Informed Consent

Attachment C

Informed Consent Document

Consent to be in a Research Study Emergency Self-Escape Task Analysis
	Who is conducting the study?	NIOSH is a federal agency that studies worker safety and health. They are part of the Centers for Disease Control and Prevention (CDC). NIOSH is partnering with The Group for Organizational Effectiveness, Inc. and Aptima, Inc.
	What is the purpose?	In the event of mine disaster that requires evacuating the mine, we want to be sure all mine personnel leave the mine safely, so we are interviewing mine personnel to learn about the tasks, skills, and knowledge needed for successful self-escape.
	What will I do?	In this project you will participate in an interview or focus group, or in some cases, both or more than one of each. During the interviews we will ask you about what happens during an evacuation, the greatest risk points, what miners need to know and be able to do to, what equipment they use and how they would use it, and what decisions they have to make. Audio recordings will be made of some interviews. If you do not wish to be audio recorded you may indicate so at the end of this informed consent process. For the focus group sessions, we will ask you about such topics as: What tasks are involved in self-escape in different kinds of disasters, the knowledge and skills needed to accomplish those tasks, the tools/technology you use, and challenges and difficulties.
	When, where, for how long will I be needed?	The study will take place at the mining location where you work. You will be involved in one or more of the following events: Interviews will require 2 hours and you may be interviewed more than once. Focus group sessions will require no more than 12 hours total, across two or three sessions, and you may participate in more than one.
Public reporting burden of this collection of information is estimated to average 5 minutes per interview response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Information Collection Review Office, 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA (0920-XXXX).	Are there any risks?	There are minimal risks associated with this study, similar to what you’d experience during a classroom training session. The researchers will make all efforts to maintain the privacy of anything you say by not identifying you in records, securely securing storing files and records, and not sharing your individual responses. All files and records, including audio, will be destroyed not later than six years after the end of this project. If you are participating in an interview, the questions in the interview guide pose minimal risk to you. We are not collecting your name. Only researchers who are involved in collecting the information will have repeated access to your responses. In any public release of results, no data will be disclosed that could be used to identify specific individuals. If you are participating in a focus group, the questions in the focus group guide pose minimal risk to you. We are not collecting your name. There is a potential risk of a loss of security because you will be sharing your opinions with other members of this group. Although we are asking all participants in the group to keep information shared secure, researchers cannot ensure this aspect of your privacy. Only researchers who are involved in collecting the information will have repeated access to your responses. In any public release of results, no data will be disclosed that could be used to identify specific individuals.
	Is my participation voluntary?	The study is voluntary. You may choose to be in the study or not. You may choose to answer any or all questions. You may drop out any time for any reason without consequences to you.
	What if I’m injured or harmed?	If necessary, the mine emergency response plan will be followed. If harmed through negligence of a NIOSH employee, you might obtain compensation under Federal Law. If a NIOSH contractor is negligent, you can file a claim with that contractor.
	Will I be reimbursed or paid?	You will not be paid or reimbursed for participating by the researchers for participating because you are participating on company time.
	Are there other benefits?	There are no individual benefits to participants. However, recommendations resulting from this study for ensuring safe and effective self-escape could provide greater safety for miners in the face of a disaster. It could help to improve the training provided to miners in self-escaping from mine accidents, lead to better-designed escape equipment, elimination of tasks or equipment that does not contribute to self-escape or enhancing self-escape procedures.
	Will my personal information be kept private?	NIOSH is authorized to collect your personal information and will protect it to the extent allowed by law. There are conditions under the Privacy Act where your information may be released to collaborators or contractors, health departments or disease registries, to the Departments of Justice or Labor, or to Congressional offices. We will not be collecting names. Any audio recordings will be stored as electronic data identified only by code number. As will all data gathered during this project, the researchers will make all efforts to maintain the security of anything you say by not identifying you in records, securely securing storing files and records, and not sharing your individual responses. All files and records, including audio, will be destroyed not later than six years after the end of this project.
	Will I or anyone else receive study results?	We will provide a summary briefing on study results to the mine. Your individual responses will not be shared with mine management. Reports will contain summary data only.
	Who can I talk to if I have more questions?	For questions about the research study, contact the principal investigator, George Alliger, Ph.D. The Group for Organizational Effectiveness, Inc., at george.alliger@groupoe.com or 518.355.9252. You may also contact Cassandra Hoebbel, Ph.D., Associate Service Fellow at the NIOSH Office of Mine Safety and Health Research, at choebbel@cdc.gov or 412.386.6133. For questions about your rights, your privacy, or harm to you, contact the Director of Human Research Protections, Mark Toraason at mtoraason@cdc.gov or 513-533-8591.
	Your agreement	Please acknowledge verbally that the study was explained to you and that your questions were answered. You also acknowledge that you have been given this Consent to be in a Research Study form and you agree to be in the study. State either: I agree to participate in this study _____ I agree to be audio recorded in this study ____ I decline _____ I have accurately described this study to the participant and they have verbally agreed to the statement checked above. ________________________________________________________ NIOSH representative/contractor signature Date

Updated July 9, 2013