There are three potential research directions that will involve the IIRTA

1. International Intestinal Failure Registry (IIFR) and International Transplant Registry (ITR) studies

   The IIFR was developed to provide the international intestinal rehabilitation and transplant community with accurate data on the outcomes and course of intestinal failure to support research, quality improvement and policy development. Data collected includes demographic characteristics, diagnoses, surgical history, bowel anatomy, nutritional history, medical therapies, medical/surgical complications, development status and overall patient outcomes.

   The mission of the ITR is to provide data on the outcomes of intestinal transplantation. The registry has been collecting data on worldwide outcomes since 1985. Data collected includes donor information, recipient demographics and pre-transplant diagnosis/status, type of transplant, post-transplant status and complications.

   The data collected as part of the IIFR is comprehensive and is the largest multicentre collection for intestinal failure data. Access to data to answer relevant research questions is encouraged to further advance knowledge in the field as the registry continues to grow.

2. Multicentre collaborations

   The Scientific Committee is strategically positioned within the IIRTA to provide oversight and guidance for scientific and research endeavours. As such there may be opportunity to facilitate the development of multicentre collaborations

3. Guideline and Position Statement development

   The Developing clinical guidelines and position statements have been identified as a priority for the IIRTA to provide and promote evidence-based practices. Clinical guidelines involve the systematic development of evidence-based recommendations that guide care for the intestinal failure and transplant populations on a variety of topics. Guidelines are developed by experts in the field based on evidence available from a rigorous review of the published literature.

The Scientific Committee and IIFR committee are an IIRTA committee. The committees supports the development and delivery of research in intestinal failure/intestinal transplantation.

1. Facilitating Use of Data

   The Scientific and IIFR Committees facilitates the use of data from the IIFR /Intestinal Transplantation Registry (ITR) or connecting collaborating centres to achieve the highest scientific benefit. Scientific proposals should be directed to the IIFR/ITR for review by their review subcommittee (ITR research to the scientific committee and IIFR research to the IIFR committee). Representatives from the IIFR/ITR will provide regular updates to the Scientific committee regarding ongoing studies. Considerations for clinicians/researchers submitting proposals include:

   1. Scientific Merit

      Ensure research studies have scientific merit to warrant the use of data/resources being requested. See section 4.1.1 (Study Proposal Submissions) for details on what should be included for proposal.

   2. Justification of Resources

      Although data is provided in kind for PI’s (for non-industry studies), the IIRTA does not provide research supports (i.e. research coordinator, statistician). Once a study is approved by the IIFR and ITR subcommittee’s registry personnel will provide the appropriate cut of data based on study proposal objectives in kind based on current funding availability (this is subject to change). Investigators need to demonstrate they have adequate resources to facilitate delivery of study objectives. Due to limited resources industry-initiated studies will require funding for registry personnel to prepare appropriate cut of data. Conflict or scientific overlap with another study.

      There is potential for a conflict to arise when there is overlap between two study proposals. To gain approval to utilize data in a similar method to a study already in progress the investigator would need to provide evidence of a different utilization of data (i.e. variation in outcome evaluated, methods utilized). A study that cannot demonstrate alternative outcomes/methods that would interfere with the completion of an ongoing study will not be approved. PLEASE NOTE: It is expected that studies will reach the dissemination phase of the study (e.g. presentation at research meeting/publication) within two years of data release to allow other investigators to evaluate outcomes that may have overlapping data.

   3. Eligibility to complete research using IIFR or ITR data requires:
      1. Active membership in IIRTA for the duration of the study
      2. Centre contribution to IIFR/ITR within the past 5 years

   4. Confidentiality – all submissions to the IIFR/ITR subcommittee including bi-annual updates to the scientific committee will remain confidential until completion of the study with submission of abstract/manuscript.

1. International Intestinal Failure Registry and Intestinal Transplant Registry Studies/Multicentre Collaborations:

   Any primary investigator (PI) or co-investigator who demonstrates an active IRTA membership and a contributing center to the IIFR/ITR may submit a study proposal.

1. Study proposal submission (submitted to IIFR and ITR subcommittees for review):
   1. Abstract: A succinct summary of the proposed study that includes the primary question, aims and hypothesis.
   2. Background/Significance: A brief review of the supporting research.
   3. Study design: A brief description of how the study will be executed including the population, inclusion/exclusion criteria, outcomes measures, primary and secondary objectives, research methods. Also include sample size calculation if indicated.
   4. Impact on IIRTA: Description of what will be required for the IIRTA/IIFR/ITR.
   5. Contribution: What the study will add to the scientific understanding of intestinal failure/intestinal transplant.
   6. Budget: Provide an estimate of research costs. Budget should include expected cost of IFR resources. Source of funding and/or plans for external funding and deadlines for application should be indicated.
   7. Publication/presentation: Describe expectations for presentation and publication.
   8. Timeline: State expected timeline for study completion.
   9. Proposals should be limited to 2-3 pages in length.

2. Access to Data:

   Data sharing will be according to the Data transfer agreement signed between the participating center and the TTS on behalf of the IIRTA. Centers that did not sign a data transfer agreement will not have access to the registry data.

3. Study Progress Updates:

   Updates twice per year will be submitted to IIRTA Scientific Committee or IIFR committee (if based on IIFR data), including:

   1. Guideline committee membership, role and responsibilities
   2. Guideline / study progress
   3. Complications to date
   4. Next steps including plan for review
   5. Updated timeline
   6. Bi-annual updates should be limited to 2 pages
2. Clinical Guideline / Position Statement

   Any clinician/investigator who demonstrates an active IIRTA membership may submit a proposal for the development of a clinical guideline/position statement. Publication of guidelines/position statements through involving the endorsement of the IIRTA will require guidance and feedback from the Scientific Committee. IIRTA supports the use of the GRADE system for guideline development.

   1. Guideline/Position Statement Proposal Submission:
      1. Abstract: Clearly state the goal of the guideline/position statement, objective and audience.
      2. PICOT: Review PICOT questions to be answered.
      3. Experts: Identify committee of experts that will be involved in guideline/position statement development.
      4. Strategy: Outline search strategy to be utilized for obtaining literature and discuss how data will be reviewed and presented (e.g. GRADE, other method).
      5. Publication/presentation: Describe expectations for presentation and publication.
      6. Timeline: State expected timeline for study completion.
      7. Proposals should be limited to 2-3 pages in length.

   2. Guideline/Position Statement Progress Updates:

      Updates twice per year will be submitted to Scientific Committee, including:

      1. Guideline/position statement committee membership, role and responsibilities
      2. Guideline/position statement progress
      3. Complications to date
      4. Next steps including plan for review
      5. Updated timeline

   3. Review Process

      Review of the guideline/position statement will take place to ensure accuracy and appropriate reporting of data if to be endorsed by the IIRTA.

      1. Submission of publication to the Chair of the Scientific committee after final review by all authors.
      2. Chair of Scientific Committee will circulate to IIRTA board for review
      3. Board will review at their next scheduled meeting (allowing for a minimum of 7 days to review).
      4. Possible outcomes of review:
         1. Acceptance and endorsement of guideline/position statement as is
         2. Acceptance and endorsement pending minor revisions
         3. Acceptance and endorsement pending major revisions
         4. Rejection

Publications and abstracts arising from studies utilizing IIFR data or ITR driven multicenter collaborations must be reviewed with the IIRTA Scientific Committee prior to submission. The purpose of the review is to ensure statements made based on IIFR / ITR data are accurate and resources that are utilized in the delivery of the study objectives are appropriately acknowledged. A secondary purpose is to ensure that there is no conflict or overlap with another existing approved or proposed study.

1. Abstract/Presentation submission

   Abstracts arising from partnerships including multicentre collaborations and use of data from the IIFR/ITR will be required to go through a review process by the IIRTA Scientific Committee (ITR related research) and the IIFR committee (IIFR related research). Submission to the IIRTA Scientific and IIFR committees involve:

   1. Abstract sent to the chair of the Scientific Committee or IIFR committee (if based on IIFR data) at time of submission to scientific meeting.
   2. Abstract will be circulated to the Scientific Committee or IIFR committee for review and authors contacted with outcome of review and any comments from committee members.
   3. Results of the review may include:
      1. Acceptance and endorsement of manuscript as is
      2. Acceptance and endorsement pending minor revisions
      3. Acceptance and endorsement pending major revisions
      4. Rejection
   4. Notification of the abstract review will be sent from the chair of the Scientific or IIFR Committees or their delegate at least 5 days prior to abstract submission deadline.
   5. Presentations (oral or poster) arising from studies facilitated through the IIRTA Scientific or IIFR Committees will not require approval, however the IIRTA appreciates being informed about presentations and will provide review of material if requested. It is expected that any presentation arising from IIFR/ITR or multicentre collaborations facilitated by the IRTA would include appropriate acknowledgement.

2. Publication utilizing data from IIFR/ITR and/or multicenter collaborations submission

   Publications arising from partnerships including multicentre collaborations and use of data from the IIFR will be required to go through a review process. Manuscripts should include:

   1. An acknowledgement of the IIFR/ITR/IIRTA as a source of data
   2. Authorship statement: Author list will include the research team, IIFR/ITR director, and then a statement stating “on behalf of the IIFR or ITR” in the author list. All site PI’s at centres who contributed data to the IIFR or ITR (depending on the registry used in the publication) will be included in the publication as collaborators.
   3. Draft manuscript should be sent to the chair of the Scientific or IIFR Committee for review (can be delegated by the Committee Chair to another member of the committee if deemed appropriate). Authors should specify target journal.
3. Review Process

   Review of the manuscript/guideline/position statement will take place to ensure accuracy and appropriate reporting of data. If during review of proposed publication overlap or conflict with other ongoing IIRTA/IIFR/ITR studies is discovered, permission to publish may be denied or revisions to the manuscript requested.

   1. Submission of publication to the Chair of the Scientific committee or IIFR committee (if based on ITR/IIFR data) after final review by authors.
   2. Reviewer for paper (either by the chair of Scientific/IIFR Committee or delegate) will be identified within 7 days of submission.
   3. Reviewer will send review to chair and corresponding author within 30 days of receipt.
   4. Possible outcomes of review:
      1. Acceptance and endorsement of manuscript as is
      2. ii) Acceptance and endorsement pending minor revisions
      3. Acceptance and endorsement pending major revisions
      4. Rejection

4. Conflict resolution

   If a manuscript or guideline/position statement is not accepted upon initial review by the Scientific Committee further review and discussion can be escalated to the IIRTA Board.