Conducting Clinical Research in the Children’s Medical Practice

ALL research project proposals that will take part in the Children’s Medical Practice (CMP) or recruit patients from the CMP must be submitted to the CMP Research Committee, led by Sarah Polk, MD for review by CMP providers and staff. Requests submitted to the CMP Research Committee should ideally have already received IRB approval.

 
 
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Submit a Proposal

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CMP Research Comittee Review Process

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Key Considerations

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Language Proficiency Requirement

 
 
 

Submit a Proposal

The first step to submit your proposal is to complete the Request for Research Services with Centro SOL and indicate your interest in conducting research in the CMP. As part of this process, you may indicate whether or not you would like to meet with someone from the Centro SOL team prior to submitting your request to the CMP Research Committee. The Centro SOL team can provide contextual information regarding patients served, clinic flow, and previous and ongoing or previous research in the CMP. More information regarding Centro SOL research services and the Request for Research Services can be found here: https://www.jhcentrosol.org/research-and-policy

Before beginning your request to the CMP Research Committee, please ensure that you have the following documents, whenever possible:

  • A copy of eForm-A from the IRB proposal

  • IRB approval letter (or explanation of current IRB status)

    • A copy of the Final IRB approval letter will be needed for the clinic before starting

  • IRB approved/submitted recruitment materials for patients and providers/staff

  • IRB approved/submitted consent materials

  • Staff language proficiency completed test

If you have already completed the Centro SOL Request for Research Services and have received your Proposal ID and password, you may submit your request here: https://jhmi.co1.qualtrics.com/jfe/form/SV_0wVhrSiaKxZixLL

CMP Research Committee Review Process

The CMP Research Committee is comprised of Faculty in the Department of Pediatrics at Bayview and staff of the CMP. Requests to perform research at the CMP are reviewed in two stages. During the first stage of review, Dr. Sarah Polk, the Medical Director of the CMP, evaluates the request using the following criteria:

  • Significance for patients

  • Patient safety

  • Time/effort/procedures required of participants

  • Potential benefit for patients

  • Level of interest to CMP

  • Level of effort for CMP staff

  • Authorship participation and salary support for CMP faculty

  • Number of participants

A rubric is used for evaluation

If the request passes initial review, it enters the Scientific Merit review. At this stage, two CMP faculty and staff review the content of the request and the results of the initial review (completed using this rubric) and select one of the following options:

  • Accept without changes

  • Accept with changes (itemized list of required changes required)

  • Request more information (explanation required)

  • Reject (explanation required)

Key Considerations for Participant Recruitment in the CMP

A clinic team member must ask permission for study staff (RA) to approach patients/parents:

  • For example, a family is waiting in an exam room for an appointment, the RA tells an MA that they would like to approach the family, and the MA asks the parent if the RA can tell them about a study for which they might be eligible. If the parent says yes, the RA introduces themselves and proceeds.

No private space is available

  • Exam rooms may be used only when patients are waiting for their child’s clinic visit to begin

  • The waiting room should not be used

  • There is a small vestibule outside of ENT that may be suitable whenever available

  • Consider how you will know if someone tries to enroll twice and how you will access CMP schedules

Language Proficiency Requirement

ALL research study team members that will recruit or interact with patients from the Children’s Medical Practice must take the staff language proficiency test for Spanish and provide the certificate of completion with the proposal to do research at the CMP. Certificates of completion must be included for all researchers participating in the study.

Process:

  • Reach out to the JHM Office of Diversity and Inclusion at bilingualstaff@jhmi.edu to be registered to take the SLA assessment through Alta

  • For clinical research, a score of at least 10 is necessary; for non-clinical research, a score of at least 9 is accepted

The cost for is $50 per assessment and must be covered by the PI. For more information on the assessment, please visit https://www.altalang.com/language-testing/speakinglisten/