Clinical Trials and Research Studies

Understanding Clinical Trials

Clinical trials are strictly controlled human studies of new and emerging therapies. At HSS, these trials incorporate state-of-the-art patient care, while carefully evaluating how best to apply the most recent innovations in orthopedics and rheumatology.

The safety of participants is our top priority. Clinical trials at HSS are first reviewed by a Clinical (Scientific) Review Panel of specialists before being reviewed and approved by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The IRB provides continuing surveillance of the trial/study as well as periodic review of results. Before a treatment can be tested in people, it must be shown to be safe and effective in laboratory and animal studies. Volunteers who agree to participate are fully informed of possible study risks and benefits and sign a consent form before being accepted into a clinical trial.

The safety and effectiveness of clinical trials are reviewed by the U.S. Food and Drug Administration (FDA) and HSS Clinical Trials are posted on the FDA web site. The FDA determines if and when a clinical trial provides evidence that the treatment under study offers improvements in care that can be made available to all patients with a particular condition.

Informed Consent

Before enrolling in a clinical trial, you will undergo the informed consent process. At this time, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

Learn more about the critical role of the HSS Institutional Review Board in protecting people who volunteer to participate in clinical trials.

Research Studies

Many people are interested in participating in research but do not know how to find studies that are right for them. ResearchMatch is a national not-for-profit recruitment registry which brings together researchers and people willing to learn more about research studies (not just clinical trials). Anyone from the United States can join ResearchMatch regardless of age, ethnicity or health conditions. A research opportunity is out there for everyone. For more information please visit ResearchMatch now to register.

Participating in Research

The Office for Human Research Protections (OHRP) works to protect the rights, welfare, and wellbeing of volunteers who participate in research. In doing so, they have developed and compiled the following resources to help you make the best decisions for you and your loved ones. They answer some common questions and suggest other questions you may want to ask if you are considering participating in research.

Check out the links below to watch informational videos, view a list of questions to ask researchers, and find additional resources related to research participation.

Video Series:

Part 1: What is Research?
This video provides basic information about scientific research, the goals of research and discusses how clinical research differs from medical care. (3:00)

Part 2: Clinical Trials
This video discusses types of human research with a focus on clinical trials, and explains common terms that potential participants should know (4:20)

Part 3: Questions to Ask
This video emphasizes that participating in research is voluntary and encourages potential participants to ask questions and get the information they need to decide whether to participate (4:44)

Questions to Ask About Volunteering for a Research Study

Additional Resources About Human Subjects Research

ClinicalTrials.gov

Regularly updated information about federally and privately supported clinical research in human volunteers with details including the trial's purpose, who may participate, locations and phone numbers.