Ethics & Engagement across the Wellcome Trust Major Overseas Programmes

End of Project Report: Understanding the context in informed consent processes in hospital-based paediatric research in urban Malawi (PRaICA)

Dear Colleagues

I hope this post finds you well. I am delighted to share with you the project summary of PRaICA study.

The main aim was to evaluate the informed consent process among guardians of research participants in purposively selected MLW paediatric research studies. The specific objectives were to 1) examine participant understanding of study information 2) compare the effect of study design (interventional and observational studies) and research setting (acute and non-acute settings) 3) assess perceptions of participants about the mode of administration and timing of IC 4) assess the challenges faced by staff around informed consent processes.

The project took a long time to complete than anticipated. Initially, Neema Mtunthama Toto conceptualised the idea in 2013. I took over the project from Neema in 2017 and resumed data collection. We had challenges in recruiting participants from acute and non- acute interventional and observational studies as all studies which permission was sought to recruit from were completed by then. We had to restart collaborating with other Principal Investigators from other studies to seek permission and apply for ethics protocol amendments. Despite this initiative, it was hard to get interventional study participants from the acute setting as no study was in operation and participants from the non-acute interventional study were scarce. This was a major challenge with the project. The data collection dragged and completed in April 2018. The project operated on No Cost Extension (NCE) approved by Professor Mike Parker. I completed data analysis in December 2018.

1. Major findings: Summary
Motivation to participate in the research
The study findings show that participants in clinical studies receive better care, services and treatment than those who do not participate in the clinical studies. This is not surprising, but it is just confirming that there are disparities on the quality of clinical care given to study participants and non- study participants in these setting. There were no differences between study types and setting as all participants associated participating in research with best hospital care. Besides, Research Staff from both study types reported guardians being interested in the treatment of the child and failed to comply with study protocols when a child is assisted.

Decision making
The subthemes emerged were: time, timing, partner involvement and consenting space. No differences were observed in study types, but differences were in the study setting. Participants from both study types complained of not involving partners in decision making, inadequate time and improper timing for informed consent, which affected their understanding. Only participants from non- acute interventional study had a positive experience on 3 started issues. The research staff from the acute setting had difficulties consenting mothers without their partners. Both research staff and guardians from the acute setting felt that the consenting timing was not right as the children were critically ill to ask a mother to decide.

Voluntary participation
The main issue raised on voluntary participation was on the explanation of the right to participate or to withdraw. While few participants thought it was properly explained to them, the majority thought otherwise. There were no differences in study types, but differences were in the study settings. There were mixed responses from acute setting while others thought their participation was voluntary others thought it was not voluntary. All participants from the non- acute setting described their participation as voluntary. Research staff from observational study in non- acute setting agreed with participants that, no much emphasis placed on the right to participate or not and it is an area to be improved.

Study information
The subthemes emerged were: an explanation of study information (benefits, risks, type and procedure), recall of information, information sheet, approach, awareness of randomisation and checking of understanding. No much differences observed between study types except on risk explanation where participants from the observational study reported not communicated about the risks and mixed responses in an interventional study. Differences were noted in study settings. Participants from non-acute setting were more likely to recall information shared during consenting than participants in the acute setting. Among the participants who were given information sheet few from the acute setting read the information sheet. Only staff in non-acute setting interventional study checked understanding of participants. Research staff agreed with participants that no much emphasis is placed on communicating the risk of study.

Participants suggestions on consenting process
• Guardians suggested of having enough time during the consenting process so that they can consult their partners and understand information better.
• Guardians also suggested that consent should be done when their child is stable if not stable; it affects their understanding of study information.
• Guardians also suggested that the study information should be shared in communities through community sensitisation when children are not sick
• Recruiting staff reported that protocol restrictions are a challenge to them (i.e., recruit within 24 to 48 hours of admission or before getting treatment). This restricts them from giving adequate information. They suggested if they can be given enough time to go back to participants when their children are stable to explain more on the study.

2. Value of this bursary
Through this project, we are linking with the Clinical Research Support Unit at MLW to use the findings in improving consent processes at MLW. The findings of this study have also been presented at national and international level. In November 2017, I presented at the College of Medicine Research Dissemination conference. In July, I presented at the International Global Health Bioethics Conference in Oxford. The Manuscript for publication in BMC medical ethics drafted and sent to supervisors, waiting for their comments. This fellowship was of much help to me as I have acquired skills in qualitative research, which I am currently using with my PhD studies in the UK. Through this project, I have also been connected with the Department of Global Health at Liverpool School of Tropical Medicine and I am joining the Global Health online teaching team. My role will be facilitating discussion board with students on ethics in research.

Lastly, I would like to thank Global Health Bioethics Network funded by WT Strategic Award for funding. Co-investigators; Neema Mtunthama, Charity Gunda, Markus Gmeiner, Prof Michael Parker and Dr. Nicola Desmond for your continuous support during this project. Neema for allowing me to complete her project, study participants, study PIs and all GHBN fellows.

Views: 77

Comment by Dina Rippon on August 6, 2019 at 14:24

Dear Mitsunge, thank you so much for this detailed report! It's very interesting to read about your process and results. I'm sorry to hear that data was scarce and difficult to collect. Nonetheless, it looks like you managed to get over this challenge and were still successful in completing your goals. How has the Clinical Research Support Unit responded to your results? You mention that you're linking with them in order to improve consent processes at MLW. Do you think this will be difficult to implement? In any case, congratulations on your completion of this Bursary Project! You have gathered significant results that will no doubt have an impact on future research at MLW. 

Comment by Mtisunge Joshua Gondwe on August 6, 2019 at 14:57

Dear Dina

Thank you very much for commenting on this post. In response to questions you have raised, the MLW Clinical Research Support Unit (CRSU) has  responded well to the findings.  I have been working with the team (CRSU Lead) through out the project which eased the process. I have shared the presentation and summary with CRSU team, Nursing Clinical team and Community Engagement team. The CRSU team will incorporate some of findings  in informed consent trainings which they conduct regularly with research team, nurses and field workers. Currently, the CRSU is drafting the informed consent SOP at MLW. The findings will also inform the contents of this SOP. One of it is to recommend two-step consenting process in acute setting. 

Comment by Kate Gooding on August 6, 2019 at 15:33

Congratulations Mtisunge, great to see this is now complete & to hear that you are using your ethics experience in Liverpool.

Comment by Dina Rippon on August 7, 2019 at 13:04

Dear Mitsunge, that sounds terrific! Wow - what an impact your research is having already - well done!

Comment by Busisiwe Nkosi on April 23, 2020 at 19:41

Dear Mitsunge,

Thank you for the interesting study. Yes consent is a complex process especially in the settings you describe. Good that you the findings will inform informed consent training. Best wishes

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