Attach 13

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 (####-####). Do not return the completed form to this address.

SALIVA SAMPLE PROTOCOL (IN SCHOOL)

INSTRUCTIONS FOR TAKING A SALIVA SAMPLE

Important: Do NOT remove the plastic film from the funnel lid

Preparation Confirm with each school whether plastic funnels can be recycled and obtain the correct procedures for recycling.

Most people take between 2 and 5 minutes to deliver a saliva sample using the following steps. Before spitting, have the subject rub his/her cheeks gently for 30 seconds to create saliva. If the subject is having a hard time creating saliva, he/she should place ¼ tsp of white table sugar on his/her tongue.

Step 1 Make sure the subject’s mouth is without food remains.

Do not use if subject has eaten, drank, smoked, or chewed gum within 30 minutes before giving a sample.

Step 2 Have the subject spit liquid saliva (not bubbles) into the collection tube until the liquid reaches the fill line shown in picture #1.

To avoid any mix-up, complete the procedure one person at a time. Verify the ID on the tubes with the ID on the subject list.

Picture 1

Step 3 Hold the tube upright with one hand. Close the lid with the other hand (as shown in picture #2) by firmly pushing the lid until you hear a loud click. The liquid in the lid will be released into the tube to mix with the saliva. Make sure that the lid is closed tightly.

Picture 2

Step 4 Hold the tube upright. Unscrew the tube from the funnel (see picture #3).

Picture 3

Step 5 Pick up the small cap for the tube. Use the small cap to close the tube tightly (see picture #4).

Picture 4

Step 6 Shake the capped tube for 5 seconds (see picture #5). Discard or recycle the funnel.

Picture 5

Step 7 Place the collected specimen inside the provided biospecimen bag Use a new bag for each specimen. Do not remove the absorbent material from within the bag. Remove as much air as possible and seal the bag by removing the adhesive strip.

Step 8 Place the sealed plastic bag (containing the sample) into the provided bubble envelope. Seal the bubble envelope.

The Next Generation Health Study

Saliva Sample Script

Important: Do NOT remove the plastic film from the funnel lid.

Note: Make sure the subject’s mouth is without food remains. Do not use if subject has eaten, drank, smoked, or chewed gum within 30 minutes before giving a sample.

Hello. My name is _______ and I am a health researcher from the NEXT Generation Health Study team. Today we are asking you to provide us with a sample of your saliva. We will use this sample to look for markers of health. It will NOT tell us if you have smoked, used drugs, or drank alcohol.

Has anyone eaten, drank, smoked, or chewed gum in the past 30 minutes or have anything in your mouth right now? If you have, we will need for you to wait 30 minutes before providing the saliva sample.

Please rub your cheeks for about 30 seconds. This will help encourage saliva production. I’m going to count to 30 while you continue to rub your cheeks.

[Count to 30]

Now hold the plastic funnel so that your bottom lip rests over the edge of the funnel. Allow your saliva to collect in the funnel. We need enough saliva to fill up to this line. Do not “cough up” the saliva. You can use the Kleenex given for privacy.

Note: If the student is having a hard time creating saliva, he/she should place ¼ tsp of white table sugar on his/her tongue.

[Ensure saliva collection in accordance with instructions in the protocol]

Thank you for your help.