Related Pages Protecting Participants in Clinical Trials A collection of material about the ways in which clinical trials participants are protected before and during the conduct of a study. Protecting Human Research Participants A free, on-line tutorial offered by the National Institutes of Health (NIH) Office of Extramural Research, for physicians, nurses, and other members of clinical research teams. This online course satisfies the NIH human subjects training requirement for extramural researchers obtaining Federal funds.

A Checklist of Questions to Ask the Research Team

The following questions deal with many of the areas that should be covered in the informed consent document (see previous section). To double-check that you have all the information you need, consider printing out this checklist and bringing it to a meeting with the research team. You also may wish to fill it out as you read the informed consent document, both to ensure your own understanding of the trial and to create a ready reference written in your own words. Many of these questions are specific to treatment trials, but the checklist still should prove useful if you are considering a prevention, screening, or supportive care trial.

The Study

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

Possible Risks and Benefits

1. What are my possible short -term benefits?
2. What are my possible long -term benefits?
3. What are my short - term risks, such as side effects?
4. What are my possible long -term risks?
5. What other options do people with my risk of cancer or type of cancer have?
6. How do the possible risks and benefits of this trial compare with those options?

Participation and Care

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

Personal Issues

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

Cost Issues

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

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