Megan M. Campbell

Community engagement strategies for genomic studies in Africa: a review of the literature.

BackgroundCommunity engagement has been recognised as an important aspect of the ethical conduct of biomedical research, especially when research is focused on ethnically or culturally distinct populations. While this is a generally accepted tenet of biomedical research, it is unclear what components are necessary for effective community engagement, particularly in the context of genomic research in Africa.MethodsWe conducted a review of the published literature to identify the community engagement strategies that can support the successful implementation of genomic studies in Africa. Our search strategy involved using online databases, Pubmed (National Library of Medicine), Medline and Google scholar. Search terms included a combination of the following: community engagement, community advisory boards, community consultation, community participation, effectiveness, genetic and genomic research, Africa, developing countries.ResultsA total of 44 articles and 1 thesis were retrieved of which 38 met the selection criteria. Of these, 21 were primary studies on community engagement, while the rest were secondary reports on community engagement efforts in biomedical research studies. 34 related to biomedical research generally, while 4 were specific to genetic and genomic research in Africa.ConclusionWe concluded that there were several community engagement strategies that could support genomic studies in Africa. While many of the strategies could support the early stages of a research project such as the recruitment of research participants, further research is needed to identify effective strategies to engage research participants and their communities beyond the participant recruitment stage. Research is also needed to address how the views of local communities should be incorporated into future uses of human biological samples. Finally, studies evaluating the impact of CE on genetic research are lacking. Systematic evaluation of CE strategies is essential to determine the most effective models of CE for genetic and genomic research conducted in African settings.

Obtaining informed consent for genomics research in Africa: analysis of H3Africa consent documents

Background The rise in genomic and biobanking research worldwide has led to the development of different informed consent models for use in such research. This study analyses consent documents used by investigators in the H3Africa (Human Heredity and Health in Africa) Consortium. Methods A qualitative method for text analysis was used to analyse consent documents used in the collection of samples and data in H3Africa projects. Thematic domains included type of consent model, explanations of genetics/genomics, data sharing and feedback of test results. Results Informed consent documents for 13 of the 19 H3Africa projects were analysed. Seven projects used broad consent, five projects used tiered consent and one used specific consent. Genetics was mostly explained in terms of inherited characteristics, heredity and health, genes and disease causation, or disease susceptibility. Only one project made provisions for the feedback of individual genetic results. Conclusion H3Africa research makes use of three consent models—specific, tiered and broad consent. We outlined different strategies used by H3Africa investigators to explain concepts in genomics to potential research participants. To further ensure that the decision to participate in genomic research is informed and meaningful, we recommend that innovative approaches to the informed consent process be developed, preferably in consultation with research participants, research ethics committees and researchers in Africa.

Sexual dysfunction: A systematic review of South African research

BACKGROUND The World Health Organization is in the process of revising the International Classification of Diseases and Related Health Problems (ICD). Sexual dysfunction disorders (F52) have been identified as having poor clinical utility. South Africa (SA) has been selected as one of five low- and middle-income countries in which studies will be developed to assess the clinical utility of the proposed ICD-11 revisions for sexual dysfunction disorders. OBJECTIVE To identify scientific research generated in SA on sexual dysfunction disorders to guide these studies. METHODS A systematic review of SA research on sexual dysfunction disorders published in peer-reviewed journals. RESULTS Despite the high prevalence of ejaculatory and erectile dysfunctions, only five SA articles have addressed male sexual dysfunction since 1970. Lack of sexual interest and inability to reach orgasm are the most commonly reported complaints for women, yet only four SA articles have been published on the topic of female sexual dysfunction. Diabetes mellitus, cardiovascular disease, genitourinary disease and psychiatric or psychological disorders are common comorbid conditions associated with sexual dysfunction in both sexes, but only nine articles address sexual dysfunction as the main topic with respect to comorbid conditions. CONCLUSION Despite growing awareness of the importance of sexual health, SA-based scientific research on sexual dysfunction is limited. Further work is needed to inform recommendations for ICD-11 revisions drawn from the SA context.

Exploring researchers’ experiences of working with a researcher-driven, population-specific community advisory board in a South African schizophrenia genomics study

BackgroundCommunity engagement within biomedical research is broadly defined as a collaborative relationship between a research team and a group of individuals targeted for research. A Community Advisory Board (CAB) is one mechanism of engaging the community. Within genomics research CABs may be particularly relevant due to the potential implications of research findings drawn from individual participants on the larger communities they represent. Within such research, CABs seek to meet instrumental goals such as protecting research participants and their community from research-related risks, as well as intrinsic goals such as promoting the respect of participants and their community. However, successful community engagement depends on the degree to which CABs legitimately represent and engage with communities targeted for research. Currently, there is little literature describing the use of CABs in genomics research taking place in developing countries, and even less in the field of genomics research relating to mental illness. The aim of this article is to describe and consider the contributions made by a researcher-driven, population-specific CAB in a genomics of schizophrenia research project taking place in South Africa, from the perspective of the research team.DiscussionFour broad discussion topics emerged during the CAB meetings namely: 1) informed consent procedures, 2) recruitment strategies, 3) patient illness beliefs and stigma experiences, and 4) specific ethical concerns relating to the project. The authors consider these discussions in terms of their contributions to instrumental and intrinsic goals of community engagement.SummaryThe CAB gave valuable input on the consent processes and materials, recruitment strategies and suggested ways of minimizing the potential for stigma and discrimination. All of these contributions were of an instrumental nature, and helped improve the way in which the research took place. In addition, and perhaps more importantly, the CAB made a unique and important contribution relating to intrinsic functions such as promoting the respect and dignity of research participants and their community. This was particularly evident in ensuring sensitivity and respect of the community’s traditional beliefs about schizophrenia and its treatment, and in this way promoting a respectful relationship between the research team and the participants.

Transgender issues in South Africa, with particular reference to the Groote Schuur Hospital Transgender Unit

This article gives an overview of transgender issues in South Africa, with a particular focus on the work of the Transgender Unit, Groote Schuur Hospital, Cape Town, South Africa. The article presents current definitions, diagnostic considerations and healthcare options in the area of gender dysphoria, and then outlines the history, mandate and role of the Transgender Unit. It concludes with some of the current challenges in the field of transgender healthcare and makes recommendations for the way forward.

Sexual disorders in DSM-5 and ICD-11: a conceptual framework.

Purpose of review The nature and classification of sexual disorders has been a focus during work on the development of DSM-5 and ICD-11. This article proposes different conceptual approaches to the sexual disorders, including classical, critical and integrative positions. Disorders associated with sexual orientation, gender dysphoria/incongruence and paraphilias/paraphilic disorders are discussed from each of these positions. Recent findings A range of conventional and nonconventional consensual sexual behaviours are prevalent but not necessarily indicative of a mental disorder; there is little diagnostic validity or clinical utility for including these in the nosology. When such behaviours are clinically excessive and associated with distress or impairment, however, a disorder may be present. Debate surrounds the medicalization of some sexual behaviours that are criminal in nature. Summary The classification of sexual behaviour as disordered is necessarily theory-dependent and value-laden. Nevertheless, reasoned debate about the relevant data and values is possible, and will hopefully further improve the diagnostic validity and clinical utility of psychiatric nosology.

Protocols for Protection of Human Participants: A Comparison of Five Countries

Research ethics protocols relating to human participants were compared across five countries, namely, Australia, Azerbaijan, Iran, the Philippines, and South Africa. These countries were considered to be geographically and culturally diverse, as well as representing both developed and developing countries. The extent to which the research participant is protected across cultures and countries was investigated, with particular focus on the use of informed consent procedures. It was argued that current ethical guidelines and practices fail to ensure the protection of the most vulnerable participants within these cultures. Informed consent mechanisms also often fail to consider cultural differences in self-concept, understanding of research methods, and power differences between researchers and participants. Discussion of these ethical challenges and recommendations for research ethics development within these cultures and countries are discussed.

Developing the science and methods of community engagement for genomic research and biobanking in Africa.

Historically, community engagement (CE) in research has been implemented in the fields of public health, education and agricultural development. In recent years, international discussions on the ethical and practical goals of CE have been extended to human genomic research and biobanking, particularly in the African context. While there is some consensus on the goals and value of CE generally, questions remain about the effectiveness of CE practices and how to evaluate this. Under the auspices of the Human Heredity and Health in Africa Initiative (H3Africa), the H3Africa CE working group organized a workshop in Stellenbosch, South Africa in March 2016 to explore the extent to which communities should be involved in genomic research and biobanking and to examine various methods of evaluating the effectiveness of CE. In this paper, we present the key themes that emerged from the workshop and make a case for the development of a rigorous application, evaluation and learning around approaches for CE that promote a more systematic process of engaging relevant communities. We highlight the key ways in which CE should be embedded into genomic research and biobanking projects.

A Xhosa language translation of the CORE-OM using South African university student samples

The translation of well established psychometric tools from English into Xhosa may assist in improving access to psychological services for Xhosa speakers. The aim of this study was to translate the Clinical Outcomes in Routine Evaluation – Outcome Measure (CORE-OM), a measure of general distress and dysfunction developed in the UK, into Xhosa for use at South African university student counselling centres. The CORE-OM and embedded CORE-10 were translated into Xhosa using a five-stage translation design. This design included (a) forward-translation, (b) back-translation, (c) committee approach, (d) qualitative piloting, and (e) quantitative piloting on South African university students. Clinical and general samples were drawn from English-medium South African universities. Clinical samples were generated from university student counselling centres. General student samples were generated through random stratified cluster sampling of full-time university students. Qualitative feedback from the translation process and results from quantitative piloting of the 34-item CORE-OM English and Xhosa versions supported the reduction of the scale to 10 items. This reduced scale is referred to as the South African CORE-10 (SA CORE-10). A measurement and structural model of the SA CORE-10 English version was developed and cross-validated using an English-speaking university student sample. Equivalence of this model with the SA CORE-10 Xhosa version was investigated using a first-language Xhosa-speaking university sample. Partial measurement equivalence was achieved at the metric level. The resultant SA CORE-10 Xhosa and English versions provide core measures of distress and dysfunction. Additional, culture- and language-specific domains could be added to increase sensitivity and specificity.

Hypersexual disorder in general practice

Hypersexual disorder is also termed compulsive sexual disorder, sexual addiction and non-paraphilic sexual disorder, reflecting different approaches to conceptualising its aetiology. Increased frequency of sexual behaviour alone does not indicate pathology. Research suggests that within the population with markedly increased frequency of sexual behaviour, there is a group in whom such behaviour leads to distress and impairment. Patients who experience increased frequency and intensity of sexual behaviour, with accompanying distress and impaired life functioning, may seek medical treatment.