Setting Up an IRB or Ethics Committee
If you are considering building an in-house IRB or EC from the ground-up, it is critical to have a knowledgeable advisor guide you through the process to ensure that research review operations are structurally and administratively sound, and that the IRB or EC is appropriately qualified through its knowledge and experience to ensure that subjects are adequately protected. A failure to address either the administrative or substantive aspects of IRB or EC review leaves both human subjects and organizations vulnerable to increased risk.
HRP has extensive experience in helping organizations start-up an IRB or EC; including compliant IRB composition, Federal registration, and the development of policies, procedures and forms, as well as training and education of the newly created IRB.
Working with External IRBs
Funding agencies and sponsors are increasingly insisting that organizations agree to reliance on a single IRB for multi-center studies. However, even when relying on an external IRB, organizations still hold overall responsibility for the oversight and conduct of the research. HRP can partner with you to develop reliance agreements that meet the needs of all parties and to develop internal processes to ensure that all organizational responsibilities are fulfilled while streamlining the process.
Collaborative IRB Development
Many organizations are turning to HRP Consulting Group to seek guidance on how to form collaborative IRBs with their regional partners. They know that collaborative IRBs offer a way to combine scarce IRB resources, decrease wasteful spending in the IRB Office, and contribute to a more efficient IRB review without having to outsource institutional review to a central IRB. With the evolving nature of IRB review, it is best to be ahead of the curve.
Customized Policies, Procedures, Forms and Checklists
HRP will work with your organization to either evaluate and enhance your current documents, or develop new SOP’s, forms and checklists customized to your organization utilizing HRP’s template as a base to ensure compliance with federal regulations and guidance.
Training and Education
IRB Process Evaluation and Enhancement
HRP can assist organizations in assessing and/or improving the administrative process associated with managing an efficient and effective IRB operation. Effective streamlined processes facilitate the development of collegial relationships between the IRB and the research community, which in turn enhances the protection of human subjects. HRP’s experienced professionals can take you through the life of a protocol from submission to approval.
In addition, HRP can provide assistance in selecting and implementing a number of commercially available electronic IRB systems.
IRB Compliance Evaluations
Organizations frequently seek HRP’s assistance to evaluate the performance of their IRB against regulatory standards and best practice. By observing IRB meetings and reviewing key documents such as minutes, HRP professionals help an institution become inspection ready.
For more information about how we can help, please contact us at (347) 862-9321 or by email at firstname.lastname@example.org.