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Introduction to Award TypesAward/Post-Award TerminologyNegotiation and Account set upOther Post-Award actions and area of focus
Functions of the Partners Post Award Teams 2011
© Partners HealthCare System, Inc., 2011
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Award Document
• Introductions & Topic Discussion• Award Post-Award References / Contacts
– Review – Grants Life Cycle• Award Acceptance, Notification and Setup in the award cycle• InfoEd and PeopleSoft overview• Post-Award Office Structure
– Before Award Setup• Types of Awards – NIH Specific• Pre-Award Spending
– Sponsor Notification of an Award• Award Set Up Steps• Establish Project Accounts
– Reviewing/Negotiating Terms and Conditions• Binding Contract to the Hospital• Other offices involvement
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More on the Award document
• Introductions & Topic Discussion
– Reviewing/Negotiating Terms and Conditions, cont.
• Examples of Hospital Guidelines and PI issues
• Overview of Key Points to consider
– Points To Be Mindful Of
• Good Stewardship
• Introduction to Cost Sharing
• Introduction to Time & Effort
• Institutional Clearances
– Animal Use and Approval
– Human Subjects
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Award / Post Award References
• Director of Post-Award Services – Eleni Ryals • Associate Director of Post-Award Services – Kate Hecht
• MGH Post-Award Team Leader – Cora Cheng-Chong • MGH Post-Award Team Leader – Mary Colangelo • BWH Post-Award Team Leader – Lynne Benoit • BWH Post-Award Team Leader – Joshh Magee
• MGH/BWH ARRA Team Manager – Dan Salvati
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Introductions & Topic Discussion
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“Learning Objectives” – What do you want to learn about post-award terminology, types of awards, award
negotiation, account set up and institutional clearances?
• What are some of the most common awards the NIH grants?
• Does the sponsor award the level of funding proposed?
• Does the post-award office always handle negotiation?
• Can there be any risk if I just give the terms and conditions a quick review?
• Why is the award set up process the most important process for the Principle Investigator?
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Review – Grants Life CycleAward Acceptance and Setup in the Award Cycle
Post-Award Office StructureTypes of Awards
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Grants Life Cycle – Roles at PartnersGrants Life Cycle – Roles at PartnersProposal
Development
Locate Funding &Write Proposal
Institutional
Clearances
ProposalSubmission
&SponsorReview
Funded:Awards Terms &Conditions
Not Funded:Reviewers’
Comments &Resubmit
EstablishProjectAccount(s)
&PI BriefingIncurring Costs
andPurchasing
Tracking and
Accounting
SponsorReports
and Close-outs
Additional Funding- means more money!
The AwardThe Award ““Life Cycle”Life Cycle”
Pre-Award
Post-AwardSubcontracting
In-coming and out-
going
Research Finance
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Grants Lifecycle within InfoEd and PeopleSoft at Partners
Funded:– Awards –Terms &
Conditions
EstablishProject
Account(s)&
PI Briefing
Spend Moneyand
Purchasing
Tracking andAccounting
SponsorReports
and Close-out
PeopleSoft Accounts Payable, Purchasing, Time & Labor, General Ledger
BillingAccounts
Receivable
PeopleSoft Contracts, Billing, Accounts Receivable
Post Award / Finance Finance
Post Award
InfoEd Proposal Tracking and PeopleSoft Grants and Contracts
Post Award / Finance
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Post-Award Office Structure• The Post-Award Office is part of the overall Office of Research ManagementThe Post-Award Office is part of the overall Office of Research Management
Post-Award RolesPost-Award Roles– Grant Administrator I, Grant Administrator II, Senior Grant Administrator, Post-
Award Team Leader, Post-Award Associate Director, Post Award Director. On the Contract team the progression is Contract/Subcontract (C/S) Coordinator, C/S Administrator, C/S Specialist, C/S Senior Specialist/Team Leader, C/S Manager, C/S Associate Director. The ARRA team is also part of the post award team as they are doing all functions for the stimulus funding awards – ARRA Manager.
• The Post-Award office is responsible for the following steps in the Grants The Post-Award office is responsible for the following steps in the Grants Lifecycle:Lifecycle:Primary Tasks;Primary Tasks;– Review the terms and conditions of all in-coming grants and contracts from
Federal funding sources, Universities or other not-for-profits and Foundations– Review, process and submit all post-award administrative actions (such as
requests for re-budgeting approval, no-cost extensions, requests for change of scope, requests to add a subcontractor, requests for carry forward)
– Review and approve employee data changes– Set up/activate accounts for new awards, subcontracts and out year amendments– Fund Management of all active award accounts– Participate in the Close Out process– Provide technical guidance to PI and Department Administrators– Liaison between PI and sponsor
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Types of Awards – NIH Specific
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Types of Awards – NIH SpecificBridge AwardBridge Award
Provides one year of funding so investigators can continue research while reapplying for an R01 grant or enables new investigators to gather preliminary data to improve their applications. Investigators do not apply for Bridge Awards but are selected from R01 grants at the pay-line margin. As soon as the Competitive Renewal is funded, the Bridge Award is terminated so it may be active for more or less than one year.
Program Project/CenterProgram Project/Center Grants Grants
Center grants are awarded to institutions on behalf of program directors and groups of collaborating investigators. They support long-term, multi-disciplinary programs of research and development.. These can also be referred to as core grants.
Career Development AwardsCareer Development Awards
Award supporting Ph.D.s and clinicians who wish to develop a career in biomedical research. Referred to as the “K” series.
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Types of Awards – NIH SpecificNIH Director’s Pioneer AwardNIH Director’s Pioneer AwardThe NIH Director's Pioneer Award supports individual scientists of exceptional creativity who propose pioneering approaches to major challenges in biomedical and behavioral research. The term “pioneering” is used to describe highly innovative – potentially transformative – approaches having the potential to produce an unusually high impact, and the term “award” is used to mean a grant for conducting research, rather than a reward for past achievements. Small Business Innovation Research (SBIR) Small Business Innovation Research (SBIR) An award designed to support projects from small businesses ultimately having commercial viability. Small Business Technology Transfer (STTR) Small Business Technology Transfer (STTR) A 3-year pilot program begun in FY 1994 under the Small Business Innovation Research Program designed to foster technological innovations through cooperative efforts between small business and research institutions. The STTR grants are awarded for projects having potential for commercialization. Training AwardsTraining AwardsAwards designed to support the research training of scientists for careers in the biomedical and behavioral sciences, as well as help professional schools to establish, expand, or improve programs of continuing professional education. Training awards consist of institutional training grants (T) and individual fellowships (F).
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Types of Awards – NIH SpecificCooperative Agreement (U Series)Cooperative Agreement (U Series)
A support mechanism used when there will be substantial Federal scientific or A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities. program staff will assist, guide, coordinate, or participate in project activities.
Interactive Research Project Grant (IRPG) Interactive Research Project Grant (IRPG)
An award made to two or more investigators funded independently as R01 grantees but An award made to two or more investigators funded independently as R01 grantees but brought together as a collaborative group receiving additional support for collaborative brought together as a collaborative group receiving additional support for collaborative work, shared resources, or the exchange of ideas.work, shared resources, or the exchange of ideas.
Interagency AgreementInteragency Agreement
Formal agreement among government agencies to collaborate on and fund research; Formal agreement among government agencies to collaborate on and fund research;
Note: most Interagency Agreements at Partners are IPA’s that are entered into with the Note: most Interagency Agreements at Partners are IPA’s that are entered into with the Veterans Administration.Veterans Administration.
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Types of Awards – NIH Specific
Clinical trials of an experimental drug, treatment, device, or intervention may proceed Clinical trials of an experimental drug, treatment, device, or intervention may proceed through four phases: through four phases:
• Phase I.Phase I. Testing in a small group of people (e.g. 20-80) to determine efficacy and evaluate safety (e.g., determine a safe dosage range and identify side effects).
• Phase II.Phase II. Study in a larger group of people (several hundred) to determine efficacy and further evaluate safety.
• Phase III.Phase III. Study to determine efficacy in large groups of people (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions, to monitor adverse effects, and to collect information to allow safe use.
• Phase IV.Phase IV. Studies done after the intervention has been marketed. These studies are designed to monitor the effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use.
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Types of Awards – NIH SpecificResearch Grants –Some of the most common “R” series awards:Research Grants –Some of the most common “R” series awards:
• R01 NIH Research Project Grant Program (R01)R01 NIH Research Project Grant Program (R01)– Used to support a discrete, specified, circumscribed research project – NIH's most commonly used grant programNIH's most commonly used grant program – No specific dollar limit unless specified in FOA – Advance permission required for $500K or more (direct costs) in any year – Generally awarded for 3 -5 years – All ICs utilize
• R03 NIH Small Grant Program (R03): R03 NIH Small Grant Program (R03): – Provides limited funding for a short period of time to support a variety of types of
projects, including: pilot or feasibility studies, collection of preliminary data, secondary analysis of existing data, small, self-contained research projects, development of new research technology, etc.
– Limited to two years of funding – Direct costs generally up to $50,000 per year – Not renewable – Utilized by more than half of the NIH ICs
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Types of Awards – NIH Specific
Research Grants –Some of the most common “R” series awards, cont.:Research Grants –Some of the most common “R” series awards, cont.:
• R13 NIH Support for Conferences and Scientific Meetings (R13 and U13)– Support for high quality conferences/scientific meetings that are relevant to NIH's
scientific mission and to the public health – Requires advance permission from the funding IC – Foreign institutions are not eligible to apply – Award amounts vary and limits are set by individual ICs – Support for up to 5 years may be possible
• R21 NIH Exploratory/Developmental Research Grant Award (R21)– Encourages new, exploratory and developmental research projects by providing
support for the early stages of project development. Sometimes used for pilot and feasibility studies.
– Limited to up to two years of funding – Combined budget for direct costs for the two year project period usually may not
exceed $275,000. – No preliminary data is generally required – Most ICs utilize
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Types of Awards – NIH SpecificCareer Development Awards –Some of the most common “K” series awards:Career Development Awards –Some of the most common “K” series awards:
• Mentored Research Scientist Development Award (K01)Mentored Research Scientist Development Award (K01)The purpose of the K01 program is to provide support and “protected time” (3-5 years) for an intensive, supervised career development experience in the biomedical, behavioral, or clinical sciences leading to research independence. Awards are not renewable, nor are they transferable from one principal investigator to another.
• Independent Scientist Award (K02)Independent Scientist Award (K02) The K02 provides support for newly independent scientists who can demonstrate the need for a period of intensive research focus as a means of enhancing their research careers. The K02 is intended to foster the development of outstanding scientists and to enable them to expand their potential to make significant contributions to their field of research.
• Mentored Clinical Scientist Research Center Development Award (K08)Mentored Clinical Scientist Research Center Development Award (K08)
The K08 represents the continuation of a long-standing NIH program that provides support and “protected time” to individuals with a clinical doctoral degree for an intensive, supervised research career development experience in the fields of biomedical and behavioral research, including translational research. Individuals with a clinical doctoral degree interested in pursuing a career in patient-oriented research should refer to the NIH Mentored Patient-Oriented Research Career Development Award (K23).
• Mentored Clinical Scientist Development Program Awards (K12) Mentored Clinical Scientist Development Program Awards (K12)
Provide support to an institution for the development of independent clinical scientists.
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Types of Awards – NIH Specific
Career Development Awards –Some more of the most common “K” series awards:Career Development Awards –Some more of the most common “K” series awards:
• Mentored Patient-Oriented Research Center Development Award (K23)Mentored Patient-Oriented Research Center Development Award (K23)The purpose of the K23 is to support the career development of investigators who have made a commitment to focus their research endeavors on patient-oriented research. Clinically trained professionals or individuals with a clinical degree who are interested in further career development in biomedical research that is not patient-oriented should refer to the Mentored Clinical Scientist Career Development Award (K08).
• Mid-career Investigator Award in Patient-Oriented Research (K24)Mid-career Investigator Award in Patient-Oriented Research (K24)The purpose of the K24 program is to provide support for clinician investigators to allow them protected time to devote to patient-oriented research (POR) and to act as research mentors primarily for clinical residents, clinical fellows and/or junior clinical faculty.
• NIH Pathway to Independence (PI) Award (K99/R00)NIH Pathway to Independence (PI) Award (K99/R00)The K99/R00 award provides an opportunity for promising postdoctoral scientists to receive both mentored and independent research support from the same award. The initial phase will provide 1-2 years of mentored support for highly promising, postdoctoral research scientists followed by up to 3 years of independent support contingent on securing an independent research position. Award recipients will be expected to compete successfully for independent R01 support from the NIH during the career transition award period.
For the complete listing of NIH “K” series awards please see the K Kiosk-
http://grants.nih.gov/training/careerdevelopmentawards.htm
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Types of Awards – NIH SpecificTraining Grants - Some of the most common “T” and “F” series awards:Training Grants - Some of the most common “T” and “F” series awards:
Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grants (T32)Grants (T32)The purpose of this program is to provide pre-doctoral and postdoctoral research The purpose of this program is to provide pre-doctoral and postdoctoral research training opportunities for individuals interested in pursuing research careers in biomedical, behavioral training opportunities for individuals interested in pursuing research careers in biomedical, behavioral and clinical research.and clinical research.
• T31 awards are designed for pre-docs, T32’s are for post-docs.
For the complete listing of NIH “T” series awards please see the T Kiosk-http://grants.nih.gov/training/T_Table.htm
• Ruth L. Kirschstein National Research Service Award (NRSA) Individual Postdoctoral Ruth L. Kirschstein National Research Service Award (NRSA) Individual Postdoctoral Fellows (F32)Fellows (F32)The objective of this program is to provide support to promising postdoctoral applicants who have the potential to become productive and successful independent research investigators in scientific health-related fields relevant to the missions of the participating NIH Institutes and Centers.
• F31 awards are designed for pre-docs, F32’s are for post-docs.
• For the complete listing of NIH “F” series awards please see the F Kiosk-
http://grants.nih.gov/training/F_files_nrsa.htm
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xTrain
.
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What is xTrain?
• xTrain is a web based program that allows users to electronically process appointments and other required paperwork associated with Kirschtein-NRSA training grants
PI’s can use xTrain to:• Create, route and submit appointments, Re-Appointments, Amendments
and Termination Notices• Track the status and timing of training actions• xTrain is part of eRA Commons, an online interface where grantees and
federal staff can access, share and transmit administrative grant information
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Why xTrain was created
• NIH developed xTrain as an electronic management tool for NRSA training grants to improve it’s efficiency in capturing research training appointments
• Adds some additional measure of flexibility in submitting forms and guarantee a base standard for both the NIH and the submitting institution
• xTrain replaces the paper copies of the PHS 2271 appointment Form and PHS 416-7 Termination Forms
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Resources
eRA Commonshttps://commons.era.nih.gov/commons/eRA Web site http://era.nih.gov/xTrain Web page: application guide, quick reference sheets, FAQs, training materials:
http://era.nih.gov/services for applicants/other/xTrain.cfmRuth L. Kirschstein National Research Service Award page: policy information, stipend
levels, FAQ’s http://grants.nih.gov/training/nrsa.htmNIH Forms & Applicationshttp://grants.nih.gov/grants/forms.htmeRA Commons Help Deskhttp://ithelpdesk.nih.gov/eRA/
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Types of Awards – NIH SpecificSome of the most common Program Project/Center Grants (P series)Some of the most common Program Project/Center Grants (P series)Program project/center grants are large, multi-project efforts that generally include a diverse array of research activities.
• P01 Research Program Project GrantP01 Research Program Project Grant– Support for integrated, multi-project research projects involving a number of independent
investigators who share knowledge and common resources – Each project contributes or is directly related to the common theme of the total research effort,
thus forming a system of research activities and projects directed toward a well-defined research program goal
– No specific dollar limit unless specified in FOA • P30 Center Core GrantsP30 Center Core Grants
– To support shared resources and facilities for categorical research by a number of investigators from different disciplines who provide a multidisciplinary approach to a joint research effort or from the same discipline who focus on a common research problem.
– The core grant is integrated with the center's component projects or program projects, though funded independently from them.
• P50 Specialized CenterP50 Specialized Center– To support any part of the full range of research and development from very basic to clinical – May involve ancillary supportive activities such as protracted patient care necessary to the
primary research or R&D effort. – The spectrum of activities comprises a multidisciplinary attack on a specific disease entity or
biomedical problem area. – Receive continuous attention from staff funding IC. – Centers may serve as regional or national resources for special research purposes.
• For the complete listing of NIH “P” series awards please see -http://grants.nih.gov/grants/funding/funding_program.htm#PSeries
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Types of Awards – NIH SpecificTwo of the most common Cooperative Agreements (U series)Two of the most common Cooperative Agreements (U series)A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.
U01 Research Project Cooperative AgreementU01 Research Project Cooperative Agreement– Supports discrete, specified, circumscribed projects to be performed by investigator(s) in an
area representing their specific interests and competencies – Used when substantial programmatic involvement is anticipated between the awarding Institute
and Center – One of many types of cooperative agreements – No specific dollar limit unless specified in FOA
U54 Cooperative Agreements Specialized CenterU54 Cooperative Agreements Specialized Center– To support any part of the full range of research and development from very basic to clinical;
may involve ancillary supportive activities such as protracted patient care necessary to the primary research or R&D effort.
– The spectrum of activities comprises a multidisciplinary attack on a specific disease entity or biomedical problem area.
– These differ from program project in that they are usually developed in response to an announcement of the programmatic needs of an Institute or Division and subsequently receive continuous attention from its staff.
– Centers may also serve as regional or national resources for special research purposes, with funding component staff helping to identify appropriate priority needs.
For the complete listing of NIH “U” series awards please see -http://grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=u&Search_Type=Activity&Search.x=18&Search.y=8
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Grants Terminology
• National Institute of Health (NIH) Application Types:
– Type 1 New
– Type 2 Competing Continuation (a.k.a. renewal, re-competing)
– Type 3 Application for additional (supplemental) support
– Type 4 Competing extension for an R37 award or first non competing year of a Fast Track SBIR/STTR Award
– Type 5 Non-competing continuation
– Type 7 Change in Grantee Institution
– Type 9 Change of NIH awarding Institute of Division (competing continuation
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Types of Awards – NIH SpecificResearch and Development Contracts (N01)Research and Development Contracts (N01) An award instrument establishing a binding legal procurement relationship between NIH and a An award instrument establishing a binding legal procurement relationship between NIH and a recipient obligating the latter to furnish a product or service defined in detail by NIH and binding the recipient obligating the latter to furnish a product or service defined in detail by NIH and binding the Institute to pay for it.Institute to pay for it.
– Utilizes different application process and forms that are specific to a procurement– Uses a different solicitation process - Request for Quotation (RFQ)– Applicant is referred to as an “Offeror”– Proposed and awarded in accordance with the Federal Acquisition Regulations (FAR)– Unlike Grant applications, uses SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND
OTHER STATEMENTS OF OFFERORSThis SECTION is made up of five parts as follows:
• 1. Annual Representations and Certifications• 2. Cost Accounting Standards• 3. Certification Regarding Environmental Tobacco Smoke• 4. Certification of Institutional Policy on Conflict of Financial Interest• 5. Disaster or Emergency Area Representation
– Certificate of Cost Pricing Data will be required at the conclusion of the negotiation stage– Much more complicated than a Grant
For more information on Federal Contracts, go to The Office of Acquisition, Management and Policy found at http://oamp.od.nih.gov/
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NEGOTIATIONS
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For-Profit Sponsors – (Industry Sponsors)
Research agreements for bench research sponsored by Industry or For-Profit Sponsors are Research agreements for bench research sponsored by Industry or For-Profit Sponsors are negotiated by the Research Ventures and Licensing Officenegotiated by the Research Ventures and Licensing OfficeRVL also handles the following for Partners PIs;
• Tech Transfer/Technology and Licensing negotiation • Material Transfer Agreements (MTA) and Non-Disclosure Agreements (NDA)• Marketing of intellectual property and establishing system-wide strategic alliances with the life
sciences industries to leverage the science base across PHS• Promoting a culture of entrepreneurship by educating our faculty and supporting the creation and
financing of start-up ventures that result from inventions from PHS laboratories. • http://www.partners.org/rvl/default.aspx
Clinical Trials from Industry or For-Profit Sponsors are negotiated by the Partners Clinical Trials from Industry or For-Profit Sponsors are negotiated by the Partners Clinical Research OfficeClinical Research OfficePCRO also offers the following services for Partners PIs:
• Develops, negotiates and executes agreements and budgets for industry-sponsored clinical research
• Prepares Medicare coverage analyses (MCA) for all clinical trials• Prepares and submits Category B Investigational Device Exemption (IDE) petitions to Medicare• Provides contracting services to specialized research service facilities (also known as “recharge
centers” or “core facilities”). • http://www.partners.org/pcro/default.aspx
Written Agreements for Outside consultant work are negotiated by the Partners Office Written Agreements for Outside consultant work are negotiated by the Partners Office for Interactions with Industryfor Interactions with Industry
• If you have been asked to provide consulting services to a company (such as a pharmaceutical orIf you have been asked to provide consulting services to a company (such as a pharmaceutical ormedical device company or any other vendor or potential vendor to Partners), and the company medical device company or any other vendor or potential vendor to Partners), and the company has sent you a contract, you can submit your agreement to OII for review, or obtain more has sent you a contract, you can submit your agreement to OII for review, or obtain more information on the process, by contacting information on the process, by contacting [email protected]..
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Negotiations Done by Research Management Contracts Team:
• Negotiations by the contracts team shall refer collectively to incoming agreements such as:
– Contracts– Subcontracts/sub award– Foundation awards
• Incoming contracts are sent by the sponsor to either a RM staff member, the Department Administrator or the Principle Investigator.
• Once received, the RM’s contracts team is responsible for reviewing, negotiating and fully executing the policies, sound business practices and accepted academic standards.
• This process can often take one to two months for standard contracts, while complex awards or those requiring substantial negotiations will require additional time
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NegotiationsNot-for Profit Sponsors (Government,
Foundations, etc.)
• Is the Award Consistent with Government Regulations for a Hospital?– Code of Federal Regulations (CFR) http://www.gpoaccess.gov/cfr/index.html– Public Health Services Regulations
http://www.access.gpo.gov/nara/cfr/waisidx_02/42cfrv1_02.html– Federal Acquisition Regulations (FAR) http://farsite.hill.af.mil/vffara.htm– Hospital Cost Principles 45 CFR Part 74 Appendix E
http://a257.g.akamaitech.net/7/257/2422/05dec20031700/edocket.access.gpo.gov/cfr_2003/octqtr/45cfr74.91.htm
• Terms and Conditions– Review, review, review! NEVER accept an award or activate the account without
reading the terms and conditions! You could accept a publication restriction, give away the rights to intellectual property or put the Hospital and Partners at risk of liability and exposure. And, if you find a term you don’t understand, ALWAYS ask!
• Flow Downs– Subcontractors have to accept the same terms and conditions as the primary
institution
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Negotiations - Adherence to Hospital Guidelines and the needs of the PI
• Examples of Hospital Guidelines – Examples of Hospital Guidelines – – Cost Sharing
• When the sponsor will not fund a portion of the award, the Hospital must contribute funds to pay for the not funded portion of the project. We strongly discourage cost sharing as it costs the Hospitals in the end.
– Conflicts of Interest
• Grantees often have internal documentation that they need to collect to ensure the researchers do not have financial interests that would preclude them from receiving sponsored funding from particular sponsors. Read the terms! Some sponsors add language reserving the right to request copies of disclosure forms at a later date. Disclosure forms are collected annually on all sponsored awards.
– Use of Space, etc.
• Each Hospital has internal policies regarding where the research can and should take place (on or off-site, etc.) Here we use both on and off site F&A rates when calculating budgets, consult pre-award staff for listing of sites.
• Any changes needed to fit the PI’s needs?Any changes needed to fit the PI’s needs?– Reporting Structure, etc. Does the PI agree with informal letter progress reports?
– Does the PI need to have samples of any biological materials created?
– Is the PI sharing any biological samples that they need to protect the rights to?
– Will they be sharing any confidential/proprietary information?
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NegotiationCritical Clauses in Hospital Negotiations
• Negotiation – Overview of key points– Confidentiality and Publication
• Academic Freedom and the right to publish is probably the single most important issue dealt with in research agreements, especially with commercial sponsors
– Intellectual Property (creations of the mind): Patents and Copyrights • Manage inventions made by its investigators for the public benefit
• Retain the rights to inventions
• Retain the flexibility to make inventions broadly available to the public
• Protect confidential/proprietary information that will be disclosed to facilitate the work
– Indemnification and Liability • To indemnify is to hold someone harmless for a claim, suit, or action. Indemnification
means that one party (the indemnifying party) will defend the other party (the indemnified party) in case of a lawsuit.
• Some vendors seek to place limits on their liability for negligence, breach of contract, or other wrongful act or omission. In some cases, these limitations are phrased so that they absolve the vendor of all liability. Such provisions are typically unacceptable to the Hospital and are negotiated out. Again, when in doubt, ask! Go to your Team Leader or Associate Director.
– Regulations commonly cited in flow-downs • Sub-Contractors are bound to the same regulations as the primary recipient
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NegotiationCritical Clauses in Hospital Negotiations
• Negotiation – Overview of key pointsPayment SchedulePayment Schedule
• Is the Sponsor paying in U. S. Currency? If not, ask that they convert the funding to US Currency. Here is the link to a Currency Converter http://www.oanda.com/convert/classic
• Try to get as much funding released up front as possible so the PI will have funds to hire staff and buy supplies.
• Try to avoid agreeing to the sponsor keeping a percent of funding to be released upon receipt of final reports and don’t agree to acceptance or approval terms.
• Don’t agree to final invoice terms that are any less than 45 days post term and try for at least 60 days post term.
• Try to negotiate terms that require backup documentation to be submitted with invoices.
Confidentiality termsConfidentiality terms• Never agree to a term that will keep something in confidence in perpetuity (forever). • Watch out for “strict confidence”, we would agree to reasonable efforts or same degree of
care as is exercised in protecting our own confidential information.
Rule of thumbRule of thumb• Never grant approval rights to publications or acceptance of deliverables/reports.• Don’t agree to the sponsor owning all rights to results, data or resulting intellectual
property.• Don’t negotiate in a vacuum, give the PI a chance to see the agreement and make sure
they don’t have any concerns that will need to be addressed. Keep the PI in the loop and provide them with updates on your progress!
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The Award is here!
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Award Setup Steps• Step 1 - Sponsor Notification of an Award
– Receiving and Routing the Award– Required Documentation/ Institutional Clearances– Require notification of Receipt?
• Step 2 - Reviewing/Negotiating Terms and Conditions – Binding Contract to the Hospital– Acceptable to the Hospital?
• Step 3 - “Setting Up” the Award– Subcontracts– Multi-project/Program Awards– Training Awards– Budget/Account Numbers– Funding Mechanism – “The financial Side”
(Letter of Credit/ Cost Reimbursable/Fixed Price) • Step 4 - Account Number and Routing the Award (InfoEd training)
– PI wants – an account number and to begin spending!!!
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Establish Project Account(s) PI/Department Roles & Responsibilities
• Award Set up:• The PI/DA is responsible for reviewing award terms and conditions and sending all
appropriate internal paperwork and approvals to the Pre-Award GA.• Incoming Contracts:
• The PI/DA is responsible for reviewing and approving the award terms and conditions and sending all appropriate internal paperwork and approvals to the Pre-Award GA. This paperwork includes the proposal, Statement of Work (SOW), budget and other proposal requirements, and IRB and IACUC approvals where applicable
• Award Renewal:• The Principal Investigator and Department Administrator prepare and submit a complete
continuation progress report package with all Partners internal forms including the Conflict of Interest Forms (COI) to Research Management for review. The documents with original signatures should be scanned or converted into the Adobe format and submitted via email.
• For NIH awards: PI/Dept should estimate remaining balance and verify if the projected unexpended balance will exceed 25% of the total accumulated award.
• Non-NIH that require an institutional signature: PI and DA should confirm that all completed COI forms are included for all Key Personnel
• Subcontracts and Non-NIH where the PI submits the progress report directly to sponsor: The PI/DA complete the Partners PI assurance and confirm that completed COI forms are included for all Key Personnel
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Establish Project Account(s) and notify the DA and PI
• Receive Notice of Award (NoA) which outlines the terms of the award.• Communicate with the department and the PI that the award has arrived and the
terms and conditions will be reviewed and negotiated as needed prior to the account being set-up beyond the instant account set up process, as applicable.
• Review the terms and conditions, ensure the project was awarded as proposed and that the PI and entity can comply with the terms of award.
• Identify any cost sharing requirements and any sub-awards.– Notify the Contract team of new award that will have subcontracts– Notify the Contract team of out year amendment that will need subcontract
amendments issued in accordance with.• Set-up the award in InfoEd so the PI can begin to incur costs.
– Communicate the new account numbers that are set-up for this award to the appropriate parties, DA and PI.
*To avoid compliance and reconciliation problems in the future, be sure the award accounts are set-up quickly and all parties are notified as
soon as possible.
The Post-Award Office is responsible for account set-up for the award and the The Post-Award Office is responsible for account set-up for the award and the communication of expectations and terms of the award to the department and the PIcommunication of expectations and terms of the award to the department and the PI
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Advance Account Setup
• Advance Account Setup
– Anticipated awards with either an unexecuted agreement on file or confirmation from sponsor that award is forthcoming
– Allows investigators to begin work
– Potential risk that award may not be realized• Department is responsible for expenses if award not issued
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Other Award Setup Activity
• Renewal Setup
– Fund setup of continuation years
– Typically based on award projected at year 1
– Internal compliance documentation required (ie COI forms, Cover sheet etc.)
• Research Sundry Setup
– Fund setup for discretionary research spending
– Request form with approval by division chief & entity controller
– $25K minimum balance to open fund
– 15% overhead
– Internal documentation will vary based upon source of funding
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Post – Award What does it mean to be a Good Steward or
Fiscal Agent?
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Responsibilities of a Good Steward
Post-Award ProcessPost-Award ProcessAll recipients of grants from the NIH, need to realize that there is a great deal of information that we, as an organization, will need to monitor in order to be successful stewards of federal funds.
Monitoring an AwardMonitoring an AwardAll Grantees are responsible for managing the day-to-day operations of their grant. To fulfill your role in regard to the stewardship of federal funds, you need to monitor the grants on your assigned workload once the account is set up and activated. This active monitoring is This active monitoring is accomplished through review of accounts and expenses, accomplished through review of accounts and expenses, correspondence with subcontractors (as applicable), requests to the correspondence with subcontractors (as applicable), requests to the Sponsor and the justification for each prior approval request made, Sponsor and the justification for each prior approval request made, audit reports, site visits, and other information that may be available. audit reports, site visits, and other information that may be available.
Monitoring ExpendituresMonitoring ExpendituresAll Grantees are required to have financial systems in place to monitor their grant expenditures. A good steward will monitor expenditures under individual grants within each budget period and within the overall project period. The funding that NIH provides for each budget period is based on an assessment of the effort to be performed during that period and the grantee’s associated budget, including the availability of “un-obligated” balances. Although NIH allows its grantees flexibilities with respect to re-budgeting (see “Administrative Requirements – Changes in Project and Budget” in the NIH Grants Policy Statement), NIH expects the rate and types of expenditures to be consistent with the approved project and budget and may question or restrict expenditures that appear inconsistent with these expectations.
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Cost Charging
Costs Charged to Sponsored Projects must be;
• Allowable
• Reasonable
• Allocable
• Consistent
• Conform
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Cost Charging
Most common types of charges
• Salaries and Wages
• Supplies
• Equipment
• Travel
• Other Expenses
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Basic Rules for EDCs
• Valid reasons for EDCs– To allocate salary at the time of a new award setup– To reflect changes in effort on a given project– To add or remove trainees/personnel– To resolve a deficit by transferring salary to a sundry– To update salary allocation to new fund number (T32)
• Invalid reasons for EDCs– To transfer costs from one sponsored project to another solely
for deficit resolution– To transfer costs onto sponsored projects in order to spend
down remaining funds– To charge salary in excess of effort contributed
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Basic Rules for EDCs (con’t)
• Examples of Acceptable Data Change Comments– “New award setup under Peoplesoft# “blank” -data change to allocate
salary based on sponsor approved budget”– To allocate effort/salary based on sponsor approved budget– Change required to allocate pre-award spending in accordance with
sponsor terms & conditions.– Change required to move individual’s allocation from project to
departmental discretionary fund to resolve deficit
• Examples of Unacceptable Data Change Comments– Per meeting with PI– To correct error– To “spend down” balance as project ends– To move deficit from project X to project Y– Per department administrator and/or central administrator
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Basic Rules for EDCs (con’t)
• The only acceptable reason for transferring personnel expenses to and from sponsored projects is to reflect the costs of the actual effort devoted to the project
• Cost transfer of salaries are appropriate only when they are reasonable, allocable, allowable and consistently applied as defined by federal regulations.
• See Cost Transfer policy, Effort Reporting Policy and Employee Data Change SOP for more information
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Submission of EDC by Dept
• Detailed rationale for request within comments field– Consistent with cost transfer policy, recertification policy and
EDC SOP.
• EDCs with insufficient explanation are denied
• Due diligence– Fund liquidity and project period must be verified– Compliance of data change with Sponsored Project Cost
Charging Policy must be confirmed– Completion of the over 90 Days questions must be entered into
the comment sections of the EDC when effective date is greater than ninety days prior.
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Responsibilities of a Good StewardPrior Approval RequestsAll requests that require prior NIH approval must be made in writing (e-mail is acceptable) to the Grants Management Officer at least 30 days before the proposed change. The request must be endorsed by the Authorized Organization Representative.
Failure to obtain required prior approval from the appropriate NIH awarding office may result in the disallowance of costs, termination of the award, or other enforcement action within the NIH’s authority.
E-mail requests must be clearly identified as prior-approval requests, must reflect the complete grant number in the subject line, and should be sent by the AOO to the GMO that signed the NGA. (E-mail addresses for NIH staff can be obtained from the NIH Directory and E-Mail Forwarding Services at http://directory.nih.gov)
E-mail requests must include the name of the grantee, the name of the initiating PI, the PI’s telephone number, fax number, and e-mail address, and comparable identifying information for the Authorized Organizational Official.
If the entire message of the request cannot be included in the body of the e-mail, the request should be submitted to NIH in hard copy.
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Pre-Award SpendingPre-award (Pre-agreement) Costs:Pre-award (Pre-agreement) Costs: A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days prior to the effective date of a new or competing continuation award if such costs: Are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval.
• If specific expenditures or activities would otherwise require prior approval, the grantee must obtain NIH approval prior to incurrence of the cost. NIH prior approval is required for any costs to be incurred more than 90 days prior to the beginning date of a new or competing continuation award.
• Grantees may incur preaward costs prior to the beginning date of a noncompeting continuation award without regard to the time parameters stated above.
• The incurrence of preaward costs in anticipation of a competing or noncompeting award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover preaward costs incurred.
• NIH expects the grantee to be fully aware that preaward costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project.
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Responsibilities of a Good Steward
ActionsActions requiring NIH prior approval: requiring NIH prior approval:
• Rebudgeting into A&R costs that would exceed 25 percent of the total approved budget for a budget period. If rebudgeting would not meet this threshold but would result in a change in scope. Any single A&R project exceeding $300,000.
• Capital expenditures (construction, land, or building acquisition). All instances when purchase proposed; any proposal to convey, transfer, assign, mortgage, lease, or in any other manner encumber real property acquired with NIH grant funds.
• Change of scope
• Changes in status of key personnel (Withdrawal from the project; absence for any continuous period of 3 months or more; reduction of time devoted to project by 25 percent or more from level in approved application)
• Change of grantee organization
• Carryover of unobligated balances (If the NGA indicates that the grantee does not have the authority to automatically carry over balances)
• Deviation from award terms and conditions (Includes undertaking any activities disapproved or restricted as a condition of the award)
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Responsibilities of a Good Steward
More actionsMore actions requiring NIH prior approval: requiring NIH prior approval:
• Foreign component added to a grant to a domestic organization
• Need for additional NIH funding (Including extension of a final budget period of a project period with additional funds)
• Pre-award costs (If more than 90 days before effective date of the initial budget period of a new or competing continuation award)
• Retention of research grant funds when the award is K series award
• Second no-cost extension or extension greater than 12 months
• Transfer of funds between construction and non-construction work
• Transferring amounts from trainee costs
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Responsibilities of a Good StewardAdhering to the Reporting RequirementsAdhering to the Reporting RequirementsNIH requires that grantees periodically submit reports. For all of the reports identified in the Notice of Award, remember that they are due at specific times during the life cycle of a grant award. It is important that all reports are accurate, complete, and submitted on time.
Progress ReportsProgress Reports (A Pre-Award task)Progress reports are usually required annually as part of the non-competing continuation award process. The “Grant Progress Report” (PHS 2590) or equivalent documentation must be submitted to (and approved by) the NIH to non-competitively fund each additional budget period within a previously approved project period (competitive segment).
Invention ReportsInvention ReportsRegulations require that grantee organizations report all inventions to the awarding agency (see NIH Grants Policy Statement), as well as include an acknowledgement of federal support in any patents. Grantee organizations are expected to use the Web-based Interagency Edison system (iEdison). NIH funding recipients are expected to use this system to comply with the Bayh-Dole Act (P.L. 96-517) and related intellectual property reporting requirements. The Research Ventures and Licensing Office will file the reports in iEdison for all Partners inventions.
Final Invention StatementFinal Invention StatementWhen a grant is completed and no more funding is provided, or when a grant is transferred from one institution to another, a Final Invention Statement and Certification (HHS 568) is one of the required forms submitted to the NIH. For grants that are closing out, the Final Invention Statement and Certification can be submitted along with the other required closeout documents through the eRA Commons.
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Responsibilities of a Good StewardCloseoutCloseoutNIH closes out a grant as soon as possible after expiration if the grant will not be extended of if continued funding is not provided.
Closeout includes ensuring timely submission of all required reports and adjustments for amounts due the grantee or NIH. Closeout of a grant does not automatically cancel any requirements for property accountability, record retention, or financial accountability.
Following closeout, the grantee remains obligated to return funds due as a result of later refunds, corrections, or other transactions, and the federal government may recover amounts based on the results of an audit covering any part of the period of grant support.
Required closeout reports include:Required closeout reports include: • Final FSR
• Final progress report
• Final Invention Statement and Certification
• Final population tracking data when applicable
• These reports are due within 90 days of the end of grant support. Failure to submit timely and accurate final reports may affect future funding to the organization or awards with the same PD/PI.
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Responsibilities of a Good Steward
Record RetentionRecord Retention
Grantees generally must retain financial and programmatic records, supporting documents, statistical records, and all other records that are required by the terms of a grant, or may reasonably be considered pertinent to a grant, for a period of 3 years from the date the annual FSR is submitted.
For awards issued under the SNAP authorities, the three-year retention period is calculated from the date the FSR is submitted for the entire competitive segment.
Closeout may also affect the time period for retention of records by the grantee, because the three-year record retention period begins with the submission of the final FSR.
For more information, see 45 CFR Part 74.53 and 45 CFR Part 92.42, Retention and access requirements for records.
Also see the Partners Document Retention Policy which indicates a 7 year retention period (MA state retention period). This policy is found on the OGC site under Compliance & Business Integrity/Legal.http://library.partners.org/PartProd/webserver/custom/trovedemoframeset.asp?P2=1&w=1024&h=768&c=32&HU=EmptyURL
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No-Cost Extensions
• An NCE allows the PI to complete the scope of work without additional funding– Does not change the scope of work– Does not involve additional funding– Does need to be justified
• Extensions can be requested through NIH Commons for 1-12 month durations and are covered under expanded authorities
• 2nd no-cost extensions always require prior approval by NIH and require a more detailed scientific justification as well as a detailed budget.
• All extension requests require the following:– Unexpended funds remain on the award– Current conflict of interest forms– Current IRB / IACUC approvals in place
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COMPLIANCE
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An Introduction to Cost Sharing and Time & Effort
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Cost Sharing
• A commitment of Hospital resources or funding that supplements externally sponsored projects.
• Cost sharing occurs when effort exceeds the payroll charged to a particular project.
• These costs are not reimbursed by the sponsor (will not be charged to the sponsored project) and therefore must be supported by Hospital funds.
• If Cost sharing is included in a proposal (which would mean the Pre-Award staff collected a completed Cost Share form reflecting appropriate approvals), the form must be reviewed as part of the account set up process to ensure the account listed is still in good standing.
• Point to remember –– Always consider your funding mechanisms. Effort on a grant with science that is
related to a career development (K series award) or a training grant (T or F series award) can be paid from any one of these mechanisms and would not be considered a cost share.
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Overview: Definition of Effort Reporting
• What is effort reporting?– A means of verifying that appropriate salary and wage expenses were
charged to sponsored programs
– A means of verifying that cost sharing was performed as promised
– A means of verifying that total effort commitments were met
– A means of verifying an individual’s total commitments do not exceed 100%
• Why have effort reporting?– Labor related charges generally comprise the majority of direct research
costs
– To be consistent with other recipients of federal funds who have detailed and precise methods of verifying labor expenses
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Overview: Effort Reporting - Federal Requirements
45 CFR Part 74, Appendix E (OASC-3) Section IX.B.7 (Compensation for Personal Services)– Audience: Hospitals
– Effort reporting requirements:• After the Fact Activity Reports• Certification encompasses all employee activities• Certification to be performed by an individual with knowledge of all the
employee’s activities
– Time requirements:• Typically Monthly • Currently BWH and MGH are bi-annually
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Types of Effort• Sponsored Effort
– Effort for work conducted on sponsored projects, regardless of whether or not the sponsored project is paying for the work.
• Hospital Effort
– Effort for work conducted on behalf of the institution that does not involve an external sponsor.
– May not be supported by sponsored projects.
– Hospital Effort includes:
• Departmental and Hospital Administration and Support Services
• Hospital Supported Instruction/Teaching Activity
• Clinical Activities
• Other Partners Activities
• Affiliated Institutional Activities
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Institutional Clearances – Use of Animals in Research (IACUC)
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“Learning Objectives” – What do you want to learn about the compliant use of animals in research?
• Are there regulations covering the use of animals in research, similar to the regulations that govern the use of human subjects?
• Do PIs write a protocol or summary of how they will use animals?
• Is there an oversight committee?
• Do PIs who use animals have to go through any special training?
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Overview
• Regulations and Agencies Governing Animal Research
– Animal Welfare Act (AWA) of 1966 • United States Department of Agriculture (USDA)
– Health Research Extension Act of 1985 • NIH’s Office of Laboratory Animal Welfare (OLAW)
• Institutional Animal Care and Use Committee (IACUC)
– Role of the IACUC
– Animal Protocols
• Animal Facilities
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Animal Welfare Act (AWA)
• Animal Welfare Act– Signed in 1966– Only Federal law to regulate the care and use of animals in laboratory research
The AWA requires that minimum standards of care and treatment be provided for certain animals bred for commercial sale, used in research, transported commercially, or exhibited to the public.
– Other laws, policies, and guidelines may include additional species coverage or specifications for animal care and use, but all refer to the Animal Welfare Act as the minimum acceptable standard.
– Enforced by the U.S. Department of Agriculture, Animal and Plant Health Inspection Service (APHIS), Animal Care (AC).
– Regulations are published each year in Code of Federal Regulations, Title 9, Chapter 1, Subchapter A - Animal Welfare which is popularly known as 9 CFR.
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AWA – 9 CFR• Key items addresses in 9 CFR
– People – Responsibilities and functions of the following:• Principal Investigator• Institutional Animal Care and Use Committee (IACUC) – Responsible for
approving the Protocols and the specifics of a proposal in the use of animals• Institutional Official – The individual at a research facility who is authorized
to legally commit on behalf of the overall research program (in this case, they mean Drs. Bierer and Bringhurst).
• Attending Veterinarians for Research Facilities
– Programs – Requirements pertaining to the following:• Veterinarian program – requires at least one attending veterinarian• Training of research facility personnel• Site visits by APHIS• Reports, notifications, certifications, and record keeping
– Animals – Housing and care requirements• Housing and care requirements by species
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AWA Enforcement
• Animal Care (AC) conducts randomly scheduled, unannounced inspections to ensure that all regulated facilities comply with the law.
• If an inspection reveals deficiencies in meeting AWA standards and regulations, the inspector instructs the facility to correct the problems within a given timeframe.
• Failure to comply can result in very extensive fines and/or an order to stop the use of the animals.
• Sometimes institutions are put on probation and their use of animals is watched very closely until all deficiencies are addressed, corrected and re-evaluated.
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Office of Laboratory and Animal Welfare (OLAW)
• NIH’s Office of Laboratory and Animal Welfare (OLAW) implements the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy)
• The PHS Policy falls under the Health Research Extension Act of 1985 and applies to the use of live, vertebrate animals in any research activity supported or conducted by PHS.
• As part of the PHS Policy, all institutions must comply with the AWA in conducting research with animals.
• In carrying out its oversight responsibility, OLAW evaluates all allegations or indications of noncompliance with PHS policy, derived from any source.
• Each awardee institution is subject to review at any time by PHS staff and advisors, which may include a site visit, in order to assess the adequacy or accuracy of the institution's compliance the policy.
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PHS Policy• The PHS Policy addresses the following key topics:
– Animal Welfare Assurance• No activity involving animals may be conducted or supported by the PHS until the
institution conducting the activity has provided a written Assurance acceptable to the PHS, setting forth compliance with the PHS Policy.
– Guide for the Care and Use of Laboratory Animals • The PHS Policy requires institutions to use this Guide as a basis for developing and
implementing an institutional program for activities involving animals.
– Institutional Animal Care and Use Committee (IACUC)• Responsibilities and requirements of the IACUC including the approval and review of
PHS-conducted or supported research projects.
– Proposals and Awards• Requirements for applications and proposals (competing and non-competing) for
awards submitted to PHS that involve the care and use of animals.
– Reporting and record keeping requirements
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Institutional Animal Care and Use Committee (IACUC)
• Hospitals and all other entities conducting research with animal subjects must have or use an Institutional Animal Care and Use Committee (IACUC)
• Responsibilities of the IACUC include:– Reviews and approves protocols for the humane care and use of animals in
research – Inspects the animal facilities and investigator laboratories– Reports its findings to the Institutional Official (IO)
• Designated by the Hospital
• Multi-year awards requires annual re-approval
– Ensures compliance with federal regulations
• IACUC committee members– Majority are Hospital or University faculty appointed by the IO– May also include a member of the public– Serve on a rotating term (i.e. three years)– Meet regularly (i.e. monthly) to review and approve protocols
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Animal Protocols• Any research project involving animal subjects must have a protocol
approved by the IACUC
• PIs submit a proposed protocol to the IACUC outlining: – Procedures to be used in research…on the basis of relevance to human or
animal health, advancement of knowledge, or the good of society– Use of and justification of appropriate species, quality, and number of animals– Assurances to avoid/minimize discomfort, distress, and pain in concert with
sound science– Experimental end points– Provision of appropriate animal husbandry (housing, food, veterinarian care, etc.)– Listing of all trained personnel who will be working with the animals
• A grantee cannot activate an award until a protocol is approved by the IACUC
• Protocols vary in length (avg. 4-5 yrs), but must be reviewed annually by the IACUC, which may result in amendments
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Helpful Animal Use Links
• OLAW home page http://grants.nih.gov/grants/olaw/olaw.htm
• PHS Policy http://grants.nih.gov/grants/olaw/references/phspol.htm
• Guide for the Care and Use of Laboratory Animals http://www.nap.edu/readingroom/books/labrats/
• Animal Welfare Act 9CFR regulations http://www.aphis.usda.gov/ac/publications.html
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Introduction to the Protection of Human Subjects in Research
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Using Humans in Research at Partners
“The Partners Human Research Committee (PHRC) is the Institutional Review Board (IRB) of Partners Research Management. The PHRC must approve all human-
subject research conducted by a Partners-affiliated investigator.”
Established to protect the rights and welfare of human subjects of research
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Questions to be Answered Today
• What is Human Subjects Research? Where does it fit in within research administration?
• How and why does the government protect human subjects?
• What is the institution’s role in protecting human subjects?
• What has happened recently in the industry?
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Human Subjects Protection – the regulatory Definition
• A human subject means a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or identifiable private information
• Human-subject research is a systematic investigation designed to develop or contribute to generalizable knowledge where an investigator obtains data on individuals either through direct intervention/interaction or through the use of identifiable private information (medical records) or specimens
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Human Subjects ProtectionsPrivate Information and HIPPA
• Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place or will not be made public.
• Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
• HIPPA (The Health Insurance Portability and Accountability Act)
• Privacy Boards
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Human Subjects ProtectionRole of the Federal Government (HHS)
• Office for Human Research Protections (OHRP)
– Responsible for the oversight of compliance by awardee institutions with the HHS Regulation for Protection of Human Subjects
– Regulations are codified at 45 CFR Part 46
• Visit the OHRP website, http://ohrp.osophs.dhhs.gov.– List Special Populations to be considered, e.g. Children
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Human Subjects ProtectionRole of the Institution
• Assurances (Federalwide Assurance – FWA)– Written assurance filed with HHS that they will comply with federal regulations– Designation of an Institutional Review Board (IRB) – Documentation of IRB procedures
• Institutional Review Board (IRB)– Review and approve all research involving human subjects– Conduct reviews of research no less than once per year– Membership is regulated to include certain types of members
• Informed Consent– Documentation of knowing consent of an individual, or his/her legally authorized
representative– Must be approved by IRB– One of most important components of human subjects protections
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What is an IRB?
It can be confusing!
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IRB - Defined
• Made up of at least 5 individuals: one scientist, one non scientist, one individual who is not affiliated with the institution
• Typically based at a University, Academic Medical Center, or Hospital
• Established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated.
• Has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy
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IRB - Scope
• The Partners Human Research Committee (PHRC) is the Institutional Review Board (IRB) of Partners Research Management.
– The PHRC must approve all human-subject research conducted by a Partners-affiliated investigator.
– Research limited to the use of non-identifiable patient information may qualify for exemption from full IRB review, however all exemptions must be determined or granted by the Human Research Office.
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IRB Jurisdiction
• A few examples:• Medical records research• Survey and questionnaire studies• Studies using “left over” blood samples and tissue samples• Drug and device studies, clinical trials• Studies we do on each other (doctors, nurses, students, interns,
residents, fellows, staff – it’s not just patients)
• It is important note: the federal government has determined that if the institution and PI are the recipients of a grant that will fund human research, you’re “engaged” in human subjects research and thus responsible for IRB review and approval.
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Types of Review
• Expedited - one IRB member makes determination – Means the study meets the definition of minimal risk and specific
criteria laid out by the Feds
• Full – more than minimal risk – IRB meets as a group
• Exempt – at Partners, a single member of the IRB can make this determination – the PI is welcome to guess or suggest though
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Exemption
• Researchers may submit grant applications with IRB approval pending.
• PI may indicate that he/she believes the study will be found exempt.
• Not official until the IRB makes the determination and issues a letter
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Grant Applications
• Does the IRB need a copy of the grant?
• Do they need a complete copy?
• Even the budget?
• Why?
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Does the IRB need a copy of the grant?
• The regs say: An institution with an approved assurance shall certify that each application or proposal for research covered by the assurance and by §46.103 of this Policy has been reviewed and approved by the IRB
What does 46.103 really mean?
• It means the IRB must receive and review a complete copy of the grant – draft is okay if complete with budget, etc.
• It means the institution can (through grant cover pages) sign off to indicate that the grant was reviewed by the IRB who also approved the protocol.
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Why all this Grant business?
• OHRP says the IRB must be certain that the scope of work in the protocol is captured in the grant and any financial support is covered in the budget
– Remember, these regulations were initially written for federally funded studies.
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Grants and Protocols
• They do not require that the study titles match the grant titles
• They rely on their review and comparison between the grant and the protocol to confirm that the study and the grant are in conjunction
• eIRB and Info Ed are linked between funding and protocol information. – Pre-award sends a requests for a link to HPRC at JIT – After they’ve reviewed the grant and assured it is supporting the
study, they create the link. – When in doubt, you can always ask the HPRC staff
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International Collaborators• The regulators expect that when federal funding is involved our
regulations apply across the board– International site must have an FWA
– International site will almost always provide IRB review in conjunction with our IRB review
– They collect copies of these approvals
• What if the international site does not have an IRB?
– This is pretty rare these days. Most places have some sort of an Ethics review committee process or a US-style IRB. Additionally many if not all countries require that their Ministry of Health or similar body review human subjects research.
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CITI Training
• Researchers and staff from the BWH/MGH clinical research community are required to take the Basic Biomedical course.
• Refresher or re-certification is required every three years – this is true now across all Harvard affiliated hospitals
• PIs and others can easily log into CITI and produce their most recent completion certificate at any time– Plus, they now get automatic reminders when they are due for
re-certification
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Partners Human Research Quality Improvement Program
The QI Program provides support and education to the research community to ensure investigator compliance with federal, institutional, and Good Clinical Practice requirements.
Their staff provide the following to the research community:– Not-for-cause audits– For-cause audits– Assistance in study start-up– Educational In-Services– Assistance with FDA applications– Assistance with ClinicalTrials.gov Registration
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Quality Improvement Program
Why Audit? Is the site compliant with regulations, policies, and protocol? Has the site appropriately documented their work? Are there adequate systems in place?
For-cause vs. Not-for-cause What it takes to complete an audit
Preparation Audit Report Follow up
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Quality Improvement Program
How does the research community request QI Program services?• Complete the QI Service Request Form located on the home page
of their website
QI Program website is located at:
http://www.partners.org/phsqi/
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ClinicalTrials.gov - How do Investigators Register?
• The institutions have an account. Investigators set up profiles on this account.
• Currently done by Human Research Affairs– Administrator for logistics– QI Staff for questions re: applicability
• Investigators provide the following information to institutional administrator: – Username– Full name– Home institution– Email address.
• ClinicalTrials.gov sends an email to the investigator when study trial registration can begin.
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Institutional Oversight Committees
ESCRO
Embryonic Stem Cell Research
Oversight
No federal mandate or statute
IACUC
Institutional Animal Care and Use Committee
Per federal statute
IRB
Institutional Review Board
Per federal Statute
COMS
Committee on Microbiological Safety
IBC – Institutional Biosafety
Federal statute
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What embryos are used?
• It is against MA State law to create an embryo by fertilization for the sole purpose using it in research
• Embryos are from IVF patients who have provided consent. Researchers may use:
– Excess embryos no longer needed
– Abnormal embryos not suitable for implantation
– Embryos with genetic mutations
– Embryos created by Somatic Cell Nuclear Transplant (SCNT) – so-called “therapeutic cloning.
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Current PHS hESC Research
• Diabetes• Obesity• Cardiac disease• Parkinsons• ALS• Liver Disease• Bone growth/Blood vessel growth• Mechanisms of Cell differentiation
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Current PHS hESC Research
• Lab research using existing stem cells
• Animal research using existing stem cells
• Derivation of new stem cell lines using embryos donated by IVF patients
• Tissue Regeneration– Cardiac– Liver– Tooth
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Federal Laws and RegulationsObama Executive Order
• March 9, 2009 “Removing Barriers to Responsible Conduct of Research Involving Human Stem Cells”
• Revokes Bush Directive
• Allows federal funding of “scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent permitted by law.”
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Federal Laws and RegulationsNIH Guidelines and “Obama lines”
July 7, 2009 -- NIH Guidelines Issued
• Focus is on expenditure of federal funds• Two principles:
– Responsible research with hESC is good– Embryo donors should donate freely, with voluntary
and informed consent
• No mention of special oversight for the use of lines, e.g., ESCRO.
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Federal Laws and RegulationsNIH Guidelines and “Obama lines”
• A new NIH Registry is established.
• Not static, like Bush Registry. New hESCs that meet criteria of NIH Stem Cell Guidelines for ethical derivation can be added.
• “Bush lines” not grandfathered.”
• Currently 75 hESC lines listed on the new Registry – some with limitations.
• Grant application must cite specific hESCs from the Registry.
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PHS Finance PolicyAllocation of Funds
Equipment, Consumables and Effort
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PHS ESCRO Office
• Resource for investigators and other institutional committees
• Coordinates ESCRO Committee meetings
• Maintains a hESC registry
• Facilitates implementation of and compliance to PHS hESC policy
• Keeps abreast of regulatory developments and makes policy recommendations
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Take Home Message
If Human
Embryonic Stem Cells Are
Being Used:
CALL ESCRO Office!
Melinda Abelman 617-424-4171
Website: http://intranet.partners.org/pscr/index.html
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Questions?
Lynne Benoit 617-954-9663 [email protected]
Theresa Jerry 617-954-9589 [email protected]
© Partners HealthCare System, Inc., 2011
