Informed Consent, Part 5

by National Cancer Institute

(Page 5 of 5)

• CONFIDENTIALITY

This statement tells you the extent to which your information will be kept confidential. It should inform you about any groups or organizations that may have access to your records for quality assurance and data analysis (such as the National Cancer Institute, the Food and Drug Administration, or other trial sponsor).

• COSTS/ ADDITIONAL EXPENSES [What are the costs?]

This section indicates whether participating in the trial will result in added costs to you or your insurance company (see Clinical Trials and Insurance Coverage - A Resource Guide 15 for more information on this topic). It also covers other cost issues, such as who will pay for emergency medical treatment in case of injury or illness, whether you will have to pay for drugs that become commercially available during the trial (if this is a drug trial), and whether or not you will receive payment for participating.

• PARTICIPANT'S RIGHTS [What are my rights as a participant?]

The document should specify that:

1. your participation is voluntary;
2. you can choose not to take part or leave at any time without penalty or loss of benefits; and
3. any new information that might affect your participation will be shared with you.

• CONTACT INFORMATION [Whom do I call if I have questions or problems?]

You should have a contact name and phone number (usually of a member of the research team) for getting answers to questions about the study or a research-related injury. You also should be given a phone number for the Institutional Review Board or a patient representative, in case you have questions about your rights as a research participant.

• SUPPLEMENTAL INFORMATION [Where can I get more information?]

This section lists additional resources that may prove useful as you make your decision, such as NCI's Cancer Information Service, informational booklets, community organizations, and Web resources.

• THE SIGNATURE

Your signature represents your legal consent to participate in the trial.

If any of these sections appears to be incomplete or missing from the informed consent document, don't hesitate to ask for the information.

Other Useful Tips

Keep a copy of the informed consent document as a helpful resource for the duration of the trial. Ask for a copy if one isn't offered to you. You may also request a copy of the protocol (full study plan).

According to Federal regulations, no informed consent document may include any language that asks or appears to ask you to waive your legal rights, or that releases or appears to release the investigator, the sponsor, or the institution from liability for negligence.

If you cannot understand the forms you are signing, don't be afraid to let someone know that you are having trouble. If you have difficulties reading the document at first, try not to get upset. Many people feel anxious about reading and signing documents and communicating with physicians. Just take your time and ask for help when you need it.

Questions to Ask

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?

About the Author

www.nci.nih.gov
The National Cancer Institute's research programs are extensive and contain many innovative initiatives. I invite you to explore our Web site to find out more about the exciting work being conducted here at NCI and by NCI-supported scientists throughout the country.