OHRP Research Community Forum and IRB Conference - Seattle July 31st
The changing face of research exerts new pressures on Institutional Review Boards (IRBs) daily. This summer, NWABR co-sponsors the OHRP Research Community Forum in Seattle with the Office for Human Research Protections. We bring together respected leaders from our professional communities to provide insight and information about the most pertinent issues impacting regulatory compliance across our region. Our Planning Committee has suggested a comprehensive, relevant and impactful program for attendees. Our team of experts in their respective fields, have suggested not only IRB Basics but a lecture track for researchers and regulatory professionals.
Participants network with peers, and together we plan creative solutions.
Join us in July at Bell Harbor Conference Center. This event counts towards the accredited hours section of the CIP CE credits and supports NWABR's mission of promoting the public's trust in biomedical research and its ethical conduct.
WHO SHOULD ATTEND THE OHRP RESEARCH COMMUNITY FORUM?
- IRB chairs, members, administrators and staff
- Regulatory affairs and compliance oversight personnel
- Institutional officials
- Scientists and ethicists
PLEASE PREVIEW THE JULY 31 AGENDA BELOW, AND THEN CLICK HERE TO REGISTER.
Thanks to Local In Kind Sponsors:
TO ASSIST OUR PLANNING, EACH REGISTRANT IS ASKED TO CHOOSE (3) BREAKOUT SESSIONS FROM THE BELOW LIST THAT THEY WILL MOST LIKELY BE ATTENDING. THERE WILL BE FLEXIBILITY ON THE DAY OF THE CONFERENCE.
7:30 Registration Begins.
Continental Breakfast Service
8:30 Welcome and Announcements
8:45 Introduction - Deb Bowen Ph.D.
University of Washington Department of Bioethics and Humanities.
Engaging Stakeholders in the Research Process: Pandora Felt Overwhelmed Too
9:45 AM. Pastries and Peers - An Informal Networking Session
(Choose one track at each time during registration process.)
Morning Breakout 1: BASIC. The Nuts and Bolts of the HHS Regulation - A Basic Session.
This basic session presented by Kristina Borror, Ph.D. (Director, Division of Compliance Oversight OHRP) shares the fundamentals of human subject protections afforded under the HHS regulation at 45 CFR part 46 including a brief history of the regulations. There will be a focus on basic information regarding institutional responsibilities, IRB composition, review and informed consent. This breakout is a review for veterans and an essential roadmap for those newer than 4 years to IRBs.
Morning Breakout 1: RESEARCH. Thorny Issues in the New Age of Biotechnology: Biorepositories and Human Embryonic Stem Cell Research. 1 credit hour
Shannon Sewards, MA, CIP (Associate Director of Human Subjects Division, UW)
Biorepositories, sometimes called biobanks - have become a critical resource for research, and give researchers access to data and specimens representing larger numbers of people than could be analyzed previously. With the growing trend in biorepositories, it is important that they operate with carefully-considered governing principles and policies. This discussion will explore the many issues that IRBs face in the review of biorepositories including the myriad of applicable regulations, best practices, and thorny ethical issues.
Kara Manning Drolet, Ph.D. (Associate Director and OHSU Research Integrity Office)
In the second part of this session, Kara will share a dynamic committee model developed for review of human embryonic stem (hES) cell research at OHSU, and discuss how the new review model could also be applied to other non-h-ES thorny issues such as mitochondrial gene transfer.
Morning Breakout 1: REGULATORY. Finding Flexibility in the HHS Regulations aka "Fear Not the Feds" (OHRP and Local Institutions) 1 credit hour
Laura Odwazny, J.D. (Senior Attorney, OHRP) joins Susan Rose Ph.D (Executive Director of the Office for the Protection of Research Subjects, USC and flex coalition advocate) for a lively session full of practical advice to IRBs. Attendees learn about the many ways in which an institution can avail itself of flexibilities in the application and interpretation of regulations in a manner that both supports the appropriate protection of human research subject and is fully compliant.
LUNCH IS PROVIDED
Breakout 2: BASIC. Issues of Informed Consent.
Mitchell E. Parrish, JD, RAC, CIP (Quorum Review IRB) shares insight regarding what information needs to be included in a consent form, and how that language should be implemented to best fulfill the ethical concerns underlying the Common Rule.
Breakout 2: RESEARCH. Technology, Internet Research and Social Media (OHRP). 1 credit hour
Laura Odwazny, J.D. (Senior Attorney, OHRP) provides attendees with guidance on how to apply HHS regulatory requirements and OHRP guidance to internet research, while addressing challenges for the IRB in reviewing internet research, including assessing when information is public versus private, subject recruitment and retention through use of social media, and protecting confidentiality and informed consent.
Breakout 2: REGULATORY. Centralized IRB Models. 1 credit hour
James Riddle MCSE, CNE, CIP (Fred Hutchinson Cancer Research Center) shares insight and challenges of coordinating multiple centralized IRB models. Different centralized models will be discussed and all participants are invited to share ideas and local practices on how to manage this increasingly complex environment.
Afternoon Breakout 3: BASIC. Protocol Review. The How-To Travel Guide.
Local experts David Forster JD, MA, CIP (Chief Compliance Officer, WIRB) and Royce Morrison MD, MSEE, CPI (Consultant) share years of combined insight and practical advice with newer IRB members.
Afternoon Breakout 3: RESEARCH. Be Compelling - Clearly Describe Potential Risks and Benefits of Your Project. 1 credit hour
The IRB is often required to assess whether an investigator-initiated study requires oversight by the FDA, either in the form of an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE). Assisting the IRB with that assessment is an important responsibility of the investigator-sponsor. Lynn M. Rose Ph.D (Benaroya Research Institute) shares standards for a waiver of the IND or IDE as well as information on requesting a waiver if required by the IRB.
Jennifer Wrobelwski (Northwest Association for Biomedical Research Speakers Bureau) shares hints researchers use to effectively articulate projects to the general public .
Afternoon Breakout 3: REGULATORY. Risky Business: Assessing Minimal Risk (OHRP).
1 credit hour
Federal representatives share how to think about assessing risk, unpacking risk, fixed and relative standards, study and design and risk, minimal risk, expedited review and Informed Consent SubParts B, C and D. This session is presented by Kristina Borror, Ph.D.
4:00PM General Session "ASK THE FEDS" question and answer panel.
Questions? Want to see a particular topic or speaker? Please email P. Janine Kennedy at firstname.lastname@example.org. We'd love to know your thoughts as we build out this day especially for you.
Non-NWABR members $425
NWABR members $325 after July 3. ($305 until July 3)
NWABR member (10+) group rate $285* and planning committee rate.
Graduate Students potentially come at cost.*
*Contact email@example.com for your registration discount code
ACCOMMODATIONS <FIRST BLOCK SOLD OUT>: A limited number of rooms are reserved at a group rate until June 30, 2014 at the Silver Cloud Hotel - Stadium (1046 1st Ave. S, Seattle, WA 98134; reservations - 206 204 2072 or 800-497-1261 - ask for Marita, sales) and include a free shuttle service to the conference center. As Seattle books up in the summer this weekend, we urge to to act quickly if you are from out of town for the best pricing. If you are having trouble booking space after June 30th, let us help, we have alternative suggestions.
To reserve online use http://www.silvercloud.com/seattlestadium (Group: NWABR, Discount Code: email firstname.lastname@example.org). < ONLINE BLOCK SOLD OUT 6/30, please email NWABR Conference Lead Janine Kennedy for assistance - email@example.com >
The Marriott Waterfront is across the street from Bell Harbor International Conference Center. For a reservation call (800) 992 2694. There are no reserved rates for the conference.
Bringing the family for the Blue Angels and Seafair weekend? Great! Here's some additional info. http://www.seafair.com/anevent.aspx?id=13&secid=917.
IF YOU ARE A SPEAKER: ALL SPEAKERS AND SPONSORS MUST REGISTER below using discount code: NWABRGUEST to receive a packet, confirmation and nametag. CLICK HERE TO REGISTER.
There will be an informal speaker gathering with light snacks 6:00PM July 30, 2014 to discuss the following day's agenda. Attendance is requested. Attire is casual. Join board and planning committee members at a small uniquely Seattle space - Gastropod in the SODO. Located at 3201 1st Ave South in a turn-of the century industrial space over Epic Ales, Chef Travis Kukull and local master brewer Cody Morris pick the evening's growlers and vittles. Get your nametags, agendas, meet other speakers and discuss with the flow of the following day's events.
*note that this area near the stadium traffic nearby will be very busy due to a large concert, and you should leave early to arrive on time. For folks staying in the Silver Cloud Hotel, this venue is a brisk 20 minute walk south from the hotel, or 3-minute drive so call us (Janine) ahead if you might need a carpool or pickup. Click HERE for directions.
Any special needs or questions? Contact P. Janine Kennedy, Conference Lead with NWABR.
Mobile: (206) 409 1202. She will be pleased to assist and direct you.
IF YOU ARE A SPONSOR:
Thanks to our sponsors for their contributions to this terrific event!
Displays shipped to Bell Harbor Conference Center should arrive no later than Monday July 28 2014 prior to 4pm PST. They will hold your items for you prior to setup. (see shipping info below)*
1) ALL SPONSORS MUST REGISTER REPRESENTATIVES using the main registration link. You may also pay during registration for your sponsorship if you choose - we know it's easier for some folks this way. If your company requires an invoice before payment this can be issued, email or phone us. We will be glad to help with that!
(2) SPONSORS please submit your day-of DISPLAY TABLE INFORMATION to the Conference Lead at: firstname.lastname@example.org.
(1) Company name (as preferred to display)
(2) Company contact (especially if different from attendee)
(3) Company address (base city, state, zip, email)
(4) Web page
(5) Day-of Representative's name, and title
(6) Day-of Representative's main phone, email
(3) Vendor displays the day of the conference are in the hallway between all conference sessions boardrooms. DAY OF Setup for ALL Sponsors is 6:45am July 31st, with breakdown by 5:30pm. Some conference attendees will be arriving for registration by 7:05am, with the bulk between 7:15-9am. You will find your company label marking your 6-foot skirted designated table when you arrive.
*SPONSOR SHIPPING: Shipping Packages must be labeled (1 of 2, 2 of 2 etc.) and include this information:
Bell Harbor International Conference Center
2211 Alaskan Way, Pier 66
Seattle WA, 98121
Phone: (206) 441 - 6666.
Attention: Dilisha Patel (email@example.com)
Event: NWABR/OHRP IRB Conference
Event Date: July 31, 2014
Hold for: Your Name, Company Name
Please keep our Bell Harbor planning manager Dilisha notified of package numbers to expect. Special arrangements can be made for palletized and other over-sized shipments call 206.269.4107 or 206.441.6666.
MEMBERSHIP RATES: NWABR membership is open to individuals or organizations affiliated with other SUBR associations. For information about becoming an NWABR member, please contact Troy Chapman at 206-957-3337 OR firstname.lastname@example.org or Ken Gordon at email@example.com.