Consent - Assent

Attachment 1 – Consent, Permission, and Assent Forms for HABs GenIC

Date: ____/____/______ Name of interviewer: _______________________

Poison center: _____________________________

State call originated from: ____________________

NPDS Case ID No. ____________________

Note: At least three attempts should be made to contact a consenting adult who was either the person who placed the original call to the poison center (PC) or an individual adult who was present at the time of the original call to the PC concerning the harmful algal bloom exposure.

Introduction Script and Consent (for adults 18 and older)

The Centers for Disease Control and Prevention and the [poison center] is doing this follow-up survey to find out about the health of people 18 years and older who may have been affected by harmful algal bloom exposures in the past 60 days. CDC is allowed to ask these questions under the Public Health Service Act Section 301 [241].

This interview will take approximately 40 minutes to complete. It should take place in a private setting. We will ask you questions about:

- where you were and what you were doing when you were exposed to the harmful algal bloom.

- health effects after exposure to the harmful algal bloom

- health messages you received harmful algal blooms

There are no known risks from taking part in the survey. Some of the questions are personal and ask about sickness. There is no direct benefit from being in the survey. However, what you tell us will help us better learn about how this public health emergency is affecting people's health. We may also be able to use what we learn to help your community. They may also learn how to better prepare for future disasters.

We are asking you to take part in this survey because you had called a poison center regarding an exposure related to the public health emergency. You can choose if you want to be interviewed. You can stop the interview at any time. You can also refuse to answer any question. If you refuse, it will not affect any government benefits that you receive.

Names of people who take part and other identifying information will not be given to CDC or used in any report. Everything we learn will be kept private to the fullest extent of the law. Only project team members will be allowed to view this information.

If you have any questions about the study investigation, you may contact ______________ from the ______________ poison center or Royal Law from the Centers for Disease Control and Prevention (hua1@cdc.gov).

Participant name: ________________________________

Are you willing to take part at this time?

Yes

No Thank the respondent and end the call

***If Yes, please read the following to the consenting adult: ***

I have been read this consent form and I understand it. I have been given a chance to ask questions and I feel that my questions have been answered. I know that being in this investigation is my choice. I agree to be in this investigation.

Date __/__/____

Name of consenting adult: ______________________________________________

Name of poison center official taking consent:________________________________________

Assent and Parental Permission (15 and <18 years)

Date: ____/____/______ Name of interviewer: _______________________

Poison center: _____________________________

State call originated from: ____________________

NPDS Case ID No. ____________________

Introduction Script

The Centers for Disease Control and Prevention and the [poison center] is doing this follow-up survey to find out about the health of people 15 and up to 18 years of age who may have been affected by harmful algal bloom exposures in the past 60 days. CDC is allowed to ask these questions under the Public Health Service Act Section 301 [241]. In order for us to proceed, we will need both your and your parent’s or guardian’s permission. I’d like to speak to you both at the same time about this survey.

This interview will take approximately 40 minutes a young person to complete. It should take place in a private setting. We will ask you questions about:

- where you were and what you were doing when you were exposed to the harmful algal bloom.

- health effects after exposure to the harmful algal bloom

- health messages you received harmful algal blooms

There are no known risks from taking part in the survey. Some of the questions are personal and ask about sickness. There is no direct benefit from being in the survey. However, what you tell us will help us better learn about how this public health emergency is affecting young people's health. We may also be able to use what we learn to help your community. They may also learn how to better prepare for future disasters.

We are asking you to take part in this survey because you had called a poison center regarding an exposure related to the public health emergency. You can choose if you want to be interviewed. You can stop the interview at any time. You can also refuse to answer any question. If you refuse, it will not affect any government benefits that you receive.

Names of people who take part and other identifying information will not be given to CDC or used in any report. Everything we learn will be kept private to the fullest extent of the law. Only project team members will be allowed to view this information.

If you have any questions about the study investigation, you may contact ______________ from the ______________ poison center or Royal Law from the Centers for Disease Control and Prevention (hua1@cdc.gov).

If participant is a minor aged 15 and <18 yrs.:

To the parent/guardian of a minor: Do you permit your child to participate?

Yes

No Thank the respondent and end the call

***If yes, you must gain parent/legal guardian assent before beginning the interview. Read the statement below to the parent/legal guardian to confirm their assent.***

As the parent/legal guardian for the above named, I give my permission for him/her to take part in this interview.

Date __/__/____

Name of assenting parent/legal guardian: ____________________________________________

Name of poison center official taking assent:________________________________________

If participant is a minor: Your parent or legal guardian has agreed for you to participate in this interview. Are you interested in taking part?

Yes

No Thank the respondent and end the call

***If yes, please read the following to the assenting minor:***

I have been read this assent form and I understand it. I have been given a chance to ask questions and I feel that my questions have been answered. I know that being in this investigation is my choice. I agree to be in this investigation.

Date __/__/____

Name of assenting minor: ______________________________________________

Name of poison center official taking consent:________________________________________

I verify that I have explained this survey to you and your parent or legal guardian. You have agreed to participate.

Consent Form for Parents or Guardians Responding for Children (< 15 yrs.)

Date: ____/____/______ Name of interviewer: _______________________

Poison center: _____________________________

State call originated from: ____________________

NPDS Case ID No. ____________________

Introduction Script

The Centers for Disease Control and Prevention and the [poison center] is doing this follow-up survey to find out about the health of people under 15 years old who may have been affected by harmful algal bloom exposures in the past 60 days. CDC is allowed to ask these questions under the Public Health Service Act Section 301 [241]. In order for us to proceed, we will need your consent, and your child’s assent, for you to answer a survey about your child’s exposures. I’d like to speak to you both at the same time about this survey.

This interview will take approximately 40 minutes for you, as a parent or legal guardian, to complete this survey about your child. It should take place in a private setting. We will ask you questions about:

- where your child was and what he or she was doing when exposed to the harmful algal bloom.

- his or her health effects after exposure to the harmful algal bloom

- health messages you received harmful algal blooms

There are no known risks from taking part in the survey. Some of the questions are personal and ask about sickness. There is no direct benefit from being in the survey. However, what you tell us will help us better learn about how this public health emergency is affecting children's health. We may also be able to use what we learn to help your community. They may also learn how to better prepare for future disasters.

We are asking you to take part in this survey because you had called a poison center regarding your child’s exposure related to the public health emergency. You and your child can choose if you want to be interviewed about your child. You both can stop the interview at any time. You both can also refuse to answer any question. If you refuse, it will not affect any government benefits that your child receives.

Names of people who take part and other identifying information will not be given to CDC or used in any report. Everything we learn will be kept private to the fullest extent of the law. Only project team members will be allowed to view this information.

If you have any questions about the study investigation, you may contact ______________ from the ______________ poison center or Royal Law from the Centers for Disease Control and Prevention (hua1@cdc.gov).

If participant is the parent or legal guardian of a minor aged <15 yrs.:

Are you willing to take part of behalf of your child at this time?

Yes

No Thank the respondent and end the call

***If Yes, please read the following to the consenting parent or legal guardian: ***

I have been read this consent form and I understand it. I have been given a chance to ask questions and I feel that my questions have been answered. I know that my child being in this investigation is my choice. I agree to allow my child to be in this investigation.

Date __/__/____

Child’s name: ________________________________

Name of permitting parent or guardian: ______________________________________________

Name of poison center official taking consent: ________________________________________

If child is a minor <15 yrs.: Your parent or legal guardian has agreed to take part in this interview about you. Is that OK?

Yes

No Thank the respondent and end the call

***If Yes, please read the following to the assenting minor:***

I have been read this assent form and I understand it. I have been given a chance to ask questions and I feel that my questions have been answered. I know that being in this investigation is my choice. I agree to be in this investigation.

Date __/__/____

Name of assenting minor: ______________________________________________

Name of poison center official taking consent:________________________________________

I verify that I have explained this survey to you and your child. You have agreed to participate.