Evidence map›Paper›PMID 39563292›Full record

ArticleBMC medical ethics2024

Ethical issues in vaccine trial participation by adolescents: qualitative insights on family decision making from a human papillomavirus vaccine trial in Tanzania.

Lucy Frost, Ms Tusajigwe Erio, Hilary Whitworth, Ms Graca Marwerwe, Richard Hayes, Kathy Baisley, Silvia de SanJosé, Deborah Watson-Jones, Kirstin Mitchell

Abstract read
In one paragraph

Article in BMC medical ethics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Lucy FrostLondon School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. lucy.frost@phc.ox.ac.uk.
Ms Tusajigwe ErioMwanza Intervention Trials Unit, National Institute of Medical Research, Isamilo, Mwanza, Tanzania.
Hilary WhitworthLondon School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.
Ms Graca MarwerweMwanza Intervention Trials Unit, National Institute of Medical Research, Isamilo, Mwanza, Tanzania.
Richard HayesLondon School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.
Kathy BaisleyLondon School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.
Silvia de SanJoséISGlobal, Barcelona, Spain.
Deborah Watson-JonesLondon School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.
Kirstin MitchellSchool of Health and Wellbeing, University of Glasgow, Glasgow, UK.

Funding

Bill and Melinda Gates Foundation OPP1167526Chief Scientist Office for Scotland SPHSU18European and Developing Countries Clinical Trials Partnership MR/R010161/1Medical Research Council MC_UU_00022/3National Institute for Health and Care Research ACF-2017-13-013UK Department for International Development/ UK Medical Research Council/ Wellcome Trust Joint Global Health Trials Scheme MR/N006135/1Wellcome Trust
6 · The paper itself

Abstract

backgroundResearch in children is essential for them to benefit from the outcomes of research but involvement must be weighed against potential harms. In many countries and circumstances, medical research legally requires parental consent until the age of 18 years, with poorly defined recommendations for assent prior to this. However, there is little research exploring how these decisions are made by families and the ethical implications of this.

aimTo explore key ethical debates in decision-making for participation of children and adolescents in a human papillomavirus (HPV) vaccine trial.

methodsSemi-structured interviews were undertaken with Tanzanian girls (aged 9-16 years) who had participated in an HPV vaccine trial (n = 13), their parents or guardians (n = 12), and girls together with their parents (in paired parent-child interviews) (n = 6). The interviews were analysed using thematic analysis. Interview data came from a qualitative acceptability study undertaken as part of the Dose Reduction Immunobridging and Safety Study of Two Human Papillomavirus (HPV) Vaccines in Tanzanian Girls (DoRIS) trial.

resultsGirls and parents desired collaborative decision-making, with parents ultimately making the decision to consent. However, girls wanted a larger part in decision-making. Decisions to consent involved many people, including extended social networks, the trial team, media outlets and healthcare professionals and this resulted in conflicts to be negotiated. Deciding where to place trust was central in participants and parents considering decisions to consent and overcoming rumours about trial involvement.

conclusionsExisting models of decision-making help to understand dynamics between parents, adolescents and researchers but neglect the important wider social impacts and the fundamental nature of trust. Children's roles in discussions can be evaluated using the principles of consent: autonomy, freedom and information. Concepts such as relational autonomy help to explain mechanisms families use to negotiate complex consent decisions. Whilst interviewees supported the maintenance of legal parental consent, researchers must design consent processes centring the child to ensure that whole family decision-making processes are supported.

Indexed as

Decision MakingPapillomavirus VaccinesParental ConsentParentsQualitative ResearchAdolescentChildEthics, ResearchFamilyFemaleHumansInformed ConsentPapillomavirus InfectionsTanzaniaTrustPapillomavirus VaccinesAdolescentAssentAutonomyConsentHPVPaediatricsRelational ethicsTanzaniaTrialVaccine

Identifiers

PMID39563292
PMCPMC11577580

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.