TTA Statement of Informed Consent

Attachment 8: STATEMENT OF INFORMED CONSENT FOR FOLLOW-UP INTERVIEW

Why is this follow-up interview being done?

We conduct performance monitoring to assess how the [Name of TTA program], through technology translation and transfer activities via meetings, trainings and other knowledge application professional development activities, enhances the quality of [mental health, prevention or addiction and recovery] services. If you choose to participate, you will be asked to complete a meeting, training, or technical assistance Follow-up Survey two months after the applicable TTA-related event that you attended. This follow-up survey will be either be mailed to you at the address you designate or emailed to you at the email address you designate. The data collected on the follow-up survey will be anonymous, so the Principal Investigator will not know your identity.

Who is being asked to take part in this follow-up interview?

You are being asked to participate in this study because you are a practitioner, executive, stakeholder, director or policy maker who plays an important role in the enhancement and the quality of [mental health, prevention or addiction treatment and recovery] services. Anecdotal reports have suggested that regional and national alliances among practitioners, researchers, policymakers, funders, and consumers need to be fostered to support and implement best treatment practices in the field of [mental health, prevention or addiction treatment and recovery] services. This performance monitoring assessment will look at this more closely. People participating in this study will typically be between 30-70 years of age. About [insert average annual number of respondents in region] people will be participating in this assessment this year.

What procedures will be performed for the follow-up interview?

If you choose to participate, you will be asked to complete a meeting, training, or technical assistance Follow-up Survey two months after the applicable TTA related meeting, event or training that you attended.

What are the possible risks, side effects, and discomforts of this follow-up interview?

There are no physical risks, side effects or discomforts associated with this research study. There are no significant risks associated with participation. If, however, you find answering any of the questions unpleasant or uncomfortable, you have the right to not answer any questions for any reason.

What are possible benefits from taking part in this follow-up interview?

Participation will not directly benefit you, but the knowledge that is gained will assist SAMHSA in identifying and determining the impact of TTA program activities on participants’ knowledge, skills, and abilities in serving substance-abusing populations.

Will my insurance provider or I be charged for the costs of any procedures performed as part of this follow-up interview?

Neither you nor your insurance provider will be charged for the costs of any part of this research study.

Will I be paid if I take part in this follow-up interview?

You will not receive any direct payment for being a participant.

Who will know about my participation in this follow-up interview?

All records related to your involvement in the follow-up interview will be stored in a locked file cabinet. Your identity on these records will be indicated by personal non-identifiable codes. All responses thus are confidential. This consent form will be kept separate from the follow-up forms. Access to this form shall be limited to the researchers involved in this study. The follow-up surveys that you complete will be maintained for at least five years after study completion.

Any information about you obtained from the follow-up interview will be kept as confidential (private) as possible. You will not be identified by name in any publication of research results. In unusual cases, your research records may be released in response to an order from a court of law. It is also possible that a University Research Conduct and Compliance Office may inspect your research records.

Is my participation in this research study voluntary?

Your participation is completely voluntary. You do not have to take part in the Follow-up Interview, and should you change your mind, you can withdraw from the study at any time.

If I agree to take part in this follow-up interview, can I be removed from the follow-up interview without my consent?

No study participant will be removed from the follow-up interview.

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VOLUNTARY CONSENT

All of the above has been explained to me and all of my current questions have been answered. I understand that I am encouraged to ask questions about any aspect of this follow-up interview, and that such future questions will be answered by the Principal Investigator listed on the first page of this form.

Any questions which I have about my rights as a participant will be answered by the Human Subject Protection Advocate of the IRB Office,

Institutional Review Board

IRB# XXXXX

Full Name (Print) ____________________________________________________________

(Last) (First) (Middle Initial)

WORK INFORMATION:

Your agency name: ________________________________________________________

Street Address:__________________________________________________________

______________________________________________________________________

(City) (County) (State) (Zip Code)

HOME ADDRESS:

Street Address:_______________________________________________________________

______________________________________________________________________

(City) (County) (State) (Zip Code)

Phone: Work (______) ________________________

Home (______) ________________________

Fax: (____)________________E-mail address _______________________________________

Mail to my work address Mail to my home address

Would you object to a follow-up interview by telephone? No Yes

By signing this form, I agree to participate in the follow-up interview. A copy of this consent form will be given to me.

_______________________________________________ __________________

Participant’s Signature Date

CERTIFICATION of INFORMED CONSENT

I certify that I have explained the nature and purpose of the follow-up interview to the above-named individual(s), and I have discussed the potential benefits and possible risks of his/her participation. Any questions the individual(s) have about this follow-up interview have been answered, and we will always be available to address future questions as they arise.

___________________________________ ________________________

Printed Name of Person Obtaining Consent Role

_________________________________ ____________

Signature of Person Obtaining Consent Date

Please return this form to the staff and begin responding to the survey.