The Proposed Revisions to the
Human Subjects Regulations
Karen Moe
Director, Human Subjects Division
MRAM Meeting
September 10, 2015
Proposed Revision
Published 9/8/15
http://www.gpo.gov/fdsys/pkg/FR-2015-0908/pdf/2015-21756.pdf (131 pages)
Historical context
Date
1974
Early 1980s
1991
2015
Event
U.S. regulations published
Revision
Revision
Proposed revision
Overall Goals
Major changes
• De-identified biospecimens are “human
subjects”
• Exclude classes of activities from regulations
• Exempt categories increased
• New consent requirements (info, process)
• Single IRB for multi-site clinical trials
• Status Reports not required for minimal risk
studies and completed studies doing only data
analysis
Many, many other changes……
Not just a “band-aid”
Revision Timetable
Date
Sept 8, 2015
Event
NPRM: Proposed revisions
published
Dec 7, 2015 5 PM Public comment period ends
Unknown
Publication of the Final Rule
(months, years) (official revised regulations)
Implementation Timetable
Date
Event
Unknown
Publication of the Final Rule
90 days later Voluntary implementation allowed
Goal: Reduce regulatory burden as
soon as possible
1 year later
General effective date
(see exceptions below)
3 years later Later effective date for:
• Biospecimen regulations
• Requirement for single IRB for
most multi-site clinical trials
What to do now
Required
Nothing
Optional
• Learn more about the proposed changes
• The published revision (link on 2nd slide)
• Summaries from professional organizations
• Webinars from OHRP (the federal agency), announced by HSD
• Submit a comment to OHRP (federal agency)
• http://www.hhs.gov/ohrp/humansubjects/regulations/nprmhome.html
• Stay informed: subscribe to the monthly HSD e-
newsletter (send your request to hsdinfo@uw.edu)
Questions?
OSP & FDP Update
Lynette Arias
Assistant Vice Provost for Research
Director, Office of Sponsored Programs
ariasl@uw.edu
Org & Staff Updates in OSP

Updated Department Assignment Listing
posted recently
◦ http://www.washington.edu/research/.SITEPA
RTS/.documents/.or/Org_Chart_OSP.pd

Updated Org Chart recently posted
◦ http://www.washington.edu/research/.SITEPA
RTS/.documents/.osp/OSP_assignments.pdf
Key Highlights

Team Lead role – being piloted thru end of year
◦ Team A – Jane Heffernan and Robin Mondares
◦ Team B – Adelia Yee and Tim Mhyre
◦ Subawards Team – Bo Park and Cathy Cottle

Provides additional support
◦ Another resource for OSP team members and managers
◦ Another resource for campus partners
◦ Escalation of operational issues


Professional growth opportunity for senior OSP administrators
How might campus interact with an OSP Team Lead?
◦ Teams A&B – your assigned OSP administrator remains unchanged, but
you have another resource within OSP when you need it. Usually, our
admins will bring the lead into the conversation, but you could do so as
well.
◦ Subteam – Leads are handling complex items, attending meetings on
specific topics, coordinating the workflow (including assigning work),
and leading the team through process improvement.
Key Highlights
Contracts team fully underway now!
Great resource! For OSP and campus
 Program Coordinators &OA3’s all on one
team now

◦ Supports cross coverage and enhanced
support throughout office

Floaters (coverage and overflow)
◦ Mike Snow (Team A)
◦ Kevin Kovach (Team B)
FDP Updates


Federal Demonstration Partnership
Agenda and Presentations Posted
◦ http://sites.nationalacademies.org/PGA/fdp/PGA_
167884

Great source of:
◦ Agency updates
◦ Info on research climate in DC/effects of
administration change
◦ Info on regulatory change – what’s coming!
◦ Networking and partnering for change
◦ Ideas and action to reduce administrative burden
Agency update highlights

NSF Updates (slides posted)
◦ Updated PAPPG coming out in Oct. 1/25/2016 effective date
◦ 5:00 pm local time deadline will now be enforced automatically in the system
◦ Information/requirements about NSF prior support continues to be clarified (we’ve
had some problems in this area)
◦ They will be piloting JIT detailed budgets on some programs after Oct 1. This should
be interesting to see what happens here!!
◦ Research Terms and Conditions are moving their way through Committee and they
hope to have them out soon
◦ It was emphasized that grants.gov not be used for NSF submissions. Grants.gov does
not do the compliance checking that Fastlane does

NIH (slides posted)
◦ Request for Info on NIH Grant Application Instructions. 9/25 response date.
◦ PMS subaccounts. All awards to be transitioned by 10/1/2016. Transitional FFR’s to be
used.
◦ Research training data tables have been improved. Coming out soon
FDP Demonstrations/Pilots





Project Certification instead of Effort Certification has
positive response. All institutions encouraged to make the
shift
Subawards - Templates are getting much improved, along
with guidance documents. Working on Clinical Trials, foreign
and other templates coming soon
FDP Clearinghouse – great momentum! Partnering with
eRA committee to move things forward to a pilot. Standard
Risk Assessment Questionnaire now available and to be
connected to questions/data elements in clearinghouse
Procurement – Work of this group helped influence OMB to
provide year extension to the UG rules. Ongoing pilot will
pursue long term change in procurement threshold
Data ACT / Open Government - Common data element
repository being created. This is the post award data portion
of UG at work!
eRA Commons Working Group

ASSIST for single project
◦ By end of year all app types will be available
◦ ASSIST intended as option only. No plans to
make it required
◦ OSP monitoring development and technical
issues closely – along with campus use

Forms set D coming
◦ 80% of forms being touched somehow
◦ Likely for submission after May 25th deadlines
◦ Will include updated data tables for training
grants
Top 10 reasons we will miss Tami!
#10 - She is always calm under pressure! Can you say NSF IG
Audit!
#9 – She has just the right amount of sense of humor, at just
the right times
#8 – She makes a mean cupcake
#7 – She’s just plain nice! For real!
#6 – She always thinks of the campus first when working on a
project
#5 – She is a fantastic partner to OSP
#4 – She is open minded when we throw random items or
situations her way. And back to #10!
#3 – She has a heart of gold and it shows in her work
#2 – She is the best hostess ever for MRAM!
#1 – She is the best at getting Mike off the podium 
Closeout
W H AT ’ S N E W ?
OFFICE OF SPONSORED PROGRAMS
2015
MRAM SEPTEMBER
Standard Closeout
Requirements
GRANTS
CONTRACTS
•Final Technical (Progress) Report•All Work Completed
Assurance/Deliverables Met
•Final Invention Statement
•Contractor’s Certification
•Final Equipment (Property)
Concerning Royalties, Patents,
Report
and Copyrights
•Final Fiscal Report
•Property Clearance Report
•Release of Claims and Final
Invoice
Nonstandard Closeout
Requirements (Project Specific)
Examples include:
•Single Audit Assurance (again . . . .)
•Subaward Completion/Closed Assurance
•List of resulting publications
•Security Report (Classified Contracts)
UW Policy related to Closeout of
Sponsored Programs (GIM 39)
•Sets out typical closeout requirements
•Explains responsibility of PI and central administrative
offices regarding meeting closeout requirements
•Imposes timeline to meet closeout requirements (90 days
after the end date)
•Includes escalation notification process if a PI is delinquent
in meeting the final technical report requirement
•Allows for OSP to return proposals without review if a PI is
severely delinquent (i.e. more than 120 days past end date)
in meeting closeout requirements on earlier grant
Closeout notification process
has changed
•OSP notifications reminders reduced from three notifications to
PI and department administrator to one notification
•Content changed:
Lists typical requirements
Reminds PI to check specific award requirements
Indicates a copy of the final report and receipt of submission to
sponsor be sent to closeout@uw.edu for central record-keeping
Provides URL to additional resources regarding specific sponsor
submission methods as well as which offices support meeting
closeout requirements
Reminds PI of escalation process
How does OSP decide when to
send these and to who?
•Notification sent to named PI and pre-award administrative
contact on the eGC1
•Only federal grant awards (federal contracts, specific grant
activity types, and non-federal awards do not get the OSP
closeout reminder)
•Those that do not appear to have a no-cost extension request or
competing renewal proposal submitted (based on our records)
•Sent one week prior to end date
•Sent by our Closeout Specialist or support from our
closeout@uw.edu account
Let closeout@uw.edu know if .
..
•The notification is sent to the wrong pre-award contact: Upon learning of
the correct contact, we’ll forward to correct individual. (Remember: the pre-award
administrative contact can be updated on an eGC1 throughout the life of the award
by anyone with access to the eGC1).
•The project has a no-cost extension request associated with it: We’ll
remove the project from the closeout list. If the no-cost extension is not in our
system, your communication will be forwarded to our Program Coordinator team for
follow-up.
•The project has a competing renewal application submitted: We’ll
remove the project from the closeout list. However, note that if the competing
proposal is not awarded, the PI may still have final closeout responsibilities on the
previous competing segment and the agency closeout specialist may start sending
delinquency notices.
•The PI is no longer with the University: Per GIM 39 policy, the Chair will
need to organize completion of the final report. If not possible from records or
associated research team, UW Closeout can work with department on
communicating with agency closeout specialist.
Other OSP Closeout
coordination activities
•Federal contract final documentation triage and coordination: If
contract forms are sent to OSP (either directly by federal sponsor, or
forwarded to us by PI), we’ll send out forms to offices that are responsible
for completing various sections of final contract documentation and
coordinate meeting all final requirements. When PI needs to complete
sections, OSP will advise which questions/sections are to be completed by
the PI.
•Forwarding of agency/sponsor specific delinquency reminders: We’ll
pass these along to the PI if these are sent to the authorized official (OSP
contacts)
•Advisement on submission method: Tips on how the PI is to submit final
reports (various sponsor methods and systems)
•Record-keeping: Closeout actions created in SPAERC to document final
technical reports and final invention statements
Coming soon . . .
•Updated matrix of agency systems used for particular final report types
(e.g. eRA Commons, Research.gov)
•Step by step instruction with screenshots of how to complete specific
types of final grant reports
•Other “end of award” activity guidance:
Relinquishments/Transfers out of UW
Early Termination
De-obligations
Thank you!
Questions? Send to closeout@uw.edu
Dual Use Research
of Concern (DURC)
Tony Han
Environmental Health and Safety Department
Select Agent and Biosafety Level – 3 Program Manager
206-616-5514, ehsbio@uw.edu
September 10, 2015
Dual Use Research of Concern
(DURC)
> DURC is life sciences research that, based on current
understanding, can be reasonably anticipated to provide
knowledge, information, products, or technologies that could
be directly misused to pose a significant threat with broad
consequences to public health and safety, agricultural crops
and other plants, animals, the environment, or national
security.
> The United States Government Policy for Institutional
Oversight of Life Sciences Dual Use Research Of Concern is
effective September 24, 2015
> United States Government Policy for Oversight of Life
Sciences Dual Use Research of Concern (March 2012)
Agents Subject to DURC Rule
Research involving these agents that also has the potential to produce effects of
higher concern could be considered DURC.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
Botulinum neurotoxins (any quantity)
Avian influenza virus (highly pathogenic)
Bacillus anthracis
Burkholderia pseudomallei
Burkholderia mallei
Foot-and-mouth disease virus
Francisella tularensis
Reconstructed 1918 influenza virus
Rinderpest virus
Toxin-producing strains of Clostridium botulinum
Yersinia pestis
Risk Group 4 agents: Ebola virus, Marburg virus, Variola major and minor viruses
Requirements for Research with
DURC Agents
1. EH&S online DURC training. For all research personnel with research
involving any of the below agents. Training is required initially and then
every three years. This is a 30-minute online training course.
2. DURC Application to EH&S for review by the DURC Institutional Review
Entity (IRE).The DURC IRE is a standing subcommittee of the Institutional
Biosafety Committee (IBC). The DURC IRE is comprised of faculty, staff, and
consultants with expertise in select agent research and regulations,
biomedical and infectious disease research, biosafety, bioethics, animal
research, environmental health and safety, export control, and UW policies
and procedures. The DURC Application is submitted to notify the IRE and
to assess research for DURC.
DURC
Experimental Effects of Concern
1. Enhances the harmful consequences of the agent or toxin
2. Disrupts immunity or the effectiveness of an immunization against the agent or toxin without
clinical and/or agricultural justification
3. Confers to the agent or toxin resistance to clinically and/or agriculturally useful prophylactic
or therapeutic interventions against that agent or toxin or facilitates their ability to evade
detection methodologies
4. Increases the stability, transmissibility, or the ability to disseminate the agent or toxin
5. Alters the host range or tropism of the agent or toxin
6. Enhances the susceptibility of a host population to the agent or toxin
7. Generates or reconstitutes an eradicated or extinct agent or toxin listed in the policy
DURC Agent + experimental effect of Concern = Possibly DURC = Risk Mitigation Plan and
notification to NIH or other federal funding sponsor
UW Responsibilities
> Establish and implement policies and practices for identification and oversight of
DURC that include:
– Establishing an Institutional Review Entity (IRE):
– Ensuring appropriate review of research with DURC potential
– Assessing the potential risks and benefits associated with DURC
– Developing and implementing risk mitigation plans, as necessary
– Ensuring compliance with the Policy and approved risk mitigation plans
– Ensuring periodic review and updating of risk mitigation plans
– Providing education and training on DURC
– Assisting investigators when questions arise regarding research that may be
subject to the Policy
– Notification to USG funding agencies of DURC research, risk mitigation plans,
non compliance issues
Implemented by EH&S and the Institutional Biosafety Committee
Investigator Responsibilities
> Refer to the IRE all research involving one or more of the agents or toxins listed in
the Policy, along with an assessment of whether the research involves any of the
seven listed experimental effects
> Work with the IRE to assess the dual use risks and benefits of the research in
question and develop risk mitigation measures
> Conduct DURC in accordance with the risk mitigation plan
> Be knowledgeable about and comply with all institutional and Federal policies and
requirements for oversight of DURC
> Continue to assess research to determine if, at any time, the research becomes
subject to the policy
> Ensure that laboratory personnel (e.g. graduate students, postdoctoral fellows,
research technicians, laboratory staff, and visiting scientists) conducting research
with any of the 15 listed agents have received education and training on DURC
> Communicate DURC in a responsible manner, throughout the research process,
not only at the point of publication
Resources
> UW EH&S DURC Website
> US Government Dual Use Homepage
> Companion Guide
– A collection of tools to assist investigators and research institutions identify,
assess, manage, and communicate dual use research of concern
> Case Studies
– A series of examples of research that demonstrates the type of analysis
conducted during institutional reviews of DURC
> UW DURC Application
> Katia Harb, EH&S Assistant Director for Research and Occupational Safety and
UW’s Institutional Contact for Dual Use Research, at ehsbio@uw.edu or
206.221.7770
OFFICE OF SPONSORED PROGRAMS
OSP
Subaward Updates
& Training
http://nationaldaycalendar.com/national-research-administrator-day/
Improved Navigation
Find Subawards directly from OSP’s home page!
OFFICE OF SPONSORED PROGRAMS
Topics, Instructions & Status Report
• Easy to find Topics & Status report linked from top of the page!
• Revised instructions & web content!
• Campus workgroup feedback incorporated
• Additional feedback welcome via ospweb@uw.edu
OFFICE OF SPONSORED PROGRAMS
Subaward Fundamentals Course
for PI’s & Departments
Register now – or express interest via the wait list*!
Hosted via the Collaborative for Research Education
(CORE) http://www.washington.edu/research/learning
Topics include:
• Roles & responsibilities
• Best practices for monitoring financial & research
performance of subawards
• Tips for troubleshooting performance challenges
*Taught Quarterly, additional sessions are scheduled based on interest.
OFFICE OF SPONSORED PROGRAMS
What’s next on the horizon for subs?
• We have heard your concerns (and we share those
concerns)
• Business process reengineering for the OSP Subawards
Intake process
• Taking action towards a new solution
• Currently working through details – more to be announced soon
• Next steps for visibility
• Subaward data to be available via the EDW
• Currently working with the EDW team on timing – more soon
OFFICE OF SPONSORED PROGRAMS
Thank you!
OFFICE OF SPONSORED PROGRAMS
SFI/FCOI Update
MRAM - September 10, 2015
Melissa Petersen
Office of Research
University of Washington
SFI/FCOI Update
Already implemented
Receipt and agreement with management plan
conditions
University of Washington
Office of Research
SFI/FCOI Update
Already implemented
Receipt and agreement with management plan
conditions
Upcoming
Monitoring for compliance
University of Washington
Office of Research
Questions?
Contact Information:
research@uw.edu
206.616.0804
petermm@uw.edu
206.616.2120
University of Washington
Office of Research
UPCOMING COURSES IN RESEARCH ADMINISTRATION
Sept 14
OSP 145 – Sub-Award Fundamentals for PIs and Departments
Sept 16
MAA 205 – Modifying an FEC Using Comments & Adjusting
Cost Sharing
Sept 17
OSP 155 – Grants.gov: The Basics
Sept 22
RAA 100 – Grant and Contract Fiscal Administration:
Compliance
MAA 210 – Modifying an FEC, Change Outside eFECS and
Recertifications
Sept 23
CORE is a collaborative effort to provide free, high
quality, cohesive training on research administration
and compliance to UW researchers and research
administrators.
To see a full list of courses and to register, visit
https://uwresearch.gosignmeup.com/public/course/browse