App L_Informed Consent form (Longitudinal boot outsole study)

Appendix K

Informed consent form for ingress/egress study

Consent to be in a Research Study Ingress/egress from mobile equipment
	Who is conducting the study?	The National Institute for Occupational Safety and Health (NIOSH) is a federal agency that studies worker safety and health. We are part of the Centers for Disease Control and Prevention (CDC).
	What is the purpose?	Slip and falls from mobile equipment is a large contributor to non-fatal injuries in mining. Features of the ingress/ingress system that contribute to slips and falls have not been documented adequately. We would like your help to identify features of the ingress/egress system and behaviors that can lead to slips and falls from large mobile equipment.
	What will I do?	For this study, you will take part in an interview or a focus group. Before we start the interview/focus group, you will read an informed consent document (this form). If you choose to participate, we will ask you to verbally indicate your agreement. The interview/focus group is made up of a series of questions that will help identify how you use, maintain, and inspect the ingress/egress systems on mobile equipment. We will be taking notes during the interview/focus group. To make sure that we don’t miss anything you say, we are also going to audio record the interview/focus groups.
	When, where, for how long will I be needed?	This interview/focus group will be conducted at a time that is convenient for you and take place where you work. We will sit together in an office at the mine site, likely in the safety department or a conference room. The interview will take about 1 hour and the focus group will take about 1.5 hours to complete.
	Are there any risks?	This study poses no more than minimal risk to you. There is a risk that your anonymity could be compromised (e.g., by linking audio recorded data to a mine worker). However, the likelihood is small because we are not asking you to sign any documents. Additionally, all collected data will be stored in a secured office that is accessible only by the researchers on the research team. Your managers will not have access to any of your data or comments.
	Is my participation voluntary?	Your participation in this study is voluntary. You may choose to be in the study or not. You may drop out at any time for any reason without consequences to you.
	What if I’m injured or harmed?	On-site emergency treatment will be provided. We will follow all emergency procedures in place at your mine site. Medical care or compensation will not be provided by NIOSH researchers. If harmed through negligence of a NIOSH employee, you might obtain compensation under Federal Law.
	Will I be reimbursed or paid?	You will receive your regular salary, provided by your company, while participating in this study if the interview/focus group is conducted during normal working hours.
	Are there other benefits?	There is no direct benefit, except for compensation of time spent outside of normal work hours, to you for participating in this study, other than the satisfaction of assisting with research that will help document issues with the ingress/egress systems for mobile equipment.
	What alternative procedures might benefit me?	There are no alternative procedures for this study.
	Will my personal information be kept private?	We will collect audio recordings during the study. However, the likelihood of anybody identifying your voice is small because 1) we are not asking you to sign any documents, 2) all of the collected data will be stored in a secured office that is accessible only by the researchers on the research team, 3) the audio recording will only be identified by a code number and 4) the audio recordings will be destroyed at the end of the study.
	Will I or anyone else receive study results?	If you would like a summary of the results of the study, please let us and your management know. If requested, we will provide a summary of results including an overall summary of data collected from several mine workers to your mine manager for distribution to you. We are unable to provide you with a summary of your own data. A summary of the information collected during this study is likely to be shared with mine sites and members of the mining community at stakeholder meetings such as the annual meeting of the National Sand, Stone, and Gravel Association (NSSGA).
	Who can I talk to if I have more questions?	For questions about the research study, contact the principal investigator, William Porter at WLPorter@cdc.gov or 412-386-5222. For questions about your rights, your privacy, or harm to you, contact the chair of the NIOSH Institutional Review Board (IRB) in the Human Research Protection Program, Angela Morley at kto0@cdc.gov or at 513-533-8591
	Verbal Consent	Please indicate whether you would like to take part in the study by saying yes or no.