Patient Participation and Safety

Health Quest strives to ensure clinical patient safety. We are guided by the principles written in the Belmont Report, a nationally recognized set of standards for proper medical ethics. These principles are respect for persons, beneficence and justice.

The Institutional Review Board

Our Institutional Review Board (IRB) reviews all human subjects research conducted within Vassar Brothers Medical Center. The mission of the IRB is to protect the rights, privacy and welfare of all human participants involved in clinical research. To achieve this, the IRB has the authority to review, approve, modify, or disapprove all proposed research study protocols before participants may be enrolled. It is the primary intent of the IRB to ensure that potential subjects are provided with sufficient information to make a free and informed decision about participation in the study.

Institutional Review Board Members:

IRB Chair: Cliff Connery, MD
Primary Specialty: Thoracic Oncology

Christina Bierling, NP
Primary Specialty:Nursing

Mikyung Choe, BS, PharmD 
Primary Specialty: Hematology/Oncology Pharmacology

Evan Goldfischer, MD
Primary Specialty: Urology

Robert Hankin, BE 
Community Representative

Neil Loevinger
Primary Specialty: Spiritual Services

James Lyons, MD
Primary Specialty: Cardiology

William Rausch, ScB, CIP
Primary Specialty: Research Compliance

Stephanie Saltzberg, MD 
Primary Specialty: Vascular Surgery

What Happens During a Clinical Trial

Clinical trials follow a carefully controlled protocol, or a study plan that details what researchers will do in the study. Your Research team, made up of your physician, nurses, and research coordinators, will be with you for every step of the clinical trial process. The Research team will:

  • Assess your health at the beginning of the trial.
  • Give specific instructions for participating in the trial.
  • Monitor you carefully during the trial.
  • Stay in touch after the trial is completed.

How Participants are Protected in a Clinical Trial

The ethical and legal codes that govern medical practice also apply to clinical trials. Additionally, specific federal regulations dictate the way clinical trials are run and ensure that participants are protected.

Participants' rights and safety are protected in three ways:

  • Informed Consent: This is more than just a document that a participant signs in order to enter a clinical trial. It is also a process. As part of this process, your Research team will inform you of the purpose, risks and benefits of a particular clinical trial before you decide to join. This is a critical part of ensuring patient safety in research. Your Research team will also discuss your rights, including making a decision about participating and the ability to leave the study at any time. Once you have had time to learn about all treatment options, what is involved in the trial, discuss the trial with the Research team and family or friends, you will be given the informed consent document to read. This document will provide you with written details of the information that has been discussed and also describes the privacy of your records.

  • Careful review and approval of the clinical trial by two review panels before the study begins: First, a scientific review panel of specialists that review a clinical trial’s written protocol, which is a carefully controlled study plan that details what researchers will do in the study. This review is conducted before the study starts accepting participants to ensure that the study is based on sound science. Second, IRB also reviews the written clinical trial protocol to make sure that it is ethical, the patients' rights are protected and the risks involved in the trial are reasonable when compared to the possible benefits.

  • Ongoing monitoring during the trial: Your Research team and the IRB monitor the progress of the trial from beginning to end. For a Phase III trial, the Data and Safety Monitoring Board (DSMB) must ensure that any risks caused by being in the study are reduced as much as possible. They must also ensure that data is sound and that a trial is stopped if safety concerns arise or as soon as its objectives have been met.

Determining if a Clinical Trial is Right for You

Choosing to participate in a clinical trial is an important personal decision. It is often helpful to talk to your physician or other healthcare providers, family members, or friends about deciding to volunteer for a clinical research study.

After identifying some study options, the next step is to contact us at (845) 483-6825 about specific studies. We will explain the study and if you like, connect you with the study investigator and the rest of the Research team so you can learn as much as possible and feel certain that you are comfortable becoming a research study participant.

Clinical Trials Educational Resources

If you are interested in learning more about clinical trials in general, we invite you to review the following:

National Institutes of Health Clinical Research Trials Basics
Food and Drug Administration Clinical Trials: What Patients Need to Know

To learn more about cancer research trial participation, please review this information provided by The National Cancer Institute.