Evidence map›Paper›PMID 27246403›Full record

SynthesisHuman vaccines & immunotherapeutics2016

A systematic review of ethical issues in vaccine studies involving pregnant women.

Jennifer A Beeler, Philipp Lambach, T Roice Fulton, Divya Narayanan, Justin R Ortiz, Saad B Omer

Abstract readSystematic Review
In one paragraph

Synthesis in Human vaccines & immunotherapeutics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–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

6 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. COVID-19 vaccine testing in pregnant females is necessary.The Journal of clinical investigation · 2021
    Review
  6. Dismantling the Taboo against Vaccines in Pregnancy.International journal of molecular sciences · 2016
    Review
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.

Jennifer A Beelera Hubert Department of Global Health , Rollins School of Public Health, Emory University , Atlanta , GA , USA.
Philipp Lambachb Initiative for Vaccine Research , World Health Organization , Geneva , Switzerland.
T Roice Fultona Hubert Department of Global Health , Rollins School of Public Health, Emory University , Atlanta , GA , USA.
Divya Narayanana Hubert Department of Global Health , Rollins School of Public Health, Emory University , Atlanta , GA , USA.
Justin R Ortizb Initiative for Vaccine Research , World Health Organization , Geneva , Switzerland.
Saad B Omera Hubert Department of Global Health , Rollins School of Public Health, Emory University , Atlanta , GA , USA.

Funding

NCEZID CDC HHS U50 CK000431World Health Organization 001
6 · The paper itself

Abstract

backgroundImmunization during pregnancy can provide protection for mother and child. However, there have been only a limited number of studies documenting the efficacy and safety of this strategy.

aimsTo determine the extent and nature of subject matter related to ethics in maternal immunization by systematically documenting the spectrum of ethical issues in vaccine studies involving pregnant women.

methodWe conducted a systematic literature review of published works pertaining to vaccine and therapeutic studies involving pregnant women through searches of PubMed, EMBASE, Web of Science, the Cochrane Database, and ClinicalTrials.gov. We selected literature meeting the inclusion criteria published between 1988 and June 2014. We systematically abstracted subject matter pertaining to ethical issues in immunization studies during pregnancy. Immunization-specific ethical issues were matched and grouped into major categories and subcategories.

resultsSeventy-seven published articles met the inclusion criteria. Published articles reported findings on data that had been collected in 26 countries, the majority of which were classified as high-income or upper-middle-income nations according to World Bank criteria. Review of these publications produced 60 immunization-specific ethical issues, grouped into six major categories. Notably, many studies demonstrated limited acknowledgment of key ethical issues including the rights and welfare of participants. Additionally, there was no discussion pertaining to the ethics of program implementation, including integration of maternal immunization programs into existing routine immunization programs.

conclusionThis review of ethical issues in immunization studies of pregnant women can be used to help inform future vaccine trials in this important population. Consistent documentation of these ethical issues by investigators will facilitate a broader and more nuanced discussion of ethics in immunization of pregnant women - offering new and valuable insights for programs developed to prevent disease in newborn children in low- and middle-income countries.

Indexed as

Clinical Trials as TopicFemaleHumansPregnancyPregnant PeopleVaccinesVaccinesethicsmaternal immunizationvaccinology

Identifiers

PMID27246403
PMCPMC4994733

What OpenQuestion holds

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LicenceCC BY
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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.