1. agenda update on reorganization of research administration office – (michele masucci) updates...

1

Departmental Administration Meeting

Presented by the Office of Sponsored Programs03/21/2013

2

AgendaUpdate on Reorganization of Research Administration

Office – (Michele Masucci)

Updates on eRA – (Krunal Cholera)Conflict of Interest (COI)Institutional Review Boards (IRB) Institutional Animal Care & Use Committee (IACUC)

COI Process/Export Controls Audit/Responsible Conduct of Research

– (Rosemary Dillon)

Task Force on Process and Procedures – (Keith Osterhage)

Research and Graduate Education

3

Updates for Research AdministrationReorganization—Rob Gage is working on strategic priorities,

budgets and coordinated internal competitions and limited submissions, Rosemary Dillon is leading Main Campus COI and initiating efforts to develop regulatory compliance for matters such as Export Controls and Responsible Conduct of Research

Three new positions have been posted for Research Administration: 1) Senior Grants and Contracts Specialist, 2) Grants and Contracts Specialist and 3) Contracts Manager (who will handle all subawards)

IRB and IACUC are also advertising new positions

Krunal is now Manager of ERA and he is advertising for both technical and training positions to support ERA

Innovation Fund—special allocation of funds to bolster research within Temple


4

ERA Updates

Conflict of Interest (COI)revisions to the module

Institutional Review Boards (IRB)phased rollout of the module—campus wide by

end of May, 2013Institutional Animal Care & Use

Committee (IACUC) module in development, initial rollout

anticipated this spring.


5

COI ProcessCOI website: http://www.temple.edu/research/researchadmin/coi/

FOR PROPOSAL SUBMISSIONS PHS entities require all Investigators to file a COI disclosure upon proposal submission.

The COI does not have to be certified, but must be on file. In order to file, the investigators must be COI trained.

The Sponsored Programs Office will need to verify with the respective COI Office - Malikah Fulton (HSC) or Rosemary Dillon (Main) - that all Investigators have filed a COI before the proposal is submitted.

Once a COI disclosure has been filed, it is valid for 12 months, unless there is a material change in any circumstance; investigators must report changes within 30 days. Investigators do not have to re-file for each submission during that one-year period.

Staff and department administrators cannot file for their PI; each PI and investigator must file for him/herself.

The Temple Research Administration website lists the range of PHS entities; please note that some other sponsors have adopted this regulation, such as ACS, AHA, HRSA, Susan G. Komen and various foundations. The COI regulation applies for those submissions as well.

Letters of intent that Temple requires from each subcontractor must include a statement indicating that they have a COI policy and will comply with the PHS COI regulation.


http://www.temple.edu/research/researchadmin/coi/


6

COI Process


FOR AWARDS

For Awards/FOAPAL set up, the COI disclosure must be filed and certified for all persons involved in the project, including sub-awardees who so certify, before a FOAPAL can be issued/updated.

For awards in place before 08/24/2012, the COI rule applies when new funding (out year increments, amendments, supplements) is received. Training, filing and certification are required for these new funding allotments.

If a new FOAPAL is being set up, that is the check to ensure compliance; in instances where the same FOAPAL is being continued that is still of concern and departments should work closely with the COI office and alert them to that situation to ensure compliance.

7

Organizations That Require FCOI Compliance With PHS Regulationshttp://sites.nationalacademies.org/PGA/fdp/PGA_070596


Administration on Aging (AoA) Administration for Children and Families (ACF) Agency for Healthcare Research & Quality (AHRQ) Agency for Toxic Substances & Disease Registry (ATSDR) Alliance for Lupus Research (ALR) American Cancer Society (ACS) American Heart Association (AHA) American Lung Association (ALA) Arthritis Foundation (AF) Biomedical Advanced Research and Development Authority (BARDA) California Breast Cancer Research Program (CBCRP) California HIV/AIDS Research Program (CHRP) Centers for Disease Control & Prevention (CDC) Centers for Medicare and Medicaid Services (CMS) [formerly HCFA] Food and Drug Administration (FDA) Health Resources & Services Administration (HRSA) Indian Health Service (IHS) Juvenile Diabetes Research Foundation (JDRF) Lupus Foundation of America (LFA) National Institutes of Health (NIH) Office of Global Affairs (OGA) Office of the Assistant Secretary for Health (ASH)

Office of the Assistant Secretary for Preparedness and Response (ASPR) Biomedical Advanced Research and Development Authority (BARDA)

Office of Minority Health Resources Center (OMH) Office of Population Affairs (OPA) Office of Research Integrity (ORI) Office of Research on Women’s Health (OWH)

Substance Abuse & Mental Health Services Administration (SAMHSA) Susan G. Komen for the Cure

http://sites.nationalacademies.org/PGA/fdp/PGA_070596


8

Export Controls Export controls are federal laws and regulations that regulate/restrict the distribution of technology, services, and

information to foreign nationals and foreign countries for reasons including foreign policy and national security.

These laws currently are implemented by: the U.S. Department of Commerce through its Export Administration Regulations (EAR—trade protection), the U.S. Department of State through its International Traffic in Arms Regulations (ITAR—national security), the U.S. Department of Treasury through its Office of Foreign Assets Control (OFAC—trade embargoes).

Export control laws and regulations have several purposes: to restrict exports of goods and technology that could contribute to the military potential of U.S. international

adversaries; to prevent proliferation of weapons of mass destruction; to advance U.S. foreign policy goals; and to protect the U.S. economy and promote trade goals.

Export controls present unique challenges to universities and colleges because they require balancing concerns about national security and U.S. economic vitality with traditional concepts of unrestricted academic freedom and publication and dissemination of research findings and results. University researchers and administrators need to be aware that these laws may apply to research, whether sponsored or not.

The EAR and ITAR apply to the transfer of specific physical items and information and the provision of specific services to persons and entities outside the U.S. (“actual exports”) and to the disclosure of specific information and the provision of specific types of services to foreign nationals inside the United States (“deemed exports”).

Attention to export controls has increased due to recent heightened concerns about national and homeland security, as well as the need to prevent proliferation of weapons of mass destruction and terrorism and leaks of technology to U.S. economic competitors.


9

Export Controls

Export Controls are required by the federal government under EAR and ITAR; a presentation by Ballard Spahr (external legal counsel) was made to this group 05/03/2012 and is archived on the Research Administration website.

To be proactive and demonstrate due diligence, we are conducting an “audit” of export controls April 8 and April 9.

The audit will be conducted by an outside consultant, Charles Palmer, (Export Compliance Solutions), not by any government entity.

A training for Export Controls also will be offered as part of the audit process.

Approximately 24 projects with potential for export control impacts have been identified, primarily because of their sponsorship by DOD, DARPA, DITRA, Navy, Energy and a few other select sponsors. Be advised the sponsor does not necessarily make it Export Control prone or not, but it is more likely. Export Control laws apply to all awards and activities on campus.

The primary Schools and Colleges affected by the audit are: College of Science and Technology, College of Engineering and School of Medicine.


EXPORT CONTROLS AUDIT

10

Export Controls

Audit will involve on-site laboratory visits, interviews and training

Interview TopicsCurrent project ITAR and EAR jurisdictional

classification criteria and process Proposal review process Project tracking and reporting systems Compliance training history Current non-U.S. research employee licensing Identification and monitoring of non-U.S. visitors Physical security IT securityViolations history


EXPORT CONTROLS AUDIT PROCESS

11

Export Controls

Training Sessions One at each campus: 2.5 hours afternoon session Open to all; researchers with sponsors most likely to have export control issues

encouraged to attend

Topics

U.S. Government ITAR and EAR jurisdictional classification requirements Pre-publication restrictions and public domain criteria What type of technology transfer constitutes a government contract violation What constitutes an export violation U.S. Government ITAR and EAR project recordkeeping, tracking and reporting

requirements Important terms and definitions U.S. regulatory agencies and authorities U.S. Government increased focus on export compliance investigations Export violation consequences


EXPORT CONTROLS AUDIT PROCESS

12

Responsible Conduct of ResearchNSF RESPONSIBLE CONDUCT OF RESEARCH

As of January 4, 2010, NSF requires that all undergraduate students, graduate students, and postdoctoral researchers supported by NSF to conduct research receive training in the Responsible Conduct of Research (RCR). Each institution that applies for financial assistance from NSF for science and engineering research or education must describe in its grant proposal a plan to provide appropriate training and oversight in the responsible and ethical conduct of research for all undergraduate students, graduate students, and postdoctoral researchers participating in the proposed research project.

Conference, symposium, workshop, or travel proposals are excluded from this requirement.

NSF expects institutions to be able to verify that those students (undergraduates and graduates) and postdoctoral researchers who receive NSF funds (support from salary and/or stipends to conduct research on NSF grants) will obtain RCR training.


13

Responsible Conduct of ResearchNIH RESPONSIBLE CONDUCT OF RESEARCH

The National Institutes of Health (NIH) requires that all trainees, fellows, participants, and scholars receiving support through any NIH training, career development award (individual or institutional), research education grant, and dissertation research grant must receive instruction in responsible conduct of research.

NSF RCR requirements differ from NIH RCR requirements in that NSF mandates that any student or postdoctoral researcher supported by NSF receive RCR training. NIH requires only those individuals receiving training grants to undergo RCR training.


14

RCR at Temple Historically each PI has been responsible to ensure that training in the eight topics

covered by RCR was accomplished for all graduate students and post docs charged all or in part to his/her award.

CITI training has been employed in most instances (and other universities do the same).

Temple is beginning an effort to monitor and ensure compliance with the RCR policy.

84 active NSF awards have been identified. Now in process of identifying all graduate students and post docs charged all or in

part to those awards. Will coordinate with CITI to identify who has completed the CITI RCR training. Assess our RCR compliance rate (percent) and work to ensure compliance for the

remaining.


15

RCR at TempleMoving forward past this initial “audit” of RCR our office will work each semester to ensure RCR compliance for active NSF awards and pertinent NIH awards. We are also working on the possibility of live, on campus RCR trainings to cover the eight RCR topics:

Introduction to the Responsible Conduct of ResearchResearch MisconductData Acquisition and ManagementResponsible AuthorshipPeer ReviewMentoringConflicts of InterestCollaborative Research


16

Process Mapping, Workflows, Checklists Forms/Checklists (draft version)

Just-in-Time Documentation Checklist Notice of Grant Award Memo FOAPAL - New and Advance FOAPAL (Advance FOAPAL Request form) Subrecipient Commitment Form Subaward Agreements, Contracts, MTAs, Data Use Agreements, CDAs, License,

Consultant and Professional Agreements Financial Impact Statement (FIS) Progress Report (eSNAP/RPPR Report) No Cost Extension, Revised Budgets/Change in Effort, Carryover Requests COI

Forms/Checklists (to be developed) Grant Proposal Submission Transferring Awards to Temple eSPAF Checklist Request to Issue Subaward Relinquishment of Award Closeout


17

COI ProcessCOI website: http://www.temple.edu/research/researchadmin/coi/

FOR PROPOSAL SUBMISSIONS

PHS entities require all Investigators to file a COI disclosure upon proposal submission. The COI does not have to be certified, but must be on file. In order to file, the investigators must be COI trained.

The Sponsored Programs Office will need to verify with the respective COI Office - Malikah Fulton (HSC) or Rosemary Dillon (Main) - that all Investigators have filed a COI before the proposal is submitted.

Once a COI disclosure has been filed, it is valid for 12 months, unless there is a material change in any circumstance; investigators must report changes within 30 days. Investigators do not have to re-file for each submission during that one-year period.

Staff and department administrators cannot file for their PI; each PI and investigator must file for him/herself.

The Temple Research Administration website lists the range of PHS entities; please note that some other sponsors have adopted this regulation, such as ACS, AHA, HRSA, Susan G. Komen and various foundations. The COI regulation applies for those submissions as well.

Letters of intent that Temple requires from each subcontractor must include a statement indicating that they have a COI policy and will comply with the PHS COI regulation.




18

COI Process


FOR AWARDS

For Awards/FOAPAL set up, the COI disclosure must be filed and certified for all persons involved in the project, including sub-awardees who so certify, before a FOAPAL can be issued/updated.

For awards in place before 08/24/2012, the COI rule applies when new funding (out year increments, amendments, supplements) is received. Training, filing and certification are required for these new funding allotments.

If a new FOAPAL is being set up, that is the check to ensure compliance; in instances where the same FOAPAL is being continued that is still of concern and departments should work closely with the COI office and alert them to that situation to ensure compliance.

19

Organizations That Require FCOI Compliance With PHS Regulationshttp://sites.nationalacademies.org/PGA/fdp/PGA_070596


Administration on Aging (AoA) Administration for Children and Families (ACF) Agency for Healthcare Research & Quality (AHRQ) Agency for Toxic Substances & Disease Registry (ATSDR) Alliance for Lupus Research (ALR) American Cancer Society (ACS) American Heart Association (AHA) American Lung Association (ALA) Arthritis Foundation (AF) Biomedical Advanced Research and Development Authority (BARDA) California Breast Cancer Research Program (CBCRP) California HIV/AIDS Research Program (CHRP) Centers for Disease Control & Prevention (CDC) Centers for Medicare and Medicaid Services (CMS) [formerly HCFA] Food and Drug Administration (FDA) Health Resources & Services Administration (HRSA) Indian Health Service (IHS) Juvenile Diabetes Research Foundation (JDRF) Lupus Foundation of America (LFA) National Institutes of Health (NIH) Office of Global Affairs (OGA) Office of the Assistant Secretary for Health (ASH)

Office of the Assistant Secretary for Preparedness and Response (ASPR) Biomedical Advanced Research and Development Authority (BARDA)

Office of Minority Health Resources Center (OMH) Office of Population Affairs (OPA) Office of Research Integrity (ORI) Office of Research on Women’s Health (OWH)

Substance Abuse & Mental Health Services Administration (SAMHSA) Susan G. Komen for the Cure



20

PA Master Agreement Sequester update and link

http://www.temple.edu/research/researchadmin/sp_sequest.html

Grant Writing Workshop Modules – April 10 & 11

Announcements




1. agenda update on reorganization of research administration office – (michele masucci) updates...

Documents