March 2017

Research Match, a national research volunteer registry, has come to SBU!

ORC is pleased to announce the availability of a new tool for our researchers to assist in subject recruitment. Stony Brook has recently signed a contract with the national registry ResearchMatch (RM), that connects researchers with volunteers who wish to get involved in research studies. This national registry provides a secure, web-based approach to address a key barrier to advancing research: participant recruitment.

This new tool allows you to conduct targeted searches for potential volunteers based on location and specific demographics. If you would like to ‘look around’, feel free to register for feasibility access. This will allow you to go into the system to explore what it is all about and even see how many people registered might fit the criteria for a study currently ongoing or one you are thinking about. Here’s all you have to do:

1. Navigate to https://www.researchmatch.org/

2. Click “Researchers” at the top of the page

3. Green button “Register Now” (If you think you’ll need help registering, click on the tutorial link below the green button)

4. Select “Stony Brook University” as the institution

5. Type in your Stony Brook email address

6. Retrieve verification code from your email, cut and paste it into RM

7. Read site instructions

8. Read Researcher Acknowledgement form and “ACCEPT”

Like what you see? The “ResearchMatch Recruitment Method Instructions”, available in the forms and templates area in IRBNet provides the details for adding this recruitment method to both new and existing studies. Once you have IRB approval for your study, including an approved RM contact message, one of our RM liaisons can approve your message to be sent to registered RM users (i.e., potential subjects). If a user is interested in volunteering for your study, they accept your invitation and release their information to you for direct contact. That’s it! We hope you find this new tool useful in facilitating your research efforts.

NIH’s Genomic Data Sharing (GDS) Policy: Update

As a follow-up to our article on the NIH GDS policy in the Fall 2016 Research News, we are happy to report that our efforts to create SBU-specific guidance, GDS plan template, institutional certification, and consent language has been completed. We again thank our colleagues from Stanford University for their generosity in allowing us to ‘not re-invent the wheel’ when coming up with these documents.

We have added a special topic on Genomic Data Sharing for NIH grant submissions to our Standard Operating Procedures that includes guidance, instructions, FAQ’s, and resources regarding compliance with this NIH policy. Similarly, our CORIHS application and consent templates have been modified to capture necessary GDS information, and the GDS plan template (“Human Genomic Data Sharing Plan Template”) now resides within the forms and template area of IRBNet for your use.

Have You Received Initial or Continuing IRB/CORIHS Approval Recently?

If yes, you may have noticed a new section on your approval letter. It states:

“When you are ready to schedule and undergo the consent process with your first post-approval subject, please contact Mary O'Neill at Mary.Oneill@stonybrook.edu to coordinate having her present to witness your consent process. This process is part of our ongoing effort to ensure maintained quality in our human research protection program.”

So, if you are still in the accrual phase of your research, please let Mary know (if at all possible), when you will be consenting your next research subject, so she can observe your consent process. Together, we need to make sure that the people who volunteer in our research activities get all the information they need to make a decision regarding participation, in an understandable, un-rushed manner.

Revised Human Research Regulations (45 CFR 46 Subpart A-‘Common Rule’) Finalized…but…

The long-awaited (and feared!) revisions to our federal regulations at 45 CFR 46 became final on January 19, 2017, with an effective date for most of the changes of January 19, 2018. The official version published in the Federal Register is here.

For those of you who would like a good synopsis and assessment of the final rule, the national organization Public Responsibility in Medicine and Research (PRIM&R) provides an excellent guidance page on all things ‘revised Common Rule’ here.

Overall, most of us in the business were quite pleased that the final rule eliminated many of the bureaucratically burdensome, ‘roadblock’ proposals that were in the prior notice of proposed rulemaking, which included considering research with completely de-identified bio specimens as constituting human research subject to regulation (including obtaining consent). That’s gone, and that’s good. Some other good changes in the final rule include:

· Adding categories of activities that specifically do not constitute human research (e.g., scholarly and journalistic activities, which includes oral history, journalism, biography etc.).

· Adding categories of activities that do constitute human research, but that are exempt from the regulations (e.g., ‘benign behavioral interventions’).

· A big change that will facilitate all our research lives is best stated per the preamble: “…continuing review is eliminated for all studies that undergo expedited review, unless the reviewer explicitly justifies why continuing review would enhance protection of research subjects.” Also, continuing review has been eliminated for research that has progressed to the point that it involves only data analysis or “accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care”.

· Many other changes too, including harmonization with the NIH new policy on requiring single IRB review for multicenter studies (reported to you in the summer 2016 edition of Research News-note the effective date of that NIH policy has been moved back to September 2017).

HOWEVER, Timing, as they say, is everything. You may have heard that a new administration came in on January 20th. Shortly thereafter, a memorandum was issued that placed a ‘freeze’ on new and pending regulations, giving the new administration time to review them. So, regulations that have been published but have not reached their effective date, like this one, are currently ‘on hold’ for 60 days to permit said review. ORC will keep you informed as to the fate of the final rule. As soon as we know (if) it is here to stay, we will begin preparing our program for the effective date and keep you apprised of all changes as we make them

Great News for IBC and IRB Investigators! No more co-Investigator e-Certifications in IRBNet!

As we are always reviewing our processes to streamline where we can, it is clear that the requirement to obtain co-investigator certifications on IRB and IBC submissions is a time-consuming process for all parties involved. These sign-offs were originally initiated to ensure: that all members of the study team were aware that they were, in fact, members of the study team; that they would know the study details and their role in it; and finally, that they would not perform any research procedure for which they were not qualified/certified/licensed (as applicable).

Removing these certifications from the members of the study team does not mean that the certifications go away completely. As the principal investigators have the critical and ultimate responsibility of the compliant and safe conduct of the research activity, their e-certifications (detailed at the end of the IRB and IBC applications) on the IRBNet package now include the responsibility of ensuring that each member of their study team knows the study details, their roles, their qualifications etc. We are confident that this change in procedure will help to speed up approval processes, while still ensuring the presence of an aware, knowledgeable, and qualified team for the study.

Please note that if you are a principal investigator of studies with external IRBs of record (e.g., Chesapeake, NCI CIRB), you will need to review and upload the 'External IRBs: Principal Investigator Certification' document (located within the forms and documents area of IRBNet) before e-certifying (signing) the IRBNet package.

Export Compliance Training

An understanding of the basics of export controls and potential red flags are important when conducting research or participating in international collaborations, travels or shipments. Penalties and sanctions for non-compliance can be imposed on both the researcher and the institution.  Training options are available on the Export Control Website.

Training Materials on the Responsible Conduct of Research and Scholarship (RCRS)

Did you know that Office of Research Compliance website provides training resources to help the campus community understand such important topics as research misconduct, authorship, mentorship, peer review (to name just a few)

Training resources include available videos created by SBU faculty and staff (from past GRD 500 sessions), articles, other short videos, infographics from external sources; as well as references to applicable SBU compliance policies. These resources are updated as they become available to us. Some new materials just recently added include (from the federal Office of Research Integrity): 

· “Case Studies: Dr. Thompson’s Lab” , that addresses topics such as mentoring relationships, authorship, publication, data integrity, and potential research misconduct.

· “The Research Clinic”, that educates researchers on the importance of protecting research subjects and avoiding research misconduct.

· A set of Infographics (“Everyone Plays a Role in Research Integrity", "5 Ways Supervisors Can Promote Research Integrity", "The Research Community Safeguards Scientific Integrity", " Possible Red Flags of Research Misconduct", "Tips for Presenting Scientific Images with Integrity", "Research Trainees: What You Should Know about Research Misconduct", "Write Ethically from Start to Finish", and "You Suspect Research Misconduct. Now What?").

Feel free to use these, or any of the training resources available on our website. If you know of others, let us know and we will post them as well! If you have any questions regarding training in the responsible conduct of research and scholarship, please contact the Office of Research Compliance at 2-9036.

New System for Diagnosing Mental Health Disorders Challenges DSM-5

Challenging the standard system for diagnosing mental disorders, a worldwide team co-led by Stony Brook University, University of Minnesota and University of Notre Dame researchers, has proposed a new approach to diagnosing mental disorders.

The approach, articulated in a paper published in the Journal of Abnormal Psychology, is a classification system of a wide range of psychiatric problems based on scientific evidence, illness symptoms and impaired functioning. The diagnostic system addresses fundamental shortcomings of the fifth edition (2013) of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), the clinicians’ and researchers’ guidebook to mental illnesses.

Dr. Roman Kotov (center) and some members of the HiTOP consortium at a planning meeting in Chicago in 2016.

Diagnosis of mental illness is important because it defines what treatment a patient should receive. Diagnosis also guides research efforts and is used by drug companies to develop new medications. The newly developed diagnostic approach is called the Hierarchical Taxonomy of Psychopathology (HiTOP). In the paper, titled “The Hierarchical Taxonomy of Psychopathology (HiTOP): A Dimensional Alternative to Traditional Nosologies,” the consortium advances classification of psychopathology beyond the traditional diagnostic systems.

According to the authors, Roman Kotov, PhD, Associate Professor of Psychiatry at Stony Brook University; Robert Krueger, PhD, Professor of Psychology at the University of Minnesota; and David Watson, PhD, Professor of Psychology at University of Notre Dame, substantial evidence has accumulated that suggest major changes to how mental illness is classified, but DSM-5 offered only modest refinements creating dissatisfaction in the research community. The National Institute of Mental Health (NIMH) produced an alternative model to guide mental health research efforts. But this approach also has been controversial, as it focuses heavily on neurobiology and much less on investigating issues that are important for everyday psychiatric care, such as prognosis about illness course and selection of treatment.

As Professor Krueger explains it, the DSM can be challenging to use in everyday practice. “It’s Byzantine,” he says. “It’s like the U.S. tax code. You can get lost in the complexity of its contents and still not find a compelling or accurate way to conceptualize your patient.”

“The HiTOP system has been articulated to address the limitations currently plaguing psychiatric diagnosis,” says lead author Dr. Kotov. “First, the system proposes to view mental disorders as spectra. Second, the HiTOP system uses empirical evidence to understand overlap among these disorders and classify different presentations of patients with a given disorder.”

DSM-5

For example, Dr. Kotov explained that mental health problems are difficult to put into categories, as they lie on the continuum between pathology and normality, much like weight and blood pressure. This is why the spectrum approach is needed. Applying an artificial boundary to distinguish mental illness from health results in unstable diagnoses, as one symptom can change the diagnosis from present to absent. It also leaves a large group of people with symptoms that do not reach the threshold untreated, although they suffer significant impairment.

Also, different DSM-5 diagnoses co-occur with surprising frequency, with most patients labelled with more than one mental health disorder at the same time. Extensive evidence indicates an underlying pattern of several major spectra that cause this overlap. Furthermore, diagnostic categories are so complex that often two patients with the same diagnosis do not share a single symptom in common.

“The HiTOP solution to these fundamental problems is to classify mental illness at multiple levels of hierarchy: the broad level captures the major spectra and specific level reflects the tightly-knit dimensions within them. This approach allows doctors and researchers to focus on finer symptom in detail, or assess broader problems, as necessary,” Dr. Kotov explains.

A good example of this new classification is social anxiety disorder, which is considered a category in DSM-5. The HiTOP model describes social anxiety as a graded dimension, ranging from people who experience mild discomfort in a few social situations (i.e., when giving a talk in front of a large audience) to those who are extremely fearful in most situations. The HiTOP system recognizes that clinical levels of social anxiety are more intense but not fundamentally different from regular social discomfort.

Also, HiTOP does not treat it as a single problem but recognizes important differences between interpersonal fears (i.e., meeting new people) and performance fears (i.e., performing in front of an audience). Moreover, people with social anxiety are prone to other anxieties and depression, and the HiTOP model describes a broad spectrum called “internalizing,” which captures overall severity of such problems.

Overall, the authors emphasize that HiTOP adheres to the most up-to-date scientific evidence, rather than relying largely on decisions by committee (the approach used to construct the DSM-5). In the assessment of mental disorders, the HiTOP approach accounts for information on shared genetic vulnerabilities, environmental risk factors, and neurobiological abnormalities, such as differences in brain activity between the patients and healthy individuals.

SBU Wins Multiple Google Faculty Research Awards

Three faculty members from the College of Engineering and Applied Sciences have received Google Faculty Research Awards, one-year awards given to support the work of world-class faculty members at top universities around the world. This honor highlights Stony Brook’s competitive presence among other top engineering universities on Google’s 2017 winners list, which includes MIT, Stanford University and University of California – Berkeley.

Each year, Google announces an open call for PhD students and faculty at accredited Universities to submit proposals on computer science-related topics. Those chosen gain the opportunity to work hand-in-hand with Google researchers and engineers to develop their research.

Stony Brook’s 2017 Google Faculty Research Award recipients are:

Xiaojun Bi, Department of Computer Science: to develop a model-based approach that will address user interface issues caused by the imprecision of current touch screen technology.

Francesco Orabona, Department of Computer Science: to design parameter-free, automatic machine learning algorithms.

Fan Ye, Department of Electrical and Computer Engineering: to investigate a low-cost, scalable solution for mapping indoor floor plans to serve as the foundation for indoor location based services.

“At Stony Brook, we know our faculty drives innovation not only in the classroom but in the real world as well,” said Stony Brook University President Samuel L. Stanley Jr.  “Receiving three Google Research Awards is a demonstration of the truly transformative work being done by our outstanding faculty. “I congratulate Professors Bi, Orabona and Ye on this award, and thank them for their contributions to the Stony Brook community.”

“I extend my congratulations to Xiaojun Bi, Francesco Orabona and Fan Ye for receiving 2017 Google Faculty Research Awards,” said Michael A. Bernstein, Provost and Senior Vice President for Academic Affairs at Stony Brook University. “We are immensely proud of the elite company that Stony Brook now joins as one of the few universities to have multiple recipients of this award. We are thrilled that the innovative research of these fine colleagues has been recognized with this esteemed honor.”

Click here for more information about each research project.

SBU Awarded NSF Funding for Multidisciplinary Project to Advance Technology

As lead institution for the U.S. ATLAS collaboration, Stony Brook University has received additional National Science Foundation (NSF) funding toward the project. This recent $5.4M award for U.S. ATLAS Operations: Discovery and Measurement at the Energy Frontier will stimulate development of a scientific and technically educated workforce, advancing the multidisciplinary application of technology and the popularization and dissemination of science to the general public.

Stony Brook Physics Professor John Hobbs is principal investigator for U.S. NSF operations of ATLAS, which has received a total amount of over $54M in funding to date. This ongoing project provides the U.S. contribution to the international ATLAS experiment at the powerful Large Hadron Collider (LHC) located at CERN in Switzerland.

This award to Stony Brook will cover the NSF-funded universities participating in the ATLAS experiment and support activities that provide opportunities to develop and maintain complex detector apparatus, custom analog and digital electronics, and software systems for data management, data processing, and technical analysis.

The operation of existing detector components, design of upgrade components, and related research activities create opportunities for interdisciplinary collaboration among personnel at Stony Brook and collaborating institutions as physicists, electrical engineers, mechanical engineers and computer scientists work with post-docs and students. Similarly, physics personnel will work closely with computing professionals at their home institutions and at national laboratories to support the various software and computing activities.

About U.S. ATLAS

 
ATLAS Experiment © 2015 CERN

U.S. ATLAS is the U.S. collaboration for the ATLAS experiment at the powerful Large Hadron Collider (LHC) located at CERN in Switzerland. ATLAS, one of four detectors at the LHC, is designed to detect particles created by proton-proton collisions. ATLAS has already completed one of its main goals, the discovery of a particle called the Higgs boson, which gives mass to the elementary particle building blocks of matter.

U.S. ATLAS is funded by the U.S. Department of Energy’s Office of Science and the NSF. Brookhaven National Laboratory is the host laboratory in the U.S. for the 47 U.S. institutions contributing to the project. In total, 178 laboratories and universities around the world are involved in building, operating and analyzing the data and upgrading parts of ATLAS.

Mark Aronoff Leads Revealing English-Language Study

A Stony Brook University-led study on the history and spelling of English suffixes demonstrates that the spelling of English words is more orderly and self-organized than linguistics have previously thought. The finding, details of which are published in the journal Language, is an indication that the self-organization of English occurred even though the language has never been regulated or governed through the centuries.

Unlike France, Italy and other countries where national academies oversee the written language, no English-speaking country has such an academy. Yet, in the paper, “Self-Organization in the Spelling of English Suffixes: The Emergence of Culture out of Anarchy,” the research examines previously unnoticed systemic aspects of English spelling and explains how the system emerged on its own.

Lead investigator Mark Aronoff, Distinguished Professor in the Department of Linguistics at Stony Brook University, and Kristian Berg from the University of Oldenburg, specifically investigated the spelling of four derivational suffixes and showed the spelling over time is quite consistent – even considering the sounds of the suffixes, like many English words, can be spelled in various ways.

The suffixes include: –ous, found in words such as hazardous and nervous; –ic, found in words like allergic; –al, such as in the word final; and –y, as in funny.

“English spelling was well on its way to its modern incarnation, and no single group seems to have played a notable role in the movement of English spelling toward greater consistency,” said Professor Aronoff. “We show in this article that the system became gradually more consistent over a period of several hundred years, starting before the advent of printers, orthoepists, or dictionary makers, presumably through the simple interaction of the members of the community of spellers, a sort of self-organizing social network,” he summarized.

For each of the suffixes, the authors analyzed a large sample of written English documents dating back close to 1,000 years. For every word that follows a certain modern spelling with the suffix, the authors looked at each instance in their sample and kept track of how the word was spelled. They found a number of spellings for each suffix over time. However, for each suffix one form of spelling eventually won out over another and followed a pattern that led to consistency in spelling.

As a follow-up to the research detailed in the paper, the linguists are now testing their findings on fluent readers of English to see if they use the regularities found and to see if those learning English can learn to read more quickly and fluently with consistent spellings.

The research for the paper was supported by the German Academic Exchange Service (DAAD) and completed while Kristian Berg was a postdoctoral fellow at Stony Brook University.

NIH Salary Cap Changed $187,000 as of January 8, 2017

Purpose

Since 1990, Congress has legislatively mandated a limitation on direct salary for individuals under NIH grant and cooperative agreement awards (referred to here as a grant). The mandate appears in the annual appropriation act that provides authority for NIH to incur obligations for a given Fiscal Year (FY). At this time NIH has not received a FY 2017 appropriation, and is operating under a Continuing Resolution "the Further Continuing and Security Assistance Appropriations Act, 2017" (Public Law 114-254) that applies the terms and conditions of the Consolidated Appropriations Act, 2016.

The Consolidated Appropriations Act, 2016, restricts the amount of direct salary to Executive Level II of the Federal Executive pay scale. The Executive Level II salary was previously set at $185,100, and increased to $187,000 effective January 8, 2017.

For awards issued in those years that were restricted to Executive Level II (see Salary Cap Summary, FY 1990 – FY 2016), including competing awards already issued in FY2017, if adequate funds are available in active awards, and if the salary cap increase is consistent with the institutional base salary, grantees may rebudget to accommodate the current Executive Level II salary level. However, no additional funds will be provided to these grant awards.

Once the Department of Health and Human Services Appropriation for FY 2017 is enacted, NIH will publish the annual Notice of legislative mandates to provide information on any statutory provisions that limit the use of NIH grant funds in FY 2017. Additional guidance on the salary cap will also be provided at that time.

For a historical record of the salary cap, including effective dates see:https://grants.nih.gov/grants/policy/salcap_summary.htm

Inquiries

Please direct all inquiries to:

Questions about specific awards may be directed to the Grants Management Specialist identified on the Notice of Award.

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