Sample - Consents

Appendix C. ACE Consent Forms SAMPLE

Reading level: 9.0

EPI CASE SURVEY

Hello, my name is __________________. The ________________________ Public Health Department is conducting this survey to learn more about the [name of incident, disaster, or emergency], which we are calling the INCIDENT. We are asking you to take part in this survey because you were in the area of the [description of the emergency incident] or might have been exposed to [the name of chemical/radiological/nuclear/biological substance].

Purpose: The information we collect with this survey will help us learn who was affected by the incident.

If you take part in the survey, we might be able to help you get connected to services or receive helpful information. Your answers also help scientists better understand the incident, the community, and any health effects that might be related to the incident.

Voluntary: Taking part in the survey is voluntary. 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 might receive.

Survey contents: The survey will take about 15 minutes to answer. We will ask you questions about

• how to contact you and people you trust,

• where you were during the incident or how you might have been exposed,

• if you got injured or ill as a result of the incident,

• your immediate needs so we can connect you to the appropriate services, and

• your Social Security number, your driver’s license number, or another state identification that will be kept confidential in our database.

Confidentiality: Your information will be kept confidential to the fullest extent of the law. We will carefully and completely destroy all your specific answers after we finish working with those. Only authorized persons will have access to your information. Nothing will be published that can identify you.

Do I have your permission to ask you questions?  Yes  No

Do I have permission to contact you again in the future if we can provide you information or services or to gain more detailed information from you? You are still eligible to take part in this survey if you say no to future contact.  Yes  No

Reason for refusal ____________________________________________________________

If you have any questions about this investigation, you can call the [this will more likely be the state or local health department] program at (XXX) XXX-XXXX.

By signing below, you agree to take part in the survey. You are also saying that we have given you a copy of this consent form. If any part of this form is not clear to you, please be sure to ask about it.

_______________________________________ ___________________________

Signature Date

If participant is a minor aged 1317 years:

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

_______________________________________ ___________________________

Parent/Guardian Signature Date

Assessment of Chemical Exposures (ACE) General Survey Consent/Adolescent (14–17 yrs.) Assent/Parent Permission

Reading level: 6.9

The [state health department] is doing this survey to find out about the health of people who may have been exposed to the [description of the emergency incident] on [date of incident]. They are being assisted by the Agency for Toxic Substances and Disease Registry (ATSDR). ATSDR is a federal government agency.

This interview will take approximately 25 minutes to complete. It should take place in a private setting. We will ask you questions about:

• where you were when the [description of the emergency incident] happened,

• your health before and after the release,

• your lifestyle,

• and work history.

There are no known risks from taking part in the survey. Some of the questions are personal and ask about sickness and medicines. There is no direct benefit from being in the survey. However, what you tell us will help us better learn how incidents affect people's health. [Name of state] 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 were in the area of the incident. 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 used in any report. If you would like a copy of the report, one can be sent to you. 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 this investigation, you can call the coordinator of the ATSDR Assessment of Chemical Exposures program, XXXXX. XX’s number is (XXX) XXX-XXXX.

By signing below, you agree to take part in the interview. You are also saying we have given you a copy of this consent form. If there is any part of this form that is not clear to you, be sure to ask about it.

_______________________________________ ___________________________

Signature Date

Household ID No. ________________Participant ID No. ______________________

Sometimes public health officials want to follow-up with people who have been exposed during chemical releases. They may call or send a survey to check in and see how the people are doing. By signing below, you give your permission for us to contact you again. Please provide ways that we may check in with you on the Contact information Form.

_______________________________________ ___________________________

Signature Date

If participant is a minor aged 1417:

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

_______________________________________ ___________________________

Parent/Guardian Signature Date

As the parent/legal guardian for the above signed, I give my permission for his/her medical record to be reviewed for the investigation related to the incident.

_______________________________________ ___________________________

Parent/Guardian Signature Date

Sometimes public health officials want to follow-up with people who have been exposed during emergency incidents. They may call or send a survey to check in and see how the people are doing. By signing below, you give your permission for us to contact your child again.

_______________________________________ ___________________________

Parent/Guardian Signature Date

Household ID No. ________________Participant ID No. ______________________

(For telephone interviews):

Participant name: ________________________________

If participant is a minor aged 1417:

Name of parent/guardian: ________________________________

Are you willing to take part at this time?

Yes

No Thank the respondent and end the call

If participant is a minor: Has your parent or legal guardian agreed for you to participate?

Yes

No Thank the respondent and end the call

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

If participant is a minor: Your parent or legal guardian has also agreed for you to participate in this interview.

If aged 13-17, read: We will be doing medical chart reviews and will be asking your parent or guardian for permission to review your medical record for the visit related to the incident. Continue to next module.

Yes  Review the medical records release form with the respondent and collect their parent’s signature

No

If aged 18 or older, read: To improve future responses, we try to study medical emergency response as thoroughly as possible. Are you willing to let us get a copy of your medical records for the medical treatment you received because of the incident?

Yes  Review the medical records release form with the respondent and collect their signature

No

Sometimes public health officials want to follow-up with people who have been exposed during incidents. They may call or send a survey to check in and see how the people are doing.

Are you willing to be contacted again?

Yes

No Continue with general survey modules

If participant is a minor: Has your parent or legal guardian given permission for you to be contacted again?

Yes

No Continue with general survey modules

I verify that I have read you information about possible follow-up. You have voluntarily agreed to be contacted again.

If participant is a minor: Your parent or legal guardian has also agreed for you to be contacted again.

Reading level: 6.8

Assessment of Chemical Exposures (ACE) Household Survey

Consent

The [state health department] is doing this survey to find out about the health of people who may have been exposed to the [description of the emergency incident] on [date of release]. They are being assisted by the Agency for Toxic Substances and Disease Registry (ATSDR). ATSDR is a federal government agency.

This interview will take approximately 10 minutes to complete. It should take place in a private setting. We will ask you questions about:

• if anyone was home when the [description of the emergency incident] happened,

• how you heard about the release,

• if your household evacuated,

• health status of household members after the release,

• and medical care they received.

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 how incidents affect people's health. [Name of state] 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 your home is in the area of the incident. 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 and addresses of people who take part and other identifying information will not be used in any report. If you would like a copy of the report, one can be sent to you. 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 this investigation, you can call the coordinator of the ATSDR Assessment of Chemical Exposures program, XXXXX. XX’s number is (XXX) XXX-XXXX.

By signing below, you agree to take part in the interview. You are also saying we have given you a copy of this consent form. If there is any part of this form that is not clear to you, be sure to ask about it.

_______________________________________ ___________________________

Signature Date

Sometimes public health officials want to follow-up with people who have been exposed during incidents. They may call or send a survey to check in and see how the people are doing. By signing below, you give your permission for us to contact you again. Please provide ways that we may check in with your child on the Contact Information Form.

_______________________________________ ___________________________

Signature Date

(For telephone interviews):

Participant name: ________________________________

Are you willing to take part at this time?

Yes

No Thank the respondent and end the call

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

Sometimes public health officials want to follow-up with people who have been exposed during incidents. They may call or send a survey to check in and see how the people are doing.

Are you willing to be contacted again?

Yes

No Continue with general survey modules

I verify that I have read you information about possible follow-up. You have voluntarily agreed to be contacted again.

Reading level: 9.5

Assessment of Chemical Exposures (ACE) Hospital Survey Consent Form

The Agency for Toxic Substances and Disease Registry (ATSDR), an agency of the U.S. Department of Health and Human Services, is doing a survey to learn how the incident at the [location of incident] on [date of incident] affected hospital emergency departments (ED). This survey is being conducted by ATSDR on behalf of [state health department].

During this survey, you will be asked about how many people your hospital ED treated following the incident at [location of incident], decontamination procedures used by the ED, how and when you were notified of the incident, your hospital’s preparedness plan and contact with other organizations, and any needs your ED had while treating victims of the incident. The interview will take about 25 minutes.

There are no expected risks or direct benefits to you from taking part in the survey. The information you provide during this survey will help ATSDR and [state health department] better understand how to better prepare for and respond to future incidents.

Taking part in this survey is up to you. You have the right to refuse to answer any question at any time or refuse to complete the interview. If you refuse, it will not affect your employment or any benefits that your hospital receives.

All answers you provide will be kept private to the extent permitted by law. No data that identifies you or your hospital will be included in any report.

If you have any questions about this survey, you can call the coordinator of the ATSDR Assessment of Chemical Exposures program, XXXXX. XX’s number is (XXX) XXX-XXXX.

I have read the description of the survey to study how the incident at the [location of incident] on [date of incident] affected hospital EDs. All of my questions have been answered to my satisfaction. I agree to participate in this survey.

_________________________________ ________________________________

Participant Name (print) Participant Signature

Date:_______________

Reading level: 7.8

Assessment of Chemical Exposures (ACE) Medical Records Release Form

To better understand the health status of people in the area of [description of incident] on [date of incident], we need to review your/your child’s medical records. We cannot review your/your child’s medical records without your permission. We will keep information we get from the records private to the extent allowed by law. Reports will not identify specific people. Only summary information will be reported. You have the right to refuse to release the medical records. If you choose not to release your/your child’s medical records, you will not lose any benefits.

Request Statement

I understand that I can refuse to release my/my child’s medical records. If I choose not to release the medical records, I will not lose any benefits.

I request the hospitals, doctors, poison center physicians, and other medical care providers that I have seen or consulted related to [description of release] on [date of release] to release information about me. I know that the [state health department] and Agency for Toxic Substances and Disease Registry (ATSDR) will only use this information to study health effects related to the release. I know the [state health department] and ATSDR will do everything in their power to make sure no information which identifies me is released. This request expires one year from the date I sign it. A copy of this document with my signature is as good as the original.

Patient name (please print): __________________________________________________

First Middle Last

Patient Date of Birth: _____/____/_______

^{MM DD YYYY}

If patient is child, name of parent/guardian (please print):

_______________________________________________________________________

Signature:_________________________________________________________

Date: _____/____/_______

^{MM DD YYYY}

Reading level: 11.5

Assessment of Chemical Exposures (ACE)

Informed Consent/Adolescent Assent for Testing of Clinical Specimens

The [state health department] is investigating health status of people who were in the area of [description of incident]. They are being assisted by the Agency for Toxic Substances and Disease Registry (ATSDR). ATSDR is a federal government agency. It is a sister agency to the Centers for Disease Control (CDC) and Prevention.

As part of the investigation, we are collecting (blood/urine) samples from people who were in the area to see if we can detect [the chemical] in their bodies.

You were chosen to participate in the investigation because you were in the area of [the incident].

Before we collect the sample, we will ask you for contact information to register you in the Rapid Response Registry as someone who was in the area at the time of [the incident]. We may also ask about your exposure to [the incident].

Blood:

We will draw about 2 ½ teaspoons of blood from a vein in your arm. The blood sample will be sent to the ([state]/CDC) laboratory to test for [the chemical].

Urine:

We will ask for a 1-2 ounce sample of urine and send it to the ([state]/CDC) laboratory to test for [the chemical].

When the laboratory has finished testing the samples, they will discard any remaining (blood/urine).  Your (blood/urine) will only be tested for the chemicals you may have been exposed to because of [description of incident]. No other tests will be done on your (blood/urine).

As part of the investigation, we will also interview you to find out more about the health effects of [the incident]. That may take place today, or we may contact you in a few days.

You will be mailed your test results as soon as the testing is complete. The test will show if you have an unusual level of [the chemical] in your body. If you do have an unusual level of [the chemical], you will be able to share the report with your doctor.

There is no cost to you for the testing.

There are no risks to providing a urine sample. Although very rare, there are risks from having blood drawn. They include:

• Bleeding

• Fainting or feeling light-headed

• Infection

• Scarring

Having a sample of your (blood/urine) tested entirely voluntary.

Participants’ names and other identifying information will not be 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 access to this information. If you would like a copy of the report, one can be sent to you.

If you have any questions about this investigation, you can call the coordinator of the ATSDR Assessment of Chemical Exposures program, XXXXX. XX’s number is (XXX) XXX-XXXX.

By signing below, you agree to provide a sample and have it tested. You are also saying we have given you a copy of this consent form. If there is any part of this form that is not clear to you, be sure to ask about it.

_________________________________ ________________________________

Participant Name (print) Participant Signature

Date:_______________

If the participant is a child, the parent or legal guardian must sign.

As the parent/legal guardian for the above signed, I give my permission for him/her to provide a sample and have it tested.

Participant name (please print): _______________________________________________

First Middle Last

Name of parent/guardian (please print):

_______________________________________________________________________

Signature:_________________________________________________________

Date: _____/____/_______

^{MM DD YYYY}

Reading level: 4.4

Assessment of Chemical Exposures (ACE)

Child (Age 7–12) Assent/Parent Permission for Testing of Clinical Specimens

Read form to the child.

The [state health department] is trying to find out if people got sick after [description of incident].

We are collecting (blood/pee) samples from people who were in the area to see if we can find [the chemical] in their bodies.

We are asking you if we can get a sample of your (blood/pee) because you were in the area of [the incident].

Blood:

If you let us, we will clean your arm by gently rubbing it with alcohol. Then we will take a little bit of blood from your arm with a needle. We will send your blood to the lab to test for [the chemical].

Urine:

We will ask you to go into the bathroom and pee into a cup for us. If you want your parents to help you they can. We will send your pee to the lab to test for [the chemical].

When the lab has finished testing the samples, they will throw away any leftover (blood/pee). 

Blood:

The needle stick in your skin may hurt a little for a few seconds. The person taking the blood will be very careful. You might have a bruise afterward.

Pee:

It will not hurt for you to pee into a cup.

Your parents have said you can get your (blood/pee) tested if you want. But it is up to you to decide if you want to or not. If you don’t want to get the test done, that’s OK. Nothing will happen to you.

If you get the test done, we will send your parents a report that tells what the lab found. They can give the report to your doctor.

We will talk to your parents to find out where you were when the [description of incident] happened. We will also ask if you got sick the week it happened.

Everything your parents tell us is private. We will not tell anyone who is not working with us what they said.

Do you have questions?

Do you want to talk to your (parents/mother/father/[guardian]) before you make up your mind about having your (blood/pee) tested? If you want to talk with your (parents/mother/father/[guardian]), tell us and we’ll leave so you can talk to them.

If you agree to have your (blood/pee) tested, write your name below.

______________________________________________________

Signature of participant 7–12 years old

______________________________________________________

Print name of participant

The parent or legal guardian must sign.

As the parent/legal guardian for the above signed, I give my permission for him/her to provide a sample and have it tested.

Participant name (please print): _______________________________________________

First Middle Last

Name of parent/guardian (please print):

_______________________________________________________________________

Signature:_________________________________________________________

Date: _____/____/_______

^{MM DD YYYY}

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