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NCURA’s YouTube Tuesday (aka How To Make Things Easier For Us)

Today’s installment of NCURA’s YouTube Tuesday deals generally with the topic of “business” issues that frequently get in the way of an ORA’s work on the substantive issues involved with each grant or contract.

While we do our best to process awards as efficiently, many times we must stop our negotiations to address more procedural intra-institutional concerns that prevent us from continuing with our efforts.  Last January, we published a Top 10 list of information we wanted PIs to know, and those nuggets will certainly assist us in our work.  To piggyback off of those exhortations, today we’ve compiled a more general list of suggestions that will make our lives less complicated and, more importantly, allow us to efficiently complete your agreement.

 

Top 10 (For Now) Suggestions For Keeping ORA Movin’

1.            Make sure that the PI flows their agreement through their department instead of going to ORA directly.  The department will eventually have to be brought in anyway, so bypassing them at the outset only adds to the turnaround time.

2.            Unless asked specifically, allow ORA to perform all of the negotiating.   We appreciate that the PI wants their subcontract to be executed yesterday, and that they’re not concerned about who owns the intellectual property.  However, like most other institutions, we must keep consistent with standard University contract parameters, as well as, in general, ensure that anything ‘legal’ is handled solely by the appropriate personnel.

3.            Engage ORA as early as possible.  A simple heads-up email is always appreciated, but if you have any questions arise even before the formal award, it doesn’t hurt to run them by our office as soon as you can so that we can make plans accordingly for the negotiation process.

4.            When possible, give us an idea of the Intellectual Property that will be used and/or created during the project, any publication expectations, etc.  IP is frequently one of the main sticking points in negotiations, so the earlier we know exactly what is transpiring, the faster we can discuss appropriate terms with the sponsor.

5.            Communicate, communicate, communicate.  If you know that the period of performance is different than what’s in the contract, let us know ASAP.  If the budget has changed since it was uploaded into COEUS, let us know ASAP.  We can’t address an issue of which we’re not aware, so keep us in the loop as much as possible.  Correspondingly, if you’re unsure how to move forward, let us know BEFORE you take any action.  Five minutes figuring out what to do is a lot better for everyone than three days figuring out how to clean up a mess.

6.            Make sure you send us ALL sponsor documentation.  If you would like us to review and sign a proposal, we need to see a copy of the RFA so that we know to what exactly we’re agreeing.  Along those lines, if there’s been a change in the budget, make sure to send us any related correspondence from the sponsor confirming the adjustment.

7.            Any time you wish for us to sign an MTA where the materials are coming in to the University, you MUST also include an executed MTA Request Form that details the other party, sponsor and contemplated uses.  Without this document, we will not proceed with review.

8.            For just about any contract, as well as complex grants that now include more legal terms, please obtain a Word copy of the draft agreement and send it to us as early as possible.  There are times where we will be able to sign the first offer from a sponsor, but, more often than not, we will need to request changes to the draft, and it’s much faster to send a red-lined copy back to the sponsor versus a listing of our various concerns.

9.            When dropping off a hard copy of an agreement for signature, make sure to include all applicable paperwork that provides the background of the contract, what exactly we’re signing, why we’re signing it, etc.  “Because it’s important and is due today” is rarely sufficient to provide comfort in lieu of actual documentation and support, so be sure that you’ve given us enough information to make an informed decision.  And then add more.

10.          Keep tabs on our blog and utilize the ‘Search’ function.  Okay, so this is somewhat of a cheapie.  But we post articles that address specific issues and questions that we regularly encounter.  Not sure what type of proposal to select in COEUS?  Bookmark our handy chart.   Unsure about effort reporting?  Check out our overview.  Admittedly, we likely can’t write about every possible concern that arises, but we generally try to hit the major topics, or at least those that are occurring with high frequency.  And if you don’t find the answer you’re looking for, see #5.

What is Bayh-Dole?

Today’s installment of NCURA’s weekly feature focuses on a definition of the Bayh-Dole Act, which contemplates the ownership of intellectual property arising from the use of federal funds.  Last November, we provided a detailed examination of Bayh-Dole, and recently discussed the important Stanford decision that clarified how Universities vested the rights bestowed by the legislation.  In an upcoming post, we’ll continue our focus on Bayh-Dole with an analysis of the repercussions of the pending StartUp Act, which could have a substantial impact on a University’s tech transfer activities.  Given the importance of IP rights, we encourage everyone to check out the NCURA video, as well as our previous posts, so that they are aware of the all of the moving parts involved.

DATA Act Update

Last month, we noted the DATA Act making its way through Congress and its impact on Research Administration.  On April 25, 2012, the House passed the Act via voice vote, and we now must wait to see how it is handled in the other Congressional chamber.  The Senate version of the bill currently resides in the Senate Homeland Security and Government Affairs Committee, and, once it is approved there, it will move to the floor for a full vote, with passage likely.

Seeing as that virtually any recipient of federal funds will be subject to the various reporting requirements (including subrecipients of a federal Prime), the DATA Act will have seismic repercussions on how Universities and similar research facilities go about their work.  Needless to say, the Research Admin community is awaiting final disposition of the Act with a sense of dread given the expenditures (both financial and otherwise) that will be required to comply with all of the new obligations.

The Creature of (Mayo v.) Prometheus

Two months ago, we discussed the Stanford v. Roche decision and its relevance to the research administration community.  Not content to rest on their laurels, the Supremes recently revisited the arena of intellectual property in Mayo v. Prometheus, which addressed the patentability of methods or processes that are borne from “laws of nature.”

Prometheus Laboratories, a pharmaceutical company, was issued two patents directed to the treatment of autoimmune diseases and whether a related drug was working as it should.  Specifically, the patents described an “administering” step (whereby the doctor is instructed to administer the drug), a “determining” step (whereby the doctor is instructed to measure levels of a certain antimetabolites in a patient’s blood after administration), and finally a “wherein” step (whereby the doctor is instructed on how to read the levels and determine whether the dosage is effective).  Originally, both Prometheus and Mayo Collaborative Services/Mayo Clinic used diagnostic kits based on the above patents.  However, Mayo eventually decided that it would produce and sell a kit that was slightly different than that created by Prometheus, and Prometheus subsequently filed suit claiming that the Mayo kits infringed on its two patents.

Patent law affords wide latitude with respect to potentially patentable subject matter, but one explicit restriction is on the protection of laws of nature, physical phenomena, and abstract ideas.  Unless some additional feature is added to these “technologies,” they will not be afforded protection, and thus anyone will be able to use them however they see fit.  Prometheus’ processes were, by and large, predicated on a naturally-occurring phenomenon (i.e. the increase or decrease of a blood marker following the introduction of a drug).  However, the case hinged on whether Prometheus, by providing the levels that represented the administration of a proper dose, had in fact created an additional, original step that made their patented processes novel.

Ultimately, in a unanimous decision, the Supreme Court struck down Prometheus’ patents, holding that “[t]he three additional steps in the claimed processes here are not themselves natural laws but neither are they sufficient to transform the nature of the claims.”  Because the instructions merely guide a doctor to perform tasks that are well-known in their field, without anything novel being added, they were insufficient to “transform an unpatentable law of nature into a patent-eligible application of such a law.”

While it might not be apparent, the Prometheus case does and will have a direct impact on the field, especially at our School of Public Health.  Much of the work performed by our investigators occurs in locales that use non-traditional methods to treat diseases.  These can range from basic homeopathic remedies to town-centric herbal combinations and similar processes, but all have relatively high levels of efficacy when used to combat a particular affliction.  As a result, our PIs frequently come back from the field with ideas as to how to turn these treatments into kits similar to those designed by Prometheus, and the discussion then becomes whether they fall under the IP clause of their related funding agreement.  However, without any above-considered ‘additional step,’ these processes generally remain open (however minimally) for the public to use, and, as a result, the school will not seek patent protection.

Who We Are, What We Do, and Why We’re Here!

Welcome to our corner of the internet!

Since our audience has increased in the months following our birth, we thought it might be a good idea to once again introduce everyone to a little background on us, our blog, and our objectives.

First, the “we” is the Johns Hopkins Bloomberg School of Public Health (SPH), and specifically the Office of Research Administration (ORA).  Most of our visitors know what we do, but for the benefit of those who ended up here after a mistyped Google search for cosmetics – We are the administrative end for all of SPH’s research grants and contracts.  What that means is that, if they want money to focus on a particular project, a researcher will invariably have to utilize the resources of our office to procure the funds.  Our office is made up of myriad souls with myriad responsibilities, and in the past year you’ve been subjected introduced to their scribblings and policies.

As you can already tell, these scribblings cover a wide variety of topics, from grant-related concerns to contractual tips, to upcoming events hosted by our office and our colleagues. While we obviously write for our Hopkins brethren most of the time, the substantive issues discussed are likely similar to those encountered by ORAs spanning the country.  Consequently, we hope that this blog will, at least in part, help to facilitate discussions amongst institutions that perhaps wouldn’t ordinarily communicate.

That, ultimately, is our goal moving forward.  Yes, this will serve as a one-way conduit of certain pieces of information, but we’re hopeful that it will largely provide a forum for the exchange of questions, answers and ideas. We encourage you to reach out to us and others through our Linked In group, Facebook page and Twitter feed.  In the end, our primary aim as research institutions is to ensure that the work of our PIs is disseminated as widely as possible, so the more we can all help each other accomplish our goals the better!.

So. . .we hope you stick around and contribute, not just here but through our other social media outlets.  We figure that you’ll be able to find something interesting and engaging from among our various platforms, but we’re not above shamelessly catering the whims of our constituents.  To that end, if you have questions, suggestions, concerns, or even simply want to acknowledge our presence, please don’t ever hesitate to shoot us a comment or an email at admin@bloggingora.com.

If you have a lot to say, we would love to feature you as a guest blogger! Contact our main email address (admin@bloggingora.com) or Katie Magrogan (kmagroga@jhsph.edu) for information on how to get published.

We’re glad you found us, so click around, use our search bar or categories and stay awhile!

Export Controls

Of all of the various rules and regulations that PIs keep at the forefront of their consciousness, our guess is that those concerning export controls are generally tucked away in some dark recess of the mind, rarely, if ever, given consideration.  To be fair, navigating the labyrinthine laws that determine what is and isn’t a subject act requires substantial effort, so PIs can’t be blamed too much for focusing their mental energies on other, more straight-forward matters.  However, running afoul of any export control parameters can result in serious penalties, and thus it is important that everyone be aware of the scope and specifics of all such laws.

The first step would probably be to learn exactly what export controls are.  Specifically, they govern the dissemination of certain information, services and products to foreign nationals and countries, and are encompassed under the areas of national security and foreign trade policy.  The actual “export” can come in many forms, be it an actual physical transfer outside of the United States, a visual presentation of the subject matter, or even an oral or written disclosure.  Before you think that export controls are limited to actions that occur outside of the fifty states, the above-noted actions are also covered when done for the benefit of a foreign person within the United States (referred to as a “deemed export”).  Consequently , even having a conversation with a foreign student in your University lab may be considered a “deemed export” and subject to restrictions.

As far as the actual content of restricted distributions is concerned, export controls generally apply to disclosures have actual or possible military applications, or that may touch on economic protection concerns.  Further, the distribution may be to a foreign place or recipient for whom the Government has concerns, such as those countries currently under some form of U.S. sanction.

Once you’ve sorted through the Who and the What, it’s time to figure out what rules are going to control your actions.  At present, there are three main areas:

International Traffic in Arms Regulations (Department of State) – For inherently military technologies.

Office of Foreign Assets Control (Department of the Treasury) – For dealings with countries subject to embargo, sanction or boycott.

Export Administration Regulations (Department of Commerce) – For technologies that can be used both in civil and military/other strategic applications (“dual use”).

Each of the above has specific regulations concerning what can and can’t be distributed, and have their own processes for determining what actions an interested “exporter” must take before moving forward.

With each law comes, of course, possible exclusions from coverage.  The first is the Public Domain Exclusion, which applies to certain information that has already been made available through publication and dissemination to the public at large.  The second, and to Universities more important, is the Fundamental Research Exclusion (FRE), which applies to information made available through research in science and engineering that is regularly published to the scientific community.

Penalties for failing to comply with the appropriate regulations range from fines to even imprisonment.  Yes, you read that correctly – You could go to prison for running afoul of ITAR, OFAC and/or EAR, and the Roth case should serve as a warning for PIs and departments everywhere.

We’ve done our best to efficiently touch on and summarize the main points and considerations, but we’re fully aware that we’ve only scratched the surface of such a complex issue.  Consequently, our faithful followers are encouraged to do further research on their own to make sure they’re aware of the regulations as well as the policies of their respective institutions.

Proposed Data Act Proves Cause for Concern

When word spread last summer that the Federal Funding Accountability and Transparency Act (FFATA) might be going the way of the dodo, there was much rejoicing.  Few regulations have incited as much stress as FFATA when it comes to reporting obligations, and the thought that its onerous requirements would cease to exist brightened the day of more than a few people.

However, any positive energies were quickly doused when FFATA’s “replacement” was revealed.  Under the proposed DATA Act (H.R. 2146), while FFATA would, in fact, be repealed, similar reporting requirements would now be mandatory under virtually every federal award.  Recipients of federal funding would, at least quarterly, be required to report on the total funds received by agency, and the amount of any such funds that were obligated or expended during the selected time period, including any done so by subrecipients.  The resultant information will be then uploaded to a public website to allow for full transparency in all government-subsidized projects.

In addition to the reporting obligations, the Act will create an independent board to provide further oversight to federally-funded awards.  Christened the Federal Accountability and Spending Transparency (FAST) Board, the board will track spending on all grants and contracts, manage the new website, and generally provide guidance to institutions as to how to meet the requirements of the Act.

While the idea of transparency in government spending is a popular one, the actual implications of the Act on research facilities may prove to be incredibly burdensome, and not just because of the manpower that would be required to complete and manage all necessary paperwork.  A study by the Federal Demonstration Partnership (FDP) had calculated that the heightened reporting requirements arising under ARRA had added approximately eight thousand dollars to the cost of each grant, and now these same requirements would be imposed on almost each and every award, not just those receiving stimulus funds.  When applied to each federal award received by an entity, this could amount to hundreds of millions of dollars worth of expenditures each year.

Not surprisingly, the reaction of most institutions wasn’t favorable.  The Council on Governmental Relations (COGR) joined with the Association of American Universities (AAU) and the Association of Public Land-Grant Universities (APLU) in releasing a statement opposing the Act and drawing attention to the issues it would cause within the research community.  In spite of these efforts, the bill is still pending before Congress (tandem legislation was introduced in the Senate), and could be brought to a vote at any time.

New NIH Policy for Just-in-Time Submissions

The NIH has issued new business procedures for submitting information using the Just in Time (JIT) feature in eRA Commons.

Applicants are now required to submit JIT information at least sixty (60) days before the applicants’ proposed start date.  Please remember that, if this information is not submitted on time, funding might be delayed, and the Principal Investigator or Signing Official may be contacted by the agency directly and instructed to submit the information promptly.

Beginning April 20, 2012, applications that receive impact scores of 40 or less will receive a standard notice for submitting JIT information. The email will be generated approximately two weeks after the scores are released and will allow the institution to prepare for the JIT process, including obtaining IRB and IACUC approvals if appropriate.

Even though the JIT link is live in eRA Commons for all applications, it is not an indicator to begin the process.  Instead, rely on the JIT notification email and specific request from the NIH staff.

Good luck!

Major Changes in NIH Proposal Budgeting Policies

The NIH recently has made two significant announcements, one regarding the direct salary an individual may receive on NIH grants, and the other regarding cost of living increases.

The consolidated Appropriations Act, 2012 is restricting direct salary to the Executive II Level of the Federal Executive pay scale. This level is capped at $179,900.  The salary limitation refers to “direct salary” and “institutional base salary” and is exclusive of the appropriate fringe benefits and facilities and administrative expenses.  The executive II limit is effective for grants with initial issue dates of on/after December 23, 2011.

If you are unsure of the executive levels to use for your award take a look at the salary cap summary page provided here:

http://grants.nih.gov/grants/policy/salcap_summary.htm

For more information on the salary limit and a comprehensive Q&A section the full notice can be viewed here:

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-035.html

In FY 2012, because the NIH is seeing a less than one percent increase in funding from FY 2011 levels, they are implementing a number of cost saving policies. One of these changes involves the inclusion of cost of living increases in future budget years.  According to the new policy, FY 2012 funding levels for non-competing awards will include no cost of living/inflationary adjustments. This policy affects all grants (research & non-research).

For future year commitments, inflationary adjustments will be discontinued for competing and non-competing research grants issued in FY 2012.  For awards already issued in 2012 the agency will revise the award amount in accordance with this new policy.

To learn more about the full policy please click on the link below:

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-036.html

In both of these cases, JHSPH ORA recommends submitting budgets with actual costs, rather than cap amounts. Actual salaries can be listed, knowing that they may be cut in the event of an award. We recommend this because of the unpredictable nature of the federal budget. By the time your proposal is awarded, the cap may have been lifted, and you’ll be able to charge the full salary amount. Similarly, we recommend including all merit increases for salaries, and cost of living increases on other line items. When awarded, these items will simply be cut from your budget. The inclusion of these items will in no way negatively affect the peer review of your proposals.

In some circumstances, there may be a total value cap on the project. In those situations, departments may at their discretion limit salary to the cap amount and/or omit cost of living or merit increases to stay under the maximum award level. The bottom line is you won’t get it if you don’t ask, and asking doesn’t hurt. Other peer institutions are taking the same tack.