Table 2 Summary of reviewed studies
Author | Publication Date | Title | Country | Focus area | Journal |
|---|---|---|---|---|---|
Afolabi, M.O., Bojang, K. D’Alessandro, U. et al. | 2014 | Digitised audio questionnaire for” assessment of informed consent comprehension in a low-literacy African research population: Development and psychometric evaluation | Gambia | Assessment tools for” IC comprehension Translation of IC documents | BMJ Open |
Afolabi, Muhammed O. Okebe, Joseph U. Mcgrath, Nuala Larson, Heidi J. Bojang, Kalifa Chandramohan, Daniel | 2014 | Informed consent comprehension in African research settings | Multi-country | Measurement of IC comprehension | Tropical Medicine and International Health |
Afolabi, Muhammed Olanrewaju Rennie, Stuart Halfords, Denise Dion Kline, Tracy Zeitz, Susannah Odongo, Frederick S. Amek, Nyaguara O. Luseno, Winnie K. | 2018 | An adapted instrument to assess informed consent comprehension among youth and parents in rural western Kenya: a validation study | Kenya | Development of a cross-cultural tool for” the adaptability and validation of an informed consent | BMJ open |
Akpa-Inyang, Francis Chima, Sylvester C. | 2021 | South African traditional values and beliefs regarding informed consent and limitations of the principle of respect for” autonomy in African communities: a cross-cultural qualitative study | South Africa | Perceptions of biomedical researchers regarding the comprehensibility of the informed consent doctrine and its application in African countries. | BMC Medical Ethics |
Marshall, P.A | 2006 | Informed Consent in International Health Research | Multi-country | Socio-cultural factors that influence comprehension of IC. Recommendations for good practice | A Journal of Empirical Research on Human Research Ethics: An International Journal |
Appiah, Richard | 2021 | Gurus and Griots: Revisiting the research informed consent process in rural African contexts | Ghana | Strategies for” context-appropriate ethical guidelines to improve IC process in African rural settings | BMC Medical Ethics |
Barchi, Francis Little, Madison T. | 2016 | National ethics guidance in SSA on the collection and use of human biological specimens: A systematic review Ethics in Biomedical Research | Multi-country | Availability of national ethics and regulatory guidance on biomedical research in Sub- Saharan African countries and | BMC Medical Ethics |
Bentley, Margaret E Sorenson, James R Henderson, Gail E Horst, Charles Van Der Moses, Agnes Nkhoma, Jacqueline Ahmed, Yusuf | 2011 | Using formative research to develop a context-specific approach to informed consent for clinical trials | Malawi | Development of context-specific consent information | |
Boga, Mwanamvua Davies, Alun Kamuya, Dorcas Kinyanjui, Samson M. Kivaya, Ester Kombe, Francis, et al. | 2011 | Strengthening the informed consent process in international health research through community engagement: The KEMRI-Wellcome Trust Research Programme experience | Kenya | Strategies for” strengthening the informed consent – developing dictionary of terminologies and community engagement. | PLoS Medicine |
Britz, Retha le Roux-Kemp, Andra | 2016 | Voluntary informed consent and good clinical practice for” clinical research in South Africa: Ethical and legal perspectives | South Africa | Review of the legal and ethical guidelines on informed consent | S Afr Med Journal |
Bukini, Daima Mbekenga, Columba Nkya, Siana Purvis, Lisa McCurdy, Sheryl Parker, Michael Makani, Julie | 2020 | A qualitative study on aspects of consent for” genomic research in communities with low literacy | Tanzania | Influence of literacy levels understanding of consent process in genomic studies | BMC Medical Ethics |
Bull, Susan Cheah, Phaik Yeong Lwin, Khin Maung Marsh, Vicki Molyneux, Sassy Parker, Michael Theobald, Sally, et al. | 2013 | Consent and Community Engagement in diverse research contexts: Reviewing and developing research and practice | Multi-country | Interplay between community engagement and researchers- IC process- comprehension, beliefs | Journal of Empirical Research on Human Research Ethics |
Burgess, Lesley Jean Gerber, Berna Coetzee, Kathleen Terblanche, Marli Agar, Gareth Kotze, Theunis Jvw | 2019 | An evaluation of informed consent comprehension by adult trial participants in South Africa at the time of providing consent for” clinical trial participation and a review of the literature | South Africa | Assessment of participants’ comprehension of IC process in a clinical trial; strategies to improve comprehension | Open Access Journal of Clinical Trials |
Campbell, Megan M. Susser, Ezra Mall, Sumaya Mqulwana, Sibonile G. Mndini, Michael M. Ntola, Odwa A. Nagdee, Mohamed Zingela, Zukiswa Van Wyk, Stephanus Stein, Dan J. | 2020 | Using iterative learning to improve understanding during the informed consent process in a South African psychiatric genomics study | South Africa | Assess research predictor’s for” better understanding of the IC- development of standardised tool to improve comprehension | PLoS ONE |
Chaisson, Lelia H. Kass, Nancy E. Chengeta, Bafanana Mathebula, Unami Samandari, Taraz | 2011 | Repeated assessments of informed consent comprehension among HIV-infected participants of a three-year clinical trial in Botswana | Botswana | Assessment of IC comprehension -translation-understand key study information | PLoS ONE |
Chapman, K.N Pevzner, E. Mangan, J.M. Breese, P. et al. | 2017 | Evaluation of the Informed Consent Process of a Multicenter Tuberculosis Treatment Trial | Multi-country | Assessment of tool designed to enhance IC comprehension | AJOB Empir Bioeth. |
Chima, Sylvester C. | 2013 | Evaluating the quality of informed consent and contemporary clinical practices by medical doctors in South Africa: An empirical study | South Africa | Evaluating whether the quality of informed consent obtained by doctors practicing in South Africa is consistent with international ethical standards and local regulations | BMC Medical Ethics |
Colom, Marcela Rohloff, Peter | 2018 | Cultural considerations for” informed consent in paediatric research in low/middle-income countries: A scoping review | Multi-country | Ethical and legal guidelines for” IC in paediatric research; assess cultural and linguistically appropriate strategies for” obtaining IC | BMJ Paediatrics Open |
Ditai, J. Kanyago, J. Nambozo, M. R. Odeke, N. M. Abeso, J. Dusabe-Richards, J. Olupot-Olupot, P. Carrol, E. D., er al. | 2018 | Optimising informed consent for” participants in a randomised controlled trial in rural Uganda: A comparative prospective cohort mixed-methods study | Uganda | Assesses comprehension of study -IC information comparing 3 strategies: standard procedure, slide show and video | BMC |
Fischer, A. E. Venter, W. D.F. Collins, S. Carman, M. Lalla-Edward, S. T. | 2021 | The readability of informed consent forms for” research studies conducted in South Africa | South Africa | Assess readability and comprehension of IC -literacy levels and comprehension of IC | South African Medical Journal |
Gikonyo, Caroline Bejon, Philip Marsh, Vicki Molyneux, Sassy | 2008 | Taking social relationships seriously: Lessons learned from the informed consent practices of a vaccine trial on the Kenyan Coast | Kenya | ||
Hanrahan, Donna Sexton, Patrina Hui, Katrina Teitcher, Jennifer Sugarman, Jeremy London, Alex John Barnes, Mark, er al. | 2015 | Linguistic and cultural challenges in communication and translation in US sponsored HIV Prevention research in emerging economies | Multi-country | Assess ethical and regulatory challenges across diverse linguistic and cultural settings | PLoS ONE |
Kamaara, Eunice Kong, Camillia Campbell, Megan | 2020 | Prioritising African perspectives in psychiatric genomics research: Issues of translation and informed consent | Multi-country | Translation of IC in genomic research | Developing World Bioethics |
Kiguba, Ronald Kutyabami, Paul Kiwuwa, Stephen Katabira, Elly Sewankambo, Nelson K. | 2012 | Assessing the quality of informed consent in a resource-limited setting: A cross-sectional study | Uganda | Assessment of quality of IC in clinical and observational studies | |
Kithinji, Caroline Kass, Nancy E. | 2011 | Assessing the readability of non-English-language consent forms: The case of Kiswahili for” research conducted in Kenya | Kenya | Assessed readability and comprehension of IC | IRB: |
Koonrungsesomboon, Nut Laothav, Junjira Karbwang, Juntra | 2015 | Understanding of essential elements required in informed consent form among researchers and institutional review board members | Multi-country | Assessment of the understanding of researchers and members of Institutional Review Boards (IRBs) regarding the essential elements of an Informed Consent Form (ICF) | Tropical Medicine and Health |
Krogstad, Donald J. Diop, Samba Diallo, Amadou Mzayek, Fawaz Keating, Joseph | 2010 | Informed consent in international research: The rationale for” different approaches | Multi-country | Describing strategies to enhance IC comprehension | American Journal of Tropical Medicine and Hygiene |
Krosin, Michael T. Klitzman, Robert Levin, Bruce Cheng, Jianfeng Ranney, Megan L. | 2006 | Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa | Mali | Assessments of challenges in comprehension during consent processes | Clinical Trials |
Mack, Natasha Ramirez, Catalina B. Friedland, Barbara Nnko, Soori | 2013 | Lost in Translation: Assessing Effectiveness of Focus Group Questioning Techniques to Develop Improved Translation of Terminology Used in HIV Prevention Clinical Trials | Tanzania | Assessment of effectiveness of techniques in enhancing participants’ understanding (translations, development of lexicons) | PLoS ONE |
Marshall, Patricia A. Adebamowo, Clement A. Adeyemo, Adebowale A. Ogundiran, Temidayo O. Strenski, Teri | 2014 | Voluntary participation and comprehension of informed consent in a genetic epidemiological study of breast cancer in Nigeria | Nigeria | Assessment of comprehension of IC in genetic study | BMC Medical Ethics |
MacQueen, Kathleen M. Chen, Mario Ramirez, Catalina Nnko, Sooriea Earp, Kelly M. | 2014 | Comparison of closed-ended, open-ended, and perceived informed consent comprehension measures for” a mock HIV prevention trial among women in Tanzania | Tanzania | Assessment of strategies to enhance comprehension of IC | PLoS ONE |
Mamotte, Nicole Wassenaar, Douglas Koen, Jennifer Essack, Zaynab | 2010 | Convergent ethical issues in HIV/AIDS, tuberculosis and malaria vaccine trials in Africa: Report from the WHO/UNAIDS African AIDS Vaccine Programme’s Ethics, Law and Human Rights Collaborating Centre consultation, 10–11 February 2009, Durban, South Africa | Multi-country | Description of factors influencing the comprehension of IC | BMC Medical Ethics |
Mandava, Amulya Pace, Christine Campbell, Benjamin Emanuel, Ezekiel | 2016 | The quality of informed consent: mapping the landscape. A review of empirical data from developing and developed countries | Multi-country | Evaluation of IC comprehension in developed and developing countries s | J Med Ethics. |
Minnies, Deon Hawkridge, Tony Hanekom, Willem Ehrlich, Rodney London, Leslie | 2008 | Evaluation of the quality of informed consent in a vaccine field trial in a developing country setting | South Africa | Assessment of the quality of consent in the case control study, and to identify factors that may influence the quality of consent. | BMC Medical Ethics |
Moodley, K. Pather, M. Myer, L. | 2005 | Informed consent and participant perceptions of influenza vaccine trials in South Africa | South Africa | Assessment of knowledge and perceptions of the informed consent process among individuals participating in influenza vaccine trials in two disadvantaged communities in | Journal of Medical Ethics |
Munung, Nchangwi Syntia Marshall, Patricia Campbell, Megan Littler, Katherine Masiye, Francis | 2016 | Obtaining informed consent for genomics research in Africa: Analysis of H3Africa consent documents | Multi-country | Assessment of consent models used in genomic research | Journal of Medical Ethics |
Muzanyi, Grace Sekitoleko, Isaac Johnson, John L. Lunkuse, Jane Nalugwa, Gladys., er al. | 2020 | Level of education and preferred language of informed consent for” clinical research in a multi-lingual community | Uganda | Assessment of educational level and preferred language of consent | African Health Sciences |
Nnabugwu, Ikenna I. Ugwumba, Fredrick O. Udeh, Emeka I. Anyimba, Solomon K. Ozoemena, Oyiogu F. | 2017 | Informed consent for” clinical treatment in low-income setting: Evaluating the relationship between satisfying consent and extent of recall of consent information | Nigeria | Assessment of factors that influence comprehension and information recall during IC | BMC Medical Ethics |
Odhiambo, Rachael Mars, Maurice | 2018 | Patients’ understanding of telemedicine terms required for” informed consent when translated into Kiswahili | Kenya | Assessment of patients’ understanding of translated IC documents | BMC Public Health |
Oduro, Abraham R. Ab”OR”igo, Raymond A. Amugsi, Dickson Anto, Francis Any”OR”igiya, Thomas., er al. | 2008 | Understanding and retention of the informed consent process among parents in rural northern Ghana | Ghana | Assessment of the comprehension and retainment of information of the informed consent process | BMC Medical Ethics |
Olanrewaju, Muhammed | 2014 | Multimedia Informed Consent Tool for” a Low Literacy African Research Population: Development and Pilot-Testing | Gambia | Evaluation of a multimedia informed consent tool for” people with low literacy in an area where a malaria treatment trial | Journal of Clinical Research & Bioethics |
Ossemane, Ezaquiel, B. Moon, Try, D. Sacarlal, J. Sevene, Esperanca Kenga, Darlene., er al. | 2016 | Assessment of Parents’/Guardians’ Initial Comprehension and One-Day Recall of Elements of Informed Consent within a Mozambican Study of Pediatric Bacteremia | Mozambique | Evaluation of tool used to enhance the comprehension of the elements of informed consent by the parents/guardians of children enrolled in a clinical study | J Empir Res Hum Res Ethics. |
Palmeirim, Marta S. Mohammed, Ulfat A. Ross, Amanda Ame, Shaali M. Ali, Said M. | 2021 | Evaluation of two communication tools, slideshow and theatre, to improve participants’ understanding of a clinical trial in the informed consent procedure on Pemba Island, Tanzania | Tanzania | Assessment of communication strategies to enhance IC comprehension | PLoS Neglected Tropical Diseases |
Palmeirim, Marta S. Ross, Amanda Obrist, Brigit Mohammed, Ulfat A. Ame, Shaali M. | 2020 | Informed consent procedure in a double blind randomized anthelminthic trial on Pemba Island, Tanzania: Do pamphlet and information session increase caregivers knowledge? | Tanzania | Assessment of strategies- pamphlets, oral information and combination of pamphlets and oral information in improving participants knowledge about study information | BMC Medical Ethics |
Penn, Claire Evans, Melanie | 2010 | Assessing the impact of a modified informed consent process in a South African HIV/AIDS research trial | South Africa | Assessment of comprehension of IC using standard and modified IC documents | Patient Education and Counseling |
Reynolds, Lindsey Cousins, Thomas Newell, Marie Louise Imrie, John | 2013 | The social dynamics of consent and refusal in HIV surveillance in rural South Africa | South Africa | Assessment of consent encounter in HIV surveillance study | Social Science and Medicine |
Ssali, Agnes Poland, Fiona Seeley, Janet | 2015 | Volunteer experiences and perceptions of the informed consent process: Lessons from two HIV clinical trials in Uganda Ethics in Biomedical Research | Uganda | Assessment of participants understanding of IC; strategies for” improving IC process | BMC Medical Ethics |
Ssali, Agnes Poland, Fiona Seeley, Janet | 2016 | Exploring informed consent in HIV clinical trials : A case study in Uganda | Uganda | Assessment of key actor’s during IC process | HLY |
Staunton, Ciara | 2015 | Informed consent for” HIV cure research in South Africa: Issues to consider | South Africa | Issues to consider to improve comprehension of IC | BMC Medical Ethics |
Staunton, Ciara de Roubaix, Malcolm Baatjies, Dianno Black, Gill Hendricks, Melany. et al. | 2018 | Ethical challenges in developing an educational video to empower potential participants during consent processes in HIV cure research in South Africa | South Africa | Challenges in use of video to enhance IC process | BMC Medical Ethics |