2002 Annual Meeting on Successful Statewide
Roundtable Topic: What is the role of "informed consent" in EHDI programs?
Two distinct aspects of informed consent with regard to EHDI programs were identified: obtaining parental permission for screening to take place and obtaining parental permission for data to be shared. The most critical aspect for state programs is the latter. If hospitals and other providers do not share data with the state EHDI program, the program cannot track children to see that needed services are received or to monitor the effectiveness of the program.
Of the five states represented at the roundtable, two have mandatory reporting of individual-level data from screening tests to the state (ME, VA), one has mandatory reporting only of aggregate-level data (OR), and two have voluntary reporting (FL, WI).
Florida mandates informed consent be obtained from parents before screening is done. Hospitals are not required to report data and many choose not to, on grounds that doing so would violate confidentiality of patient records. The hospitals do not attempt to obtain informed consent to share this information.
Maine mandates both screening and reporting of data to the state, without informed consent being required. However, the sharing of data is limited to the screening period. Without informed consent for sharing of subsequent data, the state cannot conduct long-term tracking.
Virginia mandates reporting not only of screening test results but of all follow-up audiology visits. No informed consent is required.
The new national mandate for UNHS in England requires informed consent for screening, which is a novelty. A number of hospitals in the UK have been doing infant hearing screening without obtaining informed consent and there is some concern. A second issue is the willingness of data protection offices in hospitals to allow sharing of data within the health system. A third issue is access to data for evaluation by an academic group outside of the health department. The consent form that has been developed specifies permission for both screening and use of data for program evaluation purposes. The National Health Service has prepared a 5½ minute video on newborn hearing screening, which will be distributed to obstetricians for use in antenatal (prenatal) care.
The state participants would like the federal government to provide a clearinghouse for information on informed consent issues, such as the challenges and obstacles encountered by various states in this area, whether lawsuits have arisen, and how long and how much it costs to obtain IC. It would be valuable for the clearinghouse to obtain from the states copies of protocols, consent forms, and educational materials to be shared with other states. A detailed flow chart of the process would be helpful.
Finally, an official statement from the federal government to states on recommended practices for sharing data with state health departments to allow for the maintenance of databases for surveillance and evaluation would be appreciated, including the addressing of HIPAA issues.