Recent NIH Changes in Application Submission

1. Recent NIH Changes in Application Submission Dhanonjoy C. Saha, PhD Director, Office of Grant Support Research Professor of Medicine October 16, 2019

2. Topics to be Discussed • ORCID ID and Linking it to eRA Commons • Reproducibility Through Rigor and Transparency • Single IRB (sIRB) for Multi-Site Clinical Trials • Requirement for Human Fetal Tissue (HFT) Research • Submitting HS and Enrollment Data with RPPR Using ASSIST • Foreign Influence on Research Integrity and OS Page • Early Stage Investigators (ESI) Extension

3. ORCID (Open Researcher and Contributor Identifiers) ID Requirements • ORCID IDs will be required for Individuals Supported by NIH, AHRQ, and CDC Research Training, Fellowship, Research Education, and Career Development Awards Beginning in 2020.  • https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-109.html • To create an ORCID profile please use this link. https://orcid.org/register

4. ORCID ID Needs to be linked with eRA Commons ID You will be able to associate your ORCID ID from the eRA Commons Personal Profile module. Log in to your eRA Commons account and click on Personal Profile https://era.nih.gov/erahelp/ppf/default.htm#PPF_Help/8_2_orcid.htm%3FTocPath%3D_____13

5. Use of xTrain System will be Required • Starting October 1, 2019 all trainees, scholars, and participants supported by institutional research training, career development, and research education awards will require appointments through the xTrain system.  • Beginning with receipt dates on or after January 25, 2020, this requirement will be enforced for individual fellowship and career development awards. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-109.html • Beginning with RPPRs due on or after October 1, 2019 (FY 2020), we must use the xTRACT system to create training tables for submission with NIH and AHRQ T15, T32, T90/R90, and TL1 progress reports. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-108.html

6. Reproducibility Through Rigor and Transparency • Scientific rigor and transparency in conducting biomedical research is key to the successful application of knowledge toward improving health outcomes. • Scientific rigor is the strict application of the scientific method to ensure unbiased and well-controlled experimental design, methodology, analysis, interpretation and reporting of results.  • ensure that NIH is funding the best and most rigorous science; • highlight the need for applicants to describe details that may have been previously overlooked; • highlight the need for reviewers to consider such details in their reviews through updated review language; and • minimize additional burden. https://grants.nih.gov/policy/reproducibility/guidance.htm

7. Rigor of thePrior Research • An assessment of the rigor of the prior research that serves as the key support for a proposed project—identify any weaknesses or gaps in the line of research.  • Describe the strengths and weaknesses in the rigor of the prior research that serves as the key support for the proposed project.  • Describe plans to address weaknesses in the rigor of the prior research that serves as the key support for the proposed project. • Add this to the Research Strategy section • Significance

8. Scientific Rigor (Design) • The strict application of the scientific method to ensure robust and unbiased experimental design, methodology, analysis, interpretation and reporting of results. • Emphasize how the experimental design and methods proposed will achieve robust and unbiased results. • Add this to Research Strategy section • Approach he experimental design and methods proposed will achieve robust and unbiased results.

9. Consideration of Relevant Biological Variables • Biological variables, such as sex, age, weight, and underlying health condition. • Must explain how relevant biological variables are factored into research designs, analyses, and reporting in vertebrate animal and human studies. • Strong justification from the scientific literature, preliminary data or other relevant considerations must be provided for applications proposing to study only one sex. • Human subjects section– Inclusion of women, minority & children • Inclusion of children is “Inclusion Across the Lifespan” (<18 years old & older adults) • sIRB description is included here • Add this to Research Strategy • Approach

10. Authentication of Resources • Key biological and/or chemical resources include, but are not limited to: cell lines, specialty chemicals, antibodies and other biologics. • Briefly describe methods to ensure the identity and validity of these resources used in the proposed studies: • may differ from laboratory to laboratory or over time; • may have qualities and/or qualifications that could influence the research data; • are integral to the proposed research. • Should state, in one page or less, how you will authenticate these key resources, including the frequency, as needed for your research. • Other Research Plan Section • Include as an attachment (In Cayuse, item #11 under PHS 398 Research Plan)

11. Single IRB (sIRB) for Multi-Site Research • The sIRB policy applies to domestic sites of NIH-funded multi-site studies where 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). • Please contact our IRB if you have any questions regarding sIRB. Certain sIRB costs are reimbursable by the Federal government. Budget appropriately.

12. Current Requirements and Comparison to Prior Requirements

13. Requirements for Conducting Research Involving HFT • In the Approach section of the Research Strategy, justify the need for use of HFT. The description must include a heading “Human Fetal Tissue Justification” and should be sufficiently detailed. • Include a sample of the IRB-approved informed consent form with the application or during the JIT process. • The consent form to be signed by both the woman and the person who obtains the informed consent.

14. Not Allowed in Research Involving HFT • Training awards and individual fellowships using HFT • Administrative supplements to add HFT • Modular budgets for research involving HFT (even there is no costs for the HFT or HFT is donated at no cost to the project) • https://grants.nih.gov/grants/guide/notice-files/not-od-16-033.html • https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-128.html

15. Budget Preparation for Research Involving HFT • Must use the R&R Budget Form to provide the detailed budgets, and sufficiently describe and document in the budget justification the quantity, type, and source of the HFT, and a certification that valuable consideration has not been provided. • For competing applications, a specific language must be added under section “F.8-10.” Other: Regardless of whether costs will be incurred, it must be noted as a line item here. The line item must be titled Human Fetal Tissue Costs.If no cost will be incurred, enter “0” in the “Funds Requested” column. Details regarding HFT should be specified in the Budget Justification.

16. Assurance Letter for Conducting HFT Research • A letter assuring the HFT donating organization or clinic adheres to the requirements of the informed consent process and documentation that HFT was not obtained or acquired for valuable consideration must be submitted. • Name the PDF formatted letter ‘HFTComplianceAssurance.pdf’ and attach it in the Other Attachments section of the Research & Related Other Project Information form (item # 12 in Cayuse). • Applications proposing HFT research that do not include this assurance will be administratively withdrawn and not reviewed.

17. Submitting Updated Human Subjects and Enrollment Data with the RPPR • While in the RPPR Menu screen, click the Edit button in the left-hand corner of the screen; • If inclusion enrollment updates are needed, first save any RPPR data, then click the G Special Reporting Req tab; • Under G.4.b Inclusion Enrollment Data, click the Human Subjects link – this will open a window in HSS to make any edits in the Human Subjects and Clinical Trials (HSCT) form;  • In the Application Information Screen, click on the HSCT Post Submission tab; • In the Study Records screen, click on the View button to see a particular study.

20. Submitting Updated Human Subjects and Enrollment Data with the RPPR • Click the Edit button at the top of the screen, just above the SECTION 1 header; • Scroll down to the bottom of SECTION 2 to find the Inclusion Enrollment Report(s); • Enter the enrollment figures and the system will automatically total the rows and columns;  • Click Save and Release Lock andthe Submission Status (in the Application Information Screen) will change to Work in Progress;  • Back in the Application Information screen, click on the Summary tab near the top of the screen; • Click the UPDATE SUBMISSION STATUS button in the Actions pane on the left-hand side of the screen and in the Select the new status from dropdown menu, select Ready for Submission; • Add a comment and click “add comment,” or click on the blue text stating “continue without adding a comment” to proceed; • The system will send an email to the Signing Official (SO) to notify them that the updates are ready for submission.

21. Foreign Influence on Research Integrity: The Problem • Undisclosed or not fully disclosed foreign financial conflicts of interests (FCI) • Other financial support is not accurately disclosed • Undisclosed conflicts of commitment • For example, other affiliations and positions that often come with resources and equities • Peer review violations • Disclosing confidential information to others or using the information for their own benefits

22. FCI: Opportunities for Disclosures • Grant application process, i.e., during grant submission • Other support page • During award implementation process, i.e., JIT • Updated other support • During RPPR

23. Peer Review Confidentiality “Confidentiality in NIH peer review prohibits a peer reviewer member from: Sharing applications, proposals, or meeting materials with anyone who has not been officially designated to participate in the peer review process.” We need to inform and train our PIs to abide by these rules.

24. NIH Policies on Other Support and on Policies related to Financial Conflicts of Interest and Foreign Components NIH reminds applicants and recipients that other support includes all resources made available to a researcher in support of and/or related to all of their research endeavors, regardless of whether or not they have monetary value and regardless of whether they are based at the institution the researcher identifies for the current grant. This includes resource and/or financial support from all foreign and domestic entities, including but not limited to, financial support for laboratory personnel, and provision of high-value materials that are not freely available (biologics, chemical, model systems, technology). https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-114.html

25. NIH Policies on Other Support and on Policies related to Financial Conflicts of Interest and Foreign Components • List all positions and scientific appointments both domestic and foreign held by senior/key personnel. This includes titled academic, professional, or institutional appointments whether or not remuneration is received; • Report all resources and other support for all individuals designated in an application as senior/key personnel and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way regardless they request salaries or compensation; • Report all current projects and activities that involve senior/key personnel, even if the support received is only in-kind (e.g. office/laboratory space, equipment, supplies, employees). Also report foreign “talents” or similar-type programs, or other foreign or domestic support; • Provide the total award amount for the entire award period covered (including facilities and administrative costs), as well as the number of person-months (or partial person-months) per year to be devoted to the project by the senior/key personnel involved; • All information including budgetary or scientific overlap must be disclosed during application or JIT submission. Details of any new support or changes directly to senior/key personnel must be disclosed in the RPPR.

26. NIH Policies on Other Support and on Policies related to Financial Conflicts of Interest and Foreign Components • Performance of work by a researcher or recipient in a foreign location, whether or not NIH grant funds are expended; • Performance of work by a researcher in a foreign location employed or paid for by a foreign organization, whether or not NIH grant funds are expended; • The addition of a foreign component to an ongoing NIH grant continues to require NIH prior approval; • Any non-U.S. resource that supports the research of an investigator and/or researcher must be reported in other support; • If a PD/PI of an NIH-funded grant has a collaborator outside of the U.S. who performs experiments in support of the PD/PI’s NIH-funded project, this would constitute a foreign component, regardless of whether the foreign collaborator receives funding from the PD/PI’s grant; • Additional funding from a foreign source for the NIH-supported research of a PD/PI at a U.S. institution would not constitute a foreign component but would necessitate reporting as other support.

27. Foreign Financial Conflict of Interest Investigators, including sub-recipient Investigators, must disclose all financial interests received from a foreign Institution of higher education or the government of another country (which includes local, provincial, or equivalent governments of another country).  • https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-160.html

28. How to Prepare Other Support Page Report all current projects and activities that involve senior/key personnel, even if the support received is only in-kind (e.g. office/laboratory space, equipment, supplies, employees). All research resources including, but not limited to, foreign financial support, research or laboratory personnel, lab space, scientific materials, selection to a foreign “talents” or similar-type program, or other foreign or domestic support must be reported.

29. How to Prepare Other Support Page OTHER SUPPORT Smith, William ACTIVE Domestic: NIH-R01AI026160-02(Smith) 03/01/2014-08/31/2018 2.4 cal month No cost extension Annual: $100,900 Entire Period: $2,030,500 Title: Molecular Genetic …… Goal: Generate deletion … starvation leads to sterilization. NIH-U19AI133376-01 (Jones) 08/01/2014-07/21/2020 1.2 cal month Role: Co-Investigator (Project 2 & 5) Annual: $248,700 Entire Period: $1,700,111 Title: The biomarkers and coping mechanisms in …. Goal: To evaluate novel diagnostic test …. Foreign: MRC (UK) BV25639 05/01/2019-06/15/2022 0.1 Cal month Annual $3,000 Entire Period: $20,000 Title: Vaccines inducing protein…. Goal: To characterize the protein targets … Role: Co-investigator Overlap: None

30. How to Prepare Other Support Page Other Active Agreements, Resources, and Significant Collaborations Domestic: Albert Einstein College of Medicine- ?? Endowed Chair Albert Einstein College of Medicine- Internal Research Support Albert Einstein College of Medicine- Interim support (pending award notice of grant R01HL036150-11A1) NIH- T32GM00722 (PI: Joe) 07/01/1995-06/30/2020 Effort included in academic responsibility Institution: Albert Einstein College of Medicine Title of Project: “Training Program in molecular…. Role: Trainer/Mentor NIH- R25DK140331-01A1 (PI: Rhine) 08/01/2018-07/31/2022 0.00 calendar months Title of Project: Program in Metabolism of ….. I will be consulting on the course … sending students to participate in the course. Overlap: None Foreign: If you have any trainees/postdocs in your laboratory receiving stipends or any other support from foreign entities, add here.

31. How to Prepare Other Support Page Affiliations Domestic: Institution: Brandon Institute of Science Address: XXX Avenue, Bronx, New York Role: Fellow Effort: In-kind Foreign: Institution: Indian Health Research Institute Address: XXX School of Medicine, XXX Building, Delhi, India Role: Scientific Advisor Effort: In-kind PENDING Domestic: Award: Ron E Heter, Translational Research Piolet Project Grant Award. Institution/Awardee: Albert Einstein College of Medicine, Tonya Perth (MSTP student) Project Period: 05/1/2018-06/02/2021 Title of Project: “Anti-g globulin promotes humoral responses …” Role: I will be consulting in the evaluation of the student research and serve as a thesis advisor Effort: Included in other academic responsibilities

32. How to Prepare Other Support Page NIH-HL145343 (Zio) 04/01/2019-03/31/2023 0.00 calendar months Title: “The 5ygT5 interactions: regulation of the metabolic ….” I will be consulting with Dr. Zio to provide strategies to perform genetic analyses of…. NIH-AI201800005 (Whittam) 09/01/2018-08/31/2024 0.08 cal months (2 days per year) Role: Consultant Annual: $2,838 Entire Period: $17,000 Agency: Resources Center for Infectious Disorder Title: Viral Bioinformatics …. I will provide expert consulting on drug …. Overlap: None Foreign: Include if any otherwise write “None”

33. Early Stage Investigators (ESI) 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 https://grants.nih.gov/policy/early-investigators/list-smaller-grants.htm. 

34. ESI Extension Criteria • Extensions may be granted for the following reasons as described in NOT-OD-09-034: • Childbirth • Family Care Responsibilities • Clinical Loan Repayment Requirements • Disability or Illness • Active Duty Military Service • Natural or Other Disaster • Other • https://era.nih.gov/erahelp/ESIE_ext/Default.htm#cshid=4

35. How to Request ESI Extension • Beginning on August 22, 2019, investigators are able to request an extension of their ESI eligibility directly through eRA Commons via an ESI Extension request button in the Education section of their personal profile. • Follow the directions in the link. • https://era.nih.gov/erahelp/ESIE_ext/Default.htm#cshid=4 • https://nexus.od.nih.gov/all/2019/08/05/early-stage-investigator-esi-extension-request-process-moving-to-era-commons/

36. Thank You • For general information, please contact the Office of Grant Support at (718) 430-3643 or preaward@einstein.yu.edu • For pre-award budget -- Gerard McMorrow at (718) 430-3580 or gerard.mcmorrow@einstein.yu.edu • Post-award budget – Suzanne Locke at (718) 430-2688 or Suzanne.locke@Einstein.yu.edu • For sIRB -- Melissa A. Epstein at (718) 430-2237 singleIRB@einstein.yu.edu • For Cayuse, eRA Commons and any other help -- Regina Janicki at (718) 430-3643 or Regina.janicki@einstein.yu.edu • For any other help -- D. C. Saha at (718) 430-3642 or dhanonjoy.saha@einstein.yu.edu