Jennifer DeVoe, M.D., D.Phil., associate professor of family medicine, OHSU School of Medicine, has been elected to the Institute of Medicine (IMO), one of the highest honors in the fields of health and medicine. Dr. DeVoe, a family physician and health services researcher and chief research officer at the Oregon Community Health Information Network (OCHIN), was elected in recognition of her outstanding professional achievement and commitment to services in health and medicine.
“I am humbled by this great honor,” said Dr. DeVoe. “It is so exciting to get recognized by the IOM for the amazing work done by our teams at OCHIN and in the OHSU Department of Family Medicine. We are part of a national community of innovators committed to generating and spreading new knowledge relevant to primary care. This transformative work is vital to equipping primary care clinics and communities with the tools and information needed to improve population health.”
According to the IOM Member Directory web page, there are only seven current IOM members who list their academic affiliation as Oregon. Of those, four are from OHSU: Brian Druker, M.D.; Richard Goodman, M.D., Ph.D.; Joe Gray, Ph.D.; and Gary Westbrook, M.D. Dr. DeVoe is the eighth Oregon member and the fifth from OHSU. She is the first woman to be elected from both Oregon and OHSU.
The revision is designed to make the distinction between clinical trials and clinical research studies clearer and to enhance the precision of the information NIH collects, tracks, and reports on clinical trials. It is not intended to expand the scope of the category of clinical trials. No changes have been made to the NIH definition of a “Phase III clinical trial.”
The revised NIH definition of “clinical trial” is:
A research study1 in which one or more human subjects2 are prospectively assigned3 to one or more interventions4 (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.5
- See Common Rule definition of research at 45 CFR 46.102(d).
- See Common Rule definition of human subject at 45 CFR 46.102(f).
- The term “prospectively assigned” refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of a clinical trial.
- An intervention is defined as a manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints. Examples include: drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies.
- Health-related biomedical or behavioral outcome is defined as the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status or quality of life. Examples include: positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and /or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviors; and, positive or negative changes to quality of life.
The revised definition will replace the current clinical trial definition in relevant extramural and intramural NIH policies, guidance, and instructional materials. It will apply to competing grant applications that are submitted to NIH for the January 25, 2015 due date and subsequent due dates and contracts proposals that are submitted to NIH on or after January 25, 2015.
The Edward Mallinckrodt, Jr. Foundation’s Scholar Award program is designed to support early-stage investigators engaged in any area of biomedical research that has the potential to significantly advance the understanding, diagnosis, or treatment of disease. The award provides up to $100,000 per year for four years to faculty members who hold a M.D. and/or Ph.D. degree, and who are in their fifth to eighth year of a tenure-track position, with the aim of moving the project forward to the point where R01 or other independent funding can be obtained.
OHSU has been selected as one of 30 institutions invited to submit applications this review cycle. This opportunity is categorized as a Limited Submission since OHSU can only nominate two candidates. If you intend to apply, please complete a Limited Submission Form prior to the internal deadline of Nov. 21. The sponsor deadline for applications is Jan. 15, 2015. The full proposal must be accompanied by letters of approval by the dean of the medical school and/or another senior faculty member.
We began the process of joint PVAMC/OHSU IRB review two years ago. Please join us for an update and some helpful tips on this time-saving process.
Monday, Nov. 17
11:30 a.m. to 12:30 p.m.
OHSU Hospital, 8th floor auditorium 8B60
Please note, this session is on Monday due to holiday scheduling
The Oregon Clinical & Translational Research Institute (OCTRI) has funded four projects designed to enhance translational research at OHSU. These novel, collaborative, multidisciplinary studies will lead to further research and funding in translational research. The funding was made available through institutional support of OCTRI from the School of Medicine (Research Roadmap initiative) and the Office of the Senior Vice President for Research.
Congratulations to the 2015 Catalyst Award winners:
Joshi Alumkal, M.D.
“Bromodomain Inhibition For The Treatment Of Lethal Prostate Cancer”
Willi Horner-Johnson, Ph.D.
“Reproductive Health of Women with Disabilities Initiative”
Stephen Lloyd, Ph.D.
“DNA Glycosylases: Novel Targets for Small Molecule-induced Synthetic Lethality”
William Messer, M.D., Ph.D.
“Long-term DENV immunity in a human cohort”
OCTRI Catalyst funding is specifically intended to enable the development of compelling new grant applications that will sustain the proposed research activity. Please see the OCTRI Funding Opportunities page for more information or contact Colleen Lay.
See full project abstracts here.
For more information on OCTRI’s resources and services, please visit: www.octri.org.
The NIH has released a Notice of Clarification in regards to PA-12-042 “NIH Pathway to Independence Award (Parent K99/R00).” The purpose the Notice is to clarify the eligibility requirement that K99 applicants must have no more than 4 years of postdoctoral research experience at the time of the initial application or resubmission or revision. Specifically, this Notice describes situations in which time is not counted against the 4-year limit.
The modified eligibility section now reads:
K99 applicants must have no more than 4 years of postdoctoral research experience at the time of the initial or the subsequent resubmission or revision application, and must be in mentored, postdoctoral training positions to be eligible to apply to the K99/R00 program. If an applicant achieves independence (i.e., any faculty or non-mentored research position) before a K99 award is made, neither the K99 award, nor the R00 award, will be issued.
Parental leave or other well-justified leave for pressing personal or family situations of generally less than 12 months duration (e.g., family care responsibilities, disability or illness, active military duty) is not included in the 4-year eligibility limit. In addition, time spent conducting postgraduate clinical training that does not involve research is not considered as part of the 4-year research training eligibility limit. Only time dedicated to research activities would count toward the 4-year limit.
OCTRI’s Novel Research Methodology Development Award provides funding over a one-year period to encourage and accelerate the creation, dissemination, and implementation of novel translational and clinical research methodologies.
Two levels of novel research methodology funding are available:
1. Development and dissemination of novel research methodologies (up to $25,000)
2. Publication/dissemination of novel research methodologies (up to $5,000)
For examples of pilot projects that would be viewed as responsive please see the full request for applications on the OCTRI website: OCTRI Funding Opportunities.
Novel Research Methodology Development Award: Informational Q&A session
Wednesday, Nov. 19, 2014
12 to 1 p.m.
Those on hand to answer questions include:
- Eric Orwoll, OCTRI Director
- David Ellison, OCTRI Associate Director
- Colleen Lay, OCTRI Awards Program Director
- Jonathan Jubera, OCTRI Awards Project Manager
Questions? Please contact Jonathan Jubera.
The American Asthma Foundation is looking to draw outstanding early- and mid-career scientists from other fields into the study of asthma. The Scholars Program is designed to achieve this goal by supporting highly innovative research from all fields relevant to asthma. Most scholars will be studying asthma for the first time.
Award: Up to $150,000 per year for up to three years.
Deadline: February 4, 2015
Eligibility: Applicants should have an independent research program with national-level, independent funding. The applicant will have been appointed to an independent faculty position no more than 10 years before the application deadline.
For other funding opportunities, take a look at this week’s Funding Alerts.
The third phase of the North Campus Utility Plant project behind Richard Jones Hall is expected to begin Saturday, Nov. 8, and continue in stages into the new year. The work includes positioning a crane in the research courtyard, lifting materials and equipment over the top of RJH, and installing supports and cooling towers on the backside of RJH and the Vollum Institute.
If you work in the affected areas or have visitors, impacts may include:
- The courtyard and courtyard entrances to RJH, the Vollum, and Mackenzie Hall will have limited access. The primary entrances to these buildings will be through the Oregon Institute of Occupational Health Sciences (formerly CROET) or Medical Research Building (MRB). Fencing and signage will be installed in the appropriate locations.
- ID badges will need to be programmed to allow after-hours access through CROET, RJH, the Vollum, Mac Hall, and the MRB.
- During crane work, faculty, staff and students on the top two floors of RJH will be periodically and briefly evacuated similar to previous years.
- There will be increased noise and vibrations throughout construction
- Periodic coordinated power outages in research buildings may also occur as part of the NCUP project and a transformer upgrade. More information will be provided when this phase of work gets closer.
Following is a scheduled timeline for the project:
Saturday, Nov. 8 through Wednesday, Nov. 12
- About half the Auditorium parking lot will be closed for delivery of the crane.
- Temporary protective plating will be placed in the research courtyard.
- Barrier fencing will be installed along the perimeter of the courtyard.
Saturday, Nov. 15 through early January
- Crane assembly in courtyard
- Weatherization on exterior of Vollum to occur (parallel project)
- Crane/construction work hours are 6:30 a.m. to 3:30 p.m., Monday through Friday
- The top two floors of RJH will be evacuated intermittently for safety, as in previous years.
- Pedestrian access through RJH, Vollum, MRB and Mac Hall only; limited courtyard access
- As in previous years, the underground tunnel will be reshored with four-foot travel path for animal transport for the duration of the project.
A forum is being held for faculty and other members of the OHSU community to learn more about the project and ask questions.
Thursday, Oct. 30
1 to 3 p.m.
Old Library Auditorium
Project managers will be on hand to discuss plans, impacts and proposed schedules. Attendees may ask questions and sign up for one-on-one meetings with project managers to talk through individual needs and concerns.
Questions or concerns?
Contact Jerry Witt of Facilities & Logistics: 503 494-5905
The Oregon Clinical & Translational Research Institute (OCTRI) is now accepting letters of intent to apply for its Biomedical Innovation Program. The program cultivates and selects promising translational projects that develop new biomedical devices, diagnostics, and software with the objective of moving innovative technologies to clinical application, making a meaningful impact on human health.
Deadline: Letters of intent due Nov. 12, 2014
Amount: Up to $40,000 over one year
Eligibility: Principal investigators must fit OHSU eligibility requirements.
Critical elements of successful proposals will be a well-developed idea or vision for the end product and a collaboration between clinicians, scientists, and bioengineers. That collaboration will make possible the identification of a significant clinical problem, an innovative idea for a device or diagnostic to address the problem, bioengineering approaches for device or diagnostic development, voice of consumer studies, and early clinical trials.
Learn more about this and other OCTRI funding opportunities.