Evidence map›Paper›PMID 33794891›Full record

SynthesisBMC medical ethics2021

Ethical considerations for research involving pregnant women living with HIV and their young children: a systematic review of the empiric literature and discussion.

Catherine G Raciti, Leslie A Enane, Katherine R MacDonald, Elizabeth C Whipple, Mary A Ott, Megan S McHenry

Abstract readSystematic Review
In one paragraph

Synthesis in BMC medical ethics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 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

8 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. 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

6 authors.

Catherine G RacitiIndiana University-Purdue University - Indianapolis, Indianapolis, IN, USA.
Leslie A EnaneDepartment of Pediatrics, The Ryan White Center for Pediatric Infectious Disease and Global Health, Indiana University School of Medicine, 705 Riley Hospital Drive, Room 5853, Indianapolis, IN, 46202, USA.
Katherine R MacDonaldDepartment of Adolescent and Young Adult Medicine, Children's National Hospital, Washington, DC, USA.
Elizabeth C WhippleIndiana University School of Medicine, Ruth Lilly Medical Library, Indianapolis, IN, USA.
Mary A OttDivision of Adolescent Medicine, Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USA.
Megan S McHenryDepartment of Pediatrics, The Ryan White Center for Pediatric Infectious Disease and Global Health, Indiana University School of Medicine, 705 Riley Hospital Drive, Room 5853, Indianapolis, IN, 46202, USA. msuhl@iu.edu.ORCID 0000-0001-6753-0928

Funding

Developing an Instrument to Assess Adolescent Risk for Disengagement from HIV CareK23HD095778 · NICHD · INDIANA UNIVERSITY INDIANAPOLIS · PI ENANE, LESLIE ANNE · 2018 to 2022
$786k
Neurodevelopmental screening in children born to HIV-infected mothers in KenyaK23MH116808 · NIMH · INDIANA UNIVERSITY INDIANAPOLIS · PI MCHENRY, MEGAN SONG · 2018 to 2021
$723k
NICHD NIH HHS K23 HD095778
6 · The paper itself

Abstract

backgroundThe proper and ethical inclusion of PWLHIV and their young children in research is paramount to ensure valid evidence is generated to optimize treatment and care. Little empirical data exists to inform ethical considerations deemed most critical to these populations. Our study aimed to systematically review the empiric literature regarding ethical considerations for research participation of PWLHIV and their young children.

methodsWe conducted this systematic review in partnership with a medical librarian. A search strategy was designed and performed within the following electronic databases: Ovid MEDLINE, Embase and CINAHL. We screened titles and abstracts using the following inclusion criteria: (1) a study population of PWLHIV or children under 5 years of age; and (2) collection of qualitative or quantitative data regarding ethics of research participation. Excluded were reviews, commentaries, policy statements, clinical care-related ethics concerns, abstracts, case studies, or studies unrelated to HIV research. Studies were appraised for quality, data were extracted, and studies were qualitatively analyzed using a principle-based ethical framework within the Belmont Report.

resultsOf the 7470 titles identified, 538 full-text articles were reviewed for eligibility and only three articles met full criteria for inclusion within this review. While we allowed for inclusion of studies involving young children born to mothers with HIV, only articles focused on PWLHIV were identified. Within the results of these studies, four themes emerged: (1) adequacy of informed consent; (2) consideration of paternal involvement; (3) balancing risks; and (4) access to research and treatment. A strength of this review is that it included perspectives of international research investigators, community leaders, and male partners. However, only two studies collected empiric data from PWLHIV regarding their experiences participating in research

conclusionResearchers and funding agencies should be aware of these considerations and appreciate the value of and critical need for formative research to ensure clinical trials involving PWLHIV promote ethical, well-informed research participation and, ultimately, improve care outcomes. More research is needed to create a comprehensive ethical framework for researchers when conducting studies with PWLHIV.

Indexed as

Anti-HIV AgentsBiomedical ResearchChildChild, PreschoolEthics, ResearchFemaleHIV InfectionsHumansInfantInformed ConsentMaleMothersPregnancyPregnant PeopleAnti-HIV AgentsBelmont ReportEthicsHIVPregnant womenResearch

Identifiers

PMID33794891
PMCPMC8017748

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.