Practice-based Research Network Studies and Institutional Review Boards: Two New Issues

Barbara P. Yawn; Deborah G. Graham; Susan L. Bertram; Marge J. Kurland; Allen J. Dietrich; Peter C. Wollan; Elias C. Brandt; Jessica M. Huff; Wilson D. Pace

doi:10.3122/jabfm.2009.04.080168

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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 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