Common use of Risk/Benefit Discussion Clause in Contracts

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 you have identified in Element 1. (Protect Clients and Staff from Potential Risks Risks) are reasonable compared to the anticipated benefits to participants involved in the project. PROTECTION OF HUMAN SUBJECTS REGULATIONS 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 you have identified in Element 1. (Protect Clients and Staff from Potential Risks Risks) are reasonable compared to the anticipated benefits to participants involved in the project. PROTECTION OF HUMAN SUBJECTS REGULATIONS XXXXXX Protection of Human Subjects Regulations SAMHSA 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.