Medical records and privacy: empirical effects of legislation.
OBJECTIVE
To determine the effects of state legislation requiring patient informed consent prior to medical record abstraction by external researchers for a specific study.


METHODS
Informed consent responses obtained from November 1997 through April 1998 from members of a Minnesota-based IPA model health plan.


METHODS
Descriptive case study of consent to gain access to medical records for a pharmaco-epidemiologic study of seizures associated with use of a pain medication that was conducted as part of the FDA's post-marketing safety surveillance program to evaluate adverse events associated with approved drugs.


METHODS
The informed consent process approved by an institutional review board consisted of three phases: (1) a letter from the health plan's medical director requesting participation, (2) a second mailing to nonrespondents, and (3) a follow-up telephone call to nonrespondents.


RESULTS
Of 140 Minnesota health plan members asked to participate in the medical records study, 52 percent (73) responded and 19 percent (26) returned a signed consent form authorizing access to their records for the study. For 132 study subjects enrolled in five other health plans in states where study-specific consent was not required, health care providers granted access to patient medical records for 93 percent (123) of the members.


CONCLUSIONS
Legislation requiring patient informed consent to gain access to medical records for a specific research study was associated with low participation and increased time to complete that observational study. Efforts to protect patient privacy may come into conflict with the ability to produce timely and valid research to safeguard and improve public health.
McCarthy
D B
DB
Center for Health Care Policy and Evaluation, United HealthCare, Minneapolis, MN 55440-1459, USA.
Shatin
D
D
Drinkard
C R
CR
Kleinman
J H
JH
Gardner
J S
JS
D015331:Cohort Studies; D003219:Confidentiality / Q000331:legislation & jurisprudence; D006302:Health Services Research / Q000331:legislation & jurisprudence*; D006801:Humans; D007193:Independent Practice Associations / Q000706:statistics & numerical data; D007258:Informed Consent / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data; D008499:Medical Records / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data; D008910:Minnesota; D018907:Privacy / Q000331:legislation & jurisprudence*; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data; D013221:State Health Plans / Q000706:statistics & numerical data; D014481:United States; D014486:United States Food and Drug Administration