regard to the impact on the research participants’ rights and welfare. Since the new knowledge or findings may affect the risks or benefits to research participants’ willingness to continue in the research, the IRB may require, during the ongoing review process, that the PI contact the currently enrolled research 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. Notify IRB as soon as Requires approval of the Expanded Access, 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 modifications the rights, safety, or welfare of propose any additional or made without IRB approval), the research participant; or the permanent changes, as a Violations, or Complaints. research participant’s corrective action. willingness to continue *Must be reported to the full Any complaints involving participation; or the integrity of if the event meets the translations or interpretations the research data, including requirements to be reported must also be reported to information security within 5 days. patient relations. requirements.
regard to the impact on the research participants’ rights and welfare. Since the new knowledge or findings may affect the risks or benefits to research participants’ willingness to continue in the research, the IRB may require, during the ongoing review process, that the PI contact the currently enrolled research 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 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 modifications made without IRB approval), Violations, or Complaints. *Must be reported to the full 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. 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.
IRB-01HumanResearchProtectionsProgramPolicy03.30.2017Locked.docx