Rhabdomyolysis in Basic Training

Based on our review of scientific information, we have identified several genetic varieties or polymorphisms that may be associated with an increased risk of muscle injury and/or heat illness. As part of our recruitment process we have provided you with this written study information, and will present to you a brief oral and PowerPoint presentation of the study design and schedule, and the time to address any questions not yet answered prior to issuing consent forms for those agreeing to participate.

Participation in this study is entirely voluntary; either agreeing or refusing to participate will have absolutely no effect on your status as a recruit or your standing in basic training. You will not be paid for your participation in this study. While your drill sergeant and company commander will be aware of all those who are participating in the study, this will occur only for scheduling purposes so that you and fellow participants can be excused for the 3 blood draws that will take place after basic physical training has begun. When you consent to participate in this study, you may place limitations on the use of your blood sample by selecting one of the options provided on the last page of the consent form. If at any point you decide not to continue in the study, detailed instructions for withdrawal are in the consent form.

Potential Risks: Participation in this study itself will not increase your risk of developing rhabdomyolysis. If you or any other participant should develop either rhabdomyolysis or very high CK levels, we will perform additional DNA analyses for certain conditions associated with exercise intolerance. Several of these are inherited muscle diseases that may not be diagnosed until adulthood and may only first become apparent after an episode of exercise intolerance. Diagnosis of any of these conditions is grounds for dismissal from the Army, but it is essential that you and your family be aware of these hereditary conditions if present.

Risks Associated With Genetic Analysis: There are certain additional risks that are uniquely associated with any study involving genetic testing. Using advanced genetic analysis, information about your DNA structure (genetic information) can help determine your risk of developing certain genetic diseases that run in families. This genetic information is unique to you and may indicate changes in your future health status or life expectancy, as well as possibly, that of your children and other relatives. Besides medical risks, genetic testing carries certain social risks. It can affect insurability, employability, personal family planning, family relationships, immigration status, instigate paternity lawsuits, and be associated with social stigmatization. Finding out that either you do or do not carry a gene associated with a serious illness can cause both significant stress and psychological harm.

Privacy and Confidentiality: All information provided, as part of this study will be confidential and protected to the fullest extent provided by law. Information and other records related to this study will be accessible to those persons directly involved in conducting this study and members of the Eisenhower Army Medical Center Institutional Review Committee (IRC), USUHS Research Department, and other governmental agencies, which provides oversight for protection of human research volunteers. All questionnaires, forms, and charts will be kept in a restricted-access, locked cabinet while not in use and blood samples will be stored in a restricted access, locked freezer at USUHS for up to five years, depending on how participants wish their blood to be used. After five years all remaining blood samples will be destroyed along with the code logbook. To enhance privacy of the information, all data will be entered into a database in which individual responses are not identified. After verification of the database information, all paper copies containing identifiers will be shredded.