Skip to main content

Assurances: What are they; why and when do I need them?

Compliance Key INC - Medical Device Training


                                        Sarah Fowler-Dixon
Sarah Fowler-Dixon, PhD has been working with the Washington University since May 2001. During that time, Dr. Fowler-Dixon has been a member of one or more of the IRB reviewing committees, written and/or revised numerous guidelines and submittal forms, and served on a data safety monitoring board, given hundreds of presentations on the ethics and regulations of human subjects locally and nationally.
 Webinar Id: LSHCAS001
 10:00am PT | 01:00pm ET
 12/08/2017
 Duration 60min mins 
Overview
The Federalwide Assurance is required for NIH funded studies. It is a written assurance filed with the Office for Human Research Protections (OHRP) that outlines under which terms a study will be reviewed, approved, and conducted. This document, signed by the Institutional Official, sets forth certain requirements that must be upheld by an institution who has filed such an agreement. One of the terms deals with written agreements for non-affiliated investigators and institutions. When a researcher "engages" a site or individual not currently governed by his/her home institution, the researcher has the option of asking the non-affiliated site or individual to obtain a separate IRB approval or to request that his home institutional review board become the IRB of Record. Once this request is made, the potential IRB of Record must gather certain information and require certain written agreements in order to become the IRB of Record. More often than not, when researchers establish partnerships, little thought is given to regulatory ramifications of that partnership and thus finding themselves frustrated at the thought of having to provide additional information, gather additional signatures, and explain this regulatory requirement to their partners. Attending this webinar will provide you with information that can be passed along to partners to better explain the process.
Why should you attend this webinar?
Most investigators do not think about additional regulatory criteria when designing a study. The current trend is conduct research in private physician offices and other community venues. Although this makes research more accessible to potential participants, it also invokes another set of regulations and requirements. The one that many investigators and their potential research partners struggle with are the written agreements required by the institutional review board (IRB), namely the individual investigator agreement (IIA), IRB authorization agreement (IAA) and the Federalwide Assurance (FWA). The terms of these agreements can appear to be legalistic and intimidate both researchers and potential community partners. What are these? When are the necessary? Why are they necessary? Are all questions that will be answered during this webinar.
Areas Covered in the Session:
  • Federalwide Assurance
  • Individual Investigator Agreement
  • IRB Authorization Agreement
  • When these agreements are used.
  • Why these agreements are used.
  • The process for establishing these agreements
  • Are there other types of agreements that institutions may enter into and how those would meet the regulatory framework.
Who can Benefit:
  • Principal Investigators /Sub-investigators.
  • Clinical Research Scientists (PKs, Biostatisticians,)
  • Safety Nurses
  • Clinical Research Associates (CRAs) and Coordinators (CRCs)
  • Recruiting staff
  • QA / QC auditors and staff
  • Clinical Research Data managers
  • Human Research Protection professionals
Labels:
Location: United States

Comments

Post a Comment

Popular posts from this blog

HIPAA Compliance with the New Omnibus Rule: How to Pass an Audit to Avoid Penalties and Criminal Convictions

Compliance Key INC  -  H ipaa webinar                                           Jonathan P. Tomes Jonathan P. Tomes , J.D., is Keynote Speaker at Compliance key Inc. He is a health care attorney practicing in the greater Kansas City.   Webinar Id:   HIPHJPT001  2:30 PM PT | 03:30 PM ET    01/18/2018  Duration: 60 mins  Overview Before the HITECH Act, DHHS could audit covered entities for HIPAA compliance, but did not have to. With that Act, now the must audit those entities and business associates as well. In the first audits, the Phase I audits, DHHS came on site. The subsequent Phase II audits, however, were paper audits in which those audited had to provide documentation of their compliance. As yet, we do not know what form Phase III will take, but the necessary actions to prepar...
Post a Comment
Read more

HIPAA Compliant Fundraising Under New Rules - 2019

Compliance Key  -  H ipaa   Compliance Training HIPAA Compliant Fundraising Under New Rules - 2019 Joel Simon Joel Simon is one of the nation's leading experts on the fund raising aspects of HIPAA. Joel has been a member of the Maryland bar for 30 years, and his professional experience includes work as the assistant general counsel of a community hospital. Joel is an editor of "Fundraising Under HIPAA" published by the Association of Fundraising Professionals. He has lectured on Fund Raising under HIPAA to national audiences since the original HIPAA regulations were first proposed 17 years ago. Read More Overview Not-for-Profit organizations that are governed by HIPAA often need or want to fund raise from their patients, clients, or families. What protocols should be in place to maximize philanthropic opportunities under HIPAA? What compliance measures need to be in place and assessed to properly use protected health information for fund raisi...
Post a Comment
Read more

New 2019 HIPAA Guidance on De-Identifying Protected Health Information

Compliance Key  -   HIPAA Compliance Training Overview This seminar will be addressing how practice/business managers or compliance officers need to get their HIPAA house in order, as HIPAA is now fully enforced and the government is not using kid gloves anymore. It will also address major 2019 changes taking place with the Health and Human Services regarding the enforcement of the HIPAA law as well as detailed discussions on the Phase 2 audit process and current events regarding HIPAA cases (both in courtrooms and from real-life Audits). Our instructor - Mr. Brian Tuttle  has over 20 years of experience in working as Compliance auditor and has been an expert witness on multiple HIPAA cases. He`ll thoroughly explain on HOW and in WHAT scenarios patients can claim for cash remedies. More importantly, Brian will show you how to limit those risks by simply taking proactive steps and utilizing best practices. Why should you attend this seminar? This Sem...
Post a Comment
Read more