The program of ongoing surveillance and reporting described in this summary protocol does not involve clinical research, but does involve the observation of human behavior recorded in such a manner that human subjects are necessarily identified both directly and through identifiers linked to the subject. Subjects include injury victims as well as perpetrators and, depending upon the circumstances of the event, may include identification of relatives and acquaintances of injury victims and perpetrators. The observations of human subjects, if they became known outside the program, could reasonably place some subjects at risk of liability or be damaging to their financial standing or employment. Further, the research and analysis contemplated here may deal with sensitive aspects of a subject's own behavior such as violent or illegal conduct and drug or alcohol use. See, 45 CFR Section 46.101. While basic injury surveillance is not considered human subjects research by the CDC, these linked data sets and analyses conducted with information collected in this project may be deemed human subjects research by institutional review boards.

Anticipated duration of project (may be different than the duration of current funding)

Sample Language:

The purposes for collecting and maintaining accurate and complete information about violent and intentional injuries including all firearm injuries are to assist in the development and evaluation of policies and strategies designed to reduce injuries and deaths.

In 1999 more than 1.2 million years of potential life were lost (before age 65) due to violent-related deaths in the U.S. Firearm-related deaths (which account for 65% of homicides and 60% of suicides) are estimated to account for 59% of the years of life lost due to violent injury.15

It is estimated that 2.7 million criminal assaults to persons 12 years and older resulting in injury to the victim occurred in 1994, and an estimated 750,000 parasuicides that result in emergency department visits and hospitalizations occur annually. While progress has been made to further our understanding of intentional injuries, little is known about emerging trends and characteristics of these events either nationally or within states or communities. Important questions either cannot be answered, or resources are not in place to shed light on this important public health problem, so that effective prevention strategies can be developed, tested and evaluated. This project is a linked system of data sets regarding intentional injuries that when analyzed over time may yield critical information for the development of injury intervention strategies and the evaluation of prevention programs.

The right of individuals to privacy creates a duty to protect confidentiality to assure that neither identifying information nor records are disclosed without authorization. This includes the risks associated with potential unauthorized disclosure of identifying information (i.e., unauthorized disclosure of privileged communications, release of mental health records, release or modification of electronic records, etc.) including the risk of state and federal privacy law violations.

Unauthorized disclosure or disclosure of information in violation of law or policy by any employee, intern, contractor or associated researcher will be subject to disciplinary action and will be reported to the appropriate employment, academic, or professional authority. Volunteers shall be apprised of these policies and execute an agreement subjecting them to these conditions. In the event that this project receives a request, subpoena or order from any governmental body for production of information or records that may include information identifying or tending to identify individuals, legal counsel will be consulted immediately.

In addition, the method for protecting confidential information should also be addressed. Though the purpose of a reporting system is to collect and make available comprehensive information, the collection and maintenance of linked, identifiable information, especially in an electronic database, creates a duty to preserve such information from disclosure, destruction, or corruption.

Other than the risks involved in unauthorized public disclosure, human subjects are not at risk of intrusive injury or other physical harm or disease as a result of this proposed surveillance, interpretation and analysis. Therefore, this summary of protocol is eligible for an expedited

A description of how information will be shared with researchers and the NVDRS should be included (see section on Privacy Protection and Information