2019 RESEARCH COMMUNITY FORUM AND IRB CONFERENCE - July 24 and 25, 2019

 

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Research Community Forum Conference Partners

 

THE NEW RESEARCH LANDSCAPES

Join NWABR and its conference partners, Quorum Review IRB, the WIRB-Copernicus Group and Advarra as we host in conjunction with the Office for Human Research Protections (OHRP) a two-day Research Community Forum which will include NWABR's one day IRB Conference.  The dates for the Research Communty Forum are July 24 and 25, 2019.  This progam will be hosted in the Lynnwood Convention Center Lynnwood, WA.

This program will have two key parts.  Day one of the Research Community Forum will be led by OHRP and will provide an opportunity for small group and workshop discussions that will help attendees as they operationalize their IRB programs under the new Common Rule. The program for Day one of the Research Community Forum is set out below:

July 24, 2019 8:30am – 4:15pm  

Time

Presentation

Speaker

Description

CE Hours

7.30am

Registration Opens

 

Light Breakfast and Refreshments Available

 

8.30am

Welcome and Opening Remarks

 

 

 

8.45am to 10.00am

Applying the Regulations

 

Misti Ault Anderson, MS, MA.  Senior Advisor for Public Health Education in the Division of Education and Development of the HHS Office for Human Research Protections (OHRP).

OHRP staff will engage the audience in considering how the HHS regulations are applied, particularly with regard to changes in the exemption categories.

1 ¼ hours

10.00am

Break

 

Refreshments Available

 

10.15am to 11.15am

Secondary Research with Data and Bio-specimens

 

Yvonne Lau, MBBS, MBHL, PhD.  Director of the Division of Education and Development at OHRP.

OHRP staff will focus on options for conducting secondary research activities under the revised Common Rule, including relevant changes to exemptions.

1 hour

11.15am

Break

 

Refreshments Available

 

11.30am to 12.30pm

What’s New in Informed Consent

 

Misti Ault Anderson, MS, MA.

OHRP staff will discuss the improvements to and flexibilities in informed consent.

1 hour

12.30pm to 1.30pm

Networking Lunch

 

Lunch and refreshments provided

 

1.30pm to 3.00pm

Incorpo-rating Plain Language into Informed Consent Documents

 

Jessica Ridpath.  Communications Manager at Kaiser Permanente Washington Health Research Institute.

This session will engage the audience in discussion about and training in plain-language writing related to the technical information in informed consent documents

1 ½ hours

3.00pm

Break

 

Refreshments Available

 

3.15pm to 4.00pm

Informed Consent: Putting it into Practice

 

Yvonne Lau, MBBS, MBHL, PhD.

This interactive session will discuss the informed consent process, and focus on how to increase understandability of information to support good decision making. Discussion will include organizational tips and key information requirements.

 

¾ hours

4.00pm

Wrap-up and Q&A

 

This session will close out the RCF

¼ hours

4.15pm

RCF Workshop Closes and Happy Hour

 

 

 

 

July 25, 2019 8:00am to 5:00pm  

Time

Presentation

Speaker

Description

CE Hours

7.00am

Registration Opens

 

Light Breakfast and Refreshments Available

 

7.45m

Welcome and Opening Remarks

 

 

 

8.00am to 9.00am

Keynote Address:
Regulatory and Ethical Challenges in “Big Data” Research: U.S. and International Perspectives.

Mark Barnes, JD.  Ropes & Gray LLP

As it becomes cheaper to collect, store, and re-analyze large datasets, it has become clear that informed consent at the beginning of research cannot adequately capture the possible benefits and (potentially unknown) risks of consenting to the uses of one’s data.  This presentation will outline the ethical challenges posed by Big Data in human subjects’ research and both US and international perspectives being addressed.

1 hours

9.00am to 9.45am

Update on Common Rule

OHRP Staff

The new Common Rule was fully effective as from January 20, 2019.  In this session OHRP staff will update the progress that they are seeing in relation to the implementation of the CR and highlight areas that may still need to be further addressed.

¾ hours

9.45am

Break

 

Refreshments Available

 

10.00am to 10.30am

St. Kitts Live Herpes Vaccine trial - what went wrong

Christian Westby, PhD.  IRB Vice Chair Scientific and Expedited Review at Quorum Review IRB/Advarra

The St. Kitts Live Vaccine Trials highlighted the risks associated with an ambitious researcher and potential oversight gaps with certain “international” studies.  This presentation will examine both what went wrong with the oversight of this experiment and consider how an IRB could have brought this work back under control.

 

½ hour

10.30am to 11.30am

Ethical and practical issues in conducting research during a bioemergency

Bruce Gordon, M.D., Professor, Division of Pediatric Hematology/Oncology, University of Nebraska Medical Center

Research during natural bioemergencies (such Ebola virus disease in western and central Africa) pose unique challenges for institutional review boards. Such situations raise require careful consideration of informed consent, confidentiality, fair subject selection, risk-benefit, study design and independent review.  IRBs (and investigators) must balance the necessity to develop and test potential treatments with the need to protect the rights and welfare of subjects of the research.

1 hour

10.30am to 11.30am

 

Breakout Session

The new Common Rule

Meghan Scott, BA.  The Assistant Director of the Institutional Review Office at the Fred Hutchinson Cancer Research Center (Fred Hutch).

Tools and techniques for IRB operations under the changes to the Common Rule

 

11.30am to noon

Re-envisioning the definition of private identifiable information in the information age

Michele Russell-Einhorn, JD.   Chief Compliance Officer and Institutional Official in the Central Oncology Review Division for Advarra

Following on from the opening keynote this presentation will take a deeper dive into the issue of what constitutes identifiable information.  Steps to de-identify data can be nullified in increasingly complex datasets.  This presentation will both identify the issue of re-identification and consider emerging IRB responses to this challenge.

½ hour

11.30am to 12.30pm

 

Breakout Session

Small Research Programs

Andrea McDowell, PhD.  IRB Administrator and Business Communication Lecturer at Seattle University.

Challenges and Opportunities for Institutions with Small Research Programs

 

Noon to 1.00pm

Lunch

 

Lunch and refreshments available

 

12.30pm to 1.00pm

Ask the Feds – Lunch session

OHRP Staff

This lunchtime session will be a moderated Q & A with representatives from OHRP.  Attendees will be encouraged to write questions in advance of the session.

½ hour

1.15pm to 2.45pm

Keynote address:

What Patients (or Participants or Subjects) Can Teach Us about Research Ethics

Rebecca Dresser, JD - Washington University in St. Louis, and Keith Eaton, MD, PhD  - University of Washington.

This co-presented session will consider the impacts of research on patients from the perspective of two renowned speakers who have been involved in research and have had significant experience, also, as patients who are in clinical trials.

1 ½ hours

1.15pm to 2.45pm

 

Breakout Session

Small group discussion for IRB Leaders

David Forster, JD, MA, CIP.  Chief Compliance Officer, Office of Compliance for both Western Institutional Review Board and Copernicus Group Independent Review Board.

Facilitated discussion for IRB Leaders

 

2.45pm

Break

 

Refreshments provided

 

3.00pm to 4.00pm

The IRB's role in Research on Gun Violence

 

For many years in the United States research and training in the field of firearm injury prevention has been essentially absent.  The speaker is part of a collaboration aimed at providing data to fill this critical knowledge gap.  This presentation will both outline this vital work and also consider the IRB’s role in this realm which crosses historical, social behavioral and medical research fields.

 

1 hour

4.00pm to 5.00pm

ClinicalTrials.gov requirements

 

The session will review and discuss the FDA’s role and responsibilities with ClinicalTrials.gov

1 hour

5.00pm

Conference closes and Happy Hour

 

Refreshments provided

 

Please also note: * Food and beberages provide courtesty of NWABR, WIRB, Quorum, Advarra.  OHRP does not support these portions of the event. 

The Research Community Froum and IRB Conference will be held at the Lynnwood Convention Center, Lynnwood WA.  Lynnwood is 15 miles north of Seattle.

Attendees can register for one or both days and a discount is offered for a both day registration.  Staff members of NWABR Member organizations also receive an additional discount on registration.

Attendees can expect a comprehensive program addressing the challenges faced by human subjects' researchers and the ethics review community.  From the discussion of emerging consent models to workshops on practical protocol and consent development, this conference offers a curriculum for all levels.

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WHO SHOULD ATTEND THE 2019 Research Community Forum?

  • IRB chairs, members, administrators and staff
  • Medical doctors, registered nurses and other staff involved in clinical research
  • Regulatory affairs and compliance/oversight personnel
  • Scientists and ethicists
  • Sponsors and contract and research organization staff involved in developing, managing or administering informed consent

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THANK YOU TO OUR SPONSOR PARTNERS   

 

OHRP provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). 

 

Quorum is most preferred central IRB. Clients benefit from reduced fulfillment time, the largest offering of complimentary study support services, harmonized IRB and IBC review, API integrations, industry-leading eConsent, and research consulting services.

WIRB or WCG has provided comprehensive regulatory expertise for the use of human subjects in research for more than 40 years. They offer customized training, consulting, and reviewing to support IRB research protocols and documentation.

 

 

Advarra is the premier provider of integrated IRB, IBC and global research compliance consulting services in North America. They provide customized, dedicated services for research institutions and are fully sIRB ready. 

 

Rates

2019 Research Community Forum Rates
  July 24 Workshop Only Rate July 25 IRB Conference Rate
    Early Bird (Prior to April 1, 2019) Regular Rate Ten or More Attendee Rate Discount if registering for both days
Staff and Committee Members of NWABR Member Organizations $125 $299 $349 $294 10%
Non Members $125 $424 $474 N/A 10%


Accomodations

The designated hotel for the Research Community Forum is the Courtyard Seattle North/Lynnwood Everett.  We have rooms set aside for conference attendees with all rooms meeting the requirments for the Government rate of $138 per night.  Guests will receive free complimentary breakfast, free wi-fi, shuttle service to the Convention Center.  Rooms will be available from July 23, 2019 through July 27, 2019 and bookings must be completed by June 23, 2019.  The registration link for the hotel is:

Book your group rate for Northwest Association of Biomedical Research

 

Accreditation

CIP  - The CIP Council has approved this conference for the following CIP recertification credits.  Attendance on day one of the conference has been approved for 5 3/4 hours of CIP Credits.  Attendance on day two has been approved for 7 3/4 hours of CIP Credits.  Attendance for both days has been approved for 13 1/2 hours of CIP Credits.


ACRP - An application will be made for CE contact hours for Maintenance of ACRP’s CCRC®, CCRA®, CCTI® or CPI® certification designations.  We anticipatee that up to 14 hours of credit will be available for full participation in the two-day program.

MCLE - The WA State MCLE Board has approved attendance at the full two day RCF for 8.5 Law and Legal Credits and 6.5 Other Credits for a maximum total of 13.5 Credits (Activity ID: 1101578).  The Ask the Feds Session on July 25, 2019 is not eligible for MCLE Credit.  All sessions are approved for L&L Credit except for the following sessions which are approved for Other Credits:

  • Incorporating Plain Language into Informed Consent Documents;
  • St. Kitts Live Herpes Vaccine trial - what went wrong;
  • Clinical Research in Emergencies;
  • The New Common Rule (breakout session);
  • Re-envisioning the definition of private identifiable information in the information age;
  • Small Research Programs (breakout session);
  • Facilitated discussion for IRB Leaders (breakout session); and
  • The IRB's role in Research on Gun Violence.

 Vendors

If you are interested in sponsoring the RCF/IRB Conference or being a Vendor for the event please contact Ken Gordon at (206) 957-3337.

 

 

 

 

 

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