md bill--hs football helmet sensors--opposed by md nurses assn

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_ ~. ~; , ~ ~... ~ ~~ _. ~:., , ~ s ~ c; t t ,~ t ~ tY~ rv. Oppose House Bill 426: Education —Concussion Impact Sensor Pilot Program House Ways and Means Committee February 12, 2014 The Maryland Nurses Association (MNA) opposes House Bi11426—Education —Concussion Impact Sensor Pilot Program. The bill mandates the establishment of a research program, called the Pilot Concussion Impact Sensor Pilot Program, in every county for one football team. Through the program, each team member would be provided with a concussion impact sensor; and throughout the course of the year, the high school would collect information from the sensor and related information about the team players. The high school would report the information to the Maryland State Department of Education, which would issue a report on the information, as well as recommendations related to the future of concussion impact sensors. MNA commends the bill sponsor for his work to improve the safety of school athletes. However, we believe legislation in not the appropriate vehicle to create any specific research project for the following reasons: Individuals must have the ability to give informed consent to participate in a research project. When research is mandated, it removes the opportunity for informed consent. In the case of HB 426, it appears that it is mandated that one high school in each county participate in the program if concussion impact sensors are donated to the State for the program; Medical research, such as the study contemplated in HB 426, should be reviewed and approved by an institutional review board (IRB), before being implemented. To our knowledge, MSDE and local school boards do not have IRBs. Thus, even if the bill were to require IRB review, there is not a mechanism for that review to be conducted; The pilot program does not contemplate a protocol for how the sensor might trigger the assessment of the team member by a health care practitioner. This protocol is critical in protecting the safety of team members. Such protocols should be developed by clinicians and reviewed by an IRB; and There is no mechanism by which clinicians and researchers would select the sensor to be tested. The only requirement is that the sensors be donated. When testing any medical device, it is imperative that the decision on type of device be made based on available information on the efficacy and safety of the device. Thank you for your consideration of our testimony. If you have any questions, please feel free to contact our legislative representative, Ms. Robyn Elliott, at (443) 926-3443 or [email protected] The Maryland Nurses Association, a constituent member association of the American Nurses Association (ANA), representing Maryland's professional nurses since 1904 Maryland Nurses Association 21 Governor's Court, Suite 195 Baltimore, MD 21244-2721 410-944-5800 Web Site: www.marylandrn.org

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Md Bill--HS Football Helmet Sensors--OPPOSED by Md Nurses Assn

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    Oppose

    House Bill 426: Education Concussion Impact Sensor Pilot ProgramHouse Ways and Means Committee

    February 12, 2014

    The Maryland Nurses Association (MNA) opposes House Bi11426Education ConcussionImpact Sensor Pilot Program. The bill mandates the establishment of a research program, called the PilotConcussion Impact Sensor Pilot Program, in every county for one football team. Through the program, eachteam member would be provided with a concussion impact sensor; and throughout the course of the year, thehigh school would collect information from the sensor and related information about the team players. Thehigh school would report the information to the Maryland State Department of Education, which would issue areport on the information, as well as recommendations related to the future of concussion impact sensors.MNA commends the bill sponsor for his work to improve the safety of school athletes. However, we believelegislation in not the appropriate vehicle to create any specific research project for the following reasons:

    Individuals must have the ability to give informed consent to participate in a research project. Whenresearch is mandated, it removes the opportunity for informed consent. In the case of HB 426, itappears that it is mandated that one high school in each county participate in the program ifconcussion impact sensors are donated to the State for the program;

    Medical research, such as the study contemplated in HB 426, should be reviewed and approved by aninstitutional review board (IRB), before being implemented. To our knowledge, MSDE and local schoolboards do not have IRBs. Thus, even if the bill were to require IRB review, there is not a mechanismfor that review to be conducted;

    The pilot program does not contemplate a protocol for how the sensor might trigger the assessment ofthe team member by a health care practitioner. This protocol is critical in protecting the safety ofteam members. Such protocols should be developed by clinicians and reviewed by an IRB; and

    There is no mechanism by which clinicians and researchers would select the sensor to be tested. Theonly requirement is that the sensors be donated. When testing any medical device, it is imperativethat the decision on type of device be made based on available information on the efficacy and safetyof the device.

    Thank you for your consideration of our testimony. If you have any questions, please feel free to contactour legislative representative, Ms. Robyn Elliott, at (443) 926-3443 or [email protected]

    The Maryland Nurses Association, a constituent member association of the American Nurses Association (ANA), representingMaryland's professional nurses since 1904

    Maryland Nurses Association21 Governor's Court, Suite 195Baltimore, MD 21244-2721

    410-944-5800Web Site: www.marylandrn.org