Single IRB Review: Lessons from the Real World

Reimagining your HRPP in the Single IRB Era

Long Beach, CA | June 3, 2019

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Overview

A scenario-based workshop reviewing the challenges and opportunities related to research participant protections in the era of Single IRB review. The workshop will leverage real-world experiences to highlight the important ethical considerations for any organization involved in a reliant IRB review process. The workshop will address both the relying organization and reviewing IRB perspectives and highlight strategies for addressing the inherent challenges of protecting human subjects within a single IRB review process.

View Agenda

Learning Objectives:

  • Review the roles and responsibilities of organizations and IRBs in protecting human subjects in research.
  • Identify key challenges in human subjects protections when the IRB role is placed outside of the organization.
  • Discuss real world solutions to maintain the ethical conduct of research and appropriate protections for human subjects using a single IRB model of review.
  • Identify initiatives and strategies to translate ethical oversight and protections into day-to-day operations of both relying organizations and reviewing IRBs.

Speakers

Nichelle-CobbNichelle Cobb, PhD serves as the director of the health sciences Institutional Review Boards (IRBs) at the University of Wisconsin-Madison and has worked with IRBs since 1999. She serves as the director of SMART IRB Operations and is one of the Midwest Regional Ambassadors for SMART IRB, an initiative sponsored by the National Center for Advancing Translational Science (NCATS) to create a master IRB authorization agreement and support single IRB review. In addition, she has been part of several groups working on issues surrounding single IRB review. In the non-sIRB realm, one of her current projects is working on a team to develop an approach to electronic informed consent that better leverages the possibilities IT offers, especially in terms of visual presentation of information. Nichelle acts as a site visitor for AAHRPP and is a member of PRIM&R’s 2019 Advancing Ethical Research (AER) Conference Workshop/Didactic Subcommittee.

Jeremy CrosmoJeremy J. Corsmo, MPH, CHRC, CIP leads Cincinnati Children’s Hospital’s (CCH) institutional programs related to the regulatory and compliance aspects of research. This principally includes CCH’s human research protection program, animal care and use in research program, research laboratory safety program, research compliance program, research education and training programs and conflict of interest program. Jeremy completed his undergraduate degree at Virginia Tech in biology and his graduate degree in public health from the University of Massachusetts Amherst. He is also an assistant professor of pediatrics at the University of Cincinnati College of Medicine, where his current research focuses on novel methods to evaluate and improve young adult and adolescent research participants’ understanding of critical elements of the research consenting process. Prior to joining CCH, Jeremy held regulatory/compliance positions in the pharmaceutical industry as well as with a commercial IRB.

Martha F JonesMartha F. Jones, MA, CIP is executive director of the Human Research Protection Office (HRPO) at Washington University in St. Louis (WUSTL). Nationally, Ms. Jones is a member of the PRIM&R Board of Directors, the Council on Governmental Relations (COGR) Research and Regulatory Reform Subcommittee, the SMART IRB Harmonization Steering Committee, and co-leads the National Comprehensive Cancer Centers (NCCN) IRB Directors group. She is Vice Chair of the Association for the Accreditation of Human Research Protection Programs (AAAHRP) Council, and a site visit team leader. In 2017, Ms. Jones received the AAHRPP Distinguished Team Leader Award. At WUSTL, Ms. Jones serves as a member of the IRB, the Data Policy Committee, the CTSA Clinical Trials Task Force, the EPIC implementation team, the OnCore Steering Committee, and the Research Administration IT Governance Group. Ms. Jones co-developed the IRB data management system, "myIRB," which is currently used at The University of Iowa and WUSTL, and continues to lead the WUSTL IT development team. She has a background in clinical research ethics, epidemiology, biostatistics, speech pathology, audiology, public health, and the coordination of multicenter research studies.

Pearl ORourke Webinar P. Pearl O’Rourke, MD is the director of human research affairs at Partners HealthCare System, Inc., in Boston, MA, and an associate professor of pediatrics at Harvard Medical School. She is responsible for the systems that support the regulatory and ethical oversight of human research and human embryonic stem cell research. Dr. O’Rourke’s career began as a pediatric critical care physician at Children's Hospital Boston, and then at Children's Hospital, University of Washington, as director of the Pediatric Intensive Care Unit. She did clinical research in extracorporeal membrane oxygenation, liquid ventilation, high frequency ventilation, and pediatric resuscitation. Following a Robert Wood Johnson Health Policy fellowship working for Senator Edward Kennedy from 1997 to 2000, she was the deputy director of the Office of Science Policy in the Office of the Director at the NIH, where she worked on issues such as privacy, gene therapy (transfer) embryonic stem cells, and genetic discrimination. Dr. O’Rourke is the ex-chairman and a former member of PRIM&R’s Board of Directors, and she was a member of the AER18 Core Conference Planning Committee.

Megan Kasimatis SingletonMegan Kasimatis Singleton, JD, MBE, CIP is assistant dean for human research protection and director of the Human Research Protection Program at Johns Hopkins University School of Medicine (JHM). In this role she is responsible for oversight and direction of JHM’s seven IRBs. Ms. Singleton is a licensed attorney in Pennsylvania. She earned her law degree from Temple University and her Masters in Bioethics from the University of Pennsylvania. In addition to her current role in leading the Johns Hopkins Medicine HRPP, she serves as the director of central IRB (CIRB) activities for the Johns Hopkins/Tufts Trial Innovation Center (TIC), leading the charge for innovations in operationalizing single IRB (sIRB) review. She is also heavily engaged in national efforts to streamline the implementation of sIRB review processes including as a member of the Federal Demonstration Partnership taskforce on sIRB review and as a member of the SMART IRB Harmonization Steering Committee. Ms. Singleton is the co-chair of PRIM&R’s Advancing Ethical Research Conference Workshop/Didactic Subcommittee, is an AAHRPP, Inc. site visitor, and is a member of the Steering Committee for AEREO, a consortium designed to advance effective research ethics oversight through empirical research.

Fees

If you are not yet a PRIM&R member, we encourage you to join today, and take advantage of your very first membership benefit immediately: discounted registration to this event! As a PRIM&R member, you'll enjoy registration fee discounts, as well as a variety of member benefits designed to engage and enrich your professional life.

Single IRB Review: Lessons from the Real World REGULAR
(2/28/19 - 5/2/19)
LATE
(5/3/19 - 6/3/19)
PRIM&R Member* $345 $395
Nonmember $544 $594
Registration + PRIM&R Membership $544 $594

*On May 2, 2019, the regular rates end at 11:59 PM ET; late rates go into effect at 12:00 AM ET on May 3, 2019 and end on June 3, 2019. Registration will close once we reach course room capacity.

Location

PRIM&R welcomes attendees of the Single IRB Review: Lessons from the Real World to Long Beach, CA! This workshop will take place at the Westin Long Beach Hotel. Click on the links below for more information on the local area:

Airport Transportation

Karmel Shuttle Service is offering a special discount for attendees of this workshop. Please book your roundtrip reservations directly with them.

For reservations within 12 hours of your pick-up time, or to place reservations by phone, please call (toll free): 1-888-995-RIDE (7433)
Use PROMO CODE: "PRIM19" to receive your discount.

They also offer Extreme Tours to various sites and attractions in Southern California.
Use PROMO CODE: "PRIM19" at the checkout page.

Accommodations

Westin Long Beach Hotel

333 East Ocean Boulevard
Long Beach, CA 90802
Tel: 1.562.436.3000

Rates (available until May 17, 2019 at 5:00 PM PST or until sold out):
Single/Double Occupancy $229 + tax
US Federal Government rate (must show valid Federal Government or Military ID at check-in) $180 + tax

Reservations: Registrants are required to make and pay for their hotel reservations.

  • Book online
  • Call 562.436.3000 and reference the PRIM&R Single IRBs workshop (for per diem rooms, note that you need that room rate within the PRIM&R Single IRBs workshop block)

Guest Internet: Free wireless internet is available in all guestrooms and in the workshop meeting space.

Hotel Billing and Cancellation Policies: A credit card is required to hold each guest's reservation. Such guarantee shall serve to confirm the reservation for the dates indicated.

Any reservation that is not cancelled at least seventy-two (72) hours prior to arrival will be charged one night room and tax. All cancellations must obtain a cancellation number.

Deposits are refundable for cancellations occurring seventy-two (72) hours days prior to arrival.

Certificates of Attendance and Continuing Education Credit

The certificate of attendance for Single IRB Review: Lessons from the Real World will be available upon completion of the course evaluation. Such certificates are useful for obtaining continuing education (CE) credits (not continuing medical education credit) from professional associations. Note that guidelines around CE credits may differ, and you should consult the appropriate professional association representative for further guidance. A link to the evaluation will be emailed to you after the program adjourns.

Single IRB Review: Lessons from the Real World is eligible for up to 7.5 continuing education credit hours.

CE Credit for Certified IRB Professional (CIP®) Recertification

Single IRB Review: Lessons from the Real World participants holding the CIP® credential who wish to apply the 7.5 credits from this program toward CIP® recertification may submit the certificate of attendance they received upon completing the online evaluation as documentation of their participation.

For recertification by CE, CIPs must complete 30 documented hours of continuing education. At least 15 of the 30 hours must either carry credits issued by a recognized accrediting body or have received advanced recognition from the Council for Certification of IRB Professionals (CCIP). Credits from this offering of Single IRB Review: Lessons from the Real World have received such advance recognition, and may be counted towards these 15 hours. Additional information about CIP recertification.

If you would like to receive a certificate of attendance for a previous PRIM&R conference, please email info@primr.org with the following information:

  • Full name
  • Email address
  • Conference name and date(s)
  • Dates and hours of attendance

Certificates will be delivered via email approximately three weeks after receipt of request.

Questions?

How do I receive continuing education credit for attending a workshop or boot camp?

A Certificate of Attendance is available at the conclusion of the workshop, after completion of the online evaluation. The evaluation is emailed to all registrants after the workshop ends. Certificates of Attendance may be used for obtaining continuing education (CE) credits (not Continuing Medical Education credits) from professional associations. Note that guidelines concerning CE credits may differ, and you should consult the appropriate professional association representative for further guidance.

How do I pay for my registration?

Payment in full is required prior to the start of the program.

  • Credit cards (Visa, MasterCard, and American Express) are accepted via online registration or the registration form.
  • Purchase Orders (POs) are accepted during online registration. In order to complete registration, the PO must be sent via fax (617.423.1185) or mail to our payment address, and must be received at least three weeks before the workshop or boot camp. If your PO is not received by this date, your registration will be canceled. Once your registration has been completed, you are responsible for requesting the payment indicated on the PO from the appropriate department at your institution.
  • Checks are accepted using the workshop or boot camp registration form. Your check and registration form must be received at our payment address at least three weeks before the workshop of boot camp in order for your registration to be processed.
  • Payments requiring a signature upon delivery cannot be sent to our P.O. Box. If you need a signature upon receipt of payment, please send your registration materials to PRIM&R at 20 Park Plaza, Suite 720, Boston, MA 02116.
  • Wire transactions and ACH transfers are accepted. If your institution is making payment via wire or ACH transfer, the beneficiary field of the instructions must include either the name(s) or invoice number(s) of the registrant(s) for whom the wire or ACH transfer is paying, in order to be properly credited. Your registration cannot be processed until proof of payment, along with your registration form, is received via fax to 617.423.1185.
  • Download the registration form.
How do I cancel/substitute my workshop or boot camp registration?

Once you register for the workshop or boot camp, you are responsible for all fees (regardless of whether you attend) unless you cancel according to the following policy:

  • Cancellations can only be made by completing the cancellation form and sending it, either by email, fax, or mail, so it arrives at the PRIM&R office address at least three weeks before the workshop or boot camp, May 13.
  • For cancellations submitted by May 13, refunds will be issued within 60 days of the program's conclusion, minus a processing fee of $75 (members) or $100 (nonmembers), via the same method used for payment (i.e., if payment is made by check, the refund will be made by check). Credit card refunds will be made to the card used for the original registration only.
  • Registrants who do not attend the program, and do not contact PRIM&R in writing to cancel their participation before the deadline, are responsible in full for their fees. This policy applies even if a colleague registers you for the conference.
  • Refunds will not be issued for PRIM&R membership fees. Registrants adding PRIM&R membership during registration will continue to keep their memberships for a one year term even if they cancel their event registration according to the terms detailed in the cancellation policy. 
  • Once the cancellation form has been processed, you will receive a confirmation email.
  • Cancellation form
  • Substitution form
Do you offer discounts or complimentary registration?

If you're a PRIM&R member and enjoy writing, consider applying for the PRIM&R Blog Squad. If selected, you will receive a complimentary individual registration to the workshop or boot camp.

My company would like to support a PRIM&R workshop or boot camp. How can we get involved?

Companies and organizations interested in supporting PRIM&R workshops and/or boot camps are encouraged to download the supporter prospectus. Inquiries and completed forms may be emailed to PRIM&R's program manager, Ashley Savannah, at asavannah@primr.org.

When will the electronic materials be available?

Materials for this course will be available electronically one week prior to the event. Links to access materials online will be sent to the email address we have in our system from registration@primr.org. If you believe your institution will block email messages from registration@primr.org, please add this email address to your safe sender list, or provide PRIM&R with your personal email address instead.

If you don't receive the link and password to the materials one week prior to the event, please contact Ashley Savannah.

Printed materials will not be provided and attendees may or may not have access to free printing while on-site, so it is highly recommended that you print and/or download your materials prior to attending the workshop. It is also recommended that attendees bring paper and pen and/or a fully charged laptop to take notes.

Please email info@primr.org if you have additional questions.