Research Request Process and Considerations
Our research process generally follows the steps presented below. At any time, interested investigators may contact GIQuIC via firstname.lastname@example.org with questions.
- Investigators complete a brief, standardized Project Pre-Proposal form, indicating the hypotheses to be addressed, the data requested to address the hypotheses, the expected results, and the plan for dissemination of information. Logistical information, including the name, address and affiliations of the principal investigator, similar data for co-investigators and funding sources of the work will be disclosed. The purpose of the Project Pre-Proposal is to immediately identify proposed research that is not feasible given the data in the registry, or does not comply with other aspects of allowable research as described in GIQuIC governance documents, so that neither investigator nor staff time is needlessly put toward further effort. Please email email@example.com to request the form.
- After review of the Pre-Proposal, the investigator will be contacted by a GIQuIC Data Analyst to review any preliminary questions and to discuss the feasibility of the proposed project. The purpose of this consultation is to further assure feasibility, not to perform the research or provide extensive consultation as to study design. The GIQuIC Data Analyst will furnish the investigator with the standard Research Project Proposal Instructions. The more in-depth Project Proposal includes questions regarding the project background/significance, research question and/or hypothesis, and specific aims. Proposals will also include an overview of methodology and statistical analyses. A Conflict of Interest (COI) form will be completed.
- Upon receipt of a completed Project Proposal and COI form, a GIQuIC Data Analyst will contact the investigators to inform them that the submission has been received and, if necessary, to review any items that require immediate clarification. If necessary, preliminary edits to the Project Proposal may be suggested or requested.
- If the COI form indicates a potential conflict of interest with the proposed work, this form will be forwarded to the chair of the Research Committee for evaluation and determination of disposition. The chair may either approve the work, approve the work with conditions for disclosure, or decline to involve GIQuIC in the work in cases of irredeemable conflict of interest. In complex situations, the chair may elect to bring potential COI to the entirety of the research committee for resolution.
- The GIQuIC research staff will review the Project Proposal and provide the proposing researchers with an estimated cost of the research and proposed timeline for completion of the work. The proposing researchers will review this estimate, and either approve it as written, or modify the research plan in collaboration with the GIQuIC team to bring costs within their budget. An approved, mutually agreed-to budget is required for the proposal to move forward.
- Refined proposals with accompanying budgets will be presented to the GIQuIC Research Committee on a quarterly basis. Among other considerations, proposals are evaluated for feasibility, novelty, potential impact/importance to the GI community, and overlap with other GIQuIC research projects. Only those research projects for which adequate person-power for execution will be approved at one time.
- Once approved by the Research Committee, the GIQuIC Publication Agreement should be signed and submitted to GIQuIC within 14 days by both parties.
- Upon receipt of the signed Scope of Work, Publication Agreement, and a mutually agreed upon payment schedule, a GIQuIC data analyst will initiate the analysis and regularly communicate progress to the Principal Investigator.
- If an investigator is applying for grant funding and wishes a letter of support to do an investigation in GIQuIC, proposals shall be submitted no fewer than 60 days prior to the deadline to allow for adequate processing time. GIQuIC will provide a letter of support once the grant submission and the scope of work have been approved. Due to the number and complexity of grants seeking to involve the Registry, GIQuIC is unable to provide pilot data without cost, and such requests should be submitted using the standard project request algorithms described in this document.
- Unless a GIQuIC Data Analyst is a named co-author of the manuscript and has approved the content, investigators are required to submit draft manuscripts to the Research Committee for review prior to submission for publication. The purpose of this review is to assure that the investigators have not inappropriately interpreted GIQuIC data, and this review will not serve to alter interpretations supported by the data. If concerns are raised by the Research Committee, resolution will be required via consensus between the Research Committee and the authors before submission for consideration of publication.
- If a manuscript has not been submitted to a peer-reviewed journal within 1 year of the receipt of final results completing the project, the Principal Investigator will transfer his/her rights to the use of those results back to GIQuIC.
- Consultation is available on a per hour basis for investigators who wish to consult with a GIQuIC analyst prior to the formulation of hypotheses and specific aims.
- If at any point during this process it is determined that the GIQuIC Research Data Warehouse is not an appropriate fit for a project, a research staff member will notify the investigator promptly.
- In the event proposed research is either identical to or closely resembles work already approved by the Research Committee, the investigators will be informed that the proposed study is already being undertaken, and therefore is not currently eligible for consideration. If, after publication of the earlier study, the research team can make a case that their research would substantially augment or differ from the earlier findings, the second study will become eligible for consideration.
ACG/ASGE Epidemiologic Research Award in Gastrointestinal Endoscopy Research Process
For potential GIQuIC studies that intend to apply for the ACG/ASGE Epidemiologic Research Award in Gastrointestinal Endoscopy, the research process differs from our standard research request process:
- Interested PIs must contact GIQuIC with their study idea and inform GIQuIC that they will be applying for the ACG/ASGE Epidemiological Research Award.
- GIQuIC research staff will collaborate with the PI to answer any questions about GIQuIC data and provide feedback about feasibility.
- The GIQuIC research committee does not review proposals that will be submitted to the ACG/ASGE Epidemiologic Research Award.
- Once the PI writes a proposal that is considered feasible in terms of the data collected by GIQuIC, GIQuIC will then provide a letter of support and scope of work (budget) to the PI to submit along with the research proposal to the ACG/ASGE.
Click here for more information about the ACG/ASGE Epidemiologic Research Award in Gastrointestinal Endoscopy.