Informed Consent

Attachment H-1

Informed Consent Form

Form Approved

OMB No. 0920-xxxx

Exp. Date xx/xx/20xx

Consent to be in a Research Study Evaluating interventions for airplane cargo baggage handling
	Who is conducting the study?	This study is being done by the National Institute for Occupational Safety and Health (NIOSH). NIOSH is part of the Centers for Disease Control (CDC), a government agency in the Department of Health and Human Services. We collect this information in order to learn about various kinds of work hazards that may influence the health of American workers.
	What is the purpose?	We want to find out how the physical demands of manual baggage handling in the tarmac area affect your body and the risk for musculoskeletal disorders with and without using interventions (lifting assist systems).
	What will I do?	You were selected for the study because you are working in the tarmac area. We will ask you to participate in annual and monthly questionnaire surveys for assessing your musculoskeletal health and associated risk factors, such as manual lifting, pushing and pulling baggage. We will also be collecting company records (worker compensation costs, medical records related to musculoskeletal disorders, turnover rate, and OSHA logs) to help in this assessment. A formal agreement with your company will be signed for releasing the information to NIOSH. In addition, we will collect information on the physical demands of your job by videotaping and photographing your work. The purpose of these video and pictures is to help us record information for all the different jobs we are studying so we can determine postures and motions that are required by the jobs. We will keep your photos/video secure by storing recorded data on a password protected computer network in a locked office guarded by security officers 24/7 all year around. If you choose not to be videotaped for the job assessment, you can still participate in the study by filling out questionnaires. By checking the box below, you choose not to be videotaped for the research project. □ I do not want to be videotaped or photographed for research purposes.
Public reporting burden of this collection of information is estimated to average 5 minutes per 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).
	When, where, for how long will I be needed?	You will be asked to fill out a questionnaire once a year and a short questionnaire monthly over a 2-year period. The annual and the monthly questionnaire take about 30 and 10 min, respectively. We will be returning to your workplace each year for follow-up visits to re-assess the physical demands of your job.
	Are there any risks?	You may be selected to use a power stow conveyor system in airplane cargo compartments or a vacuum lifting assist system during the study period. These systems help you transfer bags by making the job easier for you. There is little risk (such as a hit by bags dropping off the devices) to you when using the lifting assist systems. Emergency procedures for treating injuries from using the systems will be part of your company’s safety policy. These procedures will be told to you during training for using the devices. Other non-physical risk is loss of security of the data we collected by a breach in our computer system, although this risk is minimal with our data protection systems in place (described in #10).
	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. Your full participation is important to us because missing information from you may not produce results that are useful for you and your fellow baggage handlers.
	What if I’m injured or harmed?	Injury from this project is unlikely. But if it results, medical care is not provided, other than emergency treatment. If you are injured through negligence of a NIOSH employee, you may be able to obtain compensation under Federal Law. If you want to file a claim against the Federal government your contact point is: General Law Division of OGC, request the Claims Office: (202) 233-0233. If you are injured through the negligence of a NIOSH contractor, your claim would be against the contractor, not the federal government. If an injury should occur to you as the result of your participation, you also should contact either: Ming-Lun (Jack) Lu, Ph.D. at (513) 833-8158 NIOSH 4676 Columbia Parkway, C-24 Cincinnati, OH 45226 Mark Toraason, Ph.D., Chairperson, NIOSH IRB National Institute for Occupational Safety and Health 4676 Columbia Parkway, C-11 Cincinnati, OH 45226 (513) 533-8591
	Will I be reimbursed or paid?	You will not be paid or reimbursed for participating in the study. You can use your work time to fill out the questionnaires as part of our research agreement with your company and worker union(s)
	Are there other benefits?	Although there are no immediate direct benefits from being in the study, the information gained from the study may help to improve our understanding of musculoskeletal disorders that may result from physical activities at work. What is learned from this study, when combined with the knowledge gained from other studies, may benefit you and other workers by helping to determine the level of physical demands associated with baggage handling that is safe for workers.
	Will my personal information be kept private?	The information we are collecting is maintained and retrieved by personal identifiers, such as your name and worker ID. Your personal identifiable information will be kept secure and stored in the NIOSH computerized password protected record system. The location for the data storage is guarded by security officers 24/7 all year around. 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.
	Will I or anyone else receive study results?	Individual results, summary results or final report can be delivered to you upon request. Study results will be published in an aggregated form without revealing your private information. That is, your personal information remains anonymous to the public.
	Who can I talk to if I have more questions?	For questions about the research study, contact the principal investigator, Ming-Lun (Jack) Lu, Ph.D. mlu@cdc.gov or 513-833-8158. 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.
	Exclusion of pregnant women	Pregnant women will be excluded from the study because pregnancy has been shown to be highly related to musculoskeletal symptoms that may not be caused by your job demands. If you are pregnant now, you are not eligible for the study. If you become pregnant during the study period, your data after self-reported pregnancy will not be used and no additional data will be collected after the reported pregnancy. The monthly and annual questionnaires will survey your status of pregnancy. Are you pregnant now? □ Yes □ No □ Non Applicable
	Your signature	The study was explained to me. My questions were answered. I agree to be in the study. ______________________________________________________ Printed name of participant ______________________________________________________ Participant signature Date ______________________________________________________ NIOSH representative signature Date
	Additional video and photo release consent for non-research purposes	1. I agree to allow the National Institute for Occupational Safety and Health (NIOSH) to use my photographic image. I hereby agree to allow my photographic or video recorded image to be used (with or without my name, both singly and in conjunction with other persons or objects) by the National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention, U.S. Department of Health and Human Services. 2. NIOSH will use my photographic image (still photograph and/or video image) for any or all of the following: a. Obtaining research data for calculating the risk of musculoskeletal disorders. b. Use in publications and presentations (print and/or video) describing research methodology and results. c. Production of training materials or materials describing body movement requirements for baggage handling. d. Other purposes. 3. No one will ever pay me for the use of my photographic or video image. I understand that for the use of my photographic image, I will receive no financial compensation or payment of any kind from the United States Government or from any agency of the Government or from any person making a copy of the government publication now, or at any time in the future. _______________________________________________ Printed name of participant ______________________________________________________ Participant signature Date

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