Meeting and submission procedures
IRB Meetings are Southern California Brainspotting Institute will be communicated in advance and have materials attached to review before the meeting. They are generally conducted via teleconference software Zoom. Please be competent in the operation of Zoom before logging in for the first meeting, including being aware how to mute, unmute, turn video on and off and access chat functions. Also, assure your internet connection and computer is capable of handling a Zoom call and has video and auditory equipment that will allow you to participate. Please visit Zoom.us/test to test your computer if needed. Please note, logging off during the meeting at any time or leaving your computer for any reason will count the same as you not being present for that portion of the meeting and will affect votes.
Research proposals are submitted through the IRB website at https://www.socalbrainspotting.org/submission/ and include an RP Form 1 – Proposal Factsheet that covers the overview and major concerns of the research proposal. You will be delivered a copy of this along with the GR 1 Proposal Coversheet document that will detail the forms used to evaluate the research.
The Institute uses a series of forms to evaluate the compliance of research studies to federal regulation. These checklists will be completed and attached to the meeting agenda for every proposal to be sent out. These checklists are not to be a substitute for good judgment or the oversight of the IRB and research may still be denied even if they meet all the necessary criterion. The official copies are fond attached to the IRB website at https://www.socalbrainspotting.org/resources-and-trainings/ and are as follows:
GR1 Proposal Review Cover Sheet – Covers the basics of the proposals.
GR2 Human Research Determination – Determines if research involves humans (all research except Archival Research should require this).
GR3 Review Determination – A cursory examination of the appropriate review determination.
GR4 Scientific Validity – determines if a proposal abides by scientific principal
AC1.0 Additional Concerns – for any research that may involve special considerations such as vulnerable populations or altered consent.
AC1.1 Short Form Consent – to be completed and submitted with AC1.0 for studies that involve a shortened informed consent process.
AC1.2 Waived Consent – to be completed and submitted with AC1.0, for projects that waive part or all of the consent process.
AC1.3 Children – to be completed and submitted with AC1.0, for projects that enroll children
AC1.4 Pregnant Women – to be completed and submitted with AC1.0, for projects that enroll pregnant women
AC1.5 Cognitive Impaired Adults – to be completed and submitted with AC1.0, for projects that enroll cognitive impaired adults
AC1.6 Prisoners – to be completed and submitted with AC1.0, for studies that enroll prisoners.
SU1 Informed Consent Review – to assure the informed consent documents comply with all necessary regulations and considerations
SU2 Advertisement – assures advertisements used in the study are compliant
SU3 Federal Departments – describes compliance measures for differing federal departments and agencies that may be funding or otherwise involved with research
SU4 International Research – addresses concerns related to research crossing national borders.
FN1 Funding and Contracts – required for all research that involves funding, grants, payment, reimbursements or otherwise handles funds.
FN2 Payment Worksheet – required for any studies that involve payment of any kind, to staff, participants, host sites or other individuals or organizations, and reimbursements, payments, salaries, stipends or other forms of compensation.