Research Ethics Core

As science evolves, ethical norms that guide it need to evolve responsibly. Nowhere is this more important than in translational science, where researchers make the leap from basic science to clinical research and ultimately to community practice. Human subject protection programs must be prepared to meet the challenges posed by this changing landscape, both to educate and support investigators as they design and conduct research, and to protect and advocate for subjects and society.

The principal objective of the Ethics Core is for ethicists from partner institutions to work together to facilitate, develop, and administer consultative, educational, and research programs across disciplines within the Clinical and Translational Science Center. This allows translational research teams and individual investigators to move beyond the regulatory framework to appreciate the deeper ethical implications that their work has for science and the wider community. The Ethics Core will provide translational researchers the requisite tools and environment to explore complex questions regarding ethics and will provide support for researchers and research participants to ensure the highest ethical standards in the conduct of research.

The specific aims to achieve these objectives are to:

  • Establish a Research Ethics Advisory Committee
  • Provide a Research Ethics Consultation Service
  • Support a Research Participant Advocacy Program
  • Provide education in biomedical research integrity
  • Investigate scholarly questions in research ethics

Research Ethics Advisory Committee (REAC)

We have developed an Ethics Core that will leverage the ethics services at the partnering institutions coordinated through the Division of Medical Ethics at Weill Cornell Medical College. The Research Ethics Advisory Committee was established in March 2008. The members, who represent each of our member institutions, capture the entire spectrum of translational research. They are a distinguished and diverse group of basic scientists, clinical investigators in hematology/oncology, pediatric genetic disorders, community health, and outcomes; scholars of ethics and the law, research integrity specialists, and technology development experts. We will use this committee to bring people together as a multi-institutional, interdisciplinary think tank to direct the activities of the core and address ethical issues in clinical research and the CTSC as they arise.

Our first major initiative is to conduct a needs assessment of investigators within our CTSC collaborative.

Research Ethics Consultation Service

The Research Ethics Consultation Service adds a dynamic and non-regulatory element to the research process that makes it more efficient, both in terms of advancing research and of fostering high standards of research ethics. Such consultations seek to develop collaborations between investigators and ethicists aimed at sensitizing scientists to the ethical dimensions of their work and exposing ethicists to the complexities of scientific design. This dialogue should lead to more informed professional self-regulation and weave an even higher regard for human subject protection into the professional ethos of researchers than already exists.

Investigators from the partnering institutions are encouraged to consult with bioethicists with expertise in specific areas of clinical/translational research during the protocol development process to conceptualize and design trials that are ethically sound before protocols are submitted for departmental, scientific, or IRB review, and throughout the course of the study.

Ethicists are trained to uncover hidden assumptions, analyze concepts, clarify meanings, and recognize normative, epistemological and social issues. They can thus bring to the forefront of the discussion ethical and epistemological aspects of biomedical research in general and of specific projects in particular, and can also call attention to possible consequences of varying courses of action. In addition, consultants can assist with strategies to improve the quality of informed consent and minimize the therapeutic misconception, which occurs when subjects confuse research with therapy.

Protocols that involve the following issues/elements may find research ethics consultation particularly helpful:

  • Subjects who may lack decision-making capacity
  • Protocols involving surrogate decision-making
  • Recruitment of vulnerable subjects
  • Novel experimental techniques/interventions
  • Stem cells
  • Gene transfer studies
  • Pediatric studies involving moderate to high risk

To request an ethics consult for a current or prospective CTSC project, please contact:

     Inmaculada de Melo-Martin, PhD, MS
     Email: imd2001@med.cornell.edu
     Phone: (212) 746-1268

or:

     The Division of Medical Ethics, Weill Cornell Medical College
     Chief: Joseph J. Fins, MD
     Phone: (212) 746-4246

Research Participant Advocacy Program

The Research Participant Advocacy Program was originally created in 2001 in an effort to restore public trust in the research enterprise following a series of public disclosures of research abuses at prominent medical centers. Our program builds on the principles of ethics and advocacy to ensure that human research subjects are protected and given a voice to represent their needs and rights. The research participant advocates report to the Dean of the Medical College to maintain independence from individual institutions' regulatory and compliance administrations, as well as from persons responsible for day-to-day direction of Center activities, the CTSC PI and CTSC Program Directors. Research participant advocates:

  • Represent research subject interests by acting as a liaison between research participants, investigators, IRB, and staff at each participating institution.
  • Review protocols for the CTSC Translational Research Advisory Committee (TRAC) to address ethical and safety issues including consents, enrollment, and data and safety monitoring plans.
  • Review Adverse Event reports.
  • Ensure that subjects and potential subjects are provided with information about their rights as a research participant and be available to hear and address their questions and problems/complaints about their rights and safety.
  • Provide a mechanism for consultation regarding research participant-related questions or problems.
  • Collaborate with Patient Services departments at NewYork-Presbyterian Hospital, MSKCC and HSS to engage existing advocacy services.
  • Educate researchers on research ethics and advocacy.

To contact a research participant advocate:

     Cathleen Acres, RN, MA
     Email: ctscrsa@med.cornell.edu
     Phone: (212) 746-1126

At MSKCC or HSS, please contact the patient representative first:

     MSKCC: (212) 639-8254
     HSS: (212) 774-2403 (Lydia Dalley)

Educational Programs in Biomedical Research Ethics and Integrity

Educational programs are structured to advance the study and practice of ethical decision-making in the context of clinical research, and to integrate reflection about ethical issues into the fabric of the CTSC's translational research enterprise at every level — didactic, practical, experimental and regulatory.

Currently, Division of Medical Ethics faculty conduct educational sessions on research ethics in the following programs/courses: K-30 Masters Program in Clinical Research (Weill Cornell Medical College); Tri-Institutional Research training program (Weill Cornell Medical College, MSKCC, Rockefeller University); CTSC training programs; departmental fellowship programs; and division seminars in research ethics.

Investigate Scholarly Questions in Research Ethics

The Ethics Core will conduct research and pursue scholarship on issues of research integrity and the ethical conduct of research. The CTSA provides a unique opportunity to understand research ethics in academic centers and hospitals. The first project is a survey of human subject investigators at the partnering institutions as part of a needs assessment. Future plans include the development of a model of inquiry to evaluate whether the type of institution results in unique ethical challenges, and a project to explore the prevalence and nature of the therapeutic misconception at MSKCC, HSS and NewYork-Presbyterian/Weill Cornell to determine similarities and differences. Other studies may focus on investigator knowledge and attitudes regarding the ethical conduct of research, informed consent, surrogate decision-making and subject recruitment.