The Pathway Forward : Insights on Factors that Facilitate Research with Pregnant Women
© 2020 by The Hastings Center. All rights reserved..
The near-routine exclusion of pregnant women from clinical research has resulted in evidence gaps that endanger the health of pregnant women and their future offspring. Although existing literature documents numerous obstacles along the clinical trial pathway that can stymie research involving pregnant women, there is little guidance on how to facilitate such research. This qualitative study aims to fill that void by examining the experiences of individuals involved in conducting, approving, or overseeing research involving pregnant women at one academic institution. The study identifies factors throughout the clinical pathway-from protocol development, to IRB review, and ultimately trial execution-that likely contribute to the successful conduct of research with pregnant women. Attention to those factors, coupled with agreement among stakeholders that research with pregnant women should and can be done ethically and legally, is critical to shifting the narrative from "why we cannot" do such research to "how we can.".
| Errataetall: |
ErratumIn: Ethics Hum Res. 2020 Sep;42(5):16. - PMID 32937034 |
|---|---|
| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2020 |
|---|---|
| Erschienen: |
2020 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:42 |
|---|---|
| Enthalten in: |
Ethics & human research - 42(2020), 4 vom: 07. Juli, Seite 2-16 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Mastroianni, Anna C [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Clinical trials |
|---|
| Anmerkungen: |
Date Completed 08.04.2021 Date Revised 08.04.2021 published: Print ErratumIn: Ethics Hum Res. 2020 Sep;42(5):16. - PMID 32937034 Citation Status MEDLINE |
|---|
| doi: |
10.1002/eahr.500058 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM312488378 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM312488378 | ||
| 003 | DE-627 | ||
| 005 | 20231225144523.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231225s2020 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1002/eahr.500058 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1041.xml |
| 035 | |a (DE-627)NLM312488378 | ||
| 035 | |a (NLM)32672419 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Mastroianni, Anna C |e verfasserin |4 aut | |
| 245 | 1 | 4 | |a The Pathway Forward |b Insights on Factors that Facilitate Research with Pregnant Women |
| 264 | 1 | |c 2020 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 08.04.2021 | ||
| 500 | |a Date Revised 08.04.2021 | ||
| 500 | |a published: Print | ||
| 500 | |a ErratumIn: Ethics Hum Res. 2020 Sep;42(5):16. - PMID 32937034 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2020 by The Hastings Center. All rights reserved. | ||
| 520 | |a The near-routine exclusion of pregnant women from clinical research has resulted in evidence gaps that endanger the health of pregnant women and their future offspring. Although existing literature documents numerous obstacles along the clinical trial pathway that can stymie research involving pregnant women, there is little guidance on how to facilitate such research. This qualitative study aims to fill that void by examining the experiences of individuals involved in conducting, approving, or overseeing research involving pregnant women at one academic institution. The study identifies factors throughout the clinical pathway-from protocol development, to IRB review, and ultimately trial execution-that likely contribute to the successful conduct of research with pregnant women. Attention to those factors, coupled with agreement among stakeholders that research with pregnant women should and can be done ethically and legally, is critical to shifting the narrative from "why we cannot" do such research to "how we can." | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a clinical trials | |
| 650 | 4 | |a human subjects research | |
| 650 | 4 | |a institutional review board (IRB) | |
| 650 | 4 | |a pregnant research participants | |
| 650 | 7 | |a Prescription Drugs |2 NLM | |
| 700 | 1 | |a Franceschini, Robert |e verfasserin |4 aut | |
| 700 | 1 | |a Wicks, Sarah L |e verfasserin |4 aut | |
| 700 | 1 | |a Henry, Leslie Meltzer |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Ethics & human research |d 2019 |g 42(2020), 4 vom: 07. Juli, Seite 2-16 |w (DE-627)NLM293701296 |x 2578-2363 |7 nnns |
| 773 | 1 | 8 | |g volume:42 |g year:2020 |g number:4 |g day:07 |g month:07 |g pages:2-16 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1002/eahr.500058 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 42 |j 2020 |e 4 |b 07 |c 07 |h 2-16 | ||