The interactions between eCoI and eIRB

The new conflict of interest reporting system housed in Big Brain, eCoI  has been up and running since late August. This system asks researchers to report Outside Activities and Conflicts of Interest (CoIRs) in one report; previously, this required two disclosures (one in the “old” CoIR disclosure system; the other in Big Brain).

1) CoIR Compliance in eIRB: Anytime a researcher has an eCoI submission “in the works” (awaiting signature by department chair/dean; awaiting revisions after having been returned from one of the signers) or overdue, then the eCoI blocks projects from being submitted or moved through the eIRB system.

Signers are able to review/sign CoI disclosures as soon as they are submitted to eCoI; they receive an email notification within 24 hours of the eCoI submission, with a link taking them directly to the form needing review/signing. The necessary signatures (typically from Department Chair and a Dean) can happen in any order. Once those 2 signatures are obtained, compliance for eIRB functioning has been established. (A form awaiting only the CoI Office signature does NOT cause eIRB non-compliance.)

If you’re not sure why there is a non-compliance issue when trying to make an eIRB submission, check the left vertical navigation plane in your eIRB project, and click on “Visual CoIR RCR” under “RCR/COIR compliance.”

2) eIRB projects and researcher conflicts: If a researcher has a financial conflict related to an IRB study, then it is crucial to answer “yes” to that researcher’s personnel entry in the Initial Review Questionnaire (IRQ) when the study is submitted to the eIRB.

AND, it is important that the new study involving a conflict be added to the researcher’s eCoI record. This is done by going to the Project Tab in the eCoI record and clicking on “add a project.”  **NEW: Anyone listed as a researcher’s “contact” in eCoI (on the My Signers tab) is now able to enter the project on the researcher’s behalf.  (The contact may add/edit projects and travel entries but not the CoI disclosure itself.) It is CRUCIAL that the questions are answered in as much as detail as possible, so a contact (e.g., study coordinator) will need the researcher’s input.**NEW

Questions? Call the Research Integrity Office at 503-494-7887.

This July 28-31, 2013, OHSU will host the 2013 Oregon Institute for Patient-Centered Comparative Effectiveness (ICE) Annual Research Intensive. National leaders in the fields of patient-centered outcomes and comparative effectiveness research (PCOR & CER) will be coming to OHSU to teach this intensive, hands-on workshop. The program is a week-long activity sponsored by the National Institutes of Health and the National Cancer Institute.

The fields of PCOR & CER are rapidly evolving with new opportunities for funding and new directions for research. The course involves active development of proposals for primary research and provides participants the tools with which to become leaders in PCOR & CER at their institutions.

Participants in ICE 2013 will:

• Receive training from national experts in CER/PCOR principles and research methods, including systematic reviews
• Q&A with national funders
• Learn best practices in engaging stakeholders in research design, dissemination and implementation
• Participate in small group sessions and workshops on CER/PCOR grant proposal development
• Gain hands-on experience with CER/PCOR methods

By the end of the week, participants will have the tools to both design studies and use existing knowledge to discover what interventions work best for real world populations in real world situations.

Eligibility

This program is open to researchers across the U.S. with a doctorate or equivalent. Priority will be given to those who already have a strong foundation in research methods and wish to obtain additional skills in order to align their research with principles of comparative effectiveness. Applicants must have completed coursework in clinical research design or epidemiology, as well as biostatistics to ensure that all participants share a common working knowledge.

Deadlines

Space is limited and admission will be competitive. Learn more about the simple application procedure.

Final deadline: May 31, 2013

CME

Accreditation

Oregon Health & Science University School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

Credit

OHSU School of Medicine, Division of CME, designates this live activity for a maximum of 36 AMA PRA Category 1 Credits^TM. Physicians should only claim credit commensurate with the extent of their participation in the activity.

More Information

Find out more — including the list of topics and invited speakers — on the Annual Research Intensive website. Contact ice@ohsu.edu with any questions.

OHSU’s Division of Management team has organized two upcoming information sessions on Graduate Programs in Healthcare Management:

Master of Science in Healthcare Management
Wednesday, April 10 from 5:30-6:30 pm
Center for Heatlh and Healing, E. Paul Kirk Conference Center
This 52-credit program is geared toward those working on the front lines of management in the healthcare industry. The program focuses on learning and applying management techniques in the workplace.

OHSU-PSU Joint MBA Healthcare Management
Wednesday, April 17 at 5:30pm
PSU, School of Business Administration, room 550
Taught in a hybrid format of both in-person and online learning, this program is suitable for working professionals who seek to gain the skills and knowledge needed to transform the business of healthcare.

Learn more and RSVP for an event.

April 25, 2013: The new and improved HIPAA research authorization process
Led by Andrea Johnson
11:30 a.m. to 12:30 p.m. in UHS 8B60

New HIPAA regulations and guidance, which take effect on March 26, 2013, allow HIPAA authorizations for research studies to be built into the consent form in nearly all cases, even when the research has optional components. They also permit authorization for future research. This means fewer forms to submit and a more integrated process. Come learn about:

• The changes to the regulations;
• The new combined consent and authorization form templates; and
• How these changes affect past, present, and future studies.

May 23, 2013: Request for determination
Led by Melinda Allie and Kaija Maggard
11:30 a.m. to 12:30 p.m. in UHS 8B60

Determining what is human subjects research and what is not can feel like a tricky process. Come discuss with the IRB Analysts why you must submit a request for determination to the IRB and gain a clearer understanding of how these regulatory-based decisions are made. Topics include:

• Quality Assessment and Improvement v. Research
• Human Subject v. Non-Human Subject Research
• Case Studies

Quality improvement or research? How to make sure you’re in the clear

In the era of quality improvement, questions about how to make QI into scholarship come up frequently.

FAQs about Quality Improvement Projects and how they relate to research:

Is all QI research?  No.

Projects that are intended only for process improvement, and used in a local setting are quality improvement and do not require IRB approval.  An example of QI that is not research:  Chart review of all patients who have blood pressure readings above goal, with the intent to develop a process for scheduling these patients for a follow-up appointment in order to discuss their blood pressure control.  Measurement of the percentage of the clinic population before and after the intervention can inform the clinic about whether the intervention was effective.  Note that the goal of this project is improvement of quality metric (percent of patients at goal) or clinic processes and the information is used only within the context of the local health system (the clinic).

If we want to publish our QI project, is that research?  YES.

Any time you systematically collect information with intent to inform those outside your local environment, the project becomes research.  The federal definition of research is:  a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102(d)).

What if I started a QI project and then the results were really interesting and now I want to publish? I didn’t have IRB approval when I started.  What should I do?

First – stop working on the project.  Your goal has changed from a local improvement project to a generalizable systematic evaluation (in other words – it’s now research).  You need IRB approval before continuing with the project.

Second – submit a Request for Determination.  The IRB will determine whether your project qualifies as human subjects research, and if so what level of review/oversight is required.  Once this is completed, you can proceed with the project or if you’re sure its research, go ahead and just submit as a new research study.

Further information from the Dept Health & Human Services, Office for Human Research Protections:  http://answers.hhs.gov/ohrp/categories/1569.

Please contact Ames Elliot if you have any questions.

The numbers are in: 360 abstracts were submitted for OHSU Research Week–that’s over 40 more than in 2012! Thank you to everyone who submitted.

Of the 360 abstracts submitted, 154 requested oral presentations and 206 requested poster presentations. Abstract submission by rank was similar to last year, although student submissions increased by about 33 percent. This increase isn’t surprising given that 2013 marks the 30th anniversary of the OHSU Student Research Forum.

Here’s the breakdown of abstracts submitted by rank: students (148), postdocs (62), research-ranked employees (44), faculty (64), residents/fellows/instructors (31), and other (11).

Did you wait until March 22 to submit your abstract? If you did, you aren’t alone. If you look at the figure below, you can see that the majority of abstract submissions happened during the days (and even hours!) leading up to the abstract submission deadline.

These data confirm our suspicions that scientists, like other homo sapiens, are predisposed to procrastination.

If you submitted an abstract, expect to hear back from the Research Week programming committee in mid-April. Right now, they’re busy reading through your submissions and sorting them into time slots. In the meantime, mark your calendars for the upcoming Research Week skill development workshops, and keep an eye out for other Research Week news, including keynote speaker announcements, award nominations, and more!

Questions? Contact research@ohsu.edu.

Did you know that OHSU has pre-made templates for clinical study recruitment flyers and advertisements? The OHSU Branding Committee asks that you please use these templates when creating posters or advertisements for clinical studies to ensure a consistent look and feel.

Visit the OHSU Branding site and scroll down to “Research Templates.”

The OHSU Center for Diversity & Inclusion is seeking employees and students who have a desire to form a resource group to address the personal, social and professional interests of individuals with disabilities. People with disabilities and their allies welcome. Join us to learn about how to start an Employee Resource Group and network with others at this welcoming event.

When: Tuesday, April 9, 2013, Noon to 1:00 p.m.    
Where: Mackenzie Hall 2136
Finding the meeting room: Entering Mackenzie Hall by the fountain, take a right down the hall and turn left before you reach the stairs. The room is at the end of the hall on the right hand side. If you get lost, please call (503) 418-1139. If you need accommodation to attend the event, contact the Center for Diversity & Inclusion at (503) 494-5657 or cdi@ohsu.edu.

Can’t make it in person?  Call the conference line at (800) 977-8002, enter participant code: 4523566.

Do you have questions about the patent process?
Do you need to bring research materials to OHSU or send them to a potential partner?
Do you ever wonder whether your discovery has commercial value and should be protected?
Are you curious about how OHSU can support you in working with industry partners?

If you answered yes to any of these questions, OHSU’s office of Technology Transfer & Business Development (TTBD) is the place to start. Join us for a brown bag presentation and Q&A on “TTBD: An Overview” led by Andrew Watson, Ph.D., CLP, Interim Director, OHSU Technology Transfer. The presentation will take place on Wednesday, April 3 from 12 to 1 p.m. in the Marquam Room off of the Mac Hall cafeteria. A second brown bag session has been scheduled at OHSU’s West Campus, on Friday, April 12 at 12 p.m. in the ONPRC/VGTI 1st floor seminar room.

These events are open to all OHSU employees and students. It is the kick-off to a bi-monthly lunch time presentation series provided by TTBD. No RSVP is necessary. For additional information please contact the office of TTBD at 503-494-8200.

Every principal investigator wants to build and maintain a lab that attracts and retains outstanding staff members so that your science will be excellent. Juggling this endeavor with all else the PI must do – writing papers, teaching, mentoring, gaining and maintaining funding, creating collaborative and productive relationships with other PIs – can be challenging at best. This 1.5-day course, led by Jennifer Crosby-Meurisse and Rachel Dresbeck, PhD, both from the Office of the Vice President for Research, will help you learn to manage people with a focus on the particular needs of running a lab.

When: Friday, April 19, 9 a.m. to 4:30 p.m. and Saturday, April 20, 9 a.m. to 12:30 p.m.
Location: Center for Health & Healing (CHH), Third Floor, Room 4

In this course you will learn:

• Strategies for approaching the role of “coach” in the lab – developing your leadership style
• Recruitment and retention strategies – Building (and maintaining) the best team for your lab
• Steps to take when coaching doesn’t work – Performance management in the lab
• Resources that are available to you to support you and your lab staff

Enrollment is limited; there is no cost to participants. Please indicate your interest and willingness to participate by registering for this course. Participants will be notified of acceptance after registering.

Register for the course in Training Force.