1. Research Administration Updates
October 25, 2017
10:30 am
IOP Auditorium

2. Topics Covered NIH Clinical Trial Reforms Review – ORSP
NEW Funding Opportunity Announcements (FOAs)
NEW FORMS-E
NEW Human Subjects & Clinical Trials Information Form
NEW Protocol Development Tool for Phase 2 and 3
NEW Review Criteria
Good Clinical Practice Training Requirement
Single IRB (sIRB) Policy for Multi-site Research
NIH Policy on Dissemination of NIH-Funded Clinical Trial Information
Recent Notices, Updates and Reminders – ORSP

3. NIH Clinical Trial Reforms/Changes
Why Changes to Clinical Trial Policies?
The Government Accountability Office (GAO) recommended NIH improve clinical trial data collection and establish and implement a process for using this data effectively.
Enhance the application and award processes to increase NIH’s ability to assess the merits and feasibility of clinical trial applications.
Improve oversight and transparency.
Increase the sharing of clinical trial results.
NIH has an ethical mandate to assure the public that the results of all NIH-funded trials will be made available in a timely manner.
Current NIH data shows over half of all completed NIH-funded trials are not reported out within 2.5 years of completion.
The problem is widespread and pervasive.
NIH is working towards higher levels of trust and transparency.

4. New FOAs
NOT-OD
Updates to Active Funding Opportunity Announcements to Prepare for Policy Changes Impacting Due Dates On or After January 25, 2018
Impacted FOAs
All active FOAs with due dates on or after January 25, 2018 will be updated with the following exceptions:
Parent announcements will NOT be updated since they will be reissued (with new FOA numbers) for due dates on or after January 25.
FOAs that will allow applications proposing clinical trials will NOT be updated since they will be reissued (with new FOA numbers) for due dates on or after January 25.
NOTE: This notice does NOT introduce any new policies. NIH is simply updating FOA text to align with existing policy.

5. New FOAs NOT-OD-17-114 (continued) Summary of Changes To Active FOAs
Per NOT-OD , NIH will add a clinical trial allowability indicator in table in Part 2, Section II. Award Information (NIH only).
In preparation for FORMS-E application forms (NOT-OD and NOT-HS ):
NIH will add text to the PHS Inclusion Enrollment Report form instructions in Part 2, Section IV. Application and Submission Information to indicate the form is only available in FORMS-D application packages for due dates on or before January 24, 2018.
NIH will add text for the PHS Human Subjects and Clinical Trials Information form and instructions in Part 2, Section IV. Application and Submission Information and indicate the form is only available in FORMS-E application packages for due dates on or after January 25, 2018.

6. New FOAs NOT-OD-17-114 (continued) Summary of Changes To Active FOAs
To align announcements with Rigor and Transparency policies (Research: NOT-OD , Career Development: NOT-OD ), NIH will update Part 2, Section V. Application Review Information to include the appropriate rigor and transparency questions in the Research Plan section, and a section for Authentication of Key Biological and/or Chemical resources within the additional review criteria.
To align announcements with recent vertebrate animals changes (NOT-OD ), NIH will update the Vertebrate Animals section of the Additional Review Criteria in Part 2, Section V. Application Review Information (NIH only).
See Research, Career Development, Fellowship, Multi-project, and Training for program-specific text insertions/deletions associated with this notice.

7. New Forms-E
NOT-OD
New NIH "FORMS-E" Grant Application Instructions Available for Due Dates On or After January 25, 2018
NIH has updated their application guide for use with grant application due dates on or after January 25, 2018 (see NOT-OD ).
All updates to form instructions are listed at: 
These instructions will be used in conjunction with application form packages identified with a Competition ID of "FORMS-E”.

8. New Forms-E NOT-OD-17-119 (continued) Focus of changes:
New PHS Human Subjects & Clinical Trials Information Form
Consolidates human subjects, inclusion enrollment, and clinical trial information into one form.
Includes attachment to comply with NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research (see NIH-OD ).
Clarification that the Research Strategy attachment should be used to discuss the overall strategy, methodology, and analyses of the proposed research, but applicants should not duplicate information collected in the new PHS Human Subjects and Clinical Trials Information form.

9. New Forms-E NOT-OD-17-119 (continued) Focus of changes:
Incorporation of updated appendix policy (see NOT-OD ).
Incorporation of recent Grants.gov changes to R&R Budget and SBIR/STTR Information forms.
Discontinue use of supplemental instructions for all competing applications and progress reports
All information has been folded into the application guide form instructions and/or is contained in the appropriate policy website (e.g., NIH Grants Policy Statement).

10. New Forms-E NOT-OD-17-119 (continued) Resources:
High-level Summary of Form Changes in FORMS-E Application Packages
Annotated Form Set for NIH Grant Applications
Do I Have the Right Form Version For My Application?
Application Forms, Form Updates, and Choosing the Correct Forms FAQs
New Human Subjects and Clinical Trial Information Form

11. New Forms-E
KEY DATES:
September 25, 2017 – New FORMS-E Application Instructions available on the How to Apply - Application Guide website
October 25, FORMS-E Application Packages will start being published for FOAs with due dates on or after January 25, 2018.
Note that all new application packages will be published at least 60 days ahead of the first due dates; anticipated November 25th, 2017
January 25, 2018 – First due dates for NEW FORMS-E Application Packages
During the transition period from FORMS-D to FORMS-E, both form packages will be available for some FOAs. It is important that applicants pay close attention and choose the announcement specific for their due date.

12. NEW NIH Human Subjects and Clinical Trial Information Form
PURPOSE:
Consolidates all Human Subjects and Clinical Trial related information into one place.
Expands the information required for studies that meet the NIH definition of a clinical trial.
Will be included in the new FORMS-E Application Packages.
Will be required for all applications with due dates on or after January 25, 2018.

13. NEW NIH Human Subjects and Clinical Trial Information Form
Form Details:
Is the most significant change within the new FORMS-E Application Package.
Consolidates human subjects, inclusion enrollment, and clinical trial information previously collected across multiple agency forms.
Collects information on human subjects and clinical trials at the study level.
Leads applicants through the human subject and clinical trial information collection requirements.
Expands the use of discrete form fields to capture clinical trial information to provide the level of detail needed for peer review.
Presents key information to reviewers and agency staff in a consistent format.
Aligns with ClinicalTrials.gov (where possible) and positions the NIH for future data exchange with ClinicalTrials.gov.

14. NEW NIH Human Subjects and Clinical Trial Information Form
RESOURCES:
NIH Video tour of the new form
Annotated Form Set for NIH Grant Applications - FORMS-E Series
High Level Summary of Form Changes: FORMS-E to learn about other form changes.
NOT-OD  New NIH "FORMS-E" Grant Application Forms and Instructions.
Training Resources – NIH Clinical Trial Policies

15. NEW Protocol Template for Phase 2 and 3 Clinical Trials
NOT-OD
Applicants conducting phase 2 or 3 clinical trials that require Investigational New Drug applications (IND) or Investigational Device Exemption (IDE) applications can use a NIH-FDA template with instructional and sample text to help write protocols. Use of this template is optional.
The tool provides a suggested format for phase 2 and 3 clinical trials funded by NIH that are being conducted under an FDA IND or IDE Application.
A common protocol structure and organization facilitates protocol review by oversight entities.
Note that the use of the tool is voluntary and is not required for NIH applications or contract proposals.
(more information)

16. New Review Criteria NOT-OD-17-118
NIH Announces New Review Criteria for Research Project Applications Involving Clinical Trials
Additional review criteria that NIH will apply to clinical trial applications for research projects submitted to due dates on or after January 25, 2018.
The additional questions will be related to these review criteria topics:
Significance
Investigator(s)
Innovation
Approach
Environment
Study Timeline

17. New Review Criteria NOT-OD-17-121
New Review Criteria for Career Development Award Applications Involving Clinical Trials
Additional review criteria that NIH will apply to individual career development (K) award applications submitted to due dates on or after January 25, 2018.
Important Note: Review criteria will differ for individual mentored and independent K award applications, and for K award applications where the PD/PI will lead an independent clinical trial compared with individual K award applications where the PD/PI will undertake clinical trials research experience under the guidance of the mentor or co-mentor.
The additional questions will be related to these review criteria topics:
Candidate
Research Plan
Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)
Environment & Institutional Commitment to the Candidate
Study Timeline for Clinical Trials

18. New Review Criteria NOT-OD-17-122
New Review Criteria for Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellowship Applications Involving Research Experiences in Clinical Trials
Additional review criteria that NIH will apply to Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellowships if the applicant fellow is proposing to gain research experience in an ongoing clinical trial led by a sponsor or co-sponsor, submitted to due dates on or after January 25, 2018.
The additional questions will be related to these review criteria topics:
Sponsors, Collaborators, and Consultants
Research Training Plan

19. New Review Criteria NOT-OD-17-123
New Review Criteria for Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grants Involving Research Experiences in Clinical Trials
Additional review criteria that NIH will apply to Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grants if one or more appointed trainees will propose to gain research experience in an ongoing clinical trial led by a mentor or co-mentor, submitted to due dates on or after January 25, 2018.
The additional questions will be related to these review criteria topics:
Preceptors/Mentors

20. Does “my” human subjects research study meet the NIH definition of a clinical trial?
One must consider and answer the following 4 questions:
Does the study involve human participants?
Are the participants prospectively assigned to an intervention?
Is the study designed to evaluate the effect of the intervention on the participants?
Is the effect that will be evaluated a health-related biomedical or behavioral outcome?
If the answer to all four questions is yes, the NIH considers your research a clinical trial.
See ORSP or NIH links for more in-depth guidance:
(NIH Clinical Trial decision tool)
(link to NIH case studies, all 35!)

21. NIH Clinical Trial Reminder
Good Clinical Practice Training: NOT-OD
Effective January 1, 2017 – NIH expects all NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials to be trained in Good Clinical Practice (GCP).
Retain documentation of the GCP training.
GCP training should be refreshed at least every three years.
Training in GCP may be achieved through a class or course, academic training program, or certification from a recognized clinical research professional organization. NIH also offers GCP training.
See NIH FAQs on this topic. 

22. NIH Clinical Trial Reminder
CITI training module titled “Good Clinical Practice and ICH” will satisfy this requirement per NIH and can be tracked/maintained.
How to access the GCP and ICH CITI course
Login to CITI-MIAMI (
From the Main Menu select “Add a Course”
Select “Human Subjects”
Select the “Basic course” and/or the “Refresher course”
Select “Good Clinical Practice and ICH”

23. Single IRB (sIRB) Reminder
NOT-OD
Guidance on Exceptions to the NIH Single IRB Policy
Applies to domestic sites of NIH-funded multi-site studies
Each site will conduct the same protocol involving non-exempt human subjects research.
The policy does not apply to:
Foreign sites; or
Career development (K), institutional training (T), or fellowship awards (F).
Policy-based exceptions will be made where the proposed sIRB would be prohibited by a federal, state, or tribal law, regulation or policy.
Policy-based exceptions are automatically granted when identified in the sIRB plan.
Other exceptions may be considered if there is a compelling justification for the exception.
These other exceptions must be reviewed and approved by NIH.

24. Single IRB (sIRB) Reminder
NOT-OD (continued)
Who Should Request an Exception to the NIH sIRB Policy?
Applicants/offerors should identify any policy-based exceptions in the sIRB plan.
If the applicant, offeror, or awardee believes that one or more research sites should be exempt from the use of the single IRB of record to conduct local IRB review due to compelling reasons, they must request an other exception and provide compelling justification in the sIRB plan.
Identification of NIH sIRB Policy Exceptions
If review by the sIRB will not be possible because local IRB review is required by an existing federal, state, or tribal law, regulation or policy, indicate which site(s) require local review and include a specific citation to the relevant law, regulation, or policy.
Policy-based exceptions are approved without review by the NIH sIRB Exceptions Review Committee (ERC).

25. Single IRB (sIRB) Reminder
NOT-OD (continued)
Steps to Request an Other Exception to the NIH sIRB Policy
Exception requests not based on a federal/state/tribal law, regulation, or policy require the review and approval of the NIH ERC. Applicants/offerors who wish to seek an other exception should contact the Program Officer (PO) or Contracting Officer (CO) to discuss potential exception requests, and then follow the steps below:
Applicants must include justification for an other exception in the sIRB plan attachment within the grant application (section 3.2 in the Study Record: PHS Human Subjects and Clinical Trials Information form, see Application Guide).
Offerors shall follow the instructions that are contained in the Request for Proposal (RFP) for submitting an exception request. 
Applicants/offerors must include the name of the site(s) for which an IRB other than the sIRB of record is proposed to review the study for the site(s).
Applicants/offerors must substantiate their exception request with sufficient information that demonstrates a compelling justification for other exceptions to the sIRB policy. The rationale should include why the single IRB of record cannot serve as the reviewing IRB for the site(s), and why the local IRB is uniquely qualified to be the reviewing IRB for the specific site(s).
For instance, the justification may consider ethical or human subjects protections issues, population needs, or other compelling reasons that IRB review for the site(s) cannot be provided by the single IRB of record.
Note that the proposed budget in the application/proposal must reflect all necessary sIRB costs without an approved other exception. Applicants/offerors should not assume that an other exception will be granted when considering what sIRB costs to include in the budget.

26. Single IRB (sIRB) Reminder
NOT-OD (continued)
Post-Award Exception Requests
For any post-award changes that necessitate an exception request, such as the addition of a new domestic site that may be unable to use the sIRB, awardees must contact their PO or CO.
For policy-based exceptions, the awardee will need to provide the appropriate citation to verify the requirement for local IRB review for the newly added site(s) to the PO or CO.
For other exceptions, the awardee must provide compelling justification to the PO or CO to be reviewed by the NIH ERC.
Time Limited Exception: Ancillary Studies to Ongoing Research without a Single IRB
During this transitional time, new multi-site non-exempt human subjects ancillary studies, both grants and contracts, that would otherwise be expected to comply with the sIRB policy, but are associated with ongoing multi-site parent studies, will not be required to use a sIRB of record until the parent study is expected to comply with the sIRB policy.
This is a standing exception until the associated parent study is submitted for competitive renewal after the effective date of the sIRB policy.
The need for this time limited exception for these ancillary studies should be documented in the sIRB plan by identifying the associated parent study and will not require review and approval of the NIH ERC.

27. Single IRB (sIRB) Reminder
NOT-OD (continued)
Resources:
NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
Clinical Research Policy – IRB Review
FAQs on NIH Policy on the Use of a Single IRB for Multi-Site Research Costs
FAQs on Implementation of the sIRB Policy
Office of Extramural (OER) Webinars

28. Single IRB (sIRB) Reminder
NOT-OD
Single IRB Review Options for Meeting the Policy:
Any IRB serving as the sIRB of record for NIH funded research must be:
Registered with the HHS Office for Human Research Protections (OHRP)
Must have membership to adequately review the proposed study.
The following are examples of types of IRBs that could be used:
An institutional IRB associated with either the awardee or a participating site;
An independent, commercial or unaffiliated IRB; or
A central IRB organized to review the proposed study.

29. Single IRB (sIRB) Reminder
NOT-OD (continued)
Guidance on Implementation of the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
The sIRB policy applies to domestic sites of multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research funded wholly or in part by NIH.
The policy does not apply to:
Foreign sites; or
Career development (K), institutional training (T), and fellowship awards (F).
The sIRB policy will apply to all competing grant applications for due dates on or after January 25, 2018;
For R&D contracts, the policy will apply to all solicitations issued on or after January 25, 2018.

30. Single IRB (sIRB) Reminder
NOT-OD (continued)
Expectations for Applications/Proposals:
When possible, the sIRB should be identified by the applicant/offeror in the sIRB plan attachment.
Note that the Funding Opportunity Announcement (FOA) or Request for Proposal (RFP) may include specific requirements for IRB review, such as the intent to set up a central IRB for specific projects.
The applicant/offeror is expected to follow the instructions in the specific FOA or RFP.

31. Single IRB (sIRB) Reminder
NOT-OD (continued)
Expectations for Applications/Proposals:
The following resources provide additional information about the sIRB plan:
Instructions for writing a sIRB plan and providing the justification for exceptions to the sIRB policy within Section 3.2 of the Study Record in the grant application are provided in the PHS Human Subjects and Clinical Trials Information Form Application Guide.
For studies considered delayed onset, instructions for documenting the applicant's intention to comply with the single IRB policy within the justification for delayed onset of multi-site human subjects research are provided in the PHS Human Subjects and Clinical Trials Information Form Application Guide.
Instructions about sIRB costs are provided in the G R&R Budget Form.
For R&D contracts, instructions for writing a sIRB plan and documenting exceptions to the sIRB policy within a proposal are provided in the solicitation.
The approved sIRB plan will be a term and condition in the Notice of Award or in the Contract Award.

32. Single IRB (sIRB) Reminder
NOT-OD (continued)
Evaluation of sIRB Information
The adequacy of the sIRB plan will not factor into the review score or overall rating of the Protection of Human Subjects section, unless the FOA/RFP has specific requirements for the sIRB and associated review criteria.
For grant applications, a note may be included in the Summary Statement if the sIRB plan appears to be missing or is incomplete, and this will need to be addressed before an award can be made.
For contracts, the RFP will include requirements about what must be provided to NIH regarding the sIRB prior to the time of award and beyond. 
Resources
NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
Clinical Research Policy – IRB Review
FAQs on NIH Policy on the Use of a Single IRB for Multi-Site Research Costs
FAQs on Implementation of the sIRB Policy
Office of Extramural (OER) Webinars

33. Clinical Trial Reporting Reminder
NOT-OD
NIH Policy on Dissemination of NIH-Funded Clinical Trial Information
Effective January 18, 2017 – All NIH-funded awardees and investigators conducting clinical trials must register and report the results of the trial in ClinicalTrials.gov
NIH dissemination policy:
Extends previous HHS policies to apply to ALL NIH-funded clinical trials instead of defining a subset of “applicable clinical trials”
Increases the availability of information to the public about clinical trials
Learn more at

34. Recent Notices NOT-OD-17-101
Policy Supporting the Next Generation Researchers Initiative
Implementing a new policy designed to invest in the next generation of researchers
Section 2021 of the 21st Century Cures Act
Intended to provide opportunities for earlier research independence while enhancing workforce diversity
Section 404M of the Public Health Service Act

35. Recent Notices NOT-OD-17-101 (continued)
Early Stage Investigator (ESI):  An ESI is a Program Director / Principal Investigator (PD/PI) who has completed their terminal research degree or end of post-graduate clinical training, whichever date is later, within the past 10 years and who has not previously competed successfully as PD/PI for a substantial NIH independent research award.
A list of NIH grants that a PD/PI can hold and still be considered an ESI can be found at
By providing funding priority for ESIs, NIH intends to encourage funding applications that involve researchers earlier in their career. 
An NIH R01-equivalent research grant application with more than one PD/PI (MPI) will be prioritized for funding only if all MPIs have ESI status.

36. Recent Notices NOT-OD-17-101 (continued)
Early Established Investigator (EEI):  An EEI is a PD/PI who is within 10 years of receiving their first substantial, independent competing NIH R01-equivalent research award as an ESI.  A meritorious application with a designated PD/PI EEI may be prioritized for funding if:
The EEI lost or is at risk for losing all NIH research support if not funded by competing awards this year, OR
The EEI is supported by only one active award.
NIH will identify EEIs in their eRA Commons profile by January 2018.
An NIH grant application with more than one PD/PI (MPI) will be prioritized for funding only if all MPIs have EEI status and meet prioritization criteria.
By providing funding priority for applications with EEIs, the NIH intends to stabilize the career trajectory of research investigators

37. Recent Notices NOT-OD-17-101 (continued)
Requests for Extension of Next Generation Researchers Status
NIH anticipates that some PD/PIs may have experienced a lapse in their research or research training or have experienced periods of less than full-time effort during their ESI or EEI status. 
In order to accommodate such lapses, the NIH will consider requests to extend ESI or EEI period for reasons that can include medical concerns, disability, family care responsibilities, extended periods of clinical training, natural disasters, and active duty military service, determined on a case by case basis at the sole discretion of NIH.
ESIs and EEIs may request an extension of their eligibility under existing ESI procedures. 

38. Recent Notices NOT-OD-17-109
Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality
Effective October 1, 2017
All research that was commenced or ongoing on or after December 13, 2016 and is within the scope of this Policy is deemed to be issued a Certificate through this Policy and is therefore required to protect the privacy of individuals who are subjects of such research in accordance with subsection 301(d) of the Public Health Service Act.
Applies to all biomedical, behavioral, clinical, or other research funded wholly or in part by the NIH, that collects or uses identifiable, sensitive information.
Previously, NIH provided these protections through the issuance of Certificates only upon request.
May still request a Certificate for non-federally funded research.

39. Recent Notices NOT-OD-17-109 (continued) Recipient Responsibilities
Determine if this Policy applies
Is the activity biomedical, behavioral, clinical, or other research? If yes, then:
Does the research involve Human Subjects as defined by 45 CFR Part 46?
Are you collecting or using biospecimens that are identifiable to an individual as part of the research?
If collecting or using biospecimens as part of the research, is there a small risk that some combination of the biospecimen, a request for the biospecimen, and other available data sources could be used to deduce the identity of an individual?
Does the research involve the generation of individual level, human genomic data?

40. Recent Notices NOT-OD-17-109 (continued) Recipient Responsibilities
If ‘yes’ to ANY of the previous 4 questions, the Policy applies and the Certificate recipient shall not:
Disclose or provide, in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding, the name of such individual or any such information, document, or biospecimen that contains identifiable, sensitive information about the individual and that was created or compiled for purposes of the research, unless such disclosure or use is made with the consent of the individual to whom the information, document, or biospecimen pertains; or
Disclose or provide to any other person not connected with the research the name of such an individual or any information, document, or biospecimen that contains identifiable, sensitive information about such an individual and that was created or compiled for purposes of the research.

41. Recent Notices NOT-OD-17-109 (continued) Recipient Responsibilities
Disclosure is permitted only when:
Required by Federal, State, or local laws (e.g., as required by the Federal Food, Drug, and Cosmetic Act, or state laws requiring the reporting of communicable diseases to State and local health departments), excluding instances of disclosure in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding;
Necessary for the medical treatment of the individual to whom the information, document, or biospecimen pertains and made with the consent of such individual;
Made with the consent of the individual to whom the information, document, or biospecimen pertains; or
Made for the purposes of other scientific research that is in compliance with applicable Federal regulations governing the protection of human subjects in research

42. Recent Notices NOT-OD-17-124
NIH Operates Under a Continuing Resolution Through December 8, 2017
Continuing the fiscal policies under NOT-OD  and consistent with NIH practices during the CRs of FY 2006 – 2017, the NIH will issue non-competing research grant awards at a level below that indicated on the most recent Notice of Award (generally up to 90% of the previously committed level).
Upward adjustments to awarded levels will be considered after FY 2018 appropriations are enacted, but NIH expects institutions to monitor their expenditures carefully during this period. 
All legislative mandates that were in effect in FY 2017 (see NOT-OD ) remain in effect under this CR, as well as the salary limitation set at Executive Level II of the Federal Pay Scale (see NOT-OD ).
The Ruth L. Kirschstein National Research Service Award predoctoral and postdoctoral stipend levels and tuition/fees are described in NOT-OD and NOT-OD

43. Recent Notices NOT-OD-18-005
Publication of the Revised NIH Grants Policy Statement (Rev. October 2017) for FY 2018
Applicable to all NIH grants and cooperative agreements with budget periods beginning on or after October 1, 2017.
Does not introduce any new material
Incorporates new and modified requirements
Clarifies policies and implements changes in statutes, regulations, and policies since the previous version of the NIHGPS

44. Recent Notices NOT-OD-18-005 (continued)
NIHGPS:
Summary of Changes:
Examples of Changes (not all-inclusive):
Specific FOAs, GCP Training, etc. for projects that include clinical trials
Updated Federal wide Research Terms & Conditions
Certificates of Confidentiality
Final RPPR requirement

45. Recent Notices NOT-OD-17-094 (update)
Salary Supplementation and Compensation during the Entire Career ("K") award
Can supplement salary from non-federal sources
For effort directly committed to K-award
Must not require extra duties or responsibilities to interfere with the K-award goals
Can supplement salary from federal or non-federal sources
For effort not directly committed to K-award, IF
Specific aims differ from those of the K-award
During last 2 years of K-award
PI/PD role (or project leader of multi-project award, e.g. Co-I role)
NIH award budget period began on/after 10/1/17

46. eRA Commons Update
eRA Enhancement: Ability for Agency to Request Additional Materials for Interim RPPR via Commons
Software update 9/20/17
Adds capability for awarding agencies to request additional materials for Interim RPPR via eRA Commons
Interim Progress Report Additional Materials (IRAM) link on the Status Results screen, in the Available Actions column
Institutional Signing Official (SO) will be able to submit the additional materials via eRA Commons
The PI can enter/upload the IRAM, but only the SO can submit to the agency
Similar to the Final Progress Report Additional Materials (FRAM) process

47. eRA Commons Update

48. eRA Commons Update NIH eRA Items of Interest — October 2017
NIH sent targeted s to a sampling of PIs NIH believed to have duplicate eRA Commons accounts and will be sending more in the next two weeks.
PIs will be instructed to go to a new Account Verification screen in Commons which is located under the Admin tab, which has sub tabs of Accounts, Delegations, and now Account Verification.
The PI then will need to confirm that the accounts do belong to him or her, and then select the ONE account that they prefer to be their permanent account.
NIH Data Quality team will then collapse or converge the data from the multiple accounts to the one the PI specified as preferred.
NOTE:
Those who have current committee or grant involvement are required to select that Commons account as preferred. Here are the instructions for accessing the account verification page and processes to identify preferred and duplicate accounts. Do not act on these until you get an from eRA communications urging you to do so.

49. Final Thoughts Any Announcements? Questions or Comments?
PLEASE complete a survey & THANK YOU
Next ORSP Information Session:
November 15th, 11:00 IOP Auditorium