Permission Voluntary Consent

A. CONSENT DOCUMENT(S), PRIVACY ACT STATEMENT

PERMISSION/VOLUNTARY CONSENT TO PARTICIPATE IN A RESEARCH STUDY

Evaluation of Young Marines Drug Education Program

You are being asked to allow your child to participate in a research study. Before you give your permission for your child to participate, it is important that you read the following information and ask as many questions as necessary to be sure you understand what your child will be asked to do.

* Why is this study being done?

This research is being conducted to better understand educational programs that might be effective in reducing alcohol and drug use among youth. This research is being conducted by researchers from the Naval Health Research Center (NHRC) in San Diego, California, and it is being conducted at the request of Marine Corps Community Services. About 1,000 young people will be recruited from several Young Marine units throughout the US to take part in this study. To participate in this study, your child must be in the 6^th grade or above and be an active participant in the Young Marines, or a new Young Marine enrollee waiting to begin the orientation class.

* What will my child’s participation involve?

This project will assess the effectiveness of the Young Marines program in bringing about changes in attitudes and behavior related to drug use. If you agree to allow your child to participate:

• Your child will be asked to complete a survey either in-person at a Young Marines meeting, or on a secure Internet website.

• Your child may be asked to complete a second survey about 3 months after the first survey. This survey needs to be completed on a secure Internet website.

The maximum amount of time your child will be involved with the study is a total of 1½ hours (45 minutes for the first survey and if asked to participate in the second survey, another 45 minutes) over a 3 to 4 month period. Participation in the in-person surveys will take place during regularly scheduled Young Marine unit meetings. If your child chooses to complete the surveys on a secure Internet website, this will occur during the child’s own time using a computer resource that your child has access to.

* What are the risks involved in this study?

You or your child may feel some anxiety as to the privacy and security of his or her information in completing drug and alcohol surveys, either on paper or on the Internet. The survey will ask about your child’s use of tobacco, alcohol, marijuana and other illicit drugs, drug-related knowledge, perceived pressures to use drugs, disapproval of drug use and other similar questions. For example, we ask questions like, “On how many occasions (if any) have you used ecstasy during the last 30 days?” and “During the past 30 days, about how many cigarettes have you smoked per day?” Another example question on drug behavior is “On how many occasions (if any) have you been drunk or very high from drinking alcoholic beverages?” Your child’s privacy will be protected by the use of a unique code, rather than personal name. Your child will create his/her own unique code for their survey based on prompts such as what is your child’s middle initial, child’s birth month, whether or not his/her birth year is an even numbered year, child’s sex, and first letter of his/her mother’s first name. Surveys completed using the Internet option are done using Secure Sockets Layer (SSL) data transmission lines. SSL encrypts, or scrambles, all the survey data sent over the Internet. The data will only be understandable when it reaches the investigator’s database. If your child begins to feel uncomfortable at any point in the study, he/she may refuse to answer any question that disturbs him/her, or he/she may discontinue participation in the study, either temporarily or permanently. The survey data (both paper and internet surveys) will not be given to parents, Young Marine unit leaders or anyone else besides the NHRC investigators. The results of this study may be published in technical reports or articles, but only group information will be presented and no individual’s identity can be revealed.

* What happens if my child gets upset or has psychological discomfort due to this study?

If your child is upset or has psychological discomfort due to the sensitive subject matter of this survey on drug use, you may contact the study psychologist, Dr. Heidi Kraft at (619) 553-9142 or [email protected]. Dr. Kraft is a clinical psychologist and can provide guidance and information regarding any discomforts caused by this study. She may also assist you with locating appropriate counseling services in your area, if further services are needed. No formal compensation is available to you or your child. By signing this consent form, you will not be giving up any legal rights.

* What are the benefits of the study?

Your child is not expected to receive direct benefit from taking part in this study. However, this study could benefit children and society in general by contributing to a better understanding of how effective youth development programs are in decreasing drug use and related factors.

* What information will be collected from my child and how will it be kept private and secure?

Your child will be asked to fill out a survey of their drug use, knowledge, and attitudes. Your child’s answers to these questions will be used to study the effectiveness of the Young Marines drug education efforts. This information will be used only by NHRC study personnel and will be maintained until all analyses are completed. All information obtained about your child on the survey will be considered privileged and held in confidence. His/her responses on surveys will be protected by the use of unique participant codes rather than personal names (described previously). Suzanne Hurtado is responsible for storing your child’s information during the study. This information will be protected keeping all paper copies of your child’s information in a locked file in Building 328 at the Naval Health Research Center. Electronic data will be stored in password-protected files on secure computer servers at NHRC. Access to all data will be limited to staff involved in this study. The information your child discloses will not be used by or released to another institution.

The results of this study may be published in Department of Defense technical reports, scientific journals, or presented at scientific meetings; however, no publication or presentation about the research study described above will reveal your child’s identity. Lastly, individuals from official government agencies, such as the Department of Defense and the U.S. Navy, may inspect your child’s research records to ensure that the rights and safety of all research participants are protected.

* Does my child have to participate?

No, your child does not have to participate. Participation in this study is completely voluntary. Your decision about whether to allow your child to participate will not prejudice his/her future relations with the Young Marines program or the U.S. Marine Corps. If you decide to allow your child to participate, you are free to withdraw your consent and discontinue his/her participation at any time without penalty or loss of benefits to which you are otherwise entitled.

* If you have questions about this study

If you have questions about the research, you may contact Suzanne Hurtado, at (619) 553-7806 or [email protected].

If you have questions about your child’s health and safety in this study, you may contact Dr. Heidi Kraft, a clinical psychologist, at (619) 553-9142 or [email protected].

If you have questions regarding your child’s rights as a human subject and participant in this study, you may contact Christopher Blood at (619) 553-8386 or [email protected]. He is the Chairman of the Naval Health Research Center Institutional Review Board, a group of people who review the research to protect your rights and the rights of your child.

* Thank you gift

If you or your child returns a signed parent permission form whether or not you participate or allow your child to participate in the study, you or your child will be mailed a free movie rental gift card (a $4.50 value) from us.

* Consent for your child to take part in this research study

Your signature below indicates that you have read the information in this form and have had a chance to ask any questions you have about the study and its procedures and risks. All of your questions have been answered to your satisfaction. If you check the “I give permission” box below, your signature also indicates that you agree to allow your child to be in this research study and have been told that you can change your mind and withdraw your consent to allow your child to participate at any time. You authorize the use and disclosure of your child’s survey information to the persons listed in the health information and privacy section of this consent for the purposes described above. You have been given a copy of this agreement and a statement informing you about the provisions of the Privacy Act.

If you, the Young Marine, is 18 years of age or older and want to complete this form, parental consent is not needed and 18 year old may complete it. Otherwise, parent is asked to complete the information on the next page.

________________________________________________________ __________________

Printed name of 18 years of age or older Young Marine (First Last) Date of Birth of 18 yr old

____________________________________________ __________________

Signature of 18 years of age or older Young Marine Date

_________________________________________________________________________________
Email address of 18 years of age or older Young Marine (to alert you when the Internet survey is available)

Mailing address (to mail your free thank you gift if you return this signed form whether or not you give permission for your child to participate)

Street address ________________________________________________________

City ___________________________________State__________ZIP____________

What is your Young Marine Unit name:_______________________________________________

Please check one:

I wish to participate in this research study.

I do not wish to participate in this research study.

(This section is to be completed by the Young Marine 18 years of age or older.)

PARENT PERMISSION/VOLUNTARY CONSENT TO PARTICIPATE IN A RESEARCH STUDY

E valuation of Young Marines Drug Education Program

For the parent:

Please check one:

I am the parent or legal guardian of the below-named child and I give permission for my child to participate in this research study.

I am the parent or legal guardian of the below-named child and I DO NOT give permission for my child to participate in this research study.

____________________________

Printed name of child (First Last)

____________________________ _____________________________ ________________
Printed name of parent/guardian Signature of parent/guardian Date

_________________________________________________________________________________
Email address of parent/guardian (to alert you when the Internet survey is available)

Mailing address of parent/guardian (to mail your free thank you gift if you return this signed form whether or not you give permission for your child to participate)

Street address ________________________________________________________

City ___________________________________State__________ZIP____________

What is your child’s Young Marine Unit name: ________________________________________

(This section is to be completed by the parent.)

____________________________ _____________________________ ________________
Printed name of person Signature of person Date
conducting consent discussion conducting consent discussion

(Leave this line blank – for research staff to complete)

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