Stony Brook University Office of Research Services
Category: NIH

NIH Genomic Data Sharing Policy

NOT-OD-14-124

Summary

The National Institutes of Health (NIH) announces the final Genomic Data Sharing (GDS) Policy that promotes sharing, for research purposes, of large-scale human and non-human genomic1 data generated from NIH-funded research. A summary of public comments on the draft GDS Policy and NIH’s responses are also provided.

Introduction

NIH announces the final Genomic Data Sharing (GDS) Policy, which sets forth expectations that ensure the broad and responsible sharing of genomic research data. Sharing research data supports the NIH mission and is essential to facilitate the translation of research results into knowledge, products, and procedures that improve human health. NIH has longstanding policies to make a broad range of research data, in addition to genomic data, publicly available in a timely manner from the research activities that it funds.2,3,4,5,6

NIH published the Draft NIH Genomic Data Sharing Policy Request for Public Comments in the Federal Register on September 20, 2013,7 and the NIH Guide for Grants and Contracts on September 27, 2013,8 for a 60-day public comment period that ended November 20, 2013. NIH also used websites, listservs, and social media to disseminate the request for comments. On November 6, 2013, during the comment period, NIH held a public webinar on the draft GDS Policy that was attended by nearly 200 people and included a question and answer session.9

NIH received a total of 107 public comments on the draft GDS Policy. Comments were submitted by individuals, organizations, and entities affiliated with academic institutions, professional and scientific societies, disease and patient advocacy groups, research organizations, industry and commercial organizations, tribal organizations, state public health agencies, and private clinical practices. The public comments have been posted on the NIH GDS website.10 Comments were supportive of the principles of sharing data to advance research. However, there were a number of questions and concerns, and calls for clarification about specific aspects of the draft Policy. A summary of comments, organized by corresponding sections of the GDS Policy, is provided below.

Scope and Applicability

Several commenters stated that the draft Policy was unclear with regard to the types of research to which the Policy would apply. Some commenters suggested that the technology used in a research study (i.e., array-based or high-throughput genomic technologies) should not be the focus in determining applicability of the Policy. They suggested instead that the information gained from the research should determine the applicability of the Policy. Many other commenters expressed the concern that the Policy was overly broad and would lead to the submission of large quantities of data with low utility for other investigators. Several other commenters suggested that the scope of the Policy was not broad enough. Additionally, some commenters were uncertain about whether the Policy would apply to research funded by multiple sources.

NIH has revised the Scope and Applicability section to help clarify the types of research to which the Policy is intended to apply, and the reference to specific technologies has been dropped. The list of examples of the types of research projects that are within the Policy’s scope, which appeared in Appendix A of the draft GDS Policy (now referred to as “Supplemental Information to the NIH Genomic Data Sharing Policy”11), has been revised and expanded, and examples of research that are not within the scope have been added as well. Also, the final GDS Policy now explicitly states that smaller studies (e.g., sequencing the genomes of fewer than 100 human research participants) are generally not subject to this Policy. Smaller studies, however, may be subject to other NIH data sharing policies (e.g., the National Institute of Allergy and Infectious Diseases Data Sharing and Release Guidelines12) or program requirements. In addition, definitions of key terms used in the Policy (e.g., aggregate data) have been included and other terms have been clarified.

The statement of scope remains intentionally general enough to accommodate the evolving nature of genomic technologies and the broad range of research that generates genomic data. It also allows for the possibility that individual NIH Institutes or Centers (IC) may choose on a case-by-case basis to apply the Policy to projects generating data on a smaller scale depending on the state of the science, the needs of the research community, and the programmatic priorities of the IC. The Policy applies to research funded in part or in total by NIH if NIH funding supports the generation of the genomic data. Investigators with questions about whether the Policy applies to their current or proposed research should consult the relevant Program Official or Program Officer or the IC’s Genomic Program Administrator (GPA). Names and contact information for GPAs are available through the NIH GDS website.13

Some commenters expressed concern about the financial burden on investigators and institutions of validating and sharing large volumes of genomic data and the possibility that resources spent to support data sharing would redirect funds away from research. While the resources needed to support data sharing are not trivial, NIH maintains that the investments are warranted by the significant discoveries made possible through the secondary use of the data. In addition, NIH is taking steps to evaluate and monitor the impact of data sharing costs on the conduct of research, both programmatically through the Big Data to Knowledge Initiative14 and organizationally through the creation of the Scientific Data Council, which will advise the agency on issues related to data science.15

Data Sharing Plans

Some commenters pointed out that the Policy was not clear enough about the conditions under which NIH would grant an exception to the submission of genomic data to NIH. Some also suggested that NIH should allow limited sharing of human genomic data when the original consent or national, tribal, or state laws do not permit broad sharing.

While NIH encourages investigators to seek consent for broad sharing, and some ICs may establish program priorities that expect studies proposed for funding to include consent for broad sharing, exceptions may be made. The final Policy clarifies that exceptions may be requested in cases where the submission of genomic data would not meet the criteria for the Institutional Certification.

Some commenters expressed concern that it would be difficult to estimate the resources required to support data sharing plans before a study is completed. Others asked for additional guidance on resources that should be requested to support the data sharing plan. Several commenters suggested that NIH should allow certain elements of the data sharing plan, such as the Institutional Certification and associated documentation, to be submitted along with other “Just-in-Time” information. For multi-year awards, one commenter suggested that the data sharing plans should be periodically reviewed for consistency with contemporary ethical standards. Another suggested that data sharing plans should be made public.

Under the GDS Policy, investigators are expected to outline in the budget section of their funding application the resources they will need to prepare the data for submission to appropriate repositories. NIH will provide additional guidance on these resources, as necessary. The final Policy clarifies that only a basic genomic data sharing plan, in the Resource Sharing Plan section of grant applications, needs to be submitted with the funding application and that a more detailed plan should be provided prior to award. The Institutional Certification also should be provided prior to award, along with any other Just-in-Time information. Guidance on genomic data sharing plans is available on the NIH GDS website.16 Data sharing plans will undergo periodic review through annual progress reports or other appropriate scientific project reviews. Further consideration will be given to the suggestion that data sharing plans should be made public.

Non-human and Model Organism Genomic Data

The draft GDS Policy proposed timelines for data submission and data release (i.e., when data should be made available for sharing with other investigators). For non-human data, the draft Policy proposed that data should be submitted and made available for sharing no later than the date of initial publication, with the acknowledgement that the submission and release of data for certain projects may be expected earlier, mirroring data sharing expectations that have been in place under other policies.4 Some commenters suggested that the data submission expectations for non-human data were unclear. One commenter suggested that NIH should consider a more rapid timeline than the date of first publication for releasing model organism data, while other comments supported the specified data release timeline. Other commenters were concerned that the specified timeline was too short.

The final GDS Policy does not change the timeline for the submission and release of non-human and model organism data. The timeline is based on the need to promote broad data sharing while also accommodating the investigators generating the data, who often must make a significant effort to prepare the data for sharing. The Policy points out that an NIH IC may choose to shorten the timeline for data submission and release for certain projects and expects investigators to work with NIH Program or Project Officials for specific guidance on the timelines and milestones for their projects.

There was broad support for the Policy’s flexibility of allowing non-human and model organism data to be deposited in any widely used data repository. One commenter requested that a link or reference to non-NIH-designated repositories be included in the Policy. Further information about NIH-designated repositories, including examples of such repositories, is available on the GDS website,17 and additional information about non-NIH-designated data repositories will be incorporated in outreach and training materials for NIH staff and investigators and made available on the GDS website. NIH has clarified the final Policy to state that data types that were previously submitted to widely used repositories (e.g., gene expression data to the Gene Expression Omnibus or Array Express) should continue as before, while data types not previously submitted may go to these or other widely used repositories as agreed to by the funding IC.

Human Genomic Data

The Supplemental Information to the NIH GDS Policy10 establishes timelines for the submission and subsequent release of data for access by secondary investigators based on the level of processing that the data have undergone. A number of commenters expressed concern about these timelines, suggesting that they were too short and could limit an investigator’s ability to perform adequate quality control and publish results within the provided timeline. Many commenters proposed that the timeline for data release be extended to 12 or 18 months or be the date of publication, whichever comes first. Others were concerned that the timelines were too long and that they should reflect the longstanding principle of rapid data release as articulated in the Bermuda and Ft. Lauderdale agreements.5 Some commenters were concerned that the elimination of the embargo period, (i.e., the period between when a study is released for secondary research and when the submitting investigator first publishes on the findings of the study) would adversely affect the goal of rapid data release. One commenter was concerned that data would be released before investigators could discuss consequential findings with participants.

NIH has modified the Supplemental Information to clarify that the 6-month deferral for the release of Level 2 and Level 3 human genomic data does not start until the data have been cleaned and submission to NIH has been initiated, which is typically about three months after the data have been generated. Because there will be significant variation in research projects generating Level 2 and Level 3 human genomic data, the timeline for submission is project-specific and will be determined in each case by the funding NIH IC through consultation with the investigator, and the Supplemental Information has been clarified accordingly. Under the GWAS Policy,6 a publication embargo period was used as a way of making data more rapidly available. In exchange for immediate data access, secondary users were not permitted to publish or present research findings until 12 months after the data were released. NIH did not adopt this approach for the GDS Policy because in practice, the publication embargo dates were difficult for secondary users to track, especially for datasets that had multiple embargo periods for certain types of data, raising the risk of unintentional embargo violations. Regarding the concern that human genomic data will be made available before investigators can notify participants of consequential findings, such data would be considered Level 4 data and would not be expected to be released before publication, which NIH believes will provide sufficient time to discuss consequential findings with participants.

Many commenters called for the Policy to include technical data standards for the submission of human genomic data, such as platform information, controlled vocabulary, normalization algorithms, data quality standards, and metadata standards. NIH agrees with the importance of developing and using standards for genomic data and is aware that there are numerous initiatives underway to develop and promote such standards.18 NIH has revised the Supplemental Information by adding a section on resources for data standards. It provides references to instructions for data submission to specific NIH-designated data repositories, which include data standards. Additional resources for data standards will be incorporated in the Supplemental Information as they are developed and become appropriate for broad use.

Several commenters asked for a definition of an NIH-designated data repository and for guidance on determining which non-NIH repositories are acceptable as well as examples of such repositories. Commenters also expressed interest in additional details regarding the use of Trusted Partners, which are third-party partnerships established through a contract mechanism, to provide infrastructure needs for data storage and/or tools that are useful for genomic data analyses. A definition of an NIH-designated repository is now included in the final Policy. Additionally, further information about non-NIH-designated repositories that accept human genomic data will be made available on the GDS website and incorporated in outreach and training materials for NIH staff and NIH-funded investigators. Additional information about Trusted Partners, including the standards required for trusted partnerships, is also available on the NIH GDS website.16

Regarding informed consent, the GDS Policy expects investigators generating genomic data to seek consent from participants for future research uses and the broadest possible sharing. A number of commenters were concerned that participants would not agree to consent for broad sharing and that enrollment in research studies may decline, potentially biasing studies if certain populations were less likely to consent to broad use of their data. Some commenters also raised a concern about the competitiveness of an application that proposed to obtain consent for more limited sharing of data. Several commenters suggested that NIH permit alternative forms of informed consent other than broad consent, such as dynamic consent or tiered consent.

NIH recognizes that consent for future research uses and broad sharing may not be appropriate or obtainable in all circumstances. ICs may continue to accept data from studies with consents that stipulate limitations on future uses and sharing, and NIH will maintain the data access system that enables more limited sharing and secondary use. With regard to the competitiveness of grant applications that do not propose to utilize consent for broad sharing, this Policy does not propose that applications be assessed on this point during the merit review, but investigators are nonetheless expected to seek consent for broad sharing to the greatest extent possible. The breadth of the sharing permitted by the consent may be taken into consideration during program priority review by the ICs. Regarding the alternative forms of consent, the Policy does not prohibit the use of dynamic or tiered consents. It promotes the use of consent for broad sharing to enable the greatest potential public benefit. However, NIH recognizes that changing technology may enable more dynamic consent processes that improve tracking and oversight and more closely reflect participant preferences. NIH will continue to monitor developments in this area.

Several commenters were unsure whether the GDS Policy would apply to research in clinical settings or research involving data from deceased individuals. Research that falls within the scope of the GDS Policy will be subject to the Policy, regardless of whether it occurs in a clinical setting or involves data generated from deceased individuals.

Several commenters also expressed concern that the Policy is unclear about the ability of groups, in addition to participants, to opt-out or withdraw informed consent for research and whether the ability to withdraw could be transferred or inherited. The Policy states that investigators and institutions may request that NIH withdraw data in the event that individual participants or groups withdraw consent for secondary research, although some data that have been distributed for research cannot be retrieved. Institutions submitting the data should determine whether data should be withdrawn from NIH repositories and notify NIH accordingly.

Many commenters urged NIH to develop standard text or templates for informed consent documents so that investigators would be assured that their consent material would be consistent with the Policy’s expectations for informed consent and data sharing. One of these commenters noted the challenge of conveying the necessary information (e.g., broad future research uses) without adding to the complexity of consent forms. Developing educational materials or tools to guide the process for obtaining informed consent was also suggested. Other commenters expressed concern about the burden of rewriting and harmonizing existing informed consent documents. NIH appreciates the suggestion to develop template consent documents and plans to provide guidance to assist investigators and institutions in developing informed consent documents.

Many comments questioned the proposal to require explicit consent for research that is not considered humans subjects research under 45 CFR Part 46 (e.g., research that involves de-identified specimens or cell lines). There were also several comments about the draft GDS Policy proposal to grandfather data from de-identified clinical specimens and cell lines collected or generated before the effective date of the GDS Policy. The reason the Policy expects consent for research for the use of data generated from de-identified clinical specimens and cell lines created after the effective date of the Policy is because the evolution of genomic technology and analytical methods raises the risk of re-identification.19 Moreover, requiring that consent be obtained is respectful of research participants, and it is increasingly clear that participants expect to be asked for their permission to use and share their de-identified specimens for research.20,21,22 The Policy does not require consent to be obtained for research with data generated from de-identified clinical specimens and cell lines that were created or collected before the effective date of the Policy because of the practical and ethical limitations in recontacting participants to obtain new consent for existing collections and the fact that such data may have already been widely used in research.

The draft GDS Policy included an exception for “compelling scientific reasons” to allow the research use of data from de-identified, clinical specimens or cell lines collected or created after the effective date of the Policy and for which research consent was not obtained. Commenters did not object to the need for such an exception, but they asked for clarification on what constitutes a “compelling scientific reason,” and the process through which investigators’ justifications would be determined to be appropriate.

The funding IC will determine whether the investigators’ justifications for the use of clinical specimens or cell lines for which no consent for research was obtained are acceptable, as provided in their funding application and Institutional Certification. Further guidance on what constitutes compelling scientific reasons will be made available on the GDS website and will likely evolve over time as NIH ICs, the NIH GDS governance system, and program and project staff acquire greater experience with requests for research with such specimens.

For clinical specimens and cell lines lacking consent for research and collected before the effective date of the Policy, several commenters were concerned that the Policy was unclear about whether data from such specimens can be deposited in NIH repositories. This provision of the Policy is intended to allow the research use of genomic data derived from de-identified clinical specimens or cell lines collected or created after the Policy’s effective date in exceptional situations where the proposed research has the potential to advance scientific or medical knowledge significantly and could not be conducted with consented specimens or cell lines. The draft GDS Policy stated that NIH will accept data from clinical specimens and cell lines lacking consent for research use that were collected before the effective date of the Policy, and this remains unchanged in the final Policy.

A concern shared by several commenters was that the risks posed to the privacy of individuals with rare diseases, populations with higher risk of re-identification by the broad sharing of data, or populations at risk of greater potential harm from re-identification were not adequately addressed. Several commenters were particularly concerned that no additional protections were specified for these populations, and a subset suggested that research subject to the GDS Policy that involves these populations should be entirely exempt from the Policy’s expectations for data sharing.

Currently, NIH requests Institutional Review Boards (IRBs) to consider ethical concerns related to groups or populations when determining whether a study’s consent documents are consistent with NIH policy.23 In addition, NIH has clarified in the final GDS Policy that exceptions may be requested for the submission and subsequent sharing of data if the criteria in the Institutional Certification cannot be met (e.g., an IRB or equivalent body cannot assure that submission of data and subsequent sharing for research purposes are consistent with the informed consent of study participants). If a submitting institution determines that the criteria can be met but has additional concerns related to the sharing of the data, the institution can indicate additional stipulations for the use of the data through the data use limitations submitted with the study.

Several commenters suggested that return of medically actionable incidental findings should be included in the consent or that re-identification of participants should be allowed in order to return such incidental results. NIH recognizes that, as in any research study, harms may result if individual research findings that have not been clinically validated are returned to subjects or are used prematurely for clinical decision-making. The return of individual findings from studies using data obtained from NIH-designated repositories is expected to be rare, because investigators will not be able to return individual research results directly to a participant as neither they nor the repository will have access to the identities of participants. Submitting institutions and their IRBs may wish to establish policies for determining when it is appropriate to return individual findings from research studies. Further guidance on the return of results is available from the Presidential Commission for the Study of Bioethical Issues’ report, “Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts.”24

Several commenters were concerned that the draft GDS Policy was unclear about which standard should be used to ensure the de-identification of data. Another issue raised by a number of comments related to identifiability of genomic data. Several commenters were concerned that de-identified genotype data could be re-identified, even if these data are de-identified according to Health Insurance Portability and Accountability Act (HIPAA) and the Common Rule. Others asserted that genomic data could not be fully de-identified. A number of commenters suggested that the GDS Policy should explicitly state that risks exist for participant privacy despite the de-identification of genomic data and should require informed consent documents to include such a statement. Others suggested that the Policy should state that genomic information cannot be de-identified. Commenters suggested that the risks of re-identification were not adequately addressed in the draft Policy.

The final GDS Policy has been clarified to state that for the purpose of the Policy, data should be de-identified to meet the definition for de-identified data in the HHS Regulations for Protection of Human Subjects25 and be stripped of the 18 identifiers listed in the HIPAA Privacy Rule.26 NIH agrees that the risks of re-identification should be conveyed to prospective subjects in the consent process. This is one of the reasons why NIH expects explicit consent after the effective date of the Policy for broad sharing and for data that will be submitted to unrestricted-access data repositories (i.e., openly accessible data repositories, previously referred to as “open access”). NIH will provide further guidance on informing participants about the risks of re-identification through revisions to guidance documents such as the NIH Points to Consider for IRBs and Institutions in their Review of Data Submission Plans for Institutional Certifications Under NIH’s Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies.24

Several commenters were particularly concerned about the cost and burden of obtaining informed consent for the research use of data generated from clinical specimens and cell lines collected or created after the effective date of the GDS Policy. NIH recognizes that these consent expectations for data from de-identified clinical specimens collected after the effective date will require additional resources. Given growing concerns about re-identification, it is no longer ethically tenable simply to de-identify clinical specimens or derived cell lines to generate data for research use without an individual’s consent. In addition, NIH anticipates that obtaining consent for broad future research uses will facilitate access to greater volumes of data and ultimately will reduce the costs and burdens associated with sharing research data.

Some commenters expressed concern that the draft Policy’s standards for consent are more restrictive than other rules governing human subjects protections including the Common Rule27 and revisions proposed to the Common Rule in a 2011 Advance Notice of Proposed Rule Making (ANPRM).28 Some commenters sought greater clarification regarding regulatory differences or the regulatory basis for the draft Policy’s protections.

NIH has the authority to establish additional policies with expectations that are not required by laws or regulations but advance the agency’s mission to enhance health, lengthen life, and reduce illness and disability. The GDS Policy builds on the GWAS Policy, which established additional expectations that were not required by the Common Rule for obtaining consent for, handling, sharing, and using human genotype and phenotype data in NIH-funded research. NIH expects that in addition to adhering to the GDS Policy, investigators and institutions will also comply with the Common Rule and any other applicable federal regulations or laws. In response to the concern that the draft Policy is inconsistent with the ANPRM for revisions to the Common Rule, NIH will evaluate any inconsistencies between the GDS Policy and the Common Rule when the Common Rule revisions are final.

Responsibilities of Investigators Accessing and Using Genomic Data

Commenters asserted that the draft GDS Policy did not do enough to protect against the misuse of the data by investigators accessing the data. They suggested that the Policy state that responsibilities outlined in the Policy for data users should be “required” rather than “expected” and should state that there will be penalties for noncompliance with the Policy and rigorous sanctions for the intentional misuse of data. There was also a comment proposing that a submitting institution should be able to review and comment on all data access requests (DARs) to NIH before NIH completes its internal review process and proposed that NIH notify submitting institutions and research participants of any policy violations reported by users of genomic data.

NIH Data Access Committees (DACs) review DARs on behalf of submitting institutions by using the data use limitations provided by the institutions to determine whether the DAR is consistent with the limitations to ensure that participants’ wishes are respected. As part of its ongoing oversight process, NIH reviews notifications of data mismanagement or misuse, such as errors in the assignment of data use limitations during data submission, investigators sharing controlled-access data with unapproved investigators, and investigators using the data for research that was not described in their research use statement. To date, violations have been discovered before the completion of the research, and no participants have been harmed. When NIH becomes aware of any problems, the relevant institution and investigators are notified, and NIH takes appropriate steps to address the violation and prevent it from recurring. To ensure that the penalties for the misuse of data are clear for all data submitters, users, and research participants, the GDS Policy has been revised to clarify that secondary users in violation of the Policy or the Data Use Certification may face enforcement actions. In addition, a measure to protect the confidentiality of de-identified data obtained through controlled access has been added by encouraging approved users to consider requesting a Certificate of Confidentiality.

Several comments were submitted by representatives or members of tribal organizations about data access. Tribal groups expressed concerns about the ability of DACs to represent tribal preferences in the review of requests for tribal data. They also proposed new provisions for the protection of participant data, for example, including de-identification of tribal membership in participant de-identification and revision of the Genomic Data User Code of Conduct to reference protocols for accessing, sharing, and using tribal data, such as de-identification of participants’ tribal affiliation.
The final Policy has been modified to reference explicitly that tribal law, in addition to other factors such as limitations in the original informed consents or concerns about harms to individuals or groups, should be considered in assessing the secondary use of some genomic data.

Some commenters proposed changes to controlled access for human genomic data. Some commenters thought controlled access unnecessarily limited research, and many provided a range of suggestions on how to improve the process of accessing the data, such as: allowing unrestricted access to de-identified data; developing standard data use limitations for controlled-access data; streamlining and increasing transparency of data access procedures and processing time; and modifying the database of genotypes and phenotypes (dbGaP) to facilitate peer-review and collaboration.

The final GDS Policy permits unrestricted access to de-identified data, but only if participants have explicitly consented to sharing their data through unrestricted-access mechanisms. Standard data use limitations have been developed by NIH and are available through the GDS website.29 With regard to improving transparency on data access procedures, NIH plans to make statistics on access publicly available on the GDS website,30 including the average processing time for NIH to review data access requests. From its inception, dbGaP has solicited feedback from users and worked to improve data submission and access procedures, for example, the creation of a study compilation that allows investigators to submit a single request for access to all controlled-access aggregate and individual-level genomic data available for general research use.31,32 NIH will continue to seek user feedback and track the performance of the dbGaP system.

Several comments expressed concern that the GDS Policy will increase administrative burden for NIH DACs, potentially resulting in longer timeframes to obtain data maintained under controlled access. NIH is aware of the burden that may be imposed on DACs by additional data access requests and will continue to monitor this possibility and, as needed, develop methods to decrease DAC burden and improve performance for investigators, institutions, and NIH ICs.

Intellectual Property

The GDS Policy expects that basic sequence and certain related data made available through NIH-designated data repositories and all conclusions derived from them will be freely available. It discourages patenting of “upstream” discoveries, which are considered pre-competitive, while it encourages the patenting of “downstream” applications appropriate for intellectual property. Of the several comments received on intellectual property, many supported the draft Policy’s provisions. However, a few commenters opposed patenting in general, and one suggested that the Policy should explicitly prohibit rather than discourage the use of patents for inventions that result from research undertaken with data from NIH-designated repositories.

As noted above, NIH encourages the appropriate patenting of “downstream” applications. NIH will continue to encourage the broadest possible use of products, technologies, and information resulting from NIH funding or developed using data obtained from NIH data repositories to the extent permitted by applicable NIH policies, federal regulations and laws, while encouraging the patenting of technology suitable for private investment that addresses public needs. As is well known, the Supreme Court decision in Association for Molecular Pathology et al. v. Myriad Genetics, Inc. et al. prohibits the patenting of naturally occurring DNA sequences.33 Consistent with this decision, the NIH expects that patents directed to naturally occurring sequences will not be filed.

Conclusion

NIH appreciates the time and effort taken by commenters to respond to the Request for Comments. The responses were helpful in revising the draft GDS Policy and enhanced the understanding of additional guidance materials that may be necessary.

More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html

New Biographical Sketch Format Required for NIH and AHRQ Grant Applications Submitted for Due Dates on or After January 25, 2015

NOT-OD-15-024

Issued by

National Institutes of Health (NIH)

Agency for Healthcare Research and Quality (AHRQ)

Purpose

This Notice confirms that NIH and AHRQ will require use of a new biosketch format in applications for research grants submitted for due dates on or after January 25, 2015. Between now and that time, applicants will have the choice of using the old or new biosketch format.

Background

The transition to the new biosketch format follows a Request for Information and a series of pilot Funding Opportunity Announcements (FOAs) using the new format over the last year. Input from the pilots suggests that the instructions for the new forms were clear and that a majority of the applicants and reviewers felt that the new format would be helpful in describing the past experience and qualifications of researchers.

New Format

The revised forms and instructions are now available on the SF 424 (R&R) Forms and Applications page. The new format extends the page limit from four to five pages, and allows researchers to describe up to five of their most significant contributions to science, along with the historical background that framed their research. Investigators can outline the central findings of prior work and the influence of those findings on the investigator’s field. Investigators involved in Team Science are provided the opportunity to describe their specific role(s) in the work. Each description can be accompanied by a listing of up to four relevant peer-reviewed publications or other non-publication research products, including audio or video products; patents; data and research materials; databases; educational aids or curricula; instruments or equipment; models; protocols; and software or netware that are relevant to the described contribution. In addition to the descriptions of specific contributions and documentation, researchers will be allowed to include a link to a full list of their published work as found in a publicly available digital database such as MyBibliography or SciENcv .

Tool to Help Build the New Biosketch

The Science Experts Network (SciENcv), which serves as an interagency system designed to create biosketches for multiple federal agencies, will be updated and available within a few weeks to support the new biosketch format. SciENcv pulls information from available resources making it easy to develop a repository of information that can be readily updated and modified to prepare future biosketches. A YouTube video provides instructions for using SciENcv.

Inquiries

Please direct all inquiries to:

Grants Information
Office of Extramural Research (OER)
National Institutes of Health (NIH)
Phone: 301-435-0714
Email: GrantsInfo@nih.gov

Notice of Clarification of 4-Year Limit of Postdoctoral Research Eligibility for K99 Applicants for PA-14-042 “NIH Pathway to Independence Award (Parent K99/R00)”

NOT-OD-15-013

The purpose of this Notice is to clarify the eligibility requirement that K99 applicants must have no more than 4 years of postdoctoral research experience at the time of the initial application or resubmission or revision.  Specifically, this Notice describes situations in which time is not counted against the 4-year limit.

Part 2. Section III. Eligibility Information

1. Eligible Applicants

Currently reads:

Eligible Individuals (Program Director/Principal Investigator)

K99 applicants must have no more than 4 years of postdoctoral research experience at the time of the initial or the subsequent resubmission or revision application, and must be in mentored, postdoctoral training positions to be eligible to apply to the K99/R00 program. If an applicant achieves independence (i.e., any faculty or non-mentored research position) before a K99 award is made, neither the K99 award, nor the R00 award, will be issued.

Modified to read:

Eligible Individuals (Program Director/Principal Investigator)

K99 applicants must have no more than 4 years of postdoctoral research experience at the time of the initial or the subsequent resubmission or revision application, and must be in mentored, postdoctoral training positions to be eligible to apply to the K99/R00 program. If an applicant achieves independence (i.e., any faculty or non-mentored research position) before a K99 award is made, neither the K99 award, nor the R00 award, will be issued.

Parental leave or other well-justified leave for pressing personal or family situations of generally less than 12 months duration (e.g., family care responsibilities, disability or illness, active military duty) is not included in the 4-year eligibility limit. In addition, time spent conducting postgraduate clinical training that does not involve research is not considered as part of the 4-year research training eligibility limit. Only time dedicated to research activities would count toward the 4-year limit.

Additional clarifications are provided under Frequently Asked Questions. Potential candidates are encouraged to discuss their individual situation with an NIH Institute or Center Scientific Program Contact before applying.

Inquiries

Please direct all inquiries to:

Henry Khachaturian, Ph.D.
Acting NIH Research Training Officer
NIH Office of Extramural Programs
Telephone: 301-451-4225
Email: NIHTrain@mail.nih.gov

Notice of Revised NIH Definition of “Clinical Trial”

NOT-OD-15-015

The purpose of this Notice is to inform the research community that NIH has revised its definition of “clinical trial.”  The revision is designed to make the distinction between clinical trials and clinical research studies clearer and to enhance the precision of the information NIH collects, tracks, and reports on clinical trials.  It is not intended to expand the scope of the category of clinical trials. No changes have been made to the NIH definition of a “Phase III clinical trial.”  

In addition, because clinical trials are subject to additional oversight, a clearer definition will help investigators ensure that they are meeting all of their obligations, and it will help NIH ensure that the additional oversight is occurring when it is needed.  For example, NIH policy requires clinical trials to be monitored, and applicants and offerors seeking NIH support are expected to describe their plans for data and safety monitoring in their applications and proposals.  Final data and safety monitoring plans must be approved by the NIH prior to award.  In addition, throughout the life of the award, NIH staff monitors the clinical trial’s progress to ensure that milestones are met and that any safety concerns are addressed.

The revised definition will replace the current clinical trial definition in relevant extramural and intramural NIH policies, guidance, and instructional materials. It will apply to competing grant applications that are submitted to NIH for the January 25, 2015 due date and subsequent due dates and contracts proposals that are submitted to NIH on or after January 25, 2015.

The revised NIH definition of clinical trial is:

A research study in which one or more human subjects2 are prospectively assigned3 to one or more interventions4 (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.5


1See Common Rule definition of research at 45 CFR 46.102(d).

2See Common Rule definition of human subject at 45 CFR 46.102(f).

3The term “prospectively assigned” refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of a clinical trial.

4An intervention is defined as a manipultion of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints.  Examples include:  drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies.

5Health-related biomedical or behavioral outcome is defined as the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status or quality of life.  Examples include:  positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and /or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviors; and, positive or negative changes to quality of life.

NIH Biosketch

NIH is in the process of piloting new five page biographical sketches (biosketch), for release in FY 16 this would be around October 2015.  Although this change is over a year away it will have far reaching implications as most foundation and smaller sponsors defer to this biosketch format.  Attached is a sample of what the current version of the new format looks like, the basic change is the allow researchers to describe up to five of their most significant contributions to science along with historical background that framed their research.

This description can outline the central finding(s) of their work, the influence of those finding(s) on their field and how those findings may have contributed to improvements in health or technology.  For those involved in team science, it will allow the investigator to describe their specific role in the described work.  Each of these descriptions can be supported by listing up to four, relevant peer-reviewed publications.  In addition to the descriptions of their contributions, researchers will be able to include a link to a full list of their published work as found in a publicly available digital database such as MyBibliography or SciENcv.

Unless your program announcement is part of the pilot you are not permitted to use the longer format until it is rolled out next year.  If you do include a longer bio during this pilot you will only get a warning and not an error message. But your proposal will be found non-responsive once reviewed. 

As updates become available they will be passed along.  If you have any questions please contact your Grants Administrator within OSP.

NIH Commons: User IDs

Starting in October 2014, Commons User IDs will be required for all project personnel including, students (under graduate and graduate), and Post Docs and Research Support personnel. NIH will not accept RPPRs or PHS 2590s that do not have this information.

To avoid delays as you hire people to work on your project you should make sure that they have a Commons ID.  If they do not you should have one created for them.  To do this contact you the Grant Administrator assigned to your department with the following information:

  • New Personnel’s Complete Name
  • Email address
  • Phone and Fax
  • Two choices for user ID*

*Please keep in mind that this ID will be with the person for their entire research life in association with NIH projects.    

Once this id is create an email will be sent to the address given for that person. It is up to the new personnel to populate their profile once the ID is created.

NIH Announces Updated Policy for Application Submission

The National Institutes of Health (NIH) and the Agency for Healthcare Research and Quality (AHRQ) announce a change in policy on application submissions. Effective immediately, for application due dates after April 16, 2014, following an unsuccessful resubmission (A1) application, applicants may submit the same idea as a new (A0) application for the next appropriate due date. The NIH and AHRQ will not assess the similarity of the science in the new (A0) application to any previously reviewed submission when accepting an application for review. Although a new (A0) application does not allow an introduction or responses to the previous reviews, the NIH and AHRQ encourage applicants to refine and strengthen all application submissions.”

For additional information:

Policy:  http://1.usa.gov/P8caVG

Blog:    http://1.usa.gov/1gDtcCO

If you have questions regarding this new policy, contact your Program Official.

NIH Will Open the Research Performance Progress Report (RPPR) for All Type 5 Non-SNAP Progress Reports on April 25, 2014

Notice Number: NOT-OD-14-079

Key Dates
Release Date: April 15, 2014

Issued by
National Institutes of Health (NIH)

Purpose

The National Institutes of Health (NIH) will open the Research Performance Progress Report (RPPR) for all type 5 non-SNAP progress reports following the April 24, 2014, eRA release.

Background

NIH requires use of the RPPR module to submit progress reports for Streamlined Non-competing Award Process (SNAP), fellowship, and multi-year funded awards.  NIH is continuing efforts to implement the RPPR module for non-SNAP awards; please see details below.

RPPR for Non-SNAP Progress Reports
Federal Demonstration Partnership (FDP) institutions currently may opt to to submit type 5 non-SNAP progress reports using the RPPR and NIH encourages FDP institutions to continue to do so.     

On April 25, 2014, NIH will expand to all institutions the ability to submit type 5 non-SNAP progress reports using the RPPR.  NIH encourages all institutions to use the RPPR to submit type 5 non-SNAP progress reports when access is available.  While non-FDP institutions cannot submit type 5 non-SNAP progress reports using the RPPR until April 25, 2014, for institutions interested in learning more about non-SNAP RPPRs, an archive of a recent training session is available on the NIH RPPR webpage.  Beginning on April 25, 2014, all institutions may use the RPPR for type 5 non-SNAP progress reports. 

Non-SNAP progress reports not submitted using the RPPR must be submitted using the PHS 2590. 

NIH anticipates requiring all grantee institutions to use the RPPR for non-SNAP progress reports beginning on October 17, 2014; however, a separate Guide Notice announcing the requirement will be issued on a future date.  Note also, that NIH continues development of the RPPR for final progress reports and for administrative extensions (Type 4s; e.g., SBIR/STTR Fast-Track Phase II application).  NIH will update the community as progress is made.  

Additional information and resources on the RPPR, including the current RPPR Instruction Guide and training archives, can be found at: http://grants.nih.gov/grants/rppr/ .

Inquiries

General questions concerning using the eRA Commons and RPPR functionality should be directed to the eRA Commons Helpdesk at:

eRA Commons Help Desk
Web : http://grants.nih.gov/support/index.html
(Preferred method of contact)
Toll-free: 1-866-504-9552
Telephone: 301-402-7469
TTY : 301-451-5939

General inquires about this Notice may be directed to: 

Division of Grants Policy
Office of Policy for Extramural Research Administration

National Institutes of Health (NIH)
Telephone: 301-435-0938
Email: GrantsPolicy@od.nih.gov

eRA Information: eRA Commons and ASSIST Will Be Offline Memorial Day Weekend

In the interest of giving you as much advance notice as possible for planning purposes, we would like to let you know about an extended downtime that eRA has currently scheduled for the Memorial Day weekend in May 2014.

All systems, including eRA Commons and ASSIST will be offline while our systems are upgraded and the information in the databases will be converted to support Unicode compatible data.

Unicode is a computing standard that allows systems to handle virtually any type of text expressed in the world’s writing systems.  As a result of this upgrade, eRA systems will be able to accept Greek characters as they appear in the original scientific text submitted by grantees. For instance, Greek characters will now appear in progress reports without resulting in garbled text.

We will share more details about the downtime in May as the date approaches.

We are sorry for any inconvenience this may cause.

eRA Communications

Division of Communications and Outreach

NIH Office of Extramural Research

Questions? Please contact the eRA Help Desk. Check out self-help resources on the Help pagebefore submitting an online ticket; or call Toll-free: 1-866-504-9552, Phone: 301-402-7469, TTY: 301-451-5939; or email helpdesk@od.nih.gov. The Help Desk hours are Mon-Fri, 7 a.m. to 8 p.m. ET

eRA Information: New Videos on Navigating Status Available

NIH has announced that there are three new tutorial videos available for viewing to help you navigate the Status screen in eRA Commons.  These videos are the first three in a series that will look at the Status option in detail.

Status Screen Overview (tutorial #1) goes through the steps of how to get to the Status search options if you are a Signing Official (SO) or a Principal Investigator (PI); it outlines the importance of the Status screen; it also highlights some of the critical actions that must be taken to manage a grant application from submission to award to closeout.

Signing Official: Finding Information (tutorial #2)  is focused on the tools available to a Signing Official.  The video reviews the three ways an SO can search for a grant application, and the various other search options available to them.

Status Search Results (tutorial #3) covers the results of a search. The video highlights how search results are displayed and organized and the importance of checking the items listed in the Action column.

Additional Clarification on Resumption of NIH Extramural Activities Following the Recent Lapse in Appropriations

Notice Number: NOT-OD-14-014

Key Dates
Release Date: October 29, 2013

Related Announcements
NOT-OD-14-002
NOT-OD-14-003
NOT-OD-14-006
NOT-OD-14-007

Issued by
National Institutes of Health (NIH)

Purpose

This Notice provides additional clarification to the guidance on resumption of NIH extramural activities following the recent lapse in appropriations (NOT-OD-14-007).

  • All standard due dates in October have been rescheduled for November. The R21/R33 activity code was inadvertently missed in prior guidance. New R21/R33 applications originally due on October 16, 2013 are now due on November 18, 2013.
  • The statement ‘Make the refreshed application a “new”, “resubmission” or “renewal” to match the withdrawn application.’ should have also included “revision”.
  • Applicants should designate ‘Changed/Corrected Application’ as the Type of Submission on the SF424 R&R cover form of their refreshed applications.

We continue to expand our FAQs and web page of consolidated information as we encounter additional questions from applicants.

Inquiries

Please direct all inquiries to: 

NIH Grants Information
Telephone: 301-435-0714
Email: grantsinfo@od.nih.gov

Interim Guidance on Resumption of NIH Extramural Activities

Notice Number: NOT-OD-14-002

Key Dates
Release Date: October 17, 2013

Issued by
National Institutes of Health (NIH)

Purpose

NIH is working to reestablish dates for grant and contract submissions, determine how to handle missed review meetings, and reschedule dates for training and other activities that were scheduled to occur during and immediately following the period of the government shutdown.

As of today, we can confirm that we will be rescheduling all October grant application submission deadlines to the November timeframe (specific dates to be announced in a future Notice). By delaying due dates that occurred both during the lapse in funding and in the week following, applicants will have access to NIH staff and the help desks as they develop their applications.

Peer review meetings that were due to be held between October 1 and October 17 have been cancelled and are being rescheduled.

We expect the eRA Commons will be available for public access on Monday, October 21.

NIH will provide additional information, including a Notice on NIH operations during a continuing resolution, as soon as it is available.

Information for the NIH Extramural Grantee Community During the Lapse of Federal Government Funding

Notice Number: NOT-OD-13-126

Key Dates
Release Date: October 1, 2013

Related Announcements
None

Issued by
National Institutes of Health (NIH)

Purpose

The Government Fiscal Year (FY) 2013 ended on September 30, 2013 at midnight EST and an Appropriation Act for FY2014 has not been passed leading to a lapse in Federal funding.  We are providing the following information to answer questions you may have on the impact this lapse in appropriation will have on your grant/cooperative agreement or the availability of NIH’s systems and services.

RESUMING OPERATIONS

You are encouraged to stay tuned to the national media to determine when the Federal Government will resume operations.  Depending on the length of the funding lapse, once NIH non-excepted staff are authorized to resume operations it will take time for full operations to be resumed.  Depending on the length of the funding lapse, the eRA system may require at least one business day after operations resume.   We ask for patience when trying to contact NIH staff once operations resume since there will be a backlog of information to process.

CONTACT WITH NIH STAFF

E-mail, Phone, Fax, and Postal Mail Contacts:  For the duration of the funding lapse, NIH extramural employees will be prohibited from working (remotely or in the office).  Consequently, there will be no access to voice mail, e-mail, fax, or postal mail during this period.  Mail requiring someone to sign/accept may not be received.  All other postal mail, fax, and voice mail communications will not be acted upon until after operations resume. It is recommended that you delay sending such communications until after operations resume.

Help Desk Support:  For the duration of the funding lapse, all help desks, central e-mail boxes, and web ticketing systems for questions related to NIH grants policy and electronic grants systems will not be available, including the eRA Helpdesk and Grants Information Services.   

In the event of an emergency involving human safety, please contact Dr. Sally Rockey at rockeysa@od.nih.gov

SUBMISSION OF GRANT APPLICATIONS

For the duration of the funding lapse, applicants are strongly encouraged not to submit paper or electronic grant applications to NIH during the period of the lapse.  Adjustments to application submission dates that occur during the funding lapse will be announced once operations resume.  For any applications submitted immediately prior to or during the funding lapse, here is what will happen.

For electronic submissions through Grants.gov: Grants.gov will be open and can accept electronic applications.  However, applications will not be processed by NIH until the eRA Systems are back on-line.  NIH will ensure that all applications submitted within the two business days before or during the funding lapse will receive the full viewing window once the systems are back on-line.  

For electronic submission of multi-project applications through NIH’s ASSIST system: The ASISST system will not be available until NIH systems are back on-line.

Paper Submissions: Staff will not be available to receive paper applications during a funding lapse. 

The safest course is to wait to submit any application to NIH until after operations resume and a Notice in the NIH Guide concerning adjusted submission dates is posted.

PEER REVIEW AND COUNCIL MEETINGS

Initial Peer Review Meetings:  For the duration of the funding lapse, the NIH will not be able to conduct initial peer review meetings – whether in-person or through teleconferences or other electronic media. Also during this time, the NIH staff will not be able to send or receive email messages, or update website information, and NIH computer systems that support review functions will not be operational.  When operations resume, those meetings will be re-scheduled and the pending applications will be processed and reviewed as soon as possible.  

Also, the results, including final impact scores and summary statements, of some peer review meetings that took place prior to the orderly shutdown of operations may not be available until operations resume.  Therefore, applicants with applications going through the peer review process should stay tuned to the national news to determine when operations of the government resume, and then check the NIH website for information on any review meetings that may have been extended or re-scheduled.  The results of meetings held prior to a potential funding lapse will be released as soon as possible after resumption of operations.

Individuals who had agreed to serve on NIH review panels (”study sections”) that were scheduled to meet during the funding lapse will not be able to access the Internet Assisted Review (IAR) site or other NIH web-based systems during that time. Reviewers who were scheduled to travel for a review meeting on a day when operations are down will not be able to board a plane or train, and will be sent instructions on how to handle their reservations.  Reviewers who are attending an NIH review panel on the day of orderly shutdown will be able to change their travel plans and return home.  Therefore, peer reviewers should stay tuned to the national news to determine when operations of the NIH will resume, and then check the NIH website for information on meetings that have been re-scheduled.   As soon as possible after operations resume, the NIH Scientific Review Officer in charge of the review meeting will contact those reviewers with more detailed information.

Advisory Council Review: The NIH will not be able to conduct Advisory Council review meetings – whether in-person or through teleconferences or other electronic media – during the funding lapse.  Also during this time, the NIH staff will not be able to send or receive email messages, or update website information, and NIH computer systems that support review functions will not be operational.  Therefore, no applications will be processed for Council review or be taken to Council meetings during that time.  When operations resume, those pending applications will be processed, and meetings will be re-scheduled as soon as possible.  

Applicants with applications pending Council review during that time should check the NIH website for information after operations resume.  Advisory Council members should stay tuned to the national news to determine when operations of the government will resume, and then check the NIH website for information on Council meetings that have been re-scheduled.   As soon as possible after operations resume, the NIH Executive Secretary in charge of the Council meeting will contact those Council members with more detailed information.

AWARDED GRANTS

Currently Active Grant Awards:  For the duration of the funding lapse, all work and activities performed under currently active NIH grant awards may continue.  However, see below for limits on performing many of the reporting requirements associated with NIH grant funding.  

Progress Reports

Electronically Submitted Progress Reports:  For any progress reports due during the funding lapse, the eRA Commons will not be accessible.  Users will need to wait until the eRA Commons is back on-line before these progress reports can be submitted. 

Paper Submitted Progress Reports:  No NIH staff will be available to receive paper progress reports. Therefore, institutions are encouraged to delay mailing all paper progress reports due during the funding lapse until after operations resume.  

Notice of Awards (NoAs):  No NIH grant awards will be processed for the duration of the funding lapse.  For any awards processed before the funding lapse that have an issue date during the funding lapse, the awards will not be sent to the grantee on the issue date.  Once operations resume, all pending NoAs will be sent.  This will not affect the start date nor the issue date of these awards; it just affects the date the award document is actually sent to the grantee and available for access in the eRA Commons.  In the absence of actually receiving the NoA, institutions may use pre-award costs authority at their own risk.  

No-cost Extension Notifications:   The eRA Commons will not be accessible during the funding lapse.  Further, no-cost extension notification cannot be submitted via the Commons once the expiration date of the grant has passed.  For any grants due to expire during the funding lapse that plans to be given a no-cost extension, a paper notification to the IC will be required after operations resume.  

General Access to eRA Commons and Other OER-Supported Systems:  The eRA Commons will not be accessible during the funding lapse.  Therefore, no user will be able to access the Commons for viewing electronically submitted applications, accessing Internet Assisted Review, or processing such actions as Commons Registration, FSRs/FFRs, xTrain documents, Closeout documents, and/or FCOI notifications etc.  Further there will be no ability to access Commons for query or other purposes.  There also will be no access to the Interagency Edison or Electronic Council Books systems.

Prior Approval Requests and Other Communications:  NIH extramural employees will have no access to voice mail, e-mail, fax, or postal mail during the funding lapse.  All prior approval requests and other communications will not be received until operations resume.  It is recommended that you delay sending such communications until after operations resume.

Access to HHS Payment Management System (PMS):   For the duration of the funding lapse, the HHS PMS will be open; however, no Federal staff will be available to assist or process any requests.  Therefore, drawdowns (payments) on accounts can be processed as long as no Federal staff action is required to finalize the payment.  For most NIH grantees, this means drawdowns should be possible.  However, if a particular grant is on a reimbursement basis for withdrawing funds or otherwise restricted, then these requests cannot not be processed until after Federal Government operations resume.

ANIMAL WELFARE

The Office of Laboratory Animal Welfare (OLAW) business processes are funded by annual appropriations and are not designated as excepted activities under the Antideficiency Act. No activities associated with the OLAW mission will continue for the duration of the funding lapse.

For the duration of the funding lapse, PHS-funded institutions are encouraged to delay sending all Assurance documents, preliminary or final reports of noncompliance or IACUC suspensions as required under the Public Health Service Policy on Humane Care and Use of Laboratory Animals IV.F.3, or other correspondence due to OLAW during the funding hiatus period until after operations resume. OLAW will extend deadlines for all reporting activities as necessary to compensate for the period of the lapse in funding and the unavailability of the website and OLAW operational support.

Institutions are reminded that their obligation under their Animal Welfare Assurance to ensure ongoing local support and oversight, and to address and correct all situations that affect animal welfare and compliance with the PHS Policy continues during this period.

Informal Notice about Potential Lapse in Appropriated Funds

September 26, 2013

Dear Grantee: 

As you are aware, the Government Fiscal Year (FY) 2013 ends on September 30, 2013 and an Appropriation Act for FY2014 has not yet been passed.  The Administration strongly believes that a lapse in appropriations should not occur, and that there is enough time for Congress to act to prevent a lapse.  However, prudent management requires that we prepare for an orderly execution of contingency plans in the unfortunate event of a lapse.  In the event a continuing resolution or a FY2014 budget is not passed and a lapse of funding occurs, I wanted to provide you with information related to our grant administration processes.

Your particular grant program is funded by appropriations that will be affected by a government shutdown.  As a result, if there is a lapse in funding, HHS’ NIH staff will not be available to provide routine administrative support services.  HHS will, however, maintain the Payment Management System in an operational status to continue processing grant drawdown requests. Given that you have received your award prior to the gap in funding, you may be able to continue drawing funds from prior awards during an appropriations lapse.  If you received your notice of grant award with restrictive terms and conditions, or if your drawdown request triggers one of the Payment Management System edit checks and/or the drawdown limit controls, you will not be able to drawdown funds. 

If you are considering submitting an application for additional HHS federal assistance funding, please be advised that the Grants.gov system will be operational during a lapse in funding and will be accepting applications from prospective grantees.   However, for NIH applications the Grants.gov system will only accept and store applications. Applications will not be processed further until such time as the authority and funding to return to normal business operations are restored.

Please check the website at www.hhs.gov for updates.  Thank you for your assistance with this period of a potential government shut-down and your ongoing support of the NIH.

Sally J. Rockey, Ph.D.

NIH Deputy Director for Extramural Research

rockeysa@od.nih.gov

Extension of eRA Commons User IDs to Individuals in Graduate and Undergraduate Student Project Roles with Measurable Effort on an NIH Annual Progress Report (PHS2590 & RPPR)

Notice Number:  NOT-OD-13-097 

Purpose

Over the next year the NIH will start requiring an eRA Commons ID for all individuals in graduate and undergraduate student roles who participate in NIH-funded projects for at least one person month or more.  That information will appear on NIH progress reports, including those submitted on paper using the DHHS Public Health Service Grant Continuation Progress Report (PHS2590, rev. 8/2012), and electronically using the Research Performance Progress Report RPPR, rev. 08/2012).  Beginning on October 18, 2013 a warning will be generated when an RPPR is submitted that lists individuals in a graduate or undergraduate student role who have not established an eRA Commons ID.   Then beginning in October 2014, RPPRs lacking the eRA Commons ID for Graduate and Undergraduate Students will receive an error and the RPPR will not be accepted by the NIH without this information. 

The NIH PHS 2590 and RPPR forms will be modified to prompt for this information beginning on October 18, 2013.  Also beginning on that date, graduate students and postdocs who complete their eRA Commons Profile will be required to answer certain demographic questions related to their date of birth, gender, race, ethnicity, disabilities, US citizenship status and country of citizenship; and where applicable, they will need to indicate their highest educational degree and the institution where it was earned, in order to complete the data collection.  For items that request information on gender, race and ethnicity, and disability one of the acceptable responses will be ”I Do Not Wish to Provide”.

Once phased in, this new policy will extend the existing eRA Commons ID requirement for Program Directors/Principal Investigators (PDs/PIs) and postdoctoral researchers.  In addition to providing information on PD/PIs and those in the training phases of their careers, grantee institutions will be encouraged to create an eRA Commons Account for all other personnel listed on the All Personnel List of the PHS 2590 or in the Participant Section (D.1) of the RPPR. This new collection will provide more comprehensive information about the size and nature of the biomedical research workforce. Entering an eRA Commons ID in the Participant Section of the RPPR will pre-populate other components of this form reducing some of the burden associated with annual progress reporting. 

The newly revised instructions and forms will be available on October 18, 2013 at http://grants.nih.gov/grants/forms.htm.  And, the following tools for creating eRA Commons Accounts are now available:

Background

Consistent with reporting requirements from the NIH Reform Act of 2006 (P.L. 109-482, “NIH Reform Act”), NIH has collected identifying and demographic information, facilitated by eRA Commons Registration, for individuals designated in applications as the  PD/PI(s) and any individual with a postdoctoral role who participates in a NIH-funded project for at least one person month.   In addition, NIH maintains a comprehensive data collection on students and postdoctoral researchers supported by the Ruth L. Kirschstein National Research Service Award (NRSA) programs.   The inclusion of all individuals in a graduate or undergraduate student role who participated in a project for at least one person month or more will enhance the NIH’s ability to describe these populations in detail and to conduct comprehensive workforce and career outcome studies and analyses, consistent with the NIH Reform Act requirements. 

In addition to this statutory directive, the requirement for eRA Commons IDs for students responds to recommendations on the Biomedical Research Workforce  from the NIH Advisory Committee to the Director:

The NIH should ensure that all students and postdoctoral researchers supported by the NIH on both research grants and research training grants are identified and the necessary variables are collected to assess the impact of NIH funded experiences on their subsequent careers.  

Further, the NIH solicited input from the community in a Request for Information (RFI) that was issued in the NIH Guide for Grants and Contracts on February 21, 2013.   The RFI included questions specifically about the plan to gather information about students on research grants by requiring eRA Commons accounts.  In general, individuals who responded to the RFI supported the concept that the NIH should identify and track those who receive NIH support from any source during the training phases of their careers.   Some of the respondents expressed concern about burden, duplication of current data, privacy, confidentiality and security.   Some suggested close coordination with the federal scientific profile system, Science Experts Network curriculum vitae (SciENcv) that will be launched as a public beta version later this summer.  In response to the concerns raised in the RFI, all eRA Commons information will continue to be stored in a database protected by the Privacy Act.   To reduce respondent burden, information collected in the eRA Commons will be available to pre-populate the on-line SciENcv to permit users to easily generate biosketches associated with federal grant applications and progress reports.  

Implementation

Beginning this summer, on August 15, the NIH will make undergraduate, graduate student, and other project personnel roles available in the eRA Commons.   At that time, grantee Commons Account Administrators should begin working with individuals in those and other roles at their institution to establish eRA Commons accounts and to populate their profiles.  Various components of these requirements will become available at different times, as shown below:

eRA Commons Accounts: Beginning on August 15, Grantee Commons Account Administrators should start encouraging graduate and undergraduate students and others to establish eRA Commons Accounts.   All individuals establishing Commons Accounts should be encouraged to complete all requested fields.  Beginning on October 18, 2013, warnings will appear in the eRA Commons screens to alert individuals identified as undergraduate students, graduate students, and postdoctoral researchers that the following fields should be completed:  date of birth, gender, race, ethnicity, disabilities, US citizenship status and country of citizenship.  For those who have completed undergraduate or graduate degrees (graduate students and postdoctoral researchers), the highest educational degree, the degree date, and the institution where it was earned also should be completed.   Beginning on October 1, 2014, those fields in the eRA Commons screens will be required for individuals identified in any of those three roles. 

Progress Reports:  On/after October 18, 2013, all graduate and undergraduate students reported on the All Personnel Form in the PHS2590 or the Participants Section (D.1) in the RPPR should have eRA Commons IDs in addition to the current requirement for postdoctoral researchers.  A warning will be issued for all graduate and undergraduate students listed on the Participant List of the RPPR who do not have an eRA Commons ID.  Beginning October 2014, RPPRs lacking an eRA Commons ID for graduate and undergraduate students will receive an error and the RPPR will not be accepted by the NIH without this information.   eRA Commons IDs will be encouraged for all other individuals listed on the All Personnel Form or the Participants sections of those reports. 

NRSA Fellows and Trainees: Please note that these new eRA Commons roles should NOT be used for individuals submitting Individual NRSA Fellowship applications.  The PD/PI role will continue to be used for those submissions.  These roles also should not be used for individuals being reported in xTrain or on a Statement of Appointment Form (PHS2271); the Trainee Role must be used for that reporting requirement.

Inquiries

Please direct all inquiries to: 

Grants Info
Office of Extramural Research
National Institutes of Health
Telephone: 301-435-0714
TTY: 301-451-5936
Email: Grantsinfo@nih.gov
User support is provided at http://ithelpdesk.nih.gov/eRA/.