A qualitative study on informed consent decision-making at two tertiary hospitals in Uganda: Experiences of patients undergoing emergency surgery and their next of kin.

Background: In emergency situations, patients and their next of kin must make complex medical and ethical decisions in a quick and timely way. Objectives: To describe the decision-making process during informed consent for emergency surgery among patients and the next of kin of patients who have undergone emergency surgery. Methods: Consecutive sampling of 39 participants and in-depth semi-structured interviews were conducted at two tertiary teaching hospitals in Uganda. There were 22 patients and 17 next of kin of patients who had undergone emergency surgery within 24-72 h. Responses about decision-making were coded into themes using the social constructivist theory and phenomenological approach. Results: There were four emergent themes; decision-makers, people consulted, documentation of the consent and factors influencing decision-making. Most patients and next of kin made decisions on their own and documented the consent for themselves. Other family members and doctors were consulted during the decision-making process. Decision-making was influenced by reassurance of good outcomes of surgery and disclosure by the doctors. Conclusion: Decisions were made collaboratively with the patient at the center but with input of health personnel, the next of kin and other family members. A communitarian approach combined with shared decision-making between the doctor and the patient and next of kin with adequate discussion and disclosure of information in simple language would improve decision-making for patients and their next of kin.

A comparison of oral bacteriome isolated from periodontal pockets of participants with or without diabetes mellitus in Uganda: a case control study.

OBJECTIVE: Diabetes mellitus predisposes patients to increased incidence and severe forms of periodontal disease. Currently, information on the bacterial diversity of patients with diabetes mellitus and periodontitis in Uganda is scanty. This study set out to describe the bacteria associated with periodontitis in patients with diabetes mellitus in Uganda, as part of a larger study describing the association between periodontal disease and diabetes mellitus. RESULTS: This was a case control involving 45 samples of gingival crevicular fluid collected from participants with periodontitis, the cases being 26 participants with diabetes mellitus and controls 19 participants without diabetes mellitus. Sequencing using the 16s Oxford nanopore long read protocol was followed by a bioinformatics analysis pipeline for alpha and beta diversity indices in the two groups. Multivariate tests were done to determine the differences in the bacterial composition in the two groups. Of the 739 Operational Taxonomic Units and 500 phyla identified, 37.9% (280/739) were from participants with diabetes mellitus. Analysis of beta diversity revealed a dissimilarity between the two study groups (CAP score = 0) with a significant association noted between periodontitis and the subgingival bacteria (P = 0.001). Diabetes mellitus reduced the quantity and altered the composition of the subgingival microbiome in the study participants.

The role of community engagement in promoting research participants' understanding of pharmacogenomic research results: Perspectives of stakeholders involved in HIV/AIDS research and treatment.

Community engagement (CE) is praised to be a powerful vehicle in empowering communities with knowledge and skills to make informed decisions for better health care. Several CE approaches have been proposed to improve participants' and research communities' understanding of genomic research including pharmacogenomic information and results. However, there is limited literature on how these approaches can be used to communicate findings of pharmacogenomic research to communities of people living with HIV. This study explored stakeholders' perspectives on the role of community engagement in promoting understanding of pharmacogenomic research results among people living with HIV. We adopted a qualitative approach that involved 54 stakeholders between September 2021 and February 2022. We held five focus group discussions among 30 community representatives from five research institutions, 12 key informant interviews among researchers, and 12 in-depth interviews among ethics committee members. A thematic approach was used to analyze the results. Five themes merged from this data and these included (i) benefits of engaging communities prior to returning individual pharmacogenomic research results to participants. (ii) Obtaining community consensus on the kinds of pharmacogenomic results to be returned. (iii) Opinions on how pharmacogenomic research information and results should be communicated at community and individual levels. (iv) Perceived roles of community stakeholders in promoting participants' understanding and utilization of pharmacogenomic research results. (v) Perceived challenges of engaging communities when returning individual results to research participants. Stakeholders opined that CE facilitates co-learning between researchers and research communities. Researchers can adapt existing CE approaches that are culturally acceptable for meaningful engagement with minimal ethical and social risks when communicating pharmacogenomic research results. CE approaches can facilitate understanding of pharmacogenomic research and findings among research participants and communities. Therefore, if creatively adapted, existing and new CE approaches can enable researchers to communicate simple and understandable results of pharmacogenomic research.

Informed consent in cancer clinical care: Perspectives of healthcare professionals on information disclosure at a tertiary institution in Uganda.

INTRODUCTION: While there have been several studies examining the understanding and quality of informed consent in clinical trials of cancer therapies, there is limited empirical research on health practitioners' experiences on the informed consent process in cancer care, especially from low resource settings. This study explored health professionals' perspectives on information disclosure during the consenting process in cancer care. METHODS: A qualitative descriptive approach was used to collect data. Face to face interviews were conducted with 10 purposively selected healthcare professionals who were actively involved in soliciting informed consent at a cancer treatment centre in Uganda. A thematic approach was used to interpret the results. RESULTS: There were five key themes, and these included information disclosure to patients; assessment of patients' cancer awareness, treatment preferences and expectations; informed consent practices; barriers to optimal informed consent and information disclosure; and recommendations for improving the consenting process. All respondents appreciated the value of disclosing accurate information to patients to facilitate informed decision making. However, the informed consent process was deemed sub-optimal. Respondents asserted that patients should be the psychological wellbeing of patients should be protected by mentally preparing them before disclosing potentially distressing information. All healthcare professionals were appreciative of the central role the family plays in the consenting process. CONCLUSION: Overall, informed consent practices were not ideal because of the several challenges. Inadequate time is devoted to information disclosure and patient education; there is lack of privacy; and informed consent documentation is poor. There is a need for significant improvement in informed consent practices and healthcare professional-patient communication.

Data sharing practices in collaborative human genomic research in low- and middle-income countries: A systematic review protocol.

INTRODUCTION: The practice of creating large databases has become increasingly common by combining research participants' data into larger repositories. Funders now require that data sharing be considered in newly funded research project, unless there are justifiable reasons not to do so. Access to genomic data brings along a host of ethical concerns as well as fairness and equity in the conduct of collaborative research between researchers from high- income and low-and middle-income countries. MATERIALS AND METHODS: This systematic review protocol will be developed in line with PRISMA -guidelines which refers to Open Science Framework, registered in PROSPERO (https://www.crd.york.ac.uk/prospero/) record CRD42022297984 and published in a peer reviewed journal. Data sources will include PubMed, google scholar, EMBASE, Web of science and MEDLINE. Both published and grey literature will be searched. Subject matter experts including bioethicists, principal investigators of genomic research projects and research administrators will be contacted. After de-duplication, titles and abstracts will be screened for eligibility. Data extraction will be undertaken using a piloted form designed in EPPI-Reviewer software before conducting risk of bias assessments by a pair of reviewers, acting independently. Any discrepancies will be resolved by consensus. Analysis will be done using a structured narrative synthesis and where feasible metanalysis. This review will attempt to highlight the context of data sharing practices in the global North-South and South-South collaborative human genomic research in low- and middle-income countries. This review will enhance the body of evidence on ethical, legal and social implications of data sharing in international collaborative genomic research setting criteria for data sharing. The full report will be shared with relevant stakeholders including universities, civil society, funders, and departments of genomic research to ensure an adequate reach in low-and middle-income countries (LMICs).

Periodontitis is associated with insulin resistance in adults living with diabetes mellitus in Uganda: a cross- sectional study.

INTRODUCTION: Evidence suggests that majority of patients with diabetes mellitus in Uganda have poor glycaemic control as well as periodontal disease. This study set out to determine the association between periodontitis and insulin resistance in adult patients with diabetes mellitus in Uganda using the triglyceride glucose index. METHODS: Two hundred and twenty-three adult study participants with confirmed diabetes mellitus were enrolled in a cross-sectional study. Oral examination was carried with the aid of a periodontal probe to determine the periodontal status and findings recorded using the WHO Oral Health Assessment Tool for Adults, 2013. We recorded clinical details for body mass index (BMI in kg/m2) and laboratory parameters including fasting blood sugar (mmol/L), glycated hemoglobin levels (HbA1c, %) and serum triglycerides (mmol/L) using a study questionnaire. Data were analyzed using R version 4.10. The glucose triglyceride index was used as a measure of insulin resistance. Logistic regression analysis carried out to determine the factors associated insulin resistance. RESULTS: The majority of the study participants was female (70%) with an average age of 48.5 years (SD+/- 11.1). The mean body mass index was 29.6 kg/m2 (SD+/- 5.82). The mean serum triglyceride index was 9.48 (SD+/- 0.675). Eighty-six-point 1% of the participants had periodontal disease. Bivariate analysis revealed high odds for male sex (OR = 1.31, 95% C.I = 0.44-4.84, p = 0.65) and periodontitis (OR = 3.65, 95% C.I = 0.79-26.15, p = 0.13) but low odds for a high BMI (OR = 0.45. 95% C.I = 0.07-1.67, p = 0.30). Multivariate regression revealed a significant association between insulin resistance and periodontitis. (AOR = 3.52, 95% C.I = 1.19-1.83, p = 0.03). CONCLUSION: Insulin resistance is highly prevalent in patients with diabetes mellitus in Uganda and is associated with periodontitis and low body weight.

An open-source digital contact tracing system tailored to haulage.

Digital contact tracing presents numerous advantages compared to manual contact tracing methods, especially in terms of enhanced speed and automation. Nevertheless, a lack of comprehensive evaluation regarding functionality, efficiency, benefits, and acceptance within communities remains. Here we primarily focus on the functionality of THEA-GS, an open-source digital contact tracing tool developed through consultation with stakeholders. Additionally, we provide insights from its implementation on a limited sample of haulage drivers in Uganda, serving as a representative case for a low- and middle-income country. THEA-GS comprises two primary components: (a) a smartphone application, and (b) a suite of server-programs responsible for data processing and analysis, including databases and a web-based interface featuring dashboards. In essence, the mobile application records the timestamped location of haulage drivers within the road network and identifies possible transmission hotspots by analyzing factors such as the duration of stops and the communities associated with them. The tool can be integrated with national infrastructure to compare drivers' diagnostic results and contact structure, thereby generating individual and community risk assessments relative to the road network. During the Omicron-variant wave of the COVID-19 pandemic, a total of 3,270 haulage drivers were enrolled between October 2021 and October 2022. Around 75% of these drivers utilized THEA-GS for approximately two months. Based on an analysis of 3,800 test results, which included 48 positive cases, 125 contacts, and 40 million time-stamped GPS points, THEA-GS shows a significant speed improvement, being approximately 90 times faster than MCT. For instance, the average time from sample collection to notifying a case and their contacts was approximately 70 and 80 min, respectively. The adoption of this tool encountered challenges, mainly due to drivers' awareness of its purpose and benefits for public health. THEA-GS is a place-based digital contact tracing tool specifically designed to assist National Public Health Institutions in managing infectious disease outbreaks involving the haulage industry as a high-risk group. While its utility, acceptance, and accuracy have not been fully evaluated, our preliminary tests conducted in Uganda indicate the tool's functionality is robust, but social acceptance and adoption are heavily reliant on establishing trust among users.

Experiences of patients and next of kin on informed consent process for emergency surgery in two Urban university teaching hospitals in Uganda: a comparative cross sectional study.

Informed consent for emergency surgery is a process in which a patient or their next of kin must make quick decisions required for surgery in a life-threatening situation or surgery that may have life-altering outcomes. The objective of the study was to describe patients and their next of kin experiences and factors influencing the informed consent process in two urban university teaching hospitals in Uganda. METHODS: A cross-sectional survey involving patients who underwent emergency surgery and their next of kin was conducted in two tertiary care hospitals; one public and one private-not-for profit institution. A questionnaire was administered to collect sociodemographic information, type of Surgery that was done, how informed consent was obtained and experiences and expectations from the informed consent process. Univariate and multivariate analyses of the variables was done. RESULTS: We collected data from 210 patients from a public hospital and 170 from a private-not-for profit hospital. Overall, most patients did not have the risks of the surgery communicated to them (79.7%), were not given alternative options (87.6%) and had no opportunity to ask questions (57.4%). Patients at the private institution had 3.35 times the odds of expecting the consent form to be explained to them than those at the public institution. Patients at the public hospital had 0.12 times the odds of preferring to have consent administered by a nurse than patients at the private institution OR 0.12 (0.05-0.29, p < 0.001). Patients in the public institution had 0.18 times the odds of preferring to have consent administered by a doctor than patients in the private institution OR 0.18 (0.08-0.45, p < 0.001). CONCLUSION: Patients in both public and private institutions are not informed about the risks of surgery, alternative options and are not given the opportunity to ask questions. Interpretation of the findings of this study on patient preferences on who administered consent though statistically significant were inconclusive due to the responses not being mutually exclusive.

Health-related quality of life in patients with low back pain in a low resource setting: a cross-sectional study at a tertiary hospital in Uganda.

Background: Low back pain is the leading global cause of years lost to disability. The study aimed to assess the health-related quality of life in patients with low back pain attending an outpatient clinic at a national referral hospital in Uganda. Methods: This was a hospital based cross-sectional study that involved 250 adult patients with low back pain. Data were collected using the modified short form-36 Health Survey questionnaire. Data were summarised using descriptive statistics. Analysis of Variance, the F-test and linear regression analysis were used for inferential statistics. Result: Majority of participants were female (66.4%) with a mean age of 60 years (SD 12.9, range 20- 87) and 44.6% were manual labourers. 70% of participants had had low back pain for more than one year and 74% had neuropathic symptoms. The total quality of life of participants was poor with a mean score of 31.9 (SD 15.6). The factors that significantly influenced quality of life included performing manual work (p=0.01), being unemployed (p=0.027) and weakness in the lower limbs (p=0.01). Conclusion: Patients with low back pain had a poor quality of life that was significantly influenced by being unemployed, doing manual work and clinical features of nerve compression.

Attitudes and usage of visual-aids in graduate student learning of gross anatomy at Makerere University.

Background: The increasing numbers of students studying human anatomy at Makerere University are beginning to overwhelm available resources, which presents challenges in learning and necessitates an evaluation of alternative ways to enhance anatomy learning.The increasing numbers of students overwhelm resources available and presents challenges in learning. This necessitates an evaluation of alternatives to enhance gross anatomy learning at Makerere University College of Health Sciences. The study aimed to assess the usage of visual aids and generate necessary information to enhance learning. Methods: A cross-sectional study employing a concurrent triangulation mixed method design was conducted among 44 graduate students actively participating in cadaveric dissection. Data was collected using self-administered questionnaires and two focus group discussions. Descriptive statistics and thematic analysis were used to summarize data. Results: Most participants were male (77.3%) with a mean age of 31.5 years (SD 3.9, Range, 27-45 years). A majority of graduate students reported using non-traditional methods (online sources) to supplement learning. Students commonly used hard copies of Cunningham Manual of Practical Anatomy (88.6%) supplemented with well-illustrated textbooks (79.5%) and online dissection videos (72.7%). Students expressed most satisfaction with the use of videos and well-illustrated text books in supplementing learning. The availability of these electronic resources was limited by factors such as poor internet connectivity and the need to pay for online licenses and subscription fees. Conclusion: Graduate students in the Department of Anatomy at MakCHS are using non-traditional methods to supplement their learning. However, there are several challenges to accessing digital resources. There is a need to support students with accessing visual aids through integrating newer teaching modalities and modern technology to promote interest and retention of anatomical knowledge.

A case for routine microbial diagnostics: Results from antimicrobial susceptibility testing in post-traumatic wound infections at a Ugandan tertiary care hospital.

The global spread of antimicrobial resistance (AMR) poses an increasing challenge for clinicians in Uganda, where microbiological diagnostics are not routinely available or accessible. The aim of this study was to determine pathogen prevalence and antibiotic resistance patterns in patients with wound infections following trauma at a national referral hospital in Kampala, Uganda. In addition, the suitability of currently used empirical treatment options in this setting was evaluated. This prospective, observational study analysed antimicrobial prescriptions, culture results and antimicrobial sensitivity testing (AST) of wound swabs and blood samples from patients with clinical signs of wound infections on the trauma ward. A total of 124 patients (n = 99, 79.8% male) with a median age of 30 years (IQR 23-39) were enrolled between October 2021 and January 2022. Wound infections were classified as nosocomial in 69% of the cases. Pathogens were isolated from 122 wound swabs, yielding 238 bacterial isolates. The most prevalent pathogens were gram-negative bacteria including Escherichia coli (n = 48, 20.2%) and Acinetobacter spp. (n = 43, 18.1%). Empiric treatment consisted of ceftriaxone and gentamicin which was administered to 67.2% (n = 78) and 62.1% (n = 72) of patients, respectively. High rates of antimicrobial resistance could be demonstrated across gram-negative and gram-positive species towards the most common empiric antibiotics. Following the AST results, over 95% (n = 111) of patients required a change of treatment. Our findings demonstrate that current empiric treatment for wound infections is missing its target in hospitalized patients in Kampala. To address the growing problem of AMR in Uganda, there is a pressing need to enhance diagnostic capacity and implement structured antimicrobial stewardship programs.

Research Participants' Preferences for Individual Results of Pharmacogenomics Research: A Case of a Ugandan HIV Research Institute.

Little is known about whether people living with HIV would like to receive their results from pharmacogenomics research. This study explored the factors influencing participants' preferences and the reasons for their desire to receive individual results from pharmacogenomics research. We employed a convergent parallel mixed methods study design comprising a survey of 225 research participants and 5 deliberative focus group discussions with 30 purposively selected research participants. Almost all (98%) participants wanted to receive individual pharmacogenomics research results. Reasons for the desire to receive results were reciprocity for valuable time and effort, preparing for future eventualities, and the right to information about their health. Overall, participants desire to receive feedback from pharmacogenomics research, particularly if results are well established and clinically actionable.

Informed consent process for emergency surgery: A scoping review of stakeholders' perspectives, challenges, ethical concepts, and policies.

Background: A scoping review of literature about the informed consent process for emergency surgery from the perspectives of the patients, next of kin, emergency staff, and available guiding policies. Objectives: To provide an overview of the informed consent process for emergency surgery; the challenges that arise from the perspectives of the patients, emergency staff, and next of kin; policies that guide informed consent for emergency surgery; and to identify any knowledge gaps that could guide further inquiry in this area. Methods: We searched Google Scholar, PubMed/MEDLINE databases as well as Sheridan Libraries and Welch Medical Library from 1990 to 2021. We included journal articles published in English and excluded non-peer-reviewed journal articles, unpublished manuscripts, and conference abstracts. The themes explored were emergency surgery consent, ethical and theoretical concepts, stakeholders' perceptions, challenges, and policies on emergency surgery. Articles were reviewed by three independent reviewers for relevance. Results: Of the 65 articles retrieved, 18 articles were included. Of the 18 articles reviewed, 5 addressed emergency informed consent, 9 stakeholders' perspectives, 7 the challenges of emergency informed consent, 3 ethical and theoretical concepts of emergency informed consent, and 3 articles addressed policies of emergency surgery informed consent. Conclusion: There is poor satisfaction in the informed consent process in emergency surgery. Impaired capacity to consent and limited time are a challenge. Policies recommend that informed consent should not delay life-saving emergency care and patient's best interests must be upheld.

Genetic and Genomic Researchers' Perspectives on Biological Sample Sharing in Collaborative Research in Uganda: A Qualitative Study.

Numerous ethical, legal, and social issues arise with biological sample sharing. The study explored the perspectives of genetic and genomic researchers on the sharing of biological samples in international collaborative research. Qualitative in-depth interviews were conducted with 15 researchers. Participants expressed positive attitudes towards biobanking and appreciated the benefits of cross-border sharing of biological samples but noted that this practice had adversely affected local capacity building efforts. There was limited understanding of the ethical and regulatory frameworks governing sample sharing. Researchers emphasized the importance of respecting cultural values in biobanking research. Issues concerning poor governance and inequitable benefit sharing were also raised. There is a need for fair and equitable international collaborations where all researchers are treated with respect and as equal partners.

Webinar report: stakeholder perspectives on informed consent for the use of genomic data by commercial entities.

In July 2020, the H3Africa Ethics and Community Engagement (E&CE) Working Group organised a webinar with ethics committee members and biomedical researchers from various African institutions throughout the Continent to discuss the issue of whether and how biological samples for scientific research may be accessed by commercial entities when broad consents obtained for the samples are silent. 128 people including Research Ethics Committee members (10), H3Africa researchers (46) including members of the E&CE working group, biomedical researchers not associated with H3Africa (27), representatives from the National Institutes of Health (16) and 10 other participants attended the webinar and shared their views. Several major themes emerged during the webinar, with the topics of broad versus explicit informed consent, defining commercial use, legacy samples and benefit sharing prevailing in the discussion. This report describes the consensus concerns and recommendations raised during the meeting and will be informative for future research on ethical considerations for genomic research in the African research context.

Evaluation of the current status of prosthetic rehabilitation services for major limb loss: a descriptive study in Ugandan Referral hospitals.

PURPOSE: Low-and-middle-income countries (LMICs) have a large burden of major limb loss. No recent study has reported on Uganda's state of public sector prosthetics services. This study aimed to document the landscape of major limb loss, and the structure of available prosthetics services in Uganda. METHODS: This study involved a retrospective review of medical records at Mulago National Referral Hospital, Fort Portal Regional Referral Hospital, and Mbale Regional Referral Hospital, and a cross-sectional survey of personnel involved in the fabrication and fitting of prosthetic devices across orthopaedic workshops in the country. RESULTS: Upper limb amputations accounted for 14.2%, and lower limb accounted for 81.2%. Gangrene (30.3%) was the leading cause of amputation, followed by road traffic accidents and diabetes mellitus. Orthopaedic workshops offered decentralised services, and most materials used were imported. Essential equipment was largely lacking. Orthopaedic technologists had diverse experience and skill sets, but many other factors limited their service provision. CONCLUSION: The Ugandan public healthcare system lacks adequate prosthetic services both in terms of personnel and supporting resources, including equipment, materials, and components. The provision of prosthetics rehabilitation services is limited, especially in rural regions. Decentralising services could improve patients' access to prosthetic services.Implications for RehabilitationAvailability and accessibility of prosthetic services are essential to the rehabilitation and reintegration of amputees into communities in Low-and-Middle-Income countries (LMICs).For stakeholders to formulate effective plans to address issues within prosthetics service provision, quality data on the current state of services is necessary.Service providers should prioritise the decentralisation of prosthetic rehabilitation services, especially for patients in rural areas, to improve access and reach of these services.To achieve optimal limb functionality after amputation for both lower and upper limb amputees, rehabilitation professionals working in LMICs should focus on delivering comprehensive multidisciplinary rehabilitation services.Orthopaedic personnel should ensure complete and accurate documentation of patient information following amputation to enable effective tracking and monitoring of patient care to improve outcomes of rehabilitation.

Quality of life of patients with traumatic spinal cord injuries: a cross-sectional study at a tertiary hospital in Uganda.

Background: The study aimed to assess the perceived quality of life of patients with traumatic spinal cord injuries. Methodology: This was a cross sectional study conducted in the Spine Unit of a tertiary hospital in Uganda. The study population comprised of patients with spinal cord injuries. Data were collected using the WHO Quality of Life Brief questionnaire and Functional Independence Measure tool. Results: 103 patients participated in the study, most were male (73.8%), and had a mean age of 37.7 years. Most participants were married (57.3%), unemployed (72.8%) and had no steady source of income (62.1%). Road traffic accidents accounted for most injuries (59.2%). The mean duration since injury was 20.5 months. Most participants (58.3%) had incomplete spinal cord injuries and 84.5% had complications. The perceived overall quality of life was poor in 87.4% of patients. Being employed (p= 0.02), the presence of complications (p= 0.03), and injury severity (p= 0.003) significantly affected quality of life. Functional independent measure scores were significantly better in individuals less severe injuries and those with lumbar level of injury with mean scores of 113.1±8.9 and 99.9±15.3 respectively. Conclusion: The overall self-reported quality of life among patients with traumatic spinal cord injury was generally poor.

Benefit sharing in genomic and biobanking research in Uganda: Perceptions of researchers and research ethics committee members.

Background: Genomic and biobanking research has increased in Africa over the past few years. This has raised pertinent ethical, legal, and societal concerns for stakeholders such as sample or data ownership, commercialization, and benefit sharing. There is limited awareness of the concept of benefit sharing by stakeholders in sub-Saharan Africa. Objective: This study aimed to explore the perceptions of researchers and research ethics committee members on benefit sharing in international collaborative genomic and biobanking research. Methods: Qualitative in-depth interviews were conducted with 15 researchers and 19 research ethics committee members. A thematic approach was used to interpret the results. Results: Six themes emerged from the data and these included perceptions on the benefits of genomic and biobanking research; discussion of benefit sharing with participants during the informed consent process; legal implications of benefit sharing and the role of material transfer agreements; equity and fairness in sharing the benefits of genomic research; perceived barriers to fair benefit sharing; and recommendations for fostering fair and equitable benefit sharing in genomic and biobanking research. Most respondents clearly understood the various forms of benefits of genomic and biobanking research and opined that such benefits should be fairly and equitably shared with low and middle-income country researchers and their institutions, and research communities. The perceived barriers to the fair benefit sharing unfavorable include power disparities, weak research regulatory frameworks, and lack of scientific integrity. Conclusion: Overall, respondents believed that the distribution of the advantages of genomic and biobanking research in North-South collaborative research was not equitable nor fair, and that the playing field was not leveled. Therefore, we advocate the following for fair and equitable benefit sharing: Building the capacities and empowering research scientists in developing nations; strengthening regulatory frameworks and extending the purview of the research ethics committee in the development and implementation of material transfer agreements; and meaningfully involving local research communities in benefit sharing negotiations.

Remote consent approaches for mobile phone surveys of non-communicable disease risk factors in Colombia and Uganda: A randomized study.

INTRODUCTION: Automated mobile phone surveys (MPS) can be used to collect public health data of various types to inform health policy and programs globally. One challenge in administering MPS is identification of an appropriate and effective participant consent process. This study investigated the impact of different survey consent approaches on participant disposition (response characteristics and understanding of the purpose of the survey) within the context of an MPS that measured noncommunicable disease (NCD) risk factors across Colombia and Uganda. METHODS: Participants were randomized to one of five consent approaches, with consent modules varying by the consent disclosure and mode of authorization. The control arm consisted of a standard consent disclosure and a combined opt-in/opt-out mode of authorization. The other four arms consist of a modified consent disclosure and one of four different forms of authorization (i.e., opt-in, opt-out, combined opt-in/opt-out, or implied). Data related to respondent disposition and respondent understanding of the survey purpose were analyzed. RESULTS: Among 1889 completed surveys in Colombia, differences in contact, response, refusal, and cooperation rates by study arms were found. About 68% of respondents correctly identified the survey purpose, with no significant difference by study arm. Participants reporting higher levels of education and urban residency were more likely to identify the purpose correctly. Participants were also more likely to accurately identify the survey purpose after completing several survey modules, compared to immediately following the consent disclosure (78.8% vs 54.2% correct, p<0.001). In Uganda, 1890 completed surveys were collected. Though there were differences in contact, refusal, and cooperation rates by study arm, response rates were similar across arms. About 37% of respondents identified the survey purpose correctly, with no difference by arm. Those with higher levels of education and who completed the survey in English were able to more accurately identify the survey purpose. Again, participants were more likely to accurately identify the purpose of the survey after completing several NCD modules, compared to immediately following the consent module (42.0% vs 32.2% correct, p = 0.013). CONCLUSION: This study contributes to the limited available evidence regarding consent procedures for automated MPS. Future studies should develop and trial additional interventions to enhance consent for automated public health surveys, and measure other dimensions of participant engagement and understanding.

Experiences and practices of key research team members in obtaining informed consent for pharmacogenetic research among people living with HIV: a qualitative study.

This study aimed to explore experiences and practices of key research team members in obtaining informed consent for pharmacogenetics research and to identify the approaches used for enhancing understanding during the consenting process. Data collection involved 15 qualitative, in-depth interviews with key researchers who were involved in obtaining informed consent from HIV infected individuals in Uganda for participation in pharmacogenetic clinical trials. The study explored two prominent themes: approaches used to convey information and enhance research participants' understanding and challenges faced during the consenting process. Several barriers and facilitators for obtaining consent were identified. Innovative and potentially effective consenting strategies were identified in this study that should be studied and independently verified.