Risk/Benefit Discussion. Discuss why the risks are reasonable compared to expected benefits and importance of the knowledge from the project. Protection of Human Subjects Regulations XXXXXX expects that most grantees funded under this announcement will not 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 applicant’s proposed performance assessment design may meet the regulation’s criteria for research involving human subjects. In addition to the elements above, applicants whose projects must comply with the Human Subjects Regulations must fully describe the process for obtaining IRB approval. While IRB approval is not required at the time of grant award, these grantees will be required, as a condition of award, to provide documentation that an Assurance of Compliance is on file with the Office for Human Research Protections (OHRP). IRB approval must be received in these cases prior to enrolling participants in the project. General information about Human Subjects Regulations can be obtained through OHRP at xxxx://xxx.xxx.xxx/ohrp or (000) 000-0000. SAMHSA–specific questions should be directed to the program contact listed in Section VII of this announcement.
Risk/Benefit Discussion. Discuss why the risks you have identified in Element 1. Protect Clients and Staff from Potential Risks are reasonable compared to the anticipated benefits to participants involved in the project. PROTECTION OF HUMAN SUBJECTS REGULATIONS XXXXXX expects that most recipients funded under this announcement will not 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 applicant’s proposed project may meet the regulation’s criteria for research involving human subjects. Although IRB approval is not required at the time of award, you are required to provide the documentation below prior to enrolling participants into your project. In addition to the elements above, applicants whose projects must comply with the Human Subjects Regulations must: • Describe the process for obtaining IRB approval for your project. • Provide documentation that an Assurance of Compliance is on file with the Office for Human Research Protections (OHRP). • Provide documentation that IRB approval has been obtained for your project prior to enrolling participants. General information about Human Subjects Regulations can be obtained through OHRP at xxxx://xxx.xxx.xxx/ohrp or (000) 000-0000. SAMHSA–specific questions should be directed to the program contact listed in Section VII of this announcement.
Risk/Benefit Discussion. Discuss why the risks are reasonable compared to expected benefits and importance of the knowledge from the project. Protection of Human Subjects Regulations XXXXXX expects that most grantees funded under this announcement will not 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 applicant’s proposed performance assessment design may meet the regulation’s criteria for research involving human subjects. In addition to the elements above, applicants whose projects must comply with the Human Subjects Regulations must fully describe the process for obtaining IRB approval. While IRB approval is not required at the time of grant award, these grantees will be required, as a condition of award, to provide documentation that an Assurance of Compliance is on file with the Office for Human Research Protections (OHRP). IRB approval must be received in these cases prior to enrolling participants in the project. General information about Human Subjects Regulations can be obtained through OHRP at xxxx://xxx.xxx.xxx/ohrp or (000) 000-0000. SAMHSA–specific questions should be directed to the program contact listed in Section VII of this announcement. Appendix Il – Sample Budget and Justification (match required) THIS IS AN ILLUSTRATION OF A SAMPLE DETAILED BUDGET AND NARRATIVE. WITH GUIDANCE FOR COMPLETING SF 424A: SECTION B FOR THE BUDGET PERIOD. This sample budget must be used to prepare your application instead of the sample budget in PART II.
Risk/Benefit Discussion. Discuss why the risks are reasonable compared to expected benefits and importance of the knowledge from the project.
Risk/Benefit Discussion. Discuss why the risks are reasonable compared to expected benefits and importance of the knowledge from the project. Protection of Human Subjects Regulations XXXXXX expects that most grantees funded under this announcement will not 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 applicant’s proposed performance assessment design may meet the regulation’s criteria for research involving human subjects. In addition to the elements above, applicants whose projects must comply with the Human Subjects Regulations must fully describe the process for obtaining IRB approval. While IRB approval is not required at the time of grant award, these grantees will be required, as a condition of award, to provide documentation that an Assurance of Compliance is on file with the Office for Human Research Protections (OHRP). IRB approval must be received in these cases prior to enrolling participants in the project. General information about Human Subjects Regulations can be obtained through OHRP at xxxx://xxx.xxx.xxx/ohrp or (000) 000-0000. SAMHSA–specific questions should be directed to the program contact listed in Section VII of this announcement. Appendix IV - Comparison of SYT-I and SYT-P SYT-I (TI-15-004) SYT-P (TI-15-005) Purpose To provide funding to states to improve treatment for adolescents and/or transitional aged youth with SUD and/or co-occurring substance use and mental disorders by assuring youth state-wide access to evidence-based assessments and treatment models and recovery services supported by the strengthening of the existing infrastructure system and provision of direct treatment services. This is both an infrastructure and services award. To provide funding to states to develop a comprehensive strategic plan in order to improve treatment for adolescents and/or transitional aged youth with SUD and/or co- occurring substance use and mental disorders by strengthening of the existing infrastructure system. This is an infrastructure only award. Application Requirements Applicants to SYT-I must minimally have the six core state infrastructure components in place. They must demonstrate they are no longer in the planning phase, but have the presence of each core infrastructure component. The applicant will require numerous attachments to verify they meet the core components (i.e., written agreement for an Interagency Council, FY 2011 or lat...
Risk/Benefit Discussion. By using the procedures described above, we believe the risks to participants will be minimized. We believe the benefits of this project far outweigh the risks, with its potential to achieve outcomes through the use of EBPs (A-CRA) and recovery support services.
Risk/Benefit Discussion. The questions from the YMHFA post-test will pose minimal risks to participants. If distress is experienced by any participant, appropriate referral to a therapist will be done. The anticipated risk does not exceed risks that accompany any standardized psychological or behavioral trainings. Some of these might include concerns about confidentiality or self-identifying with the mental health education components. These however, will be addressed in the consent process. Because the data from the evaluation will determine how effective services that are available in the community address the needs of children/youth with serious emotional and behaviors disorders and their families, the risks to the participants are reasonable in relation to the anticipated benefits. The participants will not incur any potential financial risk. There are no direct benefits of the evaluation to the participants; however data from the evaluation will determine how effective services that are available in the community address the needs of children/youth with serious emotional and behaviors disorders and their families, which may benefit future populations. The partners have a comprehensive plan for data collection and analysis of data and outcomes for Project Xxxxx AWARE. Each instructor will be trained on the data sets to be collected and timeline for reports and follow up with first aiders. For this grant, first aiders will be asked to report data on referrals made to resources and services over at least a one year but preferably the three year period. Instructors will be responsible, with assistance from the project coordinator, to collect data from participates trained and report it on time and organized to the project coordinator. Instructors will be consulted regularly on the effectiveness of the data collection methods to reduce any cumbersome data collection at the training. The data collected from first aiders by instructors may include: Demographics - name, community agency or other affiliation to youth, location (by zip code) of where the youth served reside, how they heard about the training, identified race, and email address, etc. Consent –participant will be required to sign a consent form to be trained and to participate in data collection questionnaires. Baseline data – pre on-line questionnaires will be provided to the participant when they enroll on the on-line training. This will be the baseline for the training. A self-reported questionnaire will be used to me...
Risk/Benefit Discussion. Discuss why the risks are reasonable compared to expected benefits and importance of the knowledge from the project. Protection of Human Subjects Regulations XXXXXX expects that most grantees funded under this announcement will not 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 applicant’s proposed performance assessment design may meet the regulation’s criteria for research involving human subjects. In addition to the elements above, applicants whose projects must comply with the Human Subjects Regulations must fully describe the process for obtaining IRB approval. While IRB approval is not required at the time of grant award, these grantees will be required, as a condition of award, to provide documentation that an Assurance of Compliance is on file with the Office for Human Research Protections (OHRP). IRB approval must be received in these cases prior to enrolling participants in the project. General information about Human Subjects Regulations can be obtained through OHRP at xxxx://xxx.xxx.xxx/ohrp or (000) 000-0000. SAMHSA–specific questions should be directed to the program contact listed in Section VII of this announcement. Appendix II – List of Current Grantees Ineligible to Apply SOC Implementation Grantees Expansion Implementation Grantees (2012-2016) SM061220 District of Columbia Dept. Of Mental Health DC SM061221 Virginia State Dept. of Mental Health/Mental Retardation/Substance Abuse Services VA SM061224 Oklahoma Dept. of Mental Health /Substance Abuse OK SM061226 Hawaii State Department of Health HI SM061228 Pueblo Of San Xxxxxx NM SM061231 Maine State Dept. of Corrections ME SM061233 Monroe County Public Health Department NY SM061234 Rhode Island State Dept. for Child/Family RI SM061235 Florida State Dept. of Children & Families FL SM061237 Washington State Dept. Social/Health Services WA SM061241 Colorado Division of Behavioral Health CO SM061243 Xxxxxx Yaqui Tribe AZ SM061245 Humboldt County Department of Health and Human Services CA SM061247 Tennessee State Dept. of Health TN SM061249 NH State Dept./Health Statistics/Data Mgmt. NH SM061253 Maryland State Department. Of Health/Mental Hygiene MD Expansion Implementation Grants FY 2013-2017 SM061219 Texas Health & Human Services Commission TX SM061222 Cabinet for Health & Family Services KY SM061225 Ohio Dept. of Mental Health OH SM061227 Dept. of Mental Health & Substanc...
Risk/Benefit Discussion. Discuss why the risks you have identified in Element 1. Protect Participants and Staff from Potential Risks are reasonable compared to the anticipated benefits to participants involved in the project. Responses that will be considered unacceptable or incomplete: • Indicating there are no risks to participants in the first element and noting that this element is therefore not applicable. • Not mentioning any anticipated benefits to participants involved in the project. PROTECTION OF HUMAN SUBJECTS REGULATIONS XXXXXX expects that most recipients funded under this announcement will not 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 applicant’s proposed project may meet the regulation’s criteria for research involving human subjects. Although IRB approval is not required at the time of award, you are required to provide the documentation below prior to enrolling participants into your project. In addition to the elements above, applicants whose projects must comply with the Human Subjects Regulations must: • Describe the process for obtaining IRB approval for your project. • Provide documentation that an Assurance of Compliance is on file with the Office for Human Research Protections (OHRP). • Provide documentation that IRB approval has been obtained for your project prior to enrolling participants. General information about Human Subjects Regulations can be obtained through OHRP at xxxx://xxx.xxx.xxx/ohrp or (000) 000-0000. SAMHSA–specific questions should be directed to the program contact listed in Section VII of this announcement.
