AppxC Consent Forms

Table of Contents

ACE General Survey Consent Form 1

Epi CASE Consent Form 3

Hospital Survey Consent Form 12

Medical Records Release Form 13

Consent for Testing of Clinical Specimens 15

Reading level: 9.0

 

ACE General Survey Consent

Purpose

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.

Methods

This survey will take approximately 35 minutes to complete. It should take place in a private setting. There are questions about

• where you were when the incident happened,

• your health before and after the release,

• your lifestyle,

• and work history.

At the end you will be asked to answer additional questions, if applicable for your child (15 minutes), pets (10 mins), livestock (10 mins), first responder specific questions (20) and will be given the opportunity to provide more input into your experiences (20 mins).

Risks and Benefits

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.

Voluntary

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.

Confidentiality

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.

Contact

If you have any questions about this investigation, you can call or email the coordinator of the ATSDR Assessment of Chemical Exposures program, [email protected], (404) 567-3256.

By signing below, you agree to take part in the interview. You are also attesting that you are 18 years of age or older and 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.

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

_______________________________________ ___________________________

Signature Date

Epi CASE CONSENT FORM

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 disaster] 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 7 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

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 you agree to take part in the survey 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

Reading level: 9.5

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 or e-mail the coordinator of the ATSDR Assessment of Chemical Exposures program, at 404-357-1553, [email protected].

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

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 you or 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 assess 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.

On what date/s did you seek medical care related to this incident.

1^st first visit:

Date: ____/____/______ (MM/DD/YYYY)

Provider Name _______________________

Name of Clinic/hospital _____________________________________

What were you seen for at this visit ________________________________________________ _____________________________________________________________________________

2^nd first visit:

Date: ____/____/______ (MM/DD/YYYY)

Provider Name _______________________

Name of Clinic/hospital _____________________________________

What were you seen for at this visit ________________________________________________ _____________________________________________________________________________

3^rd first visit:

Date: ____/____/______ (MM/DD/YYYY)

Provider Name _______________________

Name of Clinic/hospital _____________________________________ What were you seen for at this visit ________________________________________________ _____________________________________________________________________________

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

Consent 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].

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 is 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 contact the coordinator of the ATSDR Assessment of Chemical Exposures program, [email protected]/ 404-567-3256.

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

Consent for Testing of Clinical Specimens

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?

11