The HIPAA authorization form and effects on survey response rates, nonresponse bias, and data quality: a randomized community study.

BACKGROUND

There has been speculation that the Health Insurance Portability and Accountability Act (HIPAA) has muted participation in research but little direct evidence to substantiate those claims exists.

OBJECTIVE

To evaluate the effects of including a HIPAA authorization form (HAF) on multiple measures of survey performance. RESEARCH DESIGN, SUBJECTS: A community survey of Olmsted County, Minnesota residents conducted between September 2005 and April 2006. A total of 6939 cases were randomly assigned to 2 experimental conditions where half of the subjects received a 1-page HAF (n = 3469) and the other half did not (n = 3470).

MAIN OUTCOME MEASURES

Response rate, nonresponse bias, and data quality.

RESULTS

At the end of data collection, a response rate of 39.8% was observed in the HAF condition and 55.0% in the No HAF condition (P < 0.0001). There was a negligible but statistically significant (P < or = 0.001) over-representation of males in the No HAF condition but no difference in the amount of missing data between the 2 groups. However, reports of general health and the percentage of respondents indicating that they were nonsmokers were both significantly (P < or = 0.01) lower in the No HAF condition than in the HAF condition.

CONCLUSIONS

Inclusion of a minimally burdensome version of the HAF reduced survey response rates by up to 15 percentage points. This could have implications for a study's statistical power. There was little evidence that the form affected nonresponse bias or data quality.