The policy on lab attire and eating/drinking were modified and strengthened in the new U-M Chemical Hygiene Plan (CHP).  This modification was necessary for regulatory compliance and to meet the ever increasing safety demands by research sponsors.  A shift in safety culture at an institution the size and complexity of U-M is not an easy process, but protecting our employees and remaining the leaders in research depends on it.  

The official release of the new CHP was January 1, 2014.  It can be found on the Occupational Safety and Environmental Health (OSEH) website.  There will be a one year grace period for labs that have a current and complete CHP.  This will give labs time to work with departmental administrators and facility managers to determine appropriate space to eat and drink. 

U-M Occupational Safety and Environmental Health (OSEH) has launched a pilot program of unannounced inspections called "Lab Visits." The program is designed to supplement the scheduled inspection program and improve awareness of safety issues.  

These "visits" will be completed across campus in FY14 and will consist of a brief inspection focused on key safety and health elements.  The visit form is a 10-question paper checklist, which includes the following topics:

2.    Chemical Hygiene Plan (CHP) document 

       binder complete

3.    No signs of eating and/or drinking in the lab

4.    Chemical labels on all containers

5.    Proper lab attire including safety glasses

6.    Compressed gas cylinders restrained

7.    Hazardous waste containers closed and dated

8.    Fume hood sash closed when not in use

9.    Emergency shower and eyewash readily accessible

10.  Bulk flammable liquids stored in flammable liquid   

      storage cabinet

A carbon copy of the inspection report is left with the inspected laboratory.  The lab is expected to correct deficiencies and notify OSEH upon completion.

The U-M Coulter Translational Research Partnership Program is pleased to announce the 2014 Call for Proposals.

The U-M Coulter Program is funded through proceeds of an endowment from the Wallace H. Coulter Foundation and supports collaborative translational research projects that involve co-investigators from the Department of Biomedical Engineering (BME) and a clinical department.

The goal of this program is to support research collaborations between biomedical engineers and clinicians in order to accelerate the development and commercialization of new medical devices, diagnostics, and other biomedical products that address unmet clinical needs and lead to improvements in health care.  Projects are supported and mentored by a team of industry-experienced experts who proactively work to accelerate Coulter Program objectives of developing new product concepts to the point of partnering with industry or forming start-up companies with 

follow-on funding to commercialize new products envisioned from research efforts.

Distinctive aspects of the Coulter Program include business assessment work that dovetails with technical milestones for each project.  Specific benefits to each project include: 

• Business Development support
• Intellectual Property advice and legal support
• Regulatory guidance
• Follow-on funding guidance
• Mentorship from Oversight Committee 

Contact Thomas Marten, Coulter Program Director, at [email protected] or (734) 647-1680 to explore the commercial potential for your project and fit for Coulter funding opportunities.

For more information, visit the Coulter Program website or download the Coulter proposal application here.  

Proposals must be submitted by 5:00 PM on Monday, 

March 3, 2014.

Two NEW specialty consent templates have been added to the IRBMED website for utilization by study teams.  The first template may be used only for a One-Time Blood or Tissue Sample for minimal risk studies.  

Importantly, this template may not be used if: 

• You plan to conduct genetic analysis on subjects' samples, and/or  
• You plan to submit subjects' samples or data to a biorepository or data repository

The second is a template for Eligibility Screening.  This template may be used only for eligibility screening and only if screening procedures pose no more than minimal risk to subjects.  

You may not use this template if:

• You plan to conduct genetic analysis of subjects' blood or tissue samples
• You plan to submit subjects' material or data to a biorepository or data repository

IRBMED has updated the Informed Consent Templates pages on their website in order to provide easier navigation between the Standard ICD Template and the newly added Specialty Templates. 

To access the main Consent Templates page, click here.  

In Part I of this presentation, IRBMED offered recommendations for creating effective informed consent documents.  In this 

follow-up presentation, they provide instructions on how to apply those principles by working through a problematic passage from a hypothetical consent document.  

The Honest Broker Office (HBO) is now one year old and has provided clinical data for over 260 requests in their first year of operation.  Twenty-five percent of these requests include automatic updates.  While deploying the initial plans for the office, they are engaged in continuous improvement activities.  The HBO satisfaction survey responses include high marks for data quality and customer service while urging a faster turnaround time for data delivery.

To enable time-sensitive data delivery, HBO is implementing a partial cost recovery model with a recharge rate of $50/hour for all projects submitted after January 6, 2014.  This will cover approximately 1/6th of the cost to the HBO per hour.  

The generated revenue will allow the office to hire additional team members to align resources with demand.  HBO has hired a third full time Data Analyst whose salary support will come directly from cost recovery.  In addition, they are working with other members of the Office of Research to assist with expanding self-service access to clinical data for research.

To assist the research team in preparing an optimal data request, HBO has instituted Office Hours every Tuesday afternoon from 2:00 to 4:00 PM. See the HBO website for location and updates.

• Clinical Genomic Sequence Analysis Software: Automated variant identification from complex genetic datasets by Elenitoba, Kojo S.J. & Lim, Megan S.
• SRB-1 targeted with anolide nanoconjugates for improved targeted therapy of endocrine cancers by Cohan, Mark & Schwendeman, Anna
• Thiopurine Monitoring with the ThioMon Algorithmic Test by Balis, Ulysses & Higgins, Peter
• Targeting EGFR-dimerization and EGFR-Hsp90 interaction for drug resistant lung and colorectal cancers by Nyati, Mukesh & Lawrence, Ted
• Fluorescent-labeled peptide for targeting early detection of colorectal cancer by Wang, Thomas D.
• Novel real-time intracardiac mapping system to guide ablation in patients with atrial fibrillation by Berenfeld, Omer & Oral, Hakan
• Taking the Guesswork out of Brain Surgery by Orringer, Dan
• Evaluation of PhScN as a Potent Systemic Therapy Combined with Hereceptin and/or Radiation for Breast Cancer by Livant, Donna L.
• In vivo Assessment of a Novel Intraocular Pressure Transducer by Mian, Shahzad & Chronis, Nikos
• Dynamic Response Impedance Volume Evaluation (DRIVE) by Tiba, Mohamad; Ward, Kevin; Shih, Albert; Blum, James; Belmont, Barry

Faculty from across the U-M Medical School (UMMS) were honored for their participation in the Mentored Research Academy: R01 Boot Camp pilot program on Wednesday, January 22.  UMMS Dean James O. Woolliscroft, who is responsible for funding the program, was also on hand to provide opening remarks and to congratulate participants on their many successes throughout the program.  As part of the closing ceremony, program participants were also invited to join a round table discussion about the "Secrets of Success, Secrets of Failure" in competing for R01 NIH Research Project Grants.

Developed by the Medical School Office of Research in consultation with faculty, the Department of Medical Education, Office of Faculty Affairs, the Associate Chairs for Research, and the Michigan Institute for Clinical and Health Research (MICHR), the Mentored Research Academy: R01 Boot Camp ("R01 Boot Camp") is a multi-tiered mentoring program to support and increase the success rate of Medical School faculty applying for their first NIH Research Project Grant (R01).

Launched in early 2013, the pilot R01 Boot Camp program consisted of 40 new investigators (mentees) from 26 departments and 11 coaches from eight departments.  Throughout the course of the eight-month program, mentees participated in both small and large interdisciplinary group meetings to develop their research plans and strategies in preparation for submitting their first R01 NIH Research Project Grant.  Mentees also were able to work with an internal subject matter expert (SME), as well as an expert external reviewer to solicit feedback on their proposal prior to submission to NIH.  

The majority of participating mentees will submit their R01 proposal by February 5, 2014. Though the program is still being evaluated, initial feedback collected by Dr. Larry Gruppen, Ph.D. from the Department of Medical Education indicates that several aspects of the program were especially well liked, including: 

• Opportunities to work with and get access to senior people at U-M
• Feedback from numerous people, including peers and subject matter experts
• The program's emphasis on a global approach to grant writing 

Due to a multi-phase review process, as well as delayed funding start dates from NIH, final data tracking the total number of successfully-funded proposals created through participation in the R01 Boot Camp program will take a few years to be compiled. However, preliminary data suggests that several mentees have already received word that their R01 proposals will be funded or are in the fundable range.  Other mentees have also received significant grant awards from other sponsors that will in turn lead the way for a successful, future R01 proposal.

A new session of the program will be announced later this year. Visit the Mentored Research Academy: R01 Boot Camp page for more information about the program, including a complete list of this year's participants.

By Chris Black, M.L.S., Assistant Director for Research Development Support, Office of Research

(One in a series of tips published in UMMS Research News about writing proposals.)

Most experienced investigators acknowledge that early contact with a program officer (PO) can be the difference between a funded and non-funded submission.  For example, POs can: clarify the fit of the scientific concept with the sponsor's priorities; give advice regarding funding mechanism, budget, and project duration; comment on project design; answer questions about guidelines or procedures; and offer insight into the review process, e.g., verify what methodologies are preferred by reviewers.  A PO's initial reaction to the proposed research may be the best indicator of success.

Since the job of most program officers is to solicit the most relevant and high quality proposals, POs are usually eager to answer questions.  Yet young investigators are often reluctant to make contact. Here are a few tips for how to approach a PO:

1.     Do your homework - Make sure you are familiar with   

        the agency's website and grant guidelines, so that you   

        are not asking the PO what is publicly known.  This is   

        not an informal chat.  Remember - first impressions are 

        critical - be prepared!

2.     Email first - Inform the PO that you are considering      

        applying for the grant opportunity and either state your   

        specific issue/questions, or ask if he or she may be 

        able to assess the attached summary (1 - 2 pp.) for 

        programmatic relevance.  Ask if s/he would rather talk   

        on the phone and give your number.  If you have not 

        heard back in a week or so, it is appropriate to follow-up 

        with a phone call or short message.  POs' personalities 

        are as varied as the rest of us in terms of 

        responsiveness - be patient - don't be a "pest." 

        (Note: email allows you to keep a record of contacts 

        and responses.)

3.     The summary of your proposal (attached to email)    

        should represent your "elevator" talk - Briefly review  

        aims, methods, expected outcomes; no jargon or too 

        much detail or; state where this will lead.

4.     Good working relationships can be further      

        developed at professional meetings, where the   

        discussion may be more informal.  You also can visit         POs when you are in D.C. or their home city; arrange in         advance and come with questions.  Often POs can    

        give insight beyond what is found in the written or   

        posted materials.

5.     Remember: don't be shy! (and always be gracious ...).