Mari Griffioen’s Return to Campus Request Summary
SUBMISSION DATE: 02/23/2021
SENT TO: Elizabeth Speakman 02/23/2021
| Submission Number | 1417 |
|---|---|
| Opening Phases | Phase 3 |
| Name | Mari Griffioen |
| Academic Classification | Assistant Professor Tenure-Track |
| PI Email | mgriffi@udel.edu |
| Emergency Contact / Phone Number | 3028318389 |
| College | College of Health Sciences |
| Department | SCHOOL OF NURSING |
| Lab/Facility | STAR HEALTH SCIENCE COMPLEX |
| Limited Face-to-Face Human Subject Interaction | This research includes face-to-face human subject interaction. I am requesting permission to restart human subjects research at the STAR Health Sciences Complex for a study examining the acceptance/participant perception, level of agreement between raw data, reliability and validity in the assessment of thermal sensitivity in the leg as a part of a quantitative sensory testing protocol using the TSA2 and Medoc Pathway. In this study we also administer a set of standard questionnaires (demographics, depression, anxiety, sleep, and personality traits). The Medoc Pathway cannot be moved and therefore necessitating bringing participants to the Tower. Study visits will follow procedures outlined in the current IRB protocol (1643591-1) and no amendments are needed to restart. However, additional procedures will be in place to minimize the exposure of Covid-19 to study staff and participants as per UD guidelines. This request is for the study visits taking place in room 511 in the Tower at STAR.
The day before a study visit, study staff will contact the participant by phone and ask the questions on the “Daily home health questionnaire” and document in the participant chart. If a participant answers yes to any of the questions, they will be rescheduled for a different day and time. If a participant answers no to all the questions, they will be instructed to present to the study visit and to wear a cloth mask. If they do not have a mask, they will be provided a disposable surgical mask before entering STAR health sciences complex. The participant will be instructed to call the research staff when parking at the STAR Health Sciences Complex. Study staff will meet the participant outside and verify a facial mask and then proceed to enter the building and have the participant check their temperature. If the participant has a temperature <99.5F, study staff will direct the participants to take the elevators (alone or with 1 family member) to the 5th floor where study staff will meet them and escort them to room 511 for the remained of the study visit. |
| Physical Distancing and Density Requirements | This study visit takes place in room 511 at the Tower. To ensure physical distancing, study staff will reserve the room 511 using the Resource Scheduler system. An ‘occupied’ sign will be placed outside the door that it is in use. Room 511 is 307 square feet and will accommodate 2 persons during phase 3 reopening. Accompanying persons will be asked to wait in one of the exam rooms (83 square feet each). Study staff will wear a surgical face mask and maintain a distance of at least 6 feet from the participants, except when handing over an iPad for participant to complete questionnaires (exposure at <6 feet will be <1 minute), attaching temperature probes (exposure at <6 feet be <1 minute), complete mechanical testing (exposure at <6 feet be ~3 minutes), vibration testing (exposure at <6 feet be ~3 minutes), mechanical temporal summation testing (exposure at <6 feet be ~5 minutes), and pressure pain testing (exposure at 2 feet to participant's face). The total time of the study visit 1 is ~2 hours and study visit 2 ~1.5 hours. The requirement of study staff to be within 6 feet of participant is ~35 minutes on and off during the visit. Following the study visit study staff will wipe down all surfaces in the room. |
| Additional team members that will need access |
Ryan Schilling TITLE: Research Assistant, EMAIL: schillre@udel.edu, CONTACT: , LAB/FACILITY: STAR HEALTH SCIENCE COMPLEX, RM# 511 |
| Department Chair | Elizabeth Speakman |
| Department Chair Email | speakman@udel.edu |
| Signature | Mari Griffioen |