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Genetics & Genomics Research Dissemination; Makerere Bioethicists Emphasize the Importance of Community Engagement

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By Joseph Odoi

As Genetics research continues growing in Uganda, Bioethicists from Makerere University College of Health Sciences have stressed the importance of community engagement, genetic counselling and Public sensitization when conducting Genetics research in Uganda.

These recommendations were made at a research dissemination workshop held on the 8th December 2022 at Makerere University College of Health Sciences.

While presenting findings of the ELSI-UG project titled “Ethical and social issues in informed consentprocesses in African genomic research”, the Project Principal Investigator -Associate Professor Mwaka Erisa Sabakaki from College of Health Sciences, Makerere University in a special way welcomed participants to the dissemination. He noted that involving communities in genetics and genomics research is very important when it comes to enhancing the understanding of genetics and genomic information by the general public.

‘’There has been an exponential increase in genetics and genomic research in the last two decades. 

However, this field of research is complex and is poorly understood by various research stakeholders. One way of enhancing understanding of genetics and genomic information by the general public is through community engagement. It is therefore crucial that communities are meaningfully involved in research processes right from conception. Community engagement provides a two-way communication channel through which researchers gain better understanding of community priorities, preferences, traditions, practices, and cultural sensitivities.’’ explained Prof. Mwaka.

The Project Principal Investigator -Associate Professor Mwaka Erisa Sabakaki sharing findings and recommendations from the study.
The Project Principal Investigator -Associate Professor Mwaka Erisa Sabakaki sharing findings and recommendations from the study.

He equally highlighted the need for translation of scientific language into local languages, genetic counsellors and consent in Genetics research adding that community engagement is crucial in building equitable research collaborations and trust between researchers and research communities.

Genetic and Genomics

According to National Institute of General Medical Sciences, Genetics is the scientific study of genes and how certain qualities, conditions or traits are passed from parents to their off springs. Genomics on the other hand involves using information about genes to: identify genetic disorders including future diseases so that doctors tailor treatment for individuals.

In same spirit, Dr. Moses Ochan, the Vice Chairperson of the Makerere University Research and Ethics Committee stressed the importance of sensitization of communities and researchers before any study is undertaken. According to him, sensitization enables communities understand the advantages and disadvantages of participating in a study thus making informed decisions.

Dr. Moses Ochan at the event.
Dr. Moses Ochan at the event.

In this United States National Institutes of Health funded study that sought to explore the knowledge,perceptions and experiences of stakeholders; researchers, bioethicists, REC members, research participants and caregivers/guardians on the informed consent process, and the ethical, legal and social implication of genomic research, 243 protocols were analyzed involving both local and international researchers

Findings

Return of individual genetic results to research participants

  • Of 122 parents/caregivers of adolescents in the study, 77.1 % expressed the desire to receive all results of their children’s genetic/genomic results.
  • 71.3 % of parents/caregivers agreed that children should be able to take part in research testing for genetic conditions that begin during childhood, even if there is no treatment that can alter the course of the condition
  • 85.3 % of parents/ caregivers expressed the desire to know genetic research results about children to see if they are more likely to get a disease in the future.
  • 71.3 % of parents/ caregivers agreed that Children should be able to take part in research testing for genetic conditions for which there is a treatment that begins during childhood that can alter the course of the condition
  • 62.3 % of parents/ caregivers  agreed that children should be able to take part in research testing for genetic conditions that start in adulthood and have no treatment that can alter the course
  • 89.4 % of parents/ caregivers agreed that children should be able to take part in research testing for genetic conditions that will arise in their adult years, only if there is treatment or prevention that should begin in childhood
Some of the participants during the dissemination.
Some of the participants during the dissemination.

On the most important issues parents should consider in deciding whether or not to get genetic research results, 81.2% cited distress knowing that there are potential problems for other family members. Additionally, 45.0 % of parents and caregivers noted that receiving their child’s genetic results might worry their family; and 27.8% worried about stigma and discrimination

To address this, 69.2 % of parents and care givers said genetic counselling should be offered prior to a sample being taken to do genetic research

On perceptions on returning individual results of genomic research, parents and caregivers indicated that It is the researchers’ moral obligation to return clinically significant results; as such, genetic results should be communicated to them by  the study doctor. Most parents preferred being informed first before involving the children; and some mothers expressed the desire to exclude the child’s father from these discussions until they (mothers) have understood the implications of the results in question.

On the role of children in making decision makings on whether to regarding return of genetic results or not, there was no consensus on the ideal age for disclosure of results.  Some parents and caregivers pointed out that  involvement of children in these discussions should depend on child’s character, level of understanding and ability to cope with the implications..

On handling findings that have familial implications, there were mixed feelings about involving other family members. Parents, especially mothers expressed fear of attribution. They  thus suggested that the biological parents of the child should be the first ones to receive these results and then decide whether to involve other family members.

On the perceived challenges to return of results, parents and caregivers cited protracted delays in communicating genetics/genomics results; difficulty in tracing the child’s family, especially when the parents die and they are being cared for by other caregivers; risks of knowing unpleasant findings and paternity disputes.

Parents and caregivers offered several suggestions for the safe return of results of paediatric genomic research and these included the need to organize peer support and sensitization activities for adolescents participating in genetic studies; feedback of results should be done by a multidisciplinary team comprising of  clinicians, genetic counsellors, the child and parents. All concurred that other family members should be involved at a later stage.

Informed consent and sharing of biological samples in collaborative genomic research and biobanking

On consent to future use of samples, 88.8% of the 187 researchers that participated in the study indicated that there is need to provide donors with the option to consent. 62% indicated that informed consent forms should include multiple options regarding the types and conditions of future research for which the samples may be used (tiered consent). 6.2% said that participants should only consent for the current study, and any future studies on the stored samples would require re-consent. However, the majority of researchers felt that the need to reconsent places an unacceptable burden on the researchers (62%) and is prohibitively costly (59.4%)

On informed consent experiences and practices, it was found that most principal investigators (12/15) were not well conversant with the informed consent procedures of their respective studies because they delegate this to study coordinators and nurses/nurse counsellors. Most nurses/nurse counsellors lacked basic knowledge and understanding of genetics, including the risks of genetic research.

On Information disclosure, researchers noted that genetic research is complex and oftentimes research participants do not adequately understand the information disclosed them during the consenting process. They thus recommended the use of an iterative approach that encourages consultation with family and/or people research participants trust, use of simple language, use of visual aids and other media, and objective assessment of comprehension. The also reiterated the need for translating informed consent documents into local languages and the use of peer educators. Researchers emphasized the role of community engagement in community education and sensitization, ensuring that researchers respect local cultural values and beliefs, and dispelling of superstitions and misinformation.

  • The perceived challenges to the informed consent process included, the poor quality and inaccuracy of translations of ICF into local languages, inadequate understanding of informed consent, limited understanding of genetics by communities and some research team members, lack of professional genetic counselling services in Uganda, and mistrust of foreign collaborators.

On Export of human biological materials (HBM), researchers had a positive attitude towards the export of samples and expressed a desire for collaborative partnerships in genetics/genomic research and bio banking that are characterized by mutual respect and equity. However, they raised several concerns:

  • They seem not to be well conversant with the guidance provided by the national ethics guidelines on bio banking and
  • They all concurred that material transfer agreements (MTA) are key in the transfer of human biological materials across the national borders. However, they surmised that these  MTA are unfair and tend to favour international Collaborators. They felt that local researchers and research institutions are not empowered enough to bargain favorably during MTA negotiations. They also indicated that the national ethics guidelines are vague on role of RECs in MTA and data sharing agreement development. Furthermore, they indicated that Uganda lacks appropriate enabling ethical and legal frameworks to protect the interests of local scientists and research institutions
  • On sharing of the benefits of research, the researchers felt the ground was not leveled and there was neither equity nor fairness in sharing of GBR benefits in international collaborative research. They attributed this to the lack of scientific integrity and questionable research practices by collaborating researchers, lack of effective communication between collaborating partners, denial of access to shared data and samples by Northern collaborators, and felt that the oversight function of UNCST during MTA implementation is limited.
Prof. Nelson Sewankambo at the dissemination. He appreciated the quality of genetics and genomics study led by Prof. Mwaka Erisa.
Prof. Nelson Sewankambo at the dissemination. He appreciated the quality of genetics and genomics study led by Prof. Mwaka Erisa.

To address the issues at hand around genetics and genomics research, they made the following recommendations;

Recommendations to enhance comprehension of informed consent for genetic/genomic research and biobanking

  • Escalating community engagement: to sensitize the general public and educate them on genetics research and its implications
  • Iterative approach to informed consent where participants are given ample time to read/be read to consent information, ask questions, make consultations with family and trusted persons
  • Encouraging the use of simple language and various media during information disclosure.
  • There is need for harmonization of translations. A dictionary of translated key scientific and medical terms/concepts in research and clinical care in local languages should be developed
  • Develop specific national guidelines for genetic and genomic research in Uganda.
  • Research ethics committees should be trained in the basics of genetic research in order to ensure that they appreciate the ELSI and are competent enough to review genetic research.
  • The use of checklists for assessing understanding of consent should become mandatory and should also be included in the national ethics guidelines.
  • All stakeholders should read and understand the available national and international guidelines, policies, and regulations pertaining to genetics/genomic research and bio banking before negotiating Material transfer agreements.
  • Research ethics committees should be empowered to review and monitor the execution of MTAs during research implementation, and this should be clearly stipulated in the national ethics guidelines.
  • The national research regulators and individual institutions should join forces and devise mechanisms for tracking and monitoring the use of exported HBM and data.
  • Encouraging meaningful involvement of communities in Material transfer agreements negotiations, particularly regarding sharing of the benefits of research.
  • There should be capacity building for clinical genetics, particularly clinical geneticists and professional genetic counsellors
  • Community engagement activities should be scaled up to prepare communities for the return of genetic research results as and when they are available

More about the Project

This project explored the knowledge, perceptions and experiences of stakeholders on the informed consent process, and the ethical, legal and social implication of genomic research. The goal of the project was to contribute to a better understanding of the ethical legal and societal issues associated with genomic research in low resource settings. The study employed both quantitative and qualitative methods of data collection and analysis. Prospective evaluation was done using questionnaire surveys; focus group discussions; in-depth interviews; direct observation of informed consent processes; and assessment of the quality of informed consent

This study was funded by United States National Institutes of Health through The Human Heredity and

Health in Africa (H3Africa) initiative which is spearheading bio banking and genomics research in Africa for Africa.

The study was conducted between November 2018 to 2022 by a team of researchers led by Associate Prof. Erisa Mwaka as Principal Investigator.

 Research team:

  • Associate Prof. Erisa Mwaka
  • Dr. Ian Munabi
  • Assoc. Prof. Joseph Ochieng
  • Dr. Janet Nakigudde
  • Prof. Nelson Sewankambo

Health

METS Newsletter May 2024

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The newly appointed CDC Uganda Country Director, Dr. Adetinuke Mary Boyd (7th from left) met with country implementing partner Executive Directors to get insights on ongoing projects, discussed leveraging of partnerships as well as strategizing for how best to strengthen health systems. Infectious Diseases Institute (IDI)-McKinnell Knowledge Centre, Makerere University, Kampala Uganda, East Africa.

The Monitoring and Evaluation Technical Support (METS) Program is a 5-year CDC-supported collaboration of Makerere University School of Public Health (MakSPH), the University of California San Francisco (UCSF) and Health Information Systems Program (HISP Uganda).

Highlights of the METS May 2024 Newsletter

  • Enhancing Response to Sexual and Gender-Based Violence
    • Responding to and preventing Sexual and Gender-Based Violence (SGBV) and Violence Against Children (VAC) are critical components of Uganda’s national HIV prevention program. METS developed a new app designed to improve support for SGBV survivors. This followed an assessment in December 2022, that revealed gaps in service access and coordination in Fort Portal and Kampala Regions.
    • The METS team, in collaboration with regional implementing partners, is scaling up the app’s use in pilot districts such as Masaka, Kiryandongo, Fort Portal, and Mubende. The team visited facilities and police stations to install the app and train selected focal persons on its use.
  • Assessing Readiness for Integrated HIV and NCD Care Services
    • METS supported the Ministry of Health to conduct a site readiness assessment for integrated delivery of HIV and Non-Communicable Diseases (NCD) services from 22nd to 26th April 2024, in collaboration with the US Centers for Disease Control and Prevention (CDC), and various implementing partners. The activity was conducted in selected health facilities in Acholi, Mubende, Kayunga, and Rwenzori regions to determine their feasibility for participating in a comprehensive NCD evaluation.
    • The 48 facilities visited have already integrated NCD services (mental Health, diabetes, and hypertension). Of these, 78% have integrated mental health services in their PMTCT clinics. 40% of the facilities have a dedicated NCD services physicians /doctor in the ART Clinic, 29% have doc have dedicated physicians in the PMTCT clinics. 90%. Most of the facilities have clinical and nurses in the ART than PMTCT facilities but more nurses offering NCD services in PMTCT sites.
  • Digitalizing the health sector through strategic partnerships
    • In collaboration with CDC and METS, the MoH organized a national Electronic Medical Records (EMR) stakeholders meeting to orient stakeholders on the national EMR agenda and transition towards a comprehensive digital health facility package. Key actions discussed included expanding the rollout of the EMR and Community Health Information System (eCHIS) and urging development partners to support prioritized health information and digital health investments.
    • The introduction of electronic medical records (EMRs) in health facilities aims to improve the quality of health service delivery by providing real-time accountability transparency, and traceability of medical supplies, monitoring health worker absenteeism, enhancing patient satisfaction through efficient care provision, reducing unnecessary or duplicate diagnostic tests, and offering easy access to management reports for decision-making. Additionally, EMRs will lay the foundation for the implementation of national health insurance.
  • UgandaEMR+ Implementation Showcased at Kisenyi HCIV
    • METS and Reach Out Mbuya (ROM) showcased the implementation of UgandaEMR+ to representatives from the USG and the Ministry of Health (MoH) at Kisenyi HCIV. The visit was aimed at providing a clear understanding of the system’s functionality at the health facility, which serves over 1,200 outpatients daily and supports over 1600 clients on ART.
    • Dr. Peter Akonyera, the ART Clinic In Charge shared positive end-user experiences, noting simplified data use and analysis, efficient data retrieval, and the system’s popularity among users despite existing challenges. He appreciated METS’ support in maintaining system synchronization. The data visualization tools have been particularly useful for clinicians to manage patient schedules and workload distribution effectively, ensuring timely and efficient healthcare delivery.
  • METS Showcases Research at INTEREST 2024 Conference in Benin
    • The International Conference on HIV Treatment, Pathogenesis, and Prevention Research (INTEREST) brought together global scientists to share cutting-edge knowledge in HIV diagnosis, treatment, and prevention. The conference also aimed to build a community of African physicians and scientists to develop local solutions for managing HIV and preventing its transmission.
    • METS submitted an abstract titled “Enhancing HIV Case Identification through a National HIV Testing Services (HTS) Continuous Quality Improvement” based on support to the Ministry of Health (MoH) in designing, implementing, and evaluating initiatives to increase the identification of HIV-positive clients, crucial for achieving the global target of 95% of people living with HIV (PLHIV) knowing their status.
  • Gallery
    • New CDC Director meets Country implementing partner Executive Directors
    • UgandaEMR+ support supervision at Kisenyi HCIV visit
    • EMR Stakeholders meeting
    • CBS guidelines meeting
    • INTEREST 2024 conference – Benin
    • Key Populations assessment – Ishaka district

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SIMCS-Trial Vacancy Announcement: Twenty-Five (25) Research Assistants

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An elevated shot of the School of Health Sciences and School of Medicine Building, College of Health Sciences (CHS), Makerere University. Mulago Campus, Kampala Uganda, East Africa.

Makerere University College of Health Sciences School of Medicine in collaboration with Baylor College of Medicine received funding from US National Institutes of Health – Fogarty International Center to carry out a study on “Development and evaluation of an information management and communication system for population-wide point of-care infant sickle cell disease screening (SIMCS-Trial)”. The program seeks to recruit 25 research assistants at its study sites. 

Roles and responsibilities  

  • Identify and screen participants for possible enrolment into the study according to the Study Protocol.
  • Obtain informed consent from caregivers of eligible participants as per protocol accordance with GCP and HSP principles.
  • Counsel and explain study procedures to the caregivers of study participants using the mobile app.
  • Enrol eligible participants into the study to meet the study accrual targets.
  • Complete study CRFs, correctly and accurately in compliance with trial procedures/ SOPs and GCP standards.
  • Ensure study participants’ safety and privacy, data integrity and confidentiality.
  • Participate in collection of appropriate study samples/specimens from the participants as per protocol and SOPs as well as performing the test.
  • Carry out any other duties as assigned by superiors in line with your work.

Required Qualification and experience 

  • A degree in any health-related discipline, and registered with the relevant national bodies.
  • Knowledge and familiarity with Microsoft word, Excel, PowerPoint and Access as well as basic internet applications 
  • Skills in using common relevant computer packages and mobile technology for data collection
  • Previous work in a research environment is added advantage.
  • Basic knowledge of clinical research regulatory procedures. 
  • Good Clinical Practice (GCP) training and Research Ethics training skills and knowledge
  • Excellent command of English (written and oral) as well as the local languages (Luganda or Lusoga)
  • Excellent interpersonal skills to develop relationships with participants.
  • Experience of living and or working both in urban and rural environment.
  • Team-working skills to work effectively as part of a multidisciplinary healthcare team 
  • Time management skills and ability to handle multiple tasks simultaneously.
  • Highly organized, detail-oriented and self-motivated/driven. 
  • Ability to handle multiple tasks simultaneously. 
  • Ability to professionally communicate in writing, verbally or other means deemed appropriate. 

Reports to: The SIMCS Co-Investigator/SIMCS Trial Coordinator 

Expected start date: July 2024

How to apply: 1-page type written application letter addressed to the Principal Investigator SIMCS Trial MakCHS SOM together with current CV, copies of academic certificates, and recommendation letters from two past employers should be e-mailed as ONE PDF DOCUMENT to makimpact22@gmail.com

Deadline for receiving applications: Friday 20th June 2024 at 5:00 pm

Only shortlisted candidates will be invited to the interview. 

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CTCA Call for Proposals: Enhance Tobacco Control Institutional Capacity in Africa

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Call for Proposals - Project Title: Enhance Tobacco Control Institutional Capacity in Africa; Grant #339. Deadline 30th June 2024, by 5pm EAT. The Centre for Tobacco Control in Africa (CTCA), School of Public Health, College of Health Sciences (CHS), Makerere University, Kampala Uganda, East Africa.

Project Title: Enhance Tobacco Control Institutional Capacity in Africa; Grant #339

Introduction:

The Centre for Tobacco Control in Africa (CTCA) received funding from the African Capacity Building Foundation (ACBF) for the 2024-2026 to implement a project on institutional capacity. The project investments are geared towards sustaining human resource capacity and knowledge generation to reduce use of all forms of tobacco products in Africa. Specifically, the project aims to:

  1. Enhance training opportunities for African governments and relevant actors in tobacco control in
    the continent
  2. Increase access to knowledge for guiding tobacco use prevention and control in Africa
  3. Reinforce the institutional development of CTCA for an optimal performance of its functions
    and processes.

In 2020, CTCA developed a Tobacco Control Research Agenda (TCRA) with the aim of providing a guide for generating local evidence to drive tobacco control policy formulation and implementation in Africa.

Therefore, CTCA with support from ACBF is seeking researchers across the African continent to be awarded 6 small grants of USD 5000 to implement research that aligns with the TCRA thematic areas below:

  1. Patterns and trends of tobacco use and exposure for all tobacco products including the new
    products at country and regional levels (sex, age, region, types of products, new products).
  2. Effects of tobacco use and exposure on sustainable development (poverty, education, culture, food security, environment, HIV, TB, reproductive health, NCDs).
  3. Tobacco use and populations at risk (youth, young adults, women/gender, elderly, residents
    of urban areas, miltary, prisoners, mental health patients, populations in low socio-economic
    dwellings like slums).
  4. Tobacco control policy research and analysis (smoke free, TAPS, GHWs, ceasation) of cost
    effectiveness, impact, drivers, enablers, innovation, challenges, communication and advocacy
    for tobacco control.
  5. Sociocultural context of tobacco use
  6. Tobacco industry and tobacco control policy
  7. Tobacco production, alternative livelihoods and environment (distribution, value chain,
    environmental impact, historical and determinants of tobacco production)
  8. The economics of tobacco and tobacco control (product, pricing, illicit tobacco trade,
    taxation)

The full research Agenda can be accessed in English and in French.

Submissions

We are pleased to invite submissions from researchers based in Africa. Successful proposals should align with any of the 8 thematic areas of the CTCA Research Agenda. Innovative proposals that address critical issues and contribute to evidence-based policy and practice in the respective areas to inform Tobacco control in Africa are particularly encouraged.

Requirements

These grants will fund work that relates to the CTCA Research Agenda. Activities will include
proposal development, data collection and analysis, report writing and dissemination. All research to be implemented will be approved by the institutional review board and published in peer reviewed journals. These grants are intended for; 1) Researchers based in Tobacco Control Programs/Response; 2) post graduate students who would like to complete their research projects aligned to this call and 3) early and middle career researchers. It is required that this research is executed, and the report completed within 12 months. The applicant should have a mentor in an established institution.

Eligibility

Eligibility is restricted to Africa-based researchers. This refers to individuals who are (a) currently studying at a university or research institute in Africa, and/or b) currently working within a university, research institute, or in tobacco control in Africa. All persons associated with tobacco industry will not be funded and therefore should not apply. Successful applicants will be required to sign a declaration of interest that they do not have any relationship with tobacco industry.

Evaluation criteria

Proposals will be reviewed by a group of experts and researchers. Projects will be assessed against six, equally weighted evaluation criteria:

  • Knowledge contribution in respect to policy, strategy, and evidence to answer local
    challenges:
    Does the study articulate the research gap? Does study make a significant
    contribution toward advancing knowledge in the tobacco control field? Does it answer
    new questions or introduce novel methods, measures, or tobacco control interventions? Is
    it aligned to the WHO FCTC and tobacco control local context requirements? Does the
    study add to the existing body of research?
  • Policy relevance: Will results from the research have generalizable implications? How,
    if at all, will the “lessons learned” have relevance beyond the study? Will the study
    outcomes influence decisions in tobacco control?
  • Technical design: Do the methods appropriately answer the objectives and the questions
    outlined in the proposal? Is the proposed study feasible in one year?
  • Project viability: Are there any other logistical or political obstacles that might threaten
    the completion of the study, for example, government authorization or Human Subjects
    review, civil strife, social cultural sensitivity?
  • Value of research: Is the cost of the study commensurate with the value of expected
    contributions to policy? Are the planned activities justified and coherent?
  • Ethics: Reviewers will consider whether there are any risks of harm to research
    participants, what the proposed risk mitigation strategies are, and how the possible
    benefits of the research compare to the possible harms.

Application Process

Apply HERE not later than 30th June 2024, by 5pm EAT. Applicants are required to provide a
recommendation/support letter from their supervisors or heads of department.

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