All Diabetes & Women’s Health Study contact information and data from questionnaires and specimen analyses are kept strictly confidential. Your private contact information (name, address, telephone number and/or email address) are known only to authorized persons at the clinical site (i.e., the Channing Laboratory at Brigham and Women’s Hospital). No one else, including the researchers at NIH and the Data Coordinating Center have access to your contact information. No other organization or persons will ever contact you regarding this study.
The data you provide via questionnaires and biological specimens will be kept confidential and will be anonymously used in the research to understand the role of gestational diabetes and other factors as risks in developing Type 2 Diabetes. In the US the Diabetes & Women’s Health Study complies with the Health Insurance Portability and Accountability Act (HIPAA) and the requirements of the Institutional Review Boards (IRBs) for Brigham and Women’s Hospital/Harvard School of Public Health (HSPH)/ Partners HealthCare and the Data Coordinating Center at the EMMES Corporation in Rockville, Maryland. To protect the confidentiality of each participant their data are assigned a unique ID number that is entered on paper forms and used as a username in combination with a unique password for web-based data entry. This ID links all your study information together without the use of your name. Only the site that recruited you to the study knows your identity and this information will never be shared with anyone outside that site.
In the US your data is also protected by a Certificate of Confidentiality issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure. This allows the investigators and other research staff who have access to the study research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative or other proceeding, whether at the federal, state or local level.
Your private contact information is maintained securely only at the clinical site that recruited you. Your confidential research data, identified only by the assigned ID number, is collected in a central database at the Data Coordinating Center that is protected by industry standard physical and logical security controls defined in an Information System Security Plan (ISSP). Online access to submit your data requires authentication using the assigned ID number and password, which should be kept secure and not shared with anyone. All data sent between the data system and the participant’s computer is protected by 128-bit SSL data encryption. Once your questionnaire data are finalized and submitted no further access for data entry may occur using this ID number and password.
Federal research regulations require us to include the following information:
There are no direct benefits to you from participating in this study. The risk of breach of confidentiality associated with participation in this study is very small. Your choice to participate in this study is completely voluntary and you may decline or withdraw at any time without penalty.
You may skip any question you do not wish to answer. You will not receive monetary compensation for participating.
If you have any questions regarding your rights as a research participant you are encouraged to call the appropriate representative:
In the US, the representative of the Human Subjects Committee at the Harvard School of Public Health (617-384-5480).