HS IRB Worksheets & Checklists
Please refer to the following checklists and worksheets. These are also available in the eIRB Library:
- CHECKLIST: Reviewing your IRB New Study Application before Submitting it to the IRB – The IRB recommends using this checklist to review your new study application before submitting it to the IRB. This will help the IRB to review and approve your study as quickly as possible.
- Departing Coordinator Checklist – For Coordinators who are leaving their position at Tufts Medical Center / Tufts University who have active studies with the Tufts Health Sciences IRB – this checklist will help ensure the smooth transfer of your studies to the new Coordinator. This checklist can be modified for your specific department or group.
- Departing Principal Investigator Checklist – For Investigators who are leaving Tufts Medical Center / Tufts University who have active studies with the Tufts Health Sciences IRB – this checklist will help you close out, identify a new PI for, or transfer your active studies before you leave Tufts.
- International Research with Human Subjects Checklist – Use this checklist when developing your protocol and other study documents for international research projects.
- Short Form Quick Reference Checklist – Use this checklist to guide you on the enrollment of Non-English speakers in your research.
- WORKSHEET: Additional Federal Criteria (HRP-318) – Use this worksheet to guide you through additional criteria required for federal research.
- WORKSHEET: Human Research Determination (HRP-310) – Use this worksheet to determine whether a project is Human Research under the federal regulations.
- WORKSHEET: Engagement Determination (HRP-311) – Use this worksheet to determine whether Tufts is engaged in research being done at or with another institution.
- WORKSHEET: Protocol Worksheet – Use this checklist to make sure the protocol includes all relevant sections.
- WORKSHEET - Communication and Responsibilities (HRP-303) – Use this worksheet to develop a communication and management plan for multi-site research.
Special Populations
Use these checklists if you plan to enroll if you plan to enroll any Special Populations:
- HRP-412 - CHECKLIST - Research Involving Pregnant Women
- HRP-413 - CHECKLIST - Research Involving Non-Viable Neonates
- HRP-414 - CHECKLIST - Research Involving Neonates of Uncertain Viability
- HRP-415 - CHECKLIST - Research Involving Prisoners
- HRP-416 - CHECKLIST - Research Involving Children
- HRP-417 - CHECKLIST - Research Involving Cognitively Impaired Adults
Informed Consent
Use these checklists when creating ICFs to make sure all of the necessary information is included:
- Elements of Informed Consent Checklist (HRP-351) (Main Study ICF)
Use these checklists for consent waivers:
- HRP-410 - CHECKLIST - Waiver or Alteration of Consent Process
- HRP-411 - CHECKLIST - Waiver of Written Documentation of the Consent Process
- HRP-441 - CHECKLIST - HIPAA Waiver of Authorization
Self-Audit Tools
Use these checklists to conduct routine quality assurance inspections of your study files: