TITLE: Key Decision Points-Is It Research Involving Human Subjects? Is It Exempt? Is IRB Review Required?
Thursday, February 28
Rebecca Sealy West 5.100
RSVP at https://my.utmb.edu/PStraining
In human subjects research, many pivotal questions need to be answeredbefore institutional review board (IRB) review. For example, does the activity count as research? Is the research exempt? Is full board review required?In this webinar hosted by PRIM&R (Public Responsibility in Medicine and Research), speakers will use case studies from both biomedical and social science/behavioral research to review the process for determining whether an activity constitutes research involving human subjects, and when such research is exempt, when it qualifies for expedited review, and when it must undergo full IRB review.
RESEARCH WEBINAR: IRB Evaluation of Advertisements and Consent Forms
Tuesday, March 5
Noon – 1:00 p.m.
Rebecca Sealy 4.302/4.304
RSVP at https://my.utmb.edu/PStraining
Development of effective recruitment tools and consent documents is essential to meeting enrollment goals and keeping a clinical trial moving forward. This webinar will address some of the common issues confronted during ethics review of advertisements and consent forms. Topics that will be discussed include: Specific requirements and types of information to include in advertisements and language to avoid; how to provide adequate discussion of procedures, risks, and alternatives in the consent form; and restrictions on exculpatory language and tips for avoiding therapeutic misconception in advertisements and consent documents.
The Sealy Center on Aging presents
THE 18TH ANNUAL LEFEBER WINTER LECTURE SERIES ON AGING
"Exercise as Medicine: Translational Research in Older Women"
Alice Ryan, PhD
Professor, Division of Geriatrics & Medicine
University of Maryland
School of Medicine
DATE: Tuesday, February 26, 2013
TIME: 5:00 - 6:00 p.m.
LOCATION: Levin Hall South Auditorium
Reception following in Levin Hall Foyer, everyone is welcome to attend
Please plan to attend the Open Forum on the Future of Research at UTMB. Your input is an important component to capturing strategic campus-wide input about the impact and benefit of research.
Participation is critical to the committee’s efforts in preparing a report that will guide leadership in strategies to showcase the path for research at UTMB as well as how to best respond to static or shrinking federal research funding over the next five years.
The Open Forum will be
Tuesday, February 26, 2013
Levin Hall North Auditorium, 2.220
Learn how to log into ITS Direct Connect and submit a ticket for help with your translational research.
Using ITS Direct Connect is quick and easy! Get your answers directly from our offices at the Institute for Translational Sciences. View the video to find out how.
Management of Technology is the first in a series of online courses designed to introduce participants to a broad range of topics related to management of technology and technological innovation in biomedical fields. The course will include discussion of technology development in industry, academia and government, the process of innovation, the drivers of innovation in a global environment, organizing and leading innovation, and incorporating technology change into company structure and strategy. This course is offered jointly through the UTMB Institute for Translational Sciences (ITS) new Collaborative Innovation & Entrepreneurship Training Program.
The 8-week course begins February 25, 2013. The program is open to all interested UTMB and UT Houston Health Science Center faculty, researchers, postdocs and graduate students. UTMB graduate students and postdocs should register for HPTM 6290 to receive transcript credit for the course. A pre-requisite in "Foundations of Management" module must be successfully completed prior to the start of the course. This self-study reading will be supplied shortly after registration.
To find out more about the Institute for Translational Sciences, visit us at:
Register Now: “Epidemiological & Statistical Methods in Clinical Investigation” Course
“Epidemiological & Statistical Methods in Clinical Investigation”, is a series of 13 weekly sessions as a module in the Institute for Translational Sciences Education Program titled, “Clinical Research: Tools and Techniques”. This module will begin Monday, February 25, 2013, 5:15 p.m., Research Building 6 (formerly Children’s Hospital), Room 2.312. The sessions provide an overview of Epidemiological and Statistical Methods in Clinical Investigation. A brochure further describing the sessions is available upon request or at http://www.its.utmb.edu/documents/EpideStatsBrochure.pdf
To register, complete and submit the registration form located on the brochure or contact the Institute for Translational Sciences – Education Office by email CTSA@utmb.edu or phone 772-1484. The course fee of $55 covers registration, letter of completion, Risk Education, GME credit, and refreshments. (Those who have already registered for this year’s course, “Clinical Research: Tools and Techniques” do not need to register again for this module.) To find out more about the Institute for Translational Sciences’ Education Programs, visit “Learning” at: http://www.its.utmb.edu/ .
Research Services announces the return of the Ethical Considerations in Human Subject Research, formerly known as Advanced Training Program on the Protection of Human Research Participants (ATP). Classes will begin Feb. 6 and continue every other week through May 29. All classes will be 11 a.m. to 1 p.m. in Rebecca Sealy East 4.302/4.304.
This program is designed for investigators, Institutional Review Board (IRB) members, potential investigators, research team personnel (including staff nurses, clinical research coordinators, and technicians), residents, fellows, graduate students, and medical students.
The program requires a 35-hour commitment. This includes 20 hours of classroom lecture and discussion, and approximately 15 hours of study and research time outside of the classroom, including small group work and attendance at a Friday IRB meeting. Classes will cover the following areas of training:
• IRB structure and operations
• Mock IRB meetings for protocol review
• Informed consent process
• Applying the principles of ethics to research design
• Good Clinical Practice
Part of the small group work will consist of drafting an initial protocol submission for IRB review. A classroom will be reserved for use by small groups during the off-weeks, at the same time as the regular classes. Attendance in the off-week is not mandatory, but the room and space will be available to help facilitate effective and productive small-group work.
Upon successful completion of the course, participants will receive a certificate of completion, as well as a full Good Clinical Practice certificate.
There are no registration fees for this program. However, an applicant Statement of Interest form, available online at http://research.utmb.edu/Education/adtraining.shtm,is required and due no later than Feb. 24.
“Scientific Writing for Clinical Research”, offered by the Institute for Translational Sciences - Education Office (Constance D. Baldwin, Ph.D., Course Director), is designed to help participants develop an effective writing style for scholarly documents, with special emphasis on research articles and grant proposals. Presented as 4 interactive seminars, the course includes constructive critique of a variety of writing samples.
The afternoon sessions are held from noon-3:00pm. All sessions will be held in Marie Hall room, 4th floor, Health Professions / Nursing Building.
Wednesday, February 13, 2013
Friday, February 15, 2013
Wednesday, February 20, 2013
Friday, February 22, 2013
If you are interested in this course, please send us your registration form by January 16, 2013. Registration after that may be possible if slots are available. The fee of $50 includes registration and refreshments.
Registration forms and detailed information about each session is available at: http://www.its.utmb.edu/documents/SciWrightingBrochure.pdf , or from Shelly Matejka via email firstname.lastname@example.org or phone 772-1484. Find out more about the Institute for Translational Sciences at: http://www.its.utmb.edu/
FUNDING PERIOD 04/01/13 – 03/31/14
ELECTRONIC LETTER OF INTENT PACKAGE DUE January 15th, 2013
ELECTRONIC PROPOSALS DUE February 15th, 2013
Funds are available through the NIEHS Center at UTMB to support pilot studies designed to improve environmentally-linked human health through basic and translational research endeavors. Proposals are open to all UTMB investigators eligible for federal funding, but should be compatible with NIEHS Center’s mission and document objectives consistent with environmental health research and/or environmentally-based community outreach and engagement. Membership discounts and privileges for the use of NIEHS Center-sponsored service cores will be extended to non-Center members who receive pilot project funding.
Two types of proposals will be accepted: Individual research pilot projects with budgets up to $25,000 for one year, and collaborative pilot projects with budgets up to $50,000 for one year. To be eligible for the collaborative research pilot funding, proposals require collaborations between at least two Principle Investigators (co-PIs).At least one co-PI should be a current member of the UTMB NIEHS Center. Similar to the NIH multiple-PD/PI model, the goal of the collaborative pilot is to encourage collaboration among equals when that is the most appropriate way to address a scientific problem, rather to replace the traditional single PD/PI model with an increased budget.Project proposing the use of core facilities, collaborations between a junior and more senior investigator, and Pilot Projects describing translational research are especially encouraged. Involvement of a Co-PI from another institution(s) is permitted. An investigator may apply for only one award per grant round as PI or Co-PI.
KEYWORDS: exposure, effects and susceptibility biomarkers; environmental genomics; gene-environment interaction; comparative biology; epigenetics; comparative genomics; exposure biology; global environmental health; epidemiology; DNA repair and mutagenesis; asthma pathogenesis; oxidative stress and signaling; toxicology; public health, community health.
Electronic Letter of Intent Package – DUE January 15th, 2013
Your letter of intent package must include your cover letter, an abstract and a list of five potential reviewers with expertise in your proposed area of research with their complete and current contact information (name, institution, address, phone number(s), web page(s) links, email address and fax number). All reviewers must have an appointment equivalent to Associate or Full Professor and be recognized nationally in the area of the proposed research. Of these five suggested reviewers, no more than three may be internal to UTMB, but not in the same department as the PI. Inclusion of former colleagues, mentors, those with whom you have published within the last 5 years, or others for whom reviewing would represent a conflict of interest is inappropriate. The intent package should be sent electronically to Tracie Albritton at email@example.com no later than 5:00pm on the due date.
ELECTRONIC PROPOSALS – DUE February 15th, 2013
Proposals should follow the standard NIH R01 guidelines. The proposal may not exceed six pages (items 1 to 4), of single spaced text using 11 point Arial font. Margins should be at least ½ inch on each side. These six pages should include:
1. Specific Aims
2. Background and Significance
3. Preliminary studies (if any)
4. Experimental design and methods
5. A one page cover letter (not included in the six page limit) describing how Pilot Project studies will be developed into an extramural grant proposal articulating a defined hypothesis, future specific aims, and identification of likely funding sources. The letter should also briefly describe environmental health relevance.
Your application must also include the following supporting documents using current NIH 398 forms:
1. face page
2. abstract (398 form page 2)
3. one year detailed budget
4. Budget justification including justification of any supply and salary support expenses. (Salary support for PI and co-PIs, computers and travel to scientific conferences are not allowable expenses.)
5. Current biosketches of key personnel
6. other support page(s)
7. resources and environment
8. any pertinent IRB or IACUC approvals
A pdf file of your original application must be electronically received by Tracie Albritton no later than 5:00pm on the due date. Incomplete application packages will be returned to the PI without further review.
For further information contact:
Tracie Albritton, NIEHS Center, Senior Administrative Manager
Phone: 772-5609, Mail Route 0654
Claude Pepper Older Americans Independence Center
Request for Applications (RFA)
Purpose: The Claude Pepper Older Americans Independence Center in collaboration with the Institute for Translational Sciences invites applications for the 2013 Pepper Pilot Research (PPR) awards in aging research.
Topics of research interest include but are not limited to: muscle function/strength, sarcopenia, disability, mobility, and recovery of physical function after illness.
Support: Based on availability of funds, we anticipate funding 2-4 highly meritorious pilot applications beginning May 1, 2013.
Award and Project Period: PPR awards will be for one or two years, with total annual direct cost not to exceed $30,000 per year. A second year of support may be requested and will be based on availability of funds and reasonable progress made toward study goals in Year 1.
Eligibility: PPR awards are open to UTMB investigators at the Assistant or Associate level.
Letter of Intent – A letter of intent (LOI) and NIH biosketch are required. The LOI (one-page) will briefly describe an area of research interest and how the PPR award will facilitate this interest. The LOI Deadline is January 7, 2013 – no extensions will be given.
LOIs will be reviewed by the Executive Leadership of the Pepper Center to identify the most promising candidates. Selected candidates will be requested to submit a full proposal with the following elements:abstract (1-page); specific aims (1-page); research strategy (5-pages) including significance, innovation, and approach; IRB approval and protection of human participants section prepared according to current NIH instructions;budget and budget justification; biosketch in NIH format; and a list of other support from intramural and extramural sources. Full proposals will be due March 21, 2013 – no extensions will be given.
For further information on the PPR Awards please visit our website:
Questions related to the RFA or LOI should be directed to Pepper Center Associate Director, Tony DiNuzzo, PhD, email: firstname.lastname@example.org.
The School of Medicine supports a robust program of university-wide core laboratory resources to facilitate its research mission. The Provost established the University Core Development Committee (UCDC) to advise the Research Executive Committee and him on issues related to core support, management and acquisition of new technology.
In order to improve our award rate for NIH instrumentation grants, the Provost has asked investigators who wish to develop applications for the Shared Instrumentation Grant (S10), High End Instrumentation Grants (S10) and Core Facility Renovation, Repair and Improvement grants (G20) to coordinate their applications with the UCDC. The purpose of the UCDC review will be to assist in enhancing the competitiveness of these applications. The UCDC can help develop a strong user group, assist in developing sustainable management plans, frame the instrumentation request in the context of on-going core laboratory activities and can plan an application strategy for instrumentation requests that may be duplicative or parallel. The involvement of a university-wide planning group, the UCDC, should strengthen the case, secure institutional support and improve competitiveness.
The next round of proposals for the Shared Instrumentation Grant (S10) is due March 21, 2013 (http://grants.nih.gov/grants/guide/pa-files/PAR-13-008.html). Thus, investigators and groups developing these applications will need to submit to the UCDC a Letter of Intent, and their Abstract fully describing the instrument, Users and the needs that it will service as well as the Management Plan by February 21, 2013. The UCDC will then assist the PI with the management plans and the institutional documents required for support of the application.
Given the anticipated value to UTMB of the UCDC review of such an application, a PI’s failure to disclose such an application to the UCDC may result in UTMB not endorsing the application.
Please have the above listed documentation to the OSP contact person (Ericia Huff, email: email@example.com) no later than February 21, 2013.
“Regulations and Ethics in Clinical Research”, is a series of 10 weekly sessions as a module in the Institute for Translational Sciences Education Program titled, “Clinical Research: Tools and Techniques”. This module will begin Monday, October 8, 2012, 5:15 p.m., Children’s Hospital, Room 2.312. The sessions provide an overview of regulations and ethical principles involved in clinical investigation. A brochure further describing the sessions is available upon request or at :
IRB ethics preparation, Risk Education, and GME credits are available for selected sessions.
To register, complete and submit the registration form located on the brochure Internet site, or contact the Institute for Translational Sciences – Education Office by email CTSA@utmb.edu or phone 772-1484. The course fee of $55 covers registration, letter of completion, Risk Education, GME credit, and refreshments. (Those who have already registered for this year’s course, “Clinical Research: Tools and Techniques” do not need to register again for this module.) To find out more about the Institute for Translational Sciences, visit us at: http://www.its.utmb.edu/index.html
“Clinical Research: Tools and Techniques”, is a series of 35 weekly sessions offered to faculty, fellows, residents, graduate students and others interested in clinical investigation by the Institute for Translational Sciences – Education Office (Karl E. Anderson, M.D. Course Director). This course will begin Monday, August 13, 2012, 5:15 p.m., Children’s Hospital, Room 2.312. The one-hour sessions provide an overview of ethics, methods, and issues in the conduct of research involving human subjects. Click here for a brochure further describing the sessions. Risk Education, and GME credits are available for selected sessions. The course is also offered to students enrolled in the Graduate School of Biomedical Sciences as PHS 6135.
To register, complete and submit the registration form located on the brochure or on the course website. Those who register may choose to attend any or all sessions and may make up missed sessions the next year. Upon request, participant attendance and self-assessment results may be reported to training program directors.
For more information contact the Institute for Translational Sciences - Education Office at 772-1484. The course fee of $55 covers registration, letter of completion, Risk Education and GME credit, and refreshments.