As the summer winds down, it’s time for some news and updates regarding our HRPP:
I. First, some procedural changes and items of interest:
- Commencing September 1st, a current registration document must be submitted in your continuing review submission packages.
- Responses to CORIHS concerns will not be forwarded for review to the applicable committee unless all study team signatures are present, and all CITI trainings are current. To help facilitate a quick turn-around for study approval, please ensure that these items are taken care of as soon into the initial submission process as possible.
- Do you use/are you considering use of MTurk as a means to conduct anonymous surveys? Over the past year, many articles have been published indicating that anonymity is not maintained using this survey tool . Be sure to consider this in your study design, and resulting implications for IRB review type (exempt, expedited etc.).
ORC has been analyzing, and trying to improve upon, turn-around times for exemption determinations for exempt studies. The average time has decreased from 77 days (April 2012-March 2013) to 41.3 days (October 2013 to June 2014). Obviously, both ORC staff and i nvestigators contribute to turn-around times for study approvals. We will continue to monitor and modify ORC efficiencies, and we ask that you take care to submit complete IRBNet packages to us, including appropriate signatures and training , and to reply to concerns in a timely manner. Our next focus for improvement will be turn-around times for expedited reviews, and we’ll keep you posted on that effort.
II. Next, Important Reminders from Past Updates:
- Completion of inclusion/exclusion criteria checklists is required for all subjects enrolled in more-than-minimal risk (full committee review) studies, including industry-initiated/funded studies reviewed by CRRI (Chesapeake Research Review, Inc.). These checklists should contain required eligibility ranges where applicable, and a line to write the subject’s actual value. Maintained along with all backup documentation (lab values, x-ray reports, confirmation of diagnosis etc.), this information provides definitive proof of your study subjects’ e ligibility. At the time of continuing review, you will need to submit a redacted, completed checklist for the last subject enrolled during the prior approval period. Random audits of the backup documentation will be conducted by ORC to assess compliance with this new requirement.
- Submit your audit/monitoring reports: If your study is ever audited or monitored by an outside agency (e.g., federal agency, pharmaceutical companies/CRO monitors etc.) please be sure to submit the resulting report in IRBNet as soon as it is received (if no findings, submit at the time of continuing review at the latest). If you need any documentation from ORC when preparing for an audit or monitoring visit, please feel free to contact us as early in the process as possible.
III. Finally, some answers to a few common questions:
- When is a research activity considered permanently closed?
a) no new subjects will be enrolled, and
b) there will be no more intervention or interaction with enrolled subjects and
c) no further analysis of identifiable data/tissue will be conducted. Either analyses are complete or data/tissue have been permanently de-identified (i.e., with all identifiers and keys to codes destroyed).
- How long do you need to keep your records once your IRB-approved research is permanently closed? Well, it depends:
General requirement for records that do NOT include identifiable health information: Records relating to the research must be retained for at least 3 years after completion of the research.
General requirement for records, that do include identifiable health information: Records relating to the research must be retained for at least 6 years after completion of the research.
For Investigational New Drug (IND) research, the FDA requires that sponsors and investigators retain “records and reports required by this part for 2 years after a marketing application is approved for the drug; or if an application is not approved for drug, until 2 years after shipment and delivery of the drug for investigational use is discontinued and the FDA so notified.”
For Investigational Device Exemption (IDE) research, the FDA requires the investigator or sponsor to maintain the records “for a period of 2 years after the latter of the following two dates: The date on which the investigation is terminated o r completed, or the date that the records are no longer required for purposes of supporting a premarket approval application or a notice of completion of a product development protocol.”
For research funded by industry or private foundations, the investigator should maintain the records for either the length of time required by the sponsor, or 3 years, whichever is longer.
Provost’s Lecture Series: Deeper Learning by Design: Seven Key Lessons from a Quarter Century of Research
Dr. Thomas Angelo is Assistant Provost, Founding Director of the Center for the Advancement of Faculty Excellence, and Professor of Higher Education at Queens University of Charlotte, NC. Over the past twenty-five years, Tom Angelo has served, often concurrently, as a faculty member, faculty developer, academic administrator and/or researcher at several institutions, including: Harvard University, the University of California-Berkeley, California State University, Long Beach, Boston College, the University of Miami, the American Association for Higher Education (AAHE), Victoria University of Wellington (New Zealand), and La Trobe University (Australia). He has directed six university teaching and learning centers, four of which he also designed and founded. Throughout, he has continued to teach undergraduate courses in political science, freshman composition, teacher education, and introductory statistic, as well as postgraduate courses in applied linguistics, assessment and evaluation, and higher education. His research interests focus on formative assessment, curriculum renewal and redesign, and research-led teaching. His best-known publication is Classroom Assessment Techniques: A Handbook for College Teachers, 2nd Edition (with K. Patricia Cross, 1993), with more than 100,000 copies in print. A substantially revised 3rd edition will be published later this year. Other publications include Classroom Research: Early Lessons from Success,Classroom Assessment and Classroom Research: An Update on Uses, Approaches, and Research Findings, and more than thirty-five articles and chapters. Co-Sponsors: Teaching, Learning & Technology Faculty Center; College of Arts and Sciencs; Program in Undergraduate Biology; Center for Science and Mathematics Education; Center for Inclusive Education.
Abstract: Over the past 25 years, research in cognitive science, psychology and higher education has advanced dramatically. Yet other than new technological tools in use, and some changes to teaching practice, how significantly has the design of most courses and programs changed as a result? In this highly interactive lecture, we’ll consider seven potentially transformative “lessons” and their implications for promoting deeper learning through research-informed curriculum design. Topics will include: metacognition, critical thinking, distraction/multi-tasking, self-assessment, stereotype threat, studying, and feedback. In each case, we’ll identify relevant, practical applications to curriculum design and teaching and even try out a few ourselves. Whatever your discipline, you can expect to take away at least three research-based strategies/techniques to apply to your own work, as well as resources and references for future use.
Thursday, August 8, 4:00 pm, Wang Center, Lecture Hall 2
|The Research Foundation (RF) has achieved a major milestone in service to campuses by making its policies, procedures and guidance documents available on the RF public website.”The accomplishment of this key operational goal provides a valuable and desired service to our campuses and sponsors, and supports our commitment to transparency to our public constituencies and stakeholders,” said RF President Dr. Timothy Killeen. “The public posting of this information allows sponsors of SUNY research to see how our policies and procedures conform to federal and state laws and regulations, and enables RF employees at campus locations across the state to perform their work more efficiently and effectively. This has been a collaborative effort across the SUNY research enterprise to which campus input and expertise was essential.”RF policies and procedures cover every step of the research grant life cycle – from application review and agreement execution to copyright and intellectual property protection. A new focused search allows users to quickly find a particular policy, procedure, or guidance by keyword and the alphabetical index lets users scan for a document by title or keyword (for example, the Bids and Proposals policy is found under both “B” for Bids and “P” for Proposals).
The RF Compliance Office is directing the next phase of this project – a long-term effort to review and standardize all policies and procedures, prioritized by risk.
Contact RF Compliance Office.
This month’s featured student is Vihitaben Patel, a senior double majoring in Biomedical Engineering and Applied Math & Statistics. Vihita has worked for the last year under the mentorship of Dr. Clinton Rubin, Chair of the Department of Biomedical Engineering, and Dr. Ete Chan, a member of the Rubin Musculoskeletal Laboratory. This past October, Vihita and several undergraduates working in the Rubin laboratory presented at the annual Biomedical Engineering Society meeting in Atlanta Georgia. Vihita was selected as a recipient of the competitive, international Research and Design Award by the Biomedical Engineering Society (BMES) for her work on “Low Intensity Vibration Treatment Tapers Obesity-Induced Type 2 Diabetes by Decreasing the Size of Adipocytes in Mice.” Prior to joining the Rubin group, Vihita had gained research experience working in the BME laboratories of Dr. Yi-Xian Qin and Dr. Helmut Strey. Vihita has presented at the annual URECA poster symposium (2011, 2012);and participated in the 2012 URECA Summer program. Vihita has held the positions of Social Chair for the SBU Biomedical Engineering Society (2012); and Director of the District Safe Kids Training program for the SBU Circle K Club; and has worked as a tutor with the PASS Tutoring Program – Undergraduate Student Government (2011); as a TA for Calculus IV (2011); and as a clerk for Financial Aid Services (2010-present). Vihita also volunteers at Stony Brook Hospital in the pain management ward, and in her freshman year was a member of the University Color Guard. Vihita emigrated from India while in high school, and graduated from Deer Park HS, NY.
For the full interview/feature, please go to: http://www.stonybrook.edu/ureca/researcher-month.shtml
Rouven Essig, PhD, cited for research on Particle Physics at the Cosmic, Intensity, and Energy Frontiers
The prestigious award is given to junior faculty at universities and for staff at national laboratories. Dr. Essig, one of 68 awardees nationwide for fiscal year 2012 chosen from among 850 proposals, was cited for his research in “Particle Physics at the Cosmic, Intensity, and Energy Frontiers.”
“Major efforts at the Intensity, Cosmic, and Energy frontiers of particle physics are rapidly furthering our understanding of the fundamental constituents of nature and their interactions,” Dr. Essig wrote of his work. “The overall objectives of this research project are to interpret and develop the theoretical implications of the data collected at these frontiers and to provide the theoretical motivation, basis, and ideas for new experiments and for new analyses of experimental data.”
According to the DOE, “The funding opportunity for researchers in universities and DOE national laboratories, now in its third year, supports the development of individual research programs of outstanding scientists early in their careers and stimulates research careers in the disciplines supported by the DOE Office of Science.”
“Professor Essig has an unusually broad research program, engaging all three of the Intensity, Cosmic and Energy frontiers that are at the forefront of the U.S. program in particle physics,” said George Sterman, Director of the C.N. Yang Institute for Theoretical Physics. “Professor Essig’s research encompasses searches for new laws of physics at giant particle accelerators and in cosmic ray detectors in both satellite observatories and earth-bound laboratories. Not content simply to suggest new experiments, Professor Essig is unusual among theorists by taking part directly, as co-leader for an experiment being carried out at the Jefferson National Accelerator Facility.”
Dr. Essig received his doctorate from Rutgers University in 2008 and was a postdoctoral research associate at the SLAC National Accelerator Laboratory before joining the faculty of Stony Brook University’s C.N. Yang Institute last year.
American Council of Learned Societies (ACLS)
The ACLS Fellowship Program invites research applications in all disciplines of the humanities and related social sciences. Appropriate fields of specialization include, but are not limited to:
- American studies
- Art and architectural history
- Languages and literatures
- Legal studies
- Political science
- Religious studies
- Communication and media studies
- Theater, dance, and performance studies
Proposals in the social science fields listed above are eligible only if they employ predominantly humanistic approaches (e.g., economic history, law and literature, political theory). Proposals in interdisciplinary and cross-disciplinary studies are welcome, as are proposals focused on any geographic region or on any cultural or linguistic group. The ultimate goal of the project should be a major piece of scholarly work by the applicant. ACLS does not fund creative work (e.g., novels or films), textbooks, straightforward translation, or pedagogical projects.
The applicant must meet the following eligibility criteria:
- A Ph.D. degree conferred at least two years before the application deadline. (An established scholar who can demonstrate the equivalent of the Ph.D. in … more »publications and professional experience may also qualify.)
- U.S. citizenship or permanent resident status as of the application deadline date.
- A lapse of at least two years between the last “supported research leave” and September 1, 2013, including any such leave to be taken or initiated during the 2012-2013 academic year.
Therefore, to be eligible, an individual’s most recent supported research leave must have concluded prior to September 1, 2011. (Supported research leave is defined as the equivalent of one semester or more of time free from teaching or other employment to pursue scholarly research or writing supported by sabbatical pay or other institutional funding, fellowships and grants, or a combination of these. This definition applies to independent scholars as well as those with institutional affiliations.)
The ACLS Fellowships are intended as salary replacement to help scholars devote six to twelve continuous months to full-time research and writing. ACLS Fellowships are portable and are tenable at the fellow’s home institution, abroad, or at another appropriate site for research. (1) An ACLS Fellowship may be held concurrently with other fellowships and grants and any sabbatical pay, up to an amount equal to the candidate’s current academic year salary. Tenure of the fellowship may begin no earlier than July 1, 2013 and no later than February 1, 2014.
The Fellowship stipend is set at three levels based on academic rank: up to $35,000 for Assistant Professor and career equivalent; up to $45,000 for Associate Professor and career equivalent; and up to $65,000 for full Professor and career equivalent. ACLS will determine the level based on the candidate’s rank or career status as of the application deadline date. Approximately 25 fellowships will be available at the Assistant Professor level, approximately 20 at the Associate Professor level, and approximately 20 at the full Professor level.
Deadline: September 28, 2012
Full details: http://www.acls.org/grants/Default.aspx?id=380
Council of Learned Societies
633 Third Avenue, Eighth Floor
New York, New York 10017-6795
Phone: (212) 697-1505
Fax: (212) 949-8058
Training on IRBNet
Need a first time, or refresher training on IRBNet or the approval process for IACUC and/or IBC? Our next in-person training for IACUC and IBC’ers will be:
Thursday, February 2nd, 1:00-2:30 p.m. in the Office of Research Compliance, Melville Library (Main Campus), 5th floor, W5530.
Snacks will be served. Interested? RSVP to firstname.lastname@example.org
The Toolbox Project Collaborative Communication Workshop provides a philosophical yet practical enhancement to cross-disciplinary, collaborative science. Rooted in philosophical analysis, the Toolbox workshop enables investigators, research development professionals, project managers, and collaborators to engage in a structured dialogue about their research assumptions and cross-disciplinary collaboration. This yields both self-awareness and mutual understanding, supplying individuals with the robust foundation needed for effective collaborative research. Led by Toolbox Project Facilitators, Workshop participants will engage in small group discussion and share respective views in response to a number of probing statements about science motivation, methodology, confirmation, objectivity, values, and reductionism.
The workshop is part of the SciTS Conference 2012, being held at the Wyndham Chicago Hotel on Monday, April 16, from 8:30 AM – 12:00 PM. The cost is $175/person and includes Continental breakfast, refreshments, and lunch. Pre-formed groups of collaborators can participate together, contact Holly Falk-Krzesinski, PhD, Conference Chair at 312-503-0889, or email@example.com for more information. Space in this Workshop is limited, and early bird discounted registration ends February 12.
Dr. Sharon Nachman, Study Chair, Calls Drug Important New Option
For children and adolescents with HIV infection, the recent Food and Drug Administration (FDA) approval of the use of raltegravir, an antiretroviral drug that slows the spread of HIV infection, offers a new weapon to treat HIV infection in children. So says Sharon Nachman, M.D., Associate Dean for Research and Professor of Pediatrics, Stony Brook University School of Medicine, and the Principal Investigator and Study Chair of a national multicenter clinical trial that studied the safety and efficacy of raltegravir in HIV-infected children and adolescents.
The FDA approved raltegravir for use with other antiretroviral drugs for the treatment of HIV infection in children and adolescents ages 2 to 18 years on December 21. Approved for use in adults in 2007, raltegravir is part of a class of medications called HIV integrase inhibitors.
In the clinical trial, sponsored by the National Institute of Health’s National Institute of Allergy and Infectious Diseases, all of the 96 patients enrolled had previously been treated with a regimen of other HIV medications before raltegravir. After being treated for 24 weeks with raltegravir, 53 percent of the patients had an undetectable amount of HIV in their blood.
“Raltegravir is an important new option for children with HIV. The trial shows it has an excellent efficacy profile in children with HIV who have failed other regimens and is also effective against the virus regardless where the child lives around the word,” says Dr. Nachman. “The data also shows no significant toxicities or interactions with other HIV medications.”
The formulation of raltegravir in children is a pill that can be taken twice daily, with or without food. For younger patients, there is a chewable form. Dr. Nachman points out that in addition to the drug being an important new option for pediatric patients, the formulations available are more convenient and may help increase patient compliance.
The FDA indicates that the most commonly reported severe, treatment-related side effects in patients taking raltegravir include insomnia and headache. The frequency of these side effects is similar in adults and children.
Dr. Nachman says that the study of the use of raltegravir to treat HIV in children and adolescents will continue. Each child enrolled will be followed for five years. During that period, Dr. Nachman and colleagues will continue to evaluate efficacy and any long-term complications of the medicine in the patient population.
The study provides the only pediatric data on the use of raltegravir in patients ages 2 to 18 years. Patients are enrolled through Stony Brook and other study locations nationwide. Dr. Nachman says that one of the next steps to advance the study is to evaluate a novel baby formulation.
Four Stony Brook University Professors — George Sterman, Ph.D. (Physics), Peter Stephens, Ph.D. (Physics), Lorna Role, Ph.D. (Neuroscience), and Benjamin Hsiao, Ph.D. (Chemistry), — have been named 2011 American Association for the Advancement of Science (AAAS) Fellows. The AAAS Council elected only 539 of its more than 125,000 members to this elevated rank because of their efforts toward advancing science applications that are deemed scientifically or socially distinguished.
They will be recognized for their contributions to science and technology at the Fellows Forum to be held on 18 February 2012 during the AAAS Annual Meeting in Vancouver, British Columbia. The new Fellows will receive a certificate and a blue and gold rosette as a symbol of their distinguished accomplishments.
Effective with the Winter 2012 deadlines beginning on January 24, 2012, American Heart Association is requiring that each applicant either be an American Heart Association Professional Member or pay $100 per application submission. This fee will help to defray the administrative cost of processing applications, making more funds available for research awards.
A new Membership/Application Fee page has been added to the AHA application form in Grants@Heart. From this page, one may click a link to renew or join AHA Professional Membership. Membership tiers start at $75. Applicants who opt to pay the $100 application fee, instead of joining, will be required to enter credit card information prior to submitting their application to the grants officer (GO). Until an applicant joins/renews AHA Professional Membership or enters credit card information to pay the fee, s/he will not be able to submit the application to the GO. As in the past, all applications are submitted to the institutional Grants Officer, who then approves and submits that application to AHA on behalf of the applicant and institution. If you choose to pay the application fee, the data fields will become blank after transmission to your institutional Grants Officer and they will not be able to see your personal payment information.
The Office of the Vice President for Research will reimburse each faculty member for the $100 application fee or the cost of the basic AHA Membership fee of $75. Please submit a Purchase Requisition (leave the ‘Department Information’ section blank) with a receipt showing your payment and submit to Jin Bentley in OVPR (zip 3365).
Questions about processing your grant application should be addressed to your Grants Administrator in the Office of Sponsored Programs. Questions regarding the process for reimbursement shouldmay be directed to Jin Bentley at 632-8589.
AHA Professional Membership Information: AHA Professional Membership
AHA’s winter 2012 program offerings: AHA winter 2012 Research Funding Opportunities
Application forms and instructions: Grants@Heart
On September 15, 2011 the Federal Office of Management and Budget directed federal agencies to accelerate stimulus fund spending by taking steps to ensure grantees complete ARRA projects by September of 2013.
Both NSF and NIH have issued guidelines with the following provisions to meet this requirement:
1) For awards that are scheduled to end on or BEFORE September 30, 2013, No Cost Extensions will require prior approval, eliminating the ability of awardees to extend the expiration date beyond September 30, 2013 without such approval. This will be specified via an amendment to the Standard Terms and Conditions of the award.
2) In those situations where a No Cost Extension is needed, and with an extension the project will still be completed on or before September 30, 2013, no amendment to the Standard Terms and Conditions is necessary. However, grantees still are encouraged to responsibly accelerate spending.
3) In those situations where prior approval of a No Cost Extension is necessary, YOU MUST REQUEST THE NO COST EXTENSION BY JUNE 1, 2012, regardless of the term date on your award. NSF and NIH will grant approvals based on the allowable exceptions per OMB M-11-34 (i.e., project is long-term by design, projects requires complex environmental review, contractual commitments with subs/vendors legally prevent adjusting the timeline, acceleration of spending may cause harm or risk to vertebrate animals or human subjects). Please work with your OSP Grants Administrator to craft the language of your request letter.
4) For awards that are scheduled to end AFTER September 30, 2013, NSF and NIH staff may reach out to you to accelerate spending, and possibly request that the award be amended to be completed on or before September 30, 2013.
5) Construction and Renovation of Facilities awards most likely are scheduled to end AFTER September 30, 2013. The guidance from both NSF and NIH is not obvious in how these types of projects are to be treated, though it seems there would be common understanding that “accelerating spending” poses unique challenges.
6) COGR has not seen similar guidance from other agencies. However, you should note all agencies are under the same pressure to accelerate spending and are likely to adopt the same or similar provisions.
Links to the full agency announcements are below:
This month’s featured student is Kenneth Ascher, a Mathematics major and musician in the Honors College, who is working on his senior honors thesis on enumerative geometry with Professor Radu Laza (Mathematics), while training as a jazz trumpeter in SB’s Big Band Jazz Ensemble under the direction of Ray Anderson, Director of Jazz Studies (Music Department). In developing his mathematical and musical identity, Kenneth has benefited from these and many other mentors and experiences from Stony Brook and across the country.
Kenneth came to SBU from Oceanside HS in fall 2008. In summer 2009, he participated in a Research Experiences for Undergraduates (REU) program at Texas A&M where he studied Fourier Analysis and Wavelet Decomposition, using MATLAB applications to distinguish between forged and genuine signatures. In his sophomore year, Kenneth gained experience in computational biology working in Professor Robert Rizzo’s research group (Applied Mathematics & Statistics). During summer 2010, Ken participated in the REU program at Texas A&M University once again, this time working with Professor J. Maurice Rojas in Computational Algebraic Geometry and tackling the study of fewnomial theory and the classical question of when a polynomial has real roots. Follow-up work on that REU project — finding sharp bounds on the number of expected (non-zero) real roots to univariate polynomials — is currently in preparation for publication; and led to Ken being selected for the Council for Undergraduate Research Award at the 2010 MAA Mathfest Conference (Pittsburgh PA) for best presentation on original research, and for an “Outstanding Presentation Award” at the 2011 Joint Math Meetings Poster Session (New Orleans, LA). This past summer, Kenneth joined an REU program at Northern Arizona University where he worked with Professor Michael J. Falk to investigate complex hyperplane arrangements, delving into advanced topics within algebra, algebraic topology, combinatorics, and algebraic geometry. When he presented “Topology of Graphic Hyperplane Arrangements,” at the 2011 Young Mathematician’s Conference at Ohio State University this past August, Ken received an Outstanding Presentation Award. Kenneth has also participated in the Garden State Undergraduate Mathematics Conference (1st place, Team Competition 2010; 2011 Poster Session Winner), at the AMS Spring Eastern Sectional (Worcester, MA); and at the URECA 2011 symposium. Kenneth was awarded the Mathematics Department Junior award (as a sophomore). He has spent many hours tutoring at the Math Learning Center (Fall 2009-present), and has also served as a TA and/or instructor for MAP 103 (Proficiency Algebra) and MAT 123 (Introduction to Calculus). Kenneth Ascher is currently applying to graduate (Ph.D.) programs in mathematics.
For the full interview/feature, please go to: