IMACS Standard Operating Procedure
The purpose of this document is to describe the steps of a research project. We always expect the process to be fully collaborative and we expect the process to result in a publication. The IMACS Research Committee (RC) is ultimately responsible for the entire process. The IMACS DCC at KIRSO will assist the IMACS Research Committee. The following steps of the entire research process are necessary to ensure both good science and good process. For ease of use, the dates listed in these steps are assuming that the abstract and paper will be submitted to the International Society of Heart and Lung Transplant.
1. Call for proposals:
Proposal submissions are welcome from IMACS members in good standing at any level of career, however, authorship of the application by a trainee or junior faculty member (assistant professor level) is strongly encouraged. If the proposal is developed with major input and/or supervision from a senior faculty member of the applying institution or member of the research committee of the IMACS, this should be indicated on the application. If the applicant suggests that the proposal would strongly benefit from inclusion of an external specialist (e.g. Oncologist, Nephrologist, Neurologist, Geneticist etc.) as part of the writing group, this should be indicated in the application and suitable individuals should be named in the application including contact information. Applications are limited to one proposal per applicant; each institution may submit multiple applications with different primary applicants.
2. Submission of a research proposal:
The purpose of the proposal is to present the background, specific aims/hypotheses, and strategy for utilization of IMACS data, anticipated results and a brief timeline. See Exhibit A for the IMACS application. In order to ensure a fair and timely process, applications will not be accepted from researchers who have research projects that have not yet resulted in a submitted manuscript. This requirement may be waived at the discretion of the Research Committee. The timeline for proposal submission and notification is shown in Exhibit B.
3. Review of applications by the Research Committee:
The RC will review each proposal for both scientific merit and the ability of IMACS data to answer the hypotheses and aims. Before review of a proposal, the IMACS DCC will update the RC on the regulatory status of the applicant's institution, including current status of the local IRB approval, and current completeness of IMACS data. If necessary, the committee will ask the applicant to participate in the conference call to present his or her proposal and/or answer questions about the proposal. Research committee members will score the projects using Exhibit C. The research committee representatives from each collective are responsible for reviewing internal studies to ensure overlap does not exist with a project being conducted by the individual collective.
4. Notification of acceptance/rejection of proposal:
The Vice Chair of the RC will provide written notification of the proposal status to each applicant as outlined in Exhibit B. In addition to acceptance or rejection, the RC may choose to delay a proposal for various reasons (e.g. additional data collection). The RC will also create a writing group consisting of other IMACS Investigators as outlined in the charter.
One RC member will be assigned to each accepted project to serve as the Project Liaison. The role of this individual will be to:
- Collaborate with DCC statisticians and primary investigators on study design and analysis
- Assist in developing timelines in line with Exhibit B
- Ensure the study stays within scope of the submitted proposal
- Provide critical review of abstracts, presentations, and the final manuscript
- Confirm all authors have had the opportunity to review manuscripts and provide comment prior to submission
- Ensure all IMACS projects are submitted to the entire RC for review and approval.
5. Authorship and Writing Group Selection:
- For each research proposal and data analysis, a principal investigator will be assigned by the IMACS® Steering Committee to serve as chairperson of the project writing group (WG).
- The Principal Investigator assigned to each specific research proposal and data analysis will be primarily responsible for all phases of manuscript preparation, from conception through publication. Responsibilities include:
- Preparation of project outlines and the identification of data analyses needed from the DCC
- Assignment of tasks to WG members, clear deadlines for completion of these tasks, and assuring that the tasks are completed on schedule.
- Assuring that the manuscript has approval of the WG before submission of the penultimate draft to the IMACS® Steering Committee.
- Ensuring all abstracts, presentations and manuscripts are submitted to the IMACS® Research Committee (RC) for approval.
- Submission of the order of authorship on the manuscript to the IMACS® RC. The major criterion for this determination will be the effort and contribution made by the members of the WG in preparation of the manuscript. (WG members who do not contribute substantially shall not be listed as authors.) Final approval of the order of authorship will be made by the IMACS RC.
- Recommendation of a journal to which the manuscript should be submitted with priority given to The Journal of Heart and Lung Transplantation.
- Correspondence with co-authors, communication with the IMACS® RC, responses to the pre-submission ISHLT review, and correspondence with journal editors.
- The rest of co-authors will be assigned as follows:
- One member of the Research Committee will be assigned as the Project Liason.
- Senior author proposed by the Principal Investigator. If the Principal Investigator has no senior author, the Project Liason could act as senior author or suggest a senior author.
- One member from the DCC
- The IMACS Chair and the IMACS Vice Chair of data studies
- Members from each of the collectives participating in IMACS: INTERMACS (N=3), EUROMACS (N=2), JMACS (N=1), UK registry (N=1), RENACER (N=1) and one representative from a non-collective participating center (N=1). This will be updated as more collectives start uploading their data to IMACS.
The positions in each collective will be offered to IMACS centers based on their previous inclusion in writing groups. Each collective can decide how they will distribute their authorship positions.
For non-collective participating centers, authorship will be assigned following a list of centers ordered by number of implants. Centers who have contributed data for less than 3 years to IMACS will not be included in the selection. - The Principal Investigator can suggest up to 2 other co-authors with due justification.
- The offer for authorship will be sent to all PIs of the selected institutions and nominations of the individual to participate in the project can be determined internally by that institution.
- If writing group members have to be removed from authorship due to journal restrictions, these individuals will be offered a position in a project in the next proposal cycle.
- The first and senior author of the project will arrange a discussion call regarding study design, methodology and core data analysis with the IMACS statistical and support staff and the Project Liaison prior to a first writing group call. Deadlines for abstract submission and preferred journal for submission can also be discussed / established at that time.
6. Applicant becomes the principal investigator:
Once a proposal is accepted, the applicant now becomes the principal investigator for the study, also referred to as lead investigator. The principal investigator is responsible for all steps of the research project.
- For analyses performed by the DCC: The IMACS DCC will collaborate with the lead investigator but the primary responsibility for the research project belongs to the lead investigator.
- The lead investigator should provide suggestions for co-authors to the IMACS RC.
7. Detailed plan of work:
The lead investigator will create a detailed plan of work including a quantitative review of the literature, specification of the endpoints, creation of templates for figures and tables, anticipated results of the analyses and a detailed timeline.
8. The research collaboration:
The actual analyses will be a collaborative effort. The IMACS DCC will produce the requested analyses and will review these analyses with the lead investigator. The lead investigator is responsible for updating and including all members of the IMACS Writing Group assigned to his abstract, including scheduling of regular conference calls, email updates, etc. for all steps of the project including detailed analyses plans, abstract generation and manuscript preparation.
9. Abstract:
The lead investigator will generate the abstract based on the collaborative analyses. The proposed abstract must be completed one month prior to the submission deadline.
- For analyses performed by the DCC, the IMACS DCC and the IMACS RC will review during the month before the deadline. The lead investigator is responsible for distribution of the proposed abstract to the co-authors and to the current members of the IMACS DCC.
- Actual submission of the abstract will be done by the lead investigator.
- Once the principal investigator is notified that the abstract is accepted for presentation at a meeting, the principal investigator must notify the co-authors, and the IMACS RC.
10. Manuscript:
The lead investigator is responsible for generating the manuscript.
- For analyses performed by the DCC, the IMACS DCC will produce the “journal ready” figures and tables using precise direction from the lead investigator.
- The lead investigator is responsible for circulating the manuscript to the co‐authors and providing the IMACS DCC with a copy one month before submission for review by the Research Committee. Ideally, the manuscript would be submitted to a journal at the same time of the ISHLT presentation. The IMACS leadership strongly recommends that the manuscript be submitted at the time of presentation.
11. Presentation:
- The lead investigator is responsible for the presentation.
- For analyses performed by the DCC, the IMACS DCC will almost always prepare the figures and the tables.
- The lead investigator must circulate the presentation to the co-authors.
12. Adjudication of Disagreements (Writing Groups):
Appeals regarding the selection of WG membership and assignment of Chairperson will be sent to the IMACS® Steering Committee at which time a conference call will be arranged among the investigator submitting the appeal to attempt resolution.
Disagreements between authors will be settled by discussion and consensus whenever possible or, if consensus cannot be achieved, by the IMACS® Steering Committee.
13. Adjudication of Disagreements (Authorship):
Disagreements regarding authorship, which cannot be resolved by the Chairperson of the WG, will be resolved by the IMACS® Steering Committee and ISHLT Board.
14. Informal Presentations:
Presentations of the study rationale, design and plan of the study are encouraged as a recruiting strategy to begin at any time and continue throughout the study. However, presentation of outcome data prior to its formal presentation at a national meeting and based on a printed abstract is prohibited. These data should be regarded as privileged by IMACS® investigators until they become part of the public domain. Caution is required about undue publicity about data presented orally but not published as well.
15. Destruction of IMACS data:
It is the responsibility of the principle investigator to destroy all IMACS data within 24 months of project acceptance or upon acceptance of the final manuscript, whichever comes first. It is also the responsibility of the principle investigator to notify IMACS in writing the data of data destruction.