Do Patient Consent Procedures Affect Participation Rates in Health Services Research?

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Background. Few studies have examined the effects of Institutional Review Board (IRB) requirements to contact potential research participants.Objective. To examine the association between requirements to contact potential research subjects and participation rates in a multisite health services research study.Research Design, Subjects. Prospective observational study of survey participation by 2673 individuals with diabetes and 1974 individuals with congestive heart failure treated at 15 clinical sites in the United States that had implemented a quality improvement intervention.Main Outcome Measures. Telephone survey response rates.Results. Of 15 IRBs, seven required sites to obtain authorization from participants to release contact information to the study team. Five required oral and two required written advance permission. The response rate was 58% (913/1571) at sites where no advance permission was required, 39% (989/2530) from sites that required oral advance permission and 27% (145/546, P <0.001) at sites requiring written advance permission. Although 85% of eligible participants contacted directly by the study team consented to complete the survey, only 43% of individuals at sites requiring written advance permission allowed the release of contact information to the study team.Conclusions. Many potential participants did not grant advance permission to be contacted by the study team. Requiring advance permission reduced participation rates, especially at sites requiring written authorization.

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