SampleCollectionVIS

OMB #: 0925-0593

Expiration Date: 06/30/2017

Sample Collection Visit Information Sheet Scripts, Phase 2g

SAMPLE COLLECTION VISIT INFORMATION

SHEET SCRIPTS

Event:	Pre-Preg, PV1, PV2, Birth, 6M, 12M, 24M, 36M, 48M, 60M
Domain:	Consent
Type of Document:	Visit Information Sheet Scripts
Version:	4.0
Release:	MDES 4.1

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SAMPLE COLLECTION VISIT INFORMATION SHEET SCRIPTS

DATA COLLECTOR INSTRUCTIONS:

• THERE ARE 3 DOCUMENTS THAT ARE USED FOR CREATING THE VISIT-SPECIFIC SAMPLE COLLECTION VISIT INFORMATION SHEET (VIS):

  • SAMPLE COLLECTION VIS SCRIPTS (THIS DOCUMENT)

    • CONTAINS THE VISIT-SPECIFIC SCRIPTS NEEDED FOR EACH VISIT;

  • SAMPLE COLLECTION VIS FIELD DOCUMENT

    • PROVIDES A LIST OF VISIT-SPECIFIC SAMPLE/SPECIMEN COLLECTIONS OR ASSESSMENTS

  • SAMPLE COLLECTION VIS TEMPLATE

    • PROVIDES A NCS STANDARD TEMPLATE THAT IS USED FOR DISPLAYING THE VISIT-SPECIFIC SCRIPTS THAT WILL BE PRESENTED TO THE PARTICIPANT/PARENT/CAREGIVER

• GO TO THE SAMPLE COLLECTION VIS FIELD DOCUMENT TO DETERMINE THE APPROPRIATE SAMPLE COLLECTIONS/ASSESSMENTS FOR THIS VISIT.

• TAKE THE ASSOCIATED SCRIPT FOR EACH OF THE SAMPLE COLLECTIONS/ ASSESSMENTS FOR THIS VISIT AND INSERT THE SCRIPTS INTO THE SAMPLE COLLECTION VIS TEMPLATE.

• WHEN COPYING SAMPLE COLLECTION VIS SCRIPTS, DATA COLLECTORS SHOULD NOT COPY TEXT THAT APPEARS IN BOLD FONT IN THE FIELD DOCUMENT OR IN ALL CAPITAL LETTERS IN THE SAMPLE COLLECTION VIS SCRIPTS DOCUMENT.

• SOME COLLECTIONS ARE ONLY DONE AS A SUB-SAMPLE (NOT ALL PARTICIPANTS WILL PARTICIPATE IN THE COLLECTION. SUB-SAMPLE COLLECTIONS ARE DENOTED IN THIS DOCUMENT AS (SUB-SAMPLE).

• CHECK FORMATTING AFTER INSERTING SCRIPTS AND REFORMAT IF NECESSARY.

• PRINT TWO (2) COPIES OF THE SAMPLE COLLECTION VIS SCRIPT:

  • ONE COPY WILL BE GIVEN TO THE PARTICIPANT/PARENT/CAREGIVER

  • ONE COPY WILL BE USED BY THE DATA COLLECTOR TO PRESENT THE VIS

SAMPLE COLLECTION VISIT INFORMATION SHEET SCRIPTS

MULTI-MODE VISIT INFORMATION SCRIPT (MMVIS) IS READ PRIOR TO REVIEW OF THE SAMPLE COLLECTION VISIT INFORMATION SHEET

1.0 INTRODUCTORY SCRIPTS

1. THE LANGUAGE BELOW SHOULD BE USED FOR THE PRE-PREGNANCY AND PREGNANCY VISIT 2.

In addition to asking you questions, we would also like to collect some samples from you today.

2. THE LANGUAGE BELOW SHOULD BE USED FOR THE PREGNANCY VISIT 1 EVENT.

In addition to asking you questions, we would also like to collect some samples from you and -and a vacuum dust sample from your home today.

3. THE LANGUAGE BELOW SHOULD BE USED FOR THE BIRTH EVENT.

In addition to asking you questions, we would also like to collect some samples from you and your child today.

4. THE LANGUAGE BELOW SHOULD BE USED FOR THE 6-MONTH EVENT.

In addition to asking you questions, we would also like to collect some samples from you and some samples and measurements from your child today.

5. THE LANGUAGE BELOW SHOULD BE USED FOR THE 12-MONTH EVENT:

 

In addition to asking you questions, we would also like to collect some samples from you, some samples and measurements from your child, a vacuum dust sample and make some observations in and around your home today.

6. THE LANGUAGE BELOW SHOULD BE USED FOR THE 24-MONTH EVENT.

In addition to asking you questions, we would also like to collect some samples from you and some samples and measurements from your child today.

7. THE LANGUAGE BELOW SHOULD BE USED FOR THE 36-MONTH AND 60-MONTH EVENTS:

 

In addition to asking you questions, we would also like to collect some samples from you, some samples and measurements from your child, collect vacuum dust and wipe samples, as well as make observations in and around your home today.

7. THE LANGUAGE BELOW SHOULD BE USED FOR THE 36-MONTH AND 60-MONTH EVENT (SUBSAMPLES):

We would also like to set up noise measurement equipment in your home.

7. THE LANGUAGE BELOW SHOULD BE USED FOR THE 48-MONTH EVENT:

In addition to asking you questions, we would also like to collect some samples from you, some samples and measurements from your child, collect vacuum dust and wipe samples, as well as make observations in and around your home today.

2. ADULT SAMPLE COLLECTION SCRIPTS

7. THE LANGUAGE BELOW SHOULD BE USED FOR THE PRE-PREGNANCY, PREGNANCY VISIT 1, PREGNANCY VISIT 2, BIRTH, 6-MONTH, 12-MONTH, 24-MONTH, 36-MONTH, 48-MONTH, AND 60-MONTH EVENTS.

What sample collections am I being asked to participate in today?

7. THE LANGUAGE BELOW SHOULD BE USED FOR ADULT URINE COLLECTION FOR THE PRE-PREGNANCY, PREGNANCY VISIT 1, PREGNANCY VISIT 2, BIRTH, 6-MONTH, 12-MONTH, 36-MONTH, AND 60-MONTH EVENTS.

We would like you to collect a urine sample.

• You will collect a small amount of your urine (about 5 tablespoons) in the cup provided.

• This will take about 11 minutes.

• We may test your urine for biological substances and chemicals that may be present in the environment.

7. THE LANGUAGE BELOW SHOULD BE USED FOR ADULT BLOOD COLLECTION FOR THE PRE-PREGNANCY, PREGNANCY VISIT 1, PREGNANCY VISIT 2, BIRTH, 6-MONTH, 12-MONTH, 36-MONTH AND 60-MONTH EVENTS.

We would like to collect a blood sample from you. To do this we will:

• Collect a small amount (about 2 tablespoons) of your blood using a small needle.

• This will take about 17 minutes.

• We may test your blood for hormones, nutrients, infections and inflammation, and for the presence of metals and other chemicals in the environment. We may use the sample for genetic analyses with your permission.

Are there any risks from this collection?

• We have trained medical professionals who know how to take blood safely. People sometimes feel brief pain when blood is taken, and there is a very small risk of infection, bruising, bleeding, or fainting.

7. THE LANGUAGE BELOW SHOULD BE USED FOR THE ADULT BREAST MILK COLLECTION FOR THE BIRTH EVENT.

We would like you to collect some breast milk samples when your child is 1 month old and again when your child is 3 months old. To do this we will:

• Either give you the breast milk collection kit when your child is born or we may mail it to you closer to the time that your child will be 1 month old.

• For the 3 month breast milk sample collection, we will mail you the kit.

• You can use these kits to collect a small amount of your breast milk.

• We ask that you freeze each sample until we can come back to pick it up.

• We may test your breast milk to see if the samples contain certain chemicals or hormones.

7. THE LANGUAGE BELOW SHOULD BE USED FOR ADULT SALIVA COLLECTION FOR THE 36-MONTH AND 60-MONTH EVENTS.

We would like you to collect a sample of your saliva.

• This will take about 11 minutes.

• We may measure your saliva sample for biological substances and environmental chemicals. We may use the sample for genetic analyses with your permission.

Are there any risks from this collection?

• This procedure may be a little uncomfortable for you.

7. THE LANGUAGE BELOW SHOULD BE USED FOR ADULT MICROBIOME COLLECTION FOR THE BIRTH EVENT.

We would like to collect swabs from your mouth, vagina, and rectum.

• This will take about 10 minutes.

• You will collect your own rectal swab using materials and instructions we provide, we will collect the others.

• We may test your swab samples for genetic material from bacteria that are present in the sample.

Are there any risks from this collection?

• This procedure may be a little uncomfortable for you.

7. THE LANGUAGE BELOW SHOULD BE USED FOR ADULT MICROBIOME COLLECTION FOR THE 6-MONTH, 24-MONTH, AND 48-MONTH EVENTS.

We would like to collect swabs from your mouth, nose, and rectum.

• This will take about 10 minutes.

• You will collect your own rectal swab using materials and instructions we provide, we will collect the others.

• We may test your swab samples for genetic material from bacteria that are present in the sample.

Are there any risks from this collection?

This procedure may be a little uncomfortable for you.

3.0 CHILD SAMPLE COLLECTION SCRIPTS

7. THE LANGUAGE BELOW SHOULD BE USED FOR THE BIRTH, 6-MONTH, 12-MONTH, 24-MONTH, 36-MONTH, 48-MONTH, AND 60-MONTH EVENTS.

What sample collection(s) is my child being asked to participate in today?

7. THE LANGUAGE BELOW SHOULD BE USED FOR THE PLACENTA COLLECTION FOR THE BIRTH EVENT.

We would like to collect the placenta shortly after your child is born.

• We will work with hospital, clinic, or birthing center staff to collect the placenta.

7. THE LANGUAGE BELOW SHOULD BE USED FOR THE CORD BLOOD COLLECTION FOR THE BIRTH EVENT.

We would like to collect umbilical cord blood shortly after your child is born.

• We will work with hospital, clinic, or birthing center staff to collect the umbilical cord blood. Blood is collected from the umbilical cord shortly after it is separated from the baby. The procedure takes about 5 minutes.

• All samples will be collected by trained medical professionals who know how to collect blood safely.

• If you have decided to participate in a cord blood bank program to store your child’s umbilical cord blood, we will not collect any umbilical cord blood for the study.

7. THE LANGUAGE BELOW SHOULD BE USED FOR THE INFANT BLOOD SPOT CARD COLLECTION FOR THE BIRTH EVENT.

We would like to collect a blood sample from your child soon after birth.

• We would like to collect a small amount of blood (up to 4 drops) from the child’s heel. We will work with hospital, clinic, or birthing center staff to collect the sample when they collect the baby’s blood for routine tests.

• All samples will be collected by trained medical professionals who know how to collect blood safely.

7. THE LANGUAGE BELOW SHOULD BE USED FOR CHILD URINE COLLECTION FOR 6-MONTH AND 12-MONTH EVENTS.

We would like to collect a urine sample from your child. To do this we will:

• Use a urine collection bag to collect a urine sample from your child.

• The amount of time that this collection takes varies by child, but we will not leave the collection bag on your child for more than 75 minutes.

• We may test his/her urine for biological substances and chemicals that may be present in the environment.

Are there any risks from this collection?

• As with any adhesive device, the adhesive component of this product may cause mild irritation upon removal.

7. THE LANGUAGE BELOW SHOULD BE USED FOR CHILD URINE COLLECTION FOR 36-MONTH AND 60-MONTH EVENT.

We would like you to collect a urine sample from your child. To do this we will:

• Ask your child to collect his/her urine in a cup we provide or we will use a urine collection bag to collect a urine sample from your child.

• If a urine bag is used to collect your child’s urine, the amount of time that this collection takes varies by child, but we will not leave the collection bag on your child for more than 75 minutes.

• If a urine collection cup is used to collect your child’s urine, then it will take about 14 minutes.

• We may test his/her urine for biological substances and chemicals that may be present in the environment.

Are there any risks from this collection?

• If a urine bag is used to collect your child’s urine, as with any adhesive device, the adhesive component of this product may cause mild irritation upon removal.

7. THE LANGUAGE BELOW SHOULD BE USED FOR CHILD BLOOD SAMPLE COLLECTION FOR THE 12-MONTH EVENT.

We would like to collect a blood sample from your child. To do this we will:

• Collect a small amount (a little less than 1 tablespoon) of your child’s blood from the arm by using a small needle.

• This will take about 17 minutes.

• We may test your child’s blood for hormones, nutrients, infections and inflammation and for the presence of metals and other chemicals in the environment. We may use the sample for genetic analyses with your permission.

Are there any risks from this collection?

• We have trained medical professionals who know how to take blood safely. People sometimes feel brief pain when blood is taken, and there is a very small risk of infection, bruising, bleeding, or fainting.

7. THE LANGUAGE BELOW SHOULD BE USED FOR CHILD BLOOD SAMPLE COLLECTION FOR THE 36-MONTH and 60-MONTH EVENT.

We would like to collect a blood sample from your child. To do this we will:

• Collect a small amount (a little more than 1 tablespoon) of your child’s blood from the arm by using a small needle.

• This will take about 17 minutes.

• We may test your child’s blood for hormones, nutrients, infections and inflammation and for the presence of metals and other chemicals in the environment. With your permission, we may use the sample for genetic analyses.

Are there any risks from this collection?

We have trained medical professionals who know how to take blood safely. People sometimes feel brief pain when blood is taken, and there is a very small risk of infection, bruising, bleeding, or fainting.

7. THE LANGUAGE BELOW SHOULD BE USED FOR CHILD SALIVA COLLECTION FOR THE 12-MONTH, 36-MONTH, AND 60-MONTH EVENTS.

We would like to collect a sample of your child’s saliva.

• This will take about 11 minutes.

• We may measure your child’s saliva sample for biological substances and environmental chemicals. We may use the sample for genetic analyses with your permission.

Are there any risks from this collection?

• This procedure may be a little uncomfortable for your child.

7. THE LANGUAGE BELOW SHOULD BE USED FOR CHILD MICROBIOME COLLECTION FOR THE 6-MONTH AND 48-MONTH EVENTS.

We would like to collect swabs from your child’s mouth, nose, and rectum.

• This will take about 8 minutes.

• We may test your child’s swab samples for genetic material from bacteria that are present in the sample.

Are there any risks from this collection?

• This procedure may be a little uncomfortable for your child.

7. THE LANGUAGE BELOW SHOULD BE USED FOR CHILD MICROBIOME COLLECTION FOR THE 24-MONTH EVENT.

We would like to collect swabs from your child’s mouth, nose, and rectum. In addition, to these swabs, we would like you to collect a sample of your child’s stool to mail-back to us.

• It will take about 8 minutes to collect the swabs.

• We will provide you with materials and instructions to collect and mail us your child’s stool sample.

• We may test your child’s swab samples and stool sample for genetic material from bacteria that are present in the sample.

Are there any risks from this collection?

• This swab collection procedure may be a little uncomfortable for your child.

7. THE LANGUAGE BELOW SHOULD BE USED FOR CHILD TEETH COLLECTION FOR THE 60-MONTH EVENT.

We would like you to collect the teeth your child loses. To do this we will:

• Provide you with materials to mail us any baby teeth your child loses.

• We may test your child’s teeth samples for biological substances and environmental chemicals. We may use the sample for genetic analyses with your permission.

7. THE LANGUAGE BELOW SHOULD BE USED FOR CHILD ANTHROPOMETRY COLLECTION FOR THE 6-MONTH EVENT.

We would like to collect some measurements from your child. We will share these measurements with you.

• We will measure his/her:

  • Weight

  • Length

  • Length of his/her upper and lower arm and upper leg

  • Skinfolds of the back of his/her upper arm and upper back

  • Distance around his/her head, waist, upper leg, and upper arm

• This will take about 20 minutes

Are there any risks from this collection?

• These procedures may be a little uncomfortable for your child.

7. THE LANGUAGE BELOW SHOULD BE USED FOR CHILD ANTHROPOMETRY AND BLOOD PRESSURE COLLECTION FOR THE 12-MONTH EVENT.

We would like to collect some measurements from your child. We will share these measurements with you.

• We will measure his/her:

  • Weight

  • Length

  • Length of his/her upper and lower arm and upper leg

  • Skinfolds of the back of his/her upper arm and upper back

  • Distance around his/her head, waist, and upper leg

  • Blood pressure and pulse/heart rate

• This will take about 30 minutes

Are there any risks from this collection?

• These procedures may be a little uncomfortable for your child.

7. THE LANGUAGE BELOW SHOULD BE USED FOR CHILD ANTHROPOMETRY AND BLOOD PRESSURE COLLECTION FOR THE 24-MONTH EVENT.

We would like to collect some measurements from your child. We will share these measurements with you.

• We will measure his/her:

  • Weight

  • Height

  • Length of his/her upper and lower arm and upper leg

  • Skinfolds of the back of his/her upper arm and upper back

  • Distance around his/her head, waist, and upper leg

  • Blood pressure and pulse/heart rate

• This will take about 30 minutes

Are there any risks from this collection?

• These procedures may be a little uncomfortable for your child.

7. THE LANGUAGE BELOW SHOULD BE USED FOR THE CHILD ANTHROPOMETRY AND BLOOD PRESSURE COLLECTION FOR THE 36-MONTH EVENT.

We would like to collect some measurements from your child. We will share some of these measurements with you.

• We will measure his/her:

  • Weight

  • Height

  • Distance around his/her head and waist

  • Blood pressure and pulse/heart rate

• This will take about 30 minutes.

Are there any risks from this collection?

• These procedures may be a little uncomfortable for your child.

7. THE LANGUAGE BELOW SHOULD BE USED FOR THE CHILD ANTHROPOMETRY AND BLOOD PRESSURE COLLECTION FOR THE 48-MONTH EVENT.

We would like to collect some measurements from your child. We will share some of these measurements with you.

• We will measure his/her:

  • Weight

  • Height

  • Length of his/her upper and lower arm

  • Distance around his/her waist

  • Blood pressure and pulse/heart rate

• This will take about 30-35 minutes.

Are there any risks from this collection?

• These procedures may be a little uncomfortable for your child.

7. THE LANGUAGE BELOW SHOULD BE USED FOR THE CHILD ANTHROPOMETRY AND BLOOD PRESSURE COLLECTION (SUBSAMPLE) FOR THE 48-MONTH EVENT.

We would like to collect some measurements from your child. We will share some of these measurements with you.

• We will measure his/her:

  • Weight

  • Height

  • Length of his/her upper and lower arm

  • Body Composition

  • Distance around his/her waist

  • Blood pressure and pulse/heart rate

• This will take about 35-40 minutes.

Are there any risks from this collection?

• These procedures may be a little uncomfortable for your child. Body composition is measured by having your child step on a scale. The scale measures body composition through an electrical pulse, which your child will not be able to feel.

7. THE LANGUAGE BELOW SHOULD BE USED FOR THE CHILD ANTHROPOMETRY, BLOOD PRESSURE, AND LUNG FUNCTION COLLECTION FOR THE 60-MONTH EVENT.

We would like to collect some measurements from your child. We will share some of these measurements with you.

• We will measure his/her:

  • Weight

  • Height

  • Length of his/her upper and lower arm

  • Distance around his/her waist

  • Blood pressure and pulse/heart rate

  • Lung function; to measure lung function we will him/her take a deep breath and blow as hard and as fast as possible into a mouthpiece.

• This will take about 45 minutes.

Are there any risks from this collection?

• These procedures may be a little uncomfortable for your child.

7. THE LANGUAGE BELOW SHOULD BE USED FOR THE CHILD ANTHROPOMETRY, BLOOD PRESSURE, AND LUNG FUNCTION COLLECTION (SUBSAMPLE) FOR THE 60-MONTH EVENT.

We would like to collect some measurements from your child. We will share some of these measurements with you.

• We will measure his/her:

  • Height

  • Weight

  • Length of his/her upper and lower arm

  • Body Composition

  • Distance around his/her waist

  • Blood pressure and pulse/heart rate

  • Lung function; to measure lung function we will him/her take a deep breath and blow as hard and as fast as possible into a mouthpiece.

• This will take about 50 minutes.

Are there any risks from this collection?

• These procedures may be a little uncomfortable for your child. Body composition is measured by having your child step on a scale. The scale measures body composition through an electrical pulse, which your child will not be able to feel.

7. THE LANGUAGE BELOW SHOULD BE USED FOR VISION FOR THE 36-MONTH EVENT.

We would also like to measure your child’s vision.

• To do this, we will ask your child to identify different sized letters on a computer screen. Only the letters H, O, T, and V will be used. Children may point to a card showing the letters if they do not know or cannot say the letter names.

• This will take approximately 3 minutes.

7. THE LANGUAGE BELOW SHOULD BE USED FOR VISION, ENDURANCE, STANDING BALANCE, 9-HOLE PEGBOARD, GRIP STRENGTH FOR THE 60-MONTH EVENT.

We would like to measure your child’s physical capabilities.

• We would like to measure how easily your child can use his/her hands:

• We will ask your child to place and remove pegs into a pegboard.

• This will take approximately 4 minutes.

• We would like to measure your child’s walking ability:

• We will ask your child to walk a short distance at his/her usual pace three times.

• This will take approximately 3 minutes.

• We would like to measure your child’s grip strength:

• We will ask your child to squeeze a device as hard as he/she can for three seconds.

• This will take approximately 3 minutes.

• We would like to measure your child’s balance:

• We will ask your child to wear a physical activity monitor.

• We will then ask your child to copy and hold 5 poses for 50 seconds each.

• This will take approximately 7 minutes.

• We would like to measure your child’s vision:

• To do this, we will ask your child to identify different sized letters on a computer screen. Only the letters H, O, T, and V will be used. Children may point to a card showing the letters if they do not know or cannot say the letter names.

• This will take approximately 3 minutes.

Are there any risks from this collection?

• These procedures may be a little uncomfortable for your child.

4.0 ENVIRONMENTAL SAMPLE COLLECTION SCRIPTS

7. THE LANGUAGE BELOW SHOULD BE USED FOR THE PREGNANCY VISIT 1, 12-MONTH, 36-MONTH, 48-MONTH, AND 60-MONTH EVENTS.

What sample(s) would you like to collect in and around my home today?

7. THE LANGUAGE BELOW SHOULD BE USED FOR THE ENVIRONMENTAL COLLECTIONS AT THE PREGNANCY VISIT 1 EVENT.

We’d like to collect an environmental sample. You may join us while we conduct this activity, or (with your permission) we can complete this activity while you perform other activities.

• We would like to collect a vacuum dust sample. To do this, we will:

  • Collect the vacuum bag or dust sample from your most used vacuum cleaner.

  • This will take about 14 minutes.

7. THE LANGUAGE BELOW SHOULD BE USED FOR THE ENVIRONMENTAL COLLECTIONS AT THE 12-MONTH EVENT.

We’d like to collect an environmental sample, measurements, and make observations in and around your home. You may join us while we conduct this activity, or (with your permission) we can complete these activities while you perform other activities.

• We would like to collect a vacuum dust sample. To do this, we will:

  • Collect the vacuum bag or dust sample from your most used vacuum cleaner.

  • This will take about 14 minutes.

• We would like to make some observations in and around the outside of your home.

  • We won’t go anyplace in or outside of your home that you don’t want us to go.

  • We will measure the temperature of your hot water.

  • With your permission, we will open drawers/cabinets/closets in a few rooms in your home.

• This will take about 30 minutes inside your home and 33 minutes outside your home.

7. THE LANGUAGE BELOW SHOULD BE USED FOR THE ENVIRONMENTAL COLLECTIONS AT THE 36-MONTH, 48-MONTH AND 60-MONTH EVENTS.

We’d like to collect environmental samples and measurements and make observations. You may join us while we conduct these activities, or (with your permission) we can complete these activities while you perform other activities.

• We would like to collect wipe samples. To do this, we will:

  • Wipe the floor in the room where your child spends the most time while awake.

    • We may test these wipes for chemicals like pesticides or metals.

    • This will take about 26 minutes.

• We would like to collect a vacuum dust sample. To do this, we will:

  • Collect the vacuum bag or dust sample from your most used vacuum cleaner.

  • This will take about 14 minutes.

• We would like to make some observations in and around the outside of your home.

  • We won’t go anyplace in or outside of your home that you don’t want us to go.

  • We will measure the temperature of your hot water.

  • With your permission, we will open drawers/cabinets/closets in select areas of your home.

• This will take about 30 minutes inside your home and 33 minutes outside your home.

7. THE LANGUAGE BELOW SHOULD BE USED FOR NOISE MONITOR (SUBSAMPLE) FOR THE 36-MONTH AND 60-MONTH EVENTS.

• We would like to measure noise levels in your home. To do this, we will:

• Set up a noise monitor in your home.

• We will leave it in your home for approximately 7 days, and will either return to pick it up, or in some cases, we will ask you to ship it back to us. We will provide a postage-paid shipper and instructions for you to ship it back.

• We will work with you to find a good spot for the noise monitor. Once we’ve agreed on a good spot, please don’t move the noise monitor. If you move it, we won’t be able to learn as much as we need to about noise levels in your home.

• You don’t need to change your daily routine while the noise monitor is in your home.

• We’ll give you instructions to help answer any questions you may have about the noise monitor.

• It will take about 18 minutes to set the noise monitor up.

• It will take about 12 minutes to pick up the noise monitor.

7. THE LANGUAGE BELOW SHOULD BE USED FOR PHYSICAL ACTIVITY MONITOR (SUBSAMPLE) FOR THE 36-MONTH, 48-MONTH, AND 60-MONTH EVENTS.

• We may ask to measure the physical activity of your child. To do this we will:

  • Place a physical activity monitor on your child's wrist and a global positioning system (GPS) monitor on your child’s waist.

  • We ask that you leave the physical activity monitor on the child's wrist for 7 days. It is waterproof so can be worn in the shower, tub, or when swimming.

  • We ask that you leave the GPS monitor on your child’s waist for 7 days. It is not waterproof so it cannot be worn when the child is swimming, bathing, or playing in water.

  • We ask that you remove the GPS monitor from your child’s waist every evening before your child goes to bed and charge it overnight and then place it back on your child’s waist in the morning.

  • We will either return to pick the monitors up, or in some cases, we will ask you to ship them back to us. We will provide a postage-paid shipper and instructions for you to ship them back.

  • You and your child do not need to change your daily routine while the monitors are worn.

  • We’ll give you instructions to help answer any questions you may have about the monitors.

  • It will take about 25 minutes to set the monitors up.

  • It will take about 18 minutes to pick up the monitors.

5.0 CLOSING SCRIPTS

7. THE LANGUAGE BELOW SHOULD BE USED FOR ALL EVENTS.

Are there any benefits from the sample collection(s)?

• Taking part in the National Children’s Study sample collections may not help you or your family right now. But the Study may help us learn things about health that could benefit all of us—including your children and grandchildren—in the years to come.

7. THE LANGUAGE BELOW SHOULD BE USED FOR THE PRE-PREGNANCY, PREGNANCY VISIT 1, PREGNANCY VISIT 2, AND BIRTH EVENTS.

Will I be paid for taking part in sample collection?

To thank you for providing your samples, we will give you $25.

7. THE LANGUAGE BELOW SHOULD BE USED FOR THE 6-MONTH, 12-MONTH, 24-MONTH, 36-MONTH, 48-MONTH, AND 60-MONTH EVENTS [USE EITHER #47 OR #48 (NOT BOTH), DEPENDING ON LSOPS].

Will I be paid for taking part in sample collection?

• To thank you for providing your samples, we will give you $25, and to thank you for providing your child’s samples, we will give you an additional $25.

7. THE LANGUAGE BELOW SHOULD BE USED FOR THE 6-MONTH, 12-MONTH, 24-MONTH, 36-MONTH, 48-MONTH, AND 60-MONTH EVENTS [USE EITHER #47 OR #48 (NOT BOTH), DEPENDING ON LSOPS].

Will I be paid for taking part in sample collection?

• To thank you for providing your samples, we will give you $25, and to thank you for providing your child’s samples, we will give you a non-cash incentive worth about $25.

7. THE LANGUAGE BELOW SHOULD BE USED FOR THE PRE-PREGNANCY EVENT.

Finally, please remember the following points that were discussed with you when you joined the Study:

• Participating in the National Children’s Study is your choice. The alternative to taking part in the Study is not taking part in the Study. If you leave the Study, you can rejoin it later.

• Some of the ways we get samples may be uncomfortable. If you feel uncomfortable, you can skip any part of the Study. You are in charge.

• If you leave the Study, we will not ask you for any new information, but we will keep using the information you have already given us.

• I understand that my data and samples will be used in the future to help researchers learn about children’s health and human development.

• We will make every effort to protect the privacy of your information and samples to the extent permitted by law.

• This is a research study and we cannot give you medical advice. None of the Study visits take the place of regular doctor or clinic visits. The Study’s environmental measurements do not take the place of any other environmental testing of your home.

• We will not routinely report the results of tests done on any samples that we collect from you or your home.

• If you have any questions about this visit or the Study, you can ask me. If I can’t answer your questions I will give you the name and phone number of someone from our local office who can.

7. THE LANGUAGE BELOW SHOULD BE USED FOR ALL OTHER EVENTS.

Finally, please remember the following points that were discussed with you when you joined the Study:

• Participating in the National Children’s Study is your choice. The alternative to taking part in the Study is not taking part in the Study. If you and your child leave the Study, you can rejoin it later.

• Some of the ways we get samples may be uncomfortable. If you or your child feel uncomfortable, you can skip any part of the Study. You are in charge.

• If you leave the Study, we will not ask you for any new information, but we will keep using the information you have already given us.

• I understand that my and my child’s data and samples will be used in the future to help researchers learn about children’s health and human development.

• We will make every effort to protect the privacy of your and your child’s information and samples to the extent permitted by law.

• This is a research study and we cannot give you or your child medical advice. None of the Study visits take the place of regular doctor or clinic visits. The Study’s environmental measurements do not take the place of any other environmental testing of your home.

• We will not routinely report the results of tests done on any samples that we collect from you or your child or your home.

• If you have any questions about this visit or the Study, you can ask me. If I can’t answer your questions I will give you the name and phone number of someone from our local office who can.

Public reporting burden for 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: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0593). Do not return the completed form to this address.