The sample, including identification and justification of the use of vulnerable populations Each procedure to which human subjects will be exposed, their frequency and duration Foreseeable risks and their type: physical, psychological, social or economic. Alternate treatments or the withholding of normal treatment Procedures to protect privacy of persons and confidentiality of data Procedures to assess understanding of the study and their ability to prospects’ give informed consent and allow time for questions or reflection about participation Procedures to minimize the risk to human subjects 2.1.1.9 Potential benefits accruing directly to participants (therapy, education, information, resources, etc.), their community, or to society by the acquisition of scientific knowledge. Benefits must not be promised and must seem logically possible or likely. (No stretch of imagination should be required to identify a possible benefit.) 2.1.1.10 Whether the potential benefits outweigh the risks inherent in the research. 2.2 Risk analysis and minimization. 2.2.1 The IRB considers the overall risk level to participants in evaluating proposed research in accordance with the conditions outlined in 45 CFR 46.111(a)(1-7), 21 CFR 56.111 7), as well as the ethical principles outlined in the Belmont Report. 2.2.2 The Research Compliance Specialists will verify that the application is complete and ready for review by the IRB using FORM: Checklist for Completeness of IRB Applications. If it is incomplete, the missing information will be obtained from investigators in time for IRB review. 2.2.3 Using FORM: IRB Checklist for Reviewers and Investigators, IRB members specifically review the application for identifiable risks to research participants and the minimization of those risks. For studies undergoing Full-Board Review at convened meetings, the nature and extent of risk and risk minimization will be specifically discussed. For studies undergoing Expedited Review, reviewers will state agreement with the judgments and actions proposed by the investigator or their own judgment about risk level and adequacy of risk minimization and any additional safeguards to be implemented. 2.2.4 The assessment of the presence of undeclared COI or the effects and management of declared COI on risk to human participants is part of the review of all applications, whether for exempt, expedited, or full board review.
The sample, including identification and justification of the use of vulnerable populations Each procedure to which human subjects will be exposed, their frequency and duration Foreseeable risks and their type: physical, psychological, social or economic. Alternate treatments or the withholding of normal treatment Procedures to protect privacy of persons and confidentiality of data Procedures to assess prospects’ understanding of the study and their ability to give informed consent and allow time for questions or reflection about participation Procedures to minimize the risk to human subjects 2.1.1.9 Potential benefits accruing directly to participants (therapy, education, information, resources, etc.), their community, or to society by the acquisition of scientific knowledge. Benefits must not be promised and must seem logically possible or likely. (No stretch of imagination should be required to identify a possible benefit.) 2.1.1.10 Whether the potential benefits outweigh the risks inherent in the research. 2.2 Risk analysis and minimization. 2.2.1 The IRB considers the overall risk level to participants in evaluating proposed research in accordance with the conditions outlined in 45 CFR 46.111(a)(1-7), 21 CFR 56.111 7), as well as the ethical principles outlined in the Belmont Report. 2.2.2 The Research Compliance Specialists will verify that the application is complete and ready for review by the IRB using FORM: Checklist for Completeness of IRB Applications. If it is incomplete, the missing information will be obtained from investigators in time for IRB review. 2.2.3 Using FORM: IRB Checklist for Reviewers and Investigators, IRB members specifically review the application for identifiable risks to research participants and the minimization of those risks. For studies undergoing Full-Board Review at convened meetings, the nature and extent of risk and risk minimization will be specifically discussed. For studies undergoing Expedited Review, reviewers will state agreement with the judgments and actions proposed by the investigator or their own judgment about risk level and adequacy of risk minimization and any additional safeguards to be implemented. 2.2.4 The assessment of the presence of undeclared COI or the effects and management of declared COI on risk to human participants is part of the review of all applications, whether for exempt, expedited, or full board review.
55-II4A-Ident-Minimize-risk-1-10-2012.docx