Attachment 3 - Consent forms for Phase I

Attachment 3

Consent Form for Phase I

NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH (NIOSH)

CENTERS FOR DISEASE CONTROL

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: Field Evaluation of a Prototype Kneel-assist device

2. Sponsor and/or Project Officer:

Susan Moore

NIOSH

Pittsburgh Research Laboratory

626 Cochrans Mill Road

PO Box 18070

Pittsburgh, PA 15236-0070

(412) 386-6613

3. Purpose and Benefits: In this study we will be testing kneel-assist devices comprised of a kneepad and a body weight support worn at the ankle. These kneel-assist devices have been designed to reduce the forces, stresses, and moments at the knee when performing your job. The purpose of this study is to determine how well the kneel-assist devices work in a mining environment. The overall goal of this project is to decrease the risk of knee injuries in low-seam mines.

II. CONDITIONS OF THE STUDY

1. Procedure

The following procedure will be followed:

1. For completing this interview, you will receive a $25 gift card to either Lowes or The Home

Depot, depending on which store is located closest to your community.

2. You will first fill out this consent form. Please feel free to ask the researchers questions at any time. (approximately 15 minutes)

3. The researchers will then ask you a few questions. The researchers will be using a questionnaire as a guide for the interview. These questions will be about the current kneepad you are using. As you answer the questions, the researchers will be writing down your answers. (approximately 30 minutes)

4. Once you have completed the questionnaire, you will be given the kneel-assist devices. You will also be given a second pair so that you may adequately clean your kneel-assist devices each night and allow time for them to dry before you use them again.

5. You will be asked to use the kneel-assist devices for 1 month. After 1 month, the researchers will again visit the mine and ask you the same questions they did previously. (approximately 30 minutes)

6. Throughout the study, you must only use the kneel-assist devices you are given. Additional pairs will be made available to you as needed. There exists the chance that the kneel-assist devices will perform poorly and not be suitable for use during a full month. In that event, you will be asked to respond to the researchers questions and still be reimbursed the $25 gift card for your time. (approximately 30 minutes)

7. After evaluating the kneel-assist devices through this individual interview, you will be asked to participate in a focus group. For completing this focus group, you will receive a $25 gift card to either Lowes or The Home Depot, depending on which store is located closest to your community.

8. You will be in a room with several other people. The researches will ask a series of questions about the prototype kneel-assist devices. After each question, time will be given for the group to discuss their opinions. As you answer the questions, the researchers will be writing down your answers. (approximately 45 minutes)

9. After your first review of the kneel-assist devices, the researchers may decide to redesign them and ask you to evaluate them again for an additional month. In this instance, you will again be interviewed and reimbursed a $25 gift card for your time.

10. If you are a section foreman, you will also be asked additional questions about the environmental conditions in the mine (e.g. seam height). You will be asked these questions once for each month the kneel-assist devices are evaluated. The researchers will call the mine to go over the questions. No additional reimbursement will be associated with answering these questions. (approximately 10 minutes per interview)

11. You may quit the study at any time, for any reason. If you feel you have experienced an injury due to use of the kneel-assist devices or kneepad, please contact NIOSH personnel immediately.

12. Risks and Discomfort

You will only perform your normal job tasks for this study. The kneel-assist device or kneepad are expected to result in only no or minimal discomfort. In the event of any problems/concerns, you should contact:

Richard Unger, PhD

Chief, NIOSH-PRL Mining Injury Prevention Branch

(412) 386-5081

Susan Moore, PhD

NIOSH-PRL Mining Injury Prevention Branch

(412) 386-6613

13. No alternative test procedures are available.

14. Injury or harm from this project is unlikely. But if it results, only emergency treatment will be provided. If you are injured through carelessness of a NIOSH worker 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: Public Health Service Claims Office: (301) 443-1904. If you are injured or harmed through the carelessness of a NIOSH contractor, your claim would be against the contractor, not the federal government. If an injury or harm should occur to you as the result of your participation, you also should contact:

Susan Moore, PhD

NIOSH-PRL Mining Injury Prevention Branch

(412) 386-6613

Cheryl Estill, PhD

Chairman, Human Subjects Review Board, NIOSH

513-533-8591

15. Contact Susan Moore at 412-386-6613 if you have any questions. Contact Cheryl Estill at 513-533-8591 if you have questions about your rights.

16. Your participation is voluntary. You may withdraw from the study at any time without penalty or loss of benefits to which you are otherwise entitled. You will be reimbursed for the portion of the study you completed.

17. The results of this study will be published and made available to you at your request. The publication process may take months or years depending on the type of publication. For a copy of any published results, please contact Susan Moore at 412-386-6613 or via email SMMoore@cdc.gov.

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 (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 the American worker.

NIOSH is allowed to collect and keep information about you, including your results from this study, along with your social security number (if applicable), 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. It is up to you. If the information we are collecting is maintained and retrieved by personal identifiers, such as your name and social security number, it will become part of the CDC record system and we will protect it to extent allowed by law. You should know, however, that there are conditions under the Privacy Act when we 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 received a copy of the conditions for data release under the Privacy Act (Appendix A). I agree to participate in this study.

PARTICIPANT Age (signature)

(and Guardian, if required) Date

I, the NIOSH representative, have accurately described this study to the participant.

REPRESENTATIVE Date

(signature)

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;

• A State Cancer Registry to report cases of cancer where the state has a legal reporting program providing for confidentiality;

• 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;

• The Department of Justice to assist in determining the eligibility for compensation to uranium workers or their survivors [optional but must be used if study pertains to uranium workers]

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.