participants to inform them of the new information. If the change to the risk/benefits ratio is adverse, the informed consent should be amended and submitted to IRB for approval. The informed consent should be updated and the IRB may require that the currently enrolled research participants be re-consented, acknowledging receipt of this new information and for affirming their continued participation. Changes Initiated to 5 days. Include an amendment, to Eliminate an Apparent propose any additional or Immediate Hazard days. permanent changes. Expanded Access, Notify IRB Chair as soon as Requires approval of the Emergency Use, or possible. Department Chair and Medical Compassionate Use of an Director before administration. Notify the IRB within 5 days of Unapproved Drug, drug administration or device Unapproved Biologic or use. Unapproved Device. Protocol Deviations 5 days, if it adversely affects: Include an amendment, to (including minor the rights, safety, or welfare of propose any additional or modifications made without the research participant; or the permanent changes, as a IRB approval), Violations, or research corrective action. participant’s Complaints. willingness to continue Any complaints involving participation; or the integrity of *Must be reported to the full translations or interpretations the research data, including board if the event meets the must also be reported to information security requirements to be reported patient relations. requirements. within 5 days. Otherwise report to IRB before continuing review or project closure.
participants to inform them of the new information. If the change to the risk/benefits ratio is adverse, the informed consent should be amended and submitted to IRB for approval. The informed consent should be updated and the IRB may require that the currently enrolled research participants be re-consented, acknowledging receipt of this new information and for affirming their continued participation. Changes Initiated to Eliminate an Apparent Immediate Hazard days. 5 days. Include an amendment, to propose any additional or permanent changes. Expanded Access, Emergency Use, or Compassionate Use of an Unapproved Drug, Unapproved Biologic or Unapproved Device. Notify IRB Chair as soon as possible. Notify the IRB within 5 days of drug administration or device use. Requires approval of the Department Chair and Medical Director before administration. Protocol Deviations (including minor modifications made without IRB approval), Violations, or Complaints. *Must be reported to the full board if the event meets the requirements to be reported within 5 days. 5 days, if it adversely affects: the rights, safety, or welfare of the research participant; or the research participant’s willingness to continue participation; or the integrity of the research data, including information security requirements. Otherwise report to IRB before continuing review or project closure. Include an amendment, to propose any additional or permanent changes, as a corrective action. Any complaints involving translations or interpretations must also be reported to patient relations.
SUNYDMCIRB-01Policy01.19.2017FINAL-LOCKED.docx