Consent History Tracking
Data and material distributions from the Framingham Heart Study are made in accordance with the individual consent history of each participant.
The documentation of informed consent at the Framingham Heart Study began under the auspices of the National Institutes of Health and Boston University Medical Center in 1971 during the first examination cycle of the Offspring Cohort and then the 12th examination cycle of the Original Cohort. The first consent form had only two sentences of text along with the record number, signature and date of the examination.
The text of the first consent form reads "I have been fully informed of the nature of this study which includes a medical history, physical examination, blood tests and electrocardiogram and give my consent to be examined. I also authorize the Framingham study staff to secure pertinent medical information from my family, physician, and/or hospital records for the purposes of this study."
Subsequent versions of the consent form became longer and more specific in details and more complex in structure. Check boxes were added in recent years to capture specific permissions for some aspects of the protocol. All consent forms, after being read and signed by the participant at the start of each new examination, were filed in the participant's main chart along with the examination forms and kept in the Framingham Heart Study record room. In the year 2000, the National Heart, Lung and Blood Institute requested that a review be made of all consent forms signed by Framingham Heart Study participants over the years. Data collection forms were designed to record every consent form each participant signed and included the following fields:
- Idtype (study group number)
- Identification number of the participant
- Examination date
- Examination number
- Correspondence of date of examination and date of consent form (Y/N)
- Version number of the consent form,
- Physical examination was obtained (Y/N)
- Consent for cell line was obtained (Y/N)
- Comment code for deviations and ad lib restrictions.
The consent review began in August of 2000 and was completed in January of 2001. Following the abstraction of data from individual consent forms, the text of the various versions of the consent forms were reviewed and analyzed so that permissions and restrictions of each version could be coded. This effort resulted in a database that has since been updated regularly with information from new consent forms. The consent history data set contains the most recent information concerning consent granted by any and all Framingham Heart Study participants. The most recent versions of the Framingham Heart Study consent forms of each cohort for the core protocol are posted here.
The research protocols of the Framingham Heart Study are reviewed annually by the Institutional Review Board of the Boston University Medical Center and by the Observational Studies Monitoring Board of the National Heart, Lung and Blood Institute. Since 1971, written consent has been obtained from participants before each examination. Information about the content of the Framingham Heart Study research examinations is presented to the participants at each examination cycle in the text of the corresponding consent form and in a discussion with a trained admitting coordinator at the beginning of the scheduled appointment. In the most recent cycle of examinations, check boxes have been used to capture the specific levels of participation selected by each participant. Information from every completed consent form is coded and recorded in a database. The most recent version of the consent forms for each cohort are displayed here.