What is an individual investigator agreement?
This is a formal written agreement between an institution conducting research and an independent investigator who is collaborating on the research, by which the institution agrees to extend its Federalwide Assurance (FWA) about human subjects research to the individual, and by which the independent investigator agrees …
What is a reliance agreement?
Definitions. Reliance Agreement: A formal, written document that provides a mechanism for an institution engaged in research to delegate institutional review board (IRB) review to an independent IRB or an IRB of another institution.
What is an IRB agreement?
An IRB Authorization Agreement (IAA) is a special agreement between two institutions who are engaged in human subjects research to establish the Single IRB reviewing. These agreements help to minimize regulatory burden on the IRB review and approval process by limiting the IRB review to one institution.
What is FWA registration?
A Federal Wide Assurance (FWA) is the documentation of an institution’s commitment to comply with Federal regulations and maintain policies and procedures for the protection of human participants.
What is the smart IRB?
SMART IRB is a platform designed to ease common challenges associated with initiating multisite research and to provide a roadmap for institutions to implement the NIH Single IRB Review policy (effective date: January 25, 2018).
What are master IRB agreements?
The Master Agreement is a standing document between the Harvard IRBs that acts like a permanent reliance agreement: it outlines the conditions for reliance, the responsibilities for each researcher, as well as the general terms and conditions of the reliance.
What is a reliance IRB?
A Reliance Agreement (also called an IRB Authorization Agreement (IAA), Cooperative Agreement, or Memorandum of Understanding (MoU)) is a document signed by two or more institutions engaged in human subject’s research that permit one or more institutions to cede review to or rely on another IRB.
How does smart IRB work?
SMART IRB is not an IRB; rather, it’s a platform that offers a master IRB reliance agreement (the SMART IRB Agreement) and a web-based system (SMART IRB’s Online Reliance System) that provides a central process for participating institutions and their investigators to request, track, and document study-specific …
What is IREx IRB?
The IRB Reliance Exchange portal (“IREx”) is an online portal that facilitates the Single Institutional Review Board (“sIRB”) review process of multi-site human subject research studies (each, a “Study”).
What is Aahrpp accreditation?
AAHRPP accreditation indicates that your organization follows rigorous standards for ethics, quality, and protections for human research. When you earn the AAHRPP seal, you earn a place among the world’s most respected, trustworthy research organizations.