Exploring the Role of Shared Decision Making in the Consent Process for Pediatric Genomics Research in Cameroon, Tanzania, and Ghana
Daima Bukini, Jantina deVries, Marsha Treadwell, Kofi Anie, Jemima Dennis-Antwi, Karene Kengne Kamga, Sheryl McCurdy, Kwaku Ohene-Frempong, Julie Makani, Ambroise Wonkam 
American Journal of Bioethics Empirical Bioethics, 5 August 2019; pp 182-189
Abstract
Background
It is customarily perceived that in Africa, decisions around research participation may be based not only on individual reflection but also on discussions with others. Some authors have argued that such decision making is reflective of a more traditional communitarian African worldview; one critique of such a perspective is that it is lacking an empirical grounding. In this study, we explore decision making around enrollment in sickle cell genomics research in three countries in Africa, namely, Ghana, Cameroon, and Tanzania. Particularly, we focus on exploring the role of shared decision making with regard to participating in genomic studies.
Results
We involved 64 participants in 15 individual interviews or in 49 focus-group discussions with research participants in rural and urban Tanzania (n = 20), Ghana (n = 30), and Cameroon (n = 14). We used a vignette to explore decision making around enrollment of children in sickle cell genomics research. Data were imported in NVivo11 and analyzed using thematic content analysis. Our findings indicate that the majority of the participants from both rural and urban settings prefer to make their own individual decisions and not consult with extended family or community leaders. Shared decision making was only considered necessary for individuals who were perceived to be in some way vulnerable.
Conclusion
We found very limited support for shared decision making as the primary process for decision making about research participation. While consultation was considered important to support individual decision making, particularly when parents were perceived as vulnerable, there was no suggestion in our data that shared decision making would be a more important or valuable means of seeking consent for research participation in the African research context.

A Formative Qualitative Study on the Acceptability of Deferred Consent in Adult Emergency Care Research in Malawi
Research Article 
Lucinda Manda-Taylor, Fanuel Meckson Bickton, Kate Gooding, Jamie Rylance
Journal of Empirical Research on Human Research Ethics, 8 August 2019 
Open Access
Abstract
Research in emergency medical care is challenging due to a limited therapeutic window for intervention, which may compromise informed consent. “Deferred consent” allows initiation of study procedures before full consent is recorded. We conducted a formative qualitative study exploring perspectives on deferred consent in Malawi among research ethics committee members, health care professionals, and lay representatives. Participants identified several advantages of deferred consent including scientific value and potential health benefits to the study subjects and wider population. Participants also had concerns, including regulatory barriers and the risk of abuse and malpractice. Conditions affecting acceptability are related to the role of proxies, the nature of the research, the availability of robust regulatory oversight, and the need for community engagement. Our findings show deferred consent would be acceptable in Malawi, provided that a clear case can be made to advance medical knowledge and that adequate regulatory and ethical protections are in place.

Consent Challenges and Psychosocial Distress in the Scale-up of Voluntary Medical Male Circumcision Among Adolescents in Western Kenya
Original Paper
Winnie K. Luseno, Samuel H. Field, Bonita J. Iritani, Stuart Rennie, Adam Gilbertson, Fredrick S. Odongo, Daniel Kwaro, Barrack Ongili, Denise D. Hallfors
AIDS and Behavior, 2 August 2019; pp 1-11
Abstract
In priority sub-Saharan African countries, on the ground observations suggest that the success of voluntary medical male circumcision (VMMC) programs should not be based solely on numbers of males circumcised. We identify gaps in the consent process and poor psychosocial outcomes among a key target group: male adolescents. We assessed compliance with consent and assent requirements for VMMC in western Kenya among males aged 15–19 (N = 1939). We also examined differences in quality of life, depression, and anticipated HIV stigma between uncircumcised and circumcised adolescents. A substantial proportion reported receiving VMMC services as minors without parent/guardian consent. In addition, uncircumcised males were significantly more likely than their circumcised peers to have poor quality of life and symptoms of depression. Careful monitoring of male adolescents’ well-being is needed in large-scale VMMC programs. There is also urgent need for research to identify effective strategies to address gaps in the delivery of VMMC services.

Knowledge and Attitudes of Mental Health Professionals Regarding Informed Consent and Patient Confidentiality in Clinical Practice and Research in Udupi District
Vidyashree S.V., Kumar Naveen, Kamath Rajesh, D’Souza Brayal, Ashok Lena, Kamat
Sagarika
Indian Journals, 8 August 2019; 19(2) pp 180-184
Abstract
The control of patient information regarding mental illness is a challenging issue in mental health care. Patients have the right to control and know all information concerning their health. In India, an individual’s identity is intimately connected to his or her family’s; family is integral to one’s self. This study was conducted to increase awareness among mental health professionals regarding informed consent and patient’s confidentiality protection in clinical practice and research. The findings of this study can help hospitals frame policies. The objectives of the study were to assess the knowledge(K) and attitudes(A) of mental health professionals regarding ‘informed consent’ and confidentiality protection in clinical practice and research. The study was conducted in three different phases. In phase one, a questionnaire was formulated, validated and distributed among the mental health professionals to analyze K&A regarding informed consent and confidentiality protection in clinical practice and research. In phase two, an education module was developed and distributed among healthcare professionals. In phase three, the participants were reassessed on their K&A using the same questionnaire. The results show no significant difference in the mean values (mean=7.46, SD =1.22) in both confidentiality and consent during phase one. However, after administering the education module, the mean score of knowledge and attitude towards consent and confidentiality has increased (mean=9.86, SD=0.40) compared to the pretest. It was concluded that the delivery of the education module incorporating the updated information on acts and amendments related to the mental health profession has been effective.

Overvaluing individual consent ignores risks to tribal participants
Comment
Krystal S. Tsosie, Joseph M. Yracheta, Donna Dickenson
Nature Reviews Genetics, 15 July 2019
Excerpt
Genomic studies often rely on individual-based consent approaches for tribal members residing outside of their communities. This consent model fails to acknowledge the risks to small groups such as tribes, which can implicate the community as a whole.

The challenge of community engagement and informed consent in rural Zambia: an example from a pilot study
Research Article
Joseph Mumba Zulu, Ingvild Fossgard Sandøy, Karen Marie Moland, Patrick Musonda, Ecloss Munsaka, Astrid Blystad
BMC Medical Ethics, 4 July 2019; 20(45)
Open Access
Abstract
Background
There is a need for empirically based research on social and ethical challenges related to informed consent processes, particularly in studies focusing on adolescent sexual and reproductive health. In a pilot study of a school-based pregnancy prevention intervention in rural Zambia, the majority of the guardians who were asked to consent to their daughters’ participation, refused. In this paper we explore the reasons behind the low participation in the pilot with particular attention to challenges related to the community engagement and informed consent process.
Methods
The pilot was implemented in two schools and examined the acceptability of a package of interventions including economic support to families to keep their girls in school, pocket money for girls, youth club meetings on reproductive health, and community meetings to sensitize the community. Focus group discussions (4) were conducted with girls who participated in the pilot, boys in their class and with parents. Individual semi-structured interviews (11) were conducted with teachers, peer educators and community health workers involved in the coordination of the intervention as well as with religious and traditional leaders. Data were analyzed through thematic analysis.
Results
The findings indicate that inadequate use of recognized community communication channels during the community engagement process and dissemination of information about the pilot resulted in limited understanding of the pilot concept by the community. This surfaced through uncertainty and fear that the intervention may result in loss of control over daughters, worries about why money was provided unconditionally to girls, and suspicion of links to satanism. The sense of insecurity appeared to be exacerbated by low literacy levels, poverty, fear of loss of bride wealth, perceived disregard for local perceptions of social status, and scanty trust in the actors implementing the pilot.
Conclusions
Inadequate use of locally appropriate channels in the dissemination of information created room for interpretation and facilitated development of mistrust, undermining the conditions for community engagement and actual informed consent. A key lesson learnt is the importance of taking seriously the complexity of local values and structures that may impact people’s capability to consent or not consent to a study in an informed manner.