Research Information for Investigators
Using Data from the Ileal Pouch-Anal Anastomosis Registry
The Ileal Pouch-Anal Anastomosis Registry (“Registry”) tracks data from patients who have undergone an IPAA procedure. There are two levels of participation in this Registry. The first level of participation involves:
The second level of participation includes the above and:
The Registry study is presented to all patients meeting eligibility criteria who are seen in the Dempsey Center for Digestive Disorders (CDD) clinic. Patients who provide informed consent participate in both levels of the Registry. We have also attempted to contact all patients meeting eligibility criteria who have not been seen in the CDD clinic since the study was approved by the Boston University IRB (November 23, 2009). If contact was successful and these patients provided informed consent, they participate in both levels of the Registry. Retrospective data from patients we were unable to contact was placed in the Registry under an approved Waiver of Authorization.
A list of all variables included in the Registry is complied in our List of IPAA Registry Variables. This can be requested by email.
Registry data will be shared with anyone who receives IRB approval or exemption for a study involving the use of Registry data. Please note:, data containing identifiable information cannot be released to anyone who is not affiliated with BMC or BUMC. Information considered identifiable is noted in the List of IPAA Registry Variables.
Registry data will not be released to an investigator until the following four items are on file:
Data from the Registry is provided to Investigators with the understanding that they will abide by polices stipulated by the Registry in the Data Use Agreement and set forth by the IRB that approved the study. We also emphasize that Investigators take reasonable steps to safeguard Registry Data in order to protect the privacy of the participants.
Investigators who receive identifiable information (including data that is provided in a Limited Data Set), may be given a Master List in addition to your data set. The Master List links your data set to an identifier (e.g. a Medical Record Number). This list must be stored in a secure location, away from your data set.
Investigators are not permitted to make duplicate copies of data files provided by the Registry. Data stored on BMC and BUMC network drives are backed-up. For this reason, the relevant IT department will need to be consulted in order to permanently remove any data stored on these drives. Should you store the data on a portable drive and subsequently misplace the drive, you may need to promptly report the loss to the Registry, depending on the Data Use Agreement signed. Investigators should also consider investing in an encrypted portable drive.
Finally, although several categories of medical record information are considered identifiers (such as medical record numbers and admission dates), a person’s name is much more readily identifiable. For this reason, we strongly urge you not to use participant names or initials anywhere in your data set.