Mammogram Study Fact Sheet
Study Title: Nurses’ Mammogram Sub-Study
Principal Investigator: Francine Laden, ScD
Contact information: nhs3@channing.harvard.edu
Purpose of this research
This is a research study. The purpose of this research is to collect digital mammograms and to understand how environmental factors and social drivers of health influence mammographic features. The long-term goal of the research is to learn how exposure to these factors impacts mammographic risk markers and breast cancer.
Mammographic density (i.e., the proportion of breast tissue on a mammogram that is radiodense and appears light) is one of the strongest risk factors for breast cancer and is considered an intermediate risk marker. Thus, studying factors that can influence mammographic density and other breast characteristics seen on mammograms is important in identifying ways to prevent breast cancer.
Combining mammogram data with the detailed information NHS3 participants have provided on their follow-up questionnaires, we will be able to learn valuable information about
breast cancer risk and prevention.
Who takes part in this research and why
About 4,000 participants will take part in this research study. All subjects are also participants in the Nurses’ Health Study 3. Many participants may take part in this study because they think environmental exposures and breast cancer are important topics of research. We couldn’t do this research without our participants.
Participation
Your participation is voluntary, and you can stop at any time. As always, not participating in a sub-study does not affect your status as a valuable member of NHS3. If you receive care at Mass General Brigham, deciding not to participate won’t affect medical care you receive at Mass General Brigham now or in the future, or any benefits you receive now or have a right to receive.
Participation involves:
- Providing information for the clinics/hospitals where you received mammograms, as many as you can remember.
- Signing a consent form and medical record release form.
Data linkage with data from other studies
The data collected in this sub-study will be de-identified by trained study staff. The de-identified data will be combined with the responses you have provided on other NHS3 questionnaires to be analyzed by approved NHS3 researchers. This will create a valuable resource for us to study many questions related to breast cancer.
Data sharing with other researchers
Your de-identified information may be used or shared with other researchers without your additional informed consent.
Information collected will not be used in clinical care.
Any risks associated with participation
The only foreseeable risk associated with this study is the unlikely and minimal risk of a breach of confidentiality. Protection is in place as described below.
Confidentiality and data security
We believe the risk of breach of confidentiality is minimal, given the protections in place. These protections include maintaining data in a secure, password-protected computing system, which is kept totally separate from the contact information of study participants. Participant names and contact information reside on a separate server. Participant data are identified by ID number only. Access to the data is provided through secure logins and granted on an as-needed basis. We have never experienced a breach of confidentiality.
This research is covered by a Certificate of Confidentiality from the National Institutes of Health. This means that the researchers cannot release or use information, documents, or samples that may identify you in any legal action or suit unless you say it is okay. They also cannot provide them as evidence unless you have agreed. This protection includes federal, state, or local civil, criminal, administrative, legislative, or other proceedings. An example would be a court subpoena.
Privacy of Health Information
We are required by the Health Insurance Portability and Accountability Act (HIPAA) to protect the privacy of health information obtained for research. This is an abbreviated notice and does not describe all details of this requirement. During this study, identifiable information about you or your health will be collected and shared with the researchers conducting the research. In general, under federal law, identifiable health information is private. However, there are exceptions to this rule. In some cases, others may see your identifiable health information for purposes of research oversight, quality control, public health and safety, or law enforcement. We share your health information only when we must, and we ask anyone who receives it from us to protect your privacy.
There are some important things that you need to know. The Certificate DOES NOT stop reporting that federal, state or local laws require. Some examples are laws that require reporting of child or elder abuse, some communicable diseases, and threats to harm yourself or others. The Certificate CANNOT BE USED to stop a sponsoring United States federal or state government agency from checking records or evaluating programs. The Certificate DOES NOT stop disclosures required by the federal Food and Drug Administration (FDA). The Certificate also DOES NOT prevent your information from being used for other research if allowed by federal regulations.
Researchers may release information about you when you say it is okay, including as described in this form. For example, you may give them permission, as you are doing in this form, to release information to insurers, medical providers or other persons not connected with the research. The Certificate of Confidentiality does not stop you from willingly releasing information about your involvement in this research. It also does not prevent you from having access to your own information.
You are agreeing to the collection, use, and sharing of your identifiable information as described in this information sheet. In this study, we may collect identifiable information about you from medical records and from research procedures, including but not limited to research visits, tests, interviews, and questionnaires. Those who may see, use, and share your identifiable information include Mass General Brigham researchers and staff, sponsors of the study and those who the sponsor hires to help perform or audit the research, other researchers, the Mass General Brigham ethics board, groups that oversee the data and safety of this study, non-research staff at Mass General Brigham to conduct their jobs, such as for treatment, payment (billing), or hospital operations, and those hired to conduct work for us, as well as federal and state agencies that oversee, evaluate and audit research, and public health and safety authorities, as noted above.
Contact information for questions
If you have questions about this sub-study, please contact us at nhs3@channing.harvard.edu
IRB contact information
If you would like to speak to someone not involved in this research about your rights as a research subject, or any concerns or complaints you may have about the research, contact the Mass General Brigham Human Research Committee at (857) 282-1900.
Sponsor of this research
This research is funded by the National Institutes of Environmental Health Sciences of the National Institutes of Health.