NIH Announces Single IRB Policy to Streamline Reviews of Multi-Site Reserach

The National Institutes of Health (NIH) recently released a new policy regarding the use of a single institutional review board of record for multi-site research. This policy establishes the expectation that all sites participating in multi-site studies involving non-exempt human subjects research funded by NIH will use a single Institutional Review Board (sIRB) to conduct the ethical review required by the Department of Health and Human Services regulations for the Protection of Human Subject at 25 CFR Part 26.
This policy will apply to all competing grant applications (new, renewal, revision, or resubmission) with receipt dates on or after May 25, 2017. It also includes contract solicitations issued on or after May 25, 2017. However ongoing, non-competing awards will not be expected to comply with this policy.

According to Dr. Collins, “Today, the time it takes to go from a sound research idea to the launch of a new, multi-site clinical research study is too long. A major contributor to the delay is that too many institutional review boards (IRBs) are reviewing the protocol and consent documents for the same study, often with no added benefit in terms of the protections for research participants. To address this bottleneck, NIH has issued a new policy to streamline the review process for NIH-funded, multi-site clinical research studies in the United States.”

For more information please click the following links below:

HHS Releases Oral Health Strategic Framework 2014-2017

By KyuLim Lee, AADR Gert Quigley Fellow

Earlier this year, the U.S Department of Health and Human Services (HHS) released the HHS Oral Health Strategic Framework 2014-2017 (the Framework). The Framework reflects the collective discussions and future plans proposed by HHS and other federal partners committed to improve oral health and overall health of the public.  The Framework is built upon five overarching goals proposed by the HHS and presents associated strategies designed from collaborative partnership of HHS resources, programs, and leadership commitment to improve collaboration on oral health activities of other federal partners. The five goals are listed below:

  • Integrate oral health and primary health care.
  • Prevent disease and promote oral health.
  • Increase access to oral health care and eliminate disparities.
  • Increase the dissemination of oral health information and improve health literacy.
  • Advance oral health in public policy and research.

The Framework reflects the most recent demonstration of the federal government’s commitment to oral health. The central vision is to increase the public’s understanding that oral health is an integral part of the overall health. During a recent webinar informing the public about the strategic framework, Dr. Bruce Dye DDS, MPH, a Dental Epidemiology Officer at the National Institute of Dental and Craniofacial Research, discussed that one of the biggest challenges towards implementing the vision laid out in the framework is the full integration of oral health and primary health care, and emphasized the need of dental and non-dental providers to work more collaboratively with one another.  He also discussed the possibility of encouraging the Institute of Medicine and or the Surgeon General to issue an updated report on the status of oral health in our country given that these reports are almost 20 years  old. Lastly, dissemination of oral health information (Goal 4) and advancing oral health in public policy and research (Goal 5),were highlighted following questions raised during the webinar about research on e-cigarettes given recent data indicating the increased utilization of these products. To improve the understanding of the effects of e-cigarettes, NIDCR recently awarded a number of grants to investigate the effects of these chemicals from e-cigarettes on oral health.

The next step to implement the strategies laid out in the Framework is to have the strategic efforts continue to be monitored and updated by participating federal agencies. Moreover, data generated via the Healthy People 2020 initiative will prove to be a useful benchmark to monitor progress. Furthermore, input from oral health stakeholders, including researchers and public health advocates will be crucial for this ongoing process as they move forward with the goal of improving oral health for all Americans.

For Additional Information:

Public Health Reports: www.publichealthreports.org
Oral Health Coordinating Committee: http://www.hrsa.gov/publichealth/clinical/oralhealth/ohcc.html
Webinar: http://www.publichealthreports.org/webinars.cfm

AADR Joins Community in Support of Department of Defense Medical Research Funding

Last week AADR joined 137 organizations in a letter to Sens. John McCain (R-AZ) and Reed (D-RI) in opposition to language included in the fiscal year 2017 National Defense Authorization Act. This language would have prohibited funding for DOD medical research unless it adhered to a narrowly defined criteria related to military relevance. Fortunately, due to the advocacy of the broader medical research community this language was stripped via an amendment authored by Sen. Durbin (D-IL) by a vote of 66-32.

AADR along with the American Dental Association (ADA) will continue to closely monitor these developments and any other legislation that may impact military dental research funded by the DOD.

AADR Submits Comments on Trans-NIH Plan for HIV-Related Research

Last week, AADR submitted comments on the National Institutes of Health (NIH) Request For Information (RFI) regarding the development of the fiscal year 2018 Trans-NIH Plan for HIV-Related Research. This plan is designed to identify and articulate possible future directions to maximize benefits of investments in HIV/AIDS research. AADR’s comments emphasized the high priority role of the oral cavity in the specific areas of HIV vaccines; mircrobicides and PrEP; cure research; test and treatment; pathogenesis and comorbidities; and health disparities research. AADR also encouraged the plan to emphasize the importance of training the next generation of oral health researchers.

Senate Bill Proposes Increased Funding for NIH & NIDCR

Yesterday, the Fiscal Year (FY) 2017 Senate Labor, Health and Human Services, and Education (LHHS) Appropriation bill was approved by the Senate Appropriations Committee by a 29-1 vote. This legislation proposes $34 billion for the National Institutes of Health (NIH) an increase of $2 billion over FY16 and $430.5 million for the National Institute of Dental and Craniofacial Research (NIDCR) which is $17.1 million over the enacted FY16 level of $413.4  million.  Some of the increases for NIH were provided for the following initiatives:

  • $300 million, an increase of $100 million for Precision Medicine;
  • $1.39 billion an increase of $400 million for Alzheimer’s disease research;
  • $250 million, an increase of $100 million, for the BRAIN Initiative to map the human brain;
  • $333.4 million an increase of $12.5 million for the Institutional Development Award;
  • $463 million, an increase of $50 million, to Combat Antibiotic Resistance;
  • And increases to every Institute and Center to continue investments in innovative research that will advance fundamental knowledge and speed the development of new therapies, diagnostics, and preventive measures to improve the health of all Americans.

The Senate LHHS Committee report also included report language pertinent to NIDCR. Specifically:

  • Dental Materials.- Biomaterials is an important section of biomedical research for practicing dentists. The Committee urges NIDCR to continue to invest in the development and innovation of dental materials.
  • Overlapping Pain Conditions.- The Committee commends the NIDCR for its ongoing support for the Orofacial Pain Prospective Evaluation and Risk Assessment program, which is yielding valuable information on many physiological aspects of temporomandibular disorders and overlapping pain conditions. The Committee encourages continued research on overlapping pain conditions and increased collaboration across NIH Institutes on epidemiological, basic, clinical and translational research related to pain conditions.

During the committee markup Chairman Blunt (R-MO) emphasized this legislation was the first bi-partisan LHHS Appropriations bill developed in seven years. This legislation does not include any new policy riders. Many Senators applauded the increased funding for NIH as a critical step to build on the momentum of the previous fiscal year. However, since the overall allocation for this bill is $270 million below the FY16 enacted level, the proposed increased funding came at the expense of other important public health programs. Specific cuts include:

  • -$118 million for the Centers for Disease Control and Prevention
  • -$2 million for the CDC Division of Oral Health
  • -$10 million for the Agency for Healthcare Research and Quality
  • -$4.4 million for the National Center for Health Statistics

Below is additional information about programs of importance to AADR:

  • HRSA Title VII Training in Oral Health Care received $35.8 million which is level with FY16. The Committee provides $35,873,000 for Training in Oral Health Care programs which includes not less than $10 million each for general and pediatric dentistry. Funds may be used to expand training in general dentistry, pediatric dentistry, public health dentistry, dental hygiene and other oral health access programs. Funds may also be used to plan and operate training programs as well as to provide financial assistance to students and residents. The agency is directed to provide continuation funding for predoctoral and postdoctoral training grants initially awarded in fiscal year 2015 for Section 748 Dental Faculty Loan Program grants initially awarded in fiscal year 2016. The Committee understands that since the Chief Dental Officer was created at HRSA, the position has been downgraded to Senior Dental Advisor. The Committee strongly encourages HRSA to restore the position of Chief Dental Officer with executive level authority and resources to oversee and lead HRSA dental programs and initiatives. The CDO is also expected to serve as the agency representative on oral health issues to international, national, State, and/or local government agencies, universities and oral health stakeholder organizations. The Committee continues long-standing bill language that prohibits funding for section 340 G-1 of the PHS Act.
  • HRSA AIDS Dental Services The Committee provides $13,122,000 for the AIDS Dental Services program. This program provides grants to dental schools, dental hygiene schools, and postdoctoral dental education programs to assist with the cost of providing un reimbursed oral health care to patients with HIV. The Ryan White Part F program provides for the Dental Reimbursement Program [DRP] which covers the unreimbursed costs of providing dental care to persons living with HIV/AIDS. Programs qualitying for reimbursement are dental schools, hospitals with postdoctoral dental education programs, and colleges with dental hygiene programs.
  • HRSA Maternal and Child Health Bureau Prenatal Oral Health.- The Committee encourages HRSA to utilize demonstration projects to support the implementation of integrating oral health and primary care practice. The projects should model the core clinical oral health competencies for non-dental providers that HRSA published and initially tested in its 2014 report, “Integration of Oral Health and Primary Care Practice.”
  • CDC Division of Oral Health received $18 million which is a $2 million decrease from FY16.

What is Next? This is an important first step in the legislative process. The House still needs to consider its version of the LHHS bill which is expected to happen sometime during the week of June 20th. Given that it is an election year it is very likely that Congress will approve a short term continuing resolution funding the federal government through the November elections. Depending on the outcome of the election Congress will either develop an omnibus appropriation bill funding the federal government through the rest of the year; approve another short term continuing resolution or just approve a year long continuing resolution.

AADR will continue to closely monitor these developments and advocate on behalf of our members to secure increased funding for NIH, NIDCR and other oral health programs in the upcoming months.

 

FDA Extends Authority to All Tobacco Products, Including E-Cigarettes, Cigars and Hookah

Recently, the Food and Drug Administration issued a final rule effective August 8, 2016 Deeming Tobacco Products to Be Subject to the Federal Food, Drug and Cosmetic Act. This rule extends FDA’s authority to include the regulation of electronic nicotine delivery systems, all cigars, hookah tobacco, pipe tobacco and nicotine gels that went on sale after February 15, 2007.  According to a press release issued by the FDA this new rule would also ban the sale of e-cigarettes, hookah or cigars to anyone under the age of 18. The new rule also includes the following:
 
  • Registering manufacturing establishments and provide product listings to the FDA
  • Reporting ingredients and harmful and potentially harmful constituents
  • Requiring premarket review and authorization of new tobacco products by the FDA
  • Placing health warnings on product packages and advertisements
  • Not selling modified risk products unless authorized by the FDA
  • Not allowing the selling to tobacco products in vending machines
  • Not allowing the distribution of free samples. 
The new rule does not ban flavored tobacco products including e-cigarettes, nor does it ban advertising of products. 
 
What is next? According to an article in the Hill, a leading manufacturer of e-liquids has filed a lawsuit in the federal district court in Washington, D.C. challenging the deeming rule. Also, some members of Congress are leading efforts to attach policy riders to the Agriculture appropriations bills limiting FDA’s authority to implement this rule. AADR joined the broader public health community by sending a letter to the House Appropriations Committee and a separate letter to the Senate Appropriations Committee voicing our opposition to these policy riders. We will continue to monitor these efforts and advocate for FDA to have the authority to oversee all tobacco products, including e-cigarettes. 
 
Additional Information: For additional information the FDA Center for Tobacco Products (CTP) hosts a series of webinars on federal tobacco regulations. These webinars are designed to provide FDA tobacco compliance education and information to retailers and to small business manufacturers. Sign up to receive email updates about this webinar series.

House Subcommittee Approves Funding for NSF

This week, the House Commerce, Justice and Science (CJS) Appropriations Subcommittee approved its fiscal year 2017 appropriation bill. The CJS bill proposes funding allocations for the Department of Commerce, the Department of Justice, the National Aeronautics and Space Administration (NASA), the National Science Foundation (NSF) and other agencies. For NSF specifically, the House allocated approximately $7.4 billion, $57 million below the fiscal year 2016 enacted level and $158 million below the President’s budget request. According to a fact sheet released by the Subcommittee Research and Related Activities were increased by $46 million and reductions were made to equipment and construction costs.

AADR will continue to closely monitor these developments and work in partnership with the Coalition for National Science Funding as this bill moves forward.

 

AADR Joins 77 Organizations Opposing an Increase in SBIR Set Aside

Last week, AADR joined 77 scientific and professional societies, higher education associations, universities and research institutions in a letter expressing opposition to a provision included in the Commercializing on Small Business Innovation Act of 2016 (H.R. 4783) which would increase the SBIR set aside from 3.46 percent to 4.5 percent in FY2022. The organizations argued that there is no evidence that this increase is necessary or beneficial to the nation, and the larger set-aside will reduce the opportunity for other crucial sectors of the research enterprise to contribute to progress in science and technology.

This letter also urges the House Science Committee to, “…exercise its jurisdiction by holding hearings to review the outcomes of the last SBIR/STTR reauthorization and what would be accomplished through a renewal of the programs.” The organizations state that the SBIR/STTR set-aside should not be increased without a thorough evaluation of existing data on these programs and the merits of and justification for increasing the set aside.

What is next? Organizations are closely monitoring developments on the National Defense Authorization Act and any other attempts to attach this bill to legislation that is moving to the floor. AADR will keep you informed as this process moves forward.

Department of Labor Issues New Overtime Rule Impacting Postdocs

This week the Department of Labor finalized a rule to the Fair Labor Standards Act (FLSA) to update overtime protections. The final rule will take effect on December 1, 2016 and doubles the salary threshold from $23, 660 to $47,476 per year under which most salaried works are guaranteed overtime. A fact sheet issued by the White House indicates this new level will be automatically updated every three years. According to a Huffington Post op-ed authored by NIH Director Francis Collins and the US Secretary of Labor, Thomas Perez,  this rule will effect 37,000 to 40,000 junior scientists.

The authors state, “Under the new FLSA overtime threshold, universities, teaching hospitals, and other institutions that employ postdocs have a choice: they can carefully track their fellows’ hours and pay overtime, or they can raise their salaries to levels above the threshold and thereby qualify them for exemption. Biomedical science, by its very nature, is not work that neatly falls into hourly units or shifts. So, from our vantage point, it seems that the only option consistent with the professional nature of scientific work is to increase salaries above the threshold. In response to the proposed FLSA revisions, NIH will increase the awards for postdoctoral National Research Service Awards recipients to levels above the threshold. At the same time, we recognize that research institutions that employ postdocs will need to readjust the salaries they pay to postdocs that are supported through other means, including other types of NIH research grants. While supporting the increased salaries will no doubt present financial challenges to NIH and the rest of the U.S. biomedical research enterprise, we plan to work closely with leaders in the postdoc and research communities to find creative solutions to ensure a smooth transition.”

White House Launches National Microbiome Initiative and AADR Member is Recognized for its Commitment

Dr. John Holdren, Assistant to the President for Science and Technology, Director of the White House Office of Science and Technology Policy

Last week, AADR attended an event at the White House announcing the launch of the National Microbiome Initiative (NMI).  According to the fact sheet released by the White House, this initiative aims to advance understanding of microbiome behavior and enable protection and restoration of healthy microbiome function. The goals of the NMI are as follows:

  • Support interdisciplinary research to answer fundamental questions about microbiomes in diverse ecosystems.
  • Develop platform technologies that will generate insights and help share knowledge of microbiomes in diverse ecosystems and enhance access to microbiome data.
  • Expand the microbiome workforce through citizen science, public engagement and educational opportunities.

The NMI launched a combined Federal agency investment of $121 million in fiscal year 2016 and 2017 for cross ecosystem microbiome studies. This funding includes an extra $20 million at the National Institutes of Health and $16 million at the National Science Foundation.  The NMI also includes $400 million in financial and in-kind contributions that support the overarching goals of the NMI.

Dr. Wenyun Shi, Professor and Chair of Oral Biology UCLA School of Dentistry and Carolyn Mullen, AADR Director of Government Affairs

This past year AADR worked on behalf of its members with the White House Office of Science and Technology Policy to highlight the importance and value of the oral microbiome. As a result of our efforts, AADR Institutional Section Member The Forsyth Institute was recognized for its new commitment for oral microbiome research as part of the National Microbiome Initiative. Specifically, Forsyth will dedicate up to $100,000 per year for three years for pilot grant funding for novel microbiome projects. This multi-year commitment to invest in groundbreaking projects in its newly formed Host-Microbiome Center will provide funding to support exploratory or proof-of-principle studies for which no other funding sources are available. Such studies must have the potential to develop into full-fledged research projects that test new paradigms, and can lead to intellectual property, and NIH or other extramural funding.

In addition to the Forsyth Institute C3 Jian was recognized for its commitment of $75 million over the next 3 to 4 years to develop antimicrobials that correct microbial imbalances in many human diseases. The investment also includes C3J’s commitment to advance their lead microbiome program towards FDA approval for the prevention of dental caries in children, adolescents and adults. The NMI also included commitments from a number of educational institutions, including the University of Michigan, University of Pittsburgh, the University of California and many others.

AADR was extremely pleased to participate in this event and we look forward to working with the community to support provisions in the NMI.

For additional information:

Click here for information about the National Microbiome Initiative

Click here to read our press release

Click here to read C3 Jian’s press release