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Research Studies: Should I Take Part?

The following is a list of useful questions (provided by the National Cancer Institute) that you may want to explore with the research staff when considering participation in a clinical study. Many of these questions may be addressed in the informed consent document, but be sure to ask any that come to mind as you make your decision about taking part in the study.

The Study

  • What is the purpose of the study?
  • Why do researchers think the approach may be effective?
  • Who will sponsor the study?
  • Who has reviewed and approved the study?
  • How are study results and safety of participants being checked?
  • How long will the study last?
  • What will my responsibilities be if I participate?
  • Whom can I speak with about questions I have during and after the trial? To find out the study results?
  • What steps will be taken to protect my privacy and the confidentiality of my medical records?

Possible Risks and Benefits

  • What are my possible short-term benefits?
  • What are my possible long-term benefits?
  • What are my short-term risks, such as side effects?
  • What are my possible long-term risks?
  • If I do not want to participate in the study, are there other options available to me?
  • How do the possible risks and benefits of this trial compare with those options?

Participation and Care

  • What kinds of therapies, procedures and /or tests will I have during the trial?
  • Will they hurt, and if so, how long?
  • How do the tests in the study compare with those I would have outside of the trial?
  • Will I be able to take my regular medications while in the clinical trial?
  • Where will I have my medical care?
  • Will I have to be hospitalized? If so, how often and for how long?
  • Who will be in charge of my care?
  • What type of follow-up care is part of the study?

Personal Issues

  • How could being in the study affect my daily life?
  • Can I talk to other people in the study?

Cost Issues

  • Will I have to pay for any part of the trial such as tests or the study drug?
  • If so, what will the charges likely be?
  • What is my health insurance likely to cover?
  • Who can help answer any questions from my insurance company or health plan?
  • Will there be many travel or child care costs that I need to consider while I am in the trial?

No one, not even medical professionals, can predict whether the treatment under evaluation in the study will prove successful. This is a serious decision. Before agreeing to participate in a study, you should feel free to take the time to discuss the study with your doctor and trusted support members. Your doctor may be able to give you helpful information, but recognize that only you can decide if the study is right for you.

Source: American Cancer Society – A Checklist of Questions to Ask the Research Team

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    Last Reviewed: May 09, 2011

    Professor of Bioethics

    School of Medicine

    Case Western Reserve University