91������Ƶ

After nearly a 50-year hiatus, there has been a resurgence of research on the use of psychedelics to treat a wide range of neuropsychiatric conditions. The FDA designated MDMA and psilocybin breakthrough therapies for PTSD and severe depression, respectively and is anticipated to approve the first psychedelic drug within the next few years. The therapeutic potential of psychedelics has been widely publicized, and patients are now inquiring about the availability and advisability of psychedelic use. Meanwhile, several US cities and both Oregon and Colorado have decriminalized or deprioritized enforcement for at least some psychedelics, with many others considering similar legislation. This growing public enthusiasm, combined with bipartisan advocacy for regulatory reform, has led to an increase in the number of companies offering private or group psychedelic retreats, often without the involvement of licensed healthcare professionals. Yet little is known about how these retreats are run, and because they typically take place in other countries, there is no oversight of their practices. Ethical concerns are mounting regarding potential for off-label and unregulated use of psychedelics without a corresponding evidence-base, leap-frogging established and safe interventions, and commercial abuse. Unchecked, such issues pose clear risk for the responsible and safe uptake of psychedelic therapies that could affect consumer safety, have legal implications, and deleteriously impact patient trust in psychiatric practice. Despite these concerns, no studies to date have systematically examined the use of psychedelics in these unregulated settings or the ethical, legal, and social implications of such use.  

The overall goal of this research is to examine the appropriate role (scope, value, and legitimacy) of healthcare gatekeeping for ensuring safe and responsible use of psychedelics. We will accomplish this by: (1)  assessing the current state of unregulated psychedelic retreats that are advertised in the U.S.; (2) examining the ethical, legal, and social implications of these programs from the perspective of those participating in them; and (3) providing recommendations for healthcare gatekeeping in the context of unregulated psychedelic retreats, informed by the results of the first two aims. 

Supported by: The Ortus Foundation

Amid today’s psychedelic renaissance, more IRBs will find themselves responsible for oversight of psychedelic research. In this gatekeeping role, IRBs must ensure appropriate participant protection without inhibiting important science. Yet neither IRB perspectives on psychedelic research nor psychedelic investigator experiences with IRBs have been studied. Through qualitative interviews with psychedelic investigators and a survey of IRB chairpersons, this project aims to promote high-quality ethics review of psychedelic research by developing empirically informed resources for both IRBs and investigators.

Supported by: The Greenwall Foundation (PI Fernandez Lynch)

Role: Collaborator (unpaid) 

Obsessive-compulsive disorder (OCD) is a debilitating psychiatric disorder. Worldwide, its prevalence is ~2% and its etiology is mostly unknown. Identifying biological factors contributing to OCD will elucidate underlying mechanisms and might contribute to improved treatment outcomes. Genomic studies of OCD are beginning to reveal long-sought risk loci, but >95% of the cases currently in analysis are of homogenous European ancestry. If not addressed, this Eurocentric bias will result in OCD genomic findings being more accurate for individuals of European ancestry than other ancestries, thereby contributing to health disparities in potential future applications of genomics.

LATINO is a new network of investigators from across Latin America, the United States, and Canada who have begun to collect DNA and clinical data from 5,000 richly-phenotyped OCD cases of Latin American ancestry in a culturally sensitive and ethical manner. This project utilizes trans-ancestry genomic analyses to accelerate the identification of OCD risk loci, fine-map putative causal variants, and improve the performance of polygenic risk scores in diverse populations. The project capitalizes on rich clinical data to examine the genetics of treatment response, biologically plausible OCD subtypes, and symptom dimensions. 

We are collaborating with the LATINO team to examine the use of psychedelics and attitudes about psychedelic assisted therapy for OCD among participants in Latin America and the U.S.

Role: Collaborator

The LATINO Project is supported by:  U01MH125050 (PI Crowley) and U01MH125062 (PI Storch), National Institute of Mental Health

As research into psychedelic assisted therapy (PAT) expands to new diagnoses and conditions, certain ethical considerations should be made to accommodate the needs and lived experiences of different groups, like neurodivergent populations. Recent studies have proposed using psychedelics as a potential therapy for individuals diagnosed with autism spectrum disorder (ASD). Before expanding PAT to this population, researchers must consider whether modifications to address behavioral, sensory, and emotional differences often experienced by autistic adults are needed. An additional consideration is the extent to which PAT impacts identity, given that autism is often viewed as a social identity. It is critical to understand the perspectives of members of the autistic community who have experience with psychedelics in medical and non-medical contexts to better understand what factors ensure harms are limited and facilitate or create a barrier to a maximally beneficial psychedelic experience for autistic adults. To this end, we are conducting semi-structured interviews with autistic adults on their experiences with psychedelics and recommendations for psychedelics in research settings.

Presentation: Cluck M, Purcell AB, Skvarkova Z, Robinson JO, Neitzke-Spruill L, McGuire AL. Perceptions and Potential Indications for Psychedelic Assisted Therapy in Autistic Adults. Psychedelic Science 2025: The Integration in Denver, CO. June 16-20, 2025.
 

The has been ongoing since 2013. The Initiative “is aimed at revolutionizing our understanding of the human brain” through the “development and application of innovative technologies” to deepen our understandings of how the brain and neural circuits interact in health and disease (The BRAIN Initiative, NIH, 2021).

Data sharing is essential to promote equity and maximize the impact of the significant public investment in the BRAIN Initiative. Data sharing plans are now required for BRAIN funding, but there is an urgent need to develop specific policies and practices that are empirically informed and address ethical challenges and concerns related to sharing human data from BRAIN research. Our own experience and research with investigators conducting BRAIN Initiative studies of closed loop or adaptive deep brain stimulation, for instance, suggests that the practice of sharing data is inconsistent and incomplete, despite broad agreement that it is important. Some ethical challenges relate to privacy, consent, the interoperability of data types and sharing platforms, and competing commercial and processional interests.

The BRAINshare Project aims to engage key stakeholders through interviews and a modified policy Delphi process to identify challenges and concerns specific to sharing human BRAIN data and to generate empirically informed policy and practice options to facilitate responsible sharing of these data.

Supported by: R01MH126937, National Institute of Mental Health (BRAIN Initiative)

Role: mPI (with Sameer Sheth, M.D., Ph.D.)

Supplement: A Case Study on Autism in Data Sharing Practices

This one-year supplement project aims to conduct a case study on ethical data sharing challenges in autism research and how to address data sharing practices that lack diversity, equity, and inclusion considerations. Data will be collected through a literature review and in-depth interviews with diverse stakeholders to explore challenges and potential solutions to address such ethical and policy challenges in data sharing. This case study will serve as an additional research input to inform the ongoing Delphi process in the BRAINshare Project and shape the Project’s broader policy recommendations.  

Supported by:  R01MH126937-03S1, National Institute of Mental Health (Research Supplement to Promote Diversity in Health-Related Research Program)

The Precision Medicine for Alzheimer’s Disease and Related Dementias Project is a joint project conducted in collaboration with the Center for Alzheimer’s and Neurodegenerative Disease (CAND) at 91������Ƶ. This project aims to integrate precision medicine (cognitive testing, genomic testing, and neuroimaging) into Alzheimer’s research and care to increase early detection of Alzheimer’s disease and related dementias (ADRD) and improve clinical outcomes. In this project, at-risk patient-participants enroll together with study partners to receive cognitive testing, genetic testing, and neuroimaging (MRI, PET), and a comprehensive profile of their risk of developing ADRD. In conjunction with CAND, the Center for Medical Ethics and Health policy is assessing the impact of precision medicine testing and disclosure on both patient-participants and their study partners to facilitate ethical and effective implementation of precision medicine disclosure.

The project is enrolling 250 patient-participants and their study partners in the Houston area. The diverse settings of the study allow us to evaluate the impact of precision medicine on a diverse community, including both English and Spanish-speaking populations.  

Patient-participants and study partners complete pre-disclosure surveys to assess their expectations around results prior to receiving them. At follow-up, both patient-participants and study partners provide information about their understanding of and reaction to their results. Study partners also provide information about their caregiver burden and gains in dementia caregiving.

Supported by: a private foundation

Role: Co-I with (Joshua Shulman, MD, Ph.D.) 

As wastewater research and monitoring programs develop and evolve beyond SARS-CoV-2 to a wide range of possible pathogens (viruses, bacteria, and protozoa), one critical challenge is determining what information ought to be shared, with whom, and how.

Wastewater research and monitoring can provide early warning of the spread of known diseases of public health importance and inform public health responses, but it can also provide highly sensitive and potentially stigmatizing information, raising ethical, legal, and social issue (ELSI), including how to communicate information in a way that maximizes benefits and builds public trust while protecting privacy and avoiding the exacerbation of health inequities. EMPOWER is an innovative embedded ELSI research project that will directly impact the development and implementation of strategies for communicating information from a statewide wastewater research and monitoring program in Texas. This project will collect critical empirical data from stakeholders and engage diverse members of the community to identify and develop strategies to address the ELSI considerations of communicating information from public health research.

The overall objective of EMPOWER is to develop a strategy for responsible reporting of information from wastewater monitoring in the state of Texas that is feasible and reflects community members’ values and perspectives. We will collaborate with the Texas Epidemic Public Health Institute (TEPHI) Wastewater Consortium (TWC) and its Action Plan Working Group to: (1) identify facilitators and barriers to results disclosure, (2) assess community members’ perspectives about results disclosures, and (3) generate evidence-based recommendations and a communication platform for community members’ review and feedback.

Supported by: R01ES036232, National Institute of Environmental Health Science, Office of the Director, National Human Genome Research Institute

Role: MPI (with Jennifer Deegan)

we're using at the beginning of focus groups we're conducting with community health workers around the state of Texas to explore their perspectives about wastewater testing. The video was developed in collaboration with Jennifer Deegan's team at UTHealth and the Texas Epidemic Public Health Institute (TEPHI).

Despite largescale government and private investment in commercializing space travel, it remains too dangerous and too impractical for most civilians.

We are working to fill critical policy gaps that advance The Translational Research Institute for Space Health (TRISH) mission of translating responsible research on commercial space travel by developing an ethical framework for involving civilians in spaceflight research and formalizing an ethics review service for TRISH researchers. This will occur through a new collaborating partnership between TRISH and the Center for Medical Ethics and Health Policy (CMEHP) at 91������Ƶ called METEORS (Mission to enhance Ethics Education, Outreach, and Research in Space). Taken together, METEORS advances the TRISH mission by developing tools to enable the ethical translation of cutting-edge biomedical research and technology development and supports education on how to proportionately balance real human risks with tangible benefits of human space exploration missions moving forward.

Supported by: TRISH’s Space Health Expeditionary Research Projects Assets (SHERPA) program

Role: mPI (with Vasiliki Rahimzadeh, Ph.D.)

Esophageal cancer is the 6th leading cause of cancer mortality worldwide. In this renewal, we will build on our prior work developing a low cost, mobile high resolution microendoscope with artificial intelligence to evaluate its performance, acceptability, feasibility and clinical impact in diverse settings in the U.S. and Brazil.

Supported by:  R01CA181275, National Cancer Institute

Role: Co-I (with Sharmila Anandasabapathy)

In 2018, the arrest of the alleged Golden State Killer made headlines around the world. He was identified using a controversial new technique called investigative genetic genealogy (IGG). This technique involves uploading crime scene DNA to genetic genealogy databases with the intention of identifying a criminal offender’s genetic relatives and, eventually, locating the offender in their family tree. Since 2018, according to one expert, IGG has helped lead to the successful identification of over 1,000 violent criminal suspects.

At the same time, the technique has been challenged by those who argue it violates fundamental privacy interests of database participants and their families. Some believe that these privacy concerns are so compelling that IGG threatens to undermine public participation in clinical and research genetic databases, especially those maintained by the government.
Past studies—including our own—have demonstrated that individuals are concerned about genetic privacy, yet they are willing to share their genetic data with certain individuals, for particular reasons, and under specific conditions. But all of these studies pre-date IGG and none probed participation by law enforcement in genetic genealogy or other recreational genetic databases. Understanding the complex trade-offs that the public makes when assessing the value and acceptability of law enforcement use of genetic data will be important in ensuring that IGG-relevant policies and practices that are adopted strike a balance between safety and privacy that is acceptable to the public.

This project involves: (1) qualitative interviews to characterize and forecast law enforcement participation in genetic genealogy databases, (2) focus groups and a discrete choice experiment to measure preferences related to law enforcement participation in genetic genealogy databases, and (c) a modified policy Delphi to develop best practices related to law enforcement participation in genetic genealogy databases.
Additional project materials available at: .

Supported by: R01HG011268, National Human Genome Research Institute
FORENSEQ is a trademark of Verogen, Inc. and Qiagen, N.V. The ForenSeq Study is not affiliated with the FORENSEQ mark.

Role: mPI (with Christi Guerrini)

Supplement: IGG on the Internet: Characterizing Public Perspectives on Law Enforcement Use of Genetic Genealogy Data in Social Media  

This supplement builds on the ForenSeq Project to collect and analyze social media coverage of IGG. 
Supported by: R01HG011268-S1, National Human Genome Research Institute

Role: mPI (with Christi Guerrini; Supplement lead: Sarah Katsanis)

Humans are remarkable hosts to microbes, and we have in fact co-evolved as highly plethoric communities. Human-associated microorganisms (the "microbiome") are present in numbers exceeding the quantities of human cells by at least 10-fold beginning in the neonatal period The collective genome (the "metagenome") exceeds our human genome in terms of gene content by more than 150-fold. With respect to microbiota and preterm birth, it has generally assumed that the majority of intrauterine infections originate in the lower genital tract, with microbiota ascending into the otherwise sterile intrauterine environment to infect the placenta (preterm birth), fetal membranes (chorioamnionitis), umbilical cord (funisitis), and the fetus (sepsis). However, we and others have recently demonstrated that (1) the vaginal and gut microbiome communities are distinctly structured in pregnancy, and (2) the placenta is in fact not sterile, but rather harbors a low-abundance microbiome which is likely acquired through hematogenous transmission of the oral microbiome. Based on our prior studies and preliminary data, our central hypothesis is that a distinct and largely commensal resident microbiome in pregnancy renders risk for preterm birth. In order to prove this hypothesis, we will execute three essential aims: Aim 1 will use 16S-based approaches with inferred metagenomics employing samples from at-risk gravidae enrolled at <20 weeks gestation to reveal distinct microbial communities which occur in association with preterm birth; Aims 2&3 will use whole-genome shotgun sequencing with integrated host genomics, metatranscriptomics, and metabolomics to build on our functional computational pipelines and enable species identification, microbial gene catalogues, metabolic reconstructions, and mechanisms and networks of susceptibility to preterm birth. In addition, we describe our concomitant efforts to build a community resource for future large-scale studies on host and microbe biomarkers acquired in this set of preterm, near term, and term births. By utilizing our state-of-the-science technology and analysis tools in a longitudinal case-cohort of preterm birth subjects, we will be able to transform "discovery based" metagenomics and multi'omics science into readily translatable mechanistic studies at a previously unparalleled level. Our proven ability to execute such clinical studies and utilize high-throughput technologies makes such large-scale "team science" feasible. Because preterm birth is prevalent in both the developed and developing world, these studies are of broad significance to our population's disease burden and will lead to potential innovative interventions.

Supported by: R01 NR014792, National Institute of Nursing Research (PI Aagaard-Tillery)
Role: Co-I

This project aimed to increase our understanding of the microbes that reside in the intestines of healthy children and children with various intestinal disorders. The findings enabled scientists to determine the nature of beneficial microbial populations in intestines of healthy children, and whether specific differences in groups of microbes may contribute to diseases in children. Ultimately, the discoveries from this project may allow physicians to manipulate microbes in the intestine in order to promote health and cure or prevent disease.

Supported by: UH3DK083990, National Institute of Diabetes and Digestive and Kidney Diseases 
Role: Co-I (with PI James Versalovic, M.D., Ph.D.)

The Human Microbiome Project (HMP) is a large study to learn more about the collections of bacteria, viruses and other tiny organisms that live in and on our bodies. We interviewed three groups: (1) those who were asked to participate in the HMP but declined, to explore why, (2) those who decided to participate in the HMP, to explore their thoughts about and their experience with participating in the project, and (3) scientists who were conducting the HMP, to understand what ethical or social issues come with this research. We also hosted a workshop with members of our research team, study participants, and outside experts to discuss the issues that were identified in the interviews and develop recommendations for managing them.

Supported by: R01HG004853, National Human Genome Research Institute 
Role: PI: