Pediatric Ethics Team Projects

From BrothersBrothers

PREDICT Focus Groups

Notes

  1. IRB Process - Complete
    • [x] 2-24-14, Waiting for updates to IRB documents to be finalized. Kyle submitting.
      • [x] Phase 1 is still covered by an active IRB approval at Vanderbilt. 2-28-14 For the PREDICT Focus Groups, the IRB at Vanderbilt has determined that NO NEW APPROVAL IS REQUIRED. They do not consider the videos of focus groups to be identifying, since we explicitly asked them not to identify themselves by last name. Essentially, then, everything that we are doing from now on is exempt, in the same way that a study of previously collected data would be.
      • [x] 3-4-14, Sarah submitting documents to UofL IRB
  2. BAA agreement
    • [ ] awaiting Dr. Dunn's signature

Carla

  1. Code Focus Groups
    • [x] Phase 1, Session 1
    • [x] Phase 1, Session 2
    • [ ] Phase 1, Session 3, Spanish
    • [x] Phase 1, Session 4
    • [x] Phase 1, Session 5
    • [x] Phase 2, Session 1
    • [x] Phase 2, Session 2
    • [ ] Phase 2, Session 3, Spanish
    • [x] Phase 2, Session 4
    • [ ] Phase 2, Session 5, In process
  2. Spanish Translation & Transcription
    • [x] 3-24-14, Contacted Accessible Translation Solutions --Madalena Sánchez Zampaulo, 614-486-5877, to start translation, transcription process.
      • [x] Use UofL Send SECURE process for sending videos
      • [x] Madalena will respond with 2 quotes:
        • [ ] We are requesting Spanish to English direct translation-transcription
    • [ ] DATE, Kyle approved estimate
    • [ ] DATE, Confirmed estimate for services and approved services to begin. Spoke with NAME.
    • [ ] DATE, Promise date
  3. Code Book
    • [ ] DATE, Complete code book to be used by Ryan and Jodie

Kyle

  1. Spanish Translation and Transcription
    • [x] 3-25-14, Bring recordings of Spanish sessions from home
    • [x] 4-9-14 - Confidentiality document emailed
      • [ ] DATE - Confidentiality document returned
    • [ ] DATE, Sent video tapes of Spanish focus groups to Madalena or an estimate

HudsonAlpha - Genomic Diagnosis in Children with Developmental Delay

Notes

  1. Synopsis: Study of the application of Whole Exome Sequencing technology as a diagnostic tool to identify the cause of intellectual disability.
  2. Also known as:
    • "HudsonAlpha Study"
    • "CSER Study"
    • "Huntsville study"

Carla

  1. 2-24-14, Waiting response from Kevin Bowling re CSER website status
  1. Enter Surveys
    • [ ] Enter Survey sets (M-D-C), 1-10
    • [ ] Enter Survey sets (M-D-C), 11-20
    • [ ] Enter Survey sets (M-D-C), 21-30
    • [ ] Enter Survey sets (M-D-C), 31-40
    • [ ] Enter Survey sets (M-D-C), 41-50
    • [ ] Enter Survey sets (M-D-C), 51-60
    • [ ] Enter Survey sets (M-D-C), 61-70
    • [ ] Enter Survey sets (M-D-C), 71-80
    • [ ] Enter Survey sets (M-D-C), 81-90
    • [ ] Enter Survey sets (M-D-C), 91-100
    • [ ] Enter Survey sets (M-D-C), 101-110
    • [ ] Enter Survey sets (M-D-C), 111-120
    • [ ] Enter Survey sets (M-D-C), 121-130
    • [ ] Enter Survey sets (M-D-C), 131-140
    • [ ] Enter Survey sets (M-D-C), 141-150
    • [ ] Enter Survey sets (M-D-C), 151-160
    • [ ] Enter Survey sets (M-D-C), 161-170
    • [ ] Enter Survey sets (M-D-C), 171-180
    • [ ] Enter Survey sets (M-D-C), 181-190
    • [ ] Enter Survey sets (M-D-C), 191-200

Kyle

  1. [x] E-mail Shirley about dates when clinic could be used for interviews
  2. [ ] E-mail Shirley families whom we hope to interview in July or August

Weisskopf CMA - Parent's Perceptions of Pre- and Post-Test Counseling for Chromosomal Microarray Study Ordered by Non-Geneticists

Notes

  1. Synopsis: This is a pilot study in which we will conduct semi-structured interviews with the parents of children with a condition for which a CMA test has been ordered by a non-geneticist, including neonatologists, family doctors, or primary care pediatricians.
  2. Also known as:
    • "Weisskopf Pilot"
    • "CEC Pilot"
    • "CMA Pilot"
  3. Cytogenetic Lab
    • The lab's process for returning results to ordering physician
      • Could we include a form letter re the study
      • Notification of date when results are returned to physician
        • through AllScripts
        • or weekly email or fax from lab employee
    • Access to patient's face page with contact info - would come from Norton
    • About 40 microarrays per month, about half of which are ordered by non-geneticists.
    • Results come from either Norton/Kosair or from a hospital in Evansville. We can get local samples by sticking with inpatient samples and those from local outpatients at Norton/Kosair.
    • Ordering physician (so we know which were ordered by non-geneticists)
  4. IRB
    • Expedited review takes about 2-3 weeks, so this is feasible for an end of May start date if we start now
    • Lab as recruitment source
      • Can we approach families w/o referring physician's approval?
    • Documents for family contact
      • Interest letter for family
      • Seeking Interest letter for family
      • Appt. card for family
  5. Interviews
    • In-town
      • Location
        • Process for scheduling a room
        • Parking arrangements
    • Out-of-town
      • Family home (most likely)
  6. NICU
    • Barriers
      • Family Availability
      • NICU docs and nurses
        • Very protective--will want to know about study before allowing approach
        • Very informative re special issues surrounding baby and family

Carla

  1. Documents for family contact - Completed
      • [x] Format/Template of Interest letter for family
      • [x] Format/Template of Seeking Interest letter for family
      • [x] Format/Template of Appt. card for family
      • [x] Interview Dialogue completed
  2. Parking - Completed
    • [x] 629-3887, Brenda--Visitor-Guest parking stamp booklet is $70 for 100 stamps. Can also use the KCH stamps used by KCPCRU
      • [x] Order booklet per Kimberly. Picked-up booklet 3-24-14

Kyle

  1. Lab
    • [x] Waiting Response; 2-25-14 Contacted GCs (genetic counselors) re entre to lab
      • [ ] Make appt with lab personnel
  2. IRB
    • [x] DATE, Check w Lisa re submission and feasibility of end of May start date
    • [x] Lab as recruitment source
    • [x] Write letter for PCPs
  3. Travel per Interview
    • [ ] Gas
    • [ ] per diem
  4. NICU
    • [ ] Talk w Dr. Dan Stewart about this study, dlstew01@louisville.edu Pgr 672-3760, cell 548-4419, Office 852-8470
    • [ ] Talk w Dr. Jonathan Cohen about this study

Patient Perspectives on Broad Consent in Biobank Research in the eMERGE Network

Notes

  1. Synopsis: Survey on issues related to consent to research that will be sent to patients of 10 healthcare institutions across the country
  2. Comprised of two different funding sources for Kyle's salary: the "Vanderbilt Site" and the "Coordinating Center". Both of these are, confusingly, located at Vanderbilt University

Carla

Kyle