Common use of Risk/Benefit Discussion Clause in Contracts

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 B – 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. 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 SAMHSA–specific questions should be directed to the program contact listed in Section VII of this announcement. Appendix B 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. 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 SAMHSA–specific questions should be directed to the program contact listed in Section VII of this announcement. Appendix B – Sample Budget and Justification (no match required) THIS IS AN ILLUSTRATION OF A SAMPLE DETAILED BUDGET AND NARRATIVE. NARRATIVE JUSTIFICATION WITH GUIDANCE FOR COMPLETING SF 424ASF-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.