The IPAA Center
Research Information for Investigators
Using Data from the Ileal Pouch-Anal Anastomosis Registry
- What is the Ileal Pouch-Anal Anastomosis (IPAA) Registry?
- What data are available from the Registry?
- Who can use Registry data?
- What must I do in order to obtain Registry data?
- What do we ask of you?
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 placement of the participants’ identifiable medical information related to their IBD and IPAA in a research database; and
- the use of this information for retrospective research studies.
The second level of participation includes the above and:
- additional contact outside of clinical care concerning health outcomes; and
- the option to be recruited for participation in future research studies. Participants who agree to the optional recruitment may choose to be contacted only by Registry investigators or by any Boston Medical Center (BMC) or Boston University Medical Center (BUMC) investigator.
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:
- An IRB approval or exemption letter. Data is released for use only for the study named on the letter. Use of Registry data for any other study or purpose is prohibited. For guidance on submitting a study to the BUMC IRB, please refer to their website. If you have specific questions about the Registry when completing your submission, please send an email.
- A Registry-specific Data Use Agreement. You must review and sign one of the three Registry-specific Data Use Agreements. Choose the appropriate Data Use Agreement for your study:
- De-identified information for a data set that does not contain any identifiable information. A complete list of data that is included can be requested by email.
- Limited Data Set for a data set that excludes most identifiable information, but contains certain identifiers such as dates, cities, states, and zip codes. A complete list of data that is included can be requested by email.
- Identifiable information for a data set that includes any identifiable information that does not meet the criteria of a Limited Data set.
- A list of requested variables. You may either provide your own list or submit a copy of the List of IPAA Registry Variables noting your requested variables. The List of IPAA Registry Variables can be requested by email.
- A completed Application to Use IPAA Registry Data.
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.