Dataset Information

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

ABSTRACT:

Background

Immunization 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.

Aims

To 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.

Method

We 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.

Results

Seventy-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.

Conclusion

This 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.

SUBMITTER: Beeler JA

PROVIDER: S-EPMC4994733 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Beeler Jennifer A JA Lambach Philipp P Fulton T Roice TR Narayanan Divya D Ortiz Justin R JR Omer Saad B SB

Human vaccines & immunotherapeutics 20160531 8

<h4>Background</h4>Immunization 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.<h4>Aims</h4>To 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.<h4>Method</h4>We conducted a systematic literature review of published works per ...[more]

PMID: 27246403

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Project description:BACKGROUND:Mentoring provides mentees and mentors with holistic support and research opportunities. Yet, the quality of this support has been called into question amidst suggestions that mentoring is prone to bullying and professional lapses. These concerns jeopardise mentoring's role in medical schools and demand closer scrutiny. METHODS:To better understand prevailing concerns, a novel approach to systematic scoping reviews (SSR) s is proposed to map prevailing ethical issues in mentoring in an accountable and reproducible manner. Ten members of the research team carried out systematic and independent searches of PubMed, Embase, ERIC, ScienceDirect, Scopus, OpenGrey and Mednar databases. The individual researchers employed 'negotiated consensual validation' to determine the final list of articles to be analysed. The reviewers worked in three independent teams. One team summarised the included articles. The other teams employed independent thematic and content analysis respectively. The findings of the three approaches were compared. The themes from non-evidence based and grey literature were also compared with themes from research driven data. RESULTS:Four thousand six titles were reviewed and 51 full text articles were included. Findings from thematic and content analyses were similar and reflected the tabulated summaries. The themes/categories identified were ethical concerns, predisposing factors and possible solutions at the mentor and mentee, mentoring relationship and/or host organisation level. Ethical concerns were found to stem from issues such as power differentials and lack of motivation whilst predisposing factors comprised of the mentor's lack of experience and personality conflicts. Possible solutions include better program oversight and the fostering of an effective mentoring environment. CONCLUSIONS:This structured SSR found that ethical issues in mentoring occur as a result of inconducive mentoring environments. As such, further studies and systematic reviews of mentoring structures, cultures and remediation must follow so as to guide host organisations in their endeavour to improve mentoring in medical schools.

Project description:BackgroundPrecision medicine is growing due to technological advancements including next generation sequencing techniques and artificial intelligence. However, with the application of precision medicine many ethical and potential risks may emerge. Although, its benefits and potential harms are relevantly known to professional societies and practitioners, patients' attitudes toward these potential ethical risks are not well-known. The aim of this systematic review was to focus on patients' perspective on ethics and risks that may rise with the application of precision medicine.MethodsA systematic search was conducted on 4/1/2023 in the database of PubMed, for the period 1/1/2012 to 4/1/2023 identifying 914 articles. After initial screening, only 50 articles were found to be relevant. From these 50 articles, 24 articles were included in this systematic review, 2 articles were excluded as not in English language, 1 was a review, and 23 articles did not include enough relevant qualitative data regarding our research question to be included. All full texts were evaluated following PRISMA guidelines for reporting systematic reviews following the Joanna Briggs Institute criteria.ResultsThere were eight main themes emerging from the point of view of the patients regarding ethical concerns and risks of precision medicine: privacy and security of patient data, economic impact on the patients, possible harms of precision medicine including psychosocial harms, risk for discrimination of certain groups, risks in the process of acquiring informed consent, mistrust in the provider and in medical research, issues with the diagnostic accuracy of precision medicine and changes in the doctor-patient relationship.ConclusionEthical issues and potential risks are important for patients in relation to the applications of precision medicine and need to be addressed with patient education, dedicated research and official policies. Further research is needed for validation of the results and awareness of these findings can guide clinicians to understand and address patients concerns in clinical praxis.

Dataset Information

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

Background

Aims

Method

Results

Conclusion

Publications

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

Similar Datasets

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