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. 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 are reasonable compared to expected benefits and importance of the knowledge from the project. 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 are reasonable compared to expected benefits and importance of the knowledge from the project. XXXXXX expects that most grantees 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 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 recipients 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 are reasonable compared to expected benefits and importance of the knowledge from the project. Protection of Human Subjects Regulations XXXXXX expects that most grantees 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 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 recipients 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.