Biomedical Ethics

Research Ethics

Professionalism in the Mayo Clinic research shield: A pilot study

• Investigators: Jennifer (Jen) McCormick, Ph.D., and Ashok Kumbamu, Ph.D., both of Mayo Clinic
• Funded by: Mayo Clinic Program in Professionalism and Ethics

The purpose of this study is to ascertain which elements of professional and social responsibility researchers espouse. After conducting a series of focus groups with researchers at different stages in their careers, investigators will use the data gathered to design and pilot a mini-course or workshop that could be tailored to the skills that basic life scientists need in order to prepare for robust civic engagement and social responsibility for the remaining course of their careers.

Ethics and values in regenerative medicine

• Investigator: Jennifer (Jen) McCormick, Ph.D., Mayo Clinic
• Funded by: Mayo Clinic Center for Regenerative Medicine

Regenerative medicine is a relatively new, rapidly advancing field in the science of medicine. In this study, Dr. McCormick will be looking at the ethics of regenerative medicine to determine if and how they differ from the ethics of medicine as a whole.

In analyzing the context of regenerative medicine in clinical trials, she will look at how the science of discovery of new treatments is translated into clinical applications in the community and how to best expedite the processes of discovery to practice.

Enhancing the informed consent process for phase I trials by integrating patients' values

• Investigators: Jennifer (Jen) McCormick, Ph.D., and Cheryl B. Thomas, both of Mayo Clinic
• Funded by: National Center for Advancing Translational Sciences grant number UL1 TR000135

The failure to grasp the differences between clinical research and clinical care (therapeutic misconception) is an ethical issue common among many phase I clinical trials. Many study participants choose to join clinical trials because they believe they will receive some sort of benefit from the trial, not because they wish to further general scientific knowledge. Likewise, a surprising number of participants fail to identify the risks and benefits in joining a phase I trial.

In this study, investigators will approach potential participants in a phase I clinical trial for patients with amyotrophic lateral sclerosis (ALS) with a values communication tool developed by Rebecca Pentz, Ph.D., and her team at Emory University. The values communication tool will allow the patient to communicate his or her values to the consenting investigator, reversing the typical relay of information from investigator to patient in the informed consent process.

Through this study, Dr. McCormick and Thomas hope to determine if such a tool is useful in including patients' values in the decision to join a clinical trial, thereby reducing the therapeutic misconception.

From bank to bench to breakthrough: The effects of funding policies on human stem cell science

• Investigators: Jason Owen-Smith, Ph.D., University of Michigan; Christopher Scott, Stanford University; and Jennifer (Jen) McCormick, Ph.D., Mayo Clinic
• Funded by: National Science Foundation grant number SBE-0949708 and Mayo Clinic

A collaborative effort with Dr. Owen-Smith and Scott, this project follows patterns of the use of different cell lines and the growth of knowledge to gain a better understanding of how the field of stem cell research has developed in reaction to the various policies.

The purpose of this project is to support collection, integration and analysis of three types of data: material transfer agreement data, publication data and in-depth interview data. Together, these data provide a comprehensive picture of patterns of use of human stem cell lines to shed light on the technical, political and institutional factors that shape the flow of materials in an important and controversial field of science.

Evaluating life scientists' perceptions of research ethics

• Investigators: Jennifer (Jen) McCormick, Ph.D., Mayo Clinic, and Mildred Cho, Ph.D., Stanford University
• Funded by: National Center for Advancing Translational Sciences grant number UL1 TR000135

Through a National Human Genome Research Institute-funded project at Stanford University, Drs. McCormick and Cho collected data from life science researchers to inform the development of the Stanford research ethics consultation service. Dr. McCormick is performing secondary analysis of the data to examine their views on ethical, social and policy implications of research.