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


METHODS
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.
Nelson
Karin
K
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
Garcia
Rosa Elena
RE
Brown
Julie
J
Mangione
Carol M
CM
Louis
Thomas A
TA
Keeler
Emmett
E
Cretin
Shan
S
D003920:Diabetes Mellitus; D028744:Ethics Committees, Research; D019538:Health Care Surveys; D006302:Health Services Research / Q000592:standards* / Q000706:statistics & numerical data; D006333:Heart Failure; D006805:Human Experimentation; D006801:Humans; D007258:Informed Consent / Q000706:statistics & numerical data*; D018579:Patient Selection; D011446:Prospective Studies; D014481:United States