to parents or guardians (established by the
p.000037: REC with evidence from the community);
p.000037: b. The research protocols include clear justification for targeting mature and emancipated minors
p.000037: as participants; and a clear justification for not involving parents or guardians in the consent process.
p.000037:
...
p.000037: staying on the street, internally displaced persons, substance abusers, handicapped (mentally and
p.000037: physically), armed forces, terminally ill and pregnant women. In some cases willingness to volunteer to
p.000037: participate in research is unduly influenced by expectation of benefits associated with their participation, or fear
p.000037: of retaliation from interested senior members of the hierarchy in case of refusal to participate.
p.000037: Vulnerable groups and individuals need special considerations to ensure their protection.
...
p.000037: d. Discrimination on the basis of health status;
p.000037: e. Limited availability of health care and treatment options;
p.000037: f. Communities in acute disaster and disease epidemics;
p.000037: 8.2.2 In order to protect vulnerable communities, RECs should ensure that:
p.000037: a. Selection of communities is justified by
p.000037: the research goals;
p.000037: b. Research is responsive to needs and priorities of the community in which it is to be conducted;
p.000037: c. With respect to pregnant women and fetuses, appropriate studies on animals and non-pregnant
p.000037: individuals have been completed.
p.000037: 8.2.3 For all vulnerable groups and individuals,
p.000037: a. Research can only be conducted in this group and individuals if the objectives of the research project
p.000037: cannot be addressed using non-vulnerable groups and individuals.
p.000037: b. Risk of participating in research is
p.000037: justified by anticipated benefits;
p.000037: c. The intervention or procedure presents experiences that are commensurate with those inherent in
...
Health / Terminally Ill
Searching for indicator terminally:
(return to top)
p.000037: children, mature and emancipated minors, street children, prisoners, the homeless, refugees, adults
p.000037: staying on the street, internally displaced persons, substance abusers, handicapped (mentally and
p.000037: physically), armed forces, terminally ill and pregnant women. In some cases willingness to volunteer to
p.000037: participate in research is unduly influenced by expectation of benefits associated with their participation, or fear
p.000037: of retaliation from interested senior members of the hierarchy in case of refusal to participate.
p.000037: Vulnerable groups and individuals need special considerations to ensure their protection.
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.000037: h. Reimbursement for costs associated with their participation in the research.
p.000037: 2.2.2 Research should aim at improving the welfare of research participants and their communities. This can be
p.000037: attained through:
p.000037: a. Ensuring adequate welfare for research participants, including compensation for inconveniences and time;
p.000037: b. Provision of health (ancillary) care beyond research related care;
p.000037: c. Provision of collateral1 benefits to
p.000037: research communities;
p.000037: d. Provision of good client care during study investigations and procedures;
p.000037: e. Taking measures to ensure easy access by the community to the test drug/ device, if proven
p.000037: beneficial.
p.000037: 2.3 Principles of Research Ethics
p.000037: In order to protect rights and welfare of human research participants, research should be conducted in
p.000037: accordance with four basic research ethics principles, namely: respect
p.000037: 1 These may include benefits that are related to but
p.000037: not directly linked to the research project.
p.000037:
p.000037:
p.000037: for persons, beneficence, non-maleficence and justice. It is generally observed that these principles guide the
...
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: 11.0 DATA OWNERSHIP, SHARING AND RESULTS
p.000037: DISSEMINATION
p.000037:
p.000037: 11.1 Data Ownership
p.000037: Data ownership and associated intellectual property rights shall be discussed and agreed upon by collaborating
p.000037: partners at the inception of a research project. Collaborating research partners shall negotiate data
p.000037: ownership and use in accordance with the host organization’s data use and ownership policies. Ownership of data
p.000037: shall be clearly stated in the research protocol or collaborative research agreements, which shall be reviewed by
p.000037: the REC and registered with UNCST.
p.000037: 11.2 Data Sharing
p.000037: a. Collaborating research partners shall agree on appropriate data access and use rights before
p.000037: commencement of the study. Researchers shall have in place mechanisms for maintaining
p.000037: confidentiality of research participants and their communities.
p.000037: b. A collaborating research partner shall not transfer data to a third party without the written consent of the
p.000037: other partner.
p.000037: c. Local researchers shall have unrestricted access rights to data sets collected through a collaborative
p.000037: research project.
p.000037: d. Researchers shall ensure that research records from which the data has been obtained are available at
p.000037: the research site for at least five years after completion of the research project. Electronic records are
p.000037: acceptable.
p.000037: 11.3 Results Dissemination
p.000037: a. Researchers shall, as appropriate, make all reasonable efforts to share findings of research with
p.000037: the host organization, research participants, key stakeholders and communities in which research was done.
p.000037: b. Researchers shall describe in the protocol plans for research results dissemination and ensure its
p.000037: execution.
...
Searching for indicator necessities:
(return to top)
p.000037: therapy, to the point of independently maintaining heart beat and respiration. If a fetus is viable after
p.000037: delivery, it is a premature infant.
p.000037: Vulnerability refers to a substantial incapacity to protect one’s own interests owing to such impediments as lack of
p.000037: capability to give informed consent, lack of alternative means of obtaining medical care or other expensive
p.000037: necessities, or being a junior or subordinate member of a hierarchical group.
p.000037:
p.000037: 38 UNCST
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: Uganda National Council for Science and Technology
p.000037: P. O. Box 6884, Kampala - Uganda. Tel: +256 414 - 705500.
p.000037: Fax: +256 414 - 234 579
...
Social / Breastfeeding Children
Searching for indicator justice:
(return to top)
p.000037: beneficial.
p.000037: 2.3 Principles of Research Ethics
p.000037: In order to protect rights and welfare of human research participants, research should be conducted in
p.000037: accordance with four basic research ethics principles, namely: respect
p.000037: 1 These may include benefits that are related to but
p.000037: not directly linked to the research project.
p.000037:
p.000037:
p.000037: for persons, beneficence, non-maleficence and justice. It is generally observed that these principles guide the
p.000037: conscientious preparation of proposals for scientific studies. They may be expressed differently and given
p.000037: different moral weight in different settings, and their application may lead to different decisions or courses of
p.000037: action in those particular settings.
p.000037: These principles are briefly described as
p.000037: follows:
p.000037: a. Respect for persons incorporates at least two fundamental ethical considerations, namely: respect for
p.000037: autonomy, which requires that those who are capable of deliberation about their personal choices should be
...
p.000037:
p.000037: b. Beneficence refers to the ethical obligation to maximize benefits and to minimize
p.000037: harms. That is to say, risks of harm by research should be reasonably justified by expected benefits,
p.000037: research design should be scientifically acceptable, and researchers should be competent to conduct research
p.000037: and to safeguard rights and welfare of research participants.
p.000037: c. Non-maleficence (i.e. to do no harm) prescribes that researchers should not deliberately inflict
p.000037: harm, or evil on research participants.
p.000037: d. Justice refers to the ethical obligation to treat each person in accordance with what is morally
p.000037: right and proper, to give each person what is due to him or her. The principle refers primarily to distributive
p.000037: justice, which requires fair and equitable distribution of both burdens and benefits of participation in research.
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: UNCST 3
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037: 3.0 REGULATORY OVERSIGHT OF RESEARCH
p.000037:
p.000037: 3.1 The Regulatory Process
p.000037: Oversight of research involving humans as research participants in Uganda is done first at the
p.000037: organizational level by Research Ethics Committees (RECs) and second at the national level by UNCST in collaboration
...
p.000037: beliefs, and experiences indigenous to different cultures, whether explicable or not, used in the maintenance
p.000037: of health as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness.
p.000037: Generally, traditional and complementary medicines research is subject to the same ethical standards as
p.000037: conventional research practices. The research should follow scientifically reliable
p.000037: procedures and observe the fundamental ethical principles of autonomy, beneficence and justice and
p.000037: the ethical review process outlined in these guidelines.
p.000037: Additional considerations are:
p.000037: a. Indigenous knowledge of the community should be recognized. There should
p.000037: be mechanisms to share equitably the benefits, which may arise out of the utilization of the
p.000037: knowledge in research. This may include support to the community to conserve their traditional knowledge and
p.000037: genetic resources.
p.000037: b. There should be considerations for protecting intellectual property or traditional knowledge
p.000037: in accordance with the relevant laws in Uganda.
p.000037: c. Research protocols should explain certain terminologies that may be unique to the indigenous languages of the
...
Social / Child
Searching for indicator child:
(return to top)
p.000037: confidentiality;
p.000037: e. The research participant presents in an emergency situation and informed consent cannot be reasonably
p.000037: obtained from the individual or his/her representative.
p.000037: 5.6 Assent
p.000037: Assent to participate in research shall be obtained from all children eight (8) years of age and above, and from
p.000037: all persons incapable of self-determination. A child’s assent is obtained after parental/guardian’s
p.000037: consent. The child’s assent or dissent takes precedence over the parent’s or guardian’s consent. Assent for
p.000037: all other persons incapable of self- determination is obtained after consent from their representatives.
p.000037: 5.7 Informed Consent by Pregnant Women
p.000037: For research involving pregnant women, informed consent should be obtained from both the mother and
p.000037: father of the embryos
...
p.000037: Mature minors are individuals 14-17 years of age who have drug or alcohol dependency or a sexually
p.000037: transmitted infection; while emancipated minors are individuals below the age of majority who are
p.000037: pregnant, married, have a child or cater for their own livelihood. Mature and emancipated minors may
p.000037: independently provide informed consent to participate in research if:
p.000037: a. In the view of the REC the research is not objectionable to parents or guardians (established by the
p.000037: REC with evidence from the community);
p.000037: b. The research protocols include clear justification for targeting mature and emancipated minors
p.000037: as participants; and a clear justification for not involving parents or guardians in the consent process.
p.000037:
p.000037: UNCST 19
p.000037:
p.000037:
p.000037:
...
p.000037: these guidelines or that repeatedly fails to comply with these guidelines.
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: 36 UNCST
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: GLOSSARY
p.000037:
p.000037: Adverse event is any untoward medical occurrence in a participant in a clinical trial who has been
p.000037: administered a pharmaceutical product or a medical device. The event may or may not be casually related to the
p.000037: treatment or procedure.
p.000037: Assent means a child’s affirmative agreement to participate in a research project. Failure to object does not
p.000037: constitute assent.
p.000037: Child is a person below the age of eighteen years.
p.000037: Clinical trial is a systematic study of pharmaceutical products or medical devices in human research
p.000037: participants in order to discover or to verify the beneficial or adverse effects, to identify any adverse
p.000037: reaction in the investigational product, and/or to study the absorption, distribution, metabolism, and excretion
p.000037: of the product with the objective of ascertaining its safety and efficacy.
p.000037: Fetus means the product of conception from the time of implantation as indicated by any of the presumptive signs of
p.000037: pregnancy, including missed menses or a medically accepted pregnancy test, until a determination is made,
p.000037: following expulsion or extraction of the fetus, that it is viable.
p.000037: Guardian means a person having parental responsibility for a child.
p.000037: Institution/Organization means an entity or agency, whether public or private legally recognized in Uganda.
p.000037: Investigational product or study product is any pharmaceutical product or medical device or placebo being
p.000037: tested or being used as a reference in a clinical trial.
p.000037: Local Investigator/Researcher is an individual who is employed by an organization in Uganda, who is
p.000037: qualified by training and has experience as an appropriate expert who conducts a research project.
p.000037: Medical device is any device that has a therapeutic, prophylactic, or diagnostic use or is intended to
p.000037: modify physiological functions and is attached, implanted, or inserted for use in humans.
p.000037: Minimal risk is the probability and magnitude of physical or psychological harm that is normally encountered in
p.000037: the daily lives or in the routine medical, dental, or psychological examination of healthy persons.
p.000037: Parent means the biological mother or father or adoptive mother or father of a child.
p.000037: Parental responsibility means all rights, duties, powers, responsibilities and authority which by law a parent
p.000037: of a child has in relation to the child.
p.000037: Permission means the agreement of the parent(s) or guardian(s) to the participation of their child or ward in
p.000037: the research project.
p.000037: Pharmaceutical product is any substance or combination of substances that has a therapeutic,
p.000037: prophylactic, or diagnostic use or is intended to modify physiological functions and is presented in a dosage form
p.000037: suitable for administration to humans.
p.000037: Pregnancy refers to the time period from confirmation of implantation through any of the presumptive signs
p.000037: of pregnancy including, for instance, missed menses or a medically accepted pregnancy test, until expulsion
p.000037: or extraction of the fetus.
p.000037:
p.000037:
p.000037: UNCST 37
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
...
Searching for indicator children:
(return to top)
p.000037: d. The only record linking the research participant and the research project would be the informed
p.000037: consent form and the risk to the research participant would be potential harm resulting from a breach of
p.000037: confidentiality;
p.000037: e. The research participant presents in an emergency situation and informed consent cannot be reasonably
p.000037: obtained from the individual or his/her representative.
p.000037: 5.6 Assent
p.000037: Assent to participate in research shall be obtained from all children eight (8) years of age and above, and from
p.000037: all persons incapable of self-determination. A child’s assent is obtained after parental/guardian’s
p.000037: consent. The child’s assent or dissent takes precedence over the parent’s or guardian’s consent. Assent for
...
p.000037: may have insufficient power, intelligence, education, resources, strength, or other requisite attributes to
p.000037: protect their own interests. Individuals and groups conventionally considered vulnerable are those with
p.000037: limited capacity or freedom to consent or decline consent. These include, but are not limited to,
p.000037: children, mature and emancipated minors, street children, prisoners, the homeless, refugees, adults
p.000037: staying on the street, internally displaced persons, substance abusers, handicapped (mentally and
p.000037: physically), armed forces, terminally ill and pregnant women. In some cases willingness to volunteer to
...
p.000037:
p.000037: Research participant means a living individual about whom an investigator conducting
p.000037: research obtains data through intervention or interaction with the individual or identifiable private
p.000037: information.
p.000037: Researcher means a person who engages in the methodical and systematic investigation of hypotheses with the
p.000037: goal of contributing to new knowledge.
p.000037: Serious adverse event is an adverse event associated with death, hospital admission, prolongation of a
p.000037: hospitalization, persistent or significant disability or incapacity, or otherwise life-threatening
p.000037: condition in connection with a clinical trial.
p.000037: Street children and orphans are persons who have not yet attained the legal age of majority
p.000037: under the applicable law and have no identifiable parent or guardian or have been abandoned by their
p.000037: parent(s) or guardian (s), are in wards of government or governmental entity, institution, organization,
p.000037: ministry, department, or subunit thereof, or are under the care of any governmental entity, institution,
p.000037: organization, ministry, department or subunit thereof.
p.000037: Viable means being able, after spontaneous or induced delivery, to survive, given the benefit of available medical
p.000037: therapy, to the point of independently maintaining heart beat and respiration. If a fetus is viable after
...
Searching for indicator vulnerable:
(return to top)
p.000031: 7.0 Responsibilities of Researcher, Sponsor and Researcher’s
p.000031: Organization of Affiliation 23
p.000031: 7.1 Researcher 23
p.000031: 7.2 Sponsor 23
p.000031: 7.3 Researcher’s Organization of Affiliation 24
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: ii UNCST
p.000031:
p.000031: National Guidelines for Research involving Humans as Research Participants
p.000031: 8.0 Vulnerable Groups and Individuals 25
p.000031: 8.1 Introduction 25
p.000031: 8.2 Additional Protection for Vulnerable Populations 25
p.000031: 9.0 Management of Serious Adverse Events 26
p.000031: 9.1 Introduction 26
p.000031: 9.2 Defining Seriousness of Adverse Events and Unexpected Events 26
p.000031: 9.3 Management of Serious Adverse Events and Unexpected Events 26
p.000031: 9.4 Reporting Serious Adverse Events and Unexpected Events 27
p.000031: 9.5 Protocol Violations and Deviations 27
p.000031: 10.0 Human Materials 28
p.000031: 10.1 Acquisition 28
...
p.000037: autonomy, which requires that those who are capable of deliberation about their personal choices should be
p.000037: treated with respect for their capacity for self-determination; and protection of persons with
p.000037: impaired or diminished autonomy, which requires that those who are dependent or vulnerable be
p.000037: afforded security against harm or abuse.
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: b. Beneficence refers to the ethical obligation to maximize benefits and to minimize
p.000037: harms. That is to say, risks of harm by research should be reasonably justified by expected benefits,
p.000037: research design should be scientifically acceptable, and researchers should be competent to conduct research
p.000037: and to safeguard rights and welfare of research participants.
...
p.000037: such aspects as medical care and treatment. Benefits also include those that accrue to the wider community such as
p.000037: capacity building or enhancement of social amenities.
p.000037: d. The selection of research participants is fair and equitable. In making this assessment the REC
p.000037: shall take into account the purposes of the research and the setting in which the research will be conducted. It should
p.000037: be particularly cognizant of special challenges associated with research on vulnerable populations.
p.000037: e. Informed consent will be sought from each individual prospective research participant or the individual
p.000037: participant’s authorized representative. Informed consent process will be appropriately documented in
p.000037: accordance with the provisions of these guidelines.
p.000037:
p.000037: f. There are adequate provisions to protect privacy of research participants and to maintain
p.000037: confidentiality of personal identifiable information.
p.000037: g. Additional safeguards have been included in the study to protect vulnerable groups.
p.000037: h. Where appropriate, there should be a provision for involvement of the community in the
p.000037: research process right from inception to post research period. The community in this context may be
p.000037: geographical or study population specific.
p.000037: 4.8 Requirements for Submission to REC
p.000037: All RECs shall develop detailed standard operating procedures for submission of protocols and
p.000037: other requirements. However, at the minimum, the requirements should include:
p.000037: a. A complete research protocol with version and date.
p.000037: b. Study instruments e.g. questionnaires, case report forms, videos, flip charts and other data collection
p.000037: tools/forms.
p.000037: c. Samples of trial drugs/devices.
p.000037: d. Informed consent documents.
...
p.000037: dissemination of research findings;
p.000037: d. Take measures to train and mentor the organization’s staff in skills necessary to achieve the
p.000037: organization’s research development goals. Such training should include regular courses in responsible
p.000037: conduct of research and research ethics;
p.000037: e. Take appropriate disciplinary action against researchers for non-compliance with these guidelines.
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: 24 UNCST
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: 8.0 VULNERABLE GROUPS AND INDIVIDUALS
p.000037:
p.000037: 8.1 Introduction
p.000037: Some groups or individuals are relatively (or absolutely) incapable of protecting their own interests. They
p.000037: may have insufficient power, intelligence, education, resources, strength, or other requisite attributes to
p.000037: protect their own interests. Individuals and groups conventionally considered vulnerable are those with
p.000037: limited capacity or freedom to consent or decline consent. These include, but are not limited to,
p.000037: children, mature and emancipated minors, street children, prisoners, the homeless, refugees, adults
...
p.000037: physically), armed forces, terminally ill and pregnant women. In some cases willingness to volunteer to
p.000037: participate in research is unduly influenced by expectation of benefits associated with their participation, or fear
p.000037: of retaliation from interested senior members of the hierarchy in case of refusal to participate.
p.000037: Vulnerable groups and individuals need special considerations to ensure their protection.
p.000037: Researchers, whose research involves vulnerable groups and individuals, shall specify how they will address
p.000037: particular vulnerabilities.
p.000037: 8.2 Additional Protection for Vulnerable Populations
p.000037: 8.2.1 Certain communities may also be vulnerable. Characteristics that constitute vulnerability in
p.000037: such communities include one or more of the following:
p.000037: a. Limited economic empowerment;
p.000037: b. Conflict and post-conflict situations;
p.000037: c. Inadequate protection of human rights;
p.000037: d. Discrimination on the basis of health status;
p.000037: e. Limited availability of health care and treatment options;
p.000037: f. Communities in acute disaster and disease epidemics;
p.000037: 8.2.2 In order to protect vulnerable communities, RECs should ensure that:
p.000037: a. Selection of communities is justified by
p.000037: the research goals;
p.000037: b. Research is responsive to needs and priorities of the community in which it is to be conducted;
p.000037: c. With respect to pregnant women and fetuses, appropriate studies on animals and non-pregnant
p.000037: individuals have been completed.
p.000037: 8.2.3 For all vulnerable groups and individuals,
p.000037: a. Research can only be conducted in this group and individuals if the objectives of the research project
p.000037: cannot be addressed using non-vulnerable groups and individuals.
p.000037: b. Risk of participating in research is
p.000037: justified by anticipated benefits;
p.000037: c. The intervention or procedure presents experiences that are commensurate with those inherent in
p.000037: their actual or expected medical, dental, psychological, social, or educational situations;
p.000037: d. The intervention or procedure is likely to yield generalizable knowledge about the group or
p.000037: individual’s disorder or condition that is of vital importance for the understanding or amelioration of
p.000037: that disorder or condition;
p.000037: e. RECs may co-opt a person knowledgeable about and has experience working with the vulnerable group and individuals.
p.000037: UNCST 25
p.000037:
p.000037:
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: 9.0 MANAGEMENT OF SERIOUS ADVERSE EVENTS
p.000037:
p.000037: 9.1 Introduction
p.000037: The researcher shall identify, manage and promptly report serious adverse events to the REC. This shall not
p.000037: apply to events that are observed among participants who are in observational studies in which no
p.000037: health related intervention is being administered.
p.000037: 9.2 Defining Seriousness of Adverse
p.000037: Events and Unexpected Events
p.000037: 9.2.1 A serious adverse event is an event,
p.000037: which:
p.000037: a. Results in death;
p.000037: b. Is life threatening;
...
Social / Educational
Searching for indicator education:
(return to top)
p.000037: from which participants are likely to be drawn.
p.000037: UNCST 9
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: e. No REC member may participate in the REC’s initial or continuing review of any project in which the member
p.000037: has a conflict of interest, except to provide information as may be requested by the REC.
p.000037: f. Each REC member shall take at least one course in human research protection within one year of
p.000037: appointment to an REC, and thereafter, should undergo continued research ethics education at least once every
p.000037: two years.
p.000037: g. A REC may, at its discretion, invite individuals with competence in special areas to assist in
p.000037: the review of protocols, which require expertise beyond, or in addition to that available in the REC.
p.000037: These individuals do not vote at REC meetings.
p.000037: h. Membership in any REC shall not exceed a term of three years. After serving for three years, a member
p.000037: is eligible for reappointment.
p.000037: i. A person may not serve as a member in more than two RECs concurrently.
p.000037: j. REC members must guard against any tendencies of unethical conduct on their own part, for example,
...
p.000037: e. Take appropriate disciplinary action against researchers for non-compliance with these guidelines.
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: 24 UNCST
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: 8.0 VULNERABLE GROUPS AND INDIVIDUALS
p.000037:
p.000037: 8.1 Introduction
p.000037: Some groups or individuals are relatively (or absolutely) incapable of protecting their own interests. They
p.000037: may have insufficient power, intelligence, education, resources, strength, or other requisite attributes to
p.000037: protect their own interests. Individuals and groups conventionally considered vulnerable are those with
p.000037: limited capacity or freedom to consent or decline consent. These include, but are not limited to,
...
p.000037: Such consultations with community stakeholders should be undertaken prior to seeking approvals from
p.000037: relevant RECs and other relevant regulatory authorities. This does not mean that consultations with
p.000037: community stakeholders should end after approval of research by the REC, neither should
p.000037: agreement with community stakeholders be
p.000037:
p.000037: taken as a substitute to the REC process; rather community engagement is to be treated as an ongoing process until
p.000037: completion of research.
p.000037: Researchers may engage with the community in a variety of innovative ways, which broadly
p.000037: include, but not limited to, community education to improve research literacy, community dialogues to
p.000037: promote understanding, research participation and ownership. Normally, researchers should develop plans
p.000037: for providing feedback on the research results and outcomes of the research process. These plans should be shared with
p.000037: the RECs.
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: 34 UNCST
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
...
Searching for indicator educational:
(return to top)
p.000037: a. Research can only be conducted in this group and individuals if the objectives of the research project
p.000037: cannot be addressed using non-vulnerable groups and individuals.
p.000037: b. Risk of participating in research is
p.000037: justified by anticipated benefits;
p.000037: c. The intervention or procedure presents experiences that are commensurate with those inherent in
p.000037: their actual or expected medical, dental, psychological, social, or educational situations;
p.000037: d. The intervention or procedure is likely to yield generalizable knowledge about the group or
p.000037: individual’s disorder or condition that is of vital importance for the understanding or amelioration of
p.000037: that disorder or condition;
p.000037: e. RECs may co-opt a person knowledgeable about and has experience working with the vulnerable group and individuals.
p.000037: UNCST 25
p.000037:
p.000037:
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: 9.0 MANAGEMENT OF SERIOUS ADVERSE EVENTS
p.000037:
p.000037: 9.1 Introduction
p.000037: The researcher shall identify, manage and promptly report serious adverse events to the REC. This shall not
...
Social / Fetus/Neonate
Searching for indicator fetus:
(return to top)
p.000037: example, in the case of illiterate, mentally incapacitated or physically handicapped research
p.000037: participants.
p.000037: n. A statement that the study has been approved by an accredited Ugandan based REC.
p.000037: 5.3.2 Any of the following shall
p.000037: be provided to the research participant, whenever appropriate, based on the nature and conduct of the study:
p.000037: a. A statement that a particular treatment or procedure under study may involve risk to the research participant, or
p.000037: to the embryo or fetus if the research participant is or may become pregnant, and that the risk is currently
p.000037: unforeseeable.
p.000037: b. An explanation of circumstances under which the researcher may terminate the research
p.000037: participant’s participation, whether or not the research participant consents to such termination.
p.000037: UNCST 17
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: c. An explanation of any additional costs to the research participant that may result from his or her
p.000037: participation in the research project.
p.000037: d. A statement explaining the consequences of a research participant’s decision to withdraw from
...
p.000037: treatment or procedure.
p.000037: Assent means a child’s affirmative agreement to participate in a research project. Failure to object does not
p.000037: constitute assent.
p.000037: Child is a person below the age of eighteen years.
p.000037: Clinical trial is a systematic study of pharmaceutical products or medical devices in human research
p.000037: participants in order to discover or to verify the beneficial or adverse effects, to identify any adverse
p.000037: reaction in the investigational product, and/or to study the absorption, distribution, metabolism, and excretion
p.000037: of the product with the objective of ascertaining its safety and efficacy.
p.000037: Fetus means the product of conception from the time of implantation as indicated by any of the presumptive signs of
p.000037: pregnancy, including missed menses or a medically accepted pregnancy test, until a determination is made,
p.000037: following expulsion or extraction of the fetus, that it is viable.
p.000037: Guardian means a person having parental responsibility for a child.
p.000037: Institution/Organization means an entity or agency, whether public or private legally recognized in Uganda.
p.000037: Investigational product or study product is any pharmaceutical product or medical device or placebo being
p.000037: tested or being used as a reference in a clinical trial.
p.000037: Local Investigator/Researcher is an individual who is employed by an organization in Uganda, who is
p.000037: qualified by training and has experience as an appropriate expert who conducts a research project.
p.000037: Medical device is any device that has a therapeutic, prophylactic, or diagnostic use or is intended to
p.000037: modify physiological functions and is attached, implanted, or inserted for use in humans.
...
p.000037: Permission means the agreement of the parent(s) or guardian(s) to the participation of their child or ward in
p.000037: the research project.
p.000037: Pharmaceutical product is any substance or combination of substances that has a therapeutic,
p.000037: prophylactic, or diagnostic use or is intended to modify physiological functions and is presented in a dosage form
p.000037: suitable for administration to humans.
p.000037: Pregnancy refers to the time period from confirmation of implantation through any of the presumptive signs
p.000037: of pregnancy including, for instance, missed menses or a medically accepted pregnancy test, until expulsion
p.000037: or extraction of the fetus.
p.000037:
p.000037:
p.000037: UNCST 37
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: Principal Investigator/Researcher is the main researcher overseeing or conducting a research
p.000037: project. Such an individual is qualified by training and has experience as an appropriate expert in
p.000037: conducting a research study, and where appropriate, under whose immediate direction the
p.000037: investigational agent under investigation is administered or dispensed. When a team of individuals
p.000037: conducts an investigation, the responsible leader of the team is a Principal investigator.
p.000037: Prisoner means any individual who is involuntarily confined or detained in a penal institution. The term is
...
p.000037: under the applicable law and have no identifiable parent or guardian or have been abandoned by their
p.000037: parent(s) or guardian (s), are in wards of government or governmental entity, institution, organization,
p.000037: ministry, department, or subunit thereof, or are under the care of any governmental entity, institution,
p.000037: organization, ministry, department or subunit thereof.
p.000037: Viable means being able, after spontaneous or induced delivery, to survive, given the benefit of available medical
p.000037: therapy, to the point of independently maintaining heart beat and respiration. If a fetus is viable after
p.000037: delivery, it is a premature infant.
p.000037: Vulnerability refers to a substantial incapacity to protect one’s own interests owing to such impediments as lack of
p.000037: capability to give informed consent, lack of alternative means of obtaining medical care or other expensive
p.000037: necessities, or being a junior or subordinate member of a hierarchical group.
p.000037:
p.000037: 38 UNCST
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
...
Searching for indicator capacity:
(return to top)
p.000037: conscientious preparation of proposals for scientific studies. They may be expressed differently and given
p.000037: different moral weight in different settings, and their application may lead to different decisions or courses of
p.000037: action in those particular settings.
p.000037: These principles are briefly described as
p.000037: follows:
p.000037: a. Respect for persons incorporates at least two fundamental ethical considerations, namely: respect for
p.000037: autonomy, which requires that those who are capable of deliberation about their personal choices should be
p.000037: treated with respect for their capacity for self-determination; and protection of persons with
p.000037: impaired or diminished autonomy, which requires that those who are dependent or vulnerable be
p.000037: afforded security against harm or abuse.
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
...
p.000037: research conducted at or sponsored by the organization. This may include an appropriate existing
p.000037: code, declaration, or statement of ethical principles, or a statement formulated by the organization itself.
p.000037: b. Assurance of availability of staff, office and meeting space for the REC; and sufficient
p.000037: resources to support the REC’s operations.
p.000037: c. A list of REC members appointed by the head of the organization or his/her designee. The members
p.000037: should be identified by name, qualifications, profession,
p.000037: specialty, organization of affiliation and
p.000037: representative capacity in REC.
p.000037: d. Written standard operating procedures for the REC;
p.000037: The ACREC shall review the organization’s application, and if satisfied, will accredit the REC. The
p.000037: REC shall not commence its activities until it has been accredited by the ACREC. Guidelines for
p.000037: accreditation of RECs are obtainable from the UNCST offices or website.
p.000037: 4.3 Composition of a REC
p.000037: a. Each REC shall be composed of at least five
p.000037: (5) members, with varying backgrounds to ensure balanced and adequate review of research activities commonly
p.000037: conducted by the organization. The REC shall be sufficiently qualified through the experience,
...
p.000037: community that is going to be studied, and risks should be minimized.
p.000037: c. Risks to research participants are minimized by using procedures that are consistent with
p.000037: sound research design and which do not unnecessarily expose research participants to risk. Risks, if any, are
p.000037: reasonable in relation to anticipated benefits to the research participants, and the knowledge that will
p.000037: be gained. Risks may include psychological, mental, social, physical and economic harms. Benefits may include
p.000037: such aspects as medical care and treatment. Benefits also include those that accrue to the wider community such as
p.000037: capacity building or enhancement of social amenities.
p.000037: d. The selection of research participants is fair and equitable. In making this assessment the REC
p.000037: shall take into account the purposes of the research and the setting in which the research will be conducted. It should
p.000037: be particularly cognizant of special challenges associated with research on vulnerable populations.
p.000037: e. Informed consent will be sought from each individual prospective research participant or the individual
...
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: UNCST 15
p.000037:
p.000037:
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: 5.0 INFORMED CONSENT PROCESS
p.000037:
p.000037: 5.1 Introduction
p.000037: Respect for persons requires that research participants be given the opportunity to make choices about
p.000037: what should be done to them. Informed consent is not just a form or a signature/mark/thumbprint but a process of
p.000037: information exchange between the researcher and research participants on the whole research process. Information
p.000037: provided should be adequate, clearly understood by the research participant with decision making capacity and the
p.000037: research participant should voluntarily decide whether or not to participate.
p.000037: 5.2 General Requirements for Informed Consent Process
p.000037: Except as provided elsewhere in these guidelines, no researcher shall involve an individual person as
p.000037: a research participant unless the researcher has obtained informed consent of the individual or the
p.000037: individual’s authorized representative. As an example, a community leader may not consent for
p.000037: participation of community members in research without the individual research participants’ informed
p.000037: consent.
...
p.000037:
p.000037: 8.0 VULNERABLE GROUPS AND INDIVIDUALS
p.000037:
p.000037: 8.1 Introduction
p.000037: Some groups or individuals are relatively (or absolutely) incapable of protecting their own interests. They
p.000037: may have insufficient power, intelligence, education, resources, strength, or other requisite attributes to
p.000037: protect their own interests. Individuals and groups conventionally considered vulnerable are those with
p.000037: limited capacity or freedom to consent or decline consent. These include, but are not limited to,
p.000037: children, mature and emancipated minors, street children, prisoners, the homeless, refugees, adults
p.000037: staying on the street, internally displaced persons, substance abusers, handicapped (mentally and
...
p.000037: rights and welfare of the research participants.
p.000037: 10.4 Exchange/Transfer of Human Materials for Research Purposes
p.000037: When it is necessary to transfer samples for storage or other uses from one organization to another within
p.000037: the country and abroad, the provider organization holding the samples on behalf of sample sources shall
p.000037: negotiate an appropriate contract with the recipient organization. This contract shall be in the form of a
p.000037: Materials Transfer Agreement (MTA).
p.000037: In order to justify transfer of human materials abroad, researchers, sponsors and collaborators
p.000037:
p.000037: 28 UNCST
p.000037:
p.000037:
p.000037: should demonstrate that in-country capacity to perform certain types of investigations/testing does not exist or
p.000037: is inadequate. Samples may be transferred for quality assurance and laboratory reference purposes. Researchers,
p.000037: sponsors and collaborators are encouraged to build, develop or strengthen local capacity for any investigative
p.000037: testing to fulfill the objectives of the proposed research.
p.000037: All exchanges and transfers (including importation and exportation) of materials for research
p.000037: purposes shall require clearance from UNCST, except for exchange of human materials between organizations within
p.000037: the country. UNCST shall maintain a depositary of all MTAs. Applications for permission to exchange or
p.000037: transfer human materials for research purposes shall be made to UNCST. The application must be accompanied
p.000037: by a MTA.
p.000037: As a guide, the MTA shall include the following clauses:
p.000037: a. Parties
p.000037: The MTA must carefully list parties and their addresses. The MTA is signed only by authorized representatives of
...
Social / Gender
Searching for indicator gender:
(return to top)
p.000037: choose to review data more frequently);
p.000037: d. Channels of communication with the study and the REC.
p.000037: 3.6.3 Community Advisory Boards
p.000037: 3.6.3.1 Establishment
p.000037: Community Advisory Boards (CABs) are established by the researcher. A CAB facilitates dialogue
p.000037: between the community and the researcher team.
p.000037: CAB members are identified from communities where research is to be undertaken. The CAB’s role and
p.000037: expectations should be clearly stated in their terms of reference. Members of a CAB may include, but are not limited
p.000037: to, the following:
p.000037: a. Individuals with understanding of local laws, cultural values and gender issues;
p.000037: b. Peer leaders;
p.000037: c. Religious leaders;
p.000037: d. Representatives of the study population;
p.000037: e. Media;
p.000037: f. Professionals who understand research or science issues;
p.000037: g. Community leaders.
p.000037: UNCST 7
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: 3.6.3.2 Functions
p.000037: The primary function of a CAB is to assist researchers understand and incorporate community
p.000037: concerns into their research activities. This happens through different ways like advising on issues central
p.000037: to the informed consent process, achieving successful volunteer recruitment and retention, among
p.000037: others.
p.000037: Responsibilities of CABs may vary according to the study location, size, and other factors, but generally, they are to:
p.000037: a. Provide information on traditional beliefs and needs of the study population and their concerns regarding the
p.000037: research project;
p.000037: b. Provide input into the design of the research protocol as appropriate including the informed consent
p.000037: process;
p.000037: c. Advise on effective methods for disseminating information about the research project
p.000037: and its outcomes;
p.000037: d. Provide advice and support regarding recruitment and retention of research participants including
p.000037: considerations of gender.
p.000037: 3.6.4 Institutional Biosafety Committees
p.000037: 3.6.4.1 Establishment
p.000037: Institutional Biosafety Committees (IBCs) are established by organizations that undertake research on potentially
p.000037: hazardous substances of a physical, chemical, biological, or any other nature. Any organization involved in or
p.000037: planning to conduct research with potentially hazardous substances is required to set up or designate a competent IBC.
p.000037: Each IBC once formed shall consist of a biosafety officer and at least three other officers with appropriate
p.000037: expertise. The IBC shall be certified by UNCST.
p.000037:
p.000037:
p.000037:
p.000037: It is the responsibility of the researcher to notify and provide the IBC with the research proposal involving
...
p.000037: d. Written standard operating procedures for the REC;
p.000037: The ACREC shall review the organization’s application, and if satisfied, will accredit the REC. The
p.000037: REC shall not commence its activities until it has been accredited by the ACREC. Guidelines for
p.000037: accreditation of RECs are obtainable from the UNCST offices or website.
p.000037: 4.3 Composition of a REC
p.000037: a. Each REC shall be composed of at least five
p.000037: (5) members, with varying backgrounds to ensure balanced and adequate review of research activities commonly
p.000037: conducted by the organization. The REC shall be sufficiently qualified through the experience,
p.000037: expertise and diversity of its members, including consideration of gender, cultural
p.000037: backgrounds and sensitivity to social issues in the community in which research participants are drawn.
p.000037: b. Each REC shall include at least one member whose primary concerns are in scientific areas and at least
p.000037: one member whose primary concerns are in nonscientific areas.
p.000037: c. Each REC shall include at least one member who is not affiliated with the organization and who
p.000037: is not part of the immediate family of a person who is affiliated with the organization.
p.000037: d. Each REC shall include at least one lay3 person from the community.
...
Social / Homeless Persons
Searching for indicator homeless:
(return to top)
p.000037: limited capacity or freedom to consent or decline consent. These include, but are not limited to,
p.000037: children, mature and emancipated minors, street children, prisoners, the homeless, refugees, adults
p.000037: staying on the street, internally displaced persons, substance abusers, handicapped (mentally and
p.000037: physically), armed forces, terminally ill and pregnant women. In some cases willingness to volunteer to
p.000037: participate in research is unduly influenced by expectation of benefits associated with their participation, or fear
...
Social / Incarcerated
Searching for indicator restricted:
(return to top)
p.000037: Members of SCs shall protect confidentiality of all information given to them in the course of their
p.000037: work, and sign confidentiality agreements with their organizations. In addition, they shall not use
p.000037: information supplied in research proposals under their consideration for their own research projects or personal
p.000037: gain.
p.000037: 3.6.1.2 Functions
p.000037: The primary function of a SC is to review and evaluate all scientific aspects of research projects with
p.000037: emphasis on suitability, relevance and feasibility of the study. Specific issues that shall be scrutinized
p.000037: by the SC include, but are not necessarily restricted to: study design, objectives of the
p.000037: study, methodology, appropriate controls, statistical methods, and feasibility of the study.
p.000037: The SC shall also build lines of communication between the various departments within the organization and RECs;
p.000037: 3.6.2 Data and Safety Monitoring Boards
p.000037: 3.6.2.1 Establishment
p.000037: A Data and Safety Monitoring Board (DSMB) is an independent group of experts established by study sponsors to review
p.000037: safety data during a clinical trial. It is to ensure that a study is conducted and data are handled in accordance with
p.000037: provisions of the research protocol. The DSMB also monitors adverse events and safety data. A DSMB
p.000037: shall be established before the commencement of a clinical trial and its composition submitted to the REC for
p.000037: record purposes.
p.000037:
p.000037: 6 UNCST
...
Social / Infant
Searching for indicator infant:
(return to top)
p.000037: under the applicable law and have no identifiable parent or guardian or have been abandoned by their
p.000037: parent(s) or guardian (s), are in wards of government or governmental entity, institution, organization,
p.000037: ministry, department, or subunit thereof, or are under the care of any governmental entity, institution,
p.000037: organization, ministry, department or subunit thereof.
p.000037: Viable means being able, after spontaneous or induced delivery, to survive, given the benefit of available medical
p.000037: therapy, to the point of independently maintaining heart beat and respiration. If a fetus is viable after
p.000037: delivery, it is a premature infant.
p.000037: Vulnerability refers to a substantial incapacity to protect one’s own interests owing to such impediments as lack of
p.000037: capability to give informed consent, lack of alternative means of obtaining medical care or other expensive
p.000037: necessities, or being a junior or subordinate member of a hierarchical group.
p.000037:
p.000037: 38 UNCST
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: Uganda National Council for Science and Technology
...
Social / LGBTQ+ Status
Searching for indicator physically:
(return to top)
p.000037: l. A statement that research participants will get feedback on findings and progress of the study, and that
p.000037: any new information that affects the study or data that has clinical relevance to research participants
p.000037: (including incidental findings) will be made available to research participants and/or their health
p.000037: care providers.
p.000037: m. Where necessary, provision for a witness at appropriate specific stages of the informed consent process, for
p.000037: example, in the case of illiterate, mentally incapacitated or physically handicapped research
p.000037: participants.
p.000037: n. A statement that the study has been approved by an accredited Ugandan based REC.
p.000037: 5.3.2 Any of the following shall
p.000037: be provided to the research participant, whenever appropriate, based on the nature and conduct of the study:
p.000037: a. A statement that a particular treatment or procedure under study may involve risk to the research participant, or
p.000037: to the embryo or fetus if the research participant is or may become pregnant, and that the risk is currently
p.000037: unforeseeable.
p.000037: b. An explanation of circumstances under which the researcher may terminate the research
...
p.000037: children, mature and emancipated minors, street children, prisoners, the homeless, refugees, adults
p.000037: staying on the street, internally displaced persons, substance abusers, handicapped (mentally and
p.000037: physically), armed forces, terminally ill and pregnant women. In some cases willingness to volunteer to
p.000037: participate in research is unduly influenced by expectation of benefits associated with their participation, or fear
p.000037: of retaliation from interested senior members of the hierarchy in case of refusal to participate.
...
Social / LGBTQ+ in NA
Searching for indicator incompetent:
(return to top)
p.000037: father of the embryos
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: and fetuses. However, the father’s consent shall not be required if (i) the purpose of the research is primarily
p.000037: to meet the health needs of the mother; (ii) the father’s identity and/or whereabouts are unknown; (iii) the
p.000037: father is not reasonably available; or iv) the pregnancy resulted from rape or incest and (v) the father is
p.000037: incompetent to give consent.
p.000037: No provision of this subsection shall be construed as authorization to terminate a pregnancy
p.000037: where such termination would not otherwise be in conformity with current laws of Uganda relating to the
p.000037: termination of pregnancy.
p.000037: 5.8 Informed Consent by Mature and Emancipated Minors
p.000037: Mature minors are individuals 14-17 years of age who have drug or alcohol dependency or a sexually
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000037: 2.2 Rights and Welfare of Human Research Participants and their Communities
p.000037: Research should be conducted in a manner that does not violate rights and welfare of human research participants and
p.000037: their communities.
p.000037: 2.2.1 Human Research Participants have a right to, inter alia:
p.000037: a. Participate in research or not, or withdraw at any time without penalty;
p.000037: b. Be respected, including the right of their autonomy, culture, beliefs and values;
p.000037: c. Information about the research (it is important to ensure that information is communicated in
p.000037: understandable language, format and in a conducive environment at all stages of the research);
p.000037:
p.000037: 2 UNCST
p.000037: d. Protection against research related injuries, harm, exploitation, and any other forms of abuse;
p.000037: e. Privacy and confidentiality of their participation, during and after the research;
p.000037: f. The standard of health care that is established nationally;
p.000037: g. Treatment and management of research related injuries;
p.000037: h. Reimbursement for costs associated with their participation in the research.
...
p.000037: that prospective research participants have acquired adequate understanding of the relevant facts and of
p.000037: the consequences of participation. Seeking consent shall be carried out under circumstances that provide the
p.000037: prospective research participant or the representative, sufficient opportunity to
p.000037: 16 UNCST
p.000037: consider whether or not to participate and that minimize the possibility of coercion or undue influence. The
p.000037: information that is given to the research participant or the representative, whether it is conveyed orally,
p.000037: in writing or other delivery mechanism, shall be in a language and form understandable to the
p.000037: participant or the representative. No informed consent, whether oral or written, shall include any exculpatory language
p.000037: through which the research participant or representative is: (1) made to waive or appear to waive any of the
p.000037: research participant’s rights, or (2) appears to release the researcher, sponsor, organization, or its agents from
p.000037: liability.
p.000037: The researcher as well as the REC shall ensure continued adequacy of the informed consent process, and re-consent
p.000037: research participants if there are changes in the conditions or procedures of the research project or if
p.000037: new information becomes available that could affect the research participant’s willingness to continue in the
p.000037: research project.
p.000037: 5.3 Key Components of the Informed Consent Form
...
p.000037: d. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be
p.000037: advantageous to the research participant.
p.000037: e. A statement describing the extent, if any, to which privacy and confidentiality of the research participant
p.000037: will be maintained.
p.000037: f. A statement about compensation and medical treatment available if injury occurs and, what they
p.000037: consist of and where further information may be obtained.
p.000037: g. Names and contact details of individual(s) who should be contacted at any time in case of questions about the
p.000037: research project, the research participants’ rights and welfare. The individual(s) should be able to
p.000037: communicate in a language understandable by the research participant or should be able to promptly secure the
p.000037: services of an interpreter to assist in responding to the research participant’s questions.
p.000037: h. A statement that participation is voluntary, that refusal to participate will not result in a penalty or a
p.000037: loss of benefits to which the research participant is otherwise entitled, and that the research
p.000037: participant may discontinue participation at any time without penalty or loss of benefits to which the
p.000037: research participant is otherwise entitled.
p.000037: i. Where applicable, a statement of how the researcher will provide medical services to the research participant.
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
...
Social / Literacy
Searching for indicator literacy:
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p.000037: Such consultations with community stakeholders should be undertaken prior to seeking approvals from
p.000037: relevant RECs and other relevant regulatory authorities. This does not mean that consultations with
p.000037: community stakeholders should end after approval of research by the REC, neither should
p.000037: agreement with community stakeholders be
p.000037:
p.000037: taken as a substitute to the REC process; rather community engagement is to be treated as an ongoing process until
p.000037: completion of research.
p.000037: Researchers may engage with the community in a variety of innovative ways, which broadly
p.000037: include, but not limited to, community education to improve research literacy, community dialogues to
p.000037: promote understanding, research participation and ownership. Normally, researchers should develop plans
p.000037: for providing feedback on the research results and outcomes of the research process. These plans should be shared with
p.000037: the RECs.
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: 34 UNCST
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: 13.0 TRADITIONAL AND COMPLEMENTARY MEDICINE RESEARCH
p.000037:
...
Searching for indicator illiterate:
(return to top)
p.000037: transport, time and meals.
p.000037: k. A brief description of sponsors of the research project and the organizational affiliation of the
p.000037: researchers.
p.000037: l. A statement that research participants will get feedback on findings and progress of the study, and that
p.000037: any new information that affects the study or data that has clinical relevance to research participants
p.000037: (including incidental findings) will be made available to research participants and/or their health
p.000037: care providers.
p.000037: m. Where necessary, provision for a witness at appropriate specific stages of the informed consent process, for
p.000037: example, in the case of illiterate, mentally incapacitated or physically handicapped research
p.000037: participants.
p.000037: n. A statement that the study has been approved by an accredited Ugandan based REC.
p.000037: 5.3.2 Any of the following shall
p.000037: be provided to the research participant, whenever appropriate, based on the nature and conduct of the study:
p.000037: a. A statement that a particular treatment or procedure under study may involve risk to the research participant, or
...
p.000037: methods should be employed. A copy shall be offered to the research participant or the research participant’s
p.000037: representative.
p.000037: The research participant or the research participant’s representative must be given sufficient time
p.000037: to read the consent form before the research participant or the research participant’s
p.000037: representative signs the form or places his or her thumbprint on the form indicating that he or she
p.000037: has read and understood and agrees to participate in the study. The consent form may be read to
p.000037: illiterate research participants.
p.000037: Verbal consent may be obtained in studies that present no more than minimal risk or in studies where for
p.000037: justifiable reasons written consent may not be feasible. However, verbal consent must be documented. RECs
p.000037: reserve the right to determine when verbal informed consent may be appropriate and acceptable.
p.000037: 5.5 Waiver of Requirement for Informed Consent
p.000037: A REC may waive some of, or all of the requirements for the researcher to obtain informed consent
...
Social / Marital Status
Searching for indicator married:
(return to top)
p.000037: termination of pregnancy.
p.000037: 5.8 Informed Consent by Mature and Emancipated Minors
p.000037: Mature minors are individuals 14-17 years of age who have drug or alcohol dependency or a sexually
p.000037: transmitted infection; while emancipated minors are individuals below the age of majority who are
p.000037: pregnant, married, have a child or cater for their own livelihood. Mature and emancipated minors may
p.000037: independently provide informed consent to participate in research if:
p.000037: a. In the view of the REC the research is not objectionable to parents or guardians (established by the
p.000037: REC with evidence from the community);
p.000037: b. The research protocols include clear justification for targeting mature and emancipated minors
p.000037: as participants; and a clear justification for not involving parents or guardians in the consent process.
p.000037:
p.000037: UNCST 19
p.000037:
p.000037:
p.000037:
...
Social / Philosophical Differences/Difference of Opinion
Searching for indicator opinion:
(return to top)
p.000037: apply to events that are observed among participants who are in observational studies in which no
p.000037: health related intervention is being administered.
p.000037: 9.2 Defining Seriousness of Adverse
p.000037: Events and Unexpected Events
p.000037: 9.2.1 A serious adverse event is an event,
p.000037: which:
p.000037: a. Results in death;
p.000037: b. Is life threatening;
p.000037: c. Requires in patient hospitalization or prolongation of existing hospitalization;
p.000037: d. Results in significant and persistent
p.000037: incapacity;
p.000037: e. Is a congenital anomaly or birth defect;
p.000037: f. Is an important medical condition in the opinion of the investigator.
p.000037: 9.2.2 An unexpected event is an event:
p.000037: a. Which is previously unobserved or undocumented in humans under the health research
p.000037: intervention (or one substantially similar);
p.000037: b. Whose nature or severity is not consistent with information in the investigators brochure or other
p.000037: safety information known at the time;
p.000037: c. Which is observed with higher frequency or severity than previously documented.
p.000037: 9.2.3 Unexpectedness shall not include events that may reasonably be extrapolated from in vitro and animal studies.
p.000037: The relatedness of serious adverse events and unexpected events to an intervention can be graded as follows:
p.000037: Definitely: When the event is directly
p.000037: caused by the intervention.
...
Social / Police Officer
Searching for indicator officer:
(return to top)
p.000037: and its outcomes;
p.000037: d. Provide advice and support regarding recruitment and retention of research participants including
p.000037: considerations of gender.
p.000037: 3.6.4 Institutional Biosafety Committees
p.000037: 3.6.4.1 Establishment
p.000037: Institutional Biosafety Committees (IBCs) are established by organizations that undertake research on potentially
p.000037: hazardous substances of a physical, chemical, biological, or any other nature. Any organization involved in or
p.000037: planning to conduct research with potentially hazardous substances is required to set up or designate a competent IBC.
p.000037: Each IBC once formed shall consist of a biosafety officer and at least three other officers with appropriate
p.000037: expertise. The IBC shall be certified by UNCST.
p.000037:
p.000037:
p.000037:
p.000037: It is the responsibility of the researcher to notify and provide the IBC with the research proposal involving
p.000037: potentially hazardous substances of a physical, chemical, biological, or any other nature.
p.000037: Members of the IBC shall protect confidentiality of all information given to them in the
p.000037: course of their work, and shall sign confidentiality agreements with their organizations. In addition,
p.000037: they shall not use information supplied in the research proposals under their consideration for their own
p.000037: research projects or personal gain.
p.000037: 3.6.4.2 Functions
...
Social / Religion
Searching for indicator special:
(return to top)
p.000031: 13.0 Traditional and Complementary Medicine Research 35
p.000031: 14.0 Penalties for Non-Compliance 36
p.000031: Glossary
p.000037: 37
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: UNCST
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: iii
p.000037:
p.000037:
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037:
p.000037: Acknowledgment
p.000037: Uganda National Council for Science and Technology (UNCST) is grateful for the contribution of its Task force in
p.000037: preparing these guidelines. Special thanks are to the following members of the Task force: Professor Nelson K.
p.000037: Sewankambo (Chair) from Makerere University College of Health Sciences, Professor David Guwatudde from Makerere
p.000037: University School of Public Health, Professor Charles Rwabukwali from Makerere University College of
p.000037: Humanities and Social Sciences, Mr. Richard Hasunira from Coalition for Health Promotion and Social
p.000037: Development Uganda, Dr. Philippa Musoke from Makerere University-Johns Hopkins University Research
...
p.000037: 3.5 Oversight by Research Ethics Committees
p.000037: RECs are established by organizations whose mandate includes carrying out research. Their primary function is to
p.000037: conduct initial and continuing review and approval of research projects, with the aim of protecting rights and
p.000037: UNCST 5
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: welfare of human research participants. RECs operating in Uganda must be accredited by an Accreditation Committee for
p.000037: Research Ethics Committees based at UNCST. RECs have a special role of monitoring research activities to ensure
p.000037: compliance with scientific and ethical requirements in accordance with these guidelines. Operations of RECs are
p.000037: described in detail in Section 4.0 below.
p.000037: 3.6 Oversight by Other Committees
p.000037: Besides RECs, there are a number of other committees that are involved in one way or another in the
p.000037: research process. These committees include:
p.000037: 3.6.1 Scientific Committees
p.000037:
p.000037: 3.6.1.1 Establishment
p.000037: Scientific Committees (SCs) are sometimes set up within organizations as an internal review mechanism for
p.000037: research proposals. Where such committees formally exist, they should approve research protocols prior to
p.000037: submission to a REC.
p.000037: SCs should be comprised of at least three experts. They should have standard operating procedures (SOPs) to
...
p.000037:
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: e. No REC member may participate in the REC’s initial or continuing review of any project in which the member
p.000037: has a conflict of interest, except to provide information as may be requested by the REC.
p.000037: f. Each REC member shall take at least one course in human research protection within one year of
p.000037: appointment to an REC, and thereafter, should undergo continued research ethics education at least once every
p.000037: two years.
p.000037: g. A REC may, at its discretion, invite individuals with competence in special areas to assist in
p.000037: the review of protocols, which require expertise beyond, or in addition to that available in the REC.
p.000037: These individuals do not vote at REC meetings.
p.000037: h. Membership in any REC shall not exceed a term of three years. After serving for three years, a member
p.000037: is eligible for reappointment.
p.000037: i. A person may not serve as a member in more than two RECs concurrently.
p.000037: j. REC members must guard against any tendencies of unethical conduct on their own part, for example,
p.000037: they must protect the confidentiality of research projects, documents and discussions; a REC
p.000037: member shall not appropriate the submitted proposal for his or her own use; and REC members shall not compel
p.000037: researchers to submit to unnecessary repetition of review.
p.000037: k. RECs have a special responsibility to determine whether the objectives of a research project
p.000037: are responsive to the health needs and priorities of the proposed study population in particular and
p.000037: of Uganda in general. The ability to judge
p.000037:
p.000037:
p.000037:
p.000037: the ethical acceptability of various aspects of a research proposal requires a thorough understanding of a
p.000037: community’s customs and traditions. The REC, therefore, must have competent members or consulting persons
p.000037: with such understanding.
p.000037: 4. 4 Functions
p.000037: RECs act as independent reviewers of any proposed study on human research participants, to
...
p.000037: be gained. Risks may include psychological, mental, social, physical and economic harms. Benefits may include
p.000037: such aspects as medical care and treatment. Benefits also include those that accrue to the wider community such as
p.000037: capacity building or enhancement of social amenities.
p.000037: d. The selection of research participants is fair and equitable. In making this assessment the REC
p.000037: shall take into account the purposes of the research and the setting in which the research will be conducted. It should
p.000037: be particularly cognizant of special challenges associated with research on vulnerable populations.
p.000037: e. Informed consent will be sought from each individual prospective research participant or the individual
p.000037: participant’s authorized representative. Informed consent process will be appropriately documented in
p.000037: accordance with the provisions of these guidelines.
p.000037:
p.000037: f. There are adequate provisions to protect privacy of research participants and to maintain
p.000037: confidentiality of personal identifiable information.
...
p.000037: physically), armed forces, terminally ill and pregnant women. In some cases willingness to volunteer to
p.000037: participate in research is unduly influenced by expectation of benefits associated with their participation, or fear
p.000037: of retaliation from interested senior members of the hierarchy in case of refusal to participate.
p.000037: Vulnerable groups and individuals need special considerations to ensure their protection.
p.000037: Researchers, whose research involves vulnerable groups and individuals, shall specify how they will address
p.000037: particular vulnerabilities.
p.000037: 8.2 Additional Protection for Vulnerable Populations
p.000037: 8.2.1 Certain communities may also be vulnerable. Characteristics that constitute vulnerability in
...
Searching for indicator religious:
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p.000037: d. Channels of communication with the study and the REC.
p.000037: 3.6.3 Community Advisory Boards
p.000037: 3.6.3.1 Establishment
p.000037: Community Advisory Boards (CABs) are established by the researcher. A CAB facilitates dialogue
p.000037: between the community and the researcher team.
p.000037: CAB members are identified from communities where research is to be undertaken. The CAB’s role and
p.000037: expectations should be clearly stated in their terms of reference. Members of a CAB may include, but are not limited
p.000037: to, the following:
p.000037: a. Individuals with understanding of local laws, cultural values and gender issues;
p.000037: b. Peer leaders;
p.000037: c. Religious leaders;
p.000037: d. Representatives of the study population;
p.000037: e. Media;
p.000037: f. Professionals who understand research or science issues;
p.000037: g. Community leaders.
p.000037: UNCST 7
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: 3.6.3.2 Functions
p.000037: The primary function of a CAB is to assist researchers understand and incorporate community
p.000037: concerns into their research activities. This happens through different ways like advising on issues central
p.000037: to the informed consent process, achieving successful volunteer recruitment and retention, among
p.000037: others.
...
Social / Social
Searching for indicator social:
(return to top)
p.000037:
p.000037:
p.000037: iii
p.000037:
p.000037:
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037:
p.000037: Acknowledgment
p.000037: Uganda National Council for Science and Technology (UNCST) is grateful for the contribution of its Task force in
p.000037: preparing these guidelines. Special thanks are to the following members of the Task force: Professor Nelson K.
p.000037: Sewankambo (Chair) from Makerere University College of Health Sciences, Professor David Guwatudde from Makerere
p.000037: University School of Public Health, Professor Charles Rwabukwali from Makerere University College of
p.000037: Humanities and Social Sciences, Mr. Richard Hasunira from Coalition for Health Promotion and Social
p.000037: Development Uganda, Dr. Philippa Musoke from Makerere University-Johns Hopkins University Research
p.000037: Collaboration, Dr. Frederick Nelson Nakwagala from Mulago Hospital, Dr. Sam Okware from Uganda National
p.000037: Health Research Organisation, Dr. Stella Neema from Makerere University College of Humanities and Social
p.000037: Sciences, Dr. Joseph Ochieng from Makerere University School of Biomedical Sciences, Dr. Alex Opio from
p.000037: Ministry of Health, Dr. Pauline Byakika from Makerere University School of Medicine, Mr. Paul Kutyabami from
p.000037: Makerere University School of Health Sciences, Dr. Edward K. Mbidde from Uganda Virus Research Institute, Dr. Hannah
p.000037: Kibuuka from Makerere University-Walter Reed Project, Ms. Hellen Ndagije from National Drug Authority, and Dr.
p.000037: Julius Ecuru (Secretary) from UNCST. The hard work and relentless efforts by UNCST staff, especially Ms. Winfred
...
p.000037: SC Scientific Committee
p.000037: SOP Standard Operating Procedures UCG Uganda Clinical Guidelines
p.000037: UNCST Uganda National Council for Science and Technology UNHROUganda National Health Research Organization
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: vi UNCST
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: 1.1 Introduction
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: 1.0 GENERAL PROVISIONS
p.000037:
p.000037: Uganda has unique health, environmental, social and economic challenges, which attract both local and international
p.000037: research interests. The number of research projects involving humans as research participants in Uganda has
p.000037: more than quadrupled since 1990. This increasing quest for knowledge and the search for novel remedies to health,
p.000037: environmental, social and economic challenges is commendable, but could, if uncontrolled,
p.000037: involve exposing research participants to a spectrum of risks. These guidelines provide a national system or
p.000037: framework for harnessing the benefits of research while ensuring that rights, interests, values and welfare of
p.000037: research participants are protected.
p.000037: 1.2 Rationale
p.000037: Research is conducted for the benefit of society. It is important to have in place a system that
p.000037: promotes beneficial research and guards against unethical research. Research has inherent burdens, which
...
p.000037: that research participant’s rights and welfare are not compromised during or after the research.
p.000037: 1.3 Objectives
p.000037: The overall objective of these guidelines is to establish a coherent regulatory framework for conduct of research
p.000037: involving humans without compromising their rights and welfare.
p.000037: Specifically, these guidelines are to:
p.000037: a. Provide mechanisms for protecting rights and welfare of research participants;
p.000037: b. Provide ethical standards and procedures for conduct of research involving humans as research participants;
p.000037: c. Ensure that researchers take into account social and cultural values of participating communities.
p.000037: 1.4 General Policy
p.000037: Research and development including scientific investigations involving humans as research participants shall be
p.000037: conducted for the benefit of communities in Uganda and abroad without causing unnecessary harm or inconvenience,
p.000037: and shall not compromise rights and welfare of research participants.
p.000037: 1.5 Scope of Application
p.000037: The aforementioned general policy and other provisions of these guidelines apply to (1) all research involving
p.000037: humans as research participants in Uganda, including research in humanities and social sciences, biomedical
p.000037: science and traditional and complementary medicine, (2) research conducted in or by public, private,
p.000037: inter-governmental and non-governmental organizations, and by individuals or groups, and (3)
p.000037: research conducted in a foreign country on human materials collected from Uganda.
p.000037:
p.000037: UNCST 1
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037: 2.0 RIGHTS AND WELFARE OF RESEARCH PARTICIPANTS
p.000037:
p.000037: 2.1 Research Involving Humans as Research Participants
p.000037: Research involving humans as research participants includes:
p.000037: a. Clinical investigations, that is, any experiment or study on one or more persons, which involves a
p.000037: test product/ article, whether a drug, treatment, procedure, or device;
p.000037: b. Social-behavioral studies, which involve interaction with or observation of people;
p.000037: c. Basic scientific research to study biology of persons or organs and specimens thereof;
p.000037: d. Systematic collection, storage and analysis of data on humans.
p.000037: 2.2 Rights and Welfare of Human Research Participants and their Communities
p.000037: Research should be conducted in a manner that does not violate rights and welfare of human research participants and
p.000037: their communities.
p.000037: 2.2.1 Human Research Participants have a right to, inter alia:
p.000037: a. Participate in research or not, or withdraw at any time without penalty;
...
p.000037: the clinical trial and of the product under investigation.
p.000037: 3.6.2.2 Functions
p.000037: Functions of a DSMB are to:
p.000037: a. Ensure safety of study participants;
p.000037: b. Preserve the integrity and credibility of the trial;
p.000037: c. Ensure availability of definitive and
p.000037: reliable results in a timely manner;
p.000037: d. Make decisions related to safety, based on the submitted results and adverse event reports and recommend
p.000037: whether the study should continue or not.
p.000037: The DSMB shall report to the sponsor(s) of the trial:
p.000037: a. Any concerns over differences in serious adverse events between study arms;
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: b. Any serious social harms;
p.000037: c. Any concerns about the conduct of the trial;
p.000037: d. Any concerns about data integrity;
p.000037: e. Whether the study should be terminated or continued based on safety and interim data;
p.000037: The DSMB shall determine before the commencement of the study, the following:
p.000037: a. Mode and time frame for receiving adverse events reports;
p.000037: b. Frequency of receiving data;
p.000037: c. Frequency of meetings to review data and adverse event reports at hand (where there may be concern, the DSMB may
p.000037: choose to review data more frequently);
p.000037: d. Channels of communication with the study and the REC.
p.000037: 3.6.3 Community Advisory Boards
p.000037: 3.6.3.1 Establishment
p.000037: Community Advisory Boards (CABs) are established by the researcher. A CAB facilitates dialogue
p.000037: between the community and the researcher team.
...
p.000037: REC shall not commence its activities until it has been accredited by the ACREC. Guidelines for
p.000037: accreditation of RECs are obtainable from the UNCST offices or website.
p.000037: 4.3 Composition of a REC
p.000037: a. Each REC shall be composed of at least five
p.000037: (5) members, with varying backgrounds to ensure balanced and adequate review of research activities commonly
p.000037: conducted by the organization. The REC shall be sufficiently qualified through the experience,
p.000037: expertise and diversity of its members, including consideration of gender, cultural
p.000037: backgrounds and sensitivity to social issues in the community in which research participants are drawn.
p.000037: b. Each REC shall include at least one member whose primary concerns are in scientific areas and at least
p.000037: one member whose primary concerns are in nonscientific areas.
p.000037: c. Each REC shall include at least one member who is not affiliated with the organization and who
p.000037: is not part of the immediate family of a person who is affiliated with the organization.
p.000037: d. Each REC shall include at least one lay3 person from the community.
p.000037: 3 “Lay person from the community” refers to an individual whose primary background is not in
p.000037: scientific research involving human participants, and who is capable of sharing his/her insights about the community
...
p.000037: ethical considerations are satisfied:
p.000037: a. The methods used are scientifically valid and practically feasible. The research project has a
p.000037: clear scientific objective, is designed using acceptable scientific
p.000037:
p.000037: UNCST 13
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: principles, methods and reliable practices; and, where applicable, has sufficient power to definitely test the study
p.000037: hypothesis.
p.000037: b. The research project demonstrates value in terms of new knowledge added and probably improvement in
p.000037: health care provision and general social wellbeing. There should be foreseeable benefits to the individuals and
p.000037: community that is going to be studied, and risks should be minimized.
p.000037: c. Risks to research participants are minimized by using procedures that are consistent with
p.000037: sound research design and which do not unnecessarily expose research participants to risk. Risks, if any, are
p.000037: reasonable in relation to anticipated benefits to the research participants, and the knowledge that will
p.000037: be gained. Risks may include psychological, mental, social, physical and economic harms. Benefits may include
p.000037: such aspects as medical care and treatment. Benefits also include those that accrue to the wider community such as
p.000037: capacity building or enhancement of social amenities.
p.000037: d. The selection of research participants is fair and equitable. In making this assessment the REC
p.000037: shall take into account the purposes of the research and the setting in which the research will be conducted. It should
p.000037: be particularly cognizant of special challenges associated with research on vulnerable populations.
p.000037: e. Informed consent will be sought from each individual prospective research participant or the individual
p.000037: participant’s authorized representative. Informed consent process will be appropriately documented in
...
p.000037: The referral process should be adequately documented and all referral guidelines should be
p.000037: adhered to as stipulated in national guidelines on referral. Furthermore, researchers should have
p.000037: prior arrangements with the referral facility to receive referred patients. Research participants should always
p.000037: be informed of all options available for management of their conditions including those outside
p.000037: the country. Where a referral has been made for a research related injury or a serious adverse event related
p.000037: to the study, the cost of referral and management of the condition shall be paid by the researcher and/ or
p.000037: study sponsor.
p.000037: 6.5 Compensation for Research Related Injury
p.000037: A research related injury may be physical, social, economic or psychological, and may be classified as
p.000037: follows:
p.000037: a. Definitely: When injury is directly caused by participation in a research project;
p.000037: b. Probably: When injury is most likely explained by participation in a research project but when
p.000037: no definite proof of causality is evident;
p.000037: c. Possibly: When explanation for injury is equally due to participation in a research project or other
p.000037: cause;
p.000037: d. Unlikely: When injury is more likely explained by another cause other than participation in a
p.000037: research project;
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: e. Not related: When injury is clearly due to another cause other than participation in a research project.
...
p.000037: 8.2.3 For all vulnerable groups and individuals,
p.000037: a. Research can only be conducted in this group and individuals if the objectives of the research project
p.000037: cannot be addressed using non-vulnerable groups and individuals.
p.000037: b. Risk of participating in research is
p.000037: justified by anticipated benefits;
p.000037: c. The intervention or procedure presents experiences that are commensurate with those inherent in
p.000037: their actual or expected medical, dental, psychological, social, or educational situations;
p.000037: d. The intervention or procedure is likely to yield generalizable knowledge about the group or
p.000037: individual’s disorder or condition that is of vital importance for the understanding or amelioration of
p.000037: that disorder or condition;
p.000037: e. RECs may co-opt a person knowledgeable about and has experience working with the vulnerable group and individuals.
p.000037: UNCST 25
p.000037:
p.000037:
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: 9.0 MANAGEMENT OF SERIOUS ADVERSE EVENTS
p.000037:
p.000037: 9.1 Introduction
...
p.000037: partnerships to achieve shared goals. Respect is demonstrated when stakeholders communicate and act in
p.000037: ways that value and honour each other’s perspectives and realities. This respect includes respect for local
p.000037: values, cultures, and perspectives as well as respect for the scientific process.
p.000037:
p.000037: 4 Adapted from Good Participatory Practice Guidelines for Biomedical HIV Prevention Trials 2011
p.000037: b) Mutual understanding
p.000037: A common understanding about objectives and how to achieve them is essential to effective partnerships among
p.000037: stakeholders. Researchers should understand the norms, practices, and beliefs of relevant local cultures, and
p.000037: local social stances, as well as diverse community stakeholder perspectives, priorities, and research needs.
p.000037: This informs the design of the study so that it is culturally appropriate.
p.000037: c) Integrity
p.000037: Researchers should strive for the highest standards of scientific and ethical integrity in the conduct
p.000037: of their research. This is vital for achieving scientific goals and maximizing benefit to the community and
p.000037: society. Researchers should, therefore, adhere to sound scientific processes and appropriately weigh and
p.000037: address ethical issues in their study.
p.000037: d) Transparency
p.000037: Transparency about research includes ensuring that stakeholders receive open, honest, and
p.000037: understandable information about the objectives and processes of research. Transparency means ensuring
...
p.000037: intended to encompass individuals sentenced to such an institution under a criminal or civil provision or ruling,
p.000037: individuals detained in other facilities by virtue of statutes or commitment procedures, which provide
p.000037: alternatives to criminal prosecution or incarceration in a penal institution, and individuals
p.000037: detained pending a final disposition of their case.
p.000037: Research involving humans as research participants is defined as any study involving persons, and directed
p.000037: to the advancement of biomedical or other knowledge, that cannot be regarded as an element in
p.000037: established clinical management, public health or social practices and that involves either physical or
p.000037: psychological intervention or assessment, or generation, storage, and analysis of records containing
p.000037: biomedical or other information referable to identifiable individuals and communities. Research
p.000037: involving humans as research participants also includes research on any material obtained from a research
p.000037: participant, whether the participant is still living or has died.
p.000037: Research means any type of systematic investigation, testing and evaluation, designed to develop or
p.000037: contribute to generalizable knowledge.
p.000037:
p.000037: Research participant means a living individual about whom an investigator conducting
p.000037: research obtains data through intervention or interaction with the individual or identifiable private
p.000037: information.
...
Social / Student
Searching for indicator student:
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p.000037: i. Put in place a quality assurance system for proper conduct of the study in order to preserve integrity of
p.000037: the data.
p.000037: j. Ensure appropriate and timely feedback on
p.000037: the research process and findings.
p.000037: k. Take all reasonable steps to engage with the community.
p.000037: l. Have adequate time to implement/ supervise the research protocol, and should be reasonably present
p.000037: and active at the study site.
p.000037: m. Take, together with his/her research team, a recognized research ethics course or equivalent within
p.000037: three years prior to commencement of the study; and thereafter, have a refresher course at least once every three
p.000037: years. Student supervisors at training organizations are similarly encouraged to take basic research ethics
p.000037: courses.
p.000037: n. Be sufficiently qualified and competent to carry out the research project, and shall, where necessary,
p.000037: have the appropriate professional license to practice. Clinical trials shall be supervised by a competent
p.000037: and appropriately qualified physician or other health care professional.
p.000037: 7.2 Sponsor
p.000037: 7.2.1 The sponsor is responsible for providing all the necessary financial support for implementation of
p.000037: the research project, including post- research obligations. Specifically, the sponsor shall:
p.000037: a. Approve the final study report whether or not the research project has been completed.
...
Social / Victim of Abuse
Searching for indicator abuse:
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p.000037: b. Be respected, including the right of their autonomy, culture, beliefs and values;
p.000037: c. Information about the research (it is important to ensure that information is communicated in
p.000037: understandable language, format and in a conducive environment at all stages of the research);
p.000037:
p.000037: 2 UNCST
p.000037: d. Protection against research related injuries, harm, exploitation, and any other forms of abuse;
p.000037: e. Privacy and confidentiality of their participation, during and after the research;
p.000037: f. The standard of health care that is established nationally;
p.000037: g. Treatment and management of research related injuries;
p.000037: h. Reimbursement for costs associated with their participation in the research.
p.000037: 2.2.2 Research should aim at improving the welfare of research participants and their communities. This can be
p.000037: attained through:
p.000037: a. Ensuring adequate welfare for research participants, including compensation for inconveniences and time;
...
p.000037: treated with respect for their capacity for self-determination; and protection of persons with
p.000037: impaired or diminished autonomy, which requires that those who are dependent or vulnerable be
p.000037: afforded security against harm or abuse.
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: b. Beneficence refers to the ethical obligation to maximize benefits and to minimize
p.000037: harms. That is to say, risks of harm by research should be reasonably justified by expected benefits,
p.000037: research design should be scientifically acceptable, and researchers should be competent to conduct research
p.000037: and to safeguard rights and welfare of research participants.
p.000037: c. Non-maleficence (i.e. to do no harm) prescribes that researchers should not deliberately inflict
p.000037: harm, or evil on research participants.
...
Social / Women
Searching for indicator women:
(return to top)
p.000031: 5.3 Key Components of the Informed Consent Form 16
p.000031: 5.4 Documentation of Informed Consent Process 18
p.000031: 5.5 Waiver of Requirement for Informed Consent 18
p.000031: 5.6 Assent 19
p.000031: 5.7 Informed Consent by Pregnant Women 19
p.000031: 5.8 Informed Consent by Mature and Emancipated Minors 19
p.000031: 6.0 Care for Research Participants 20
p.000031: 6.1 Care and Treatment for Research Participants 20
p.000031: 6.2 Care for Research Participants in Control Groups 20
p.000031: 6.3 Care for Research Related Injuries 20
p.000031: 6.4 Referral of Research Participants 21
p.000031: 6.5 Compensation for Research Related Injury 21
...
p.000037: consent. The child’s assent or dissent takes precedence over the parent’s or guardian’s consent. Assent for
p.000037: all other persons incapable of self- determination is obtained after consent from their representatives.
p.000037: 5.7 Informed Consent by Pregnant Women
p.000037: For research involving pregnant women, informed consent should be obtained from both the mother and
p.000037: father of the embryos
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: and fetuses. However, the father’s consent shall not be required if (i) the purpose of the research is primarily
p.000037: to meet the health needs of the mother; (ii) the father’s identity and/or whereabouts are unknown; (iii) the
p.000037: father is not reasonably available; or iv) the pregnancy resulted from rape or incest and (v) the father is
p.000037: incompetent to give consent.
...
p.000037: staying on the street, internally displaced persons, substance abusers, handicapped (mentally and
p.000037: physically), armed forces, terminally ill and pregnant women. In some cases willingness to volunteer to
p.000037: participate in research is unduly influenced by expectation of benefits associated with their participation, or fear
p.000037: of retaliation from interested senior members of the hierarchy in case of refusal to participate.
p.000037: Vulnerable groups and individuals need special considerations to ensure their protection.
p.000037: Researchers, whose research involves vulnerable groups and individuals, shall specify how they will address
...
p.000037: d. Discrimination on the basis of health status;
p.000037: e. Limited availability of health care and treatment options;
p.000037: f. Communities in acute disaster and disease epidemics;
p.000037: 8.2.2 In order to protect vulnerable communities, RECs should ensure that:
p.000037: a. Selection of communities is justified by
p.000037: the research goals;
p.000037: b. Research is responsive to needs and priorities of the community in which it is to be conducted;
p.000037: c. With respect to pregnant women and fetuses, appropriate studies on animals and non-pregnant
p.000037: individuals have been completed.
p.000037: 8.2.3 For all vulnerable groups and individuals,
p.000037: a. Research can only be conducted in this group and individuals if the objectives of the research project
p.000037: cannot be addressed using non-vulnerable groups and individuals.
p.000037: b. Risk of participating in research is
p.000037: justified by anticipated benefits;
p.000037: c. The intervention or procedure presents experiences that are commensurate with those inherent in
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000037: d. A REC shall notify researchers in writing about the outcome of review of the researchers’ project
p.000037: within 14 calendar days from the date of review. In case the REC does not approve a research activity, it shall
p.000037: include in its written notification reasons for its disapproval.
p.000037: e. A REC shall conduct continuing review of research covered by these guidelines at intervals appropriate to the
p.000037: degree of risk, but not less than once a year, and shall have a plan for onsite monitoring of approved studies.
p.000037: 4.5.2 Expedited Review
p.000037: a. The REC may use an expedited review process for research involving no more than minimal risk or for
p.000037: minor changes in previously approved research protocols during a period of one year or less for which
p.000037: approval is given. Minor changes include such changes as addition of a collaborator or a small change
p.000037: in the number of research participants, or spelling corrections. Expedited review process
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: may also be applied to annual renewal of studies, in which the only outstanding activity is data analysis
p.000037: and report writing. Major changes include, but are not limited to, significant changes in the research
p.000037: methodology or a change in procedures for research participants. Each REC shall develop standard operating
p.000037: procedures to define eligibility for expedited review.
p.000037: b. Expedited review may be done by the REC chairperson and/or one or more REC members he/she designates, and
...
Searching for indicator minors:
(return to top)
p.000031: 5.4 Documentation of Informed Consent Process 18
p.000031: 5.5 Waiver of Requirement for Informed Consent 18
p.000031: 5.6 Assent 19
p.000031: 5.7 Informed Consent by Pregnant Women 19
p.000031: 5.8 Informed Consent by Mature and Emancipated Minors 19
p.000031: 6.0 Care for Research Participants 20
p.000031: 6.1 Care and Treatment for Research Participants 20
p.000031: 6.2 Care for Research Participants in Control Groups 20
p.000031: 6.3 Care for Research Related Injuries 20
p.000031: 6.4 Referral of Research Participants 21
p.000031: 6.5 Compensation for Research Related Injury 21
p.000031: 6.6 Compensation for Participation in Research 21
p.000031: 6.7 Incentives for Research Participation 22
...
p.000037: to meet the health needs of the mother; (ii) the father’s identity and/or whereabouts are unknown; (iii) the
p.000037: father is not reasonably available; or iv) the pregnancy resulted from rape or incest and (v) the father is
p.000037: incompetent to give consent.
p.000037: No provision of this subsection shall be construed as authorization to terminate a pregnancy
p.000037: where such termination would not otherwise be in conformity with current laws of Uganda relating to the
p.000037: termination of pregnancy.
p.000037: 5.8 Informed Consent by Mature and Emancipated Minors
p.000037: Mature minors are individuals 14-17 years of age who have drug or alcohol dependency or a sexually
p.000037: transmitted infection; while emancipated minors are individuals below the age of majority who are
p.000037: pregnant, married, have a child or cater for their own livelihood. Mature and emancipated minors may
p.000037: independently provide informed consent to participate in research if:
p.000037: a. In the view of the REC the research is not objectionable to parents or guardians (established by the
p.000037: REC with evidence from the community);
p.000037: b. The research protocols include clear justification for targeting mature and emancipated minors
p.000037: as participants; and a clear justification for not involving parents or guardians in the consent process.
p.000037:
p.000037: UNCST 19
p.000037:
p.000037:
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: 6.0 CARE FOR RESEARCH PARTICIPANTS
p.000037:
p.000037: 6.1 Care and Treatment for Research Participants
p.000037: A care package for research participants should be stated before initiation of a research project. Care
p.000037: and treatment for research participants should be provided with the ideal aim of providing the best proven
p.000037: intervention and, at the least, should be in accordance with the current Uganda Clinical Guidelines and other
...
p.000037: may have insufficient power, intelligence, education, resources, strength, or other requisite attributes to
p.000037: protect their own interests. Individuals and groups conventionally considered vulnerable are those with
p.000037: limited capacity or freedom to consent or decline consent. These include, but are not limited to,
p.000037: children, mature and emancipated minors, street children, prisoners, the homeless, refugees, adults
p.000037: staying on the street, internally displaced persons, substance abusers, handicapped (mentally and
...
Searching for indicator emergency:
(return to top)
p.000037: should typically be done within 21 calendar days. In reviewing the research, the reviewers may exercise all of
p.000037: the authority of the REC except that the reviewers may not disapprove the research.
p.000037: c. Each REC shall present all expedited review decisions at the next full REC meeting for
p.000037: ratification.
p.000037: d. The ACREC may restrict or choose not to authorize a REC to conduct expedited review when it is
p.000037: determined that the REC is abusing the process.
p.000037: 4.5.3 Exemption from REC Review
p.000037: The following categories of research are exempt from REC review:
p.000037: a. Use of publicly available unlinked data that does not identify individuals or communities;
p.000037: b. Emergency use of a test article provided that such emergency use is reported to the REC within seven
p.000037: calendar days. Any subsequent use of the test article at the organization is subject to REC approval.
p.000037: If a researcher believes that his/her research project would satisfy the requirements for exemption by REC
p.000037: review, the researcher
p.000037:
p.000037: UNCST 11
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: shall apply to the REC for his/her study to be exempt from REC review. The REC shall review the
p.000037: application to ensure that the proposed study satisfies requirements for exemption from REC review, and
p.000037: will, thereafter, grant exemption.
p.000037: 4.5.4 Review of Collaborative Research
p.000037: Projects
...
p.000037: b. The research project could not practicably be carried out without the waiver or alteration (whenever
p.000037: appropriate the research participants will be provided with additional pertinent information after
p.000037: participation);
p.000037: c. In situations where deception needs to be applied to achieve the objectives of the study;
p.000037: d. The only record linking the research participant and the research project would be the informed
p.000037: consent form and the risk to the research participant would be potential harm resulting from a breach of
p.000037: confidentiality;
p.000037: e. The research participant presents in an emergency situation and informed consent cannot be reasonably
p.000037: obtained from the individual or his/her representative.
p.000037: 5.6 Assent
p.000037: Assent to participate in research shall be obtained from all children eight (8) years of age and above, and from
p.000037: all persons incapable of self-determination. A child’s assent is obtained after parental/guardian’s
...
p.000037: REC. After explaining the need to store the samples, the research participant shall be given the option to choose
p.000037: whether his/her sample should or should not be stored for future studies. A Ugandan scientist shall be included
p.000037: as co-investigator in all future studies using the human materials collected from Uganda. A research
p.000037: participant shall not be penalized for his/her refusal to store the samples. Research participants reserve
p.000037: the
p.000037: right to withdraw their samples from storage if the samples are linked. Any future research study on such samples is
p.000037: subject to review by a REC.
p.000037: Where identifiable samples have been collected, for example, as part of routine surveillance,
p.000037: emergency procedures, laboratory quality control, notifiable diseases, routine counseling and testing, etc,
p.000037: without the prior intention of conducting research on the samples, samples sources shall be traced to provide consent
p.000037: for use of the samples in research.
p.000037: 10.3 Ownership
p.000037: Sample sources own the samples. Samples sources may withdraw their samples if the samples are linked.
p.000037: Samples shall be held in trust on behalf of the sample sources by a duly registered and recognized
p.000037: organization in Uganda. The organization entrusted with custodianship of the samples shall have the
p.000037: authority to decide use, transfer, storage and future use of the samples taking into consideration
...
Economic / Economic/Poverty
Searching for indicator economic:
(return to top)
p.000037: UNCST Uganda National Council for Science and Technology UNHROUganda National Health Research Organization
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: vi UNCST
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: 1.1 Introduction
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: 1.0 GENERAL PROVISIONS
p.000037:
p.000037: Uganda has unique health, environmental, social and economic challenges, which attract both local and international
p.000037: research interests. The number of research projects involving humans as research participants in Uganda has
p.000037: more than quadrupled since 1990. This increasing quest for knowledge and the search for novel remedies to health,
p.000037: environmental, social and economic challenges is commendable, but could, if uncontrolled,
p.000037: involve exposing research participants to a spectrum of risks. These guidelines provide a national system or
p.000037: framework for harnessing the benefits of research while ensuring that rights, interests, values and welfare of
p.000037: research participants are protected.
p.000037: 1.2 Rationale
p.000037: Research is conducted for the benefit of society. It is important to have in place a system that
p.000037: promotes beneficial research and guards against unethical research. Research has inherent burdens, which
p.000037: individuals and communities who volunteer as research participants bear in order to bring about a future
...
p.000037: health care provision and general social wellbeing. There should be foreseeable benefits to the individuals and
p.000037: community that is going to be studied, and risks should be minimized.
p.000037: c. Risks to research participants are minimized by using procedures that are consistent with
p.000037: sound research design and which do not unnecessarily expose research participants to risk. Risks, if any, are
p.000037: reasonable in relation to anticipated benefits to the research participants, and the knowledge that will
p.000037: be gained. Risks may include psychological, mental, social, physical and economic harms. Benefits may include
p.000037: such aspects as medical care and treatment. Benefits also include those that accrue to the wider community such as
p.000037: capacity building or enhancement of social amenities.
p.000037: d. The selection of research participants is fair and equitable. In making this assessment the REC
p.000037: shall take into account the purposes of the research and the setting in which the research will be conducted. It should
p.000037: be particularly cognizant of special challenges associated with research on vulnerable populations.
...
p.000037: adhered to as stipulated in national guidelines on referral. Furthermore, researchers should have
p.000037: prior arrangements with the referral facility to receive referred patients. Research participants should always
p.000037: be informed of all options available for management of their conditions including those outside
p.000037: the country. Where a referral has been made for a research related injury or a serious adverse event related
p.000037: to the study, the cost of referral and management of the condition shall be paid by the researcher and/ or
p.000037: study sponsor.
p.000037: 6.5 Compensation for Research Related Injury
p.000037: A research related injury may be physical, social, economic or psychological, and may be classified as
p.000037: follows:
p.000037: a. Definitely: When injury is directly caused by participation in a research project;
p.000037: b. Probably: When injury is most likely explained by participation in a research project but when
p.000037: no definite proof of causality is evident;
p.000037: c. Possibly: When explanation for injury is equally due to participation in a research project or other
p.000037: cause;
p.000037: d. Unlikely: When injury is more likely explained by another cause other than participation in a
p.000037: research project;
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: e. Not related: When injury is clearly due to another cause other than participation in a research project.
...
p.000037: Researchers, whose research involves vulnerable groups and individuals, shall specify how they will address
p.000037: particular vulnerabilities.
p.000037: 8.2 Additional Protection for Vulnerable Populations
p.000037: 8.2.1 Certain communities may also be vulnerable. Characteristics that constitute vulnerability in
p.000037: such communities include one or more of the following:
p.000037: a. Limited economic empowerment;
p.000037: b. Conflict and post-conflict situations;
p.000037: c. Inadequate protection of human rights;
p.000037: d. Discrimination on the basis of health status;
p.000037: e. Limited availability of health care and treatment options;
p.000037: f. Communities in acute disaster and disease epidemics;
p.000037: 8.2.2 In order to protect vulnerable communities, RECs should ensure that:
p.000037: a. Selection of communities is justified by
p.000037: the research goals;
...
Economic / Welfare Recipient
Searching for indicator welfare:
(return to top)
p.000031: Preface
p.000031: v
p.000031: Acronyms
p.000031: vi
p.000031: 1.0 General Provisions 1
p.000031: 1.1 Introduction 1
p.000031: 1.2 Rationale 1
p.000031: 1.3 Objectives 1
p.000031: 1.4 General Policy 1
p.000031: 1.5 Scope of Application 1
p.000031: 2.0 Rights and Welfare of Research Participants 2
p.000031: 2.1 Research involving Humans as Research Participants 2
p.000031: 2.2 Rights and Welfare of Human Research Participants and
p.000031: their Communities 2
p.000031: 2.3 Principles of Research Ethics 2
p.000031: 3.0 Regulatory Oversight of Research 4
p.000031: 3.1 The Regulatory Process 4
p.000031: 3.2 Oversight by Uganda National Council for Science and Technology 4
p.000031: 3.3 Oversight by the National Drug Authority 5
...
p.000037: greatly enriched these guidelines.
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: iv UNCST
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037:
p.000037: Preface
p.000037: The purpose of research is to generate or contribute to knowledge that could benefit present and future generations.
p.000037: People who volunteer as research participants bear the burden of research in order to bring about the future benefit.
p.000037: It is necessary, therefore, to ensure that people who bear the burden of research also benefit in some way or
p.000037: that their rights and welfare are not compromised during the research process. These Guidelines establish a system
p.000037: in Uganda for carrying out research without compromising rights and welfare of individual research participants and
p.000037: communities.
p.000037: The Guidelines are a revised version of the 2007 National Guidelines for Research involving Humans as Research
p.000037: Participants. The revisions were in keeping with changing conditions and new information and practices in the field of
p.000037: research ethics. The revised Guidelines, therefore, reflect consensus among research stakeholders on norms and
p.000037: standards, which should be adhered to in order to assure research participants of protection of their
p.000037: rights and welfare during and after research. The Guidelines are intended to assist individuals and organizations plan
p.000037: and conduct and/or participate in research following sound scientific and ethical principles.
p.000037: Readers who detect errors of omission or commission are invited to send corrections and suggestions to UNCST, P. O. Box
p.000037: 6884, Kampala. E-mail: info@uncst.go.ug.
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: Dr. Peter Ndemere
p.000037: Executive Secretary, UNCST
p.000037:
p.000037: Professor Nelson K. Sewankambo
p.000037: Chair, Task Force
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: UNCST v
p.000037:
p.000037:
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037: Acronyms
p.000037:
...
p.000037: research interests. The number of research projects involving humans as research participants in Uganda has
p.000037: more than quadrupled since 1990. This increasing quest for knowledge and the search for novel remedies to health,
p.000037: environmental, social and economic challenges is commendable, but could, if uncontrolled,
p.000037: involve exposing research participants to a spectrum of risks. These guidelines provide a national system or
p.000037: framework for harnessing the benefits of research while ensuring that rights, interests, values and welfare of
p.000037: research participants are protected.
p.000037: 1.2 Rationale
p.000037: Research is conducted for the benefit of society. It is important to have in place a system that
p.000037: promotes beneficial research and guards against unethical research. Research has inherent burdens, which
p.000037: individuals and communities who volunteer as research participants bear in order to bring about a future
p.000037: benefit. Individuals and communities should not be unfairly denied the benefits of research or be
p.000037: unjustifiably exposed to potentially risky research. These guidelines are, therefore, necessary to ensure
p.000037: that research participant’s rights and welfare are not compromised during or after the research.
p.000037: 1.3 Objectives
p.000037: The overall objective of these guidelines is to establish a coherent regulatory framework for conduct of research
p.000037: involving humans without compromising their rights and welfare.
p.000037: Specifically, these guidelines are to:
p.000037: a. Provide mechanisms for protecting rights and welfare of research participants;
p.000037: b. Provide ethical standards and procedures for conduct of research involving humans as research participants;
p.000037: c. Ensure that researchers take into account social and cultural values of participating communities.
p.000037: 1.4 General Policy
p.000037: Research and development including scientific investigations involving humans as research participants shall be
p.000037: conducted for the benefit of communities in Uganda and abroad without causing unnecessary harm or inconvenience,
p.000037: and shall not compromise rights and welfare of research participants.
p.000037: 1.5 Scope of Application
p.000037: The aforementioned general policy and other provisions of these guidelines apply to (1) all research involving
p.000037: humans as research participants in Uganda, including research in humanities and social sciences, biomedical
p.000037: science and traditional and complementary medicine, (2) research conducted in or by public, private,
p.000037: inter-governmental and non-governmental organizations, and by individuals or groups, and (3)
p.000037: research conducted in a foreign country on human materials collected from Uganda.
p.000037:
p.000037: UNCST 1
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037: 2.0 RIGHTS AND WELFARE OF RESEARCH PARTICIPANTS
p.000037:
p.000037: 2.1 Research Involving Humans as Research Participants
p.000037: Research involving humans as research participants includes:
p.000037: a. Clinical investigations, that is, any experiment or study on one or more persons, which involves a
p.000037: test product/ article, whether a drug, treatment, procedure, or device;
p.000037: b. Social-behavioral studies, which involve interaction with or observation of people;
p.000037: c. Basic scientific research to study biology of persons or organs and specimens thereof;
p.000037: d. Systematic collection, storage and analysis of data on humans.
p.000037: 2.2 Rights and Welfare of Human Research Participants and their Communities
p.000037: Research should be conducted in a manner that does not violate rights and welfare of human research participants and
p.000037: their communities.
p.000037: 2.2.1 Human Research Participants have a right to, inter alia:
p.000037: a. Participate in research or not, or withdraw at any time without penalty;
p.000037: b. Be respected, including the right of their autonomy, culture, beliefs and values;
p.000037: c. Information about the research (it is important to ensure that information is communicated in
p.000037: understandable language, format and in a conducive environment at all stages of the research);
p.000037:
p.000037: 2 UNCST
p.000037: d. Protection against research related injuries, harm, exploitation, and any other forms of abuse;
p.000037: e. Privacy and confidentiality of their participation, during and after the research;
p.000037: f. The standard of health care that is established nationally;
p.000037: g. Treatment and management of research related injuries;
p.000037: h. Reimbursement for costs associated with their participation in the research.
p.000037: 2.2.2 Research should aim at improving the welfare of research participants and their communities. This can be
p.000037: attained through:
p.000037: a. Ensuring adequate welfare for research participants, including compensation for inconveniences and time;
p.000037: b. Provision of health (ancillary) care beyond research related care;
p.000037: c. Provision of collateral1 benefits to
p.000037: research communities;
p.000037: d. Provision of good client care during study investigations and procedures;
p.000037: e. Taking measures to ensure easy access by the community to the test drug/ device, if proven
p.000037: beneficial.
p.000037: 2.3 Principles of Research Ethics
p.000037: In order to protect rights and welfare of human research participants, research should be conducted in
p.000037: accordance with four basic research ethics principles, namely: respect
p.000037: 1 These may include benefits that are related to but
p.000037: not directly linked to the research project.
p.000037:
p.000037:
p.000037: for persons, beneficence, non-maleficence and justice. It is generally observed that these principles guide the
p.000037: conscientious preparation of proposals for scientific studies. They may be expressed differently and given
p.000037: different moral weight in different settings, and their application may lead to different decisions or courses of
p.000037: action in those particular settings.
p.000037: These principles are briefly described as
p.000037: follows:
...
p.000037: afforded security against harm or abuse.
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: b. Beneficence refers to the ethical obligation to maximize benefits and to minimize
p.000037: harms. That is to say, risks of harm by research should be reasonably justified by expected benefits,
p.000037: research design should be scientifically acceptable, and researchers should be competent to conduct research
p.000037: and to safeguard rights and welfare of research participants.
p.000037: c. Non-maleficence (i.e. to do no harm) prescribes that researchers should not deliberately inflict
p.000037: harm, or evil on research participants.
p.000037: d. Justice refers to the ethical obligation to treat each person in accordance with what is morally
p.000037: right and proper, to give each person what is due to him or her. The principle refers primarily to distributive
p.000037: justice, which requires fair and equitable distribution of both burdens and benefits of participation in research.
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
...
p.000037: executing this function, UNHRO collaborates with UNCST to register all research protocols related to health. This
p.000037: registration process is done centrally at UNCST.
p.000037: 3.5 Oversight by Research Ethics Committees
p.000037: RECs are established by organizations whose mandate includes carrying out research. Their primary function is to
p.000037: conduct initial and continuing review and approval of research projects, with the aim of protecting rights and
p.000037: UNCST 5
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: welfare of human research participants. RECs operating in Uganda must be accredited by an Accreditation Committee for
p.000037: Research Ethics Committees based at UNCST. RECs have a special role of monitoring research activities to ensure
p.000037: compliance with scientific and ethical requirements in accordance with these guidelines. Operations of RECs are
p.000037: described in detail in Section 4.0 below.
p.000037: 3.6 Oversight by Other Committees
p.000037: Besides RECs, there are a number of other committees that are involved in one way or another in the
p.000037: research process. These committees include:
p.000037: 3.6.1 Scientific Committees
p.000037:
p.000037: 3.6.1.1 Establishment
...
p.000037: in biosafety;
p.000037: e. Establish a health-monitoring plan for all high-risk personnel involved in application, use and production of
p.000037: potentially hazardous substances.
p.000037:
p.000037: 8 UNCST
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: 4.0. ESTABLISHMENT AND FUNCTIONS OF RESEARCH ETHICS COMMITTEES
p.000037:
p.000037: 4.1 Introduction
p.000037: RECs are established in or by an organization to conduct initial and continuing review of research projects
p.000037: with the primary goal of protecting rights and welfare of research participants. All organizations
p.000037: in Uganda that conduct research involving humans as research participants may set up RECs in accordance
p.000037: with these guidelines. Where an organization cannot set up a REC, it may rely on a REC of another organization
p.000037: to review their research projects, provided the REC is accredited by the Accreditation Committee for RECs in
p.000037: Uganda (ACREC) based at UNCST.
p.000037: 4.2 Establishment
p.000037: An organization that wishes to establish a REC shall apply for accreditation of the REC at UNCST, with assurance
p.000037: that the organization shall comply with the requirements set forth in these guidelines. The assurance shall at the
p.000037: minimum include:
p.000037: a. A statement of principles for protecting rights and welfare of human research participants of
p.000037: research conducted at or sponsored by the organization. This may include an appropriate existing
p.000037: code, declaration, or statement of ethical principles, or a statement formulated by the organization itself.
p.000037: b. Assurance of availability of staff, office and meeting space for the REC; and sufficient
p.000037: resources to support the REC’s operations.
p.000037: c. A list of REC members appointed by the head of the organization or his/her designee. The members
p.000037: should be identified by name, qualifications, profession,
p.000037: specialty, organization of affiliation and
p.000037: representative capacity in REC.
p.000037: d. Written standard operating procedures for the REC;
...
p.000037: are responsive to the health needs and priorities of the proposed study population in particular and
p.000037: of Uganda in general. The ability to judge
p.000037:
p.000037:
p.000037:
p.000037: the ethical acceptability of various aspects of a research proposal requires a thorough understanding of a
p.000037: community’s customs and traditions. The REC, therefore, must have competent members or consulting persons
p.000037: with such understanding.
p.000037: 4. 4 Functions
p.000037: RECs act as independent reviewers of any proposed study on human research participants, to
p.000037: ensure ethical conduct of research, and that participant’s rights and welfare are not violated.
p.000037: Therefore, the major responsibility of RECs is to safeguard the rights, safety, and welfare of research
p.000037: participants. It is important for RECs to review the scientific soundness of the research proposals. In
p.000037: view of this, the functions of any REC in Uganda shall be to:
p.000037: a. Maintain ethical standards of practice in research;
p.000037: b. Protect research participants and researchers from harm or exploitation;
p.000037: c. Preserve the research participants’ rights and welfare;
p.000037: d. Provide assurance to society of the protection of rights and welfare of research
p.000037: participants; and
p.000037: e. Ensure adherence to ethical conduct of research protocols approved by the REC;
p.000037: 4. 5 Review Mechanisms
p.000037: Each REC must have written procedures, including procedures to be followed in their review mechanism. The
p.000037: following are the minimum requirements for a REC review mechanism:
p.000037:
p.000037: 10 UNCST
p.000037:
p.000037:
p.000037: 4.5.1 General Requirements
p.000037: a. REC shall review proposed research at convened meetings at which at least fifty percent (50%) of the
p.000037: members of the REC are present, including at least one lay member. Quorum should be maintained at all times
p.000037: during the meeting and at voting.
p.000037: b. In order for the research project to be approved, it shall receive the approval of a simple majority of
...
p.000037: review, the researcher
p.000037:
p.000037: UNCST 11
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: shall apply to the REC for his/her study to be exempt from REC review. The REC shall review the
p.000037: application to ensure that the proposed study satisfies requirements for exemption from REC review, and
p.000037: will, thereafter, grant exemption.
p.000037: 4.5.4 Review of Collaborative Research
p.000037: Projects
p.000037: a. Collaborative research projects are projects that involve more than one organization
p.000037: locally and internationally. When conducting collaborative research projects, each participating organization
p.000037: is responsible for safeguarding rights and welfare of research participants and for complying with these
p.000037: guidelines. This involves securing REC approvals in both the local and foreign organization prior to
p.000037: registration of the study by UNCST. Where desirable participating organizations in a collaborative research project
p.000037: may have a joint review arrangement for that particular research project.
p.000037: b. The local REC overseeing an international collaborative research project is the REC of record in view of its better
p.000037: understanding of cultural sensitivities of the population in which the proposed research is to be
p.000037: conducted. It is also better placed to monitor compliance with these guidelines in the course of a study.
p.000037: c. An international collaborative research project should have a co-principal investigator in
...
p.000037: c. A description of the benefits to the research participant or to others that may reasonably be expected to result
p.000037: from the research project.
p.000037: d. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be
p.000037: advantageous to the research participant.
p.000037: e. A statement describing the extent, if any, to which privacy and confidentiality of the research participant
p.000037: will be maintained.
p.000037: f. A statement about compensation and medical treatment available if injury occurs and, what they
p.000037: consist of and where further information may be obtained.
p.000037: g. Names and contact details of individual(s) who should be contacted at any time in case of questions about the
p.000037: research project, the research participants’ rights and welfare. The individual(s) should be able to
p.000037: communicate in a language understandable by the research participant or should be able to promptly secure the
p.000037: services of an interpreter to assist in responding to the research participant’s questions.
p.000037: h. A statement that participation is voluntary, that refusal to participate will not result in a penalty or a
p.000037: loss of benefits to which the research participant is otherwise entitled, and that the research
p.000037: participant may discontinue participation at any time without penalty or loss of benefits to which the
p.000037: research participant is otherwise entitled.
p.000037: i. Where applicable, a statement of how the researcher will provide medical services to the research participant.
...
p.000037: without the prior intention of conducting research on the samples, samples sources shall be traced to provide consent
p.000037: for use of the samples in research.
p.000037: 10.3 Ownership
p.000037: Sample sources own the samples. Samples sources may withdraw their samples if the samples are linked.
p.000037: Samples shall be held in trust on behalf of the sample sources by a duly registered and recognized
p.000037: organization in Uganda. The organization entrusted with custodianship of the samples shall have the
p.000037: authority to decide use, transfer, storage and future use of the samples taking into consideration
p.000037: rights and welfare of the research participants.
p.000037: 10.4 Exchange/Transfer of Human Materials for Research Purposes
p.000037: When it is necessary to transfer samples for storage or other uses from one organization to another within
p.000037: the country and abroad, the provider organization holding the samples on behalf of sample sources shall
p.000037: negotiate an appropriate contract with the recipient organization. This contract shall be in the form of a
p.000037: Materials Transfer Agreement (MTA).
p.000037: In order to justify transfer of human materials abroad, researchers, sponsors and collaborators
p.000037:
p.000037: 28 UNCST
p.000037:
p.000037:
p.000037: should demonstrate that in-country capacity to perform certain types of investigations/testing does not exist or
...
General/Other / Cultural Differences
Searching for indicator cultural:
(return to top)
p.000037: 1.3 Objectives
p.000037: The overall objective of these guidelines is to establish a coherent regulatory framework for conduct of research
p.000037: involving humans without compromising their rights and welfare.
p.000037: Specifically, these guidelines are to:
p.000037: a. Provide mechanisms for protecting rights and welfare of research participants;
p.000037: b. Provide ethical standards and procedures for conduct of research involving humans as research participants;
p.000037: c. Ensure that researchers take into account social and cultural values of participating communities.
p.000037: 1.4 General Policy
p.000037: Research and development including scientific investigations involving humans as research participants shall be
p.000037: conducted for the benefit of communities in Uganda and abroad without causing unnecessary harm or inconvenience,
p.000037: and shall not compromise rights and welfare of research participants.
p.000037: 1.5 Scope of Application
p.000037: The aforementioned general policy and other provisions of these guidelines apply to (1) all research involving
p.000037: humans as research participants in Uganda, including research in humanities and social sciences, biomedical
...
p.000037: b. Frequency of receiving data;
p.000037: c. Frequency of meetings to review data and adverse event reports at hand (where there may be concern, the DSMB may
p.000037: choose to review data more frequently);
p.000037: d. Channels of communication with the study and the REC.
p.000037: 3.6.3 Community Advisory Boards
p.000037: 3.6.3.1 Establishment
p.000037: Community Advisory Boards (CABs) are established by the researcher. A CAB facilitates dialogue
p.000037: between the community and the researcher team.
p.000037: CAB members are identified from communities where research is to be undertaken. The CAB’s role and
p.000037: expectations should be clearly stated in their terms of reference. Members of a CAB may include, but are not limited
p.000037: to, the following:
p.000037: a. Individuals with understanding of local laws, cultural values and gender issues;
p.000037: b. Peer leaders;
p.000037: c. Religious leaders;
p.000037: d. Representatives of the study population;
p.000037: e. Media;
p.000037: f. Professionals who understand research or science issues;
p.000037: g. Community leaders.
p.000037: UNCST 7
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: 3.6.3.2 Functions
p.000037: The primary function of a CAB is to assist researchers understand and incorporate community
p.000037: concerns into their research activities. This happens through different ways like advising on issues central
...
p.000037: The ACREC shall review the organization’s application, and if satisfied, will accredit the REC. The
p.000037: REC shall not commence its activities until it has been accredited by the ACREC. Guidelines for
p.000037: accreditation of RECs are obtainable from the UNCST offices or website.
p.000037: 4.3 Composition of a REC
p.000037: a. Each REC shall be composed of at least five
p.000037: (5) members, with varying backgrounds to ensure balanced and adequate review of research activities commonly
p.000037: conducted by the organization. The REC shall be sufficiently qualified through the experience,
p.000037: expertise and diversity of its members, including consideration of gender, cultural
p.000037: backgrounds and sensitivity to social issues in the community in which research participants are drawn.
p.000037: b. Each REC shall include at least one member whose primary concerns are in scientific areas and at least
p.000037: one member whose primary concerns are in nonscientific areas.
p.000037: c. Each REC shall include at least one member who is not affiliated with the organization and who
p.000037: is not part of the immediate family of a person who is affiliated with the organization.
p.000037: d. Each REC shall include at least one lay3 person from the community.
p.000037: 3 “Lay person from the community” refers to an individual whose primary background is not in
...
p.000037: locally and internationally. When conducting collaborative research projects, each participating organization
p.000037: is responsible for safeguarding rights and welfare of research participants and for complying with these
p.000037: guidelines. This involves securing REC approvals in both the local and foreign organization prior to
p.000037: registration of the study by UNCST. Where desirable participating organizations in a collaborative research project
p.000037: may have a joint review arrangement for that particular research project.
p.000037: b. The local REC overseeing an international collaborative research project is the REC of record in view of its better
p.000037: understanding of cultural sensitivities of the population in which the proposed research is to be
p.000037: conducted. It is also better placed to monitor compliance with these guidelines in the course of a study.
p.000037: c. An international collaborative research project should have a co-principal investigator in
p.000037: Uganda, who must be employed at and/or affiliated to a recognized local organization that
p.000037: is relevant to the area of the proposed research. The co-principal investigator should be
p.000037: qualified and competent and should actively participate in and/or supervise the research project.
p.000037:
p.000037: 4.5.5 Multiple REC Review
p.000037: a. As a general rule, a researcher shall submit his/her research protocol to the REC of his/her organization of
...
Searching for indicator culture:
(return to top)
p.000037: c. Basic scientific research to study biology of persons or organs and specimens thereof;
p.000037: d. Systematic collection, storage and analysis of data on humans.
p.000037: 2.2 Rights and Welfare of Human Research Participants and their Communities
p.000037: Research should be conducted in a manner that does not violate rights and welfare of human research participants and
p.000037: their communities.
p.000037: 2.2.1 Human Research Participants have a right to, inter alia:
p.000037: a. Participate in research or not, or withdraw at any time without penalty;
p.000037: b. Be respected, including the right of their autonomy, culture, beliefs and values;
p.000037: c. Information about the research (it is important to ensure that information is communicated in
p.000037: understandable language, format and in a conducive environment at all stages of the research);
p.000037:
p.000037: 2 UNCST
p.000037: d. Protection against research related injuries, harm, exploitation, and any other forms of abuse;
p.000037: e. Privacy and confidentiality of their participation, during and after the research;
p.000037: f. The standard of health care that is established nationally;
...
p.000037:
p.000037: i. Certificate of analysis;
p.000037: j. Batch release certificate;
p.000037: k. Stability studies done on the drug/ device;
p.000037: l. Authorisation of the clinical trial from the country of origin;
p.000037: m. Good Manufacturing Practice certificate of plant from which drug/device was manufactured;
p.000037: n. Containers in which products is packaged;
p.000037: o. Labelling; and
p.000037: p. Relevant published literature on the drug/device.
p.000037: 3.4 Oversight by Uganda National Health Research Organization
p.000037: UNHRO is established by Act of Parliament to create a sustainable culture of health research by providing policy and
p.000037: ethical guidelines and national coordination of and regulation of health research. UNHRO is mandated
p.000037: under section 6(e) of the UNHRO Act “to register, renew and coordinate different types of health research in
p.000037: Uganda and promote multi-disciplinary and inter-sectoral research collaboration in a bid to establish
p.000037: essential national health research, which is consistent with National Health Strategic Plan.” In
...
General/Other / Dependent
Searching for indicator dependent:
(return to top)
p.000037: follows:
p.000037: a. Respect for persons incorporates at least two fundamental ethical considerations, namely: respect for
p.000037: autonomy, which requires that those who are capable of deliberation about their personal choices should be
p.000037: treated with respect for their capacity for self-determination; and protection of persons with
p.000037: impaired or diminished autonomy, which requires that those who are dependent or vulnerable be
p.000037: afforded security against harm or abuse.
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: b. Beneficence refers to the ethical obligation to maximize benefits and to minimize
p.000037: harms. That is to say, risks of harm by research should be reasonably justified by expected benefits,
p.000037: research design should be scientifically acceptable, and researchers should be competent to conduct research
...
General/Other / Diminished Autonomy
Searching for indicator age:
(return to top)
p.000037: consent form and the risk to the research participant would be potential harm resulting from a breach of
p.000037: confidentiality;
p.000037: e. The research participant presents in an emergency situation and informed consent cannot be reasonably
p.000037: obtained from the individual or his/her representative.
p.000037: 5.6 Assent
p.000037: Assent to participate in research shall be obtained from all children eight (8) years of age and above, and from
p.000037: all persons incapable of self-determination. A child’s assent is obtained after parental/guardian’s
p.000037: consent. The child’s assent or dissent takes precedence over the parent’s or guardian’s consent. Assent for
p.000037: all other persons incapable of self- determination is obtained after consent from their representatives.
...
p.000037: father is not reasonably available; or iv) the pregnancy resulted from rape or incest and (v) the father is
p.000037: incompetent to give consent.
p.000037: No provision of this subsection shall be construed as authorization to terminate a pregnancy
p.000037: where such termination would not otherwise be in conformity with current laws of Uganda relating to the
p.000037: termination of pregnancy.
p.000037: 5.8 Informed Consent by Mature and Emancipated Minors
p.000037: Mature minors are individuals 14-17 years of age who have drug or alcohol dependency or a sexually
p.000037: transmitted infection; while emancipated minors are individuals below the age of majority who are
p.000037: pregnant, married, have a child or cater for their own livelihood. Mature and emancipated minors may
p.000037: independently provide informed consent to participate in research if:
p.000037: a. In the view of the REC the research is not objectionable to parents or guardians (established by the
p.000037: REC with evidence from the community);
p.000037: b. The research protocols include clear justification for targeting mature and emancipated minors
...
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: 36 UNCST
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: GLOSSARY
p.000037:
p.000037: Adverse event is any untoward medical occurrence in a participant in a clinical trial who has been
p.000037: administered a pharmaceutical product or a medical device. The event may or may not be casually related to the
p.000037: treatment or procedure.
p.000037: Assent means a child’s affirmative agreement to participate in a research project. Failure to object does not
p.000037: constitute assent.
p.000037: Child is a person below the age of eighteen years.
p.000037: Clinical trial is a systematic study of pharmaceutical products or medical devices in human research
p.000037: participants in order to discover or to verify the beneficial or adverse effects, to identify any adverse
p.000037: reaction in the investigational product, and/or to study the absorption, distribution, metabolism, and excretion
p.000037: of the product with the objective of ascertaining its safety and efficacy.
p.000037: Fetus means the product of conception from the time of implantation as indicated by any of the presumptive signs of
p.000037: pregnancy, including missed menses or a medically accepted pregnancy test, until a determination is made,
p.000037: following expulsion or extraction of the fetus, that it is viable.
...
p.000037: information.
p.000037: Researcher means a person who engages in the methodical and systematic investigation of hypotheses with the
p.000037: goal of contributing to new knowledge.
p.000037: Serious adverse event is an adverse event associated with death, hospital admission, prolongation of a
p.000037: hospitalization, persistent or significant disability or incapacity, or otherwise life-threatening
p.000037: condition in connection with a clinical trial.
p.000037: Street children and orphans are persons who have not yet attained the legal age of majority
p.000037: under the applicable law and have no identifiable parent or guardian or have been abandoned by their
p.000037: parent(s) or guardian (s), are in wards of government or governmental entity, institution, organization,
p.000037: ministry, department, or subunit thereof, or are under the care of any governmental entity, institution,
p.000037: organization, ministry, department or subunit thereof.
p.000037: Viable means being able, after spontaneous or induced delivery, to survive, given the benefit of available medical
p.000037: therapy, to the point of independently maintaining heart beat and respiration. If a fetus is viable after
p.000037: delivery, it is a premature infant.
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
(return to top)
p.000037: c. Basic scientific research to study biology of persons or organs and specimens thereof;
p.000037: d. Systematic collection, storage and analysis of data on humans.
p.000037: 2.2 Rights and Welfare of Human Research Participants and their Communities
p.000037: Research should be conducted in a manner that does not violate rights and welfare of human research participants and
p.000037: their communities.
p.000037: 2.2.1 Human Research Participants have a right to, inter alia:
p.000037: a. Participate in research or not, or withdraw at any time without penalty;
p.000037: b. Be respected, including the right of their autonomy, culture, beliefs and values;
p.000037: c. Information about the research (it is important to ensure that information is communicated in
p.000037: understandable language, format and in a conducive environment at all stages of the research);
p.000037:
p.000037: 2 UNCST
p.000037: d. Protection against research related injuries, harm, exploitation, and any other forms of abuse;
p.000037: e. Privacy and confidentiality of their participation, during and after the research;
...
p.000037: 1 These may include benefits that are related to but
p.000037: not directly linked to the research project.
p.000037:
p.000037:
p.000037: for persons, beneficence, non-maleficence and justice. It is generally observed that these principles guide the
p.000037: conscientious preparation of proposals for scientific studies. They may be expressed differently and given
p.000037: different moral weight in different settings, and their application may lead to different decisions or courses of
p.000037: action in those particular settings.
p.000037: These principles are briefly described as
p.000037: follows:
p.000037: a. Respect for persons incorporates at least two fundamental ethical considerations, namely: respect for
p.000037: autonomy, which requires that those who are capable of deliberation about their personal choices should be
p.000037: treated with respect for their capacity for self-determination; and protection of persons with
p.000037: impaired or diminished autonomy, which requires that those who are dependent or vulnerable be
p.000037: afforded security against harm or abuse.
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: b. Beneficence refers to the ethical obligation to maximize benefits and to minimize
p.000037: harms. That is to say, risks of harm by research should be reasonably justified by expected benefits,
p.000037: research design should be scientifically acceptable, and researchers should be competent to conduct research
...
p.000037:
p.000037: Traditional and complementary medicine is the sum total of knowledge, skills, and practices based on the theories,
p.000037: beliefs, and experiences indigenous to different cultures, whether explicable or not, used in the maintenance
p.000037: of health as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness.
p.000037: Generally, traditional and complementary medicines research is subject to the same ethical standards as
p.000037: conventional research practices. The research should follow scientifically reliable
p.000037: procedures and observe the fundamental ethical principles of autonomy, beneficence and justice and
p.000037: the ethical review process outlined in these guidelines.
p.000037: Additional considerations are:
p.000037: a. Indigenous knowledge of the community should be recognized. There should
p.000037: be mechanisms to share equitably the benefits, which may arise out of the utilization of the
p.000037: knowledge in research. This may include support to the community to conserve their traditional knowledge and
p.000037: genetic resources.
p.000037: b. There should be considerations for protecting intellectual property or traditional knowledge
p.000037: in accordance with the relevant laws in Uganda.
...
General/Other / Incapacitated
Searching for indicator incapacitated:
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p.000037: researchers.
p.000037: l. A statement that research participants will get feedback on findings and progress of the study, and that
p.000037: any new information that affects the study or data that has clinical relevance to research participants
p.000037: (including incidental findings) will be made available to research participants and/or their health
p.000037: care providers.
p.000037: m. Where necessary, provision for a witness at appropriate specific stages of the informed consent process, for
p.000037: example, in the case of illiterate, mentally incapacitated or physically handicapped research
p.000037: participants.
p.000037: n. A statement that the study has been approved by an accredited Ugandan based REC.
p.000037: 5.3.2 Any of the following shall
p.000037: be provided to the research participant, whenever appropriate, based on the nature and conduct of the study:
p.000037: a. A statement that a particular treatment or procedure under study may involve risk to the research participant, or
p.000037: to the embryo or fetus if the research participant is or may become pregnant, and that the risk is currently
p.000037: unforeseeable.
...
Searching for indicator incapacity:
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p.000037:
p.000037: 9.0 MANAGEMENT OF SERIOUS ADVERSE EVENTS
p.000037:
p.000037: 9.1 Introduction
p.000037: The researcher shall identify, manage and promptly report serious adverse events to the REC. This shall not
p.000037: apply to events that are observed among participants who are in observational studies in which no
p.000037: health related intervention is being administered.
p.000037: 9.2 Defining Seriousness of Adverse
p.000037: Events and Unexpected Events
p.000037: 9.2.1 A serious adverse event is an event,
p.000037: which:
p.000037: a. Results in death;
p.000037: b. Is life threatening;
p.000037: c. Requires in patient hospitalization or prolongation of existing hospitalization;
p.000037: d. Results in significant and persistent
p.000037: incapacity;
p.000037: e. Is a congenital anomaly or birth defect;
p.000037: f. Is an important medical condition in the opinion of the investigator.
p.000037: 9.2.2 An unexpected event is an event:
p.000037: a. Which is previously unobserved or undocumented in humans under the health research
p.000037: intervention (or one substantially similar);
p.000037: b. Whose nature or severity is not consistent with information in the investigators brochure or other
p.000037: safety information known at the time;
p.000037: c. Which is observed with higher frequency or severity than previously documented.
p.000037: 9.2.3 Unexpectedness shall not include events that may reasonably be extrapolated from in vitro and animal studies.
...
p.000037: Research means any type of systematic investigation, testing and evaluation, designed to develop or
p.000037: contribute to generalizable knowledge.
p.000037:
p.000037: Research participant means a living individual about whom an investigator conducting
p.000037: research obtains data through intervention or interaction with the individual or identifiable private
p.000037: information.
p.000037: Researcher means a person who engages in the methodical and systematic investigation of hypotheses with the
p.000037: goal of contributing to new knowledge.
p.000037: Serious adverse event is an adverse event associated with death, hospital admission, prolongation of a
p.000037: hospitalization, persistent or significant disability or incapacity, or otherwise life-threatening
p.000037: condition in connection with a clinical trial.
p.000037: Street children and orphans are persons who have not yet attained the legal age of majority
p.000037: under the applicable law and have no identifiable parent or guardian or have been abandoned by their
p.000037: parent(s) or guardian (s), are in wards of government or governmental entity, institution, organization,
p.000037: ministry, department, or subunit thereof, or are under the care of any governmental entity, institution,
p.000037: organization, ministry, department or subunit thereof.
p.000037: Viable means being able, after spontaneous or induced delivery, to survive, given the benefit of available medical
p.000037: therapy, to the point of independently maintaining heart beat and respiration. If a fetus is viable after
p.000037: delivery, it is a premature infant.
p.000037: Vulnerability refers to a substantial incapacity to protect one’s own interests owing to such impediments as lack of
p.000037: capability to give informed consent, lack of alternative means of obtaining medical care or other expensive
p.000037: necessities, or being a junior or subordinate member of a hierarchical group.
p.000037:
p.000037: 38 UNCST
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: Uganda National Council for Science and Technology
p.000037: P. O. Box 6884, Kampala - Uganda. Tel: +256 414 - 705500.
p.000037: Fax: +256 414 - 234 579
...
General/Other / Other Country
Searching for indicator vulnerability:
(return to top)
p.000037: Researchers, whose research involves vulnerable groups and individuals, shall specify how they will address
p.000037: particular vulnerabilities.
p.000037: 8.2 Additional Protection for Vulnerable Populations
p.000037: 8.2.1 Certain communities may also be vulnerable. Characteristics that constitute vulnerability in
p.000037: such communities include one or more of the following:
p.000037: a. Limited economic empowerment;
p.000037: b. Conflict and post-conflict situations;
p.000037: c. Inadequate protection of human rights;
p.000037: d. Discrimination on the basis of health status;
p.000037: e. Limited availability of health care and treatment options;
p.000037: f. Communities in acute disaster and disease epidemics;
p.000037: 8.2.2 In order to protect vulnerable communities, RECs should ensure that:
...
p.000037: under the applicable law and have no identifiable parent or guardian or have been abandoned by their
p.000037: parent(s) or guardian (s), are in wards of government or governmental entity, institution, organization,
p.000037: ministry, department, or subunit thereof, or are under the care of any governmental entity, institution,
p.000037: organization, ministry, department or subunit thereof.
p.000037: Viable means being able, after spontaneous or induced delivery, to survive, given the benefit of available medical
p.000037: therapy, to the point of independently maintaining heart beat and respiration. If a fetus is viable after
p.000037: delivery, it is a premature infant.
p.000037: Vulnerability refers to a substantial incapacity to protect one’s own interests owing to such impediments as lack of
p.000037: capability to give informed consent, lack of alternative means of obtaining medical care or other expensive
p.000037: necessities, or being a junior or subordinate member of a hierarchical group.
p.000037:
p.000037: 38 UNCST
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: Uganda National Council for Science and Technology
p.000037: P. O. Box 6884, Kampala - Uganda. Tel: +256 414 - 705500.
...
General/Other / Presence of Coercion
Searching for indicator coercion:
(return to top)
p.000037: adequate understanding of the relevant facts and of the consequences of participation. For certain types of
p.000037: research, the REC may require the researcher to administer a comprehension test (or test of understanding) to ensure
p.000037: that prospective research participants have acquired adequate understanding of the relevant facts and of
p.000037: the consequences of participation. Seeking consent shall be carried out under circumstances that provide the
p.000037: prospective research participant or the representative, sufficient opportunity to
p.000037: 16 UNCST
p.000037: consider whether or not to participate and that minimize the possibility of coercion or undue influence. The
p.000037: information that is given to the research participant or the representative, whether it is conveyed orally,
p.000037: in writing or other delivery mechanism, shall be in a language and form understandable to the
p.000037: participant or the representative. No informed consent, whether oral or written, shall include any exculpatory language
p.000037: through which the research participant or representative is: (1) made to waive or appear to waive any of the
p.000037: research participant’s rights, or (2) appears to release the researcher, sponsor, organization, or its agents from
p.000037: liability.
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000031: 2.2 Rights and Welfare of Human Research Participants and
p.000031: their Communities 2
p.000031: 2.3 Principles of Research Ethics 2
p.000031: 3.0 Regulatory Oversight of Research 4
p.000031: 3.1 The Regulatory Process 4
p.000031: 3.2 Oversight by Uganda National Council for Science and Technology 4
p.000031: 3.3 Oversight by the National Drug Authority 5
p.000031: 3.4 Oversight by Uganda National Health Research Organization 5
p.000031: 3.5 Oversight by Research Ethics Committees 5
p.000031: 3.6 Oversight by Other Committees 6
p.000031: 3.6.1 Scientific Committees 6
p.000031: 3.6.2 Data and Safety Monitoring Boards 6
p.000031: 3.6.3 Community Advisory Boards 7
p.000031: 3.6.4 Institutional Biosafety Committees 8
...
p.000037: Health Research Organisation, Dr. Stella Neema from Makerere University College of Humanities and Social
p.000037: Sciences, Dr. Joseph Ochieng from Makerere University School of Biomedical Sciences, Dr. Alex Opio from
p.000037: Ministry of Health, Dr. Pauline Byakika from Makerere University School of Medicine, Mr. Paul Kutyabami from
p.000037: Makerere University School of Health Sciences, Dr. Edward K. Mbidde from Uganda Virus Research Institute, Dr. Hannah
p.000037: Kibuuka from Makerere University-Walter Reed Project, Ms. Hellen Ndagije from National Drug Authority, and Dr.
p.000037: Julius Ecuru (Secretary) from UNCST. The hard work and relentless efforts by UNCST staff, especially Ms. Winfred
p.000037: Nazziwa Badanga and Ms. Leah Nawegulo Omongo, in servicing the Task force is very much appreciated. UNCST also thanks
p.000037: AVAC for co-funding meetings of the Task force. Finally, UNCST is thankful to all stakeholders for their inputs, which
p.000037: greatly enriched these guidelines.
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: iv UNCST
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037:
p.000037: Preface
p.000037: The purpose of research is to generate or contribute to knowledge that could benefit present and future generations.
...
p.000037: Executive Secretary, UNCST
p.000037:
p.000037: Professor Nelson K. Sewankambo
p.000037: Chair, Task Force
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: UNCST v
p.000037:
p.000037:
p.000037:
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037: Acronyms
p.000037:
p.000037: ACREC Accreditation Committee for Research Ethics Committees in Uganda CAB Community Advisory Board
p.000037: CV Curriculum Vitae
p.000037: DSMB Data and Safety Monitoring Board IBC institutional Biosafety Committee MTA Material Transfer
p.000037: Agreement NDA National Drug Authority
p.000037: R&D Research and Development REC Research Ethics Committee S&T Science and Technology SAE
p.000037: Serious Adverse Event
p.000037: SC Scientific Committee
p.000037: SOP Standard Operating Procedures UCG Uganda Clinical Guidelines
p.000037: UNCST Uganda National Council for Science and Technology UNHROUganda National Health Research Organization
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: vi UNCST
p.000037:
p.000037:
p.000037:
p.000037:
p.000037: 1.1 Introduction
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
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p.000037: Oversight of research involving humans as research participants in Uganda is done first at the
p.000037: organizational level by Research Ethics Committees (RECs) and second at the national level by UNCST in collaboration
p.000037: with Uganda National Health Research Organization (UNHRO) for health research. UNCST liaises with the
p.000037: Research Secretariat in the office of the President on national security issues in respect of research conducted
p.000037: in Uganda. An additional requirement with regard to clinical trials is for the researcher to obtain a certificate from
p.000037: the National Drug Authority (NDA) in respect of a trial drug/device preferably prior to review of the
p.000037: research protocol (or proposal) by a REC and registration of the protocol with UNCST.
p.000037: The mandates of UNCST, UNHRO and NDA with respect to oversight of research are briefly mentioned below.
p.000037: 3.2 Oversight by Uganda National Council for Science and Technology
p.000037: UNCST is a semi-autonomous government agency established in 1990 (CAP 209 of the Laws of
p.000037: Uganda) to develop and implement strategies for integrating science and technology (S&T) into the
p.000037: national development process, provide advice to government of Uganda on policy matters necessary
p.000037: for advancing S&T and, oversee and coordinate research and development (R&D) in Uganda. Sections 4 and 5 of the
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p.000037: instruments such as questionnaires, and where applicable, informed consent documents.
p.000037: a clearinghouse for information on research
p.000037: and experimental development taking place
p.000037:
p.000037: in scientific institutions, centres and other
p.000037: enterprises and on the potential applications
p.000037: 2 The registration is for oversight in accordance with the UNCST Act, and may involve additional
p.000037: review of a research proposal by specialized/ethics committees, task forces or expert review.
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p.000037: 3.3 Oversight by National Drug Authority
p.000037: NDA regulates safety, quality, efficacy, handling and use of drugs or drug related products and
p.000037: devices in research. Part IV, section 40 of the National Drug Policy and Authority Act (Chapter 206) states
p.000037: that, with respect to clinical trials: a) the authority may issue a certificate to any person for the purpose of
p.000037: carrying out clinical trials in respect of a drug that may be specified in the certificate, and b) no person may
p.000037: carry out any clinical trial in respect of any drug unless he or she is in possession of a certificate
p.000037: issued under subsection (1).
p.000037: It is the responsibility of each trial sponsor and/or researcher to obtain such authorization certificate for
p.000037: all experimental drugs/devices, irrespective of whether the drug/device has previously been licensed for use in
p.000037: humans or not. Researchers must file a copy of the NDA certificate authorizing the importation and/or use of the trial
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p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: may also be applied to annual renewal of studies, in which the only outstanding activity is data analysis
p.000037: and report writing. Major changes include, but are not limited to, significant changes in the research
p.000037: methodology or a change in procedures for research participants. Each REC shall develop standard operating
p.000037: procedures to define eligibility for expedited review.
p.000037: b. Expedited review may be done by the REC chairperson and/or one or more REC members he/she designates, and
p.000037: should typically be done within 21 calendar days. In reviewing the research, the reviewers may exercise all of
p.000037: the authority of the REC except that the reviewers may not disapprove the research.
p.000037: c. Each REC shall present all expedited review decisions at the next full REC meeting for
p.000037: ratification.
p.000037: d. The ACREC may restrict or choose not to authorize a REC to conduct expedited review when it is
p.000037: determined that the REC is abusing the process.
p.000037: 4.5.3 Exemption from REC Review
p.000037: The following categories of research are exempt from REC review:
p.000037: a. Use of publicly available unlinked data that does not identify individuals or communities;
p.000037: b. Emergency use of a test article provided that such emergency use is reported to the REC within seven
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p.000037: conduct of the research at the organization, which the researcher should pay.
p.000037: d. The approving REC has the primary responsibility for monitoring approved studies regardless
p.000037: of where they are conducted. However, where the implementing organization has a REC, the approving
p.000037: REC may, at their discretion, assign the monitoring role to the REC of the
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p.000037: 12 UNCST
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p.000037: implementing organization. The approving REC and the REC of the implementing organization shall agree on
p.000037: modalities for study monitoring.
p.000037: 4.5.6 REC Suspension or Termination of Approved Research
p.000037: a. A REC shall have authority to halt, suspend or terminate approval of research that is not being conducted
p.000037: in accordance with the REC’s requirements or that has been associated with unexpected serious harm to
p.000037: research participants or that contravenes these guidelines. The REC may suspend research when, for instance:
p.000037: i. It finds that the researcher has implemented major changes in the research protocol without
p.000037: prior approval of the REC,
p.000037: ii. When the researcher has failed to follow specific procedures or requirements enunciated by the REC in
p.000037: its initial review of the research protocol, or
p.000037: iii. When there is unexpected serious harm to research participants including, but not limited to, serious physical
p.000037: injury or death.
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p.000037: emergency procedures, laboratory quality control, notifiable diseases, routine counseling and testing, etc,
p.000037: without the prior intention of conducting research on the samples, samples sources shall be traced to provide consent
p.000037: for use of the samples in research.
p.000037: 10.3 Ownership
p.000037: Sample sources own the samples. Samples sources may withdraw their samples if the samples are linked.
p.000037: Samples shall be held in trust on behalf of the sample sources by a duly registered and recognized
p.000037: organization in Uganda. The organization entrusted with custodianship of the samples shall have the
p.000037: authority to decide use, transfer, storage and future use of the samples taking into consideration
p.000037: rights and welfare of the research participants.
p.000037: 10.4 Exchange/Transfer of Human Materials for Research Purposes
p.000037: When it is necessary to transfer samples for storage or other uses from one organization to another within
p.000037: the country and abroad, the provider organization holding the samples on behalf of sample sources shall
p.000037: negotiate an appropriate contract with the recipient organization. This contract shall be in the form of a
p.000037: Materials Transfer Agreement (MTA).
p.000037: In order to justify transfer of human materials abroad, researchers, sponsors and collaborators
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p.000037: Medical device is any device that has a therapeutic, prophylactic, or diagnostic use or is intended to
p.000037: modify physiological functions and is attached, implanted, or inserted for use in humans.
p.000037: Minimal risk is the probability and magnitude of physical or psychological harm that is normally encountered in
p.000037: the daily lives or in the routine medical, dental, or psychological examination of healthy persons.
p.000037: Parent means the biological mother or father or adoptive mother or father of a child.
p.000037: Parental responsibility means all rights, duties, powers, responsibilities and authority which by law a parent
p.000037: of a child has in relation to the child.
p.000037: Permission means the agreement of the parent(s) or guardian(s) to the participation of their child or ward in
p.000037: the research project.
p.000037: Pharmaceutical product is any substance or combination of substances that has a therapeutic,
p.000037: prophylactic, or diagnostic use or is intended to modify physiological functions and is presented in a dosage form
p.000037: suitable for administration to humans.
p.000037: Pregnancy refers to the time period from confirmation of implantation through any of the presumptive signs
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General/Other / Undue Influence
Searching for indicator undue influence:
(return to top)
p.000037: adequate understanding of the relevant facts and of the consequences of participation. For certain types of
p.000037: research, the REC may require the researcher to administer a comprehension test (or test of understanding) to ensure
p.000037: that prospective research participants have acquired adequate understanding of the relevant facts and of
p.000037: the consequences of participation. Seeking consent shall be carried out under circumstances that provide the
p.000037: prospective research participant or the representative, sufficient opportunity to
p.000037: 16 UNCST
p.000037: consider whether or not to participate and that minimize the possibility of coercion or undue influence. The
p.000037: information that is given to the research participant or the representative, whether it is conveyed orally,
p.000037: in writing or other delivery mechanism, shall be in a language and form understandable to the
p.000037: participant or the representative. No informed consent, whether oral or written, shall include any exculpatory language
p.000037: through which the research participant or representative is: (1) made to waive or appear to waive any of the
p.000037: research participant’s rights, or (2) appears to release the researcher, sponsor, organization, or its agents from
p.000037: liability.
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Orphaned Trigger Words
p.000031: 4.5.4 Review of Collaborative Research Projects 12
p.000031: 4.5.5 Multiple REC Review 12
p.000031: 4.5.6 REC Suspension or Termination of Approved Research 13
p.000031: 4.6 REC Records 13
p.000031: 4.7 Basic Ethical Considerations for Approval of Research Protocols 13
p.000031: 4.8 Requirements for Submission to REC 14
p.000031: 4.9 Obligations of a REC 15
p.000031: 4.10 Appeals/Arbitration 15
p.000031: 5.0 Informed Consent Process 16
p.000031: 5.1 Introduction 16
p.000031: 5.2 General Requirements for Informed Consent Process 16
p.000031: 5.3 Key Components of the Informed Consent Form 16
p.000031: 5.4 Documentation of Informed Consent Process 18
p.000031: 5.5 Waiver of Requirement for Informed Consent 18
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p.000037: record purposes.
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p.000037: 6 UNCST
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p.000037: All Phase I, Phase II, and Phase III clinical trials conducted in Uganda should have a safety monitoring
p.000037: plan and a DSMB. Other interventional studies, such as community trials, may be required to set up DSMBs
p.000037: on a case by case basis.
p.000037: A DSMB shall comprise of at least three persons including a clinician with competence in the research field
p.000037: of the trial and a bio- statistician.
p.000037: In general, membership of the DSMB shall include:
p.000037: a. Individuals knowledgeable in the processes of conducting the trial, including requirements for
p.000037: research protocol amendments;
p.000037: b. Individuals with adequate medical, pharmaceutical, scientific, and/or ethics qualifications and
p.000037: clinical trial experience. The qualifications most appropriate for a specific DSMB will depend on the nature of
p.000037: the clinical trial and of the product under investigation.
p.000037: 3.6.2.2 Functions
p.000037: Functions of a DSMB are to:
p.000037: a. Ensure safety of study participants;
p.000037: b. Preserve the integrity and credibility of the trial;
p.000037: c. Ensure availability of definitive and
p.000037: reliable results in a timely manner;
p.000037: d. Make decisions related to safety, based on the submitted results and adverse event reports and recommend
p.000037: whether the study should continue or not.
p.000037: The DSMB shall report to the sponsor(s) of the trial:
p.000037: a. Any concerns over differences in serious adverse events between study arms;
p.000037: National Guidelines for Research involving Humans as Research Participants
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p.000037: injury or death.
p.000037: b. Any suspension or termination of approval shall include a written statement of the reasons for the REC’s
p.000037: action and shall be reported promptly to the researcher(s), appropriate organizational officials,
p.000037: UNCST and other relevant regulatory agencies.
p.000037: 4.6 REC Records
p.000037: RECs shall prepare and maintain adequate documentation of their activities, including the following:
p.000037: a. Detailed written standard operating procedures.
p.000037: National Guidelines for Research involving Humans as Research Participants
p.000037:
p.000037: b. Copies of all research proposals reviewed, scientific evaluations that accompany the proposals, approved
p.000037: consent documents, progress reports submitted by researchers, reports of injuries to research participants, etc.
p.000037: These records shall be kept for at least five (5) years after completion of the research project.
p.000037: c. Minutes of REC meetings, which shall be in sufficient detail to show attendance at the meetings,
p.000037: conflicts of interests declared, actions taken by the REC and the vote on these actions including number of
p.000037: members voting for, against, and abstaining, the basis for requiring changes in or disapproving research, and a
p.000037: written summary of discussions of controversial issues and their resolution.
p.000037: d. Copies of confidentiality agreements, CVs
p.000037: and training records of members.
p.000037: e. Records of continuing review activities.
p.000037: f. Copies of all correspondence between the REC and researchers.
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p.000037: research participant’s rights, or (2) appears to release the researcher, sponsor, organization, or its agents from
p.000037: liability.
p.000037: The researcher as well as the REC shall ensure continued adequacy of the informed consent process, and re-consent
p.000037: research participants if there are changes in the conditions or procedures of the research project or if
p.000037: new information becomes available that could affect the research participant’s willingness to continue in the
p.000037: research project.
p.000037: 5.3 Key Components of the Informed Consent Form
p.000037: 5.3.1 The information to be included in the informed consent form,
p.000037: which is provided to each potential research participant, shall include the following:
p.000037: a. A statement that this is a study rather than provision of clinical care; that the study involves research;
p.000037: an explanation about the research project; the estimated duration the research participant will take in the
p.000037: research project; a description of the study procedures, and identification of any other procedures that are
p.000037: experimental.
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p.000037: b. A description of any reasonably foreseeable risks or discomforts that the research participant may
p.000037: experience.
p.000037: c. A description of the benefits to the research participant or to others that may reasonably be expected to result
p.000037: from the research project.
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p.000037: the researchers or others that may relate to the research participant’s willingness to continue his or
p.000037: her participation, shall be provided to the research participant in a timely manner.
p.000037: f. The approximate number of individuals participating in the research study.
p.000037: g. Whether, when, how and for how long any of the products or interventions proven by the research project to be safe
p.000037: and effective will be made available to the research participants at the end of the study and whether
p.000037: they will be expected to pay for them.
p.000037: h. With regards to research involving the collection of human materials, an explanation should
p.000037: be provided on how specimens will be managed at the end of the study. If the samples will be stored for
p.000037: future use, separate consent should be obtained (See section on storage of human materials).
p.000037:
p.000037: 5.4 Documentation of Informed Consent Process
p.000037: The researcher shall document the informed consent process. In addition, and except as provided in
p.000037: section 5.5 below, research participants or their representative shall sign/ mark/thumbprint an informed consent
p.000037: form approved by a REC. The person obtaining the consent, and where applicable, the research participant’s witness
p.000037: shall also sign the form. Where the use of signed consent forms is not feasible, alternative viable
p.000037: methods should be employed. A copy shall be offered to the research participant or the research participant’s
p.000037: representative.
p.000037: The research participant or the research participant’s representative must be given sufficient time
p.000037: to read the consent form before the research participant or the research participant’s
p.000037: representative signs the form or places his or her thumbprint on the form indicating that he or she
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p.000037: justifiable reasons written consent may not be feasible. However, verbal consent must be documented. RECs
p.000037: reserve the right to determine when verbal informed consent may be appropriate and acceptable.
p.000037: 5.5 Waiver of Requirement for Informed Consent
p.000037: A REC may waive some of, or all of the requirements for the researcher to obtain informed consent
p.000037: and/or a signed /thumb printed consent form for some or all of the research participants of a
p.000037: particular study if the REC determines that:
p.000037: 18 UNCST
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p.000037:
p.000037: a. The research project carries no more than minimal risk, that is, risk that is no more than the risks encountered in
p.000037: normal daily life in a stable society;
p.000037: b. The research project could not practicably be carried out without the waiver or alteration (whenever
p.000037: appropriate the research participants will be provided with additional pertinent information after
p.000037: participation);
p.000037: c. In situations where deception needs to be applied to achieve the objectives of the study;
p.000037: d. The only record linking the research participant and the research project would be the informed
p.000037: consent form and the risk to the research participant would be potential harm resulting from a breach of
p.000037: confidentiality;
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p.000037: REC, sponsor and researcher shall agree on an appropriate mechanism for arbitration.
p.000037: 6.6 Compensation for Participation in Research
p.000037: Research participants shall be fairly compensated for inconveniences, time spent and expenses
p.000037: incurred in taking part in a study such as travel costs, refreshments, meals, and any other compensation deemed
p.000037: appropriate by the REC. Research participants may also receive free medical services.
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p.000037: National Guidelines for Research involving Humans as Research Participants
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p.000037: The compensation or medical services shall not be out of proportion as to induce prospective
p.000037: research participants to consent to participate in the research against their better judgment.
p.000037: 6.7 Incentives for Research Participation
p.000037: Incentives to research participants for their participation in research projects shall not be considered
p.000037: a research benefit, but a recruitment incentive, and should not present undue inducement to potential
p.000037: research participants.
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p.000037: National Guidelines for Research involving Humans as Research Participants
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p.000037: Notification to the REC and where applicable the collaborating organization’s REC or any other regulatory bodies
p.000037: should be made by the researcher within seven (7) calendar days of becoming aware of the event.
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p.000037: National Guidelines for Research involving Humans as Research Participants
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p.000037: 10.0 HUMAN MATERIALS
p.000037:
p.000037: Human materials are substances including, but not limited to, blood, urine, stool, saliva, hair, nail clippings, skin,
p.000037: and any other associated bio-products obtained from human research participants or patients or healthy persons.
p.000037: 10.1 Acquisition
p.000037: Any person who collects identifiable human materials shall ensure that appropriate informed consent
p.000037: has been obtained from the sample sources, including consent for storage for possible uses in future.
p.000037: Collection of samples should follow acceptable standard procedures.
p.000037: 10.2 Storage and Future Use
p.000037: A separate informed consent form shall be used for samples, which are collected with the intention of
p.000037: being stored and used in future studies. The consent form, which is separate from the one used for
p.000037: enrollment of research participants into the study, shall include the following components: purpose of sample
p.000037: storage, quantities of samples to be stored, place where samples will be stored, measures to protect
p.000037: confidentiality, policies that will govern use of the samples in future research, potential risks and benefits
p.000037: of storing samples for future research and any other information deemed necessary by the researcher or
p.000037: REC. After explaining the need to store the samples, the research participant shall be given the option to choose
p.000037: whether his/her sample should or should not be stored for future studies. A Ugandan scientist shall be included
p.000037: as co-investigator in all future studies using the human materials collected from Uganda. A research
p.000037: participant shall not be penalized for his/her refusal to store the samples. Research participants reserve
p.000037: the
p.000037: right to withdraw their samples from storage if the samples are linked. Any future research study on such samples is
p.000037: subject to review by a REC.
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p.000037: The materials being transferred/ exchanged must be fully described, including a description
p.000037: of derivative products, if any. Quantities must be specified and appropriately packaged.
p.000037: c. Purpose and usage
p.000037: The recipient should fully describe the intended use of the materials. The recipient should also
p.000037: specify whether
p.000037: National Guidelines for Research involving Humans as Research Participants
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p.000037: the materials would be used for research purposes only or for commercial applications or both.
p.000037: d. User(s)
p.000037: Authorized users of the materials should be mentioned. The users cited must agree to abide by the terms and conditions
p.000037: of the MTA. Transfer to third parties not mentioned in the MTA is prohibited without written consent
p.000037: of the provider organization or their assignees.
p.000037: e. Location
p.000037: The place (full address) where material is to be transferred, used and or stored should be indicated.
p.000037: f. Period of use of material
p.000037: A date for termination of use of the material may be set to avoid indefinite use of the material
p.000037: by the recipient organization. This date may be extended by written mutual consent of the parties. At the
p.000037: termination date, the provider organization may ask for the return of the material or its destruction. It
p.000037: should be noted that terminating use of the material does not render null and void other provisions of the
p.000037: MTA. It should be mentioned if the material would be stored for future unknown uses.
p.000037: g. Disposal of material
p.000037: A disposal plan for the materials must be described in the MTA, including methods of disposal. Disposal of material
p.000037: must be sufficiently documented.
p.000037: h. Restrictions
p.000037: If there are specific restrictions for the
p.000037: recipient organization, they should be
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p.000037: Parties must, however, make provisions for benefit sharing of any accruing or anticipated future benefit at
p.000037: the point of termination.
p.000037: When preparing MTAs care should be taken not to contravene provisions of other existing agreements pertaining to the
p.000037: human material in question. If, for example, the human material is to be used together with a material
p.000037: governed by a separate MTA, care should be taken under such circumstances to avoid granting two or more
p.000037: parties conflicting rights to the same material or product.
p.000037: Usually before negotiating a MTA, parties correspond by mail to reach consensus on particular issues
p.000037: regarding the material. Such correspondences, which include, for example, signed letters indicating consent or
p.000037: willingness to exchange, transfer or acquire the material, may be attached as annexes to the MTA.
p.000037: Where parties have a memorandum of understanding (MoU) to exchange, transfer or acquire human
p.000037: materials within a given research programme over a specified period of time, the MTA should be prepared within
p.000037: the framework of the MoU. The MoU usually does not specify details of the human materials, but allows in principle,
p.000037: the exchange, transfer or acquisition of the human materials.
p.000037: National Guidelines for Research involving Humans as Research Participants
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p.000037: 10.5 Procedure for Exchange/Transfer of Human Materials Abroad or From Abroad for Research Purposes
p.000037: The following are the necessary steps for the exchange or transfer of materials for research purposes abroad or from
p.000037: abroad:
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p.000037: research project.
p.000037: d. Researchers shall ensure that research records from which the data has been obtained are available at
p.000037: the research site for at least five years after completion of the research project. Electronic records are
p.000037: acceptable.
p.000037: 11.3 Results Dissemination
p.000037: a. Researchers shall, as appropriate, make all reasonable efforts to share findings of research with
p.000037: the host organization, research participants, key stakeholders and communities in which research was done.
p.000037: b. Researchers shall describe in the protocol plans for research results dissemination and ensure its
p.000037: execution.
p.000037: c. Researchers shall be sensitive about the ethical implications of the research results, and take
p.000037: appropriate measures to protect research participants and their communities.
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p.000037: 12.0 COMMUNITY ENGAGEMENT
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p.000037: 12.1 Introduction
p.000037: Researchers shall make reasonable effort to involve community stakeholders in the research process,
p.000037: where appropriate, right from the inception of research to post research period. Community stakeholders may
p.000037: include individuals and groups that are ultimately representing the interests of people who would be recruited to
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Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| HIV | HIV/AIDS |
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| age | Diminished Autonomy |
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| capacity | Fetus/Neonate |
| child | Child |
| children | Child |
| coercion | Presence of Coercion |
| cultural | Cultural Differences |
| culture | Cultural Differences |
| dependency | Drug Dependence |
| dependent | Dependent |
| diminished | Illegal Activity |
| disability | Mentally Disabled |
| displaced | Captive/Exiled Population |
| drug | Drug Usage |
| economic | Economic/Poverty |
| education | Educational |
| educational | Educational |
| emergency | Youth/Minors |
| family | Motherhood/Family |
| fetus | Fetus/Neonate |
| gender | Gender |
| health | Health |
| homeless | Homeless Persons |
| ill | Physically Ill |
| illiterate | Literacy |
| illness | Physically Ill |
| impaired | Cognitive Impairment |
| impairment | Cognitive Impairment |
| incapable | Mentally Incapacitated |
| incapacitated | Incapacitated |
| incapacity | Incapacitated |
| incompetent | LGBTQ+ in NA |
| indigenous | Indigenous |
| infant | Infant |
| influence | Drug Usage |
| justice | Breastfeeding Children |
| language | Linguistic Proficiency |
| literacy | Literacy |
| married | Marital Status |
| mentally | Mentally Disabled |
| minor | Youth/Minors |
| minors | Youth/Minors |
| necessities | Access to Social Goods |
| officer | Police Officer |
| opinion | Philosophical Differences/Difference of Opinion |
| party | Political |
| physically | LGBTQ+ Status |
| pregnant | Pregnant |
| prisoners | Criminal Convictions |
| religious | Religion |
| restricted | Incarcerated |
| social | Social |
| special | Religion |
| student | Student |
| substance | Drug Usage |
| terminally | Terminally Ill |
| undue influence | Undue Influence |
| vulnerability | Other Country |
| vulnerable | Child |
| welfare | Welfare Recipient |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| access | ['necessities'] |
| capacity | ['fetus'] |
| child | ['children', 'vulnerable'] |
| children | ['child', 'vulnerable'] |
| cultural | ['culture'] |
| culture | ['cultural'] |
| disability | ['mentally'] |
| drug | ['influence', 'substance'] |
| education | ['educational'] |
| educational | ['education'] |
| emergency | ['minor', 'minors'] |
| fetus | ['capacity'] |
| ill | ['illness'] |
| illiterate | ['literacy'] |
| illness | ['ill'] |
| impaired | ['impairment'] |
| impairment | ['impaired'] |
| incapacitated | ['incapacity'] |
| incapacity | ['incapacitated'] |
| influence | ['drug', 'substance'] |
| literacy | ['illiterate'] |
| mentally | ['disability'] |
| minor | ['minors', 'emergency'] |
| minors | ['minor', 'emergency'] |
| necessities | ['access'] |
| religious | ['special'] |
| special | ['religious'] |
| substance | ['influence', 'drug'] |
| vulnerable | ['child', 'children'] |
Trigger Words
consent
developing
ethics
harm
protect
protection
risk
self-determination
sensitive
volunteer
vulnerable
Applicable Type / Vulnerability / Indicator Overlay for this Input