Consent script

Attachment D – Consent Script

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 Virtual Reality Training Evaluation STUDY

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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.

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I. DESCRIPTION

1. Title: Virtual Reality to Training and Assess Emergency Responders; Mine Rescue and Escape Training

2. Sponsor and/or Project Officer: Launa Mallett, Ph.D.

3. Purpose and Benefits: The purpose of this research is to improve mine safety and health training by studying new methods and technologies. The results will be provided to the mining industry so better training can be provided, resulting in safer mines. As a participant in this study, you will experience state-of-the-art virtual reality training and play an important role in improving future training for you and your co-workers.

II. CONDITIONS OF THE STUDY

1. During this study, you will participate in one mine safety and health training session presented using virtual reality technologies. The content of the training is similar to that presented in your regular mandated mine safety and health or mine rescue training classes. As part of training, you may experience simulated immersive virtual environments created by 3D stereoscopic projection systems. Before and after the training, you will be asked to complete evaluation forms to assess your opinion of the session and what you learned from it. These forms will take no more than 15 minutes to complete. Individual escape and rescue training module sessions will take 3 to 4 hours to complete. Bench training sessions take approximately 1 hour. Training sessions will also be observed by NIOSH researchers and/or trainers and your interactions with the computer generated environment will be recorded. Your name or other personal identifiable information will not be collected. Research activities will take place in training classrooms/laboratories either in the Mine Rescue and Escape Training (MRET) Laboratory on the Bruceton Research site near Pittsburgh, PA or in usual training surface locations at mine sites or academic institutions. No photography, video, or sound recording will be taken.

2. Some study participants may experience symptoms similar to motion sickness when in a virtual environment or observing stereoscopic images. Symptoms could include: headache, drowsiness, nausea, dizziness, vomiting or sweating. If this should occur, inform a NIOSH employee conducting the testing immediately and you will be assisted to leave the virtual environment. The symptoms are likely to be mild and of short duration.

If you have any comment about the tests/procedures, you should contact Launa Mallett, Ph.D., Training Research and Development Team Leader, 412-386-6658.

3. There are no alternative test procedures for this research.

4. Injury or harm 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 or harmed through the negligence 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: Launa Mallett, Ph.D., Training Research and Development Team Leader, 412-386-6658 or Mark A. Toraason, Chair NIOSH HSRB, 513-533-8591.

5. If you have questions about this research, contact Launa Mallett, Ph.D., Training Research and Development Team Leader, 412-386-6658. If you have questions about your rights as a member of this study, contact Mark A. Toraason, Chair, NIOSH Human Subjects Review Board, 513-533-8591.

6. Your participation is voluntary and you may withdraw your consent and your participation in this study at any time without penalty or loss of benefits to which you are otherwise entitled.

You will not be paid in cash or in-kind by NIOSH for your participation. You may be eligible for credit for required training hours at the discretion of your employer and under their formal plan.

7. NIOSH will publish analyses of collated data from this research project in public documents. For questions related to obtaining these results, contact Launa Mallett, Ph.D., Training Research and Development Team Leader, 412-386-6658.

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. 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 the 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 Date (signature)

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.