The PHA Registry Institutional Review Board approved additional options to remotely conduct PHAR data entry and informed consent during the pandemic. With this flexibility, PHAR has continued to thrive despite the pandemic challenges with about 460 new participants enrolled in the last 12 months. PHAR now nears the milestone of 2,200 enrolled participants.
Remote Informed Consent
This consent option is intended for use in situations when standard, in-person or written informed consent is not practical. In those cases, the patient must be confirmed eligible prior to contact. The six-month window of eligibility applies.
The participant may be contacted for informed consent without a corresponding PH clinic visit, but the baseline data entry should only occur with a corresponding PH clinic visit.
Approved personnel (i.e., those with human subjects training and authorization on the Delegation of Responsibilities who conduct informed consent for PHAR) may call the patient via telephone or use a hospital-approved communication platform.
Read the patient the IRB-approved verbal consent script. The script includes a brief overview of the study as an introduction. If the patient is interested in hearing more, the personnel can read through their site’s regular full informed consent document (i.e., current IRB-approved). If the patient consents to participate, the personnel should sign the attestation and locally file the documentation.
You also need to provide a copy of the regular consent form to the patient for their records via postal mail or hospital-approved communication platform like MyChart. This copy could be mailed in advance of the discussion or after. No written signature needs to be obtained from the participant.
Remote Data Entry
This option should only be used in association with a scheduled in-person or telehealth PH appointment for the participant. The participant should not be contacted for PHAR data entry unless they have an appointment with their PH care team. The PHAR data entry does not need to be conducted on the same day as the appointment but should be conducted within two weeks after the appointment.
Scripts for introducing remote data entry are on PHCCRegistry.org (Baseline and Follow-up, English and Spanish).
If the participant is willing to proceed, administer the Participant CRF and PRO CRF interview-style. Enter the participant’s responses into the PHAR eCRF software programmed on the tablet.
The “visit date” entered on the PHAR tablet should correspond to the clinical appointment date rather than the date of entry.
You may mail or email a copy of the CRFs to the participant in advance to follow along on but do not collect data on these paper forms. Remote data entry should only occur interview-style.