NIH Health Care Systems Research Collaboratory Offers New Perspectives on Clinical Research

September 15, 2015 – A special series of articles addressing the ethical and regulatory challenges to pragmatic clinical trials appears this week on the website of the journal Clinical Trials.

The 12 articles were sponsored by the NIH Health Care Systems Research Collaboratory with additional support from the Patient-Centered Outcomes Research Institute, and include authors drawn from the fields of clinical research and patient advocacy, as well as clinicians, bioethicists, and regulatory experts.

The articles can be found on the Clinical Trials website.

An overview of the series was written by the leaders of the project, bioethicist Jeremy Sugarman, professor of bioethics and medicine and deputy director of the Johns Hopkins Berman Institute of Bioethics, and cardiologist Robert Califf, former vice chancellor for clinical and translational research at Duke University and now the Deputy Commissioner for Medical Products and Tobacco at the Food and Drug Administration.

The remaining 11 articles focus on topics including defining and evaluating research risks, protection of vulnerable research participants,  informed consent, privacy of research participants, and the appropriate interpretation and application of current federal regulations governing research.

Established by a 2013 grant from the National Institutes of Health Common Fund, the Collaboratory is dedicated to supporting investigations into new and better ways of conducting clinical research. In particular, the Collaboratory is focused on pragmatic clinical research, which aims to answer important research questions quickly and efficiently by applying novel research designs and tools.

However, these approaches are currently applied within an existing structure of rules, regulations, and ethical guidelines that was created to govern more traditional types of healthcare research. The result has been an increasing tension between the imperative to protect the rights and welfare of research participants while enabling the research needed to provide information that future patients and their healthcare providers will rely upon to make informed choices.

“We’re facing a serious gap in terms of the scientific evidence we need to better guide decisions about medical treatments,” said Califf, who together with Sugarman served as an editor for the issue. “The problem is ensuring that we can converge upon an ethical and regulatory framework that’s appropriate for the kinds of research that will be essential in the coming era of patient-centered precision medicine.”

“These articles address a number of areas that for years have been marked by uncertainty, even for experts,” Sugarman said. “What we have tried to do here is clarify some of the most pressing issues and point toward some possible solutions.”


 

Special series of articles addressing the ethical and regulatory challenges to pragmatic clinical trials

Johns Hopkins GIM Housestaff Research Awards

GIM Housestaff Research Awards, 2014

On behalf of the faculty, fellows, and staff of the Johns Hopkins University Division of General Internal Medicine, I’m delighted to announce the eighth annual national competition for Housestaff GIM Research Awards. Our goals in establishing the Awards are

  • to stimulate interest in academic GIM at a time when interest in the everyday practice of GIM is flagging, and
  • to recognize outstanding house officers who have the potential to become leaders in GIM-related research.

We offer five Awards, each named for an internationally regarded mentor and researcher at Johns Hopkins who have a primary faculty appointment in the Division of General Internal Medicine.

The Jeremy Sugarman Award

recognizes research achievement in bioethics. Dr. Sugarman is the Harvey M. Meyerhoff Professor of Bioethics and Medicine; Professor of Medicine; Professor of Health Policy and Management; and Deputy Director for Medicine of the Johns Hopkins Berman Institute of Bioethics. Dr. Sugarman is currently Chair for the Ethics Working Group of the HIV Prevention Trials Network, the Ethics Officer for the Resuscitation Outcomes Consortium, and Co-Chair of the Johns Hopkins Embryonic Stem Cell Research Oversight Committee. Dr. Sugarman conducts both theoretical and empirical research in medical ethics. He is renowned for his work on informed consent, research ethics and the ethical issues associated with emerging technologies.

The L. Randol Barker Award 

recognizes research achievement in medical education. Dr. Barker is Professor of Medicine and former Co-Director of the Division of General Internal Medicine at the Johns Hopkins Bayview Medical Center. He co-directs the Johns Hopkins Faculty Development Program in Teaching Skills and is one of the founding editors of the textbookPrinciples of Ambulatory Medicine, now in its 7th edition. Dr. Barker’s core interests are in how learning occurs in clinical medicine, and in the professionalism of the educator-learner relationship. He developed the precepting model used in the Medical House Staff Practice and the continuity practice he founded and continues to direct. His recent innovative work introduces reflective practice as a method for personal learning and growth in both residents and faculty. In 2001, he was awarded SGIM’s Award for Career Achievement in Medical Education.

The Diane Becker Award 

recognizes research achievement in clinical epidemiology and prevention. Dr. Becker is a Professor of Medicine and Health Policy and Management, and Director of the Center for Health Promotion in the Division of General Internal Medicine. She is the Founding Director of the Johns Hopkins Sibling and Family Heart Study and Director of the GeneSTAR Research Program. She was the recipient of the 2008 Distinguished Alumni Award from the Johns Hopkins University and the 2004 Katherine A. Lembright Research Award from the American Heart Association. Dr. Becker is renowned for her research on the epidemiology and genetic underpinnings of premature heart disease and related conditions.

The Daniel Ford Award 

recognizes research achievement in health services and outcomes research. Dr. Ford is Professor of Medicine, Epidemiology, and Health Policy & Management; former Director of the Johns Hopkins Preventive Medicine Residency and the University Health Service; and currently Vice Dean for Clinical Research; Principal Investigator of the NIH grant which supports the General Clinical Research Centers at Johns Hopkins; and Principal Investigator on the institution’s proposal to build a new Clinical and Translational Science Award (CTSA). He directs a multi-disciplinary HRSA-funded training program (T32) on primary care research. He is renowned for his research on the treatment of depression in primary care.

The David Levine Award 

recognizes research achievement in behavioral medicine and health disparities. Dr. Levine is Professor of Medicine and Health Behavior & Society; Director of Fellowship Programs in the Department of Medicine; and former Director of the Division of General Internal Medicine. He directs a multi-disciplinary NIH-funded training program  (T32) on behavioral aspects of cardiovascular disease which has been continuously funded for over 30 years and has been called “perhaps the best of its kind in the history of the NHLBI.” In recognition of his unsurpassed reputation as a research mentor, The Department of Medicine at Hopkins has institutionalized his legacy with annual “Levine Awards” for outstanding faculty mentors. Dr. Levine is renowned for his research on health behaviors related to disparities in cardiovascular risk and disease.

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Each award carries a cash prize and an invitation to travel to Baltimore to attend a celebratory dinner and to present the winning abstract to the faculty of Hopkins GIM. If you are a house officer who has conducted research in any of these GIM-related areas and you are on track for a career in academic general internal medicine, we invite you to compete. Please review additional details below. And while you’re visiting us on the web, we welcome you to check out our NIH-funded GIM Fellowship Program which over the past three decades has prepared over 125 general internists for exciting careers in academic medicine.

Best regards and good luck!

Jeanne M. Clark, MD, MPH, FACP
Frederick Brancati Professor of Medicine
Interim Director, Division of General Internal Medicine

Requirements

Application

Recommendation Form

Honor Roll of Past Award Winners

Bioethicist Jeremy Sugarman Elected to AAP

Jeremy Sugarman, MD, MPH, MA, deputy director for medicine at the Johns Hopkins Berman Institute of Bioethics, has been elected to the Association of American Physicians (AAP). 

An internationally recognized leader in the field of biomedical ethics, Sugarman has worked on such issues as the ethics of informed consent, umbilical cord blood banking, stem cell research, international HIV prevention research, global health and research oversight.

Sugarman has authored over 200 articles, reviews and book chapters, as well as edited or co-edited four influential books:  Beyond Consent: Seeking Justice in Research; Ethics of Research with Human Subjects: Selected Policies and Resources; Ethics in Primary Care; and Methods in Medical Ethics.

In public service, Sugarman has served as senior policy and research analyst for the White House Advisory Committee on Human Radiation Experiments, consultant to the National Bioethics Advisory Commission, senior adviser to the Presidential Commission for the Study of Bioethical Issues, and completed a six-year term on the Maryland Stem Cell Research Commission.

Sugarman currently serves on the Scientific and Research Advisory Board for the Canadian Blood Services, the Ethics and Public Policy Committee of the International Society for Stem Cell Research, and the board of directors of Public Responsibility in Medicine and Research (PRIM&R). He is co-chair of the Johns Hopkins Institutional Stem Cell Research Oversight Committee. In addition, he is chair of the Ethics Working Group of the HIV Prevention Trials Network and is the ethics officer for the Resuscitation Outcomes Consortium.

Four other physicians at Johns Hopkins Medicine join Sugarman in being honored by election to AAP: Stephen Desiderio, MD, PhD; Hal Dietz, MD; Drew Pardoll, MD, PhD; and David Valle, MD. Founded in 1885, the nonprofit, professional organization works to advance medical research and its application to practice. The names of this year’s new members will be announced April 26 at AAP’s annual joint meeting with the American Society for Clinical Investigation in Chicago.