About

Steven Joffe, MD, MPH, is the Art and Ilene Penn Professor of Medical Ethics & Health Policy at the University of Pennsylvania Perelman School of Medicine. He is a member of the Abramson Cancer Center and the Institute for Translational Medicine and Therapeutics (ITMAT). Dr. Joffe serves as a Senior Fellow at the Leonard Davis Institute and is the Director of the Postdoctoral T32 Training Program in the Ethical, Legal, and Social Implications (ELSI) of Genetics and Genomics at the university. He has held the positions of Interim Chair (2019-2022) and Chair (2022-present) of the Department of Medical Ethics and Health Policy at Perelman School of Medicine. His research focuses on medical ethics, health policy, and the ethical considerations surrounding genetics and genomics. Dr. Joffe has contributed extensively to the field through his work on the ethics of heritable human genome editing, stakeholder responsibilities in clinical trials, and the regulation of oncology therapies, among other topics.

Research topics

• Political Science
• Computer Science
• Psychiatry
• Engineering
• Medicine
• Engineering ethics
• Public relations
• Law
• Sociology
• Business
• Biology
• Pathology
• Virology
• Family medicine
• Computational biology
• Genetics
• Psychology
• Data science
• Internet privacy

Selected publications

• How Variants of Uncertain Significance Impact Clinical Decisions: A Systematic Review

  Genetics in Medicine · 2026-05-01

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  PublisherDOI

• Hypertension in a randomized trial of dolutegravir- versus efavirenz-based antiretroviral therapy in pregnant and postpartum women with HIV

  Clinical Infectious Diseases · 2026-04-09

  article

  INTRODUCTION: We performed an analysis of incident hypertension in a randomized trial comparing dolutegravir(DTG)+emtricitabine(F)/tenofovir alafenamide(TAF) vs DTG+F/tenofovir disoproxil fumarate(TDF) vs efavirenz(EFV)/F/TDF in pregnant and postpartum women with HIV. METHODS: Women were randomized at 14-28 weeks gestational age (GA) to start DTG+F/TAF, DTG+F/TDF, or EFV/F/TDF and followed through 50 weeks postpartum. The composite incident hypertension outcome was defined as initiation of antihypertensive medication or ≥2 elevated blood pressures categorized as: elevated (130-139 and/or 80-89mmHg), mild (140-159 and/or 90-99mmHg), moderate (≥160-179 and/or ≥100-109mmHg), severe (≥180 and/or ≥110mmHg). Incident gestational hypertension was defined by initiation of antihypertensive medication or ≥2 blood pressures ≥140 and/or ≥90mmHg at ≥20 weeks GA with resolution by 12 weeks postpartum. Cox proportional hazard models were used for by-arm comparisons of the composite outcome and to look for the effect of weight change within arm. RESULTS: Of 626 women without baseline hypertension (median age 26.6 years), the composite incident outcome occurred in 49% (n=308), predominantly due to the incident elevated category of elevated blood pressure, with no significant differences by arm, although hypertension was numerically more likely in the DTG arms. Each additional 5kg of weight was associated with an 8-17% higher hazard of the composite hypertension outcome. Twenty-seven participants (4.3%) had gestational hypertension with no apparent differences between arms. CONCLUSIONS: Our data contribute information regarding the safety of DTG-based ART and TAF in pregnant and postpartum women and highlight the importance of monitoring weight and performing hypertension screening as part of maternal health care for young women with HIV.

  PublisherDOI

• Response to Sansom et al

  Genetics in Medicine · 2026-01-01

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  PublisherDOI

• Specificity of Food and Drug Administration postmarketing requirements and associations with timely submissions and regulatory decisions for oncology accelerated approvals, 2011–2023: a cross-sectional analysis

  BMJ Oncology · 2025-05-01

  articleOpen access

  Objectives: To assess the specificity of postmarketing requirement (PMR) statements and associations between PMR statement specificity and PMR study characteristics, timeliness and regulatory decisions. Methods and analysis: This was a cross-sectional analysis of publicly available Food and Drug Administration (FDA) databases to characterise PMR statements for oncology accelerated approvals (AAs) between January 2011 and July 2023. Characteristics of trials supporting AA and PMR studies were identified from product labels on the Drugs@FDA database and ClinicalTrials.gov. Main outcomes and measures included PMR statement characteristics, PMR study submission timeliness (on-time vs late) and regulatory decision (regular approval vs withdrawal). Results: We analysed 181 PMR statements for 161 oncology indications. Most PMR statements specified target population (98%), endpoints (81% (44% included clinical endpoints; 37% surrogate endpoints only)), use of randomisation (63%) and comparator (54%). Fewer PMR statements specified a particular trial or protocol (45%), follow-up duration (30%), enrolment targets (26%), multicentre trial (24%), double-blinding (13%) or enrolment diversity (8%). PMR statements for indications granted regular approval were more likely than those for withdrawn indications to specify follow-up duration <1 year (27% vs 0%, p<0.001), allow endpoints other than overall or progression-free survival (27% vs 4%, p=0.01) and mention a specific trial or protocol (71% vs 36%, p=0.003). Compared to those submitted late, on-time PMR studies had fewer sites (110 vs 156, p=0.03), less use of blinding (20% vs 42%, p=0.02), more use of a continuous trial for AA and PMR (37% vs 8%, p=0.003) and more use of primary endpoints other than overall or progression-free survival (37% vs 6%, p<0.001). Conclusion: PMR statement specificity for oncology AAs varies substantially. Less rigorous PMR statement and study characteristics were associated with timely PMR study submission and transition to regular approval but with important trade-offs. Given that AAs are granted without demonstrated clinical benefit, improving the balance between PMR study timeliness and rigour should be a priority when negotiating PMR statements.

  PublisherOA PDFDOI

• How Neonatologists Use Genetic Information

  The Journal of Pediatrics · 2025-02-13 · 1 citations

  articleOpen access
  PublisherOA PDFDOI

• Advancing Trust in Science: Institutional Obligations to Promote Research Integrity

  The Journal of Law Medicine & Ethics · 2025-01-01

  articleSenior author

  Abstract Preventing and addressing research misconduct demands more than imploring scientists to do better. It is also essential to address the structural issues that allow misconduct to flourish. With these structural factors in mind, this Special Issue explores the institutional obligations of journals and publishers, research institutions, funders, and the government to promote scientific integrity and advance trust in science. Articles from researchers affected by fraud, science “sleuths,” systematic reviewers, journal editors, academic officials, regulators, and leading experts on research integrity offer a range of ideas for responding to the research misconduct crisis, including increased transparency, stronger journal processes for review and retraction, improved scientific lab culture, and efforts to hold investigators prospectively accountable for scientific integrity, among several others.

  PublisherDOI

• Parents’ perceptions of the utility of genetic testing in the NICU

  Genetics in Medicine · 2025-02-19 · 4 citations

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  PublisherDOI

• Weight Changes and Adverse Pregnancy Outcomes With Dolutegravir- and Tenofovir Alafenamide Fumarate–Containing Antiretroviral Treatment Regimens During Pregnancy and Postpartum

  UNC Libraries · 2025-01-06 · 1 citations

  articleOpen access

  BACKGROUND: We evaluated associations between antepartum weight change and adverse pregnancy outcomes and between antiretroviral therapy (ART) regimens and week 50 postpartum body mass index in IMPAACT 2010. METHODS: Women with human immunodeficiency virus (HIV)-1 in 9 countries were randomized 1:1:1 at 14-28 weeks' gestational age (GA) to start dolutegravir (DTG) + emtricitabine (FTC)/tenofovir alafenamide fumarate (TAF) versus DTG + FTC/tenofovir disoproxil fumarate (TDF) versus efavirenz (EFV)/FTC/TDF. Insufficient antepartum weight gain was defined using Institute of Medicine guidelines. Cox-proportional hazards regression models were used to evaluate the association between antepartum weight change and adverse pregnancy outcomes: stillbirth (≥20 weeks' GA), preterm delivery (<37 weeks' GA), small size for GA (<10th percentile), and a composite of these endpoints. RESULTS: A total of 643 participants were randomized: 217 to the DTG + FTC/TAF, 215 to the DTG + FTC/TDF, and 211 to the EFV/FTC/TDF arm. Baseline medians were as follows: GA, 21.9 weeks; HIV RNA, 903 copies/mL; and CD4 cell count, 466/μL. Insufficient weight gain was least frequent with DTG + FTC/TAF (15.0%) versus DTG + FTC/TDF (23.6%) and EFV/FTC/TDF (30.4%). Women in the DTG + FTC/TAF arm had the lowest rate of composite adverse pregnancy outcome. Low antepartum weight gain was associated with higher hazard of composite adverse pregnancy outcome (hazard ratio, 1.44 [95% confidence interval, 1.04-2.00]) and small size for GA (1.48 [.99-2.22]). More women in the DTG + FTC/TAF arm had a body mass index ≥25 (calculated as weight in kilograms divided by height in meters squared) at 50 weeks postpartum (54.7%) versus the DTG + FTC/TDF (45.2%) and EFV/FTC/TDF (34.2%) arms. CONCLUSIONS: Antepartum weight gain on DTG regimens was protective against adverse pregnancy outcomes typically associated with insufficient weight gain, supportive of guidelines recommending DTG-based ART for women starting ART during pregnancy. Interventions to mitigate postpartum weight gain are needed.

  PublisherDOI

• A Framework for Assessing the Permissibility of Academic Leaders’ Outside Activities

  Milbank Quarterly · 2025-06-04

  articleOpen access

  Policy Points Many have urged academic institutions to rethink conflict of interest policies governing leaders' outside activities, which pose not only individual conflicts for leaders themselves but institutional conflicts for their academic employers. Although the American Association of Medical Colleges and Association of American Universities have provided guidance on managing such conflicts, neither offer a structured approach for determining when and under what conditions it is appropriate for a leader to engage in specific outside activities. To address this gap, this article develops a decision-making framework that institutional oversight bodies can use to assess the permissibility of academic leaders' proposed outside activities.

  PublisherOA PDFDOI

• Germline Cancer Predisposition Results From the National Cancer Institute—Children's Oncology Group Pediatric MATCH Trial

  JCO Precision Oncology · 2025-10-01 · 3 citations

  articleOpen access

  PURPOSE Precision oncology trials have generally focused on tumor testing to identify actionable alterations. The National Cancer Institute—Children's Oncology Group Pediatric MATCH trial incorporated return of germline results to assess feasibility of reporting in a cooperative group setting and characterize germline cancer predisposition in patients with refractory cancers. PATIENTS AND METHODS Tumor and blood DNA from patients 1-21 years of age with treatment-refractory solid tumors, non-Hodgkin lymphomas, or histiocytic disorders underwent cancer gene panel sequencing. Clinical germline reports returned to 151 study sites included pathogenic/likely pathogenic (P/LP) germline variants found in 38 cancer predisposition genes (CPGs). European Society of Medical Oncology (ESMO) recommendations for germline follow-up of tumor variants in CPGs were assessed. RESULTS Both tumor and germline reports were completed for 1,167 patients (87.5% of enrolled). A total of 295 tumor reports (25%) included 361 CPG variants of which 70 variants (19.4%) were found in the germline sample. Three additional germline-only CPG variants resulted in 73 (6.3%) of 1,167 germline reports containing variants across 21 CPGs previously associated with pediatric and/or adult cancers. Among frequently mutated CPGs in tumors, concurrent germline findings ranged from 8/32 NF1 (25.0%) and 25/163 TP53 (15.3%) to zero of 27 ALK and 18 PTEN tumor variants. ESMO guidelines recommended clinical follow-up for 110 (30.5%) of 361 tumor CPG variants which included 40 (57.1%) of 70 germline variants. CONCLUSION Coordinated germline and tumor panel testing was feasible and revealed P/LP CPG variants in 6.3% of the Pediatric MATCH cohort. Tumor variant fraction, germline association of CPG with tumor type, and adult-oriented guidelines were not predictive of germline status, emphasizing the need for systematic germline follow-up after tumor genomic testing for pediatric patients.

  PublisherDOI

Recent grants

• Shared Resource Core

  NIH · $40.3M · 2010–2026

• NIH Grant R01HG005083

  NIH · $1.4M · 2014

• NIH Grant K01CA096872

  NIH · $721k · 2007

• Penn Postdoctoral Training Program in the Ethical, Legal and Social Implications of Genetics and Genomics

  NIH · $3.1M · 2017–2027

Frequent coauthors

• Conrad V. Fernandez

  Dalhousie University

  121 shared

• Yoram Unguru

  Johns Hopkins Berman Institute of Bioethics

  113 shared

• Catherine Woodman

  University of Iowa

  101 shared

• Stacey L. Berg

  Mayo Clinic

  100 shared

• Kim Pyke-Grimm

  100 shared

• M. Brooke Bernhardt

  St. Jude Children's Research Hospital

  100 shared

• Stacy W. Gray

  City of Hope

  86 shared

• Sharon E. Plon

  Baylor College of Medicine

  67 shared

Labs

• Medical Ethics and Health PolicyPI

Education

• B.A., Fine Art

  Harvard College

  1988

• M.D.

  University of California, San Francisco School of Medicine

  1992

• Other, Epidemiology

  University of California, Berkeley

  1996

Awards & honors

• Art and Ilene Penn Professor of Medical Ethics & Health Poli…
• Member, Abramson Cancer Center
• Member, Institute for Translational Medicine and Therapeutic…
• Senior Fellow, Leonard Davis Institute
• Director, Postdoctoral T32 Training Program in the Ethical,…