The Human Research Protection Program has dedicated resources to assist you with:
Human subject-related questions you may have as you prepare a proposal for submission to a sponsor
Writing a human subject protocol that meets regulatory requirements
FDA regulatory compliance
Template language for your protocol, consent forms, and grant proposals
Ensuring you are adhering to your protocol and regulatory requirements, via provision 0f voluntary ‘audits’ via the Quality Assurance / Quality Improvement program.
Offering general training about “IRB Basics” and related policies and procedures via Learning Point
Contact us to request any of the above!
This is a one hour session which focuses on providing guidance and recommendations related to IRB file organization and maintenance. Topics covered include best practices related to the maintenance of IRB approved study procedures and protocols, and consistency with Brown University policies and procedures concerning human research participants. Investigators and any research staff involved in field work, data collection and/or study record keeping may find this session particularly helpful. Best Practices sessions may be scheduled to take place at your research lab or you may choose to attend a pre-scheduled session located at South Street Landing. Please check Learning Point for dates and times and to register for a session held at South Street Landing.
Best Practices Checklist
Investigators and study staff can confirm if they are incorporating best practices into their research projects by using this checklist. This is a good way to quickly, easily and independently confirm the use of basic best practices and consistency between IRB approved research procedures and actual research activities. This checklist can also serve to remind investigators of some of the important details related to human research participant protections as well as identify issues that need attention, helping to minimize the chance of an impact on study progress.
Voluntary, Best Practices Individualized Review:
Another helpful resource for investigators is a one-on-one Best Practices review. This is an in person review of study procedures and IRB documentation related to human research participants. It offers individualized assistance and guidance from HRPP staff. The completion of this review can help with streamlining IRB submissions which may reduce the time between submission and approval.
For additional information about best practices sessions, please contact Christiana Provencal at 401-863-5729 or 401-863-3050.
Guidance on how to prepare for and what to expect from a Sponsor-Investigator FDA inspection.
Webinar slides provided by Quorum IRB on creating recruitment materials that are both compliant and compelling.