FAQs

Study Population

What should I do first when trying to determine my study population?

We want to make sure you are set up for success with a feasible and large enough recruitment pool. This document may help you think through your study sample, sampling method, and sample size.

How do I determine my inclusion and exclusion criteria?

Carefully describing your study population through inclusion and exclusion criteria increases the chances that your results will be reliable and reproducible.

• What are the characteristics of participants needed for your study? Consider the variables you wish to include in your study. It may help to think through inclusion criteria first; inclusion criteria may be thought of as a potential subject’s ticket through the door for consideration in your study (common factors: age, gender, stage of disease, etc). Next, think through any factors that would disqualify participants from being a good fit for your study (e.g. comorbidities, current medications etc.).
• The IT data analysis form, which you complete to obtain data, requires specifics on the population within the EMR or data registry.

Where can I find my study population? 

You may want to use already collected data for your study (e.g. from the EMR at CMHS). Alternatively, you may need to go straight to the source – the participants themselves – and recruit subjects. GME Research Staff can connect you with CMHS data on your proposed study population and support you through this decision.

What should I do if my study population is too small? 

If you are worried that your sample will be too small, consider:

• Broadening the variable categories you have applied to your study population (such as a wider age range)
• Determining whether you can remove an exclusion criterion or comorbidity to analyze separately while still maintaining the integrity of the research question, scope of the project, and the scientific value
• Expanding the study population to nearby hospitals through a proxy IRB process
• Utilizing data from national databases

Recruitment

What if I don’t directly care for the patients who would be enrolled in my prospective study? 

If you do not have access to the study population, you need to figure out who will collaborate with you on your study idea. Consider what would be required of that potential collaborator and what they would get from collaboration. In line with the level of involvement, research team members should be listed as co-investigators.

What should I consider when designing my recruitment plan? 

• Conceptually, your recruitment plan will need to be non-coercive, voluntary, and respectful.
• Logistically, think through: when, where, and how you will approach potential participants. Consider if your recruitment site location is appropriate – both in terms of logistics as well as whether or not the potential participant would have enough time and capacity to participate. 
• To make sure that participants have all the information they need to decide whether or not to participate, make sure that the approach occurs in an appropriate setting: consider where potential participants are at the time that they might consent to participate in your study. Do patients have the medical decision making capacity to process the opportunity fully and provide fully informed consent?
  • Ex: it would not be appropriate to attempt to recruit or consent a patient if they were in acute and overwhelming pain or impaired.
• The IRB must approve all recruitment materials, such as scripts, emails, or printed/electronic materials used to recruit participants.
  • Pro Tip: be sure to use plain and clear language when communicating with a potential participant during the recruitment and consenting process. A great resource can be this glossary that allows you to look up lay language for medical terms.

We want to make sure you are set up for success with a feasible and large enough recruitment pool. This document may help you think through your study sample, sampling method, and sample size.

Carefully describing your study population through inclusion and exclusion criteria increases the chances that your results will be reliable and reproducible.

• What are the characteristics of participants needed for your study? Consider the variables you wish to include in your study. It may help to think through inclusion criteria first; inclusion criteria may be thought of as a potential subject’s ticket through the door for consideration in your study (common factors: age, gender, stage of disease, etc). Next, think through any factors that would disqualify participants from being a good fit for your study (e.g. comorbidities, current medications etc.).
• The IT data analysis form, which you complete to obtain data, requires specifics on the population within the EMR or data registry.

You may want to use already collected data for your study (e.g. from the EMR at CMHS). Alternatively, you may need to go straight to the source – the participants themselves – and recruit subjects. GME Research Staff can connect you with CMHS data on your proposed study population and support you through this decision.

If you are worried that your sample will be too small, consider:

• Broadening the variable categories you have applied to your study population (such as a wider age range)
• Determining whether you can remove an exclusion criterion or comorbidity to analyze separately while still maintaining the integrity of the research question, scope of the project, and the scientific value
• Expanding the study population to nearby hospitals through a proxy IRB process
• Utilizing data from national databases

Design a question that can be answered via a qualitative or quantitative or mixed methods study design.

• Conceptually, your recruitment plan will need to be non-coercive, voluntary, and respectful.
• Logistically, think through: when, where, and how you will approach potential participants. Consider if your recruitment site location is appropriate – both in terms of logistics as well as whether or not the potential participant would have enough time and capacity to participate. 
• To make sure that participants have all the information they need to decide whether or not to participate, make sure that the approach occurs in an appropriate setting: consider where potential participants are at the time that they might consent to participate in your study. Do patients have the medical decision making capacity to process the opportunity fully and provide fully informed consent?
  • Ex: it would not be appropriate to attempt to recruit or consent a patient if they were in acute and overwhelming pain or impaired.
• The IRB must approve all recruitment materials, such as scripts, emails, or printed/electronic materials used to recruit participants.
  • Pro Tip: be sure to use plain and clear language when communicating with a potential participant during the recruitment and consenting process. A great resource can be this glossary that allows you to look up lay language for medical terms.
  • Pro Tip: upon IRB approval, the Research Department can assist you in translating your study documents into Spanish.
• Consider whether the time burden is reasonable for a potential participant and whether you will offer compensation. If you plan to offer compensation, it should be proportionate to the commitment, and you will need approval from the ADGME for study funding.

Consider the following:

• Whether you will need to put a flyer on the wall in a common space, such as a clinic (which would also require permission of the clinic director), or if a recruiter needs to present the study to the patient.
• Whether you need to translate your forms into additional languages. (Reminder: GME Research Staff and IRB must approve all written recruitment materials, including flyers/emails, etc.

The FDA considers study advertisements to be the beginning of the informed consent process. The IRB will make sure you get it right from the get go. Required information for study advertisements includes:

• Name and address of investigator/ research facility;
• Purpose of the study;
• Summarized inclusion/exclusion criteria;
• List of any procedures involved;
• Time (or other) commitment required;
• Location of research;
• Who to contact for further information.

If you do not have access to the study population, you need to figure out who will collaborate with you on your study idea. Consider what would be required of that potential collaborator and what they would get from collaboration. In line with the level of involvement, research team members should be listed as co-investigators.

Yes, but you must consider the following:

• All research study team members must be listed on the IRB application. Before recruiting team members, consider whether they have time to be trained in obtaining informed consent for research participation and if they have time in their workflow to recruit and/or consent participants.
• When asking for assistance with recruiting, remember that people are giving of their limited time and doing you a favor. In line with their level of involvement, research team members should be listed as investigators, names on presentation, etc. (You can always refer to the CMHS Authorship Policy as a guide on who to include, how to determine authorship order, and responsibilities.)
• Review the study population to consider whether recruiters must speak languages other than English.
• If others assist you with recruiting, determine how you will be alerted if an eligible patient needs to be approached.
  • Who needs to know about your study and what do they need to know to be able to tell if a patient would be a good fit?
  • Where will you keep recruitment materials?
  • How will you and your Research Study Team access them when needed?  Remember, study data must be protected at all times.
• If others assist you with consenting, determine where you will keep blank Informed Consent materials and how consenters will access them when needed. Likewise, come up with a plan for where you will store signed forms.
  • Will this need to be electronic or printed?
  • How will any paper study documents be securely protected?
  • What will others need access to?
  • How will they know where they are kept and how to access them?

• For background, check out this Coursera course on scientific writing.
• First, assemble your team. Utilize the CMHS Authorship Policy as a guide on: who to include, how to determine authorship order, and responsibilities.
  • To be listed as an author on a manuscript, one must:
    • Make substantial contributions to the conception or design of the work OR the acquisition, analysis, or interpretation of data for the work; AND
    • Draft the work or revise it critically for important intellectual content; AND
    • Give final approval of the version to be published; AND
    • Agree to be accountable for all aspects of the work that ensure that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
  • Those who meet fewer than all four of the above criteria for authorship should not be listed as authors, but their contributions can be described in the Acknowledgements section. (Ex: data entry, general supervision of a research project, proofreading or editing, etc.)
  • Authorship order depends on the relative contribution of the individual authors. It depends on the specialty, but often the first named author will be the individual who contributed the most to the research project. The first named author typically drafts the manuscript. If you are the first author, you will be asked to submit a Checklist for Publication. The last named author will be a senior investigator who has expertise in the subject matter and who provided close project oversight (this person may be your faculty advisor).
  • The corresponding author takes primary responsibility for communication with the journal during the submission, peer review, and publication processes, and typically ensures that the journal’s administrative requirements (ex: providing details of authorship, ethics committee approval, clinical trial registration documentation, gathering conflict of interest forms and statements, etc.)
• Next, choose the right journal to apply to (and a backup or two). Think through journals you and your colleagues read and reference.
  • Pro Tip: enter keywords that pertain to your study into PubMed and read through the names of journals in which similar work has been published. From there, read up on the journal’s description as well as any special calls for articles (making sure that they aren’t an invite-only journal). Skimming titles of recently published articles will also give you a sense of the journal’s focus, which may not be explicitly described.
• Remember: exploitative, predatory journals are on the rise. If you are concerned about legitimacy, reach out to the CMHS Medical Librarian to review Cabell’s International Predatory Journals List (found here while you are on campus along with other helpful subscribed databases) or GME Research Staff for their input.
  • High level Red Flags include: a journal that you have not had contact with emailed you with a high and/ or unclear submission fee structure, quick turnarounds, submissions via email, and poor language skills. A few resources to help you spot the phonies:
    • Red Flags are described here while this checklist can help you discern if a journal might be predatory. Short on time? How about a video explainer in < 3 minutes (with pirates)? This infographic helps you to spot a fake, and examples of common predatory tricks can be found here.
    • You can even check a journal in question against this blog where sketchy journals are put on blast, these crowdsourced lists of known predatory journals, conferences, and fake impact metrics, or look it up in the Directory of (legit) Open Access Journals.
    • Still not sure? Use this tool or this rubric to evaluate the publisher’s website or this checklist to evaluate a questionable email you received.
    • They say prevention is the best medicine- refer back to this webpage on how to protect yourself from predatory journals in the future.

Structure your article via the IMRAD format. Follow the journal publication requirements closely.

Review journal rankings in your discipline. Review impact factors and publications specifics. Remember that the higher impact factor, the more difficult it is to publish.

• Time for some succession planning. At the start of the academic year, you should identify who will take over the study, even though the goal is to finish the project in the year. When planning to pass along your study, consider:
  
  • Is there anyone on your Research Study team or in your program who might be interested in and able to replace you as PI? (Pro Tip: think through if anyone in the year behind you has an interest in research and/or your study topic.) From there, submit a Change in PI and/or Change in research team form.
    
  • Consider:
    • What will happen to the data collected thus far?
    • Is the location where the data are currently stored appropriate for the new PI to gain seamless access?
    •  Do you currently store any data that needs to be transferred to the new PI?
    • What level of involvement do you want to have after you transfer off the study as PI? Would you want to be kept on as a sub-investigator?
    • Do you want to be involved in any dissemination efforts?

Be sure to have direct conversations about these desires with the new PI.

• Complete a Notice of Study Closure Form (The first 3 pages are the form that needs to be filled in and you only need to fully complete the portions that apply to your study design.)
  
• Discuss with the GME Research Support Team how study records and collected data will be protected after study closure. Records (including the approved IRB application, all amendments, continuing reviews, and signed informed consent forms) must be retained for at least three years per federal regulations.  Deidentified data without codes attached can be stored indefinitely; keep this in mind in case data analysis is ongoing or you may want to revisit your data in the future. You will also need a plan for who will destroy any data and/or delete records no longer needed from your personal devices. Other conditions may apply based on your specific study so check in with GME Research Staff for specifics on your situation after opening the Notice of Study Closure Form and scrolling down to Page 4 where data retention guidance is given for each regulatory body.
  
• Decide what to do with any unused supplies/equipment.
  
• If you received but did not use all funds allotted from GME Research, the remaining funds will be deducted from your paycheck.