Do I need to submit the Mentor-Mentee Compact at the same time as the Project Approval Request?
The purpose of the Mentor-Mentee compact is to document that a designated Mentor is established, including a plan for communication to ensure that you can make progress on your project. You do not need to have project details finalized because those details will go in your Student Scholarship & Inquiry Project Approval Form, which has a separate and later due date for most cohorts (cohort-specific deadlines are published in the restricted-access course website maintained by the university).
Would I need to meet for advising to have the project approved before initiating the IRB process?
In order to use the project to fulfill program requirements, the project approval is required at the start of the project. There is no requirement for an IRB status at the time of starting the Inquiry approval process. In some cases, IRB approval has already been received when the Inquiry project approval is requested. In other cases, IRB approval is part of the project start-up timeline. There are also scenarios when IRB approval is not required (e.g., systematic reviews, meta-analysis). There is no requirement to meet for advising before initiating an IRB process, but I have regular availability to meet for advising for questions, brainstorming, troubleshooting, advice, etc. Similarly, there is no requirement to meet before submitting an Inquiry Approval form, but I remain available to meet when it is helpful to you at any stage (planning, data collection, analysis, publication, post-publication). [See also Advising FAQs]
Does a systematic review project require IRB approval?
In most cases, systematic review projects do not require IRB approval because they involve analyzing and synthesizing data from already-published and publicly available studies. There is usually no participant-level individual data collection involved and any meta-analysis is using aggregated/grouped and publicly available data. IRB oversight is generally not needed for systematic reviews or meta-analysis projects. Of note, if your project involves any additional components beyond the review of published literature (e.g., surveys of experts, secondary analysis of unpublished data, or use of identifiable records), then IRB review may be necessary. Advisors and mentors are available to confirm expectations. [See also Topic Resources]
What is the typical timeline to receive decisions/feedback on Project submissions?
Decisions with feedback are generally provided within 1-2 weeks of project submission. Most initial submissions receive a "Revise and Resubmit" status with comments requesting specific information. The most common reasons for a "revise and resubmit" status are described in the next entry. It is common to receive "revise and resubmit" decisions at each stage of the research process (throughout every career stage), including but not limited to, Inquiry Project Approvals, IRB applications, manuscript submissions.
Do you have any advice on Project application submissions?
Common "revise and resubmit" requests include
The Data Analysis plan (sample size justification/power analysis and statistical analysis plan) is missing and is needed for review.
For chart reviews: What is the individual student responsibility for the number of charts to screen, review and abstract data? What is the abstraction burden in terms of number of measures, estimated time per chart review for data entry, etc.?
For chart reviews or data extractions: Please include a copy of the Data Collection Form.
What is the purpose of an iRIS account?
The IRB at the health system uses an electronic research submission process with an internet-based platform: "Integrated Research Information System" (iRIS). If project approval (or exemption determination) is needed, the documentation of the submission is handled by the IRB administrative team using the iRIS platform. Individual user iRIS accounts are needed for all named investigators, collaborators, and research staff for each project.
I am interested in conducting a QI project to fulfill program requirements. Do QI projects differ from research projects for the program?
Generally, Quality Improvement (QI) projects differ from research in their purpose and methodology. QI typically focuses only on improving a local process or outcome, and common methodologies include Plan-Do-Study-Act (PDSA) cycles with QI-specific analysis plans to evaluate change. In contrast, research is designed to generate generalizable knowledge with varied study designs.
The regulatory process (IRB review) can vary, but it depends entirely on the scope of the project. Some QI projects require IRB approval while others are designated as QI by the IRB and don’t undergo formal review and approval processes.
Reporting guidance can also vary. QI projects often use the SQUIRE guidelines, while observational research studies use STROBE, systematic reviews use PRISMA, etc.
As you’re developing a project (whether QI or research), I recommend seeking early input on the analysis plan from our biostatistics team that is available for consultation.
If using the option for "working in pairs", should the approval form and mentor-mentee form be completed separately for credit, or is only one submission needed?
Students can work individually or in pairs. If working in a pair, each member of the pair must provide a justification on their individual submission of the program Project Approval Form for how each member will contribute to the project. Students must receive approval to work in pairs from their Project Advisors prior to starting the project.
To fulfill Program documentation requirements, each individual student must submit each component of documentation individually to receive academic credit. This includes individual submission of the Project Approval Form, individual submission of the Mentor-Mentee Compact, and individual submissions of the Progress Reports and Final Report work products. The content of the Approval Form and Final Report work products can be identical because of working in pairs on the project and because the justification and distribution of shared workload is pre-approved at the start.
Do you have recommendations on resources for writing a manuscript for submission to a medical journal?
Yes, in addition to iterative team writing with the senior author/mentor and your coauthors, I recommend reviewing Viglianti 2019 CHEST (PMC6904852) for practical advice on common team-related aspects and advice on style and framing for manuscript writing. [See Research Writing]
Is there a specific length requirement for an original research manuscript or a systematic review?
There is not a specific length requirement for approval for the Inquiry project. Final versions of full-length manuscripts submitted to research journals are typically 3,000-3,500 words. Some journals allow for 3,000-6,000 words for systematic reviews. [See Research Writing]
Are there major differences in the components for the Final Report and a submission of an original research manuscript for publication?
The Final Report is intentionally designed to include the same components as the submission of an original research manuscript for publication to a scientific journal.
If you have prepared a research manuscript for submission and are the first author on the research manuscript submission, the PDF from the journal submission site (or the published version if already accepted) can be uploaded for scoring to fulfill the Final Report requirement without any reformatting.
If the project was initially approved for "working in pairs", the first author can be either of the individuals working as a pair.
Can I receive feedback on my submission before submitting it?
Yes, I’m happy to provide feedback and answer questions about course/program assignments.
My practice for pre-review requests in advance of submission for assignment scoring is to offer standing office hours to provide feedback and answer questions. The reason is because direct editing/revision recommendations from the advisor role cannot be offered for all submissions, but office hours are available to all.
The default duration for office hours in my scheduling link is 15 minutes, but up to 30 minutes is available by booking consecutive appointments.
If scheduling time for office hours, it’s the most helpful to send related materials a few days prior to meeting to allow for pre-review.
Should I send news of abstract and manuscript acceptance decisions?
Yes! Please do, and I will use the information to send a congratulations note via the health system recognition system.
Do you have recommendations for identifying conference/presentation options in addition to the local option at the health system, which typically occurs in May?
Your project mentor is often the best resource for identifying appropriate society-sponsored conferences aligned with your work. Established professional medical society conferences are generally highly ranked options because of the quality of peer review, professional networking, and expert dialogue at the time of presentation.
As you search, I recommend strong critical appraisal because of the prevalence of predatory conferences. Predatory conferences are often characterized by broad scopes, aggressive email marketing, and unclear affiliations with recognized professional organizations.
Components to consider include:
Is the conference from a recognized professional medical society or academic institution or is the organizing body unfamiliar, difficult to verify, or not well known in the field?
Did you receive an unsolicited or mass email inviting you to submit or speak?
Does the invitation use broad language (e.g., all specialties welcome) or excessive flattery?
Is there little or no description of the abstract review process?
Are registration fees high, unclear, or required before peer review?
Does the conference have little history, or does it change names or locations frequently?
Is there limited evidence of prior abstract listings/proceedings?
Has your mentor or advisor heard of or recommended the conference?
In addition to consultations with your mentor, I am available for office hours throughout each semester and I'm happy to discuss or review specific scenarios together.
Notes
This content is a courtesy resource with supplemental information tailored to common discussion topics that I have encountered. Other Research Advisors may have different advice, perspectives, resources and recommendations.
All assignment requirements, rubrics, due dates, and course-related contact information should be sourced from the restricted-access course website maintained by the university.
Additional Information
Standing office hour appointments are available throughout each semester (Fall, Spring, Summer). Office hour appointments are not typically available during university-designated breaks. If you don't have the office hour scheduling link, please contact me using your institutional email account to request it anytime.
Additional resource pages include
Research Project FAQs (this page)