FDA Guidance
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Office of Clinical Trials (OCT)

Deciding to Participate in a Study

Deciding whether or not to participate in a clinical trial is a personal decision you should make after discussing the option with your care provider(s). Before deciding to participate, it is important that you assess the details of the study to ensure you understand the extent of your participation. Below are some questions to consider before deciding to participate in a study.

What are the possible benefits of participating in a clinical trial?

  • A clinical trial may improve your health, but there is no guarantee.
  • You may be offered new experimental drugs or treatments that are not available outside of the study, and you will be monitored closely for any possible side effects.
  • You will be seen by leading doctors at the forefront of their fields.
  • Results of this research might help develop new information about your medical condition.

What are the possible risks and discomforts associated with participating in a clinical trial?

  • There is no guarantee the study treatment will help you.
  • There is a chance you will experience some side effects from the study treatment. The risks will be different from study to study, and they will be explained to you in detail by the study team during the informed consent process.

What are my rights?

  • It is your choice to join a Clinical Trial or not; no one can force you.
  • You have the right to change your mind and quit the trial at any time. This will not affect your medical care at Montefiore Medical Center or Albert Einstein College of Medicine.
  • The Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services also have laws that regulate how we protect volunteers in research.
  • Before you take part in a study you will go through an informed consent process in which the research staff will explain the study to you. They will answer any questions you may have throughout the trial.

Tell me more about the Informed Consent Process.

Before you take part in a study you will go through an Informed Consent process in which the research staff will explain the purpose and procedures of the research study to you, including what your role will be in the study. The Informed Consent Process will outline the following for you:

  • what will happen to you during the study,
  • how the protocol (plan of research) works,
  • what potential risks or discomforts you may experience,
  • what potential benefits, if any, you may experience,
  • confidentiality of the study data,
  • what personnel is involved in the research,
  • information on whether any compensation is available,
  • information about potential costs to you, if any,
  • your rights as a research patient,
  • whom to call with any questions,
  • that participation is completely voluntary on your part, and you can quit the study at any time for any reason.

These details of the study are also outlined in a document called the Informed Consent Form, which you should review with the study team to ensure you understand all aspects of the study. If you decide to participate in the study, you and the Principal Investigator (the doctor leading the study) will sign the Informed Consent Form and you will be given a copy.


Are Clinical Trials safe?

  • Your safety will be monitored closely by the Principal Investigator, who is the doctor in charge of the study.
  • An Institutional Review Board (IRB), a local independent committee made up of medical experts and members of your community, also oversees all Clinical Trials to make sure that all patients' rights are protected.

Do I have to pay anything to participate?

  • Study drugs and tests in Clinical Trials are often provided at no cost.
  • Only routine medical expenses you would incur outside of a Clinical Trial may be billed to your insurance company.
  • Every trial is different, so it is important to ask the research staff about potential costs.

Can I continue seeing my own doctor while participating in the study?

  • You can keep seeing your own medical doctor when you volunteer for a Clinical Trial.
  • You should discuss your decision to take part in a Clinical Trial with your doctor.

Before giving consent 

Remember that your participation in a research study is completely voluntary. Before giving consent to participate, be sure that all your questions are answered, and that you understand all aspects of your participation in the study. Below are some examples of questions you may want to ask the study team before you give consent:

  • What is the purpose of the trial?
  • How might this treatment help me?
  • How does this treatment compare with the treatment I am currently receiving?
  • What are the risks? Could my condition get worse?
  • What tests and procedures are involved? Are they different from tests and procedures I would have if I were not in the trial?
  • How long will the trial last?
  • How much of my time is required?
  • What are my responsibilities?
  • Will I get paid for my time and travel expenses?
  • Who will pay for this treatment?
  • Can I leave the trial at any time?
  • Who will see the results of this trial?
  • Whom do I contact if I have any questions?

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The Montefiore Einstein Office of Clinical Trials 

Montefiore Medical Center
111 East 210th Street
Moses Research Tower, 8th Floor, Room 8-014

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