Common use of CONFIDENTIALITY AND PARTICIPANT PROTECTION Clause in Contracts

CONFIDENTIALITY AND PARTICIPANT PROTECTION. It is important to have safeguards protecting individuals from risks associated with their participation in SAMHSA projects. As part of Attachment 7 of the application, all applicants (including those who plan to obtain Institutional Review Board (IRB) approval) must address the elements below. If some elements are not applicable to the proposed project, explain why the element(s) is not applicable. In addition to addressing these elements, you will need to determine if the section below titled “Protection of Human Subjects Regulations” applies to your project. If so, you must submit the required documentation as described below. Protect Clients and Staff from Potential Risks Identify and describe the foreseeable physical, medical, psychological, social, and legal risks or potential adverse effects participants may be exposed to because of the project. Identify and describe the foreseeable physical, medical, psychological, social, and legal risks or potential adverse effects staff may be exposed to as a result, of the project. Describe the procedures you will follow to minimize or protect participants and staff against potential risks, including risks to confidentiality. Identify your plan to provide guidance and assistance in the event there are adverse effects to participants and/or staff. Fair Selection of Participants Explain how you will recruit and select participants. Identify any individuals in the geographic catchment area where services will be delivered who will be excluded from participating in the project and explain the reasons for this exclusion. Absence of Coercion If you plan to compensate participants, state how participants will be awarded incentives (e.g., gift cards, bus passes, gifts, etc.) If you have included funding for incentives in your budget, you must address this item. (A recipient or treatment or prevention provider may provide up to $30 non-cash incentive to individuals to participate in required data collection follow up. This amount may be paid for participation in each required follow-up interview.) Provide justification that the use of incentives is appropriate, judicious, and conservative and that incentives do not provide an “undue inducement” that removes the voluntary nature of participation. Describe how you will inform participants that they may receive services even if they chose to not participate in or complete the data collection component of the project. Data Collection Identify from whom you will collect data (e.g., participants, family members, teachers, others). Describe the data collection procedures and specify the sources for obtaining data (e.g., school records, interviews, psychological assessments, questionnaires, observation, or other sources). Identify what type of specimens (e.g., urine, blood) will be used, if any. State if the specimens will be used for purposes other than evaluation. In Attachment 2, “Data Collection Instruments/Interview Protocols,” you must provide copies of all available data collection instruments and interview protocols that you plan to use (unless you are providing the web link to the instrument(s)/protocol(s)). Privacy and Confidentiality Explain how you will ensure privacy and confidentiality. Describe: Where data will be stored, Who will have access to the data collected, and How the identity of participants will be kept private, for example, using a coding system on data records, limiting access to records, or storing identifiers separately from data. NOTE: Recipients must maintain the confidentiality of alcohol and drug abuse client records according to the provisions of Title 42 of the Code of Federal Regulations, Part II, Subpart B. Adequate Consent Procedures Include, as appropriate, sample consent forms that provide for: informed consent for participation in service intervention. informed consent for participation in the data collection component of the project; and informed consent for the exchange (releasing or requesting) of confidential information. The sample forms must be included in Attachment 3, “Sample Consent Forms”, of your application. If needed, give English translations. Explain how you will obtain consent for youth, the elderly, people with limited reading skills, and people who do not use English as their first language. Describe how the consent will be documented. For example: Will you read the consent forms? Will you ask prospective participants questions to be sure they understand the forms? Will you give them copies of what they sign?

CONFIDENTIALITY AND PARTICIPANT PROTECTION. It is important to have safeguards protecting individuals from risks associated with their participation in SAMHSA projects. As part of Attachment 7 of the application, all applicants (including those who plan to obtain Institutional Review Board (IRB) approval) must address the elements below. If some elements are not applicable to the proposed project, explain why the element(s) is not applicable. In addition to addressing these elements, you will need to determine if the section below titled “Protection of Human Subjects Regulations” applies to your project. If so, you must submit the required documentation as described below. Protect Clients and Staff from Potential Risks Identify and describe the foreseeable physical, medical, psychological, social, and legal risks or potential adverse effects participants may be exposed to because of the project. Identify and describe the foreseeable physical, medical, psychological, social, and legal risks or potential adverse effects staff may be exposed to as a result, of the project. Describe the procedures you will follow to minimize or protect participants and staff against potential risks, including risks to confidentiality. Identify your plan to provide guidance and assistance in the event there are adverse effects to participants and/or staff. Fair Selection of Participants Explain how you will recruit and select participants. Identify any individuals in the geographic catchment area where services will be delivered who will be excluded from participating in the project and explain the reasons for this exclusion. Absence of Coercion If you plan to compensate participants, state how participants will be awarded incentives (e.g., gift cards, bus passes, gifts, etc.) If you have included funding for incentives in your budget, you must address this item. (A recipient or treatment or prevention provider may provide up to $30 non-cash incentive to individuals to participate in required data collection follow up. This amount may be paid for participation in each required follow-up interview.) Provide justification that the use of incentives is appropriate, judicious, and conservative and that incentives do not provide an “undue inducement” that removes the voluntary nature of participation. Describe how you will inform participants that they may receive services even if they chose to not participate in or complete the data collection component of the project. Data Collection Identify from whom you will collect data (e.g., participants, family members, teachers, others). Describe the data collection procedures and specify the sources for obtaining data (e.g., school records, interviews, psychological assessments, questionnaires, observation, or other sources). Identify what type of specimens (e.g., urine, blood) will be used, if any. State if the specimens will be used for purposes other than evaluation. In Attachment 2, “Data Collection Instruments/Interview Protocols,” you must provide copies of all available data collection instruments and interview protocols that you plan to use (unless you are providing the web link to the instrument(s)/protocol(s)). Privacy and Confidentiality Explain how you will ensure privacy and confidentiality. Describe: Where data will be stored, Who will have access to the data collected, and How the identity of participants will be kept private, for example, using a coding system on data records, limiting access to records, or storing identifiers separately from data. NOTE: Recipients must maintain the confidentiality of alcohol and drug abuse client records according to the provisions of Title 42 of the Code of Federal Regulations, Part II, Subpart B. Adequate Consent Procedures Include, as appropriate, sample consent forms that provide for: informed consent for participation in service intervention. ; informed consent for participation in the data collection component of the project; and informed consent for the exchange (releasing or requesting) of confidential information. The sample forms must be included in Attachment 3, “Sample Consent Forms”, of your application. If needed, give English translations. Explain how you will obtain consent for youth, the elderly, people with limited reading skills, and people who do not use English as their first language. Describe how the consent will be documented. For example: Will you read the consent forms? Will you ask prospective participants questions to be sure they understand the forms? Will you give them copies of what they sign?

CONFIDENTIALITY AND PARTICIPANT PROTECTION. It is important to have safeguards protecting individuals from risks associated with their participation in SAMHSA projects. As part of Attachment 7 of the application, all All applicants (including those who plan to obtain Institutional Review Board (IRB) approval) must address the elements below. If some elements are not applicable to the proposed project, explain why the element(s) is not applicable. In addition to addressing these elements, you will need to determine if the section below titled “Protection of Human Subjects Regulations” applies to your project. If so, you must submit the required documentation as described below. There are no page limits for this section. Protect Clients and Staff from Potential Risks Identify and describe the foreseeable physical, medical, psychological, social, social and legal risks or potential adverse effects participants may be exposed to because as a result of the project. Identify and describe the foreseeable physical, medical, psychological, social, social and legal risks or potential adverse effects staff may be exposed to as a result, of the project. Describe the procedures you will follow to minimize or protect participants and staff against potential risks, including risks to confidentiality. Identify your plan to provide guidance and assistance in the event there are adverse effects to participants and/or staff. Fair Selection of Participants Explain how you will recruit and select participants. Identify any individuals in the geographic catchment area where services will be delivered who will be excluded from participating in the project and explain the reasons for this exclusion. Absence of Coercion If you plan to compensate participants, state how participants will be awarded incentives (e.g., gift cards, bus passes, gifts, etc.) If you have included funding for incentives in your budget, you must address this item. (A recipient or treatment or prevention provider may provide up to $30 non-cash incentive to individuals to participate in required data collection follow up. This amount may be paid for participation in each required follow-up interview.) Provide justification that the use of incentives is appropriate, judicious, judicious and conservative and that incentives do not provide an “undue inducement” that removes the voluntary nature of participation. Describe how you will inform participants that they may receive services even if they chose to not participate in or complete the data collection component of the project. Data Collection Identify from whom you will collect data (e.g., participants, family members, teachers, others). Describe the data collection procedures and specify the sources for obtaining data (e.g., school records, interviews, psychological assessments, questionnaires, observation, observation or other sources). Identify what type of specimens (e.g., urine, blood) will be used, if any. State if the specimens will be used for purposes other than evaluation. In Attachment 2, “Data Collection Instruments/Interview Protocols,” you must provide copies of all available data collection instruments and interview protocols that you plan to use (unless you are providing the web link to the instrument(s)/protocol(s)). Privacy and Confidentiality Explain how you will ensure privacy and confidentiality. Describe: Where data will be stored, . Who will have access to the data collected, and . How the identity of participants will be kept private, for example, using through the use of a coding system on data records, limiting access to records, or storing identifiers separately from data. NOTE: Recipients must maintain the confidentiality of alcohol and drug abuse client records according to the provisions of Title 42 of the Code of Federal Regulations, Part II, Subpart B. . Adequate Consent Procedures Include, as appropriate, sample consent forms that provide for: (1) informed consent for participation in service intervention. ; (2) informed consent for participation in the data collection component of the project; and (3) informed consent for the exchange (releasing or requesting) of confidential information. The sample forms must be included in Attachment 3, “Sample Consent Forms”, of your application. If needed, give English translations. Explain how you will obtain consent for youth, the elderly, people with limited reading skills, and people who do not use English as their first language. Describe how the consent will be documented. For example: Will you read the consent forms? Will you ask prospective participants questions to be sure they understand the forms? Will you give them copies of what they sign?

CONFIDENTIALITY AND PARTICIPANT PROTECTION. It is important to have safeguards protecting individuals from risks associated with their participation in SAMHSA projects. As part of Attachment 7 of the application, all applicants (including those who plan to obtain Institutional Review Board (IRB) approval) must address all of the elements below. If some elements are not applicable to the proposed project, explain why the element(s) is not applicable. In addition to addressing these elements, you will need to determine if the section below titled “Protection of Human Subjects Regulations” applies to your project. If so, you must submit the required documentation as described below. There are no page limits for your response to the elements in this appendix. Protect Clients Participants and Staff from Potential Risks Identify and describe the foreseeable physical, medical, psychological, social, and legal risks or potential adverse effects participants may be exposed to because of the project. Identify and describe the foreseeable physical, medical, psychological, social, and legal risks or potential adverse effects staff may be exposed to as a result, of the project. Describe the procedures you will follow to minimize or protect participants and staff against potential risks, including risks to confidentiality. Identify your plan to provide guidance and assistance in the event there are adverse effects to participants and/or staff. Responses that will be considered unacceptable or incomplete: Indicating that there are no risks to participants. If services are being delivered as part of the project, it is very unlikely that there will be no foreseeable physical, medical, psychological, social, or legal risks or potential adverse effects as a result of their involvement in the project. Addressing potential risks to participants but not addressing risks to staff Neglecting to describe how the organization will provide guidance and assistance in the event there are adverse effects to participants and whether alternative treatments will be available to participants. Fair Selection of Participants Explain how you will recruit and select participantsparticipants ensuring all populations have equitable opportunities to participate in the program. Identify any individuals in the geographic catchment area where services will be delivered who will be excluded from participating in the project and explain the reasons for this exclusion. Responses that will be considered unacceptable or incomplete: Not explaining reasons for including or excluding participants Not identifying how participants will be selected Absence of Coercion If you plan to compensate participants, state how participants will be awarded incentives (e.g., gift cards, bus passes, gifts, etc.) If you plan to implement a contingency management program, specify the evidence-based model you will use and briefly justify its use with your population(s) of focus. If you have included funding for incentives in your budget, you must address this item. (A recipient or treatment or prevention provider may provide up to $30 non-cash incentive to individuals to participate in required data collection follow up. This amount may be paid for participation in each required follow-up interview.For specific information about incentives, see xxxxx://xxx.xxxxxx.xxx/grants/grants-management/policies-regulations/additional-directives) Provide justification that the use of incentives is appropriate, judicious, and conservative and that incentives do not provide an “undue inducement” that removes the voluntary nature of participation. Describe how you will inform participants in a culturally competent manner that they may receive services even if they chose choose to not participate in or complete the data collection component of the project. Responses that will be considered unacceptable or incomplete: Indicating that you do not plan to compensate participants, such as through incentives, but including funding for incentives in the budget or describing the use of incentives in the Project Narrative. Not specifying how participants will be told that they may receive services even if they choose not to participate in the data collection component of the project. Data Collection Identify from whom you will collect data (e.g., participants, clients, family members, teachers, others). Describe the data collection procedures and specify the sources for obtaining data (e.g., school records, interviews, psychological assessments, questionnaires, observation, or other sources). Identify what type of specimens (e.g., urine, blood) will be used, if any. State if the specimens will be used for purposes other than evaluation. In Attachment 2, “Data Collection Instruments/Interview Protocols,” you must provide copies of all available data collection instruments and interview protocols that you plan to use (unless you are providing the web link to the standardized instrument(s)/protocol(s)). Privacy Include any culturally adapted data collection instruments and Confidentiality Explain how you interview protocols. Responses that will ensure privacy and confidentiality. Describebe considered unacceptable or incomplete: Where Not clearly identifying all the entities from which data will be stored, Who will have access collected. Describing the use of drug testing in the Project Narrative but not providing the requested information about specimen collection. Not including data collection instruments/interview protocols (or links to websites for the data collected, and How the identity of participants will be kept private, for example, using a coding system on data records, limiting access to records, or storing identifiers separately from datainstruments) in Attachment 2. NOTE: Recipients must maintain the confidentiality of alcohol and drug abuse client records according to the provisions of Title 42 of the Code of Federal Regulations, Part II, Subpart B. Adequate Consent Procedures Include, as appropriate, sample consent forms that provide for: informed consent for participation in service intervention. informed consent for participation in Not including how the data collection component of will occur (i.e., paper surveys versus electronic survey links; at a school setting or at the project; and informed consent for the exchange (releasing or requesting) of confidential information. The sample forms must be included in Attachment 3organization’s clinic, “Sample Consent Forms”, of your application. If needed, give English translations. Explain how you will obtain consent for youth, the elderly, people with limited reading skills, and people who do not use English as their first language. Describe how the consent will be documented. For example: Will you read the consent forms? Will you ask prospective participants questions to be sure they understand the forms? Will you give them copies of what they sign?etc.).

CONFIDENTIALITY AND PARTICIPANT PROTECTION. It is important to have safeguards protecting individuals from risks associated with their participation in SAMHSA projects. As part of Attachment 7 of the application, all applicants (including those who plan to obtain Institutional Review Board (IRB) approval) must address the elements below. If some elements are not applicable to the proposed project, explain why the element(s) is not applicable. In addition to addressing these elements, you will need to determine if the section below titled “Protection of Human Subjects Regulations” applies to your project. If so, you must submit the required documentation as described below. Protect Clients and Staff from Potential Risks Identify and describe the foreseeable physical, medical, psychological, social, and legal risks or potential adverse effects participants may be exposed to because of the project. Identify and describe the foreseeable physical, medical, psychological, social, and legal risks or potential adverse effects staff may be exposed to as a result, of the project. Describe the procedures you will follow to minimize or protect participants and staff against potential risks, including risks to confidentiality. Identify your plan to provide guidance and assistance in the event there are adverse effects to participants and/or staff. Fair Selection of Participants Explain how you will recruit and select participants. Identify any individuals in the geographic catchment area where services will be delivered who will be excluded from participating in the project and explain the reasons for this exclusion. Absence of Coercion If you plan to compensate participants, state how participants will be awarded incentives (e.g., gift cards, bus passes, gifts, etc.) If you have included funding for incentives in your budget, you must address this item. (A recipient or treatment or prevention provider may provide up to $30 non-cash incentive to individuals to participate in required data collection follow up. This amount may be paid for participation in each required follow-up interview.) Provide justification that the use of incentives is appropriate, judicious, and conservative and that incentives do not provide an “undue inducement” that removes the voluntary nature of participation. Describe how you will inform participants that they may receive services even if they chose to not participate in or complete the data collection component of the project. Data Collection Identify from whom you will collect data (e.g., participants, family members, teachers, others). Describe the data collection procedures and specify the sources for obtaining data (e.g., school records, interviews, psychological assessments, questionnaires, observation, or other sources). Identify what type of specimens (e.g., urine, blood) will be used, if any. State if the specimens will be used for purposes other than evaluation. In Attachment 2, “Data Collection Instruments/Interview Protocols,” you must provide copies of all available data collection instruments and interview protocols that you plan to use (unless you are providing the web link to the instrument(s)/protocol(s)). Privacy and Confidentiality Explain how you will ensure privacy and confidentiality. Describe: Where data will be stored, Who will have access to the data collected, and How the identity of participants will be kept private, for example, using a coding system on data records, limiting access to records, or storing identifiers separately from data. NOTE: Recipients must maintain the confidentiality of alcohol and drug abuse client records according to the provisions of Title 42 of the Code of Federal Regulations, Part II, Subpart B. Adequate Consent Procedures Include, as appropriate, sample consent forms that provide for: informed consent for participation in service intervention. informed consent for participation in the data collection component of the project; and informed consent for the exchange (releasing or requesting) of confidential information. The sample forms must be included in Attachment 3, “Sample Consent Forms”, of your application. If needed, give English translations. Explain how you will obtain consent for youth, the elderly, people with limited reading skills, and people who do not use English as their first language. Describe how the consent will be documented. For example: Will you read the consent forms? Will you ask prospective participants questions to be sure they understand the forms? Will you give them copies of what they sign?

CONFIDENTIALITY AND PARTICIPANT PROTECTION. It is important to have safeguards protecting individuals from risks associated with their participation in SAMHSA projects. As part of Attachment 7 6 of the application, all applicants (including those who plan to obtain Institutional Review Board (IRB) approval) must address all of the elements below. If some elements are not applicable to the proposed project, explain why the element(s) is not applicable. In addition to addressing these elements, you will need to determine if the section below titled “Protection of Human Subjects Regulations” applies to your project. If so, you must submit the required documentation as described below. There are no page limits for your response to the elements in this appendix. Protect Clients Participants and Staff from Potential Risks Identify and describe the foreseeable physical, medical, psychological, social, and legal risks or potential adverse effects participants may be exposed to because of the project. Identify and describe the foreseeable physical, medical, psychological, social, and legal risks or potential adverse effects staff may be exposed to as a result, of the project. Describe the procedures you will follow to minimize or protect participants and staff against potential risks, including risks to confidentiality. Identify your plan to provide guidance and assistance in the event there are adverse effects to participants and/or staff. Responses that will be considered unacceptable or incomplete: Indicating that there are no risks to participants. If services are being delivered as part of the project, it is very unlikely that there will be no foreseeable physical, medical, psychological, social, or legal risks or potential adverse effects as a result of their involvement in the project. Addressing potential risks to participants but not addressing risks to staff Neglecting to describe how the organization will provide guidance and assistance in the event there are adverse effects to participants and whether alternative treatments will be available to participants. Fair Selection of Participants Explain how you will recruit and select participantsparticipants ensuring all populations have equitable opportunities to participate in the program. Identify any individuals in the geographic catchment area where services will be delivered who will be excluded from participating in the project and explain the reasons for this exclusion. Responses that will be considered unacceptable or incomplete: Not explaining reasons for including or excluding participants Not identifying how participants will be selected Absence of Coercion If you plan to compensate participants, state how participants will be awarded incentives (e.g., gift cards, bus passes, gifts, etc.) If you plan to implement a contingency management program, specify the evidence-based model you will use and briefly justify its use with your population(s) of focus. If you have included funding for incentives in your budget, you must address this item. (A recipient or treatment or prevention provider may provide up to $30 non-cash incentive to individuals to participate in required data collection follow up. This amount may be paid for participation in each required follow-up interview.For specific information about incentives, see xxxxx://xxx.xxxxxx.xxx/grants/grants-management/policies-regulations/additional-directives) Provide justification that the use of incentives is appropriate, judicious, and conservative and that incentives do not provide an “undue inducement” that removes the voluntary nature of participation. Describe how you will inform participants in a culturally competent manner that they may receive services even if they chose choose to not participate in or complete the data collection component of the project. Responses that will be considered unacceptable or incomplete: Indicating that you do not plan to compensate participants, such as through incentives, but including funding for incentives in the budget or describing the use of incentives in the Project Narrative. Not specifying how participants will be told that they may receive services even if they choose not to participate in the data collection component of the project Data Collection Identify from whom you will collect data (e.g., participants, clients, family members, teachers, others). Describe the data collection procedures and specify the sources for obtaining data (e.g., school records, interviews, psychological assessments, questionnaires, observation, or other sources). Identify what type of specimens (e.g., urine, blood) will be used, if any. State if the specimens will be used for purposes other than evaluation. In Attachment 2, “Data Collection Instruments/Interview Protocols,” you must provide copies of all available data collection instruments and interview protocols that you plan to use (unless you are providing the web link to the standardized instrument(s)/protocol(s)). Privacy Include any culturally adapted data collection instruments and Confidentiality Explain how you interview protocols. Responses that will ensure privacy and confidentiality. Describebe considered unacceptable or incomplete: Where Not clearly identifying all the entities from which data will be stored, Who will have access collected. Describing the use of drug testing in the Project Narrative but not providing the requested information about specimen collection. Not including data collection instruments/interview protocols (or links to websites for the data collected, and How the identity of participants will be kept private, for example, using a coding system on data records, limiting access to records, or storing identifiers separately from data. NOTE: Recipients must maintain the confidentiality of alcohol and drug abuse client records according to the provisions of Title 42 of the Code of Federal Regulations, Part II, Subpart B. Adequate Consent Procedures Include, as appropriate, sample consent forms that provide for: informed consent for participation instruments) in service intervention. informed consent for participation in Attachment 2 Not including how the data collection component of will occur (i.e., paper surveys versus electronic survey links; at a school setting or at the project; and informed consent for the exchange (releasing or requesting) of confidential information. The sample forms must be included in Attachment 3organization’s clinic, “Sample Consent Forms”, of your application. If needed, give English translations. Explain how you will obtain consent for youth, the elderly, people with limited reading skills, and people who do not use English as their first language. Describe how the consent will be documented. For example: Will you read the consent forms? Will you ask prospective participants questions to be sure they understand the forms? Will you give them copies of what they sign?etc.).

CONFIDENTIALITY AND PARTICIPANT PROTECTION. It Because of the confidential nature of the work in which many SAMHSA grantees are involved, it is important to have safeguards protecting individuals from risks associated with their participation in SAMHSA projects. As part of Attachment 7 of the application, all All applicants (including those who plan to obtain Institutional Review Board (IRB) approval) must address the elements seven bullets below. Appendix F of this RFA provides a more detailed discussion of issues applicants should consider in addressing these seven bullets. If some elements are not applicable or relevant to the proposed project, explain why the element(s) is simply state that they are not applicableapplicable and indicate why. In addition to addressing these elementsseven bullets, you will need read the section that follows entitled Protection of Human Subjects Regulations to determine if the section below titled “Protection of Human Subjects Regulations” applies regulations may apply to your project. If so, you must submit the are required documentation as described below. Protect Clients and Staff from Potential Risks Identify and to describe the process you will follow for obtaining Institutional Review Board (IRB) approval. While we encourage you to keep your responses brief, there are no page limits for this section and no points will be assigned by the Review Committee. Problems with confidentiality, participant protection, and the protection of human subjects identified during peer review of the application must be resolved prior to funding.  Identify foreseeable risks or adverse effects due to participation in the project and/or in the data collection (performance assessment) activities (including physical, medical, psychological, social, legal, and legal risks confidentiality) and provide your procedures for minimizing or potential adverse effects protecting participants may be exposed to because of the projectfrom these risks. Identify and describe the foreseeable physical, medical, psychological, social, and legal risks or potential adverse effects staff may be exposed to as a result, of the project. Describe the procedures you will follow to minimize or protect participants and staff against potential risks, including risks to confidentiality. Identify your plan plans to provide guidance and assistance in the event there are adverse effects to participants and/or staffparticipants. Fair Selection  Describe the population of Participants focus and explain why you are including or excluding certain subgroups. Explain how you and who will recruit and select participants. Identify any individuals in the geographic catchment area where services will be delivered who will be excluded from participating  State whether participation in the project and explain the reasons for this exclusionis voluntary or required. Absence of Coercion If you plan to provide incentives/compensate participants, state how participants will be awarded incentives specify the type (e.g., gift cards, bus passesmoney, gifts, etc.) If you have included funding for incentives in your budgetcoupons), you must address this itemand the value of any such incentives. (A recipient or treatment or prevention provider may provide up to $30 non-cash incentive to individuals to participate in required data collection follow up. This amount may be paid for participation in each required follow-up interview.) Provide justification that the use of incentives is appropriate, judicious, and conservative and that incentives do not provide an “undue inducement” that which removes the voluntary nature of participation. Incentives should be the minimum amount necessary to meet the programmatic and performance assessment goals of the grant. Applicants should determine the minimum amount that is proven to be effective by consulting with existing local programs and reviewing the relevant literature. In no case may the value of an incentive paid for with XXXXXX discretionary grant funds exceed $20. (See Appendix F: Confidentiality and Participant Protection.)  Describe how you will inform participants that they may receive services even if they chose to not participate in or complete the data collection component of the project. Data Collection Identify from whom you will collect data procedures, including sources (e.g., participants, family members, teachers, others). Describe school records) and the data collection procedures and specify the sources for obtaining data collecting setting (e.g., school recordsclinic, interviews, psychological assessments, questionnaires, observation, or other sourcesschool). Identify what type Provide copies of specimens (e.g., urine, blood) will be used, if any. State if the specimens will be used for purposes other than evaluation. In Attachment 2proposed data collection instruments and interview protocols in Appendix 2 of your application, “Data Collection Instruments/Interview Protocols,.” you must provide copies State whether specimens such as urine and/or blood will be obtained and the purpose for collecting the specimens. If applicable, describe how the specimens and process will be monitored to ensure both the safety of all available data collection instruments participants and interview protocols that you plan to use (unless you are providing the web link to integrity of the instrument(s)/protocol(s))specimens. Privacy and Confidentiality  Explain how you will ensure privacy and confidentialityconfidentiality of participants’ records, data collected, interviews, and group discussions. Describe: Where Describe where the data will be stored, Who safeguards (e.g., locked, coding systems, storing identifiers separate from data), and who will have access to the data collected, information.  Describe the process for obtaining and How the identity documenting consent from adult participants and assent from minors along with consent from their parents or legal guardians. Provide copies of participants will be kept private, for example, using a coding system on data records, limiting access to records, or storing identifiers separately from data. NOTE: Recipients must maintain the confidentiality of alcohol and drug abuse client records according to the provisions of Title 42 of the Code of Federal Regulations, Part II, Subpart B. Adequate Consent Procedures Include, as appropriate, sample all consent forms that provide for: informed consent for participation in service intervention. informed consent for participation in the data collection component Appendix 3 of the project; and informed consent for the exchange (releasing or requesting) of confidential information. The sample forms must be included in Attachment 3your application, “Sample Consent Forms”, of your application. .” If needed, give English translations. Explain how you  Discuss why the risks are reasonable compared to expected benefits from the project. Protection of Human Subjects Regulations XXXXXX expects that most grantees funded under this announcement will obtain consent for youthnot have to comply with the Protection of Human Subjects Regulations (45 CFR 46), which requires Institutional Review Board (IRB) approval. However, in some instances, the elderlyapplicant’s proposed performance assessment design may meet the regulation’s criteria of research involving human subjects. For assistance in determining if your proposed performance assessment meets the criteria in 45 CFR 46, people Protection of Human Subjects Regulations, refer to the SAMHSA decision tree on the SAMHSA Web site, under “Applying for a New SAMHSA Grant,” xxxx://xxx.xxxxxx.xxx/grants/apply.aspx. Applicants whose projects must comply with limited reading skillsthe Human Subjects Regulations must, and people who do in addition to the bullets above, fully describe the process for obtaining IRB approval. While IRB approval is not use English as their first language. Describe how required at the consent time of grant award, these grantees will be documentedrequired, as a condition of award, to provide documentation that an Assurance of Compliance is on file with the Office for Human Research Protections (OHRP). For example: Will you read IRB approval must be received in these cases prior to enrolling clients in the consent forms? Will you ask prospective participants project. General information about Human Subjects Regulations can be obtained through OHRP at xxxx://xxx.xxx.xxx/ohrp, or xxxx@xxxxxx.xxxx.xxx, or (240) 453- 6900. SAMHSA–specific questions should be directed to be sure they understand the forms? Will you give them copies program contact listed in Section VII of what they sign?this announcement.