Statement of Information

Attachment 10_TTC Statement of Informed Consent_5.2.2019.doc

Technology Transfer Center (TTC) Program Monitoring

Statement of Information

OMB: 0930-0383

Document [doc]
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OMB No. 0930-03xx

Expiration Date: xx/xx/2020

Burden Statement: This information is being collected to assist the Substance Abuse and Mental Health Services Administration (SAMHSA) for the purpose of program monitoring of the Technology Transfer Centers (TTC) Network Program. This voluntary information collected will be used at an aggregate level to determine the reach, consistency, and quality of the TTC Program. Under the Privacy Act of 1974 any personally identifying information obtained will be kept private to the extent of the law. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. The OMB control number for this project is 0930-03xx. Public reporting burden for this collection of information is estimated to average less than 10 minutes per encounter, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to SAMHSA Reports Clearance Officer, 5600 Fishers Ln, Room 15 E57B, Rockville, MD 20857.

Why is this follow-up interview being done?


We conduct performance monitoring to assess how the [Name of TCC site], 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 one month after the applicable TCC-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 one month after the applicable TCC-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 TCC 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. 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 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.

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File TitleApproval Date: October 13, 2005
Authoramy
Last Modified BySYSTEM
File Modified2019-05-07
File Created2019-05-07

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