Information for Biomedical Research Volunteers

Questions to ask before you agree to volunteer as a research participant in Biomedical Research:
Before participating in a biomedical research study (a clinical trial), you should make an effort to know as much about the trial as possible. You could use the following questions as a guide when you are discussing your participation with the research staff and/or your family/friends.

• Who is responsible for conducting this research? Who are the responsible investigators?

• Who is the sponsor of the research?

• What is the official title of the research project?

• What is the purpose of the research?

• How much previous research has been done on this topic/drug/device?

• How do I know if I am eligible to participate in this research?

• How do I know if I should not participate in this research?

• Are there any known drug interaction concerns?

• What will happen if I decide to quit the study?

• What is being done as part of the research?

• What is being done as part of my standard treatment?

• Is my standard treatment being withheld as part of this research?

• What are the potential risks and inconveniences of this study?

• Should I and my sexual partner use birth control while participating in this research?

• Is there any danger to my unborn or breast-fed child?

• Can I participate in more than one research project at a time?

• Will my participation in this research be confidential?

• Will my name be in the research records?

• Will someone going over the research records be able to recognize who I am?

• Who has access to the research records?

• If I am injured as a result of my participation, what will be done?

• How will the risks of the research be minimized?

• What are the benefits of this study?

• Would I benefit directly from volunteering to participate?

• Will I receive any kind of compensation as a result of participating in the research?

• Are there benefits to other people in the future as a result of this research?

• Will I need to cover any of the costs of the research myself?

• Will my insurance company need to cover any of the costs of the research?

• Will information or results from the research be used for commercial gain?

• Who can I contact if I have questions about the research?

• Who can I contact if I have questions about my rights?

• Has an Institutional Review Board (IRB) approved this research?

• Is there a written consent document for this study? If so, how do I get a copy of the consent document?

• Will the results of this research be shared with me?

Understanding Clinical Trials – information from the National Cancer Institute (NCI)

Introduction to Clinical Trials - information from www.ClinicalTrials.gov

Additional Information about Children and Participation in a Clinical Trial

Children's Assent to Clinical Trial Participation – information from the National Cancer Institute (NCI)