Upcoming Webinars

Research Nurses Compliance Webinar Series:  What To Expect When We Sequence Expecting Moms

My Compass Code: 1963-0365

Overview 

Noninvasive prenatal testing can be used to perform prenatal whole genome sequencing (PWGS) by collecting fetal DNA from a simple maternal blood draw.  Although prenatal genome sequencing isn’t yet part of routine clinical care during pregnancy, many believe it will be shortly, as the price of sequencing continues to plummet and commercial entities in the health and ancestry space push the public to obtain more personal genetic information. This panel will also explore what types of genetic information should be returned to prospective parents who undergo clinical trials of PWGS and how directive healthcare providers should be when communicating the information.

Date: Friday, February 21, 2020

Building: Cancer Institute        Floor: 10th          Room: Walton Auditorium

Time: 7:30 a.m. – 8:45 a.m.

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Research Nurses Compliance Webinar Series:  Legal and Regulatory Changes: A Year in Review 

My Compass Code: 1963-0366

Overview 

A lot has happened this year! Get up to Speed with this session designed to bring you the highlights and breaking news since last year’s AER Conference. How are recent legal and regulatory changes fundamentally affecting research? What should institutions be ready for in the coming months and years? Get answers to these questions and more through this session’s issue-spotting exploration and analysis of changes in laws, regulations, and guidance issued by FDA, HHS, and NIH. During this session, speakers and attendees will

  • Identify recently proposed and adopted legislative and regulatory initiatives affecting research
  • Illustrate the likely impact on current practices and evaluate the importance of change
  • Evaluate whether further changes is necessary and/or likely forthcoming

Date: Friday, March 6, 2020

Building: Cancer Institute       Floor: 10th          Room: Betsy Blass Conference Room 10014

Time: 7:30 a.m. – 8:45 a.m.

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Research Nurses Compliance Webinar Series:  The Etiquette and Necessity of Communication in the Single IRB World 

My Compass Code: 1963-0367

Overview 

When communication does not occur or go well, frustration, potential increase in research risks, and failure to provide new information to subjects can occur.  Before attending this session, attendees should have some experience working with IRB reliance arrangements, as either a reviewing IRB or a relying institution. This session will use case studies to explore how institutions can work together proactively and collegially under the single IRB model by addressing critical components of communication.  During this session, speakers and attendees will:

  • Review what local context information a reviewing IRB should collect, both about relying institutions and study implementation, how to tailor it for the study type, and mechanisms for retaining that information to reduce burdens on the relying institution
  • Explore how to engage relying institutions so they address noncompliance and unanticipated problems
  • Determine when to reach out to relying institutions to obtain input on amendments
  • Identify what information to include in approval notices or other documents to assist the relying institution with their oversight responsibilities
  • Share writing policies that are accessible to and take into account the perspectives of relying institutions and relying site study teams

Date: Friday, March 20, 2020

Building: Cancer Institute       Floor: 10th          Room: Strauss McCaskill CTR

Time: 7:30 a.m. – 8:45 a.m.

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Research Nurses Compliance Webinar Series: Standard of Care, Medical Innovation, or Research: How Should We Decide? 

My Compass Code: 1963-0368

Overview 

A frequent regulatory issue is whether a practice conducted by a physician or an institution, when consistently practiced in that institution, but novel and not yet adopted by the community, counts as medical innovation or research.  For example: when a physician or group of physicians want to collect data on their consistently provided, but unique/novel practice, is this standard of care, medical innovation, or research? If it is research, how should it be reviewed? This issue is important as it comes up frequently in IRB review, although it may be addressed differently by IRBs. This session will present the issue, discuss potential ways of addressing it, and attempt to problem solve the best treatment of these common situations, This session will make heavy use of active  learning techniques, such as small group work, case studies, hands-on activities, and interactive discussion, and presumes sufficient experience and understanding to actively contribute to the discussion of and solution to these problems.   This session will not review basic concepts.   During this session, speakers and attendees will:

  • Recognize how standard of care, medical innovation, and research are highly intertwined in medical contexts
  • Analyze a case (s) where an IRB is faced with the decision of how to regulate a particular study, and the strengths and weaknesses of different approaches
  • Suggest best practices when faced with this type of situation

Date: Friday, April 3, 2020

Building: Cancer Institute       Floor: 10th          Room: Strauss McCaskill CTR

Time: 7:30 a.m. – 8:45 a.m.

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Research Nurses Compliance Webinar Series: Investigational Device Exemptions (IDE), Mobile Medical Applications, and IRB Review 

My Compass Code: 1963-0369

Overview 

In general, the IDE regulations apply to clinical investigations of medical devices designed to determine safety and effectiveness.  When do you need an IDE for a clinical investigation of a medical device? What about mobile applications? When does a mobile application meet the definition of a medical device under the Food, Drug, and Cosmetic Act, and how does FDA intend to apply its regulatory authorities to mobile medical applications? IRBs may struggle with these questions and what their review responsibilities are when a protocol involves mobile medical application.  During this session, speakers and attendees will:

  • Share a basic overview of the applicability of the IDE regulations that address when IDE is required
  • Distinguish when mobile applications meet the definition of a medical device
  • Discuss FDA’s current approach to applying its regulatory authorities to oversight of mobile medical applications
  • Provide IRBs with a review framework for studies involving mobile medical applications and suggest policies and procedures to develop to ensure HRPPs remain relevant in a tech savvy world

Date: Friday, April 17, 2020

Building: Cancer Institute       Floor: 10th          Room: Betsy Blass Conference Room 10014

Time: 7:30 a.m. – 8:45 a.m.

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Research Nurses Compliance Webinar Series: Implementation of a System to Promote Compliance with 45CFR 46.116(h): Posting Consent Forms

My Compass Code: 1963-0370

Overview 

This session will explore the use of a monitoring system designed to comply with 45 CFR 46.116(h) of the revised Common Rule, which requires an unsigned copy of one IRB-approved consent form (ICF) that has been used in enrolling participants in a clinical trial conducted or supported by a Common rule department/agency be posted on a publicly available federal website.  This posting must occur after recruitment closes, and no later than 60 after the last study visit.  Although this specific timeframe poses challenges, it’s possible to leverage a number of extant policies and resources to develop and implement an ICF Posting System to promote compliance with this requirement. During this session, speakers and attendees will:

  • Review the requirements of 45 CFR 46.116(h)
  • Discuss how existing institutional HRPP policies can provide a framework for implementation  of a system designed to comply with 45 CFR 46.116(h) of the revised Common Rule
  • Describe a plan for ongoing monitoring of compliance

Date: Friday, May 1, 2020

Building: Cancer Institute       Floor: 10th          Room: Strauss McCaskill CTR

Time: 7:30 a.m. – 8:45 a.m.

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Research Nurses Compliance Webinar Series: Identifying and Avoiding the Conduct of Low Value Clinical Trials

My Compass Code: 1963-0371

Overview 

Clinical trials are conducted and subjects are recruited in the name of advancing science.   However, a growing body of research suggests that many initiated trials have little or no chance of providing valuable information. More broadly, human experimentation that has little to no prospect of generating valuable knowledge violates basic ethical principles and can cause considerable harm.  First, participants may be burdened by the demands of study enrolment, while mistakenly believing that they are from other endeavors, including more valuable trials.   Third, valueless trials degrade the evidence used in research, care and policy.   Academic medical centers and IRBs frequently serve as the main gatekeeper to the initiation of new studies, and thus must do what they can to ensure that the promise of scientific advancement is reasonably likely to be achieved. This panel will address the role academic institutions and IRBs can play in identifying and reducing the initiation and continuation of low value trials by (a) understanding key principles underlying potential value of a trial; (b) ensuring a landscape analysis has been conducted to enable consideration of the scientific context in which the research will occur; and (c) ensuring the trial will be registered and reported in accordance with current legal and other policies.

Date: Friday, May 15, 2020

Building: Cancer Institute       Floor: 10th          Room: Betsy Blass Conference Room

Time: 7:30 a.m. – 8:45 a.m.

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