The Proposed Revisions to the Human Subjects Regulations

Karen Moe

Director, Human Subjects Division

MRAM Meeting

September 10, 2015

Proposed RevisionPublished 9/8/15

http://www.gpo.gov/fdsys/pkg/FR-2015-09-08/pdf/2015-21756.pdf (131 pages)

Historical contextDate Event1974 U.S. regulations publishedEarly 1980s Revision1991 Revision2015 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 EventSept 8, 2015 NPRM: Proposed revisions

publishedDec 7, 2015 5 PM Public comment period endsUnknown(months, years)

Publication of the Final Rule (official revised regulations)

Implementation Timetable Date EventUnknown Publication of the Final Rule90 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 AriasAssistant Vice Provost for ResearchDirector, Office of Sponsored Programsariasl@uw.edu

Org & Staff Updates in OSPUpdated Department Assignment

Listing posted recently◦http://www.washington.edu/research/

.SITEPARTS/.documents/.or/Org_Chart_OSP.pd

Updated Org Chart recently posted◦http://www.washington.edu/research/

.SITEPARTS/.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 officeFloaters (coverage and overflow)

◦Mike Snow (Team A)◦Kevin Kovach (Team B)

FDP UpdatesFederal Demonstration PartnershipAgenda 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 useForms 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

CloseoutWHAT’S NEW?

OFFICE OF SPONSORED PROGRAMS MRAM SEPTEMBER 2015

Standard Closeout Requirements

GRANTS

•Final Technical (Progress) Report

•Final Invention Statement

•Final Equipment (Property) Report

•Final Fiscal Report

CONTRACTS

•All Work Completed Assurance/Deliverables Met

•Contractor’s Certification Concerning Royalties, Patents, and Copyrights

•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 requirementsReminds PI to check specific award requirementsIndicates a copy of the final report and receipt of submission to

sponsor be sent to closeout@uw.edu for central record-keepingProvides 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 UWEarly TerminationDe-obligations

Thank you!

Questions? Send to closeout@uw.edu

Dual Use Research of Concern (DURC)

Tony HanEnvironmental Health and Safety DepartmentSelect Agent and Biosafety Level – 3 Program Manager206-616-5514, 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. Botulinum neurotoxins (any quantity) 2. Avian influenza virus (highly pathogenic) 3. Bacillus anthracis 4. Burkholderia pseudomallei5. Burkholderia mallei 6. Foot-and-mouth disease virus 7. Francisella tularensis8. Reconstructed 1918 influenza virus 9. Rinderpest virus 10. Toxin-producing strains of Clostridium botulinum 11. Yersinia pestis 12. 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

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

Experimental Effects of Concern

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/

OFFICE OF SPONSORED PROGRAMS

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

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.

Subaward Fundamentals Course for PI’s & Departments

OFFICE OF SPONSORED PROGRAMS

• 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

What’s next on the horizon for subs?

OFFICE OF SPONSORED PROGRAMS

Thank you!

SFI/FCOI Update

MRAM - September 10, 2015Melissa Petersen

Office of ResearchUniversity of Washington

Already implementedReceipt and agreement with management plan

conditions

SFI/FCOI Update

University of Washington Office of Research

Already implementedReceipt and agreement with management plan

conditions

Upcoming Monitoring for compliance

SFI/FCOI Update

University of Washington Office of Research

Contact Information:research@uw.edu

206.616.0804

petermm@uw.edu 206.616.2120

Questions?

University of Washington Office of Research

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

UPCOMING COURSES IN RESEARCH ADMINISTRATIONSept 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

Sept 23 MAA 210 – Modifying an FEC, Change Outside eFECS and Recertifications