# Ethics of Including Pregnant People in Clinical Trials

> **NIH NIH P30** · JOHNS HOPKINS UNIVERSITY · 2024 · $163,750

## Abstract

Project Summary
This is a supplemental application under NOT-OD-24-031 to conduct bioethics research related to inclusion
of pregnant people in tuberculosis clinical trials. Women bear a large proportion of the global tuberculosis
burden, and 250,000 pregnant women develop tuberculosis annually. Millions more pregnant people need
tuberculosis preventive therapy and/or vaccines. Despite this, almost all clinical trials of new tuberculosis
therapeutics and vaccines have excluded pregnant people from participating, resulting in a lack of evidence to
inform clinical guidelines and practice. Over the past year, our team at the Johns Hopkins TB Research
Advancement Center, working under the aegis of the USAID-funded SMART4TB Consortium, has led an
initiative to increase access for pregnant people to TB clinical trials. In collaboration with the World Health
Organization (WHO) and the IMPAACT Network, we sponsored a global consensus meeting in October 2023
to research equity for pregnant people. Over the coming year we are working with the WHO and other
partners to gain stakeholder input and develop guidance documents for inclusion of pregnant people in
research. In this supplemental application to our TRAC, we request support to conduct outreach to clinical
trialists and clinicians to identify barriers to inclusion of pregnant people in TB trials. Input from other
stakeholders is being collected by the WHO, SMART4TB, and advocacy groups. We propose to conduct in-
depth interviews with key informants from the TB research and treatment community to identify the most
important barriers to inclusion of pregnant people in trials, then use the themes that emerge to design and
implement a larger stakeholder survey for up to 300 clinicians and triallists. We will employ methods previously
used in the PHASES Project, which addressed a lack of equity for women in HIV research. Our research team
includes experts in clinical trials, bioethics, TB in women, survey research, and community advocacy. The
results of this work will support development of global guidance by the WHO, research networks, and funders.

## Key facts

- **NIH application ID:** 11064506
- **Project number:** 3P30AI168436-03S1
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** Richard E. Chaisson
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $163,750
- **Award type:** 3
- **Project period:** 2022-03-16 → 2027-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11064506

## Citation

> US National Institutes of Health, RePORTER application 11064506, Ethics of Including Pregnant People in Clinical Trials (3P30AI168436-03S1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/11064506. Licensed CC0.

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