Informed Consent Form

4-6 Attachment F Informed Consent (No Burden) R2.docx

Anthropometric Information on Law Enforcement Officers

Informed Consent Form

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Attachment F: Informed Consent


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Consent to be in a Research Study

Anthropometric Information on Law Enforcement Officers

1

Who is conducting the study?

NIOSH is a federal agency that studies worker safety and health. We are part of the Centers for Disease Control and Prevention (CDC). NIOSH is partnering with Anthrotech Inc.

2

What is the purpose?

The purpose of this study is to collect Law Enforcement Officer (LEO) body size information so that better vehicle layout and protective equipment can be developed.

3

What will I do?

  1. A. Upon arriving at the data collection site, the investigator will explain the test procedures to you. You may ask questions if you have any. Then, if you decide to participate in the study, you will be asked to show your current LEO identification and read and sign a consent form before participating in this study.

  2. B. After you sign the consent form, you will change clothes in a changing room: shorts for men and shorts with sports bra for women. After changing clothes, you will be asked to assume two postures: standing and sitting. The standing posture requires that you stand erect with heals apart for 30 cm and hands 30 degrees from trunk by each side. You will be told to look ahead and stand with equal weight on both feet. The sitting posture requires that the participant sit erect on a specially designed bench with the head facing forward. The shoulders and upper arms are relaxed, and the forearms and hands are extended forward and up for about 45 degrees with the palms facing each other. The thighs are 15 degrees slope forward and the knees are flexed 90 degrees to the seat surface. Then, the researcher who is trained in body measurement will mark, with an eyeliner pen, bony points on your body that will serve as reference points for taking measurements of your body. If you are a female, you will be marked and measured by a female researcher. After marks are placed on your body, the investigator will measure your body dimensions with a tape measure and ruler in an area of the room designated for measurements. During the course of body measurement, you will also use a tablet computer to complete an assessment on challenges you encounter with you vehicle cab space and operation, seat belt use, and armor use.

Consent to be in a Research Study

Anthropometric Information on Law Enforcement Officers



C. After the manual body measurement, you will be asked to participate in further testing, during which scanning devices will be used to obtain 3D whole-body, head, hand and foot images of you. The researcher will locate some more bony points on your body and mark some spots with white dots. Then you will be asked to step up to a whole-body scanner and be scanned twice (once in a standing posture and again in a sitting posture). After the whole-body scanning, you will then be asked to sit in the scanning area of a head and face scanner where a scanner will obtain a 3D head and face image of you. Next, you will place your right hand on a flatbed scanner. A 2D image of your hand will be taken. Then, you will place your right foot on a foot scanner and the scanner will take a 3D image of your foot. Each of the scans will take about 5 to 17 seconds. The scanners contain safe, low-power lights (similar to those of grocery store bar code scanners) that are swept across the human body to record dimensions and brightness. The lights are safe to your eyes and will NOT penetrate your body or the clothing to harm you.


After you are done with the scanning, you will change to your uniform with the gear you use in daily work. Sixteen dimensions (with gear) will be taken using traditional anthropometric devices. Finally, you will change back into street clothes and be released.

4

When, where, for how long will I be needed?

If you qualify and agree to participate in the study, you may be asked to make up 1.5 hours to participate in the study. If you participate in the study during your working hours, as part of your duty, you will not receive an incentive for your study visit. Otherwise, you will receive $50 as a token of appreciation for the study. You may decline further participation in this study at any and every point.

5

Are there any risks?

The risk of injury is very low since you only need to sit or stand and be measured and scanned. Other possible risks include discomfort of having the tape measure and anthropometric rulers around your face. There is a slight risk that the ruler may slip over the eye, but the instrument is not sharp. The researcher will be extremely gentle and careful when conducting measurements on your face.


There is a small chance that you may develop some irritated skin or allergic reactions to the eyeliner pencil used to mark some bony spots on your body. Still, the scanning procedures (i.e., being in an enclosed space) may carry a small risk of causing anxiety for some participants. If you know you have preexisting conditions such as skin allergies or anxiety, you should inform the investigator prior to the testing. In both cases, the testing shall terminate immediately.


If you feel that you cannot or should not perform any of these tasks, you should not participate in this study.


Consent to be in a Research Study

Anthropometric Information on Law Enforcement Officers

6

Is my participation voluntary?

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 must be at least 18 years of age and be an employed police officer. Women who are pregnant and therefore not actively patrolling will be excluded as their body dimension measurements at this stage would not reflect their non-pregnancy condition.

Please let us know if you are in this status.

7

What if I’m injured or harmed?

Injury or harm from this project is unlikely. In the event an injury occurs, first aid or emergency treatment will be obtained. If necessary, a team member will call 911 in an emergency.

However, there are no provisions for financial compensation or free medical treatment. If you are injured through negligence of a NIOSH employee or contractor, 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, the Claims Office: 202-233-0233. If an injury should occur to you as the result of your participation, you should also contact Hongwei Hsiao, Ph.D., Chief, Protective Technology Branch, Division of Safety Research, (304) 285-5910, or Angela Morley, chair, NIOSH Institutional Review Board, 513-533 8591.

8

Will I be reimbursed or paid?

If you participate in the study during your working hours, as part of your duty, you will not receive an incentive for your study visit. Otherwise, you will receive $50 as a token of appreciation for the study. Payment will be made at the end of study visit.

9

Are there other benefits?

There are no direct benefits to you for participating in this research. There is a potential indirect benefit of contributing to the research in the field of anthropometric data for law enforcement officer populations.

10

Will my personal information be kept private?

The personal information that is collected for the study is limited to biographical information, height, weight, the challenges you have with your vehicle and protective equipment, pictures of you, and various related body measurements. The data collected is assigned to a subject number for identification. The data will be used to improve police vehicles and protective equipment design.


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


Consent to be in a Research Study

Anthropometric Information on Law Enforcement Officers



collaborators or contractors, health departments or disease registries, to the Departments of Justice or Labor, or to Congressional offices.


The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), an agency of the Department of Health and Human Services, is authorized to collect this information, including your social security number (if applicable), under provisions of the Public Service Act, Section 301 (42 U.S.C. 241); Occupational Safety and Health Act, Section 20 (29 U.S.C. 669); and the Federal Mine Safety and Health Act of 1977, Section 501 (30 U.S.C. 95).

11

Will I or anyone else receive study results?

The overall results of the study will be documented in a journal article or a NIOSH research report. No individual results or facial identifications of you will be published. Copies will be provided to you upon publication at your request. Please call Dr. Hsiao, the project officer, at the end of 2020, if you would like a copy of the summary report.

12

Who can I talk to if I have more questions?

For questions about the research study, contact the principal investigator, Dr. Hongwei Hsiao at [email protected] or 304-285- 5910.


For questions about your rights, your privacy, or harm to you, contact the Institutional Research Board Chair at [email protected], or 513-533-8591.

13

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



I have accurately described this study to the participant.


_ _ NIOSH representative signature Date


Consent to be in a Research Study

Anthropometric Information on Law Enforcement Officers

14

Additional consent

PHOTOGRAPHY CONSENT:

Photographs and digital images may be taken of your face, hand, foot, and body as part of your participation in this study. These photographs and digital images will not reveal your identity, but they may not be used without your written consent. By checking the box below, you give your permission to use photographs and digital images, which were taken during this study, for the purposes of professional publications, training, or education. You may still participate in the study should you choose not to give your consent at this time.


I may cancel or withdraw my photography consent at any time during or after my participation in this study. I must do so in writing and submit that withdrawal of consent to the study investigator.


Statement:

I agree to have photographs taken as part of this study as described in this paragraph.


Yes No Participant’s initials

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File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
File TitlePilot Study of Truck Driver Anthropometry in the U
AuthorGuan, Jinhua
File Modified0000-00-00
File Created2021-01-21

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