This section is required when research involves more than Minimal Risk to subjects. Describe: The plan to periodically evaluate the data collected regarding both harms and benefits to determine whether subjects remain safe. The plan might include establishing a data monitoring committee and a plan for reporting data monitoring committee findings to the IRB and the sponsor. What data are reviewed, including safety data, untoward events, and efficacy data. How the safety information will be collected (e.g., with case report forms, at study visits, by telephone calls with participants). The frequency of data collection, including when safety data collection starts. Who will review the data. The frequency or periodicity of review of cumulative data. The statistical tests for analyzing the safety data to determine whether harm is occurring. Any conditions that trigger an immediate suspension of the research. Withdrawal of Subjects* Describe anticipated circumstances under which subjects will be withdrawn from the research without their consent. Describe any procedures for orderly termination. Describe procedures that will be followed when subjects withdraw from the research, including partial withdrawal from procedures with continued data collection. Risks to Subjects* List the reasonably foreseeable risks, discomforts, hazards, or inconveniences to the subjects related the subjects’ participation in the research. Include as may be useful for the IRB’s consideration, a description of the probability, magnitude, duration, and reversibility of the risks. Consider physical, psychological, social, legal, and economic risks. If applicable, indicate which procedures may have risks to the subjects that are currently unforeseeable. If applicable, indicate which procedures may have risks to an embryo or fetus should the subject be or become pregnant. If applicable, describe risks to others who are not subjects. Potential Benefits to Subjects*
This section is required when research involves more than Minimal Risk to subjects. Describe: The plan to periodically evaluate the data collected regarding both harms and benefits to determine whether subjects remain safe. The plan might include establishing a data monitoring committee and a plan for reporting data monitoring committee findings to the IRB and the sponsor. What data are reviewed, including safety data, untoward events, and efficacy data. How the safety information will be collected (e.g., with case report forms, at study visits, by telephone calls with participants). The frequency of data collection, including when safety data collection starts. Who will review the data. The frequency or periodicity of review of cumulative data. The statistical tests for analyzing the safety data to determine whether harm is occurring. Any conditions that trigger an immediate suspension of the research. Withdrawal of Subjects* Describe anticipated circumstances under which subjects will be withdrawn from the research without their consent. Describe any procedures for orderly termination. Describe procedures that will be followed when subjects withdraw from the research, including partial withdrawal from procedures with continued data collection. Risks to Subjects* List the reasonably foreseeable risks, discomforts, hazards, or inconveniences to the subjects related the subjects’ participation in the research. Include as may be useful for the IRB’s consideration, a description of the probability, magnitude, duration, and reversibility of the risks. Consider physical, psychological, social, legal, and economic risks. If applicable, indicate which procedures may have risks to the subjects that are currently unforeseeable. If applicable, indicate which procedures may have risks to an embryo or fetus should the subject be or become pregnant. If applicable, describe risks to others who are not subjects. Potential Benefits to Subjects*
irb_HRP-503%20-%20TEMPLATE%20PROTOCOL.docx