Informed Consent

Attachment G-1:

Informed Consent

Form Approved.

OMB No. 0920-0907

Exp. Date xx/xx/20xx

Exp.Date xx/xx.20xx

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 (0920-0907).

This informed consent will be completed by all participating employees at the start of the study.

National Institute for Occupational Safety and Health (NIOSH)

Centers for Disease Control and Prevention

U.S. Public Health Service

U.S. Department of Health and Human Services

Consent to participate in a research study

You have been asked to participate in a NIOSH research study. We explain here the nature of your participation, describe your rights, and specify how NIOSH will treat your records.

I. DESCRIPTION

1: Title: Musculoskeletal disorder (MSD) intervention effectiveness in wholesale/ retail trade and material handling operations

2: Sponsor and Project Officers: This study is being done by the National Institute for Occupational Safety and Health (NIOSH), 4676 Columbia Parkway, Cincinnati, Ohio, 45226. The Project Officer is Steve Wurzelbacher, Ph.D.

3: Purpose and Benefits:

We want to find out how effective workplace controls like powered hand trucks and truck lift gates are in reducing low back and shoulder pain among workers performing material handling tasks. To determine this, we are asking you to participate in a questionnaire-based health assessment. We will also be collecting company records from your employer and records from the Ohio Bureau of Workers Compensation to help in this assessment. All company data and workers compensation data will be coded so that individual names will not be provided to NIOSH.

You are being asked to participate in the study because you are manually handling large and/ or heavy materials at your company. Since we want to be able to look at changes over time, we will be conducting the study over a 2-year period. We are asking you to completed regular questionnaires (at the start of the study and every 3 months).

Although there may be no immediate direct benefits to you from being in the study, the information gained from the study may help to improve our understanding of how to prevent low back and shoulder disorders. The information may also help design tools, equipment, and practices to improve delivery tasks.

II. CONDITIONS OF THE STUDY

1: Questionnaires: As a participant, you will be asked to complete four types of brief questionnaires. You have the choice to answer the questionnaires either online, using paper forms, or by telephone. Questionnaire data will be coded with a number and will not be provided to your company or to the Ohio Bureau of Workers Compensation.

General work environment and health (28 items): This questionnaire asks about your work background, your activities outside of work, your general health, and your symptoms of pain or discomfort for different body areas. You will be asked to complete this questionnaire at the start of the study and once every year for 2 years. It is estimated it will take on average 10 minutes each time to complete.

Self-reported low back health (17 items): This questionnaire asks about your low back health. You will be asked to complete this questionnaire at the start of the study and every 3 months for 2 years. It is estimated it will take on average 5 minutes each time to complete.

Self-reported shoulder and arm health (16 items): This questionnaire asks about your shoulder and arm health. You will be asked to complete this questionnaire at the start of the study and every 3 months for 2 years. It is estimated it will take on average 5 minutes each time to complete.

Job tasks and safety incidents (20 items): This questionnaire asks about how often on average you perform certain tasks in your daily work or if you experienced certain safety incidents. You will be asked to complete this questionnaire at the start of the study and every 3 months for 2 years. It is estimated it will take on average 5 minutes each time to complete.

It is estimated it will require 3 hours total of your time over 2 years for the entire questionnaire study.

2: There is little risk to you from filling out the questionnaire or being observed while you do your normal job duties. Data will be treated in a secure manner and will not be disclosed, unless otherwise compelled by law. If you have any concerns about this study, you should contact the NIOSH Project officer, Steve Wurzelbacher at (513) 841-4322.

3: NIOSH is partnering with the Ohio Bureau of Workers Compensation (OBWC) and your company for this study. OBWC and your company are providing funds to pay for the material handling equipment. The OBWC is providing workers compensation information and your company may provide information about absenteeism, delivery quality and productivity. All data from your company and from the OBWC will be coded so that individual names will not be provided to NIOSH. Questionnaire data that NIOSH collects will be coded with a number and will not be provided with your name to your company or to the OBWC. NIOSH has designed the study and will analyze the data to determine if controls like powered hand carts and truck lift gates are effective in preventing injuries and illnesses on the job.

4: No alternative tests are appropriate for this study.

5: Your participation is voluntary and you may withdraw from this study at any time without penalty or loss of benefits that are due to you. Participants will be given a $5 debit card upon completion of each combined questionnaire data collection (a total of $45 for the entire study). If you choose to leave the study, you will be asked to complete a voluntary, brief 5 minute phone survey.

6: Injury or illness from this project is unlikely. The targeted workplace controls (powered hand truck or truck lift gate etc.) are not expected to increase your risk of injury beyond the risks of your regular delivery work. You will be trained on the proper use of the equipment to minimize risks. But if an injury or illness 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: Claims Office: (202) 233-0233, General Law Division of the Office of General Council (OGC). 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:

Steve Wurzelbacher, Ph.D., Project Officer

National Institute for Occupational Safety and Health

4676 Columbia Parkway, R-14

Cincinnati, OH 45226

(513) 841-4322

[email protected]

Mark Toraason, Ph.D., Chairperson, NIOSH HSRB

National Institute for Occupational Safety and Health

4676 Columbia Parkway, C-11

Cincinnati, OH 45226

(513) 533-8591

If you have questions about this study, contact Steve Wurzelbacher at the email addresses and phone numbers listed above. If you have questions about your rights as a member of this study, contact Mark Toraason at the address and phone number above.

III. USE OF INFORMATION

This study is being done by The National Institute for Occupational Safety and Health (NIOSH). NIOSH is part of the Centers for Disease Control and Prevention (CDC), a government agency in the Department of Health and Human Services. NIOSH collects this information in order to learn about various kinds of work hazards that may influence the health of the American worker.

NIOSH is allowed to collect and keep such information, including results from this study because of three laws passed by Congress. These laws are:

1. The Public Health Service Act (42 U.S.C 241)

2. The Occupational Safety and Health Act (29 U.S.C. 669)

3. The Federal Mine Safety and Health Act of 1977 (30 U.S.C. 951)

You will decide whether you want to provide us with this information by being in this study. You are free to choose not to be in this study. Personally identifiable information and company information will be protected to the extent allowed by law. There are conditions under the Privacy Act when NIOSH could be authorized to release this information to outside sources. These conditions under which we might release this information are listed in Appendix A (the Privacy Act).

IV. SIGNATURES

I have read this consent form and I agree to participate in this study.

PARTICIPANT______________________________

(Signature)

Name (printed)_______________________________ Today’s Date:____________

Address:

Street _____________________________________ Phone ( )_____________

City_________________________State____________ Zip_______________

Email Address ______________________________________

Date Of Birth: MONTH_______ DAY_________YEAR_________

Please indicate here whether NIOSH has permission to contact you at the above address, phone number, and email address for the purpose of conducting this study. Yes________ No __________

Please indicate with an “X” below how you prefer to complete the surveys:

Online version (using the internet) _____

Paper version (a copy will be mailed to you) _____

I, the NIOSH representative or their agent (contractor), have accurately described this study to the participant:

REPRESENTATIVE:___________________________ Date:_____________

(Signature)

Informed Consent Form

Appendix A

The Information you provide will become part of the CDC Privacy Act System, 09-20-0147, “Occupational Health Epidemiological Studies and EEOICPA Program Records” and may be disclosed to

• Appropriate state or local health departments to report communicable diseases;

• Private contractors assisting NIOSH;

• Collaborating researchers under certain circumstances to conduct further investigations;

• One or more potential sources of vital statistics to make determinations of death, health status or to find last known address;

• The Department of Justice or the Department of Labor in the event of litigation;

• Congressional offices assisting an individual in locating his or her records;

You may request an accounting of the disclosures made by NIOSH.

Except for these and other permissible disclosures authorized by the Privacy Act, or in limited circumstances required by the Freedom of Information Act, no other disclosures may be made without your written consent.