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Research institutions often lack policies addressing the risks and benefits of enrolling "invested parties" such as investigators, research staff, and patient, caregiver, and community representatives (groups most affected by a disease or intervention) in studies where they have direct involvement. Invested parties may have both strong motivations to study the condition or intervention and to participate as study subjects. More guidance is needed to promote appropriate access to research participation and mitigate potential risks. This article addresses the gap in guidance by presenting an ethical framework and practical guidelines for the enrollment of invested parties. Drawing from experiences with the Researching COVID to Enhance Recovery (RECOVER) Initiative, a large multisite observational cohort study, we argue that invested parties should not be categorically excluded from enrollment in their own research studies if certain criteria are met and appropriate safeguards are in place. We underscore the need to balance inclusion with fairness, promote valid voluntary informed consent, ensure data privacy, protect scientific validity, and mitigate unique risks to invested parties as participants. Additionally, we recommend regular reporting and empirical assessment to evaluate the impact of enrolling invested parties on participants and study outcomes., (© 2024 The Authors. Ethics & Human Research, published by Wiley Periodicals LLC on behalf of The Hastings Center.)

Objective: To estimate the prevalence of post-acute sequelae of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (PASC) after infection with SARS-CoV-2 during pregnancy and to characterize associated risk factors., Methods: In a multicenter cohort study (NIH RECOVER [Researching COVID to Enhance Recovery]-Pregnancy Cohort), individuals who were pregnant during their first SARS-CoV-2 infection were enrolled across the United States from December 2021 to September 2023, either within 30 days of their infection or at differential time points thereafter. The primary outcome was PASC , defined as score of 12 or higher based on symptoms and severity as previously published by the NIH RECOVER-Adult Cohort, at the first study visit at least 6 months after the participant's first SARS-CoV-2 infection. Risk factors for PASC were evaluated, including sociodemographic characteristics, clinical characteristics before SARS-CoV-2 infection (baseline comorbidities, trimester of infection, vaccination status), and acute infection severity (classified by need for oxygen therapy). Multivariable logistic regression models were fitted to estimate associations between these characteristics and presence of PASC., Results: Of the 1,502 participants, 61.1% had their first SARS-CoV-2 infection on or after December 1, 2021 (ie, during Omicron variant dominance); 51.4% were fully vaccinated before infection; and 182 (12.1%) were enrolled within 30 days of their acute infection. The prevalence of PASC was 9.3% (95% CI, 7.9-10.9%) measured at a median of 10.3 months (interquartile range 6.1-21.5) after first infection. The most common symptoms among individuals with PASC were postexertional malaise (77.7%), fatigue (76.3%), and gastrointestinal symptoms (61.2%). In a multivariable model, the proportion PASC positive with vs without history of obesity (14.9% vs 7.5%, adjusted odds ratio [aOR] 1.65, 95% CI, 1.12-2.43), depression or anxiety disorder (14.4% vs 6.1%, aOR 2.64, 95% CI, 1.79-3.88) before first infection, economic hardship (self-reported difficulty covering expenses) (12.5% vs 6.9%, aOR 1.57, 95% CI, 1.05-2.34), and treatment with oxygen during acute SARS-CoV-2 infection (18.1% vs 8.7%, aOR 1.86, 95% CI, 1.00-3.44) were associated with increased prevalence of PASC., Conclusion: The prevalence of PASC at a median time of 10.3 months after SARS-CoV-2 infection during pregnancy was 9.3% in the NIH RECOVER-Pregnancy Cohort. The predominant symptoms were postexertional malaise, fatigue, and gastrointestinal symptoms. Several socioeconomic and clinical characteristics were associated with PASC after infection during pregnancy., Clinical Trial Registration: ClinicalTrials.gov , NCT05172024., Competing Interests: Financial Disclosure Torri D. Metz is the site PI for a Pfizer study of Paxlovid in pregnancy and was the site PI for a Pfizer study of COVID-19 vaccination in pregnancy. She has received UpToDate royalties for two topics on trial of labor after cesarean. Carmen J. Beamon disclosed receiving payments from Wellcare of North Carolina. Ann Chang's institution received payment from New York University for her efforts on this study. Kelly S. Gibson disclosed that her institution received funding from the NICHD, NHLBI, and Materna. Rachel Hess received payment from Astellas Pharmaceuticals. M. Camile Hoffman disclosed her institution received payment for her expert testimony for one medicolegal trial from Wheeler, Trigg, and Associates (a defense attorneys firm). Her institution also received payment for a disease state presentation on postpartum depression and zuranolone from SAGE/Biogen. Brenna L. Hughes disclosed receiving payments from UpToDate and Moderna. Stuart Katz disclosed payments for providing expert testimony for Venable LLP. Jennifer Hadlock has received funding (paid to institution) for retrospective studies of COVID-19 from Pfizer, Novartis, Janssen, and Gilead. Grace A. McComsey served as an advisor for Gilead and ViiVGlaxoSmithKline. Patrick Ramsey disclosed receiving royalties from UpToDate. His institution was paid by the Texas Collaborative for Healthy Mothers and Babies (TCHMB)—Texas PQC for part of his efforts. Daniel W. Skupski reports receiving payments from Organon, Inc and Cooper Surgical. Alan T.N. Tita disclosed money paid to his institution from Pfizer for his efforts in this study. Andrea Foulkes disclosed receiving past payments from Round Table, Inc. The other authors did not report any potential conflicts of interest., (Copyright © 2024 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)