Feasibility Considerations

Questions to consider:

1. Did my literature review yield knowledge gaps that my study can help answer.
   • Is there a strong rationale for my study?
   • Does the gap I am trying to fill make good sense to my colleagues and GME Research Staff?
2. Is my idea ethically sound? Are there any unmitigated risks that outweigh potential benefits or unmanageable conflicts of interest?
3. Does GME have the resources to conduct this type of study design? Note: resident-led prospective drug trials, meta-analyses, and randomized controlled trials are not currently supported.

Question to consider:

1. Is my research study timeline feasible? Find guidance via “How do I know if the research study is possible in the time I have?”.

Questions to consider:

1. Do CMH facilities, equipment, supplies, and storage meet the needs of my study?
2. For prospective studies, will services need to be delivered above and beyond the standard of care for the patient population enrolled in my study?

• • If so, is there time, staff, and funding to cover this?

Questions to consider:

1. Will my study require funding?
2. If so, will the GME research project funding available for approved studies cover all study costs? If not, I need to consider a different study design.

Other items to keep in mind:

1. You must submit a budget to the ADGME in order to receive support.
2. You must receive approval from both the IRB and your Program Director beforeyour project can begin. The Program Director and ADGME will make the funding decision, and you may purchase supplies in advance with approval from the ADGME.
3. You MUST have receipts for reimbursement. Common covered expenses include: supplies/equipment, participant compensation for time or costs incurred due to participation. Expenses that often exceed allowable expenses: clinical coordinator, cost of drugs, blood draws, any and all imaging not covered by insurance for standard of care.
4. GME will provide financial support to attend a regional or national conference if your abstract or research is accepted for poster or podium presentation.
5. GME helps cover publication costs in a GME-approved and peer reviewed journal.

Questions to consider:

1. Do I have the technical expertise to complete this study? Does my Research Study Team have the expertise it needs?
   • Prospective drug trials, meta-analyses, and randomized controlled trials are not currently supported.
2. Do I have the right Research Study Team necessary to complete this study with integrity?
   • Does everyone have time to commit to training and to conduct the study?
3. Do I have enough time in my week to commit to doing research well?

Other items to keep in mind:

1. Review the following PI responsibilities before IRB Approval:
   • Assemble and Manage Research Study Team. Assure that they have been properly trained for both study of human subjects (specifically CITI training on the intranet) and Informed Consenting (if needed).
   • Build your budget, if needed.
   • If conducting a case report, PI must complete a paper Case Report application.
   • Remember that patients need to sign a consent form for publication in a journal.
   • Complete the IRB protocol and associated attachments located on the CMH IRB homepage on the intranet. IRB submissions will not be accepted without GME Research Staff approval.
   • You can use the Common IRB Forms Explained document to prepare your submission.
2. To review PI Responsibilities after IRB approval see “My study got approved.” → “Now that my study was approved, what’s next?”

Questions to consider:

1. Is the data I need available within the CMH EMR?
   • We have multiple EMRs and each has a separate IT analyst. Our current EMR systems only collect discrete data fields (e.g., ICD codes, labs, demographic details). It will not include elements from surgical reports, patient histories, medications, nor patient vitals.
   • If you need data from the EMR, you will need to contact the GME Research Team for assistance in completing the IT Request Form.
2. Will I need any data not already collected in the EMR? If so, who will collect it and how?
3.  How will data be stored and protected? (Including: consent forms, study documents)
   • You are not allowed to store PHI on your personal computers at home.
4. Will data need to be sent to/received from a source external to CMH? If so, who will collect it and how?

Other items to consider:

1. Data being sent in email needs to be encrypted using #Secure
   • Enter #SECURE# in the subject field for manual encryption
     OR
   • Open Outlook Web Access and compose your email message as you normally would. When you have finished composing the text of your email message, click the PGP Tray icon -> Select Current Window, then click Encrypt, Sign, or Encrypt & Sign. The PGP Desktop -Key Selection Dialog screen is displayed -> Drag or double-click users to add user keys to the Recipients list -> Click OK and enter the passphrase for your key when prompted.

1. Is the potential participant pool large enough?
   • Does CMH have the patient population for this study to be completed in a timely manner? You might chat with GME Research Staff who can connect you with CMH data on your study population to make more targeted projections on
     feasibility.
   • If in doubt, can you remove and analyze any criterion/comorbidity separately while still maintaining the integrity of the research question, scope of the project, and scientific value?
2. Do I have adequate time to recruit?
   • Think through how many subjects would need to be enrolled per month/week/day to gather enough data to complete your study within a timely manner.
3. Site considerations
   • Are there additional/other recruitment sites that could help funnel patients your way?
   • Is the recruitment site appropriate? Do patients have the medical decision making capacity to process the opportunity fully and provide fully informed consent?
   • Is there anything that could be done to improve the environment?
4. Screen/Recruit/Consent considerations
   • Do you need to translate your consent form into additional languages? The GME department has translation services available for approved projects.
   • Does your Research Study Team have what it needs to screen, recruit and consent properly?
   • Is the flyer/script recruiters are using clear?
   • Is the time burden for the participant commensurate with the potential benefits of study participation?
   • Is compensation offered and if so, is it in proportion to the commitment?