Parental Informed Consent Form

Attachment D

Cognitive Interview Parental Permission Form

December 3, 2010

Prescription Drug Redesign

Parental Permission Form

National Survey on Drug Use and Health (NSDUH)

The National Survey on Drug Use and Health is a large survey given to about 70,000 people across the country every year. RTI International conducts the National Survey on Drug Use and Health. It collects information on many health-related issues. Right now we’re interested in testing some new questions on drug use that we might ask in the study. This will help us see how well young people your child’s age understand these questions. We are under contract with the Substance Abuse and Mental Health Services Administration to do this survey. Your child responded to an advertisement that we placed for research participants. At present, we are seeking the help of young people like your child to see how our new questions work.

Your child is one of twelve adolescent respondents in Chicago, IL, Washington, DC, and Research Triangle Park, NC who are participating in this study. Taking part in the interview is strictly voluntary, and you also can withdraw your permission at any time. Your child can skip any questions he/she does not want to answer. There is no penalty if he/she chooses to skip any part of the interview. The interview will be conducted in private so no one else, including a parent, can hear your child’s answers. We will not share the information given to us with any person outside the project staff. Also, your child's name will never be connected to the answers he/she provides. Federal law requires us to keep your child’s answers confidential and to use his/her answers only for statistical purposes (the Confidential Information Protection and Statistical Efficiency Act of 2002).¹

The interview will take about 60 minutes. During the interview, your child will enter most of his/her answers to questions about drug use and nonuse into a laptop computer by himself/herself. We will ask questions about health, alcohol use, prescription drug use, and other drug use. The interviewer will be sitting next to your child and will be able to see your child’s answers. The interviewer will discuss with your child about how well he/she understood some questions. This will help us test how our new questions work. However, your child may not be asked all questions. If your child becomes uncomfortable or upset while answering our questions, we will remind him/her that he/she can skip any questions he/she does not want to answer. Your child also can ask the interviewer to stop the interview at any time.

Your child will receive a $30 Visa gift card in appreciation for the interview. In addition, we would like to audio record the conversation between your child and the interviewer. The recording will be heard only by members of the research team. This will help us make sure we have all the information from your child about how these questions work. To protect your child’s privacy, the recording will be kept on a computer and protected by a password. The password will expire in just a few weeks, and the recording will be destroyed at that time. Only members of the study team and the sponsor of the study will be able to listen to the recording. However, having the conversation recorded is voluntary and you can decline for your child.

If you have any questions about this study or if you change your mind, you can contact Larry Kroutil or Liz Dean at RTI at 1-800-334-8571 (a toll-free number). Mr. Kroutil's extension is 26067. Ms. Dean's extension is 27445. If you have any questions about your rights as a parent or legal guardian or your child's rights as a study participant, you can call RTI's Office of Research Protection at 1-866-214-2043 (a toll-free number).

As Parent/Guardian, I give my permission for my child to participate in this interview. I also understand that I will not be present to see or hear my child’s interview.

As Parent/Guardian, I give my permission for my child’s interview to be audio recorded. (PLEASE CHECK ONE)

____Yes ____No

Signature: ___________________________________________________Date:__________________

Printed Name: ___________________________________________________

Parental Permission for Your Child to Be Observed During Interview

Another member of our study team or a representative of the sponsor of this study also may be present to observe your child's interview. This person is interested in learning how well young people understand these questions. The person observing the interview is required to keep your child’s answers confidential. If you would prefer that this other person not observe the interview, your child can still participate. We will simply ask the other person to leave.

Do we have your permission for the other member of the study team or representative of the sponsor to observe your child's interview?

CHECK ONE OF THESE BOXES. THEN PLEASE SIGN AND DATE BELOW.

____Other study team member or sponsor representative may observe the interview

____Other study team member or sponsor representative may not observe the interview.

___________________________ __________________________

Parent/Guardian Signature Date

Copy 1. Please sign this copy and return it in the self-addressed envelope.

Prescription Drug Redesign

Parental Permission Form

National Survey on Drug Use and Health (NSDUH)

The National Survey on Drug Use and Health is a large survey given to about 70,000 people across the country every year. RTI International conducts the National Survey on Drug Use and Health. It collects information on many health-related issues. Right now we’re interested in testing some new questions on drug use that we might ask in the study. This will help us see how well young people your child’s age understand these questions. We are under contract with the Substance Abuse and Mental Health Services Administration to do this survey. Your child responded to an advertisement that we placed for research participants. At present, we are seeking the help of young people like your child to see how our new questions work.

Your child is one of twelve adolescent respondents in Chicago, IL, Washington, DC, and Research Triangle Park, NC who are participating in this study. Taking part in the interview is strictly voluntary, and you also can withdraw your permission at any time. Your child can skip any questions he/she does not want to answer. There is no penalty if he/she chooses to skip any part of the interview. The interview will be conducted in private so no one else, including a parent, can hear your child’s answers. We will not share the information given to us with any person outside the project staff. Also, your child's name will never be connected to the answers he/she provides. Federal law requires us to keep your child’s answers confidential and to use his/her answers only for statistical purposes (the Confidential Information Protection and Statistical Efficiency Act of 2002).²

The interview will take about 60 minutes, but no more than 2 hours. During the interview, your child will enter most of his/her answers to questions about drug use and nonuse into a laptop computer by himself/herself. We will ask questions about health, alcohol use, prescription drug use, and other drug use. The interviewer will be sitting next to your child and will be able to see your child’s answers. The interviewer will discuss with your child about how well he/she understood some questions. This will help us test how our new questions work. However, your child may not be asked all questions. If your child becomes uncomfortable or upset while answering our questions, we will remind him/her that he/she can skip any questions he/she does not want to answer. Your child also can ask the interviewer to stop the interview at any time.

Your child will receive a $30 Visa gift card in appreciation for the interview. In addition, we would like to audio record the conversation between your child and the interviewer. The recording will be heard only by members of the research team. This will help us make sure we have all the information from your child about how these questions work. To protect your child’s privacy, the recording will be kept on a computer and protected by a password. The password will expire in just a few weeks, and the recording will be destroyed at that time. Only members of the study team and the sponsor of the study will be able to listen to the recording. However, having the conversation recorded is voluntary and you can decline for your child.

If you have any questions about this study or if you change your mind, you can contact Larry Kroutil or Liz Dean at RTI at 1-800-334-8571 (a toll-free number). Mr. Kroutil's extension is 26067. Ms. Dean's extension is 27445. If you have any questions about your rights as a parent or legal guardian or your child's rights as a study participant, you can call RTI's Office of Research Protection at 1-866-214-2043 (a toll-free number).

As Parent/Guardian, I give my permission for my child to participate in this interview. I also understand that I will not be present to see or hear my child’s interview.

As Parent/Guardian, I give my permission for my child’s interview to be audio recorded. (PLEASE CHECK ONE)

____Yes ____No

Signature: ___________________________________________________Date:__________________

Printed Name: ___________________________________________________

Parental Permission for Your Child to Be Observed During Interview

Another member of our study team or a representative of the sponsor of this study also may be present to observe your child's interview. This person is interested in learning how well young people understand these questions. The person observing the interview is required to keep your child’s answers confidential. If you would prefer that this other person not observe the interview, your child can still participate. We will simply ask the other person to leave.

Do we have your permission for the other member of the study team or representative of the sponsor to observe your child's interview?

CHECK ONE OF THESE BOXES. THEN PLEASE SIGN AND DATE BELOW.

____Other study team member or sponsor representative may observe the interview

____Other study team member or sponsor representative may not observe the interview.

___________________________ __________________________

Parent/Guardian Signature Date

Copy 2. Please keep this copy for your records.

1The information you provide will be used for statistical purposes only. In accordance with the Confidential Information Protection provisions of Title V, Subtitle A, Public Law 107–347 and other applicable Federal laws, your responses will be kept confidential and will not be disclosed in identifiable form to anyone other than employees or agents. By law, every employee of the Center for Behavioral Health Statistics and Quality (CBHSQ), SAMHSA as well as every agent has taken an oath and is subject to a jail term of up to 5 years, a fine of up to $250,000, or both if he or she willfully discloses ANY identifiable information about you.

2 The information you provide will be used for statistical purposes only. In accordance with the Confidential Information Protection provisions of Title V, Subtitle A, Public Law 107–347 and other applicable Federal laws, your responses will be kept confidential and will not be disclosed in identifiable form to anyone other than employees or agents. By law, every employee of the Center for Behavioral Health Statistics and Quality (CBHSQ), SAMHSA as well as every agent has taken an oath and is subject to a jail term of up to 5 years, a fine of up to $250,000, or both if he or she willfully discloses ANY identifiable information about you.

December 3, 2010