HRPP / Protocol Checklist
Expedited Research / CHK-21
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Protocol reviewed: / Review completed by:
Protocol #:
PD: / Name:
Date: / IRB#:
Yes / No / N/A / Protocol Checklist
☐ / The research presents no more than minimal risk to participants.
☐ / The identification of subjects or their responses will not reasonably place them at risk of criminal or civil liability or be damaging to their financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal
☐ / The research is not classified
☐ / ☐ / Correct expedited review category/categories selected in eProtocol
☐ / ☐ / Personnel Info: Protocol Director appropriate for the study (see AID-25)
☐ / ☐ / Protocol has undergone Scientific and Scholarly Validity by Dept. Chair, Faculty Sponsor, or other source
☐ / ☐ / Personnel Info: All required personnel have completed CITI training
☐ / ☐ / ☐ / Participant Population: If targeting participants with Impaired Decision Making Capacity, the Decisionally Challenged comment code has been sent
☐ / ☐ / ☐ / Participant Population: If vulnerable populations targeted, consistent with eProtocol sections 8 and/or 9f
☐ / ☐ / ☐ / Study Location: Stanford University selected unless VA-only study
☐ / ☐ / ☐ /
Study Location: For International Research, eProtocol section 9b completed and International Research Supplemental Questions have been attached to section 16
☐ / ☐ / ☐ /Study Location: If study takes place at VAPAHCS, Kristin Frazier has been added as a Reviewer and VA Research Required Questions have been completed/ attached to section 16
☐ / ☐ / ☐ / General Checklist: If Stanford is the coordinating institution/lead site, IRB approval letters from other sites have been received or appropriate approval note will be added☐ / ☐ / ☐ / General Checklist and eProtocol section 8k are consistent regarding payment.
☐ / ☐ / ☐ / General Checklist and Funding section are consistent regarding funding.
☐ / ☐ / ☐ / If the study meets the definition of a clinical trial, send out “GCP” comment code asking investigators to confirm they have completed GCP training.
☐ / ☐ / ☐ / Funding: If federally funded and Stanford is prime awardee of grant, a copy of the federal grant has been attached to section 16
☐ / ☐ / ☐ / eProtocol section 2c: If deception will be used, rationale for use of deception has been provided and debriefing attached to section 16.
☐ / ☐ / ☐ / eProtocol section 5: Study includes the use of an In-Vitro Diagnostic Device (IVD) and either consent is being obtained and attached in section 13 or the study meets the criteria for enforcement discretion to waive consent and a note to file has been attached in section 13
☐ / ☐ / ☐ / eProtocol section 5: Study includes the use of an IDE Exempt Device which is being studied
☐ / ☐ / ☐ / eProtocol section 5 and 6: Verify that intake has emailed a pdf (print view) of protocol to Director of OTL . If not, IRB manager has done this.
☐ / ☐ / ☐ / eProtocol section 7: For Lucas Center MRI studies, the appropriate language has been included.
☐ / ☐ / ☐ / eProtocol section 8a: Number of participants to be enrolled consistent with consent form and all other documents
☐ / ☐ / ☐ / eProtocol section 8g: If PHI will be reviewed for recruitment, the patient will initially be informed about the study by someone they have a treating relationship with or the patient’s physician has obtained approval from the patient to be contacted by study team
☐ / ☐ / ☐ / eProtocol section 8g: If calling participants for recruitment, confirm there will be no cold-calling
☐ / ☐ / ☐ / eProtocol section 9c: Methods to ensure proper protections are in place maintain confidentiality (e.g. encryption, password protected, etc.) are consistent with section 11.
☐ / ☐ / ☐ / eProtocol section 9e: The appropriate child risk determination has been made (OHRP vs. FDA) and justification provided.
☐ / ☐ / ☐ / eProtocol section 9e: For research including pregnant women or fetus, the required conditions have been met.
☐ / ☐ / eProtocol section 11b: includes both PHI and identifiers and is consistent with eProtocol section 15 and the HIPAA Authorization section in the consent form.
☐ / ☐ / eProtocol section 12: OPACS completed for all listed Investigators
☐ / ☐ / ☐ / eProtocol section 12: If COI indicated, action report has been received and attached to section 16 and appropriate language added to consent form.
☐ / ☐ / ☐ / eProtocol section 13: For FDA regulated studies (IVD, NSR, IDE Exempt) a waiver of consent has NOT been requested
☐ / ☐ / ☐ / eProtocol section 13 and 15: Short form consent process and alteration of HIPAA Authorization requested
☐ / ☐ / ☐ / eProtocol section 13 and 15: Waiver of documentation for phone screening and waiver of HIPAA Authorization for recruitment requested .
☐ / ☐ / ☐ / eProtocol section 14: If the study includes children, section correctly completed.
☐ / ☐ / ☐ / eProtocol section 14: For children who become adults during active participation, details regarding the plan to re-consent the child as an adult has been provided
☐ / ☐ / ☐ / eProtocol section 15: If PHI will be obtained prior to obtaining consent, waiver of HIPAA Authorization for recruitment has been requested.
☐ / ☐ / ☐ / eProtocol section 16: Questionnaires attached to section 16
☐ / ☐ / ☐ / eProtocol section 16: Advertisements, flyers, etc. have been attached to section 16
☐ / ☐ / ☐ / eProtocol section 16: All additional checklists (i.e. VA, DoD, ED, DOE, DOJ, EPA, etc.) have been completed
CHK03021 rev12 06/2017 Research Compliance Office