April 2017

Changes to the Investigator Conflict of Interest Policy that affect proposal submissions

The P209 Investigator Conflict of Interest Policy has been revised to enable the transition from a submission-based paper process to an online Annual Certification process through the new myResearch portal (Huron Click).

Therefore, beginning May 1st, the Conflict of Interest (COI) PDF forms will no longer be required for any faculty, staff and students that have previously been required to submit paper COI forms to the Office of Sponsored Programs for COEUS proposals submissions, PHS annual awards, changes/additions of investigators to current/new awards and/or to the Office of Research Compliance for participation as study personnel on IRB applications.

All Annual Certifications are required to be submitted in myResearch no later than May 31st.

During the May transition month,all faculty and staff (as required above) must have completed an Annual Certification in myResearch for new awards received in this month, for PHS award anniversaries and for new IRB submissions for COI review in accordance with the campus and federal policies.

Please direct any questions you may have regarding this change you may visit the Conflict of Interest Website or contact Susan Gasparo, in the Office of Research Compliance, susan.gasparo@stonybrook.edu, 631-632-1954

Office/Topic 

Request for Proposals - Long Island Biosciences Hub

The Center for Biotechnology, in collaboration with Stony Brook University, Cold Spring Harbor Laboratory, Brookhaven National Laboratory, and Feinstein Institute for Medical Research, have formed the Long Island Biosciences Hub (LIBH).  A principal goal of the LIBH is to foster the development of therapeutics, diagnostics, medical devices and research tools emerging from the four partner institutions that address diseases within the broad mission of NIH:

 http://centerforbiotechnology.org/center-for-biotech-receives-nih-award-to-develop-a-bioscience-hub/

Two specific funding programs have been designed to help faculty, physicians, surgeons, medical fellows, and post-docs develop their academic innovations toward commercial goals.  The RFP is attached, and forms for the funding programs can be found on the Center for Biotechnology website.

Those interested in applying are strongly encouraged to discuss the proposal with Dr. Li Liu (Li.Liu.1@stonybrook.edu) and/or Dr. William Hanes (William.hanes@stonybrook.edu). They are also available to attend faculty meetings to introduce the scope of LIBH in general, and this Technology Development program in particular, as well as to answer questions about the application.

Deadline for submission is June 1st, 2017.  All proposal should be submitted through the online portal HERE. Please note an approval from your Sponsored Programs Office is NOT required prior to the submission but will be required if the project is selected to move on  a secondary review by a panel run by NIH specifically designed for the REACH hubs. Eligible applicants will be notified if their application is selected to move forward.
This program will be available twice per year through the next year, with the next deadline for proposals popping up around December 2017.

The LIBH is very grateful to the National Institutes of Health REACH initiative (Research Evaluation and Commercialization Hub), our four partner institutions, The Research Foundation for SUNY, and Empire State Development for their support of this initiative.

Stony Brook University Gala Raises More Than $6.9 Million for Cancer Research and Student Scholarships

47th Vice President Joe Biden honored for cancer research advocacy

In recognition of his dedication to the fight against cancer, Joseph R. Biden Jr., 47th Vice President of the United States of America, was honored at the Stars of Stony Brook, Stony Brook University’s annual fundraising gala at Chelsea Piers in Manhattan on Wednesday, April 19.

Hosted by the Stony Brook Foundation, the Gala generates funds for student financial aid and a select academic area of excellence. This year, the University raised $6,946,000 in gifts and pledges including $2,051,000 for scholarships and $4,895,000 to support the Stony Brook University Cancer Center. Since 2000, the event has raised more than $50 million.

As Vice President, Joe Biden led the White House “Cancer Moonshot” with the mission to double the rate of progress in preventing the disease that leads to more than 8 million deaths worldwide every year. The intention, said Biden in his remarks, was to infuse the cancer research culture with “the urgency of now.”

Gala
At the Stars of Stony Brook Gala, from left, SBU President Samuel L. Stanley Jr., Hon. Joseph R. Biden, James Simons, Richard Gelfond ‘76
Under his leadership, the Cancer Moonshot Task Force catalyzed novel, innovative and impactful partnerships among 20 government agencies, departments and White House offices as well as over 70 private sector collaborations. Biden also helped lead the effort to pass the 21st Century Cures Act, which provides $1.8 billion over seven years for the Cancer Moonshot scientific priorities.

“The Moonshot is a program,” said Biden that “has become a movement, giving cancer patients and the people impacted by their illness new hope. And what cancer patients want more than ever is hope. But we can only hope to make sustainable progress if we’re preparing the next generation of cancer scientists and doctors.”

“At Stony Brook, we share Joe Biden’s determination, sense of urgency and confidence,” Stony Brook President Samuel L. Stanley Jr. said to the record-breaking 870 guests in attendance. “The Stony Brook Cancer Center brings together the brightest minds, enhancing purposeful collaboration and creating strategic partnerships to share information and accelerate research. Our researchers are receiving worldwide attention for a pioneering study of the genesis and behavior of cancer cells at the molecular level, with the goal of one day helping to detect, treat and eventually eliminate the disease for good.”

Proceeds from the Stars of Stony Brook Gala also generate financial assistance for many of Stony Brook’s most talented students. In his remarks, Foundation Chair and IMAX President Richard Gelfond ‘76 said Stony Brook offers talented, deserving students a pathway to a world they might never have been part of. In fact, just this year a study led by the Stanford Institute for Economic Policy Research ranked Stony Brook among the top 10 public and private institutions in the US as an engine of income mobility.

Mallaganda
Surrounded by SBU students and other community members, Biden chats with Naveen Mallangada ’17.
“Other universities may make similar claims about social mobility,” said Foundation Chair and IMAX President Richard Gelfond ’76, “but few if any are among the most select institutions with an incredibly diverse student body with a focus on STEM, and can do so while managing a national energy laboratory and delivering excellent healthcare at the only tertiary care facility in the county. That’s a rare combination in American higher education.”

Through continual research and discovery, Stony Brook University Cancer Center is on the forefront of cancer care. In the new Kavita and Lalit Bahl Center for Metabolomics and Imaging, for instance, Dr. Yusuf Hannun and Dr. Lina Obeid are receiving international recognition for their pioneering studies in lipid metabolism and cancer. Their work is changing what is known about the role lipid metabolism plays in cancer and brings us closer than ever before to understanding how to prevent and treat it.

Tsunis
George Tsunis, President of Chartwell Hotels, and wife Olga Tsunis, who recently established a fellowship in cancer prevention at the Stony Brook University Cancer Center, pictured with President Stanley, right.
The Stony Brook Cancer Center will relocate next year to the new 254,000 square-foot Medical and Research Translation facility (MART), designed to enable scientists and physicians to work side by side to advance cancer research and imaging diagnostics.

Mr. Biden joins a distinguished roster of scholars, politicians, celebrities and luminaries who have been honored by the Gala for their outstanding and relentless commitment to society, such as Nobel laureate C.N. Yang; IMAX CEO Richard Gelfond; actors Ed Harris, Julie Andrews and Alan Alda, Jim Simons and Marilyn Simons (‘74, ‘84);and world-renowned conservationists Patricia Wright and Richard Leakey.

Dollars raised at the Gala count toward the $600 million Campaign for Stony Brook.

We are now a proud participating member of SMART IRB

SMART IRB?

We are in the company of other fine institutions,​ all seeking to simplify the IRB process for multi-center studies.

Human Research Training Updates

a) CITI refresher course content is changing

Remember when you'd take a refresher course every three years on the same topics over and over again? Well, those days are over. Starting next week, when it's time to recertify your training, you will still do refreshers on a *few* topics, however you will now also choose three (3) elective modules (out of about 25 choices) on topics that interest you! "Consent and Subject Recruitment Challenges: Therapeutic Misconception", "Research with Critically Ill Subjects", "Illegal Activities or Undocumented Status in Human Research" to name just a few.

b) The Good Clinical Practice (GCP) course through CITI satisfies NIH's new (1/1/17) training requirement

The NIH policy (https://www.grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html) applies to all NIH-funded investigator and clinical trial site staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials . NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of these interventions on health-related biomedical or behavioral outcomes [emphasis mine]. And don't forget the clinicaltrials.gov requirement for these studies as well (as reported in previous VPR Research News-see #4 below)

c) The CITI course for Clinical Research Coordinators (CRC) is now available

Those of you who are "on file" as Research Coordinators through the SOM's Office of Clinical Trials recently received a message from me regarding the appreciation and importance of training initiatives for this extremely critical group in our HRPP. To this end, the CRC course through CITI is available for you to casually peruse so that you can learn for the first time or review your knowledge about the responsibilities of your profession. It's casual now, but of course it is important enough to make it a mandatory part of your training portfolio, effective June 30, 2017.

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

Winter 2017

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

Winter 2017

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?

Winter 2017

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…

Winter 2017

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

.

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’.

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 multi-center 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.

Thomas Allison Wins 2017 Discovery Prize

How do electrons move within molecules?

Thomas Allison presents at the 2017 Discovery Prize ceremony.
Thomas Allison, an assistant professor in the Departments of Chemistry and Physics at Stony Brook University, posed this fundamental question on the way to winning the 2017 Discovery Prize.

In a presentation delivered April 13 at the Charles B. Wang Center Theatre, Allison convinced a panel of three distinguished judges that his project deserved a $200,000 cash prize to help fund his postdoctoral research. The award will finance equipment that will help scientists see how molecules move and behave in real time.

The winner was chosen by a distinguished panel of judges, including 2016 Nobel Laureate in Physics from Princeton, F. Duncan Haldane, Berkeley’s Director of the Nuclear Science Division, Professor Barbara Jacak, and Chairman of the Simons Foundation and a member of the National Academy of Sciences, James H. Simons.

Allison was chosen from among four faculty finalists, including Gábor Balázsi, associate professor, Laufer Center for Physical and Quantitative Biology/Department of Biomedical Engineering; Matthew Reuter, assistant professor, Department of Applied Mathematics and Statistics/Institute for Advanced Computational Science; and Neelima Sehgal, PhD, assistant professor, Department of Physics and Astronomy. Each presenter spoke for 10 minutes and then responded to five minutes of questions from the judges.

“I think our research is important because we are making new tools that enable chemists and physicists to see how electrons move in molecules. And that fundamental dynamic is important in so many reactions and devices that affect our daily lives,” said Allison.

The Discovery Prize was established in 2013 with a generous donation from the Stony Brook Foundation Board of Trustees with this goal in mind. The Prize is awarded to an early-career Stony Brook faculty member in the STEM disciplines.

President Samuel L. Stanley Jr. opened the ceremony, emphasizing the critical role that the Discovery Prize Competition plays in an era of diminished federal funding for projects that will lead to ongoing technological breakthroughs. He cited the development of the technology for the MRI as one example.

Laurie Krug, the inaugural Discovery Prize winner in 2014 and an associate professor in the Department of Molecular Genetics and Microbiology, said it is a scientist’s challenge to avoid “technobabble.”

“I am pleased to share with you that the Discovery Prize has provided a tremendous boost to my lab research,” she added. “We have accomplished several goals of our initial proposal: We have a recent publication, and we have secured additional National Institutes of Health funding to support our gene-editing project.” Krug’s cutting-edge research is aimed at advancing the understanding of herpes virus pathogenesis.

SBU Visiting Professor Alan Alda, whose Alan Alda Center for Communicating Science champions scientific plain speaking, spoke about the difficulty of winning funding for research if “it doesn’t seem to lead to a better toaster.” He reminded the crowd that Einstein’s Theory of Relativity is only a little more than a century old, and joked that the finalists’ obligation was to make sure that he would be able to understand everything they said.Duncan Haldane, a 2016 Nobel Prize winner in Physics, served as one of the three judges. Haldane said he found all four presentations compelling and worthy of funding, but added that the concrete nature of Allison’s project won him over.

“If he can succeed in getting the molecular orbitals to move in real time and to change with light, as opposed to seeing them represented abstractly by numbers, a spectrum or a graph, it will make a real difference,” Haldane said.

Another judge, Barbara Jacak, a professor of physics at the University of California, Berkeley, and member of the National Academy of Sciences, said the project intrigued her because it would explain whether molecules “hop around or move slowly and smoothly.” She said that she and her colleagues tend towards the latter hypothesis, but this could offer definitive proof.

James H. Simons, founder of Renaissance Technologies and chairman of the Simons Foundation, was the third judge.

During his presentation, Jacak asked Allison if his proposal was pioneering. “I won’t say that no one has thought of this before, but I will say that no one has been in a position to do this before now,” Allison said.

Now, perhaps, all that has changed.

In the aftermath of the announcement that he had won, Allison’s excitement was palpable.

“I can’t wait to do this experiment,” he said. “Every time you make a new tool that lets you see further or deeper or smaller or faster it can lead to new breakthroughs in science and technology. The Discovery Prize funding will allow us to develop that new tool.”

— Glenn Jochum

Conflict of Interest Reporting Is Going Paperless with New myResearch (Huron Click) Portal

The myResearch (Huron Click) Conflict of Interest Module is live!

This electronic submission process replaces our current PDF forms that must be submitted with every new proposal, at the time of PHS/NIH annual anniversaries, and as part of IRB submissions. Instead, you will complete an online Annual Certification of outside interests. This new practice will streamline business processes and reduce faculty administrative burden. Research certifications may be required at the time of an award or protocol submission to clarify if a specific interest is related to a specific project. The CITI Training requirements remain unchanged.

Beginning April 17th, the following groups may begin submission of an Annual Certification in myResearch

  1. Faculty members that participate in research;
  2. Staff that meet the definition of Investigator and are named on a current funded project or proposal submitted within the last year; and
  3. Staff named as study personnel on IRB submissions that have current or pending funding.

All Annual Certifications are required to be submitted in myResearch no later than May 31st.

Beginning May 1st:

The PDF forms will no longer be required for any proposal submissions, for PHS award anniversaries, or for staff named in IRB submissions.

During this May transition month, all faculty and staff (as required above) must have completed an Annual Certification in myResearch for new awards received in this month, for PHS award anniversaries and for new IRB submissions for COI review in accordance with the campus and federal policies.

Beginning June 1st:

The myResearch COI Module will be fully implemented. Any changes in outside interests must be reported in myResearch within 30 days of acquiring said interest, and Annual Certifications will be due each year by May 1st.

Login and Training

Login information, training videos and guides, and CITI Training information are available at myResearch

References

Questions

  • For login and technical issues, contact DoIT Client Support at 2-9800
  • For questions on annual certification or COI policies, please contact Susan Gasparo or (631) 632-1954.

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