Consent form_Aim 2 and 3

Consent to be in a Research Study Assessing Fatigue and Fatigue Management in U.S. Onshore Oil and Gas Extraction
	Key Information Summary	The National Institute for Occupational Safety and Health (NIOSH) is a federal agency that studies worker safety and health and is part of the Centers for Disease Control and Prevention (CDC). NIOSH is conducting a study to understand how fatigue affects U.S. onshore oil and gas extraction (OGE) workers. You are being invited to participate in this study where we will be conducting focus groups with workers and interviews with supervisors, senior health and safety leaders, and academic researchers. Before starting the focus group or interview, you will be asked to verbally indicate that you agree to participate. The focus group or interview will last approximately one hour and will ask about worker and work design factors to consider when developing and implementing fatigue management strategies. Answers will be documented in writing and, if you approve, will also be audio recorded to capture answers exactly as provided and not miss any information. Participation in this research is voluntary. You may refuse to answer any questions, and/or stop your participation at any time without any consequences. To protect your privacy and confidentiality, focus groups and interviews will be conducted in a private location and researchers will not collect any personal identifying information. Participation in this research involves minimal risks to you. There is a small risk that collected information will be accidently released. The risk will be minimized by identifying each paprticipant with a unique code that cannot be linked back to you. While there is no direct benefit, participation in this study will help identify factors that are associated with fatigue and provide information to develop policies or practices to prevent worker fatigue. We will release summaries of information we collect in reports, presentations, and publications. Only NIOSH staff who are involved in this research will have access to the data. Workers and supervisors are eligible to receive a gift card in the amount of $10 as a token of appreciation for your participation. Senior health and safety leaders and academic researchers are not eligible to receive a gift card. You may want to participate in this study to help companies like yours understand practical ways to reduce the hazards associated with fatigue and improve working conditions for you, and workers like you. However, you may not want to participate in this study if you are concerned about increasing the burden of work during your workday or concerns about your information being released and used against you. The study team would like to reassure you that the benefits of participating in this study outweigh the risks and precautions have been taken to minimize these concerns.
	Who is conducting the study?	The NIOSH is a federal agency that studies worker safety and health part of the CDC.
	What is the purpose?	The purpose of this research is to identify worker and work design factors to consider when developing and implementing fatigue management strategies in the oil and gas industry; and to describe how fatigue prevention strategies are being adopted in the oil and gas industry.
	What will I do?	You will answer questions in the focus group or interview. NIOSH researchers will ask about your experience with fatigue in the oil and gas industry. We will take notes to capture your answers. If you agree, we will also audio record the interview so that we don’t miss any information you give us. Focus groups and interviews will be conducted during work hours in a private location at the worksite. If travel is not possible, secure virtual focus groups and key informant interviews will be scheduled. Key informant interviews with health and safety senior leaders and academic researchers will be conducted virtually through a secure platform. You will have the option to sign a voluntary General Photo Release Form, which if signed, would give the research team permission to take photos you during the data collection period. These photos will be solely used for health communication purposes.
	When, where, for how long will I be needed?	Your total direct participation time will be: 90 minutes for the focus group, or 60 minutes for the supervisor key informant interview, or 60 minutes for the health and safety senior leader, or 60 minutes for the academic researcher key informant interview.
6	Are there any risks from participating in the study?	There is very little risk to you if you take part in this study. There is a small risk that the information you provide could be accidentally released, which could cause mental stress due to a loss of privacy. This risk will be minimized by setting ground rules emphasizing the importance that anything said will not be repeated outside the group, identifying your responses by a unique code that cannot be linked back to you, and by only releasing summaries of the information that is collected. Only NIOSH staff who are involved in this research will have access to your responses. Physical injury or harm is not likely. There is a very small risk you could get a respiratory infection (e.g., COVID-19, influenza) through an in-person interaction while participating in this study. To minimize your risk of exposure to viruses and maximize your protection against infection, NIOSH researchers follow COVID-19 and other relevant respiratory infectious disease guidance for CDC and NIOSH staff and workplaces.
7	Are there other benefits?	You will not receive any direct benefits from participating in this study. Your participation in this research will help to better understand how fatigue affects oil and gas extraction workers and identify factors to consider when developing and implementing fatigue management strategies in the industry.
8	Is my participation voluntary?	Your participation in the study is voluntary. You may choose to participate in some or all portions of the study and answer any or all questions. You may decline to participate or drop out at any time, for any reason, with no penalty or loss of benefits to which you are otherwise entitled. If you decline to participate of withdraw, you will not be eligible to receive a gift card.
9	What if I am injured or harmed at a NIOSH research facility or at another location where the NIOSH research project is being conducted?	NIOSH will summon emergency medical aid by calling 911 if needed. NIOSH will not provide payment for medical care or compensation. 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.
10	Will I be reimbursed or paid?	Workers and supervisors will receive a $10 gift card at the end of the focus group or interviews as a token of appreciation. Senior health and safety leaders and academic researchers who participate in interviews are not eligible to receive a gift card.
11	What alternative procedures might benefit me?	No alternative procedures are available for this study.
12	Will my personal information be kept confidential?	The study is anonymous. We will not be collecting or recording any personal identifiable information.
13	Certificate of Confidentiality	This research project has a Certificate of Confidentiality from the Centers for Disease Control and Prevention (CDC). Unless you say it is okay, researchers cannot release information that may identify you for a legal action, a lawsuit, or as evidence. This protection applies to requests from federal, state, or local civil, criminal, administrative, legislative, or other proceedings. As an example, the Certificate would protect your information from a court subpoena. There are some important things that you need to know. The Certificate DOES NOT protect your information if a federal, state or local law says it must be reported. For example, some laws require reporting of abuse, communicable diseases, and threats of harm to yourself or others. The Certificate CANNOT BE USED to stop a federal or state government agency from checking records or evaluating programs. The Certificate DOES NOT stop reporting required by the U.S. Food and Drug Administration (FDA). The Certificate also DOES NOT stop your information from being used for other research if allowed by federal regulations. Researchers may release your information when you say it is okay. For example, you may give them permission to release information to insurers, your doctors, or any other person not connected with the research. The Certificate of Confidentiality does not stop you from releasing your own information. It also does not stop you from getting copies of your own information.
14	Will I or anyone else receive study results?	We will share a summary of results with oil and gas industry health and safety organizations, including your company’s. We will not share individual details of your interview with anyone.
15	Is this a Clinical Trial?	This is not a clinical trial.
16	Did you receive all necessary information?	Is there anything about this research study that is unclear to you, or you would like to discuss?
17	Who can I talk to if I have more questions?	For questions about the research study, contact the principal investigator, Alejandra Ramirez-Cardenas at [email protected] or 303-236-5957. 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 at 513-533-8591.
18	Your consent	The study was explained to me. My questions were answered. I agree to participate in the focus group or key informant interview component of the study. I agree to participate in the focus group/key informant interview component of the study. [Please say Yes or No out loud.] ___ Yes ___ No I agree to allow research staff to audio record my interview. [Please say Yes or No out loud.] ___ Yes ___ No I have accurately described this study to the participant. ______________________________________________________ NIOSH representative signature Date

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