I am a bioethicist with more than 15 years’ experience within academic medicine. My areas of expertise include: medical and research ethics, human subjects protection regulation, decision-making for research participation, research literacy, global health research, disaster medicine and emergency medicine research. I serve as an IRB Chair for the Program for the Protection of Human Subjects (PPHS) at Mount Sinai and am on faculty with the Department of Environmental Medicine and Public Health. My role at PPHS involves advocacy for study participants. In addition, I serve as a resource for scientific and lay communities on matters pertaining to human subjects research regulation and ethics.
Postdoctoral Research Training
09/2000 – 04/2001: NIH Short Course on Racial and Ethnic Minorities, Bethesda, MD. Research Subjects: Challenges for Research Ethics. Tuskegee, AL
American Association for the Advancement of Science, Tuskegee University and the University of Wisconsin, Primary Mentor: Not Applicable
08/2003 – 05/2004: Certificate Program, Bioethics and Medical Humanities, New York, NY, New York University-Montefiore Medical Center. Primary Mentors: Nancy Neveloff Dubler, LLB; Tia Powell, MD
- Leadership Award, National Audubon Society, 05/1977
- General Academic Scholarship, Teachers College, Columbia University, 09/1982 - 05/1986
- Award of Excellence as Research Director, Department of Emergency Medicine, Mount Sinai School of Medicine, 06/2002
Peer Reviewed Original Contributions
Mildvan D, Machado SG, Wilets I, Grossberg SE. Endogenous interferon and triglyceride concentrations to assess response to zidovudine in AIDS and advanced AIDS-related complex. The Lancet, 1992; 339: 453-56. This high impact paper presents research designed to improve the evaluation of new antiretroviral drugs for the acquired immune deficiency syndrome (AIDS). Two sensitive biological markers, endogenous interferon (E-IFN) and serum triglycerides (TG) were studied to determine whether either accurately predicted response to AIDS treatment. Dr. Wilets served as one of two statisticians on this project, contributing significantly to the interpretation of data and presentation of findings.
Schlesinger MH, Wilets IF, Nagler HM. Treatment outcome after varicocelectomy: A critical analysis. Urol Clin North Am, 1994 Au;21 (3): 517-29 Review.
- Salomon N, Perlman DC, DePalo VA, Kolokathis A, Wilets I. Drug-resistant tuberculosis: factors associated with rise in resistance in an HIV-infected urban population. Mt Sinai J Med, 1994; 61(4): 341- 348.
- Levine S, Byrne K, Wilets I, Fraser M, Leal D, Kato K. Competency of geropsychiatric patients to consent to voluntary hospitalization. Am J Geriatr Psychiatry, 1994; 2(4):300-308.
- Levetan CS, Salas JR, Wilets I, Zumoff B. Impact of endocrine and diabetes team consultation of hospital length of stay for patients with diabetes. Am J Med, 1995; 99:22-28.
- Westreich L, Levine S, Ginsburg P, Wilets I. Patient knowledge about electroconvulsive therapy: Effect of an informational video. Convuls Ther, 1995; 11(1):32-37.
- Lugay M, Otto G, Kong M, Mason D, Wilets I. Recovery time and safe discharge of endoscopy patients after conscious sedation. Gastroenterol Nurs, 1996; 19(6):194-200.
- Topsis J, Kandall S, Weinstein J, Wilets I. Tolerance of initial diphtheria-tetanus-pertussis immunization in preterm infants, J Perinatol, 1996; 16(2 Pt 1):98-102.
- Bialer PA, Wallack JJ, Prenzlauer SL, Bogdonoff L. Wilets I. Psychiatric co-morbidity among hospitalized AIDS patients vs. non-AIDS patients referred for psychiatric consultation. Psychosomatics, 1996; 37(5) 469-475.
- Freudenberg N, Wilets I, Green MB, Richie BE. Linking women in jail to community services: Factors associated with re-arrest and retention of drug-using women following release from jail. J Am Med Womens Assoc. 1998 Spring; 53(2):89-93.
- Kalman D, Colker CM, Stark R, Minsch A, Wilets I, Antonio J. Effect of pyruvate supplementation on body composition and mood. Current Therapeutic Research, 1998; 59 (11): 793-802.
- Argiris A, Mathur-Wagh U, Wilets I, Mildvan D. Abnormalities of serum amylase and lipase in HIV-positive patients. Am J Gastroenterol, 1999; 94(5):1248-1252. on body composition and mood. Current Therapeutic Research, 1998; 59 (11): 793-802.
- Kalman D, Colker CM, Wilets I, Roufs JB, Antonio J. The effects of pyruvate supplementation on body composition in overweight individuals. Nutrition, 1999; 15(5):337-340.
- Nassisi D, Bruns J, Baumlin K, Wilets I, Jagoda A. Out-of-hospital management of stroke: Surveying local practice with implication for change. Acad Emerg Med, 2000; 7(3):402-405.
- Wilets I, O’Rourke M, Nassisi D. How patients and visitors to an urban emergency department view clinical research. Acad Emerg Med, 2003; 10(10):1081-1085. Dr. Wilets conceived of the research for this first author publication assessing views about clinical research among a diverse group of patients and visitors presenting to the Mount Sinai Emergency Department. After moderating two focus groups, Dr. Wilets developed a 27-item structured interview, and along with co-investigators, interviewed a total of 172 individuals. Dr. Wilets conducted the data analysis and interpreted results with the investigative team. She assumed primary responsibility in writing the Methods, Results and Discussion sections of the manuscript.
- Richardson LD, Gunnels MD, Groh WJ, Peberdy MA, Pennington S, Wilets I, Campbell V. Van Ottingham L, McBurnie MA; PAD Trial Investigators. Implementation of community-based public access defibrillation in the PAD trial. Acad Emerg Med, 2005; 12(8): 688-97.
- Richardson LD, Wilets I, Fish-Ragin D, Holohan J, Smirnoff M, Rhodes R, Winkel G, Rodriguez R, Ricci E. Research without consent: Community perspectives from the Community VOICES Study. Acad Emerg Med, 2005;12 (11):1082-1090. The primary aim of this research was to explore community attitudes regarding the federal regulation that allows for investigators to conduct emergency research without obtaining prospective informed consent from research participants or surrogates. Dr. Wilets worked closely with the Principal Investigator, Dr. Lynne Richardson, in developing the design of the study, and moderated a number of focus groups with community members. She actively participated in the content analysis of focus group data, as well as in writing and refining the Results and Discussion sections of the publication.
- Wilets I, Schears RM, Gligorov N. Communicating with subjects: Special Challenges for resuscitation research. Acad Emerg Med, 2005; 12(11):1060-1063. In May 2005, Academic Emergency Medicine sponsored a one-day consensus conference in New York entitled, “The Ethical Conduct of Resuscitation Research”. In this first author publication, Dr. Wilets reports findings from a breakout session within this conference, in which she and a panel of experts developed “consensus statements” about the conduct of resuscitation research; the methodological and ethical challenges related to informed consent, and how to surmount them. Dr. Wilets assumed primary responsibility for writing the manuscript Background and Discussion sections.
- Christie J., Nassisi D, Wilets I, DuHamel KN, Winkel G, Hilliard R, Jandorf L. Assessing endoscopic colorectal screening adherence in an emergency department population. J Natl Med Assoc, 2006; 98(7):1095-1101.
- Ra‘gin D, Lu E, Wilets I, Holohan J, Rhodes R, Smirnoff M, Winkel G. Defining the ‘Community’ in community consultation for emergency research: Findings from the Community VOICES study. Acad Emerg Med, 2006; 13 (5 suppl 1) S145
- Wilets I, Ragin D, Holohan J, Rhodes R, Smirnoff M, Winkel G, Ricci E. Do research participants trust clinical investigators? Findings from the Community VOICES study. Acad Emerg Med, 2006 13 (5 suppl 1) S100. The Community VOICES study was designed to understand how members of the East Harlem community view the prospect of a waiver of informed consent for research conducted in emergency situations. This paper presents a subset of data collected from Community VOICES, addressing the topic of “medical mistrust”. Dr. Wilets analyzed responses to items examining trust and distrust of clinical researchers, and of the medical establishment at large. She assumed a leadership role in the writing of Methods, Results, and Discussion sections for this journal supplement.
- Richardson LD, Holohan J, Wilets I, Ragin D, Rhodes R, Smirnoff M, Winkel G, Ricci E. Evaluation of Community Consultation and Public Disclosure in the New York City Public Access Defibrillation (PAD)Trial Acad Emerg Med, 2006; 13 (5 suppl 1). S19.The Public Access Defibrillation (PAD) Trial is a multicenter study designed to determine whether the deployment of automated external defibrillators in senior housing facilities a selected sites across nation can reduce cardiac event mortality. This paper presents an evaluation, at the New York City site, of community consultation and public disclosure as a means of informing communities about the research. Dr. Wilets worked closely with the Principal Investigator, Dr. Lynne Richardson, and the New York-based research team, in developing the evaluation plan. She also participated in the interpretation of data and reporting of results.
- O’Rourke M, Richardson LD, Wilets I, D’Onofrio G. Alcohol-related problems: Emergency physician’s current practice and attitudes. J Emerg Med, 2006; 30(3):263-268.
- Caravella, R., Robinson, L., Wilets, I., Weinberg, M., Cabaniss, D., Cutler, J., Kymissis, C., Arbuckle, M. A Qualitative Study of Factors Affecting Morale in Psychiatry Residency Training. Academic Psychiatry, April 2016.
- Smirnoff M, Wilets I, Fish Ragin D, Richardson LD. A Paradigm for Understanding Trust and Mistrust in Medical Research: The Community Voices Study. AJOB Empir Bioeth, Jan-Mar 2018; 8(1):39-47.
- Chisolm-Straker M, Nassisi D, Daya MR, Cook JNB, Wilets I, Clesca C, Richardson LD. Exception from informed consent: How IRB reviews assess community consultation and public disclosure. AJOB Empir Bioeth, Jan-Mar 2020; 12(1):24-32.
Articles and Refereed Commentaries
. Richardson LD, Rhodes R, Ragin DF, Wilets I. The role of community consultation in the ethical conduct of research without consent. Am J Bioeth, 2006; 6(3):33-35. This editorial discusses the importance of properly conducted community consultation in research qualifying for a waiver of the general requirements for informed consent, under the 1996 federal exception rule. The editorial also counters criticisms pertaining to this regulation and underscores the importance of the waiver for the advancement of emergency medicine research. Dr. Wilets, as a senior author on this paper, made major contributions toward writing and editing the editorial.
Wilets I, Martin G, Silverstein JH. De minimis risk proposal offers little to current approach. Letter to the editor. Amer J Bioeth, 2012; 12(3):46-48. As first author of this letter to the editor of the American Journal of Bioethics, Dr. Wilets conceived and developed this position piece in response to a previously published manuscript proposing a new category of research risk (“de minimis” risk) involving activities for which physical risks are deemed negligible as compared with risks inherent in everyday life, and for which no social or psychological harms are foreseen. Dr. Wilets, in concert with two additional IRB Chairs from Mount Sinai, rebutted the premise that studies within this subcategory need not meet the requirement of obtaining informed consent.
Kelmenson A, Wilets I. Historical practice of separating twins at birth. JAMA, 2019; 322(18).
Kelmenson A, Wilets I. Ethical questions remain in controversial twin study. International Journal of Controversial Discussions. 2020;1(1):189-196.
- Jacobson S, Majeed S, Wilets I. A survey on the use of alternative therapy in children by adult caregivers, 1992. Poster presented at the ACEP National Meeting, Las Vegas, NV.
- Merchant R, Keshavarz R, Wilets I, Hamilton K, Richardson B, Jacobson J. HIV post-exposure prophylaxis: A survey of New York State emergency department practitioners, 2001. Poster presented at the SAEM Regional Meeting, Rochester, NY.
- Merchant R, Keshavarz R, Low C, Wilets I, Richardson B, Jacobson J. HIV post-exposure prophylaxis provided in a large urban pediatric emergency department after sexual assault, 2001. Poster presented at the SAEM Regional Meeting, Rochester, NY.
- Merchant R, Keshavarz R, Wilets I, Richardson B, Jacobson J. Hepatitis B post-exposure prophylaxis: A survey of emergency department practitioners, 2001. Poster presented at the SAEM Regional Meeting, Rochester, NY.
- Iavicoli L, Givre S, Wilets I, Kreisman E, Amir T. Cultural attitudes towards domestic violence, 2001. Poster presented at the SAEM National Meeting, Atlanta, GA.
- Richardson L, Wilets I. Minority faculty in academic emergency medicine, 2001. Poster presented at the SAEM National Meeting, Atlanta, GA.
- Wilets I. Silverstein JH, Sicherer S, Deiner S, Richardson LD. Recruitment and retention. Understanding barriers and motivators for research participation, June 20-21, 2011.
- Poster presented at Fourth Annual CTSA Clinical Research Management Workshop: The Role of Metrics to Drive Change and Measure Success in Implementing Process Improvement. Bethesda, MD.
- Wilets I. Silverstein JH, Sicherer S, Deiner S, Richardson LD. Understanding barriers and motivators for research participation, Sept. 21, 2011.
- Poster presented at Clinical Research Day - hosted by Conduits: Institutes for Translational Sciences, Mount Sinai School of Medicine, New York, NY.
- Wilets I, Ortiz JM, Richardson LD. Why clinical studies are often unsuccessful in meeting recruitment goals: Perspectives from research personnel, April 18-20, 2012.
- Poster presented at Translational Science 2012: Improving Health through Research and Training, Washington DC.
- Wilets I, Gagliardi R, Poultney M, Jandorf L, Sano M. Clinical trial recruitment: Lessons learned from the Mount Sinai School of Medicine, June 4-5, 2012.
- Poster presented at Fifth Annual CTSA Clinical Research Management Workshop, Learning by Doing: Applying Evidence-based Tools to Re-engineer Clinical Research Management. Yale University, New Haven CT.
- Wilets I. Improving public relations for your IRB: What would Don Draper do? December 5-7, 2014.Poster presented at the PRIM&R Applied Ethics in Research national meeting, Baltimore, MD.