Informed Consent

Attachment f

Informed Consent

Consent to be in a Research Study Characterization of Haul Truck Health and Safety Issues
	Who is conducting the study?	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?	The purpose of this research study is to characterize health and safety issues related to haul trucks. Specifically, NIOSH researchers are hoping to gain a better understanding of 1) the goals, skills, challenges, and task requirements for haul truck operators 2) how haul truck operators respond to challenging or non-routine scenarios and gain a greater depth of knowledge about these scenarios.
	What will I do?	For this study, you will take part in an interview. Before we start the interview, I will read you an informed consent. If you choose to participate, I will ask you to verbally indicate your agreement. For the interview, you will be asked questions from an interview guide that was developed by NIOSH researchers. All questions asked during the interview are designed to give NIOSH researchers a better understanding of the task requirements for haul truck operators and how haul truck operators respond to challenging scenarios. A scenario is the retelling of an event from your experience. An example of a challenging event may be a near miss, a collision involving property damage, or loss of control due to environmental conditions. During the interview, NIOSH researchers will be taking handwritten notes to document your responses to the questions. To make sure we can record your full responses, we are also asking your permission to audio record the interviews.
	When, where, for how long will I be needed?	The study will take place either where you work, at a neutral location (e.g. hotel lobby), or over the telephone. If the interview takes place where you work, we will sit together in a convenient location at the mine site, such as the mine office, shop, or safety department. The interview will take no more than 1 hour to complete.
	Are there any risks?	The activities of this study pose no more than minimal risk to you. There is a risk that your anonymity could be compromised (e.g., by linking voice recorded data to a mine worker); however, the likelihood is small because we are not asking you to sign any documents and because all collected data will be stored in a secured office that is accessible only by the researchers on the research team. Refer to Section 11: Will my personal information be kept private? of this form for addition information. The researchers will be asking participants to recall and describe events from past experiences. The researchers are interested in learning more about events that forced the participant to use cognitive efforts that go beyond background and routine procedural knowledge. The recalling of these events is intended to enable the researchers to learn about skilled performance during an event. Examples of these type of events may include a near miss, a collision involving property damage, or loss of control due to environmental conditions. There is a minimal risk that recalling these events may cause emotional distress or negative thoughts and feelings. Participation in the study is voluntary. You may choose to not answer questions that may cause emotional distress. You may drop out any time for any reason without any consequence. The health and safety of the mine worker and the research team will be considered for interviews. All interviews will take place within an office or similar environment.
	Is my participation voluntary?	Participation in 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?	NIOSH will summon emergency medical aid by calling 911. If NIOSH finds your injury was a direct result of participation in the study and if appropriate documentation is provided, NIOSH may provide short-term medical treatment that it deems necessary to treat the immediate medical needs arising from the injury. In general, no long-term medical care or financial compensation of research-related injuries will be provided by NIOSH, the CDC, or the Federal Government. However, if you believe NIOSH has been negligent in conducting the research study and you believe you have suffered a harm as a result, you have the right to pursue a legal remedy under the Federal Tort Claims Act (28 U.S.C. §§ 2671-2680 and 28 U.S.C. § 1346(b)). To learn more about how to file a Federal Tort claim, call the General Law Division of the HHS Office of the General Counsel at (202) 619-2155 or go to https://www.hhs.gov/about/agencies/ogc/key-personnel/general-law-division/index.html
	Will I be reimbursed or paid?	You will not be paid or reimbursed for participating.
	Are there other benefits?	There is no direct benefit to you for participating in this study, other than the satisfaction of assisting with research that will increase our understanding of haul truck-related safety issues.
	What alternative procedures might benefit me?	There are no alterative procedures for this study.
	Will my personal information be kept private?	We will be collecting voice recordings during the study. However, the likelihood of anybody identifying your voice is small because we are not asking you to sign any documents and the voice recordings will be transcribed into written text. Additionally, all the collected data will be stored in a secured office that is accessible only by the researchers on the research team. The voice recordings will be destroyed at the end of the study. 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. Certificate of Confidentiality This research is covered by a Certificate of Confidentiality from the Centers for Disease Control and Prevention. The researchers with this Certificate may not disclose or use information, documents, or biospecimens that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is a court subpoena, unless you have consented for this use. Information, documents, or biospecimens protected by this Certificate cannot be disclosed to anyone else who is not connected with the research except, if there is a federal, state, or local law that requires disclosure (such as to report child abuse or communicable diseases but not for federal, state, or local civil, criminal, administrative, legislative, or other proceedings, see below); if you have consented to the disclosure, including for your medical treatment; or if it is used for other scientific research, as allowed by federal regulations protecting research subjects. The Certificate of Confidentiality will not be used to prevent disclosure for any purpose you have consented to in this informed consent document.
	Will I or anyone else receive study results?	If you would like a summary of the results of this evaluation, please let the researcher know. You will have to provide your name and email address; this information will be kept separate from your evaluation data. The summary of results will be an overall summary of evaluations collected from your mine site. We are unable to provide you with a summary of your own evaluation. A summary of the information collected during this study is likely to be shared with members of the mining community at stakeholder meetings such as the annual meeting of the Society of Mining, Metallurgy, and Exploration (SME) or similar events.
	Who can I talk to if I have more questions?	For questions about the research study, contact the principal investigator, Jennica Bellanca at [email protected] or 412-386-6445. For questions about your rights, your privacy, or harm to you, contact the NIOSH IRB Chair at 513.533.8591.
	Your Verbal Consent	The study was explained to me. My questions were answered. If you agree to be in the study, please say Yes out loud now.
	Additional consent	Do I have your permission to voice record this interview? Yes or no?

Updated March 29, 2016