Caleigh Propes (she/her)
@CaleighPropes
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PhD Student in Bioethics & Health Policy @JohnsHopkinsSPH/ @Yale alum/ research ethics, FDA policy / Kentuckian/ opinions my own
Baltimore, MD
Joined October 2021
New article published in @JAMAHealthForum that examines and critiques 4 aspects of the current pathwork of regulations covering access to psychedelics––and then provides constructive, sensible, and actionable ways forward for each. Work led by drug policy expert @CaleighPropes
Was a lot of fun to work on "Gaps in US Psychedelic Policy and How to Close Them" led by @CaleighPropes, with @ExistWell, @MattDEisenberg
https://t.co/bWJdEDcWf2
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We outline 4 issues exacerbated by the current patchwork of health policies governing access to psychedelics – 1) misleading advertising, 2) unsafe self-directed psychedelic use, 3) informed consent, & 4) coverage & payment– & offer some recommendations.
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Was a lot of fun to work on "Gaps in US Psychedelic Policy and How to Close Them" led by @CaleighPropes, with @ExistWell, @MattDEisenberg
https://t.co/bWJdEDcWf2
jamanetwork.com
This Viewpoint discusses how to fill policy gaps surrounding the use of psychedelics to treat mental health and substance use conditions, should they be approved by the US Food and Drug Administrat...
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With @CaleighPropes, we expand upon how social value is communicated to participants in psychedelic clinical trials in a short commentary, in response to Earl et al's target article "The Social Value Misconception in Clinical Research" (both linked below)
New paper thread! 🧵 Many have called for “enhanced” informed consent documents (ICD) for psychedelic research & treatments, with growing calls for tailored ICDs in the psychedelic bioethics lit. But how closely do ICDs in psychedelic clinical trials reflect these proposals?
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With @CaleighPropes, @MariannaGrazz, Kyle Patch & @ExistWell, we reviewed ICDs from psilocybin clinical trials across the U.S., and provided a systematic qualitative description of these ICDs.
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New paper thread! 🧵 Many have called for “enhanced” informed consent documents (ICD) for psychedelic research & treatments, with growing calls for tailored ICDs in the psychedelic bioethics lit. But how closely do ICDs in psychedelic clinical trials reflect these proposals?
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🧠 Three or more neurology drugs have garnered expedited FDA approvals, sometimes conflicting with advisory panel recommendations. Experts call for more attention to the process between FDA panelists and industry. @washumedicine @AANMember #NeuroTwitter
https://t.co/KEV5EQNMbM
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We’re happy to share HOPE’s (@psychedelethics) response to the PATH Caucus’s Request for Information (RFI) on psychedelics. Our response, linked below, highlights key considerations for the field. @Katherine_Chg, @CaleighPropes, @eddietalksdrugs, @briandavidearp, & @ExistWell
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With @CaleighPropes, @eddietalksdrugs, @briandavidearp & @ExistWell, we’re happy to share HOPE’s (@psychedelethics) response to the PATH Caucus's Request for Information (RFI) on psychedelic research for mental health (linked below) 🧵
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Sharing aggregate results from pragmatic clinical trials presents ethical & logistical considerations that are distinct from conventional clinical trials, argues Stephanie Morain and colleagues. @smorain @Collaboratory1 @SCTorg #clinicaltrials
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Viewpoint: @CaleighPropes, Kayla Mehl, and @SMorain explore the potential of pragmatic clinical trials to improve demographic representativeness and health equity in clinical research. https://t.co/KdXvnKyqIp
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Ethical considerations for sharing aggregate results from pragmatic clinical trials - Stephanie R Morain, Abigail Brickler, Joe Ali, Pearl O’Rourke, Kayte Spector-Bagdady, Benjamin Wilfond, Vasiliki Rahimzadeh, Caleigh Propes, Kayla Mehl, David Wendler
journals.sagepub.com
A growing literature has explored the ethical obligations and current practices related to sharing aggregate results with research participants. However, no pri...
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Viewpoint: @CaleighPropes, Kayla Mehl, and @SMorain explore the potential of pragmatic clinical trials to improve demographic representativeness and health equity in clinical research. https://t.co/feC7cu9HrM
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Untapped Potential? Representativeness in Pragmatic Clinical Trials | Research, Methods, Statistics - By Caleigh Propes, Kayla Mehl, & Stephanie R. Morain | JAMA
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A study co-authored by HPM Doctoral Student @Katherine_Chg aims to identify key elements of an optimal genetic nondiscrimination policy and inform policymakers as they seek to reduce anxieties related to genetic nondiscrimination. Learn more:
jamanetwork.com
This consensus statement examines genetic discrimination worldwide and identifies issues to be addressed by policymakers.
The study highlights the need for binding regulations grounded in human rights to address genetic discrimination.
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In our new Special Communication, we argue that ethics oversight for #pragmatictrials needs to be fit-for-purpose @bermaninstitute @BSPH_HPM
This Special Communication examines the evolution of ethical oversight for clinical research, highlighting the need for a more nuanced approach to IRB review and informed consent. https://t.co/1wQwhrezyE
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Thrilled to have worked on this with amazing co-authors @briandavidearp @ExistWell @KRPatch - paper thread soon! Tldr: psychedelics may appear unusual or unique, & their ethical issues exceptional. But might they be more similar to other interventions than first meets the eye?
New work led by @Katherine_Chg, forthcoming in AJOB: Distinctive but not Unique: The Risks of Psychedelic Ethical Exceptionalism https://t.co/Ij8GuIWVL0
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Viewpoint from @RKMetcalfe and @jayjhpark1: @US_FDA is mandating diversity action plans for trial sponsors but focusing on enrollment quotas could lead to token-istic efforts. https://t.co/ZDM3eoW4yP
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In a new article from our Ethics and Regulatory Core, coauthors @CaleighPropes, @SMorain, and Pearl O'Rourke discuss the key recurring and emerging challenges for pragmatic clinical trials. ➡️
rethinkingclinicaltrials.org
In an invited commentary published this month in Circulation: Cardiovascular Quality and Outcomes, authors from the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core describe the...
Embedded pragmatic clinical trials (ePCTs) can present new challenges and complicate familiar ethical issues in research @SMorain @CaleighPropes @Collaboratory1 #AHAJournals
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Recurring and Emerging Ethical Issues in Pragmatic Clinical Trials by Caleigh Propes, Pearl O'Rourke, Stephanie Morain | Circulation: Cardiovascular Quality and Outcomes
ahajournals.org
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