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Med Care. 2002 Apr;40(4):283-8.

Do patient consent procedures affect participation rates in health services research?

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1
VA Puget Sound Health Care System, University of Washington, 1660 South Columbian Way (S-111-GIMC), Seattle, WA 98108-1597, USA. karin.nelson@med.va.gov

Abstract

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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