HIV AIDS Vaccines Ethics Group

2020 -2022

Davey, D., Bekker, LG., Bukusi, E., Chi, B., Delany-Moretlwe, S., Goga, A., Drapkin Lyerly, A., Mgodi, N., Mugo, N., Myer, L., Noguchi, L., Stranix-Chibanda, L., Slack, C., & Pintye, J. (2022). Where are the pregnant and breastfeeding women in new PrEP trials?: The imperative to overcome the evidence gap. Lancet HIV.
Wilkinson, A., Slack, C., Thabethe, S., & Salzwedel, J. (2022). It’s almost as if stakeholder engagement is the annoying ‘have-to-do’ “ How could the ethics review process facilitate excellent engagement in clinical trials and beyond? Journal of Empirical Research on Human Research Ethics. DOI: 10.1177/15562646221078415
Slack, C., Ndebele, P., Allen, M, & Salzwedel, J. (2021). Shifts in UNAIDS Ethics Guidance and Implications for Ethics Review of Preventive HIV Vaccine Trials. Journal of the International AIDS Society 2021, 24(S7):e25796. https://doi.org/10.1002/jia2.25796
Slack, C & Soudeyns, H. (2021). Editorial Comment: Key milestones and participant engagement strategies in research with HIV-affected adolescents and young adults from low-to-middle income countries. AIDS, 35, 2539-2540.
Wilkinson, A., Slack, C., Crews, C., Singh, N., Salzwedel, J., & Wassenaar, D. (2021). How can Research Ethics Committees help to strengthen stakeholder engagement in health research in South Africa? An evaluation of REC documents. South African Journal of Bioethics and Law, 14(1), 6-10. doi:10.7196/SAJBL.2021.v14i1.698
Strode, A., Slack, C., Essack, Z., Toohey, J & Bekker, LG. (2020). Be Legally-Wise: When is parental consent required for adolescent PrEP. South African Journal of HIV Medicine. ISSN: (Online) 2078-6751, (Print) 1608-9693
Shah, S., Byron, K., Essack, Z., Slack, C., Reirden, D., Van Rooyen, H., Jones, N., & Wendler, D. (2020). Adolescent Barriers to HIV Prevention Research: Are parental consent requirements the biggest obstacle? Journal of Adolescent Health
Gill K, Happel A, Pidwell T, Mendelsohn A, Duyver M, Johnson L, Myer L, Slack C, Strode A, Hosek S, Mendel E, Fynn L, Wallace M, Spiegel H, Smit D, Jaspan H, Passmore J-A, Rinehart A, Bekker L-G. (2020). An Open-Label, Randomized Crossover Study to Evaluate the Acceptability and Preference for Contraceptive Options in Healthy HIV-Uninfected Female Adolescents, 15-19 Years of Age, as a proxy for HIV prevention methods. [UCHOOSE] – Journal of the International AIDS Society, 23:e25626 https://doi.org/10.1002/jia2.25626
Strode, A., & Slack, C. (2020). Three Billboards to support ethical-legal adolescent HIV prevention trials in Southern and Eastern Africa. Chapter 5 in Edited Book (Eds Govender K & Poku N). Preventing HIV Among Adolescents and Young People in Eastern and Southern Africa: Emerging Evidence and Intervention Strategies. Routledge Studies in Health in Africa. DOI https://doi.org/10.4324/9780429462818
Day, S., Kapogiannis, B., Shah, S., Wilson, C., Ruel, T., Conserve., D., Strode, A., Donenberg, G., Kohler, P., Slack, C., Ezechi, O., Tucker, J on behalf of the PATC3H Consortium (2020). Adolescent Bioethics Working Group Adolescent participation in HIV research: Consortium experience in low and middle-income countries and scoping review. Lancet HIV, 7: e844–52. https://doi.org/10.1016/s2352-3018(20)30269-1.
Gill, K., Johnson, L., Dietrich, J., Myer, L., Marcus, R., Wallace, M., Pidwell, T., Mendel, E., Fynn, L., Jones, K., Wiesner, L., Slack, C., Strode, A., Spiegel, H., Hosek, S., Rooney, J., Gray, G., Bekker, L-G. (2020). Acceptability, safety, and patterns of use of oral tenofovir disoproxil fumarate and emtricitabine for HIV pre-exposure prophylaxis in South African adolescents: an open-label single-arm phase 2 trial. Lancet Child and Adolescent Health, 4, 875–83. https://doi.org/10.1016/S2352-4642(20)30248-0

2015 -2019

Silaigwana, B., & Wassenaar, D.R. (2019). Views of South African biomedical research ethics committee (REC) members about their ethics review outcomes South African Journal of Bioethics and Law 12(1), 8-13. DOI: 10.7196/SAJBL.2019.v12i1.654
Silaigwana, B., & Wassenaar, D.R. (2019). Research ethics committees’ oversight of biomedical research in South Africa: A thematic analysis of ethical issues raised during ethics review of non-expedited protocols. Journal of Empirical Research on Human Research Ethics 14(2), 107-116. DOI: 10.1177/1556264618824921
Essack, Z. & Toohey, J. (2018). Unpacking the 2-year age-gap provision in relation to the decriminalisation of underage consensual sex in South Africa. South African Journal of Bioethics Law, 11(2):85-88. DOI:10.7196/SAJBL.2018.v11i2.657
Thabethe, S., Slack, C., Lindegger, G., Wilkinson, A., Wassenaar, D., Kerr, P., Bekker, LG., Mngadi, K., & Newman P. (2018). “Why don’t you go into suburbs? Why are you targeting us? Trust and mistrust in HIV vaccine trials in South Africa. Journal of Empirical Research on Human Research Ethics. Vol. 13(5) 525– 536 DOI: 10.1177/1556264618804740
Slack, C., Wilkinson, A., Salzwedal, J & Ndebele, P. (2018). Strengthening stakeholder engagement through ethics review in biomedical HIV prevention trials: Opportunities and complexities. Journal of The International AIDS Society. 21(S7):e25172 http://onlinelibrary.wiley.com/doi/10.1002/jia2.25172
Strode, A., Singh, P., Slack, C., & Wassenaar, D. (2018). RECs in a tight spot: Approving consent strategies that are prima facie illegal but are ethical in terms of national guidelines. South African Medical Journal 108(10):828-832. DOI:10.7196/SAMJ.2018.v108i10.13203
Newman, P., Slack, C., & Lindegger, G. (2018). Commentary on “A Framework for Community and Stakeholder Engagement: Experiences from a multi-centre study in Southern Africa”. Journal of Empirical Research on Human Research Ethics, 13(4), 333-337.
Essack, Z., & Wassenaar, D. (2018). South African Research Ethics Committee review of standards of prevention in HIV vaccine trials. Journal of Empirical Research on Human Research Ethics. DOI: 10.1177/1556264618763422
Wallace, M., Middelkoop, K., Smith, P., Pike, C., Bennie, T., Chandia, J., Churchyard, G., Gray, G., Latka, M., Mathebula, M., Nchabaleng, M., Roux, S., Slack, C., Strode, A., & Bekker, L-G. (2018). Feasibility and acceptability of conducting HIV vaccine trials in adolescents in South Africa: Going beyond willingness to participate towards implementation. South African Medical Journal, 108 (4), 291-298.
Lutge, E., Slack, C., & Wassenaar, D. (2017). Defining, negotiating and realizing the social value of research in public health facilities: Perceptions of stakeholders in a research-active province of South Africa. Bioethics, 31(2), 128-135.
Koen, J., Wassenaar, D., & Mamotte, N. (2017). The ‘over-researched community’: An ethics analysis of stakeholder views at two South African HIV prevention research sites. Social Science and Medicine, 194, 1-9. doi.org/10.1016/j.socscimed.2017.10.005
Strode, A., & Essack, Z. (2017). Facilitating access to adolescent sexual and reproductive health services through legislative reform: Lessons from the South African experience. South African Medical Journal, 107(9), 741-744. DOI:10.7196/SAMJ.2017.v107i9.12525
Slack, C. (2016). Ethical considerations in vaccine trials in developing countries. In B. Bloom & P. Lambert (Eds), The Vaccine Book II (pp.447-458). Elsevier.
Slack, C., Thabethe, S., Lindegger, G., Matandika, L., Newman, P., Kerr, P., Wassenaar, D., Roux, S., & Bekker, LG (2016). ‘I’ve gone through this my own self, so I practice what I preach’: Strategies to enhance understanding and other valued outcomes in HIV vaccine trials in South Africa. Journal of Empirical Research on Human Research Ethics, 11(4), 322-333: DOI: 10.1177/1556264616675202.
Wassenaar, D., & Slack, C. (2016). How to learn to love your REC: Recommendations for psychologists. South African Journal of Psychology, 46(3) 3016-315: DOI: 10.1177/0081246316654348 sap.sagepub.com.
Bhamjee, S., Essack, Z., & Strode, A. (2016). Amendments to the Sexual Offences Act dealing with consensual underage sex: Implications for doctors and researchers. South African Medical Journal, 106(3):256-259. DOI:10.7196/SAMJ.2016.v106i3.9877
Strode, A., Toohey, J., & Slack, C. (2016). Addressing legal and policy barriers to male circumcision for adolescent boys in South Africa. South African Medical Journal, 106 (12), 1173-1176.
Slack, C., & Strode, A. (2016). But is this really the parent or guardian? Practical strategies for consent to child research in South Africa. South African Journal of Bioethics and Law, 9 (1), 35-38.
Van Rooyen, H., Strode, A., & Slack. C. (2016). HIV testing of children is not simple for health providers and researchers: Legal and policy frameworks guidance in South Africa. South African Medical Journal, 106 (5), 451-453.
Strode, A., & Slack., C. (2015). Child research in South Africa: How do the new regulations help? SAMJ, 105 (11), 899-900.
Newman, P., Rubincam, C., Slack, C., Essack, Z., Chakrapani, V., Chuang, D. et al. (2015). Towards a science of community stakeholder engagement in biomedical HIV prevention trials: An embedded four-country case study. PLoS ONE 10(8): e0135937. doi:10.1371/journal.pone.0135937.
Strode, A., Toohey, J., Singh, P., & Slack, C. (2015). Boni Mores and consent to child research in South Africa. South African Journal of Bioethics and Law, 8(1), 22-25.
Rautenbach, C., Lindegger, G., Slack, C., Wallace, M., & Newman, P. (2015) ‘I’m positive, but I’m negative’: Competing voices in informed consent: Implications for HIV vaccine trials. Journal of Empirical Research on Human Research Ethics, 10(2), 151-156.

2010-2014

Strode, A., & Singh, P. (2014). Compensation for research-related harm: The implications of Venter v Roche Products (Pty) Limited and Others for research ethics committees. South African Medical Journal, 104(11), 759-761.
Strode, A., Richter, M., Wallace, M., Toohey, J. & Technau, K. (2014). Failing the vulnerable: Three new consent norms which will undermine health research with children. Southern African Journal of HIV Medicine, 15(2), 46-49.
Moorhouse, R., Slack, C., Quayle, M., Essack, Z., & Lindegger, G. (2014). Stakeholder views of ethical guidance regarding prevention and care in HIV vaccine trials. BMC: Medical Ethics, 15(51), 1-11.
Essack, Z. (2014). Ensuring access to HIV prevention services in South African HIV vaccine trials: Correspondence between guidelines and practices. Public Health Ethics, 7 (2): 195-206. doi: 10.1093/phe/phu010.
Slack, C. (2014). Ancillary care in South African HIV vaccine trials: Addressing needs, drafting protocols and engaging community. Journal of Empirical Research on Human Research Ethics, 9(1), 83-95.
Bekker, LG, Slack, C., Lee, S., Shah, S., & Kapogiannis, B. (2014). Ethical Issues in Adolescent HIV Research in resource-limited countries. JAIDS, 65(1) s24-s28.
Strode, A., Toohey, J., Slack, C., & Bhamjee, S. (2013). Reporting underage consensual sex after the Teddy Bear case: A different perspective. South African Journal of Bioethics and Law, 6(2), 45-47.
Strode, A., Van Rooyen, H., & Makusha, T. (2013). Is it lawful to offer HIV self-testing to children in South Africa? Southern African Journal of HIV Medicine, 14(4), 151-154.
Strode, A. (2013). The parameters of the current legal framework for health research: Forms of health research which are regulated and obligations imposed on researchers. South African Journal of Bioethics and Law, 6(2), 69-71.
Strode, A., & Slack, C. (2013). Child privacy rights: A ‘Cinderella’ issue in HIV prevention research. Southern African Journal of HIV Medicine, 14(3), 108-110.
Slack, C., Strode, J. and Singh, P. (2012). Compensation for research-related injury in South Africa: A critique of the Good Clinical Practice (GCP) guidelines. South African Journal of Bioethics and Law, 5 (2), 91-94.
Koen, J., Essack, Z., Slack, C., Lindegger, G., & Newman, P. (2012). ‘It looks like you just want them when things get rough’: Civil society on negative trial results and stakeholder engagement in prevention trials. Developing World Bioethics. http:// doi:10.1111/j.1471-8847.2012.00338.
Essack, Z., Koen, J., Slack, C., Lindegger, C., & Newman, P. (2012). Civil society perspectives on negative biomedical HIV prevention trial results and implications for future trials. AIDS Care http://dx.doi.org/10.1080/09540121.2012.656566.
Slack, C., Strode, A., & Essack, Z. (2012). Reply to Naidoo: Consent for children participating in research. South African Medical Journal, 101 (3), 110.
Strode, A. & Slack, C. (2011). Using the concept of ‘parental responsibilities and rights’ to identify adults able to provide proxy consent to child research in South Africa. South African Journal of Bioethics and Law, 3(2), 55-58.
Strode, A., Slack, C. & Essack. (2011). Child Consent in South African law: Implications for researchers, service providers and policy-makers. South African Medical Journal, 101 (9), 604-606.
Bull, S & Lindegger, G. (2011). Ensuring consent to research is voluntary: How far do we need to go? Open Peer Commentary. The American Journal of Bioethics, 11 (8), 27-28.
Slack, C. (2011). Why we don’t need a relative risk standard for adolescent HIV vaccine trials in South Africa. Open Peer Commentary. American Journal of Bioethics, 11(6), 1-2.
Strode, A., Slack, C., & Essack, Z. (2010). Child consent in South African law: Implications for researchers, service providers and policy-makers. South African Medical Journal, 100(4), 247-249.
Essack, Z., Slack, C., Koen, J., & Gray, G. (2010). HIV prevention responsibilities in HIV vaccine trials: Complexities facing South African researchers. South African Medical Journal, 100 (1), 45-48.
Barsdorf, N., Maman, S., Kass, N., & Slack, C. (2010). Access to treatment in HIV prevention trials: Perspectives from a South African community. Developing World Bioethics, 10(2), 78-87.
Essack, Z., Koen, J., Barsdorf, N., Slack, C., Quayle, M., Milford, C., Lindegger, G., Ranchod, C., & Mukuka, R. (2010). Stakeholder perspectives on ethical challenges in HIV vaccine trials in South Africa. Developing World Bioethics, 10(1), 11-12.

2005-2009

Strode, A., & Slack, C. (2009). Sex, lies and disclosures: Researchers and the reporting of underage sex. Southern African Journal of HIV Medicine, 10(2), 8-10.
Lindegger, G., & Van Loon, K. (2009). Informed consent in clinical trials: Perceptions and experiences of a sample of South African researchers. Health SA Gesondheid, 14(1), 1-7.
Koen, J., Slack, C., Barsdorf., N., & Essack., Z. (2008). Payment of clinical trial participants can be ethically sound: Moving past a flat rate. South African Medical Journal, 98(12), 926-931.
Slack, C., & Stobie., M. (2008). Response to ‘HIV vaccine trials: Reconsidering the therapeutic misconception and the question of what constitutes trial related injuries’. Developing World Bioethics, 2, 159-161.
Milford, C., Barsdorf, N., & Kafaar, Z. (2007). What should South African HIV vaccine trials do about social harms? AIDS Care, 19(9), 1110-1117.
Slack, C., Strode, A., & Mamashela, M. (2007). Ethical-legal challenges in adolescents HIV vaccine trials. Southern African Journal of HIV Medicine, 8(2), 12-13.
Slack, C., Strode, A., Fleischer, T., Gray., G., & Ranchod., C. (2007). Enrolling adolescents in HIV vaccine trials: Reflections on legal complexities from South Africa. BMC Medical Ethics, 8, 5.
Strode, A., Slack, C., Wassenaar, D., Singh, J. (2007). One step forward, two steps back: Requiring ministerial approval for all ‘non-therapeutic’ health research with minors. South African Medical Journal, 97(3), 200-202.
Lindegger, G., Quayle, M., & Ndlovu, M. (2007). Local knowledge and experiences of vaccination: Implications for HIV-preventive vaccine trials in South Africa. Health Education & Behavior, 34(1), 108-123.
Lindegger, G., Milford, C., Slack, C., Quayle, M., Xaba, X. & Vardas, E. (2006). Beyond the checklist: Assessing understanding for HIV vaccine trial participation in South Africa. JAIDS, 43(5), 560-566.
Lindegger, G., Milford., C., Ranchod., C & Slack, C. (2006). Potential behavioural and psychological contributions to ethical HIV vaccine trials in South Africa. South African Journal of Psychology (36), 715-733.
Gray, G., De Bruyn, G., Slack, C., Steele, G., & Williamson, C. (2006). Preparing developing countries for efficacy trials. Current Opinion in HIV and AIDS, 1(4), 330-335.
Milford, C., Wassenaar, D., & Slack, C. (2006). Resources and needs of research ethics committees in Africa: Preparation for HIV vaccine trials. IRB: Ethics and Human Research, 28 (2), 1-9.
Barsdorf, N.W., & Wassenaar, D.R. ( 2005 ). Racial differences in public perceptions of voluntariness of medical research participants. Social Science and Medicine, 60(5), 1087-1098.
Slack, C., Stobie, M., Milford, C., Lindegger, G., Wassenaar, D., Strode, A., & IJsselmuiden, C. (2005). Provision of HIV treatment in HIV preventive vaccine trials: A developing country perspective. Social Science and Medicine, 60 (6), 1197-1208.
Slack, C., & Kruger, M. (2005). The South African Medical Research Council's Guidelines on Ethics for Medical Research: Implications for HIV-preventive vaccine trials with children. South African Medical Journal, 95 (4), 269-271.
Slack, C., Strode, A., Grant, K., & Milford, C. (2005). Implications of the ethical-legal framework for adolescent HIV vaccine trials: Report of a consultative forum. South African Medical Journal, 95 (9), 682-684.
Strode, A., Grant, C., Slack, C., Mushariwa, M. (2005). How well does South Africa’s National Health Act regulate research involving children? South African Medical Journal, 95 (4), 265-266.
Strode, A., Slack, C., & Mushariwa, M. (2005). HIV vaccine research - South Africa’s ethical-legal framework and its ability to promote the welfare of trial participants. South African Medical Journal, 95 (8), 598-601.
Strode, A., Slack, C., Grant, K., & Mushariwa, M. (2005). Ethical and legal challenges in enrolling adolescents in medical research in South Africa: implications for HIV vaccine trials. South African Journal of Science, 101, 224-228.
Jaspan, H., Bekker, L.G., Grant, C., Slack, C., Strode, E., & Berwick, J. (2005). Protecting South Africa's children from HIV; giving them our best shot. South African Journal of Science, 101, 216-217.
Stobie, M., Strode, A., & Slack, C. (2005). The dilemma of enrolling children in HIV vaccine research in South Africa: What is in ‘the child’s best interest’? Chapter in AIDS in Africa. Van Niekerk, A. & Kopelman, L. (Eds). Pp. 190-207. Cape Town: David Philip/New Africa Books.

2000-2004

Tucker, T., & Slack, C. (2003). Not if but how? Caring for HIV-1 vaccine trial participants in South Africa. Lancet, 362(9388), 995.
Slack, C., Lindegger, G., & Vardas E. (2002). Are the ethical issues in HIV vaccine trials any different? Continuing Medical Education, 20, 9, 596-7.
Vardas, E. & Slack, C. (2002). Getting HIV Vaccine Trials started in Soweto. Continuing Medical Education, 20, 9, 593-4.
Slack, C., Lindegger, G., Vardas, E., Richter, L., Strode, A., & Wassenaar, D. (2000). Ethical issues in HIV vaccine trials in South Africa. South African Journal of Science, 96(6), 291 - 313.
Lindegger, G & Richter, L (2000). HIV Vaccine Trials: Critical issues in informed consent. South African Journal of Science, 96, 313 - 318.
Lindegger, G., Slack, C., & Vardas, E. (2000). HIV vaccine trials in South Africa: Some ethical considerations. South African Medical Journal, 90(8), 767-771.

HIV AIDS Vaccines Ethics Group

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