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

Med Care. 2002 Apr;40(4):283-8. doi: 10.1097/00005650-200204000-00004.


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.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Diabetes Mellitus
  • Ethics Committees, Research
  • Health Care Surveys
  • Health Services Research / standards*
  • Health Services Research / statistics & numerical data
  • Heart Failure
  • Human Experimentation*
  • Humans
  • Informed Consent / statistics & numerical data*
  • Patient Selection*
  • Prospective Studies
  • United States