The Bayh-Dole Act of 1980 is arguably one of the most influential pieces of legislation to impact the field of intellectual property law in the twentieth century. The Bayh-Dole Act permits a university, small business, or non-profit institution using federal funds for research to produce an invention to retain the title on any patent issued for such inventions. Prior to this act, the government retained ownership of all patents granted using government money. The government also retained the right to license out the inventions to the private sector, which it did non-exclusively. This, however, was detrimental to the growth of the U.S. because companies wanted to develop products it had the exclusive rights to sell. Thus, universities were creating new and exciting technology using government funds that were never reaching the industry or the public. The Bayh-Dole act changed the way these government funded patents were handled and there was an explosion of university patenting following 1980. For a good while it seemed the Bayh-Dole Act produced only positive consequences for academia and the private sector. However, especially recently, there have been some issues raised about the effects of the act upon trends in research, conflicts of interest and the problems with biomedical patents. The effects of the Bayh-Dole Act and the concerns raised about it are significant to intellectual property and it is an important task to review the act and determine its effectiveness.
History of Federally Funded Patents Prior to 1980
The Bayh-Dole Act
The transfer of technology from research laboratories in American universities to the U.S. commercial market place is a crucial part of the growth of the United States technologically and financially. The funding for the research carried out at the universities has come in a large part from the federal government. For the greater portion of the 20th century this process, known as technology transfer, was very slow and often stifled by government policy. The reason for the small amount of technology moving from universities to industry was due mostly to the fact that the United States government retained the rights to all inventions produced by universities using government funding. Prior to 1980, the federal government retained the licenses to all patents granted to universities using federal money to support their research. This slowed down the process of technology transfer because many government agencies were reluctant to relinquish ownership of the patents to universities or industry. Instead these agencies granted non- exclusive licenses to anyone who wished to produce the inventions. The non- exclusive licenses were the major factor in suppressing the flow of technology. As a result of the non-exclusive licenses companies were turned off to the idea of manufacturing the inventions owned by the government. Companies resisted purchasing licenses for government owned patents because their competitors could just as easily acquire the same license, and develop and sell the same product. There was no incentive for a company to purchase the licenses so they simply did not. In fact, prior to 1980, only 5% of government owned patents had ever been used in industry. This was an extraordinarily low number and it concerned the government beginning in the 1970’s.
There were many attempts to increase the flow of technology from universities prior to 1980, but none have been as successful or as important as the Bayh-Dole Act. The act was enacted into law on December 12, 1980. Specifically the Bayh-Dole Act allows universities, small businesses and other non-profit organizations to elect to retain any “subject invention” made with federal funds. The institution retaining the title must commit to the commercialization of that invention. The university is also required to share a portion of the royalties from the invention with the inventors and must use a portion of the royalties for laboratory purposes. The government does reserve certain rights to protect the public interest. It retains a “nonexclusive, nontransferable, irrevocable, paid-up license to practice on behalf of the United States any subject invention”. The government also has the right to require the contractor who owns either the title or an exclusive license to the invention to grant a nonexclusive, partially exclusive or exclusive license in any field of use to a responsible applicant. This right is reserved to protect the public from having universities withhold licenses for patents that could affect the safety of the public.
Because of the act, the universities can control the title for any inventions and have the right to exclusively license out the invention to private industry. The Bayh-Dole Act works positively for all parties involved and creates incentives for research. The university is able to retain the title to the patents and create revenue by licensing the patent or selling it entirely to a private company. The private sector is provided with the incentive to develop the inventions created because they can purchase the exclusive rights to produce the inventions from the university. Although the government loses the funds from the sale of the non-exclusive licenses, it gains revenue from the taxes levied on the sales of the products that the private sector sells because of the exclusive licenses companies can now purchase. Also, only 5% of government owned patents had been used in the industry before 1980 so the government was not losing much from the sale of its licenses after the passage of the act.
Positive Effects of the Bayh-Dole Act
Following the passage of the act, the number of patents granted to universities increased exponentially. The percentage of all domestic patents granted assigned to United States research universities. It is clear that since Bayh-Dole the number of research related patents has dramatically increased. There was an increase in the rate of patenting as far back as 1975 as indicated in but it is clear that there was a turning point in 1980. There are arguments that the Bayh-Dole Act did not begin, but merely helped along a period of change in the number of university patents. Regardless, it is clear that after the act was passed into law, universities gained a much larger share of total patents granted.
The Percentage of Patents Granted to Research Universities.
Besides an increase in the sheer number of patents granted to research universities, several other cited stats show the positive impact of the act. For example, it has been estimated that since 1980 there has been a ten-fold increase in the number of universities actively engaging in patenting their research. This statistic can help explain the jump around 1980 which was on top of what looks like an already steadily increasing percentage of patents granted to universities. There were several research universities in the early 1970’s who began to file for an increasing number of patents. In 1980, with the passage of the act, new universities saw the incentive to patent and began doing so. This explains the increase in the percentages in the 1970’s and the subsequent increase following 1980.
Today, about thirty billion dollars of economic activity per year and 250,000 jobs can be attributed to technologies born in academic institutions. Also, over 2200 new companies have been formed since 1980 that were based on the licensing of an invention from an academic institution. These statistics all lead to the conclusion that the Bayh-Dole Act has significantly contributed to the development of technology transfer in the latter quarter of the twentieth century.
Issues and Concerns
Generally, the Bayh-Dole Act is regarded as having a large positive impact on U.S. research and on the U.S. economy. It certainly has been influential in increasing the number of university-based patent applications and has aided the growth of the economy and the growth of technology. There are, however several issues that have been raised due to the passing of this act which will be elaborated upon here.
One of the major incentives for universities is that they have the right to grant exclusive licenses for their patented invention or sell the title to the patent to private industry. There have been concerns that because of this there will be conflicts of interest created between industry and the research universities.
According to senior research scholar Mildred Cho of Stanford University states:
The Bayh-Dole Act has created opportunities for conflict of interest for university faculty members because academic-industry partnerships can offer direct financial rewards to individual faculty members in the form of consulting fees, royalties, and equity in companies while simultaneously funding these faculty members’ research.
Many researchers have consulted for and worked for the private sector which creates ties to certain companies. This may lead researchers to favor certain companies when licensing out the patents, which would not promote fair competition. It may also lead to skewed research, which is another possibility that concerns critics of the act.
Universities have remained the main institutions where fundamental scientific research has taken place. With the passage of the Bayh-Dole Act there is much more incentive for universities to shy away from basic research which will produce less patents and applicable inventions, and move towards applied research to gain more royalties from patenting. Mildred Cho “asserts that university research is ‘skewed’ toward marketable products and not basic research”. This issue seems like a viable possibility, but a study of 3,400 faculty at six major research institutions showed that the ratio of applied research projects to basic science research has not changed over the period between 1983 to 1999. According to the National Science Foundation from 1980 to 2001 the percentage of basic science research actually increased from 66.6% to 74.1% and applied researched decreased from 33.4% to 25.9%. While conflicts of interest and a skewing in choice of research may be reasonable concerns associated with the Bayh-Dole Act, there has been insufficient proof of these issues creating actual negative effects.
The criticism of the act with the most clout is the argument concerning biomedical research that is funded by the government. The largest portion of federal funding for academic research falls within the realm of medical and biological sciences. Since the passage of the act, the support for biomedical research has increased from $4.296 million (in 1996 dollars) in 1980 to $13.652 million (in 1996 dollars) in 1996. This jump sparked some concern about the patenting of fundamental research. Patents are designed to foster innovation, but there is an argument that universities patenting biomedical discoveries made with federal dollars inhibit the creation of final products, which are available to sell. Many of the discoveries made by universities in the biomedical field are the first steps in a process to create new drugs and therapies. These university patents are called research tools. Research tools are not final products and are not available to commercialize.
By allowing universities to retain the title to patents that are simply the beginning steps of the process to a final product, the cost of the final product increases. Industry must pay for the cost of the license to use the biomedical patent as well as its own R&D costs to develop the rest of the process to create the final drug or therapy. In the end, it is the consumer who ends up covering the cost of the original licensing fee. This is a problem because this process goes against everything the patent system was created for. It slows and may even stop innovation instead of promoting it. The private sector dealing with biomedical products must go through the process of purchasing the license and may even decide that it is not financially sound to pursue the development of the university patent. Of course, it can also be argued that the first steps in the process would never have been created if not for the Bayh-Dole Act promoting biomedical innovation, but either way the general public is left to cover the cost of the new drug or therapy or may be left without it at all.
There have been few resolutions passed which protect against the concerns over the Bayh-Dole Act.
The negative consequences are quite serious and need to be addressed as so. Just because there is little evidence concerning the existence of conflicts of interest does not mean that it does not take place. It would be easy to disguise and gathering data would be difficult. Many university researchers do have ties to private industry and may even own their own company. There must be more research done into this to determine the effects of conflict of interest. While research skewing seems to have not been an issue thus far there could potentially be problems in the future if the economy takes a dive or universities lose funding for some reason. The biomedical patent problem is a very real one and needs to be addressed more clearly than it has, which will be discussed below.
Conclusions
In general the benefits created by the Bayh-Dole Act greatly outweigh any possible negative consequences. The act was built quite soundly to allow incentives for all involved parties (government, academia, industry), but also has safety measures to ensure that the inventions are handled correctly. The act defines how the university must appropriate the funds created through royalties due to licensing fees and the government retains a special license to use when the invention is deemed critical to public interest. Financial and technological growths are promoted well in academia and the public and private sectors. The results speak for themselves as well. The number of research university related patents has increased enormously since the passage of the act, the number of businesses created around an idea involved with a university patent has increased, the number of jobs involved with university patents has increased, and the American economy has certainly benefited from these positive consequences of the Bayh-Dole Act.
Unfortunately, the act is not flawless.
While there have been few adverse effects that are directly linked to the act there is the possibility of certain issues becoming major problems. Just because there has been little evidence of conflicts of interest between university researchers and the private sector does not mean measures should not be taken to prevent this from happening. The same preventative measures should be taken to ensure the appropriate balance between basic and applied research. The government should require a committee to be created at any university electing to retain the rights to the title of their patent. Many universities have hired professional technology managers to work with the university and act as a liaison to the private sector. While this is a good step, it is not enough. The committee should consist of more than just an outside professional hired by the university. The Technology Transfer committee needs to consist of faculty from every department that uses federal funding for their research as well as an expert trained in the field. There needs to be a contact for the committee with the federal government. The committee should be required to report to this contact at least once every year.
The purpose of this committee will be to act as an interface between the university, the government and industry. Having multiple members of the faculty as well as reporting to a government agency designed to handle technology transfer allows for a system of checks and balances to ensure that there will be no conflicts of interest present and that every company has a fair shot at acquiring the exclusive license to a patent. Having a member from every department that utilizes federal funds while ensure that the research is not swayed away from basic research towards applied research as faculty that does not often patent will have a say in the committee. Also, reporting to the government contact will allow data about university patenting and revenues due to licensing to be easily gathered and analyzed. Thus, it will be easy to locate trends in university patenting and technology transfer.
To alleviate the problems associated with biomedical patents there have already been steps supposedly taken by the National Institutes of Health (NIH) and the United States Patent and Trademark Office (USPTO). The NIH has created guidelines asserting that research tools (patents granted for processes that do not lead to commercialization) that are developed with federal funds must be made available to other scientists under reasonable terms. The USPTO has also changed their guidelines to determine the patentability of biotechnology discoveries. While these are good steps to ensure that licensing fees for biomedical patents are reasonable, they are not concrete. Congress needs to step in and develop a plan that will protect the inventors of the research tool while still making it available to the private sector to develop into drugs and therapies. Congress could set a licensing fee for research tools deemed important to the public sector that the university must abide by. After all, financial rewards from patenting comprised only 3% percent of total funding for university research in the 2000 fiscal year. Thus, a smaller licensing fee for only certain research tools will not significantly impact the university. It is more important to keep the public health in mind when considering biomedical patents than funding for universities and their right to license out patents.
Works Cited
The Bayh-Dole Act of 1980 has played an important role in the field of intellectual property, and will continue to have significant consequences for years to come. The country has benefited as a whole from the legislation. Universities are patenting much more and industry is producing advanced technology for the general public. However, there are some foreseeable problems associated with the act. Universities, industry and the government must be made aware of the possible negative effects of the act and take a proactive stance in preventing them from occurring.
[1] Academic Research and Development Expenditures: Fiscal Year 2001.
[2] Council on Governmental Relations. 1999. The Bayh-Dole Act: A Guide to the Law and Implementing Regulations.
[3] Mowery, David and Sampat, Bhaven. 2004. The Bayh-Dole Act of 1980 and University-Industry Technology Transfer: A Model for Other OECD Governments?
[4] Schacht, Wendy. 2005. The Bayh-Dole Act: Selected Issues in Patent Policy and the Commercialization of Technology.
[5] Thursby, Jerry and Thursby, Marie. University Licensing Under Bayh-Dole: What are the Issues and Evidence?, May 2003.
FROM WIKIPEDIA
https://en.m.wikipedia.org/wiki/Bayh%E2%80%93Dole_Act
VIDEO
Bayh-Dole Regulations
Code of Federal Regulations: https://www.govinfo.gov/app/collection/cfr/
Title 37 – Patents, Trademarks, and Copyrights: https://www.law.cornell.edu/cfr/text/37
Bayh-Dole Regulations: Code of Federal Regulations
Resource: https://grants.nih.gov/grants/bayh-dole.htm
The Bayh-Dole Act: Knowledge is your friend
- Homepage of Essential Inventions, the non-profit corporation which petitioned the US Department of Health and Human Services for licenses to manufacture and sell inexpensive generic versions of Xalatan and Norvir.
The Bayh-Dole Act allows for the transfer of exclusive control over many government funded inventions to universities and businesses operating with federal contracts for further development and commercialization.
The contracting universities and businesses are then permitted to exclusively license the inventions to other parties. The federal government, however, retains “March-in” rights to license the invention to a third party, without the consent of the patent holder or original licensee, where it determines the invention is not being made a vailable to the public on a reasonable basis, (in other words, to issue a compulsory license.)
- Text of the Bayh-Dole Act (35 USC 200-212).
- Text of 35 USC 203, which grants the federal government march-in rights. Here is an exerpt from the section:With respect to any subject invention in which a small business firm or nonprofit organization has acquired title under this chapter, the Federal agency under whose funding agreement the subject invention was made shall have the right… to grant such a license itself.
- CPT Page on CellPro and Bayh-Dole March-in Rights. This page is about a firm named CellPro’s attempt to get the Clinton Administration to issue a compulsory license for a treatment for cancer.
- November 23, 2004. Arti K. Rai and Rebecca S. Eisenberg. Bayh-Dole Reform and the Progress of Biomedicine. Law and Contemporary Problems, Vol. 66, No. 1.
- January, 2001. Peter Arno and Michael Davis in the Tulane Law Review. Why Don’t We Enforce Existing Drug Price Controls? The Unrecognized and Unenforced Reasonable Pricing Requirements Imposed upon Patents Deriving in Whole or in Part from Federally Funded Research.
- April 11, 2002. Birch Bayh and Bob Dole’s letter to the editor of the Washington Post in response to the March 27 op-ed on the Bahy-Dole Act. Our Law Helps Patients Get New Drugs Sooner.
- 1999. The Council on Governmental Relations (made up of faculty from a number of US universities.)The Bayh-Dole Act – A Guide to the Law and Implementing Regulations.
- June 2, 1998. Association of American Universities. University Technology Transfer of Government-Funded Research Has Wide Public Benefits.
Efforts to Have the NIH License the World Health Organization the Rights to Its Health Patents
- March 28, 2001. Letter from Ralph Nader, James Love, and Robert Weissman to US Secretary of Health and Human Services Tommy Thompson.
- October 19, 1999. Letter from NIH Director, Dr. Harold Varmus to Ralph Nader, James Love and Robert Weissman responding to their request calling on the NIH to provide the World Health Organization, WHO, access to US government funded medical inventions.
- September 3, 1999. Letter from Ralph Nader, James Love, and Robert Weissman to NIH Director Harold Varmus asking for NIH to give the World Health Organization, WHO, access to US government funded medical inventions.
A Few Archived News Stories
- September 78, 2005. Clifton Leaf in Fortune Magazine. The Law of Unintended Consequences.
- December 16, 2004. Jane Burgermeister for the Nature Publishing Group. Hungarian Parliament expected to pass a new innovation law.
- April 2004. Shannon Brownlee for the Washington Monthly. Doctors Without Borders – Why You Can’t Trust Medical Journals Anymore.
- January 12, 2003. Jane Larson for the Arizona Republic. Tech transfer on table: Inventors, governor eager to change law.
- December 14, 2002. The Economist. Innovation’s Golden Goose.
- March 27, 2002. Op-ed by Peter Arno and Michael Davis in the Washington Post. Paying Twice for the Same Drugs.
- January 21, 2002. Joseph Paone for The Scientist. When Big Pharma Courts Academia.
- June 13, 2000. Judith Gorman for AlteNnet. PAPER CUTS: The Golden Fleece.
- 1998, Winter. Michael Odoza for 21st Centery MetaNews, vol. 3-1. (Columbia University). From the Ivory Tower to the Marketplace. This story is from an issue of the publication devoted exclusively to technology transfer from university to pivate enterprise. Here is the URL for the full issue.
Return to: CPTech Home -> Main IP Page -> IP and Healthcare -> Research and Development Page
Current updates: Bayh-Dole Regulations
Code of Federal Regulations
Bayh-Dole Regulations
Title 37 – Patents, Trademarks, and Copyrights
Volume: 1 Date: 2013-07-01 Original Date: 2013-07-01 As Amended: 2018-04-13
37 CFR 401 §401.2 Definitions.
§401.3 Use of the standard clauses at §401.14.
§401.4 Contractor appeals of exceptions.
§401.5 Modification and tailoring of clauses.
§401.6 Exercise of march-in rights.
§401.7 Small business preference.
§401.8 Reporting on utilization of subject inventions.
§401.9 Retention of rights by contractor employee inventor.
§401.10 Government assignment to contractor of rights in invention of government employee.
§401.11 Appeals.
§401.12 Licensing of background patent rights to third parties.
§401.13 Administration of patent rights clauses.
§401.14 Standard patent rights clauses.
§401.15 Deferred determinations.
§401.16 Electronic filing.
§401.17 Submissions and inquiries.
Authority: 35 U.S.C. 206; DOO 30-2A.
Source: 52 FR 8554, Mar. 18, 1987, unless otherwise noted.
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March 29
Registration Process Changes in SAM.govMarch 26Summary of Leave, Part-Time and Extension Policies Available to Ruth L. Kirschstein National Research Service Awards (NRSA) Trainees and FellowsMarch 9Register Today – Space is Limited and Savings End Soon for the NIH Regional Seminar on Program Funding & Grants Administration: Washington, D.C. – May 2-4, 2018March 7Guidance on Salary Limitation for Grants and Cooperative Agreements FY 2018February 2018February 20Advance Notice of Transition to the xTRACT System for Preparing Research Training Data TablesFebruary 8NIH Operates Under a Continuing Resolution Through February 8, 2018February 2Notice of ORIP’s Interest to Highlight Resource-Related Research Projects for Development of Animal Models and Related materials that Address High Priority HIV/AIDS-related ResearchJanuary 2018January 31Request for Information (RFI): Research Questions to Inform Development of the All of Us Research ProgramJanuary 23Grant Application Due Dates Following the Recent Lapse in AppropriationsJanuary 18Grant Application Instruction Corrections for Training Grants with Human Subjects InvolvementJanuary 16HHS issues Four (4) PHS 2018-2 SBIR and STTR Omnibus/Parent Grant Solicitations with FORMS-E and Clinical Trials Policy UpdatesJanuary 12NIH Operates Under a Continuing Resolution Through January 19, 2018January 12Reminder: Updated Appendix Policy Eliminates Clinical Trial-Related Materials for NIH/AHRQ/NIOSH Applications Submitted to Due Dates on or After January 25, 2018December 2017December 22Maintaining Integrity in NIH Peer Review: Responsibilities and ConsequencesDecember 19Revision: NIH Policy and Guidelines on the Inclusion of Individuals across the Lifespan as Participants in Research Involving Human subjectsDecember 19NIH Operates Under a Continuing Resolution Through December 22, 2017December 14Reminder: Annual Reports to OLAW due January 31, 2018December 12Additional Short-Term Administrative Relief to Institutions Impacted by Hurricane Harvey, Irma, and MariaDecember 7Notice of Requirement for Electronic Submission of Research Supplements to Promote Diversity in Health-Related Research and Upcoming System ValidationDecember 1Revision: The NIH Announces Additional Review Criteria for Career Development Award Applications Involving Clinical TrialsDecember 1Notice of Intent to Revise the NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human SubjectsNovember 2017November 30Standards for Documentation of Personnel ExpensesNovember 30NIH Enforcement of Closeout PoliciesNovember 30Reminder: Policy on Finding Opportunity Announcements (FOA) for Clinical Trials Takes Effect January 25, 2018November 28Amendment: NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical ResearchNovember 27Revision: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp)November 172018 NIH Regional Seminar on Program Funding & Grants Administration – Early Registration Rates Available NowNovember 16NIH will Make the Project Outcomes Section of all Interim and Final RPPR’s Submitted on or After October 1, 2017 Available via the NIH RePORTERNovember 3Statement on Article Publication Resulting from NIH Funded ResearchOctober 2017October 25NIH Plans for Clinical Trial Specific Parent R01 and Parent R21 Funding Opportunity AnnouncementsOctober 24Reminder: FORMS-E Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2018October 12Publication of the Revised NIH Grants Policy Statement (Rev. October 2017) for FY 2018October 11Guidance on Implementation of the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site ResearchOctober 11Guidance on Exceptions to the NIH Single IRB PolicyOctober 6The NIH Announces New Review Criteria for Career Development Award Applications Involving Clinical TrialsOctober 6The NIH Announces New Review Criteria for Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grants Involving Research Experiences in Clinical TrialsOctober 6The NIH Announces New Review Criteria for Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellowship Applications Involving Research Experiences in Clinical TrialsOctober 4NIH Offers Assistance to Active Phase I HHS SBIR and STTR Awardees through the Niche Assessment Program 2017-2018October 3Application and Report Submission Flexibilities Available to Institutions Impacted by Hurricane MariaOctober 2NIH Operates Under a Continuing Resolution Through December 8, 2017September 2017September 25New NIH “FORMS-E” Grant Application Instructions Available for Due Dates On or After January 25, 2018September 21The NIH Announces New Review Criteria for Research Project Applications Involving Clinical TrialsSeptember 20Request for Comment: Proposal to Update Data Management of Genomic Summary Results Under the NIH Genomic Data Sharing PolicySeptember 20Updates to Active Funding Opportunity Announcements to Prepare for Policy Changes Impacting Due Dates On or After January 25, 2018September 20Review the Accuracy of Grants Information for Fiscal Year 2017September 19NIH Peer Review Online Briefings for AREA (R15) and SBIR/STTR Grant ApplicantsSeptember 14Reminder: NIH Natural Disaster Policy – Hurricane IrmaSeptember 12Reminder: NIH Applications Must Be Complete and Compliant With NIH Policy and Application Instructions At Time of SubmissionSeptember 11Notice of Assistance Available to Institutions Impacted by Hurricane HarveySeptember 1Notice of Changes to NIH Policy for Issuing Certificates of ConfidentialityAugust 2017August 31Policy Supporting the Next Generation Researchers InitiativeAugust 30Notice to Extend the Response Date for NOT-OD-17-090 “Request for Information (RFI): Inviting Comments on the Environmental Influences on Child Health Outcomes (ECHO)-wide Cohort Data Collection ProtocolAugust 28Reminder: NIH Natural Disaster Policy – Hurricane HarveyAugust 15Notice of Correction to NOT-OD-17-090 “Request for Information (RFI): Inviting Comments on the Environmental Influences on Child Health Outcomes (ECHO)-wide Cohort Data Collection Protocol”August 14Request for Information (RFI): Infrastructure for Research in Nonhuman PrimatesAugust 10Request for Information (RFI): Inviting Comments on the Environmental Influences on Child Health Outcomes (ECHO)-wide Cohort Data Collection ProtocolAugust 3NIH Offers Assistance to Phase II HHS SBIR and STTR Awardees through the NIH Commercialization Accelerator Program (CAP) 2017-2018August 2Updated Appendix Policy Eliminates Clinical Trial-Related Materials for NIH/AHRQ/NIOSH Applications submitted to Due Dates on or After January 25, 2018July 2017July 24Additional Guidance on “Full-Time Training” for Ruth L. Kirschstein National Research Service AwardsJuly 24Clarification and Update: Salary Supplementation and Compensation on Research Caree Development (“K”) AwardsJuly 10NIH Implementation of Final Research Performance Progress Reports (Final RPPR) for Small Business and Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Grants and Cooperative AgreementsJuly 3Revision: Guidance on Salary Limitation for Grants and Cooperative AgreementsJune 2017June 30NIH Fiscal Policy for Grant Awards – FY 2017June 27Revision: Ruth L. Kirschstein National Research Service Awards (NRSA) Predoctoral Stipends, Training Related Expenses, Institutional Allowance, and Tuition/Fees Effective for Fiscal Year 2017June 23Protecting Life in Global Health AssistanceJune 22RESCINDED Ruth L. Kirschstein National Research Service Awards (NRSA) Predoctoral Stipends, Training Related Expenses, Institutional Allowance, and Tuition/Fees Effective for Fiscal Year 2017June 16Revision: Notice of Extension of Effective Date for Final NIH Policy on the Use of Single Institution Review Board for Multi-Site ResearchJune 9Notice of Legislative Mandates in Effect for FY 2017June 5HHS Issues PHS 2017-2 SBIR and STTR Onmibus Grant SolicitationsJune 5NIH Reminds Recipients to Submit Complete , Timely and Accurate Progress and Financial ReportsMay 2017May 31Reminder: Authentication of Key Biological and/or Chemical ResourcesMay 30Additional Change to the NIH/AHRQ/NIOSH Policy on Post-Submission MaterialsMay 30NIH Offering Fall Seminar on Program Funding & Grants Administratoin in Baltimore, MD Early Registration Ends June 9May 11Interagency Edison Requests for Extensions of Time to Retain Title to a Subject Invention or to File an Initial Patent Application under NIH Funding Agreements May 2NIH and FDA Release Protocol Template for Phase 2 and 3 IND/IDE Clinical TrialsApril 2017April 27New “FORMS-E” Grant Application Forms and Instructions Coming for Due Dates On or After January 25, 2018April 26Request for Information (RFI): Invitation to Comment on Inclusion in Clinical Research Across the LifespanApril 14Guidance for Adjustments to Appointment Records in xTrain to Reflect Stipend Level Increases for Postdoctoral Trainees on Institutional Ruth L. Kirschstein National Research Service Awards (NRSA)April 12Notice of Form Correction for PA-16-268 “Successor-in-Interest (Type 6 Parent)”April 11Request for Information on the Development of the FY 2019 Trans-NIH Plan for HIV-Related ResearchApril 3Change to NIH Method of Payment for Award to Federal Institutions and Individual Fellowships at Federal Sponsoring InstitutionsMarch 2017March 24Reporting Preprints and Other Interim Research ProductsMarch 17Interim Guidance on Salary Limitation for Grants and Cooperative Agreements
December 2016
December 21Change to Standard Due Dates for Ruth L. Kirschstein National Research Service Award Individual Predoctoral Fellowships to Promote Diversity in Health Related Research (F31 – Diversity)December 21Notice of Change to PA-17-078 “Administrative Supplement for Research on Sex/Gender Influences (Admin Supp)” December 16Notice of Extension of Effective Date for Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site ResearchDecember 15New to the NIH Grants Process? NIH Announces 2017 NIH Regional Seminar Locations in New Orleans, LA and Baltimore, MDDecember 15Revised SF424 (R&R) Application Guides and Supplemental Instructions AvailableDecember 15Ruth L. Kirschstein National Research Service Awards (NRSA) Postdoctoral Stipends, Training Related Expenses, Institutional Allowances and Tuition/Fees Effective FY17December 8Notice of Extension of the Response Date for NOT-OD-17-015 “Strategies for NIH Data Management, Sharing and Citation”December 1Reminder: Annual Reports to the Office of Laboratory Animal Welfare due January 31, 2017
November 2016
November 23NIH Implementation of Final Research Performance Progress Report (Final RPPR)November 17Publication of the Revised NIH Grants Policy Statement (Rev. November 2016) for FY 2017November 7Adjustments to Stipend Levels for Postdoctoral Trainees and Fellows on Ruth L. Kirschstein National Research Service Awards (NRSA)November 4Additional Awardees Eligible for PA-16-289”Research Supplements to Promote Re-Entry into Biomedical and Behavioral Research (Admin Supplement)November 4Additional Awardees Eligible for PA-16-288”Research Supplements to Promote Diversity in Health-Related Research (Admin Supplement)
October 2016
October 25Reports on Site Visits to the National Primate Research Centers and Federally Supported Chimpanzee SanctuaryOctober 21Notice of Extension of the Response Date for NOT-OD-17-006 Including Preprints and Interim Research Products in NIH Applications and ReportsOctober 18Request for Information: Research Supplement to Promote Workforce Diversity in Small BusinessesOctober 14Reminder: NIH Natural Disaster Policy – Hurricane MatthewOctober 7NIH Operates Under a Continuing ResolutionOctober 6Request for information (RFI): Including Preprints and Interim Research Products in NIH Applications and ReportsOctober 6Optional Electronic Submission Method to Request to Submit an Unsolicited Application that will exceed $500,000 in Direct Costs
September 2016
September 28NIH Peer Review Online Briefings for Fellowship and R01 Grant Applicants, and Basic Research Grant Applicants and ReviewersSeptember 16NIH Policy on the Dissemination of NIH-Funded Clinical Trial InformationSeptember 16Policy on Good Clinical Practice Training for NIH Awardees in NIH-funded Clinical TrialsSeptember 16Policy on Funding Opportunity Announcements (FOA) for Clinical TrialsSeptember 9Notice of Correction to PA-16-309 “Ruth L. Kitschstein National Research Service Award (NRSA) Individual Predoctoral Fellowship (Parent F31)”September 8Optional Electronic Method to Request Withdrawal of Applications from Consideration for Funding
August 2016
August 19Reminder: NIH Natural Disaster Policy – Flooding in LouisianaAugust 12Changes to the NIH/AHRQ/NIOSH Policy on Post-Submission Materials for Applications Submitted for Due Dates On or After January 25, 2017August 12New Policy Eliminates Most Appendix Material for NIH/AHRQ/NIOSH Applications Submitted for Due Dates On or after January 25, 2017August 10Revised: Projected FY 17 Stipend Levels for Postdoctoral Trainees and Fellows on NRSA AwardsAugust 9Notice of Extension of the Response Date for NOT-OD-16-128 “Request for Public Comment on the Proposed Changes to the NIH Guidelines for Human Stem Cell Research and the Proposed Scope of an NIH Steering Committee’s Consideration of Certain Human-Animal Chimera Research”August 5NIH Offers Assistance to Phase II HHS SBIR and STTR Awardees through the NIH Commercialization Accelerator ProgramAugust 4Request for Public Comment on the Proposed Changes to the NIH Guidelines for Human Stem Cell Research and the Proposed Scope of an NIH Steering Committee’s Consideration of Certain Human-Animal Chimera ResearchAugust 2Rescission of NOT-OD-16-088 “Notice of Intent to Release Names of NIH-Funded Research Project Personnel in the NIH Research Portfolio Online Reporting Tools Expenditures and Results (REPORTER) System”August 2Notice of Change in Animal Welfare Assurance Numbering System
July 2016
July 29Update: Availability of Resources for Instruction in the Responsible Conduct of ResearchJuly 26Change of Eligibility Period in the NIH Continuous Submission Policy for Reviewers with Recent Substantial Service
June 2016
June 30OMB Approval for SF424 R&R Forms Used Federal-wide Underway – Continue to Use Current Forms Until Further Notice June 21Additional Awardees Eligible for PA-16-288 “Research Supplements to Promote Diversity in Health-Related Research (Admin sup)”June 21Scenarios to Illustrate the Use of Direct and Indirect Costs for Single IRB Review under the NIH Policy on the Use of Single IRB for Multi-Site ResearchJune 21Final NIH Policy on the use of Single Institutional Review Board for Multi-Site ResearchJune 21Modification of No-Cost Extension and Carryover of Funds Policies for the NIH Pathway to Independence Award (Parent K99/R00)June 13Revised NIH Parental Leave Policy for Ruth L. Kirschstein National Research Service Awards June 10Form Correction Made for All NIH Fellowship Opportunities
May 2016
May 26NIH Research Involving ChimpanzeesMay 17Request for Information (RFI): Data Annotation in Biomedical Core Research Facilities and Related Needs for Community Education and TrainingMay 11Request for Information on the Development of the FY 2018 Trans-NIH Plan for HIV-Related ResearchMay 3Notice of Intent to Release Names of NIH-Funded Research Project Personnel in the NIH Research Portfolio Online Reporting Tools Expenditures and Results (RePORTER) System
March 2016
March 28Restructured and Streamlined Application Guides and Supplemental Instructions Available for Applications Due Dates On or After May 25, 2016March 24Reporting Instructions for Publications Supported by Shared Resources in Research Performance Progress Reports (RPPR) and Renewal ApplicationsMarch 23Revision of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) to Streamline Review Process for Human Gene Transfer ProtocolsMarch 23Reminder: NIH & AHRQ Grant Application Changes for Due Dates On or After May 25, 2016March 23Clarifications and Consolidated Biosketch Instructions and Format Pages Available for Applications with Due Dates On or After May 25, 2016
February 2016
February 25Requirement for the Appropriate Signatures on NIH Forms and Official DocumentationFebruary 22NIHs Implementation of the Federal Awardee Performance and Integrity Information System (FAPIIS) RequirementsFebruary 19Plan to Move to Updated Forms (FORMS-D) for Administrative Supplement, Successor-In-Interest and Change of Institution OpportunitiesFebruary 17Reminder: All Subject Inventions Must Be Reported on the HHS 568 – Final Invention Statement and Certification (For Grant or Award) and in iEdisonFebruary 12Impact of Grant Application Form Update (FORMS-D) on Late and Continuous Submission ApplicationsFebruary 11NIH Policy on Informed Consent for Human Fetal Tissue ResearchFebruary 9Registration Now Open for the Spring & Fall 2016 NIH Regional Seminars on Program Funding & Grants Administration
January 2016
January 28Notice of Correction to Salary Limitation on NIH Grants, and Cooperative Agreements January 26Revised: Ruth L. Kirschstein National Research Service Award (NRSA) Stipends, Tuition/Fees and Other Budgetary Levels Effective for Fiscal Year 2016 January 25Reminder: NIH Natural Disaster Policy — Winter Storm Jonas January 25Streamlining the eRA Commons Registration Process January 22Reminder: NIH & AHRQ Grant Application Changes for Due Dates On or After January 25, 2016January 20Change in eRA Commons Registration ProcessJanuary 20Clarification: New Salary and Research Cost Allowances for K08 and K23 Career Development AwardsJanuary 20Ruth L. Kirschstein National Research Service Award (NRSA) Stipends, Tuition/Fees and Other Budgetary Levels Effective for Fiscal Year 2016January 20NIH Fiscal Policy for Grant Awards – FY 2016January 14Notice of Correction to the Application Instructions for RFA-OD-16-003 “Environmental influences on Child Health Outcomes: Patient Reported Outcomes Research Resource Center Core (ECHO PRO Core) (U24)”January 12Notice Clarifying SBIR Direct-to-Phase II Eligibility Criteria
December 2015
December 18Notice of Reissuance of the Parent Research Career Development (K) Award Funding Opportunity AnnouncementsDecember 6Notice of Reissuance of Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grant (Parent T32) and Short-Term Institutional Research Training Grant (Parent T35)December 4Change in the NIH Continuous Submission Policy
The Trailblazing Patriot 