Cancer Control Program

The Cancer Genetics Network (CGN)

An Invitation…

You are being invited to participate in a national research program called the Cancer Genetics Network (CGN). The CGN, sponsored by the National Cancer Institute, is enrolling participants throughout the United States. Georgetown is just one of several sites involved in this program.

Purpose

The main purpose of the CGN is to help scientists and health care providers understand the causes of cancer, and help them to detect, prevent and treat cancer. The CGN is inviting people who have had cancer and their families to be on a list, which is known as a registry, of people willing to be part of future cancer genetic research studies. Individuals without a personal or family history of cancer may also be included in the registry.

Some examples of future studies might include:

Identifying factors which affect a person's risk for getting cancer
Studying different types of drugs or treatments that might be used to prevent cancer

These types of studies need to have many people participate in order to get information that will be useful. Most research centers are not able to find enough people in their own areas to do these studies. The CGN will help by keeping a nation-wide list of people who are willing to be involved in studies. By combining participants from many centers, research may be done more quickly.

The CGN will also collect basic medical and family information on each participant. This information will be updated every year and may be useful in answering some basic research questions about cancer and genetics.

Benefits

There are no direct medical benefits to you from participating in the CGN. However, you or your family may benefit from receiving information about the causes, detection, prevention or treatment of cancer, and may have the opportunity to learn about future research studies. If you desire, Georgetown University will add your name to our mailing list for newsletters and brochures, as well as any publications that the CGN will provide in the future.

The main benefit of the CGN will be to society and future patients, if the information collected helps us to understand the causes of cancer and improve its prevention, detection and treatment.

Participation Requirements

Participation in the CGN is free. By enrolling, you are agreeing to the following:

To complete a 15-minute questionnaire by mail or telephone. You will be asked personal information such as age, gender, ethnic background, medical and family history, and health habits. This information is treated as confidential and will be kept within the Cancer Genetics Network. Please refer to the "Confidentiality" section.
To be contacted once every year to update your information, even if you do not participate in any future studies. To make this possible you agree to keep the CGN informed of any changes in your contact information.
To be contacted by other researchers and/or centers regarding future research studies for which you may be eligible. If you qualify for future studies within the CGN, the study purposes will be explained to you and you will have the option to participate. No information containing personal identifiers will be released to other researchers or centers without your express permission.

If you decide to participate in a future study, you will be asked to provide a separate informed consent form for that particular study. Depending on the type of study, you may be asked to consent to any or all of the following:

Authorize release of additional medical records, including results of genetic tests, if applicable.
Provide additional information such as could be obtained from a blood test or sample of tissue from a past surgery.
Undergo genetic testing on your blood or sample of tissue, the results of which may or may not be disclosed to you;
Obtain genetic counseling and testing which may provide you and your family members with information about the risk of cancer and other genetic disease.

It is possible that you may not be contacted about future research studies if you do not qualify for any of the proposed studies.

Voluntary Participation

Your participation is voluntary. Declining participation will not affect your health care at Georgetown University Medical Center. If at any time you decide you no longer wish to participate, simply notify the office and all of your records will be destroyed. Lastly, if you choose to participate in the CGN you will still be able to participate in other research studies unrelated to the CGN.

You will not be paid for enrolling in the CGN. You may or may not be paid for participation in future studies, depending on the individual project. There are no costs for participating in the national registry. Future studies may or may not involve a cost (for genetic counseling or testing, for example). You will always be notified of any possible costs before you consent to participate in a future study.

Possible Risks Associated With Participation

You may feel worried or sad when you are asked about your personal or family history of cancer.
Your may feel anxious when you are contacted in the future to update this information.
Although we make every effort to protect your confidentiality, there may be a small risk of loss of privacy from being part of a national registry. Please refer to "Confidentiality", below.

Confidentiality

The Cancer Genetics Registry is covered by a Certificate of Confidentiality issued by the National Cancer Institute on behalf of the Secretary of the Department of Health and Human Services. The certificate protects against the involuntary release of information about you collected during the course of this study, although such information can be released if you or your guardian requests it in writing. The researchers involved in this project can not be forced to disclose your identity or any information about you collected in this study in any legal proceedings at the Federal, State, or local level, regardless of whether they are criminal, administrative, or legislative proceedings. However, the certificate does not prevent the review of your research records under some circumstances (for example, under the Federal Food, Drug and Cosmetic Act or during the course of an internal program audit or evaluation.

Every effort will be made by Georgetown University staff to protect your privacy. All data collected for the CGN at Georgetown will be maintained on a stand-alone computer kept in a locked room. Only authorized Cancer Genetics personnel have permission to examine or change records in the CGN computer. In order to open the computer records, each authorized user of the database must use a password known only to the individual.

All of your personal information, including your name, birth date, address, etc. will be kept in a computer database separate from your medical information (i.e. cancer history, etc.). An identification number that can only be linked to your name by qualified research personnel will track all medical information. Only the personnel who are assigned to the CGN project at Georgetown University will be able to link these databases. Before the information from your questionnaire is sent to the national registry, all information that can identify you will be removed. Your information will be kept in the national registry using only a number, and not your name.

Because your contact information will only be kept at Georgetown University, you will only be contacted by a Georgetown University staff member, unless you give your permission for someone else to contact you. (For example, you may consent to participate in a CGN study that involves a telephone survey. When you give informed consent for that study, you would be asked for permission for that researcher to contact you directly.)

Contacts

If you have any questions or comments about the CGN or your rights as a participant, please do not hesitate to contact Angela Pinto, the CGN Coordinator at Georgetown University Medical Center, at (202) 687-8070.

Participant's Statement
(Available in PDF format - KB. Click here for more information on pdf format.)