Summary of new Institutional Review Board (IRB) issues for the Translating Research Into Practice for Postpartum Depression Practice-Based Research Network (PBRN) Study
| IRB Requirement | Implications for This Study | Adverse Outcomes | Costs | Suggested Solutions |
|---|---|---|---|---|
| Stamped date on consent form | 1. Reprint English and Spanish consent forms yearly | Delays in obtaining stamped and dated consent forms, which resulted in enrollment interruptions | Extra printing costs | Stamp 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 yearly | Confusion and frustration of local site staff about the need to replace “perfectly good” packets | Central staff need extra time to assemble new enrollment packets yearly | If 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 mail | Need 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 years | 1. Retraining of 218 persons with exactly the same material | Decision by 2 local IRBs to not participate in any future PBRN studies because of the cost and repetition of human subjects training | Retraining 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 physicians | Do 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 retraining | Need for central site staff to deal with anger and frustration from local site personnel | Time for central staff to enhance required retraining materials and to deal with angry local site personnel | Develop 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 study | Develop human subjects training materials that are appropriate to PBRN studies |