Table 1.

Summary of new Institutional Review Board (IRB) issues for the Translating Research Into Practice for Postpartum Depression Practice-Based Research Network (PBRN) Study

IRB RequirementImplications for This StudyAdverse OutcomesCostsSuggested Solutions
Stamped date on consent form1. Reprint English and Spanish consent forms yearlyDelays in obtaining stamped and dated consent forms, which resulted in enrollment interruptionsExtra printing costsStamp the consent forms by “version” rather than date and require a new version only if the consent form changes
2. Print, assemble, and send new enrollment packets yearlyConfusion and frustration of local site staff about the need to replace “perfectly good” packetsCentral staff need extra time to assemble new enrollment packets yearlyIf no changes are made to the consent form then use the initially approved stamped consent form for the entire study
3. Send packets by express mailNeed to send new packets by express mail because of delays by IRBs in sending new dated consent forms
4. Complete early submission for annual IRB review and therefore complete an extra “yearly” review during course of the study
Human subjects retraining every 1–2 years1. Retraining of 218 persons with exactly the same materialDecision by 2 local IRBs to not participate in any future PBRN studies because of the cost and repetition of human subjects trainingRetraining time of more than 300 hours for the local sites, with hourly rates from $25 for medical assistants to revenue losses of more than $600 per hour for physiciansDo studies to gain evidence about how often human subjects training should be repeated to maintain knowledge
2. Asking local sites to absorb unbudgeted costs of retrainingNeed for central site staff to deal with anger and frustration from local site personnelTime for central staff to enhance required retraining materials and to deal with angry local site personnelDevelop human subject updates for new human subjects issues to replace retraining
3. Work by the central staff to attempt to make the required human subjects retraining relevant to this PBRN studyDevelop human subjects training materials that are appropriate to PBRN studies