79C3C34C52B45572883A05D425EB0F82

Building Research Ethics Review Capacity in Swaziland

http://www.cohred.org/wp-content/uploads/2011/05/SwazilandRECTrainingFinalReport.pdf

http://leaux.net/URLS/ConvertAPI Text Files/AAFFCACEF06E000BD3678E54FFC98854.en.txt

Examining the file media/Synopses/AAFFCACEF06E000BD3678E54FFC98854.html:

This file was generated: 2020-12-01 09:20:33

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

Vulnerability Type	Vulnerability	Indicator	# Matches
Political	vulnerable	vulnerable	9
Political	vulnerable	vulnerability	2
Health	HIV/AIDS	HIV	1
Health	HIV/AIDS	hiv/aids	0
Health	stem cells	stem cells	2
Health	visual impairment	blind	2
Social	Access to Social Goods	access	2
Social	Fetus/Neonate	fetuses	3
Social	Linguistic Proficiency	language	1
Social	Occupation	job	1
Social	Police Officer	officer	1
Social	Women	women	1
Social	education	education	1
Social	gender	gender	2
Social	philosophical differences/differences of opinion	philosophy	1
Economic	Economic/Poverty	poor	2
General/Other	Impaired Autonomy	autonomy	1
General/Other	Public Emergency	emergency	2
General/Other	Relationship to Authority	authority	2
General/Other	belmont	belmont	1
General/Other	cioms guidelines	cioms	1
General/Other	declaration of helsinki	helsinki	1
General/Other	participants in a control group	placebo	3

Political / vulnerable

Searching for indicator vulnerable:

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p.000005: to ensure that RECs operate with a clear mandate, authority, accountability and autonomy.
p.000005:
p.000005: Currently, over 173 RECs are known to be operating in 37 African countries with great variability in skills,
p.000005: membership, resources and capacity (www.researchethicsweb.org)4. Presently, the Swaziland Scientific
p.000005: and Ethics Committee (SEC) is faced with lack of capacity, which is characterised by
p.000005: undefined structures, limited research ethics knowledge, skills as well as resources. The situation
p.000005: is worsened by the increasing concerns about the self-instituted SEC’s inadequacy in the health research
p.000005: regulatory framework, and its capacity to handle the ever- increasing volume and complexity of the
p.000005: national and international research conducted in Swaziland. Therefore, there is an urgent need to
p.000005: collaboratively build and strengthen the capacity of the research oversight framework in Swaziland to promote
p.000005: and improve the ethical review
p.000005:
p.000006: 6
p.000006:
p.000006: quality and throughput systems. This requires continued training to avoid potential violation of the rights of research
p.000006: participant’s particularly vulnerable populations.
p.000006:
p.000006: Although there is research recognition in Swaziland, there is still a lack of research culture, limited coordination,
p.000006: governance, management and funding. Currently, there is no research agenda and research guidelines for the
p.000006: conduct of human research although the SEC has drafted a guiding document. At present, there is no
p.000006: budgetary allocation for research governance and at a very low scale, SEC manages and conducts ethics reviews although
p.000006: Swaziland has been trying to establish a research coordinating body for quite some time.
p.000006:
p.000006: Objectives
p.000006: To conduct basic research ethics training.
p.000006: To identify and discuss practical ethical challenges and dilemmas encountered in the conduct of human
p.000006: subjects research in Swaziland.
p.000006: To assist participants strengthen their research ethics committee and improve the quality of the research ethics
p.000006: oversight in Swaziland.
p.000006: To guide the Swaziland SEC on the next steps for improving research ethics capacity in Swaziland.
p.000006: To establish country level partnership with Swaziland.
p.000006:
p.000006:
p.000006: Expected Outcomes of the Workshop
p.000006:
p.000006: The training of SEC members is expected to result into:
p.000006: Strengthening of legal framework for the National Research Ethics Committee (NHREC). Guidance on the role of the
p.000006: research unit on SEC operation.
...

p.000007: experiences from real situations.
p.000007:
p.000007: Fundamental softcopy reading materials were provided ahead of the workshop, this included: international
p.000007: research ethics codes and regulations such as the Nuremberg Code (1947), the World Medical Assembly of the
p.000007: Declaration Of Helsinki (1964-2013), the Belmont Report (1974), the 2002 Council for International
p.000007: Organizations of Medical Sciences (CIOMS)/WHO) and ICH/GCP- International Conference Tripartite on
p.000007: Harmonization-Good Clinical Practice. The pre-test results reflected that most participants actually read the
p.000007: above highlighted documents. All the training materials were shared with participants in a USB for easy
p.000007: readability and future use. The movie “Constant Gardner” was watched and participants had to analyse the
p.000007: ethical and practical issues that can arise during the informed consent process in a research setting. Details of
p.000007: theoretical and practical topics covered are shown in the workshop program (Annex 1).
p.000007:
p.000007: Topics covered included; the background and importance of research ethics using examples of research
p.000007: atrocities that gave rise to research ethics. Theoretical topics such as fundamental principles of
p.000007: research ethics, vulnerable populations, risk/benefit analysis, informed consent, confidentiality in the African
p.000007: context, institutionalizing research ethics committees, compensating research participants, dissemination of
p.000007: research results and research misconduct, in-depth analysis of the ethics review process, ethical
p.000007: issues in international collaborative research and public health research ethics were covered. Specific practical
p.000007: sessions were designed in such a way that they link to the theoretical topic and all the participants (see annexes
p.000007: 2,3,4).
p.000008: 8
p.000008:
p.000008: A post-test was administered on the last day of the workshop to evaluate the knowledge acquired from the weeklong
p.000008: training. The lowest mark from the pre-test was 40% and the highest was 75%. Results from the post-test showed
p.000008: significant improvement in knowledge with the lowest mark being 45% and the highest being 80%.
p.000008:
p.000008: Figure 1: Pre and Post Test Results
p.000008:
p.000008:
p.000008: Participant Code 001
p.000002: 002
p.000003: 003
p.000004: 004
p.000005: 005
p.000006: 006
p.000007: 007
p.000008: 008
p.000009: 009
p.000014: 0014
p.000015: 0015
p.000016: 0016
p.000016: Pre-test Mark (%)
p.000055: 55
p.000055: 55
p.000065: 65
p.000050: 50
p.000040: 40
p.000050: 50
p.000050: 50
p.000075: 75
p.000075: 75
p.000045: 45
p.000080: 80
p.000080: Absent
p.000080: Post-test Mark (%)
p.000080: Absent 60
p.000080: 80
p.000065: 65
p.000065: 65
p.000065: 65
p.000065: 65
p.000060: 60
p.000075: 75
p.000030: 30
p.000030: Absent 60
p.000030:
...

p.000011: by prioritizing according to a rating scale of: 1= Must be taught, 2= Can be taught if time allows 3= No need to be
p.000011: taught. Results are reflected in table two below.
p.000011:
p.000011: Table 2: Rating of Research Ethics topics to be included in the training curriculum
p.000011:
p.000011:
p.000011: Topic
p.000011: Foundational Bioethics (History, Philosophy, moral reasoning, fundamental principles, ethical Codes)
p.000011: Establishment of RECs
p.000011: Drafting National Research Guiding Documents (Application forms, Research Guidelines, SOPs, Research Bill)
p.000011: Responsibilities of the Sponsor, Investigator, Institution Participant and RECs in the research ethics review
p.000011: process
p.000011: Ethical issues regarding: Study designs and methodology
p.000011: Challenges of conducting international research in developing countries Science of Clinical Trials and Scientific
p.000011: Evaluation of Clinical Trial Protocols Informed consent
p.000011: Risk /Benefit Analysis
p.000011: Essential Elements of the REC Review process (Expedited/Full, continuing review, amendments, close
p.000011: outs, adverse events)
p.000011: Informed Consent Process
p.000011: Special topics in research ethics: Vulnerable Participants, Privacy and confidentiality, Compensating research
p.000011: participants, Conflict of interest
p.000011: Monitoring an Auditing approved studies Participant Recruitment Procedures
p.000011: Dissemination of study results and research misconduct Quality Assurance Guidance and Legal Enforcements Organizing and
p.000011: Administering Research Ethics Committees Public Health Ethics
p.000011: Grant Proposal writing
p.000011: GROUP 1
p.000001: 1
p.000001:
p.000001: 1
p.000001: 1
p.000001:
p.000002: 2
p.000002:
p.000002: 2
p.000002: 2
p.000002: 2
p.000002: 2
p.000001: 1
p.000001: 1
p.000001:
p.000001: 1
p.000001: 1
p.000001:
p.000001: 1
p.000001: 1
p.000001: 1
p.000001: 1
p.000001: 1
p.000001: 1
p.000001: 1
p.000001: GROUP 2
p.000001: 1
p.000001:
p.000001: 1
p.000001: 1
p.000001:
p.000001: 1
p.000001:
p.000002: 2
p.000002: 2
p.000002: 2
p.000002: 2
p.000001: 1
p.000001: 1
p.000001:
p.000002: 2
p.000001: 1
p.000001:
p.000002: 2
p.000001: 1
p.000002: 2
p.000001: 1
p.000001: 1
p.000001: 1
p.000001: 1
p.000001:
p.000001: The above ratings conclude that participants needed further continued training on both basic and advanced research
p.000001: ethics topics. Participants were also exposed to the current direction that other countries are taking, in order to
p.000001: improve the management of the ethics review process, by using a web-based platform known as: Research
p.000001: for Health Innovation Organizer (RHInnO; www.rhinno.net). RHInnO was developed by COHRED and is
p.000001: intended to replace the current complex paper based system widely used by RECs across Africa5. The advantages of
...

p.000015: Participants NREC
p.000015: Chairperson
p.000015:
p.000015:
p.000015: Activities
p.000015:
p.000015:
p.000015: 10:00 am – 10:20 am
p.000015: Social Break
p.000015:
p.000015:
p.000015: 10:20am – 11:00am
p.000015: Background and Importance of Health Research Ethics BM
p.000015:
p.000015:
p.000015: 11:00 am – 12:30 pm
p.000015:
p.000015: 12:30 pm – 13:30 pm
p.000015:
p.000015: 13:30 pm – 16:00 pm
p.000015:
p.000015: 16:00pm – 16:30 pm
p.000015: Fundamentals of Research Ethics
p.000015:
p.000015: Lunch
p.000015:
p.000015: Case Study: 1 Wrap Up
p.000015:
p.000015: MK
p.000015:
p.000015:
p.000015:
p.000015: Group Work
p.000015:
p.000015:
p.000015: Tuesday 23rd July
p.000015: Activities
p.000015:
p.000015: Responsible
p.000015:
p.000015:
p.000015: 8:15 am –08:30am
p.000015:
p.000015: 08:30am – 08:45am
p.000015:
p.000015: 08:45am – 10:45am
p.000015: Registration
p.000015:
p.000015: Recap of Day one Participant
p.000015:
p.000015: Informed Consent Process BM
p.000015: Activities
p.000015:
p.000015:
p.000015: 10:45 am – 11:00 am
p.000015: Social Break
p.000015:
p.000015:
p.000015: 11:00am – 12:00pm
p.000015: Case Study 2
p.000015: Group Work
p.000015:
p.000015:
p.000015: 12:00 am – 13:00 pm
p.000015:
p.000015: 13:00 pm – 14:00 pm
p.000015:
p.000015: 14:00 pm – 16:00 pm
p.000015:
p.000015: 16:00 pm – 16:30 pm
p.000015: Risk/Benefit Analysis and Standard of Care
p.000015:
p.000015: Lunch
p.000015:
p.000015: Research with Vulnerable Populations Wrap up
p.000015: MK
p.000015:
p.000015:
p.000015:
p.000015: Group Work
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000016: 16
p.000016:
p.000016: Wednesday 24th July
p.000016:
p.000016:
p.000016: 8:15 am –08:30am
p.000016: Activities
p.000016:
p.000016: Registration
p.000016:
p.000016: Responsible
p.000016:
p.000016: Activities
p.000016:
p.000016:
p.000016: 08:30am – 08:45am
p.000016: Recap of Day two
p.000016: Volunteer
p.000016:
p.000016:
p.000016: 08:45am -10:30am
p.000016:
p.000016: 10:30 am – 11:00 am
p.000016: Institutionalizing Research Committees MK
p.000016:
p.000016: Social Break
p.000016:
p.000016:
p.000016: 11:00 am – 13:00 pm
p.000016: Group Exercise & Discussion MK
p.000016:
p.000016:
p.000016: 13:00 pm – 14:00 pm
p.000016:
p.000016: 14:00 pm – 15:00 pm
p.000016:
p.000016: 15:00pm – 16:00pm
p.000016:
p.000016: 16:00 pm – 16:30 pm
p.000016: Lunch
p.000016:
p.000016: Compensating Research Participants MK
p.000016:
p.000016: Confidentiality in the African Context BM
p.000016:
p.000016: Wrap Up
p.000016:
p.000016:
p.000016: Thursday 25th July
p.000016: Activities
p.000016:
p.000016: Responsible
p.000016:
p.000016:
p.000016: 8:15 am –08:30am
p.000016: Registration
p.000016:
p.000016:
p.000016: 08:30am – 08:45am
p.000016:
p.000016: 08:45am – 10:30am
p.000016:
p.000016: 10:30 am – 11:00 am
p.000016:
p.000016: 11:00 am – 11:45 pm
p.000016:
p.000016: 11:45am – 13:00pm
p.000016:
p.000016: 13:00 pm – 14:00 pm
p.000016:
p.000016: 14:00 pm – 16:00 pm
p.000016:
p.000016: 16:00 pm – 16:30 pm
p.000016:
p.000016: Friday 26 th July
p.000016: Recap of Day three
p.000016:
...

p.000017: providing no treatment?
p.000017:
p.000017: 4. How might Dr W demonstrate that this method is effective (other than by conducting a controlled clinical trial)? Is
p.000017: there an international standard for determining effectiveness?
p.000017:
p.000017: 5. In a hospital setting, whose responsibility is it to monitor the activities of physicians? In general, whose
p.000017: Responsibility is it to monitor activities of physicians?
p.000017:
p.000017:
p.000018: 18
p.000018:
p.000018: Annex 3: Case Study 2: This case was based on a movie ‘The Constant Gardner’
p.000018:
p.000018:
p.000018: The movie (Constant gardener) was shot in Kibera, the largest slum in sub Saharan Africa, located in the capital city
p.000018: of Kenya, Nairobi. Second day of the training was kicked off with the viewing of the movie ‘Constant
p.000018: Gardener’, which was shot in Kibera, the largest slum in sub Saharan Africa, located in the East African country of
p.000018: Kenya. The movie shows Kenya as a developing country burdened with many public health challenges
p.000018: including HIV/AIDS and tuberculosis. Lesson learnt from the movie were highlighted by the importance of
p.000018: having an informed consent, and informed consent as a process rather than just signing the form. The
p.000018: importance of participants’ differentiates between routine clinical care and research, the importance of
p.000018: sensitizing and the public about research and also empowering them. Research conducted in vulnerable and
p.000018: impoverished with communities was also portrayed in the movie – and this highlighted the need for extra
p.000018: protections especially in circumstances were participants see that they only way to have access to treatment is through
p.000018: participation in research. This special vulnerability was also further discussed during the session on
p.000018: research with vulnerable populations.
p.000018: The need for a very simple, well documented and easily digestible consent form was noted, and the complexity of consent
p.000018: in the African context was discussed, with the role of the REC being outlined. Participants took keen interest in the
p.000018: discussions that followed the movie and tried to identify the ethical and practical implications of unethical conduct
p.000018: of the informed consent process in a research setting. Participants pointed out the research therapeutic misconception
p.000018: common in vulnerable research populations. They recommended the need to sensitize the public about
p.000018: research and empowering them. Participants also raised concerns about research conducted in vulnerable and
p.000018: impoverished communities as portrayed in the movie – and this highlighted the need for extra protections especially in
p.000018: circumstances were participants see that they only way to have access to treatment is through participation in
p.000018: research. This special vulnerability was also further discussed during the session on research with vulnerable
p.000018: populations. Participants recommended that consent forms should written in a simple language that participants
p.000018: understand, The complexity of the informed consent process in the African context was discussed at length, and the role
p.000018: of the REC in this process.
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000019: 19
p.000019:
p.000019: Annex 4: Case study 3: Establishing Research Ethics Committees
p.000019:
p.000019:
p.000019: This case study portrayed a scenario where Swaziland National Research Ethics Committee (NREC) was awarded
p.000019: a grant of $8 million over a period of three years to develop and implement strategies for setting up and
p.000019: strengthening the capacity of the NREC. Participants were requested to identify the major challenges
p.000019: currently hampering the establishment of a NREC; propose short and long term solutions to these
p.000019: challenges. Using the findings from the needs assessment study implement the identified needs to come up
p.000019: with a country and regional plan to promote the regulatory oversight system in Swaziland. The results of this
p.000019: exercise are shown in Table 1 above.
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019: Challenges identified
p.000019: Objective
p.000019: Short-term solution
p.000019: Long-term solution
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
...

Searching for indicator vulnerability:

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p.000017:
p.000017:
p.000018: 18
p.000018:
p.000018: Annex 3: Case Study 2: This case was based on a movie ‘The Constant Gardner’
p.000018:
p.000018:
p.000018: The movie (Constant gardener) was shot in Kibera, the largest slum in sub Saharan Africa, located in the capital city
p.000018: of Kenya, Nairobi. Second day of the training was kicked off with the viewing of the movie ‘Constant
p.000018: Gardener’, which was shot in Kibera, the largest slum in sub Saharan Africa, located in the East African country of
p.000018: Kenya. The movie shows Kenya as a developing country burdened with many public health challenges
p.000018: including HIV/AIDS and tuberculosis. Lesson learnt from the movie were highlighted by the importance of
p.000018: having an informed consent, and informed consent as a process rather than just signing the form. The
p.000018: importance of participants’ differentiates between routine clinical care and research, the importance of
p.000018: sensitizing and the public about research and also empowering them. Research conducted in vulnerable and
p.000018: impoverished with communities was also portrayed in the movie – and this highlighted the need for extra
p.000018: protections especially in circumstances were participants see that they only way to have access to treatment is through
p.000018: participation in research. This special vulnerability was also further discussed during the session on
p.000018: research with vulnerable populations.
p.000018: The need for a very simple, well documented and easily digestible consent form was noted, and the complexity of consent
p.000018: in the African context was discussed, with the role of the REC being outlined. Participants took keen interest in the
p.000018: discussions that followed the movie and tried to identify the ethical and practical implications of unethical conduct
p.000018: of the informed consent process in a research setting. Participants pointed out the research therapeutic misconception
p.000018: common in vulnerable research populations. They recommended the need to sensitize the public about
p.000018: research and empowering them. Participants also raised concerns about research conducted in vulnerable and
p.000018: impoverished communities as portrayed in the movie – and this highlighted the need for extra protections especially in
p.000018: circumstances were participants see that they only way to have access to treatment is through participation in
p.000018: research. This special vulnerability was also further discussed during the session on research with vulnerable
p.000018: populations. Participants recommended that consent forms should written in a simple language that participants
p.000018: understand, The complexity of the informed consent process in the African context was discussed at length, and the role
p.000018: of the REC in this process.
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000019: 19
p.000019:
p.000019: Annex 4: Case study 3: Establishing Research Ethics Committees
p.000019:
p.000019:
p.000019: This case study portrayed a scenario where Swaziland National Research Ethics Committee (NREC) was awarded
p.000019: a grant of $8 million over a period of three years to develop and implement strategies for setting up and
p.000019: strengthening the capacity of the NREC. Participants were requested to identify the major challenges
p.000019: currently hampering the establishment of a NREC; propose short and long term solutions to these
p.000019: challenges. Using the findings from the needs assessment study implement the identified needs to come up
p.000019: with a country and regional plan to promote the regulatory oversight system in Swaziland. The results of this
p.000019: exercise are shown in Table 1 above.
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019: Challenges identified
p.000019: Objective
p.000019: Short-term solution
...

Health / HIV/AIDS

Searching for indicator HIV:

(return to top)
p.000017:
p.000017: Questions
p.000017: 1. Is Dr W providing innovative therapy; conducting an experiment; or carrying out medical research? How are these
p.000017: different, generally or in this case?
p.000017:
p.000017: 2. Would it be unethical to conduct a placebo-controlled trial, as Dr W maintains?
p.000017:
p.000017: 3. How does the use of placebo in a setting where “no treatment” is the standard of care differ ethically from simply
p.000017: providing no treatment?
p.000017:
p.000017: 4. How might Dr W demonstrate that this method is effective (other than by conducting a controlled clinical trial)? Is
p.000017: there an international standard for determining effectiveness?
p.000017:
p.000017: 5. In a hospital setting, whose responsibility is it to monitor the activities of physicians? In general, whose
p.000017: Responsibility is it to monitor activities of physicians?
p.000017:
p.000017:
p.000018: 18
p.000018:
p.000018: Annex 3: Case Study 2: This case was based on a movie ‘The Constant Gardner’
p.000018:
p.000018:
p.000018: The movie (Constant gardener) was shot in Kibera, the largest slum in sub Saharan Africa, located in the capital city
p.000018: of Kenya, Nairobi. Second day of the training was kicked off with the viewing of the movie ‘Constant
p.000018: Gardener’, which was shot in Kibera, the largest slum in sub Saharan Africa, located in the East African country of
p.000018: Kenya. The movie shows Kenya as a developing country burdened with many public health challenges
p.000018: including HIV/AIDS and tuberculosis. Lesson learnt from the movie were highlighted by the importance of
p.000018: having an informed consent, and informed consent as a process rather than just signing the form. The
p.000018: importance of participants’ differentiates between routine clinical care and research, the importance of
p.000018: sensitizing and the public about research and also empowering them. Research conducted in vulnerable and
p.000018: impoverished with communities was also portrayed in the movie – and this highlighted the need for extra
p.000018: protections especially in circumstances were participants see that they only way to have access to treatment is through
p.000018: participation in research. This special vulnerability was also further discussed during the session on
p.000018: research with vulnerable populations.
p.000018: The need for a very simple, well documented and easily digestible consent form was noted, and the complexity of consent
p.000018: in the African context was discussed, with the role of the REC being outlined. Participants took keen interest in the
p.000018: discussions that followed the movie and tried to identify the ethical and practical implications of unethical conduct
p.000018: of the informed consent process in a research setting. Participants pointed out the research therapeutic misconception
...

Searching for indicator hiv/aids:

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Health / stem cells

Searching for indicator stem cells:

(return to top)
p.000016: Participant
p.000016:
p.000016:
p.000016: 08:45am – 09:15am
p.000016:
p.000016: 09:15am – 11:00am
p.000016:
p.000016:
p.000016: 11:00 am – 11:20 am
p.000016: Post-Test
p.000016:
p.000016: Dissemination of Research Results & Research Misconduct
p.000016:
p.000016: Social Break
p.000016: Participants MK
p.000016:
p.000016:
p.000016: 11:00 am – 11:45 pm
p.000016:
p.000016: 11:45am – 12:45pm
p.000016:
p.000016: 12:45pm – 13:00pm
p.000016:
p.000016: 13:00pm – 13:15pm
p.000016:
p.000016: 13:30 pm – 14:30 pm
p.000016: Public Health Research Ethics
p.000016:
p.000016: Exercise: Swaziland NREC Capacity Building Wrap up
p.000016: Closing remarks
p.000016:
p.000016: Lunch
p.000016: MK
p.000016:
p.000016: Group work BM
p.000016: MoH CDC
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000017: 17
p.000017:
p.000017: Annex 2: Case Study 1: A treatment for Central Nervous System.
p.000017:
p.000017: This case study was aimed to at assisting participants to differentiate between clinical care and
p.000017: research and appreciating the thin line between the two.
p.000017: Dr W is a neurosurgeon in a hospital in one of Asia’s major metropolitan centres. He earned his medical degree in that
p.000017: city and then studied in the United States of America before returning to practise in his own country. Over the past 3
p.000017: years, Dr W has treated more than 500 patients with central nervous system (CNS) conditions
p.000017: – including amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig’s disease), Parkinson’s disease, stroke,
p.000017: paraplegia, and tetraplegia – by injecting these patients’ brains or spinal cords with olfactory stem cells harvested
p.000017: from the noses of aborted fetuses. Dr W is convinced that this intervention, which he describes to patients as an
p.000017: “innovative therapy,” is effective, and he has declined to conduct a controlled clinical trial of this
p.000017: method. Cell transplantation experiments have been undertaken for several decades and continue to be pursued in
p.000017: several countries. Dr W’s method is unique, however, because he uses olfactory ensheathing cells from fetuses
p.000017: aborted at 16 weeks. The women who agree to allow the cell harvesting of their aborted fetuses
p.000017: all provide consent and do not receive payment or other compensation. Using a hypodermic syringe, Dr
p.000017: W transplants the culled cells into paralysed patients above and below the damaged area of the spinal cord; ALS
p.000017: patients receive the injections directly into the atrophied area of the frontal lobe of the brain, through a small hole
p.000017: drilled in the skull (a burr hole).
p.000017:
p.000017: Despite having only an incomplete explanation of how the injections produce their results, Dr W is convinced by his
p.000017: patients’ outcomes that the method works. Both lay and medical publications have reported the positive results of the
p.000017: treatment, and Dr W recently submitted an article to a local journal describing his success. Many of
p.000017: his current patients come from other countries to receive his treatment. Long-term follow-up data on Dr
p.000017: W’s work remains preliminary. However, patients – particularly those who have spinal injuries – whom he
p.000017: has contacted by e-mail several months after their operations have reported continued progress. The only adverse
p.000017: effect noted had been pain that accompanied restoration of feeling in some patients. Dr W claims that the
p.000017: surgery stabilizes the condition in about 50% of his patients, and that it causes an improvement in the quality of
p.000017: life (QOL) in about 70% of patients. His estimates are derived from videos he has taken of patients before and after
p.000017: surgery, as well as a survey he conducted of 142 patients, using criteria for function assessment established by a
p.000017: North American spinal injury association.
p.000017:
p.000017: a spinal neurosurgery programme at a leading North American university, have urged him to conduct
p.000017: double-blind trials to meet the scientific standards of developed countries. Since no recognized treatments
p.000017: can reverse the CNS conditions that his patients have, the intervention given to the control group in
p.000017: a double-blind study would be an injection of an inert fluid instead of the stem cells or “sham surgery” on the
p.000017: skull or spine (surgery to drill a hole and then close up the site, without putting in any cells). Research trials of
p.000017: this type have been used previously for other cellular treatments for neurological diseases, but Dr W refuses
p.000017: to do this, asserting that such studies would be unethical. “Even if the whole world refuses to believe me, I
p.000017: would not do a control test,” he says. “These patients are already suffering. If we open them up just for a
p.000017: placebo test, it will only do them harm. We would be doing it for ourselves not for the patient.”
p.000017:
p.000017: Questions
p.000017: 1. Is Dr W providing innovative therapy; conducting an experiment; or carrying out medical research? How are these
p.000017: different, generally or in this case?
p.000017:
p.000017: 2. Would it be unethical to conduct a placebo-controlled trial, as Dr W maintains?
p.000017:
p.000017: 3. How does the use of placebo in a setting where “no treatment” is the standard of care differ ethically from simply
p.000017: providing no treatment?
p.000017:
p.000017: 4. How might Dr W demonstrate that this method is effective (other than by conducting a controlled clinical trial)? Is
p.000017: there an international standard for determining effectiveness?
p.000017:
p.000017: 5. In a hospital setting, whose responsibility is it to monitor the activities of physicians? In general, whose
p.000017: Responsibility is it to monitor activities of physicians?
p.000017:
p.000017:
p.000018: 18
p.000018:
p.000018: Annex 3: Case Study 2: This case was based on a movie ‘The Constant Gardner’
p.000018:
p.000018:
...

Health / visual impairment

Searching for indicator blind:

(return to top)
p.000017: W transplants the culled cells into paralysed patients above and below the damaged area of the spinal cord; ALS
p.000017: patients receive the injections directly into the atrophied area of the frontal lobe of the brain, through a small hole
p.000017: drilled in the skull (a burr hole).
p.000017:
p.000017: Despite having only an incomplete explanation of how the injections produce their results, Dr W is convinced by his
p.000017: patients’ outcomes that the method works. Both lay and medical publications have reported the positive results of the
p.000017: treatment, and Dr W recently submitted an article to a local journal describing his success. Many of
p.000017: his current patients come from other countries to receive his treatment. Long-term follow-up data on Dr
p.000017: W’s work remains preliminary. However, patients – particularly those who have spinal injuries – whom he
p.000017: has contacted by e-mail several months after their operations have reported continued progress. The only adverse
p.000017: effect noted had been pain that accompanied restoration of feeling in some patients. Dr W claims that the
p.000017: surgery stabilizes the condition in about 50% of his patients, and that it causes an improvement in the quality of
p.000017: life (QOL) in about 70% of patients. His estimates are derived from videos he has taken of patients before and after
p.000017: surgery, as well as a survey he conducted of 142 patients, using criteria for function assessment established by a
p.000017: North American spinal injury association.
p.000017:
p.000017: a spinal neurosurgery programme at a leading North American university, have urged him to conduct
p.000017: double-blind trials to meet the scientific standards of developed countries. Since no recognized treatments
p.000017: can reverse the CNS conditions that his patients have, the intervention given to the control group in
p.000017: a double-blind study would be an injection of an inert fluid instead of the stem cells or “sham surgery” on the
p.000017: skull or spine (surgery to drill a hole and then close up the site, without putting in any cells). Research trials of
p.000017: this type have been used previously for other cellular treatments for neurological diseases, but Dr W refuses
p.000017: to do this, asserting that such studies would be unethical. “Even if the whole world refuses to believe me, I
p.000017: would not do a control test,” he says. “These patients are already suffering. If we open them up just for a
p.000017: placebo test, it will only do them harm. We would be doing it for ourselves not for the patient.”
p.000017:
p.000017: Questions
p.000017: 1. Is Dr W providing innovative therapy; conducting an experiment; or carrying out medical research? How are these
p.000017: different, generally or in this case?
p.000017:
p.000017: 2. Would it be unethical to conduct a placebo-controlled trial, as Dr W maintains?
p.000017:
p.000017: 3. How does the use of placebo in a setting where “no treatment” is the standard of care differ ethically from simply
p.000017: providing no treatment?
p.000017:
p.000017: 4. How might Dr W demonstrate that this method is effective (other than by conducting a controlled clinical trial)? Is
p.000017: there an international standard for determining effectiveness?
p.000017:
p.000017: 5. In a hospital setting, whose responsibility is it to monitor the activities of physicians? In general, whose
p.000017: Responsibility is it to monitor activities of physicians?
p.000017:
p.000017:
...

Searching for indicator access:

(return to top)
p.000017:
p.000017: 5. In a hospital setting, whose responsibility is it to monitor the activities of physicians? In general, whose
p.000017: Responsibility is it to monitor activities of physicians?
p.000017:
p.000017:
p.000018: 18
p.000018:
p.000018: Annex 3: Case Study 2: This case was based on a movie ‘The Constant Gardner’
p.000018:
p.000018:
p.000018: The movie (Constant gardener) was shot in Kibera, the largest slum in sub Saharan Africa, located in the capital city
p.000018: of Kenya, Nairobi. Second day of the training was kicked off with the viewing of the movie ‘Constant
p.000018: Gardener’, which was shot in Kibera, the largest slum in sub Saharan Africa, located in the East African country of
p.000018: Kenya. The movie shows Kenya as a developing country burdened with many public health challenges
p.000018: including HIV/AIDS and tuberculosis. Lesson learnt from the movie were highlighted by the importance of
p.000018: having an informed consent, and informed consent as a process rather than just signing the form. The
p.000018: importance of participants’ differentiates between routine clinical care and research, the importance of
p.000018: sensitizing and the public about research and also empowering them. Research conducted in vulnerable and
p.000018: impoverished with communities was also portrayed in the movie – and this highlighted the need for extra
p.000018: protections especially in circumstances were participants see that they only way to have access to treatment is through
p.000018: participation in research. This special vulnerability was also further discussed during the session on
p.000018: research with vulnerable populations.
p.000018: The need for a very simple, well documented and easily digestible consent form was noted, and the complexity of consent
p.000018: in the African context was discussed, with the role of the REC being outlined. Participants took keen interest in the
p.000018: discussions that followed the movie and tried to identify the ethical and practical implications of unethical conduct
p.000018: of the informed consent process in a research setting. Participants pointed out the research therapeutic misconception
p.000018: common in vulnerable research populations. They recommended the need to sensitize the public about
p.000018: research and empowering them. Participants also raised concerns about research conducted in vulnerable and
p.000018: impoverished communities as portrayed in the movie – and this highlighted the need for extra protections especially in
p.000018: circumstances were participants see that they only way to have access to treatment is through participation in
p.000018: research. This special vulnerability was also further discussed during the session on research with vulnerable
p.000018: populations. Participants recommended that consent forms should written in a simple language that participants
p.000018: understand, The complexity of the informed consent process in the African context was discussed at length, and the role
p.000018: of the REC in this process.
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000019: 19
p.000019:
p.000019: Annex 4: Case study 3: Establishing Research Ethics Committees
p.000019:
p.000019:
p.000019: This case study portrayed a scenario where Swaziland National Research Ethics Committee (NREC) was awarded
p.000019: a grant of $8 million over a period of three years to develop and implement strategies for setting up and
p.000019: strengthening the capacity of the NREC. Participants were requested to identify the major challenges
p.000019: currently hampering the establishment of a NREC; propose short and long term solutions to these
p.000019: challenges. Using the findings from the needs assessment study implement the identified needs to come up
p.000019: with a country and regional plan to promote the regulatory oversight system in Swaziland. The results of this
p.000019: exercise are shown in Table 1 above.
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
...

Searching for indicator fetuses:

(return to top)
p.000016:
p.000016:
p.000016: 11:00 am – 11:20 am
p.000016: Post-Test
p.000016:
p.000016: Dissemination of Research Results & Research Misconduct
p.000016:
p.000016: Social Break
p.000016: Participants MK
p.000016:
p.000016:
p.000016: 11:00 am – 11:45 pm
p.000016:
p.000016: 11:45am – 12:45pm
p.000016:
p.000016: 12:45pm – 13:00pm
p.000016:
p.000016: 13:00pm – 13:15pm
p.000016:
p.000016: 13:30 pm – 14:30 pm
p.000016: Public Health Research Ethics
p.000016:
p.000016: Exercise: Swaziland NREC Capacity Building Wrap up
p.000016: Closing remarks
p.000016:
p.000016: Lunch
p.000016: MK
p.000016:
p.000016: Group work BM
p.000016: MoH CDC
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000017: 17
p.000017:
p.000017: Annex 2: Case Study 1: A treatment for Central Nervous System.
p.000017:
p.000017: This case study was aimed to at assisting participants to differentiate between clinical care and
p.000017: research and appreciating the thin line between the two.
p.000017: Dr W is a neurosurgeon in a hospital in one of Asia’s major metropolitan centres. He earned his medical degree in that
p.000017: city and then studied in the United States of America before returning to practise in his own country. Over the past 3
p.000017: years, Dr W has treated more than 500 patients with central nervous system (CNS) conditions
p.000017: – including amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig’s disease), Parkinson’s disease, stroke,
p.000017: paraplegia, and tetraplegia – by injecting these patients’ brains or spinal cords with olfactory stem cells harvested
p.000017: from the noses of aborted fetuses. Dr W is convinced that this intervention, which he describes to patients as an
p.000017: “innovative therapy,” is effective, and he has declined to conduct a controlled clinical trial of this
p.000017: method. Cell transplantation experiments have been undertaken for several decades and continue to be pursued in
p.000017: several countries. Dr W’s method is unique, however, because he uses olfactory ensheathing cells from fetuses
p.000017: aborted at 16 weeks. The women who agree to allow the cell harvesting of their aborted fetuses
p.000017: all provide consent and do not receive payment or other compensation. Using a hypodermic syringe, Dr
p.000017: W transplants the culled cells into paralysed patients above and below the damaged area of the spinal cord; ALS
p.000017: patients receive the injections directly into the atrophied area of the frontal lobe of the brain, through a small hole
p.000017: drilled in the skull (a burr hole).
p.000017:
p.000017: Despite having only an incomplete explanation of how the injections produce their results, Dr W is convinced by his
p.000017: patients’ outcomes that the method works. Both lay and medical publications have reported the positive results of the
p.000017: treatment, and Dr W recently submitted an article to a local journal describing his success. Many of
p.000017: his current patients come from other countries to receive his treatment. Long-term follow-up data on Dr
p.000017: W’s work remains preliminary. However, patients – particularly those who have spinal injuries – whom he
p.000017: has contacted by e-mail several months after their operations have reported continued progress. The only adverse
p.000017: effect noted had been pain that accompanied restoration of feeling in some patients. Dr W claims that the
p.000017: surgery stabilizes the condition in about 50% of his patients, and that it causes an improvement in the quality of
p.000017: life (QOL) in about 70% of patients. His estimates are derived from videos he has taken of patients before and after
p.000017: surgery, as well as a survey he conducted of 142 patients, using criteria for function assessment established by a
p.000017: North American spinal injury association.
p.000017:
p.000017: a spinal neurosurgery programme at a leading North American university, have urged him to conduct
...

Searching for indicator language:

(return to top)
p.000018: research with vulnerable populations.
p.000018: The need for a very simple, well documented and easily digestible consent form was noted, and the complexity of consent
p.000018: in the African context was discussed, with the role of the REC being outlined. Participants took keen interest in the
p.000018: discussions that followed the movie and tried to identify the ethical and practical implications of unethical conduct
p.000018: of the informed consent process in a research setting. Participants pointed out the research therapeutic misconception
p.000018: common in vulnerable research populations. They recommended the need to sensitize the public about
p.000018: research and empowering them. Participants also raised concerns about research conducted in vulnerable and
p.000018: impoverished communities as portrayed in the movie – and this highlighted the need for extra protections especially in
p.000018: circumstances were participants see that they only way to have access to treatment is through participation in
p.000018: research. This special vulnerability was also further discussed during the session on research with vulnerable
p.000018: populations. Participants recommended that consent forms should written in a simple language that participants
p.000018: understand, The complexity of the informed consent process in the African context was discussed at length, and the role
p.000018: of the REC in this process.
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000019: 19
p.000019:
p.000019: Annex 4: Case study 3: Establishing Research Ethics Committees
p.000019:
p.000019:
p.000019: This case study portrayed a scenario where Swaziland National Research Ethics Committee (NREC) was awarded
p.000019: a grant of $8 million over a period of three years to develop and implement strategies for setting up and
p.000019: strengthening the capacity of the NREC. Participants were requested to identify the major challenges
p.000019: currently hampering the establishment of a NREC; propose short and long term solutions to these
p.000019: challenges. Using the findings from the needs assessment study implement the identified needs to come up
p.000019: with a country and regional plan to promote the regulatory oversight system in Swaziland. The results of this
p.000019: exercise are shown in Table 1 above.
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019: Challenges identified
p.000019: Objective
p.000019: Short-term solution
p.000019: Long-term solution
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019: .
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
...

Searching for indicator job:

(return to top)
p.000012: management system for submission and review of protocols (RHInnO Ethics).
p.000012: Review and finalization of the national research governance documents currently in draft form (Research Agenda,
p.000012: Research Policy, SOPs, Research Guidelines, Human Research Bill and Application documents).
p.000012: Continued training in research ethics at both basic and advanced level.
p.000012: Plan strategies for an on-going support mechanism from both national governments, internal and external
p.000012: donors for sustainability of established RECs.
p.000012: Collaboration of the Ministry of Health and Ministry of CST to set up a national research coordinating
p.000012: body and finalize the national research bill that will encompass the Human Research Bill.
p.000012: Identifying research ethics networks for Swaziland to participate such as the discussion forums on the MARC
p.000012: website.
p.000012: Identifying capacity building opportunities for the national research unit coordinator Separation of clinical trials
p.000012: review and the need to set up sub committees for expert reviews.
p.000012:
p.000012: Workshop Evaluation
p.000012: A detailed analysis of all completed evaluation forms was done, which revealed a gender imbalance in the Swaziland
p.000012: SEC with majority being females (73%). Participants had qualifications in medicine, Public Health,
p.000012: Management, IT, Laboratory Technology, Research, Nursing and Epidemiology. The participants job titles
p.000012: varied; Director, lecturer, Research Officer, Strategic management Manager, Statistician, IT Manager,
p.000012: Laboratory Technologist and Program Coordinator. Only two participants had formal research ethics
p.000012: training as part of their academic programs, while only two participants had attended research ethics workshops
p.000012: before. Overall, the workshop was rated as either good or excellent, most reasons being: excellent training materials
p.000012: provided, the practical and interactive discussions, which enabled participants to relate to their
p.000012: experiences. One participant was happy about being taken through the research ethics challenges
p.000012:
p.000013: 13
p.000013:
p.000013: from the historical perspective, fundamental principal and topical issues. All the participants agreed
p.000013: that the training had been relevant to their work setting and to the ethical issues encountered
p.000013: in health and health related research. The participants alluded that the training had enhanced their understanding
p.000013: of some of the ethical challenges in health research, the different questions that need to be answered to
p.000013: make improvements in protecting the rights and welfare of research participants, the different approaches to
p.000013: ethical review of research and had improved their review skills and capacity. Participants also agreed that the
...

Searching for indicator officer:

(return to top)
p.000012: Review and finalization of the national research governance documents currently in draft form (Research Agenda,
p.000012: Research Policy, SOPs, Research Guidelines, Human Research Bill and Application documents).
p.000012: Continued training in research ethics at both basic and advanced level.
p.000012: Plan strategies for an on-going support mechanism from both national governments, internal and external
p.000012: donors for sustainability of established RECs.
p.000012: Collaboration of the Ministry of Health and Ministry of CST to set up a national research coordinating
p.000012: body and finalize the national research bill that will encompass the Human Research Bill.
p.000012: Identifying research ethics networks for Swaziland to participate such as the discussion forums on the MARC
p.000012: website.
p.000012: Identifying capacity building opportunities for the national research unit coordinator Separation of clinical trials
p.000012: review and the need to set up sub committees for expert reviews.
p.000012:
p.000012: Workshop Evaluation
p.000012: A detailed analysis of all completed evaluation forms was done, which revealed a gender imbalance in the Swaziland
p.000012: SEC with majority being females (73%). Participants had qualifications in medicine, Public Health,
p.000012: Management, IT, Laboratory Technology, Research, Nursing and Epidemiology. The participants job titles
p.000012: varied; Director, lecturer, Research Officer, Strategic management Manager, Statistician, IT Manager,
p.000012: Laboratory Technologist and Program Coordinator. Only two participants had formal research ethics
p.000012: training as part of their academic programs, while only two participants had attended research ethics workshops
p.000012: before. Overall, the workshop was rated as either good or excellent, most reasons being: excellent training materials
p.000012: provided, the practical and interactive discussions, which enabled participants to relate to their
p.000012: experiences. One participant was happy about being taken through the research ethics challenges
p.000012:
p.000013: 13
p.000013:
p.000013: from the historical perspective, fundamental principal and topical issues. All the participants agreed
p.000013: that the training had been relevant to their work setting and to the ethical issues encountered
p.000013: in health and health related research. The participants alluded that the training had enhanced their understanding
p.000013: of some of the ethical challenges in health research, the different questions that need to be answered to
p.000013: make improvements in protecting the rights and welfare of research participants, the different approaches to
p.000013: ethical review of research and had improved their review skills and capacity. Participants also agreed that the
p.000013: training had provided them with awareness about the tools and resources available for quality review of proposals.
p.000013:
...

Searching for indicator women:

(return to top)
p.000016: Closing remarks
p.000016:
p.000016: Lunch
p.000016: MK
p.000016:
p.000016: Group work BM
p.000016: MoH CDC
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000017: 17
p.000017:
p.000017: Annex 2: Case Study 1: A treatment for Central Nervous System.
p.000017:
p.000017: This case study was aimed to at assisting participants to differentiate between clinical care and
p.000017: research and appreciating the thin line between the two.
p.000017: Dr W is a neurosurgeon in a hospital in one of Asia’s major metropolitan centres. He earned his medical degree in that
p.000017: city and then studied in the United States of America before returning to practise in his own country. Over the past 3
p.000017: years, Dr W has treated more than 500 patients with central nervous system (CNS) conditions
p.000017: – including amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig’s disease), Parkinson’s disease, stroke,
p.000017: paraplegia, and tetraplegia – by injecting these patients’ brains or spinal cords with olfactory stem cells harvested
p.000017: from the noses of aborted fetuses. Dr W is convinced that this intervention, which he describes to patients as an
p.000017: “innovative therapy,” is effective, and he has declined to conduct a controlled clinical trial of this
p.000017: method. Cell transplantation experiments have been undertaken for several decades and continue to be pursued in
p.000017: several countries. Dr W’s method is unique, however, because he uses olfactory ensheathing cells from fetuses
p.000017: aborted at 16 weeks. The women who agree to allow the cell harvesting of their aborted fetuses
p.000017: all provide consent and do not receive payment or other compensation. Using a hypodermic syringe, Dr
p.000017: W transplants the culled cells into paralysed patients above and below the damaged area of the spinal cord; ALS
p.000017: patients receive the injections directly into the atrophied area of the frontal lobe of the brain, through a small hole
p.000017: drilled in the skull (a burr hole).
p.000017:
p.000017: Despite having only an incomplete explanation of how the injections produce their results, Dr W is convinced by his
p.000017: patients’ outcomes that the method works. Both lay and medical publications have reported the positive results of the
p.000017: treatment, and Dr W recently submitted an article to a local journal describing his success. Many of
p.000017: his current patients come from other countries to receive his treatment. Long-term follow-up data on Dr
p.000017: W’s work remains preliminary. However, patients – particularly those who have spinal injuries – whom he
p.000017: has contacted by e-mail several months after their operations have reported continued progress. The only adverse
p.000017: effect noted had been pain that accompanied restoration of feeling in some patients. Dr W claims that the
p.000017: surgery stabilizes the condition in about 50% of his patients, and that it causes an improvement in the quality of
p.000017: life (QOL) in about 70% of patients. His estimates are derived from videos he has taken of patients before and after
p.000017: surgery, as well as a survey he conducted of 142 patients, using criteria for function assessment established by a
...

Searching for indicator education:

(return to top)
p.000009: (SEC) and the newly established research Unit at the MoH.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: 4. Training
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: There is need for basic and advanced continuous training for all
p.000009: research
p.000009: stakeholders in research ethics, particularly specialized training on
p.000009: ethical issues in clinical trials and public health ethics.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: Table 1: Key issues and recommended solutions
p.000010: The following key issues were identified as major challenges, and the proposed solutions were ranked on a scale of
p.000010: short, mid and long term.
p.000010:
p.000010:
p.000010: ISSUE
p.000010: Objective
p.000010: MID TERM
p.000010: LONG TERM
p.000010:
p.000010:
p.000010: 1. Lack of infrastructure (office space, supplies, vehicles, information management
p.000010: system) and human and financial resources resulting thus limited capacity to conduct
p.000010: research and ethics reviews
p.000010: 2. Lack of opportunities for continued education and training
p.000010:
p.000010:
p.000010: 3. Inadequate appreciation and recognition of SEC roles and responsibilities
p.000010: and importance
p.000010:
p.000010:
p.000010: 4. Lack of national research guiding documents (Research Agenda, Research Policy,
p.000010: Research Bill, Standard Operating Procedures)
p.000010: To have a fully functional SEC secretariat and ensure effective and efficient management of the committee.
p.000010:
p.000010:
p.000010: A highly skilled, competent and motivated SEC
p.000010:
p.000010:
p.000010: To improve compliance to ethical conduct in human research
p.000010:
p.000010:
p.000010:
p.000010: To ensure quality assurance of research
p.000010: Have designated officers to provide the secretariat
p.000010: Charge research fees and mobilize from external sources To rent office space and solicit supplies and equipment
p.000010: from MoH
p.000010:
p.000010: Short term trainings Mentoring Benchmarking Networking
p.000010: Advocate for recognition of the SEC by policy makers (meetings, workshops and IEC)
p.000010: Sensitize researchers and the public (meetings, workshops and IEC, BCC)
p.000010: To liaise with the research unit to develop a research agenda
p.000010: Full time employment of qualified staff
p.000010: To assign a budget to the research responsibility centre
p.000010: Build a research Institute
p.000010:
p.000010: Long term trainings on Human and Research Ethics for the Secretariat.
p.000010: Opportunities for SEC members to attend regional, global workshops and conferences
p.000010:
...

Searching for indicator gender:

(return to top)
p.000012: Swaziland.
p.000012: Swaziland must establish a national research ethics Committee to coordinate health research
p.000012: oversight in Swaziland.
p.000012: Establishment of a Health Research Unit with a Secretariat to manage NREC. Implementation of the REC information
p.000012: management system for submission and review of protocols (RHInnO Ethics).
p.000012: Review and finalization of the national research governance documents currently in draft form (Research Agenda,
p.000012: Research Policy, SOPs, Research Guidelines, Human Research Bill and Application documents).
p.000012: Continued training in research ethics at both basic and advanced level.
p.000012: Plan strategies for an on-going support mechanism from both national governments, internal and external
p.000012: donors for sustainability of established RECs.
p.000012: Collaboration of the Ministry of Health and Ministry of CST to set up a national research coordinating
p.000012: body and finalize the national research bill that will encompass the Human Research Bill.
p.000012: Identifying research ethics networks for Swaziland to participate such as the discussion forums on the MARC
p.000012: website.
p.000012: Identifying capacity building opportunities for the national research unit coordinator Separation of clinical trials
p.000012: review and the need to set up sub committees for expert reviews.
p.000012:
p.000012: Workshop Evaluation
p.000012: A detailed analysis of all completed evaluation forms was done, which revealed a gender imbalance in the Swaziland
p.000012: SEC with majority being females (73%). Participants had qualifications in medicine, Public Health,
p.000012: Management, IT, Laboratory Technology, Research, Nursing and Epidemiology. The participants job titles
p.000012: varied; Director, lecturer, Research Officer, Strategic management Manager, Statistician, IT Manager,
p.000012: Laboratory Technologist and Program Coordinator. Only two participants had formal research ethics
p.000012: training as part of their academic programs, while only two participants had attended research ethics workshops
p.000012: before. Overall, the workshop was rated as either good or excellent, most reasons being: excellent training materials
p.000012: provided, the practical and interactive discussions, which enabled participants to relate to their
p.000012: experiences. One participant was happy about being taken through the research ethics challenges
p.000012:
p.000013: 13
p.000013:
p.000013: from the historical perspective, fundamental principal and topical issues. All the participants agreed
p.000013: that the training had been relevant to their work setting and to the ethical issues encountered
p.000013: in health and health related research. The participants alluded that the training had enhanced their understanding
p.000013: of some of the ethical challenges in health research, the different questions that need to be answered to
p.000013: make improvements in protecting the rights and welfare of research participants, the different approaches to
p.000013: ethical review of research and had improved their review skills and capacity. Participants also agreed that the
p.000013: training had provided them with awareness about the tools and resources available for quality review of proposals.
p.000013:
p.000013: The duration of the training was rated as good, visual aids and handouts were good and the workshop
p.000013: venue was rated as very good. When asked what they liked the most about the workshop, most participants
p.000013: highlighted the interactive nature of combining presentations and case study discussions, which brought
p.000013: out real life experiences. One participant described the workshop as a motivation to venture into
p.000013: research ethics as a profession in order to become an effective and efficient SEC member. Two participants
p.000013: expressed their disappointment about poor time management by some of their colleagues and recommended that the next
p.000013: training be held at a venue far from participants’ places of work.
p.000013: Recommendations for future workshops included use of a bigger venue far from participants/ places of work,
p.000013: gender balanced group and research methodology and design to be included in the program. Finally, participants were
p.000013: also asked to list three things they would do better after the workshop. These mostly included:
p.000013: Use of information and materials provide to improve review process Make decisions about the review with reference to
p.000013: research guidelines Critically review the consent form
p.000013: Take time to identify ethical issues in a protocol
p.000013:
p.000013:
p.000013: Conclusion
p.000013: The workshop increased participants’ awareness about the importance of building and strengthening
p.000013: capacity of NREC in Swaziland. There seemed to be a consensus among the participants
p.000013: regarding the existence of gaps in the clinical trial regulatory oversight systems including the need
p.000013: for more training in research ethics and establishing/improving REC information management systems.
p.000013: Participants committed to working together towards sensitizing their institutions, governments, clinical trial
p.000013: sponsors and other donor agencies about the importance of investing more into strengthening the capacity
p.000013: of the NREC to enable the integration of ethics. The workshop served as a very engaging platform through
p.000013: open dialogue among REC members, it enabled very fruitful discussions and sharing of best regulatory practices. The
p.000013: forum
p.000013:
p.000013:
p.000014: 14
p.000014:
...

Searching for indicator philosophy:

(return to top)
p.000010: small number of members
p.000010:
p.000010: 6. Limited capacity to conduct research and ethics reviews
p.000010: To ensure an effectiveness and efficiency of SEC
p.000010:
p.000010:
p.000010:
p.000010: Availability of sound research evidence and products
p.000010: To update current guidelines to include the new developments
p.000010: Re- constitution of membership (appointment of chairperson, vice - chair and the skills mix)
p.000010: To develop a National Research Agenda (Channelling research needs)
p.000010: Appointing an authority that can ensure that the tenure is adhered to.
p.000010:
p.000010:
p.000010: Sustainable Training of researchers & reviewers
p.000010:
p.000010:
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: To further address the needed capacity in Swaziland, participants were further requested to identify topics
p.000011: of interest that they would like to see included in the initial training curriculum for the research ethics committees,
p.000011: by prioritizing according to a rating scale of: 1= Must be taught, 2= Can be taught if time allows 3= No need to be
p.000011: taught. Results are reflected in table two below.
p.000011:
p.000011: Table 2: Rating of Research Ethics topics to be included in the training curriculum
p.000011:
p.000011:
p.000011: Topic
p.000011: Foundational Bioethics (History, Philosophy, moral reasoning, fundamental principles, ethical Codes)
p.000011: Establishment of RECs
p.000011: Drafting National Research Guiding Documents (Application forms, Research Guidelines, SOPs, Research Bill)
p.000011: Responsibilities of the Sponsor, Investigator, Institution Participant and RECs in the research ethics review
p.000011: process
p.000011: Ethical issues regarding: Study designs and methodology
p.000011: Challenges of conducting international research in developing countries Science of Clinical Trials and Scientific
p.000011: Evaluation of Clinical Trial Protocols Informed consent
p.000011: Risk /Benefit Analysis
p.000011: Essential Elements of the REC Review process (Expedited/Full, continuing review, amendments, close
p.000011: outs, adverse events)
p.000011: Informed Consent Process
p.000011: Special topics in research ethics: Vulnerable Participants, Privacy and confidentiality, Compensating research
p.000011: participants, Conflict of interest
p.000011: Monitoring an Auditing approved studies Participant Recruitment Procedures
p.000011: Dissemination of study results and research misconduct Quality Assurance Guidance and Legal Enforcements Organizing and
p.000011: Administering Research Ethics Committees Public Health Ethics
p.000011: Grant Proposal writing
p.000011: GROUP 1
p.000001: 1
p.000001:
p.000001: 1
p.000001: 1
p.000001:
p.000002: 2
p.000002:
...

Economic / Economic/Poverty

Searching for indicator poor:

(return to top)
p.000004: strengthen their REC, improve quality and reduce the turnaround times. Specific scenarios were shared highlighting the
p.000004: settings in other LMICs, as a way for Swaziland to benchmark. The MARC Project
p.000004: (www.researchethicsweb) was introduced as a platform for networking, increasing REC visibility, and a capacitating
p.000004: tool, while the Research for Health Innovation Organizer (RHInnO) (www.rhinno.net) was shared as
p.000004: an information management solution for the current complex manual paper based system widely used by RECs in
p.000004: Africa.
p.000004: Key words: Research Ethics Committee, Ethical Review, Ethics, Capacity Building,
p.000004: Governance Framework, Science.
p.000005: 5
p.000005:
p.000005: Introduction
p.000005: Health research initiatives worldwide are growing in scope and complexity, particularly as they
p.000005: move into the developing world1. The ever increasing activity in health research involving human participants in low
p.000005: and middle income countries (LMICs) has resulted in a greatly increased and increasing need for sound ethical review
p.000005: structures and functions within these countries, and for greatly increased efficiencies in ethical review
p.000005: processes if the full potential benefits of health research are to be realized. Yet both expertise and
p.000005: efficiency are lagging behind as a result of the enormous challenges facing these countries, including poor
p.000005: resource availability, lack of expert capacity and user-friendly information management systems to support
p.000005: the flow of research proposals through the ethics review process. The complexities of research are
p.000005: increasing, hence the capacity to ethically review research protocols and provide ethical oversight of
p.000005: clinical trials including genetic/genomic studies is a core component of responsible and responsive
p.000005: research systems, and are key topics of the many international guidelines on research with
p.000005: human
p.000005: participants2. Each country and major institutions involved in the conduct of research, clinical trials and other
p.000005: research involving human subjects should have adequate capacity to conduct expert and efficient ethical review of such
p.000005: research, as this will promote better health, equity and development
p.000005: outcomes3.
p.000005:
p.000005: The purpose of health and health related research is to generate and contribute to generalizable knowledge that
p.000005: could benefit the present and future generations. In order to achieve these purposes, some people and
p.000005: communities have to bear the burden of research. It is therefore, important that the research
p.000005: participants’ safety, rights and welfare must not be compromised during the research. To ensure this
...

p.000012:
p.000013: 13
p.000013:
p.000013: from the historical perspective, fundamental principal and topical issues. All the participants agreed
p.000013: that the training had been relevant to their work setting and to the ethical issues encountered
p.000013: in health and health related research. The participants alluded that the training had enhanced their understanding
p.000013: of some of the ethical challenges in health research, the different questions that need to be answered to
p.000013: make improvements in protecting the rights and welfare of research participants, the different approaches to
p.000013: ethical review of research and had improved their review skills and capacity. Participants also agreed that the
p.000013: training had provided them with awareness about the tools and resources available for quality review of proposals.
p.000013:
p.000013: The duration of the training was rated as good, visual aids and handouts were good and the workshop
p.000013: venue was rated as very good. When asked what they liked the most about the workshop, most participants
p.000013: highlighted the interactive nature of combining presentations and case study discussions, which brought
p.000013: out real life experiences. One participant described the workshop as a motivation to venture into
p.000013: research ethics as a profession in order to become an effective and efficient SEC member. Two participants
p.000013: expressed their disappointment about poor time management by some of their colleagues and recommended that the next
p.000013: training be held at a venue far from participants’ places of work.
p.000013: Recommendations for future workshops included use of a bigger venue far from participants/ places of work,
p.000013: gender balanced group and research methodology and design to be included in the program. Finally, participants were
p.000013: also asked to list three things they would do better after the workshop. These mostly included:
p.000013: Use of information and materials provide to improve review process Make decisions about the review with reference to
p.000013: research guidelines Critically review the consent form
p.000013: Take time to identify ethical issues in a protocol
p.000013:
p.000013:
p.000013: Conclusion
p.000013: The workshop increased participants’ awareness about the importance of building and strengthening
p.000013: capacity of NREC in Swaziland. There seemed to be a consensus among the participants
p.000013: regarding the existence of gaps in the clinical trial regulatory oversight systems including the need
p.000013: for more training in research ethics and establishing/improving REC information management systems.
p.000013: Participants committed to working together towards sensitizing their institutions, governments, clinical trial
p.000013: sponsors and other donor agencies about the importance of investing more into strengthening the capacity
...

General/Other / Impaired Autonomy

Searching for indicator autonomy:

General/Other / Public Emergency

Searching for indicator emergency:

(return to top)
p.000001: Building Research Ethics Review Capacity in Swaziland
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: Health Research Ethics Workshop Report
p.000001:
p.000001: Research Ethics Training Workshop 22nd – 26th July, 2013
p.000001: Lugogo Sun, Ezwilini, Swaziland
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: 1
p.000001:
p.000001: ACKNOWLEDGEMENTS
p.000001: COHRED extends appreciation to MOH especially the research unit for this capacity building initiative.
p.000001:
p.000001: The Council on Health Research for Development (COHRED; www.cohred.org) through the MARC (Mapping African
p.000001: Research Ethics Review and Medicines Regulatory Capacity: (www.researchethicsweb.org) project is indebted
p.000001: to the President’s Emergency Plan for AIDS Relief (PEPFAR) with USAID and CDC funding) through PSI
p.000001: Swaziland and University Research Cooperation (URC) for funding and according COHRED the opportunity to facilitate
p.000001: the first ever Health Research Ethics training workshop in Swaziland.
p.000001:
p.000001: Sincere appreciation is extended to all SEC members for their participation and for being an absolutely wonderful
p.000001: audience who greatly enriched the workshop with their enthusiastic participation.
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000002: 2
p.000002:
p.000002: Table of contents
p.000002: Acknowledgements
p.000002: 2
p.000002: Table of contents
p.000003: 3
p.000003: Acronyms
p.000004: 4
p.000004: Executive Summary
p.000005: 5
p.000005: Introduction
p.000006: 6
p.000006: Objectives
p.000007: 7
p.000007: Expected Outcomes of the Workshop
p.000007: 7
p.000007: Proceedings of the workshop
p.000008: 8
p.000008: Figure 1: Pre and Post Test Results
p.000009: 9
p.000009: Table 2: Rating of Research Ethics topics to be included in the training curriculum 12
p.000009: Recommendations and Workshop Evaluation
p.000013: 13
p.000013: Conclusion
p.000014: 14
p.000014: Closing Remarks
p.000015: 15
p.000015: Annex 1: Workshop Program
p.000016: 16
p.000016: Annex 2: Case Study 1: A treatment for Central Nervous System
p.000018: 18
p.000018: Annex 3: Case Study 2: This case was based on a movie ‘The Constant Gardner’ 19
p.000018: Annex 4: Case study 3: Establishing Research Ethics Committees
p.000020: 20
p.000020: Annex 5: Participants List
p.000021: 21
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000003: 3
p.000003:
p.000003: Acronyms
p.000003:
p.000003:
p.000003: CDC COHRED EDCTP GCP
p.000003: IC IMS ICH IRB LMIC MARC
p.000003: MoH MTA NHREC NRC NREC PEPFAR RECs PSI
p.000003: RHInnO SEC SOP USAID URC
p.000003: Centre for Disease Control
p.000003: Council on Health Research for Development
p.000003: European and Developing Countries Clinical Trials Partnership Good Clinical Practice
p.000003: Informed Consent
p.000003: Information Management System International Conference on Harmonization Institutional Review Boards
p.000003: Low and Middle Income Countries
p.000003: Mapping African Research Ethics Review and Medicines Regulatory Capacity Ministry of Health
p.000003: Material Transfer Agreement
p.000003: National Health Research Ethics committee National Research Committee
p.000003: National Research Ethics Committee
p.000003: President’s Emergency Plan for AIDS Relief Research Ethics Committees Population Services International
p.000003: Research for Health and Innovation Organizer
p.000003: Scientific Ethics Committee Standard Operational Procedures
p.000003: United States Agency for International Development University Research Cooperation
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: Executive Summary
p.000004:
p.000004: Research ethics is a cornerstone for human subjects research and research ethics committees (RECs) have a
p.000004: key responsibility of protecting the rights and welfare of human subjects in research. Therefore, RECs must be
p.000004: competent and well resourced in order to optimally fulfil this role. This requires basic and continuous research
p.000004: ethics training and an understanding of the research process and governance. Although many programs have
p.000004: recently been designed to facilitate this need and strengthen RECs in Africa, much more needs to be
p.000004: accomplished before RECs can function optimally.
p.000004:
p.000004: The Swaziland Ministry of Health (MoH) established the Science and Ethics committee (SEC) with the mandate of
...

General/Other / Relationship to Authority

Searching for indicator authority:

(return to top)
p.000005: clinical trials including genetic/genomic studies is a core component of responsible and responsive
p.000005: research systems, and are key topics of the many international guidelines on research with
p.000005: human
p.000005: participants2. Each country and major institutions involved in the conduct of research, clinical trials and other
p.000005: research involving human subjects should have adequate capacity to conduct expert and efficient ethical review of such
p.000005: research, as this will promote better health, equity and development
p.000005: outcomes3.
p.000005:
p.000005: The purpose of health and health related research is to generate and contribute to generalizable knowledge that
p.000005: could benefit the present and future generations. In order to achieve these purposes, some people and
p.000005: communities have to bear the burden of research. It is therefore, important that the research
p.000005: participants’ safety, rights and welfare must not be compromised during the research. To ensure this
p.000005: protection, all human subjects research is subjected to independent ethics review. Hence, governments
p.000005: and research institutions must establish an appropriate governance structure for research ethics review
p.000005: to ensure that RECs operate with a clear mandate, authority, accountability and autonomy.
p.000005:
p.000005: Currently, over 173 RECs are known to be operating in 37 African countries with great variability in skills,
p.000005: membership, resources and capacity (www.researchethicsweb.org)4. Presently, the Swaziland Scientific
p.000005: and Ethics Committee (SEC) is faced with lack of capacity, which is characterised by
p.000005: undefined structures, limited research ethics knowledge, skills as well as resources. The situation
p.000005: is worsened by the increasing concerns about the self-instituted SEC’s inadequacy in the health research
p.000005: regulatory framework, and its capacity to handle the ever- increasing volume and complexity of the
p.000005: national and international research conducted in Swaziland. Therefore, there is an urgent need to
p.000005: collaboratively build and strengthen the capacity of the research oversight framework in Swaziland to promote
p.000005: and improve the ethical review
p.000005:
p.000006: 6
p.000006:
p.000006: quality and throughput systems. This requires continued training to avoid potential violation of the rights of research
p.000006: participant’s particularly vulnerable populations.
p.000006:
p.000006: Although there is research recognition in Swaziland, there is still a lack of research culture, limited coordination,
...

p.000010: Sensitize researchers and the public (meetings, workshops and IEC, BCC)
p.000010: To liaise with the research unit to develop a research agenda
p.000010: Full time employment of qualified staff
p.000010: To assign a budget to the research responsibility centre
p.000010: Build a research Institute
p.000010:
p.000010: Long term trainings on Human and Research Ethics for the Secretariat.
p.000010: Opportunities for SEC members to attend regional, global workshops and conferences
p.000010:
p.000010: Development of a plan for sustained advocacy and social mobilization on research ethics
p.000010:
p.000010:
p.000010: Availability of national research governance framework guided by
p.000010: documented regulations and guidelines.
p.000010:
p.000010:
p.000010: 5. Inadequate composition of the current committee regarding its diversity, commitment and the
p.000010: small number of members
p.000010:
p.000010: 6. Limited capacity to conduct research and ethics reviews
p.000010: To ensure an effectiveness and efficiency of SEC
p.000010:
p.000010:
p.000010:
p.000010: Availability of sound research evidence and products
p.000010: To update current guidelines to include the new developments
p.000010: Re- constitution of membership (appointment of chairperson, vice - chair and the skills mix)
p.000010: To develop a National Research Agenda (Channelling research needs)
p.000010: Appointing an authority that can ensure that the tenure is adhered to.
p.000010:
p.000010:
p.000010: Sustainable Training of researchers & reviewers
p.000010:
p.000010:
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: To further address the needed capacity in Swaziland, participants were further requested to identify topics
p.000011: of interest that they would like to see included in the initial training curriculum for the research ethics committees,
p.000011: by prioritizing according to a rating scale of: 1= Must be taught, 2= Can be taught if time allows 3= No need to be
p.000011: taught. Results are reflected in table two below.
p.000011:
p.000011: Table 2: Rating of Research Ethics topics to be included in the training curriculum
p.000011:
p.000011:
p.000011: Topic
p.000011: Foundational Bioethics (History, Philosophy, moral reasoning, fundamental principles, ethical Codes)
p.000011: Establishment of RECs
p.000011: Drafting National Research Guiding Documents (Application forms, Research Guidelines, SOPs, Research Bill)
p.000011: Responsibilities of the Sponsor, Investigator, Institution Participant and RECs in the research ethics review
p.000011: process
p.000011: Ethical issues regarding: Study designs and methodology
p.000011: Challenges of conducting international research in developing countries Science of Clinical Trials and Scientific
p.000011: Evaluation of Clinical Trial Protocols Informed consent
...

General/Other / belmont

Searching for indicator belmont:

(return to top)
p.000007: research ethics knowledge; (see Figure 1 for results). The training combined mixed interactive
p.000007: approaches: from formal presentation ‘lecture like’ sessions to open discussions and group
p.000007: work. Both theoretical and practical aspects of basic research ethics and good practices were incorporated. There
p.000007: were a number of group discussion using case studies, exercises and REC simulation to allow
p.000007: participant to have practical experience about good practices and be able to identify ethical and practical
p.000007: issues encountered during the ethics review process. Sixteen (16) REC members out of the expected 25 participated in
p.000007: the five-day workshop. Participants were very enthusiastic and interactive during the discussions and made
p.000007: very good presentations and feedback at the end of each exercise. They also took very keen interest in
p.000007: the REC simulation exercise and used real protocols to work with. Participants appreciated the review guide as a good
p.000007: tool to guide the review process. Very interesting discussions took place during the workshop supported by life
p.000007: experiences from real situations.
p.000007:
p.000007: Fundamental softcopy reading materials were provided ahead of the workshop, this included: international
p.000007: research ethics codes and regulations such as the Nuremberg Code (1947), the World Medical Assembly of the
p.000007: Declaration Of Helsinki (1964-2013), the Belmont Report (1974), the 2002 Council for International
p.000007: Organizations of Medical Sciences (CIOMS)/WHO) and ICH/GCP- International Conference Tripartite on
p.000007: Harmonization-Good Clinical Practice. The pre-test results reflected that most participants actually read the
p.000007: above highlighted documents. All the training materials were shared with participants in a USB for easy
p.000007: readability and future use. The movie “Constant Gardner” was watched and participants had to analyse the
p.000007: ethical and practical issues that can arise during the informed consent process in a research setting. Details of
p.000007: theoretical and practical topics covered are shown in the workshop program (Annex 1).
p.000007:
p.000007: Topics covered included; the background and importance of research ethics using examples of research
p.000007: atrocities that gave rise to research ethics. Theoretical topics such as fundamental principles of
p.000007: research ethics, vulnerable populations, risk/benefit analysis, informed consent, confidentiality in the African
p.000007: context, institutionalizing research ethics committees, compensating research participants, dissemination of
...

General/Other / cioms guidelines

Searching for indicator cioms:

(return to top)
p.000007: approaches: from formal presentation ‘lecture like’ sessions to open discussions and group
p.000007: work. Both theoretical and practical aspects of basic research ethics and good practices were incorporated. There
p.000007: were a number of group discussion using case studies, exercises and REC simulation to allow
p.000007: participant to have practical experience about good practices and be able to identify ethical and practical
p.000007: issues encountered during the ethics review process. Sixteen (16) REC members out of the expected 25 participated in
p.000007: the five-day workshop. Participants were very enthusiastic and interactive during the discussions and made
p.000007: very good presentations and feedback at the end of each exercise. They also took very keen interest in
p.000007: the REC simulation exercise and used real protocols to work with. Participants appreciated the review guide as a good
p.000007: tool to guide the review process. Very interesting discussions took place during the workshop supported by life
p.000007: experiences from real situations.
p.000007:
p.000007: Fundamental softcopy reading materials were provided ahead of the workshop, this included: international
p.000007: research ethics codes and regulations such as the Nuremberg Code (1947), the World Medical Assembly of the
p.000007: Declaration Of Helsinki (1964-2013), the Belmont Report (1974), the 2002 Council for International
p.000007: Organizations of Medical Sciences (CIOMS)/WHO) and ICH/GCP- International Conference Tripartite on
p.000007: Harmonization-Good Clinical Practice. The pre-test results reflected that most participants actually read the
p.000007: above highlighted documents. All the training materials were shared with participants in a USB for easy
p.000007: readability and future use. The movie “Constant Gardner” was watched and participants had to analyse the
p.000007: ethical and practical issues that can arise during the informed consent process in a research setting. Details of
p.000007: theoretical and practical topics covered are shown in the workshop program (Annex 1).
p.000007:
p.000007: Topics covered included; the background and importance of research ethics using examples of research
p.000007: atrocities that gave rise to research ethics. Theoretical topics such as fundamental principles of
p.000007: research ethics, vulnerable populations, risk/benefit analysis, informed consent, confidentiality in the African
p.000007: context, institutionalizing research ethics committees, compensating research participants, dissemination of
p.000007: research results and research misconduct, in-depth analysis of the ethics review process, ethical
...

General/Other / declaration of helsinki

Searching for indicator helsinki:

General/Other / participants in a control group

Searching for indicator placebo:

(return to top)
p.000017: has contacted by e-mail several months after their operations have reported continued progress. The only adverse
p.000017: effect noted had been pain that accompanied restoration of feeling in some patients. Dr W claims that the
p.000017: surgery stabilizes the condition in about 50% of his patients, and that it causes an improvement in the quality of
p.000017: life (QOL) in about 70% of patients. His estimates are derived from videos he has taken of patients before and after
p.000017: surgery, as well as a survey he conducted of 142 patients, using criteria for function assessment established by a
p.000017: North American spinal injury association.
p.000017:
p.000017: a spinal neurosurgery programme at a leading North American university, have urged him to conduct
p.000017: double-blind trials to meet the scientific standards of developed countries. Since no recognized treatments
p.000017: can reverse the CNS conditions that his patients have, the intervention given to the control group in
p.000017: a double-blind study would be an injection of an inert fluid instead of the stem cells or “sham surgery” on the
p.000017: skull or spine (surgery to drill a hole and then close up the site, without putting in any cells). Research trials of
p.000017: this type have been used previously for other cellular treatments for neurological diseases, but Dr W refuses
p.000017: to do this, asserting that such studies would be unethical. “Even if the whole world refuses to believe me, I
p.000017: would not do a control test,” he says. “These patients are already suffering. If we open them up just for a
p.000017: placebo test, it will only do them harm. We would be doing it for ourselves not for the patient.”
p.000017:
p.000017: Questions
p.000017: 1. Is Dr W providing innovative therapy; conducting an experiment; or carrying out medical research? How are these
p.000017: different, generally or in this case?
p.000017:
p.000017: 2. Would it be unethical to conduct a placebo-controlled trial, as Dr W maintains?
p.000017:
p.000017: 3. How does the use of placebo in a setting where “no treatment” is the standard of care differ ethically from simply
p.000017: providing no treatment?
p.000017:
p.000017: 4. How might Dr W demonstrate that this method is effective (other than by conducting a controlled clinical trial)? Is
p.000017: there an international standard for determining effectiveness?
p.000017:
p.000017: 5. In a hospital setting, whose responsibility is it to monitor the activities of physicians? In general, whose
p.000017: Responsibility is it to monitor activities of physicians?
p.000017:
p.000017:
p.000018: 18
p.000018:
p.000018: Annex 3: Case Study 2: This case was based on a movie ‘The Constant Gardner’
p.000018:
p.000018:
p.000018: The movie (Constant gardener) was shot in Kibera, the largest slum in sub Saharan Africa, located in the capital city
p.000018: of Kenya, Nairobi. Second day of the training was kicked off with the viewing of the movie ‘Constant
p.000018: Gardener’, which was shot in Kibera, the largest slum in sub Saharan Africa, located in the East African country of
p.000018: Kenya. The movie shows Kenya as a developing country burdened with many public health challenges
p.000018: including HIV/AIDS and tuberculosis. Lesson learnt from the movie were highlighted by the importance of
p.000018: having an informed consent, and informed consent as a process rather than just signing the form. The
p.000018: importance of participants’ differentiates between routine clinical care and research, the importance of
...

Orphaned Trigger Words

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p.000004: 4
p.000004:
p.000004: Executive Summary
p.000004:
p.000004: Research ethics is a cornerstone for human subjects research and research ethics committees (RECs) have a
p.000004: key responsibility of protecting the rights and welfare of human subjects in research. Therefore, RECs must be
p.000004: competent and well resourced in order to optimally fulfil this role. This requires basic and continuous research
p.000004: ethics training and an understanding of the research process and governance. Although many programs have
p.000004: recently been designed to facilitate this need and strengthen RECs in Africa, much more needs to be
p.000004: accomplished before RECs can function optimally.
p.000004:
p.000004: The Swaziland Ministry of Health (MoH) established the Science and Ethics committee (SEC) with the mandate of
p.000004: reviewing and approving research protocols under the MoH. Since its inception, SEC has done tremendous
p.000004: work in providing research oversight in Swaziland. With advent in health research, there is a constant need to
p.000004: update and equip the committee on emerging issues and appropriate skills required in protocol reviews. SEC has never
p.000004: had any formal training hence the MoH research unit advocated for this capacity building initiative.
p.000004: The five day research ethics workshop, held in Swaziland, Ezulweni at the Lugogo Sun Hotel on 22- 26 July, 2013, marks
p.000004: the Council on Health Research for Development (COHRED) comprehensive approach of developing and strengthening the
p.000004: research for health governance systems in low and middle income countries (LMICs). COHRED partners with
p.000004: governments, institutions and civil society organizations in their efforts to use research, innovation, science and
p.000004: technology to achieve equity and national development. COHRED’s Africa office’s team executed this training.
p.000004:
p.000004: The workshop aimed to contribute to the development and strengthening of ethical-legal framework
p.000004: for protection of human subjects in research in Swaziland, by ensuring that those responsible for the
p.000004: research ethics oversight; administration of RECs and medicines regulation demonstrate an advanced level of
p.000004: knowledge, understanding, and experience of the ethics review process and REC functionality. The workshop provided
p.000004: basic training on research ethics, identified research ethical dilemmas and provided practical interactive
p.000004: exercises to solve such dilemmas. Additionally, the workshop aimed to empower participants in ways that can
p.000004: strengthen their REC, improve quality and reduce the turnaround times. Specific scenarios were shared highlighting the
p.000004: settings in other LMICs, as a way for Swaziland to benchmark. The MARC Project
p.000004: (www.researchethicsweb) was introduced as a platform for networking, increasing REC visibility, and a capacitating
p.000004: tool, while the Research for Health Innovation Organizer (RHInnO) (www.rhinno.net) was shared as
p.000004: an information management solution for the current complex manual paper based system widely used by RECs in
p.000004: Africa.
p.000004: Key words: Research Ethics Committee, Ethical Review, Ethics, Capacity Building,
p.000004: Governance Framework, Science.
p.000005: 5
p.000005:
p.000005: Introduction
p.000005: Health research initiatives worldwide are growing in scope and complexity, particularly as they
p.000005: move into the developing world1. The ever increasing activity in health research involving human participants in low
p.000005: and middle income countries (LMICs) has resulted in a greatly increased and increasing need for sound ethical review
p.000005: structures and functions within these countries, and for greatly increased efficiencies in ethical review
p.000005: processes if the full potential benefits of health research are to be realized. Yet both expertise and ...

p.000006:
p.000006: Although there is research recognition in Swaziland, there is still a lack of research culture, limited coordination,
p.000006: governance, management and funding. Currently, there is no research agenda and research guidelines for the
p.000006: conduct of human research although the SEC has drafted a guiding document. At present, there is no
p.000006: budgetary allocation for research governance and at a very low scale, SEC manages and conducts ethics reviews although
p.000006: Swaziland has been trying to establish a research coordinating body for quite some time.
p.000006:
p.000006: Objectives
p.000006: To conduct basic research ethics training.
p.000006: To identify and discuss practical ethical challenges and dilemmas encountered in the conduct of human
p.000006: subjects research in Swaziland.
p.000006: To assist participants strengthen their research ethics committee and improve the quality of the research ethics
p.000006: oversight in Swaziland.
p.000006: To guide the Swaziland SEC on the next steps for improving research ethics capacity in Swaziland.
p.000006: To establish country level partnership with Swaziland.
p.000006:
p.000006:
p.000006: Expected Outcomes of the Workshop
p.000006:
p.000006: The training of SEC members is expected to result into:
p.000006: Strengthening of legal framework for the National Research Ethics Committee (NHREC). Guidance on the role of the
p.000006: research unit on SEC operation.
p.000006: Capacity building to inform review and finalization of the national research governance documents currently in draft
p.000006: form (research agenda, research policy, standard operational procedures, research guidelines, human research bill and
p.000006: application documents).
p.000006: Continued training in research ethics at both basic and advanced level.
p.000006: Developing strategic and action plans for obtaining on-going financial and other resources support from the government,
p.000006: internal and external donors for sustainability of established RECs.
p.000006: Collaboration of the Ministry of Health and Ministry of science and technology to set up a national research
p.000006: coordinating body and finalize the national research bill that will encompass the human research.
p.000006:
p.000006:
p.000006:
p.000006:
p.000007: 7
p.000007:
p.000007: Proceedings of the workshop
p.000007:
p.000007: The workshop commenced on the most memorable day in Swaziland; ‘the late kings birthday who is the father to the
p.000007: current reigning king’. There was 80% attendance, which was pretty good for a public holiday.
p.000007: Following comprehensive participants’ introductions, a pre test was administered to evaluate levels of
p.000007: research ethics knowledge; (see Figure 1 for results). The training combined mixed interactive
p.000007: approaches: from formal presentation ‘lecture like’ sessions to open discussions and group
p.000007: work. Both theoretical and practical aspects of basic research ethics and good practices were incorporated. There
p.000007: were a number of group discussion using case studies, exercises and REC simulation to allow
p.000007: participant to have practical experience about good practices and be able to identify ethical and practical
p.000007: issues encountered during the ethics review process. Sixteen (16) REC members out of the expected 25 participated in
p.000007: the five-day workshop. Participants were very enthusiastic and interactive during the discussions and made ...

p.000007: 2,3,4).
p.000008: 8
p.000008:
p.000008: A post-test was administered on the last day of the workshop to evaluate the knowledge acquired from the weeklong
p.000008: training. The lowest mark from the pre-test was 40% and the highest was 75%. Results from the post-test showed
p.000008: significant improvement in knowledge with the lowest mark being 45% and the highest being 80%.
p.000008:
p.000008: Figure 1: Pre and Post Test Results
p.000008:
p.000008:
p.000008: Participant Code 001
p.000002: 002
p.000003: 003
p.000004: 004
p.000005: 005
p.000006: 006
p.000007: 007
p.000008: 008
p.000009: 009
p.000014: 0014
p.000015: 0015
p.000016: 0016
p.000016: Pre-test Mark (%)
p.000055: 55
p.000055: 55
p.000065: 65
p.000050: 50
p.000040: 40
p.000050: 50
p.000050: 50
p.000075: 75
p.000075: 75
p.000045: 45
p.000080: 80
p.000080: Absent
p.000080: Post-test Mark (%)
p.000080: Absent 60
p.000080: 80
p.000065: 65
p.000065: 65
p.000065: 65
p.000065: 65
p.000060: 60
p.000075: 75
p.000030: 30
p.000030: Absent 60
p.000030:
p.000030:
p.000030: The average mark in the pre-test was 58% while the average for the post-test was 63%.
p.000030: Unfortunately some participants missed either the pre or post-test, as the attendance fluctuated during the
p.000030: week, making it difficult to generalize results. However, the overall performance shows evidence of learning.
p.000030:
p.000030:
p.000030:
p.000030:
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p.000030:
p.000009: 9
p.000009:
p.000009: Key Identified Barriers
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: 1. Lack of Research Ethics Review Capacity
p.000009: 1.1 Currently Swaziland has a limited capacity to conduct research and ethics
p.000009: reviews. This is partly due to lack of clearly defined structures and process to
p.000009: guide the review process. For example, at the moment the country does not have a national
p.000009: research governance framework to regulate all health and health related research activities
p.000009: conducted in the country. The country operates with a self- constituted ethics
p.000009: committee that caters only for the scientific community.
p.000009:
p.000009: 1.2 Lack of research ethics review-guiding documents such as research
p.000009: agenda, research policy and standard operating procedures. Therefore, there is
p.000009: an urgent for support to establish and
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: 2. Lack of official recognition and undefined roles and responsibilities.
p.000009:
p.000009: The REC expressed that it is not legally constituted hence lack of official recognition and a
p.000009: legal framework to support the establishment and operation of a National Research Council
p.000009: (NRC) to enhance the existence of the National Research Ethics Committee (NREC) and Institutional Review Boards
p.000009: (IRBs). Furthermore, the roles and responsibilities of the committee are not clearly
p.000009: defined.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: 3. Lack of resources
p.000009:
p.000009:
p.000009: Lack of resources such as well-qualified human resources; infrastructure, including: office space
p.000009: and essential equipment to ensure the RECs efficiency; computers, telephone, printer,
p.000009: photocopier, vehicle and an information management system. The lack of resources is mainly attributed to
p.000009: lack of financial support from government or external grants. This inadequacy
p.000009: applies both to the currently voluntarily constituted scientific ethics committee
p.000009: (SEC) and the newly established research Unit at the MoH.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: 4. Training
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: There is need for basic and advanced continuous training for all
p.000009: research
p.000009: stakeholders in research ethics, particularly specialized training on
p.000009: ethical issues in clinical trials and public health ethics.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
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p.000009:
p.000009:
p.000010: 10
p.000010: ...

p.000011: Monitoring an Auditing approved studies Participant Recruitment Procedures
p.000011: Dissemination of study results and research misconduct Quality Assurance Guidance and Legal Enforcements Organizing and
p.000011: Administering Research Ethics Committees Public Health Ethics
p.000011: Grant Proposal writing
p.000011: GROUP 1
p.000001: 1
p.000001:
p.000001: 1
p.000001: 1
p.000001:
p.000002: 2
p.000002:
p.000002: 2
p.000002: 2
p.000002: 2
p.000002: 2
p.000001: 1
p.000001: 1
p.000001:
p.000001: 1
p.000001: 1
p.000001:
p.000001: 1
p.000001: 1
p.000001: 1
p.000001: 1
p.000001: 1
p.000001: 1
p.000001: 1
p.000001: GROUP 2
p.000001: 1
p.000001:
p.000001: 1
p.000001: 1
p.000001:
p.000001: 1
p.000001:
p.000002: 2
p.000002: 2
p.000002: 2
p.000002: 2
p.000001: 1
p.000001: 1
p.000001:
p.000002: 2
p.000001: 1
p.000001:
p.000002: 2
p.000001: 1
p.000002: 2
p.000001: 1
p.000001: 1
p.000001: 1
p.000001: 1
p.000001:
p.000001: The above ratings conclude that participants needed further continued training on both basic and advanced research
p.000001: ethics topics. Participants were also exposed to the current direction that other countries are taking, in order to
p.000001: improve the management of the ethics review process, by using a web-based platform known as: Research
p.000001: for Health Innovation Organizer (RHInnO; www.rhinno.net). RHInnO was developed by COHRED and is
p.000001: intended to replace the current complex paper based system widely used by RECs across Africa5. The advantages of
p.000001: the platform includes:
p.000001: • Improving RECs efficiencies through speeding up the research ethics review process.
p.000001: • Prevents loss of submitted materials, delays in communication between RECs and researchers
p.000001: hence bringing about accountability.
p.000001: • Standardization and harmonization of the ethical review process
p.000001: • Enhanced control of research activities
p.000001: • Less resources needed e.g. personnel, stationary
p.000001: • Sharing or use of standardized research regulation documents like SOPs and research guidelines.
p.000001: One of the partners pledged to support the implementation of RHInnO ethics in Swaziland following
p.000001: tremendous interest from the REC members.
p.000012: 12
p.000012:
p.000012: Recommendations
p.000012:
p.000012: The Ministry of Health should take the lead to engage the ethics committee to discuss some of the cooperative steps to
p.000012: improve EC/Research.
p.000012: The REC should disseminate information on the importance of research to all institutions of higher learning in
p.000012: Swaziland.
p.000012: Swaziland must establish a national research ethics Committee to coordinate health research
p.000012: oversight in Swaziland.
p.000012: Establishment of a Health Research Unit with a Secretariat to manage NREC. Implementation of the REC information
p.000012: management system for submission and review of protocols (RHInnO Ethics).
p.000012: Review and finalization of the national research governance documents currently in draft form (Research Agenda,
p.000012: Research Policy, SOPs, Research Guidelines, Human Research Bill and Application documents).
p.000012: Continued training in research ethics at both basic and advanced level.
p.000012: Plan strategies for an on-going support mechanism from both national governments, internal and external
p.000012: donors for sustainability of established RECs.
p.000012: Collaboration of the Ministry of Health and Ministry of CST to set up a national research coordinating
p.000012: body and finalize the national research bill that will encompass the Human Research Bill.
p.000012: Identifying research ethics networks for Swaziland to participate such as the discussion forums on the MARC
p.000012: website.
p.000012: Identifying capacity building opportunities for the national research unit coordinator Separation of clinical trials ...

p.000013: research guidelines Critically review the consent form
p.000013: Take time to identify ethical issues in a protocol
p.000013:
p.000013:
p.000013: Conclusion
p.000013: The workshop increased participants’ awareness about the importance of building and strengthening
p.000013: capacity of NREC in Swaziland. There seemed to be a consensus among the participants
p.000013: regarding the existence of gaps in the clinical trial regulatory oversight systems including the need
p.000013: for more training in research ethics and establishing/improving REC information management systems.
p.000013: Participants committed to working together towards sensitizing their institutions, governments, clinical trial
p.000013: sponsors and other donor agencies about the importance of investing more into strengthening the capacity
p.000013: of the NREC to enable the integration of ethics. The workshop served as a very engaging platform through
p.000013: open dialogue among REC members, it enabled very fruitful discussions and sharing of best regulatory practices. The
p.000013: forum
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: also acted as a gateway to new and future collaborations between COHRED/PSI /Swaziland MoH/URC and PEPFAR.
p.000014:
p.000014: Closing Remarks
p.000014: The workshop was wrapped up with a formal closing session, at which, the COHRED Africa Director
p.000014: (Boitumelo Mokgatla-Moipolai) highlighted COHRED’s mandate and commitment in developing and
p.000014: strengthening the research for health governance systems in low and middle income countries (LMICs). She
p.000014: highlighted that COHRED partners with governments, institutions and civil society organizations in their efforts
p.000014: to use research, innovation, science and technology
p.000014: to achieve equity and national development. She also outlined COHRED’s initiatives in building and strengthening the
p.000014: research ethics landscape in Africa. The PEPFAR Swaziland country Director (Peter Ehenkranz) emphasized the
p.000014: commitment of the American people to improve health systems in Africa by helping to build and strengthen these
p.000014: systems. He noted that the goal of evidence- based research needs particular attention to all the systems from
p.000014: defining the standard operating procedures to analysis of data. He reiterated the need to answer questions
p.000014: through research supported by epidemiology. He also pointed out the need for integration, collaboration, networking
p.000014: among all research stakeholders as well as the importance of data sharing to avoid blocking research. He
p.000014: committed to support health research initiative in Swaziland.
p.000014:
p.000014: The Swaziland Ministry of Health Director (Rejoice Nkambule) extended a note of appreciation to the workshop
p.000014: organizers, the participants and the facilitators. She emphasized her commitment to support SEC and the research unit
p.000014: in their efforts to improve health research capacity in Swaziland. She requested the participants to document all their
p.000014: requests and recommendations and submit to her office, following which, she will set up a meeting to tackle
p.000014: the raised issues. However, she pointed out that although the issue of setting up the National Research
p.000014: Council is beyond the Ministry of Health, she will initiate its advocacy.
p.000014:
p.000014: References
p.000014: 1. Maïga D, Akanmori BD, Chocarro L. Regulatory Oversight of Clinical Trials in Africa: Progress Over
p.000014: the Past 5 Years. Vaccine. 2009; 27: 7249–7252.
p.000014: 2. Bhat SS, Hegde TT. Ethical international research on human subjects research in the absence of local
p.000014: institutional review boards. J Med Ethics. 2006; 32: 535–536.
p.000014: 3. Council on Health Research for Development; The Global Forum 2012;
p.000014: http://www.forum2012.org/wp- content/uploads/2012/10/Beyond-Aid-Research-and-
p.000014: innovation-as-key-drivers-for-health-equity-and- development1.pdf
p.000014: 4. http://www.healthresearchweb.org/files/AARECFinalReport.pdf
p.000014: 5. IJsselmuiden C., Marais D., Wassenaar D.R, Mokgatla-Moipolai., B. Mapping African Ethical Review Committee
p.000014: activity onto capacity needs. The MARC initiative and HRWebs interactiveness database on RECs
p.000014: in Africa: Developing World Bioethics 2012; 1471- 8847.ewb_325 1..
p.000015: 15
p.000015:
p.000015:
p.000015: Annex 1: Workshop Program
p.000015:
p.000015:
p.000015: Monday 22nd July
p.000015:
p.000015: 8:00 am –08:30am
p.000015:
p.000015: 08:30am – 08:45am
p.000015:
p.000015: 08:45am – 0900am
p.000015:
p.000015:
p.000015: 09:00 am – 09:30am
p.000015:
p.000015: 09:30am – 10:00am
p.000015: A c t i v i t i e s
p.000015:
p.000015: Registration
p.000015:
p.000015: Opening Remarks
p.000015:
p.000015: Introductions Workshop Overview
p.000015:
p.000015: Pre-Test
p.000015:
p.000015: Overview of Research ethics in Swaziland
p.000015: Responsible
p.000015:
p.000015:
p.000015:
p.000015: MoH & PEPFAR
p.000015:
p.000015: BM
p.000015: Participants NREC
p.000015: Chairperson
p.000015:
p.000015:
p.000015: Activities
p.000015:
p.000015:
p.000015: 10:00 am – 10:20 am
p.000015: Social Break
p.000015:
p.000015:
p.000015: 10:20am – 11:00am
p.000015: Background and Importance of Health Research Ethics BM
p.000015:
p.000015:
p.000015: 11:00 am – 12:30 pm
p.000015:
p.000015: 12:30 pm – 13:30 pm
p.000015:
p.000015: 13:30 pm – 16:00 pm
p.000015:
p.000015: 16:00pm – 16:30 pm
p.000015: Fundamentals of Research Ethics
p.000015:
p.000015: Lunch
p.000015:
p.000015: Case Study: 1 Wrap Up
p.000015:
p.000015: MK
p.000015:
p.000015:
p.000015:
p.000015: Group Work
p.000015:
p.000015:
p.000015: Tuesday 23rd July
p.000015: Activities
p.000015:
p.000015: Responsible
p.000015:
p.000015:
p.000015: 8:15 am –08:30am
p.000015:
p.000015: 08:30am – 08:45am
p.000015:
p.000015: 08:45am – 10:45am
p.000015: Registration
p.000015:
p.000015: Recap of Day one Participant
p.000015:
p.000015: Informed Consent Process BM
p.000015: Activities
p.000015:
p.000015:
p.000015: 10:45 am – 11:00 am
p.000015: Social Break
p.000015:
p.000015:
p.000015: 11:00am – 12:00pm
p.000015: Case Study 2
p.000015: Group Work
p.000015:
p.000015:
p.000015: 12:00 am – 13:00 pm
p.000015:
p.000015: 13:00 pm – 14:00 pm
p.000015:
p.000015: 14:00 pm – 16:00 pm
p.000015:
p.000015: 16:00 pm – 16:30 pm
p.000015: Risk/Benefit Analysis and Standard of Care ...

p.000015: MK
p.000015:
p.000015:
p.000015:
p.000015: Group Work
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000016: 16
p.000016:
p.000016: Wednesday 24th July
p.000016:
p.000016:
p.000016: 8:15 am –08:30am
p.000016: Activities
p.000016:
p.000016: Registration
p.000016:
p.000016: Responsible
p.000016:
p.000016: Activities
p.000016:
p.000016:
p.000016: 08:30am – 08:45am
p.000016: Recap of Day two
p.000016: Volunteer
p.000016:
p.000016:
p.000016: 08:45am -10:30am
p.000016:
p.000016: 10:30 am – 11:00 am
p.000016: Institutionalizing Research Committees MK
p.000016:
p.000016: Social Break
p.000016:
p.000016:
p.000016: 11:00 am – 13:00 pm
p.000016: Group Exercise & Discussion MK
p.000016:
p.000016:
p.000016: 13:00 pm – 14:00 pm
p.000016:
p.000016: 14:00 pm – 15:00 pm
p.000016:
p.000016: 15:00pm – 16:00pm
p.000016:
p.000016: 16:00 pm – 16:30 pm
p.000016: Lunch
p.000016:
p.000016: Compensating Research Participants MK
p.000016:
p.000016: Confidentiality in the African Context BM
p.000016:
p.000016: Wrap Up
p.000016:
p.000016:
p.000016: Thursday 25th July
p.000016: Activities
p.000016:
p.000016: Responsible
p.000016:
p.000016:
p.000016: 8:15 am –08:30am
p.000016: Registration
p.000016:
p.000016:
p.000016: 08:30am – 08:45am
p.000016:
p.000016: 08:45am – 10:30am
p.000016:
p.000016: 10:30 am – 11:00 am
p.000016:
p.000016: 11:00 am – 11:45 pm
p.000016:
p.000016: 11:45am – 13:00pm
p.000016:
p.000016: 13:00 pm – 14:00 pm
p.000016:
p.000016: 14:00 pm – 16:00 pm
p.000016:
p.000016: 16:00 pm – 16:30 pm
p.000016:
p.000016: Friday 26 th July
p.000016: Recap of Day three
p.000016:
p.000016: Research Ethics Review Process
p.000016:
p.000016: Social Break
p.000016:
p.000016: Ethical Issues in International Collaborative Research Preparation for simulated REC /Research Proposal
p.000016: Lunch
p.000016:
p.000016: Simulated Research Ethics Committee
p.000016:
p.000016: Wrap up
p.000016:
p.000016: Activities
p.000016: Volunteer MK
p.000016:
p.000016:
p.000016: BM
p.000016:
p.000016: Participants
p.000016:
p.000016:
p.000016:
p.000016: Group Work
p.000016:
p.000016:
p.000016:
p.000016: Responsible
p.000016:
p.000016: Activities
p.000016:
p.000016:
p.000016: 8:15 am –08:30am
p.000016: Registration
p.000016:
p.000016:
p.000016: 08:30am – 08:45am
p.000016: Recap of day four
p.000016: Participant
p.000016:
p.000016:
p.000016: 08:45am – 09:15am
p.000016:
p.000016: 09:15am – 11:00am
p.000016:
p.000016:
p.000016: 11:00 am – 11:20 am
p.000016: Post-Test
p.000016:
p.000016: Dissemination of Research Results & Research Misconduct
p.000016:
p.000016: Social Break
p.000016: Participants MK
p.000016:
p.000016:
p.000016: 11:00 am – 11:45 pm
p.000016:
p.000016: 11:45am – 12:45pm
p.000016:
p.000016: 12:45pm – 13:00pm
p.000016:
p.000016: 13:00pm – 13:15pm
p.000016:
p.000016: 13:30 pm – 14:30 pm
p.000016: Public Health Research Ethics
p.000016:
p.000016: Exercise: Swaziland NREC Capacity Building Wrap up
p.000016: Closing remarks
p.000016:
p.000016: Lunch
p.000016: MK
p.000016:
p.000016: Group work BM
p.000016: MoH CDC
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000017: 17
p.000017:
p.000017: Annex 2: Case Study 1: A treatment for Central Nervous System.
p.000017:
p.000017: This case study was aimed to at assisting participants to differentiate between clinical care and
p.000017: research and appreciating the thin line between the two.
p.000017: Dr W is a neurosurgeon in a hospital in one of Asia’s major metropolitan centres. He earned his medical degree in that ...

p.000019: Objective
p.000019: Short-term solution
p.000019: Long-term solution
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019: .
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000019:
p.000020: 20
p.000020:
p.000020: Annex 5: Participants List
p.000020:
p.000020:
p.000020: Name
p.000020: 1 Buthelezi Gcinile
p.000020: 2 Dlamini Xolisile
p.000020: 3 Gindindza Hendry
p.000020: 4 Lukhele Sisi
p.000020: 5 Haumba Damson
p.000020: 6 Maziya Rudolph
p.000020: Name
p.000020: 7 Mndzebele Comfort
p.000020: 8 Nomcebo Phungwayo
p.000020: 9 Nhlabatsi Nhlanhla
p.000020: 10 Simelane Zanela
p.000020: 11 Shongwe Babazile
p.000020: 12 Zwane Fortunate
p.000020:
p.000020:
p.000020: 1 Boitumelo Mokgatla-Moipolai
p.000020: 2 Mary Kasule
p.000020: Facilitators
p.000020:
p.000020:
p.000020: 1 Victoria Masuku
p.000020: 2 Bonsile Bhembe
p.000020:
p.000020: Annex 6: Training Photos
p.000020: PSI Representatives
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020: We sincerely thank PSI Swaziland for initiating research for health capacity building initiatives in Swaziland.
p.000020:
p.000020:
p.000020:
p.000020: ...

Appendix

Indicator List

Indicator	Vulnerability
HIV	HIV/AIDS
access	Access to Social Goods
authority	Relationship to Authority
autonomy	Impaired Autonomy
belmont	belmont
blind	visual impairment
cioms	cioms guidelines
education	education
emergency	Public Emergency
fetuses	Fetus/Neonate
gender	gender
helsinki	declaration of helsinki
hiv/aids	HIV/AIDS
job	Occupation
language	Linguistic Proficiency
officer	Police Officer
philosophy	philosophical differences/differences of opinion
placebo	participants in a control group
poor	Economic/Poverty
stem cells	stem cells
vulnerability	vulnerable
vulnerable	vulnerable
women	Women

Indicator Peers (Indicators in Same Vulnerability)

Indicator	Peers
HIV	['hiv/aids']
hiv/aids	['HIV']
vulnerability	['vulnerable']
vulnerable	['vulnerability']

Trigger Words

capacity

consent

developing

ethics

harm

protection

risk

welfare

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Political	vulnerable	vulnerable	9
Political	vulnerable	vulnerability	2
Health	HIV/AIDS	HIV	1
Health	HIV/AIDS	hiv/aids	0
Health	stem cells	stem cells	2
Health	visual impairment	blind	2
Social	Access to Social Goods	access	2
Social	Fetus/Neonate	fetuses	3
Social	Linguistic Proficiency	language	1
Social	Occupation	job	1
Social	Police Officer	officer	1
Social	Women	women	1
Social	education	education	1
Social	gender	gender	2
Social	philosophical differences/differences of opinion	philosophy	1
Economic	Economic/Poverty	poor	2
General/Other	Impaired Autonomy	autonomy	1
General/Other	Public Emergency	emergency	2
General/Other	Relationship to Authority	authority	2
General/Other	belmont	belmont	1
General/Other	cioms guidelines	cioms	1
General/Other	declaration of helsinki	helsinki	1
General/Other	participants in a control group	placebo	3

Building Research Ethics Review Capacity in Swaziland

Applicable Type / Vulnerability / Indicator Overlay for this Input

Political / vulnerable

Health / HIV/AIDS

Health / stem cells

Health / visual impairment

Social / Access to Social Goods

Social / Fetus/Neonate

Social / Linguistic Proficiency

Social / Occupation

Social / Police Officer

Social / Women

Social / education

Social / gender

Social / philosophical differences/differences of opinion

Economic / Economic/Poverty

General/Other / Impaired Autonomy

General/Other / Public Emergency

General/Other / Relationship to Authority

General/Other / belmont

General/Other / cioms guidelines

General/Other / declaration of helsinki

General/Other / participants in a control group

Orphaned Trigger Words

Appendix

Indicator List

Indicator Peers (Indicators in Same Vulnerability)

Trigger Words

Applicable Type / Vulnerability / Indicator Overlay for this Input