NIH Proactive Compliance Site Visit Collaborative Training and Education Seminar Medical University of S.C. July 26, 2000 Compliance / Oversight NIH’s Compliance Program Gary Thompson Director, Division of Compliance OPERA 301-435-0934 email@example.com The Research Institution: Compliance It is not apparent that a culture of compliance is universally present in the biomedical research enterprise. Getting to Compliance: Our Objective is to… Move from Reactive Noncompliance to Proactive Compliance A Look at the NIH Budget... FY1999 BUDGET: $15.9 Billion Extramural Budget: $12.8 Billion 81% of NIH Total Grants $11.8 Billion 92% of NIH Extramural A further look at 1999’s total of $12.856B Ranking of ALL Institutions Top 5 $1.414B 11.0% Top 10 $2.493B 19.4% Top 15 $3.397B 26.4% Top 20 $4.173B 32.5% Top 25 $4.879B 38.0% 2,430 $12.856B 100% Characteristics and Principles of Compliance Leadership InstitutionalCommitment Zero Tolerance Focus on “high risk” events Why is Compliance important? It strengthens the relationship of trust that exists between sponsor and recipient It suggests a presence of the stewardship necessary to properly safeguard the Federal investment in biomedical research What’s happening at NIH... Personnel/Organizational changes in OPERA Division of Compliance Parallel with OHRP, OLAW, ORI and Grantees Institutionalassignments Incorporating compliance into the grant managers stewardship role From Not-for-Cause S-V’s to Proactive Compliance Site Visits N-F-C-S-V’s and PCSV’s JHU[1/1] 1010 $351M $255M UCSF [4/4] 778 $256M $218M HARVARD U.[8/19] 625 $217M $109M VANDERBILT[29/25] 393 $111M $94M OHSU*[34/29] 365 $103M $81M UTSWMC/D[35/21] 325 $102M $102M INDIANA U. [40/38] 345 $92M $71M U. ARIZONA[49/50] 252 $72M $43M U. MIAMI[50/42] 207 $72M $59M MUSC[84/60] 162 $37M $36M THESE 10 INSTITUTIONS ONLY 4462 $1.413M [11%] $1.068M [16%] ALL INSTITUTIONS/MED SCHOOLS $12.856M $6.562M NIH Proactive Compliance Site Visits GOALS: Increase Educational Outreach Enhance Administrative Oversight of Sponsored Research Renew Institutional Commitment to Compliance Receive feedback on obstacles to implementing Federal rules/NIH policies NIH Proactive Compliance Site Visits PURPOSE OF SITE VISIT: Assess level of understanding of certain NIH rules by discussing policies, procedures, and practices at recipient institutions to ensure compliance with NIH requirements NIH Proactive Compliance Site Visits THESE SITE VISITS... Are NOT audits Are NOT investigations May or may not result in a formal report Will deflect back to the institution any issues of concern that need to be addressed with the appropriate NIH organization Encourage institutional views and perspectives on ways to enhance coordination and communication between Federal and local oversight programs May contribute to the development of “best practices ” NIH Proactive Compliance Site Visits WHY THIS, WHY HERE, WHY NOW? This proactive effort is consistent with ongoing NIH compliance goals and objectives Another step in moving from “reactive noncompliance” to “proactive compliance” The Proactive Compliance site visit helps us to determine the congruency of our mutual understanding of certain administrative requirements Do we both understand the nature of the requirements the same way NIH Proactive Compliance Site Visits THE FIRST SERIES OF N-F-C SITE VISITS ADDRESSED: Roles and Responsibilities Training and Education Financial Conflict of Interest* Invention Reporting* Policies and Procedures for: Clinical Gene Therapy Research* Reporting Adverse Events in Clinical Trials* *Regulatory Proactive Grants Compliance: N-F-C S-V’s - Feedback... Constructive and helpful comments Open and responsive Positive assessment along with constructive suggestions for further improvement Positive experience Worthwhile and helpful to University efforts to address various compliance areas N-F-C S-V’s: Overall General Observations Begins process of moving from reactive to proactive Confirmed that Compliance is... an ongoing and dynamic process more likely to be present if it is established as institutional expectation Value added through... discussion of issues in a non-crisis, non-adversarial manner educational/outreach effort on 2nd day Site Visits build foundation of acquaintance and mutual trust Faculty resist notion of being “trained”… they want to be “educated” Presence of effective institutional oversight was not always evident NIH Proactive Compliance Site Visits Thewhole is greater than the sum of its parts... Observations from an individual site visit offer a limited view; however, there is significant value added with each subsequent site visit, especially when viewed cumulatively In this context... three offers more than one ten will offer more than three NIH Proactive Compliance Site Visits A culture of compliance is more likely to be present when communicated through an institutional commitment to… Excellence Prevention rather than treatment Quality Do the right thing Perform “Beyond Exceptional” NIH Proactive Compliance Site Visits NIH will conduct seven more site visits before 9/30/2000 Initial contacts have been made with all seven All seven are genuinely enthused about participating NIH will join with Institution in a collaborative Education and Outreach Seminar Institution would promote faculty and staff attendance… Attendees may receive training credit This will help meet NIH goals of: Increased Educational Outreach Renewed Institutional Commitment to Compliance It will also convey an important sense of mutual endeavor and a sense that NIH cares... Proactive Compliance Site Visits Theme: Institutional Oversight Roles and Responsibilities Training and Education Financial Management of Sponsored Projects Financial Conflict of Interest Inventions and Patents Data and Safety Monitoring Interactive Education/Outreach Seminar NIH Proactive Compliance Site Visit Institutional Commitment to Compliance Medical University of S.C. NIH Proactive Compliance Site Visit NIH OVERSIGHT Gary Thompson Increased scrutiny of NIH and what influences that scrutiny... Climate of Expanding Resources Demand for Stewardship Effective Use of the Publics Funds Accountability Integrity Trust EXPANDING RE$OURCE$ plus $4B from FY1998-2000 More $$ = More Congressional scrutiny scrutiny Chairman, Senate Budget Committee “closely monitor agency’s handling of increase” Lightning rod for oversight: Better accountability Assure the public and Congress that $$$ are well spent COMPLIANCE ISSUES Who’s looking and what they are Congress saying: Ordered independent audit administrative and management practices Asked IoM The highest oversight assess NIH’s decision- making process Challenged NIH Director scientific opportunity and administrative capacity American Association for the Advancement of Sciences when you spend public money you must be held accountable Sources of Compliance News media Issues Audits and reviews Whistleblowers or anonymous complaints Grants Management/Program Oversight OMA/NIH reviews Office of Inspector General oversight GAO audits DOJ investigations Institutional internal audits (A-133) 100 recent allegations: OIG 24%; NIH 32%; ORI 4%; Anonymous 11%; University 6%; Outside 23% NIH Proactive Compliance Site Visit Institutional Oversight Medical University of S.C. Administration/Science Partnership Diane Dean Kathleen Shino The NIH Extramural Management Team Review Grants Management Program Grants Management Officer The Grants Management Officer (GMO) is the NIH official responsible for the business management of the award, including but not limited to: evaluating grant applications for administrative content and compliance with statutes, regulations and guidelines negotiating grants providing consultation and technical assistance to applicants and grantees, including interpretation of grants administration policies and provisions administering and closing out grants Grants Management Officer The GMO is the only NIH official authorized to obligate NIH to the expenditure of funds or to change the funding, duration, or other terms and conditions of award Grants Management Specialist Analyzes grant application budgets and other grant related information Interprets Federal regulations and policies Awards grant funds Reviews and responds to grantee requests or identifies need for other grant changes Agent for the Chief Grants Management Officer Assures compliance with Federal regulations, policies and procedures Program Official The Program Official is the NIH official knowledgeable of the programmatic, scientific, and/or technical aspects of assigned applications and grants The Program Official is responsible for the scientific monitoring of the research Scientific Review Administrator Performs administrative and technical review of applications Selects reviewers Manages study sections and project site visits Prepares summary statements Provides any requested information about study section recommendations Point of contact for applicants The Management Team at Medical University of S.C. Authorized Institutional Official This official is the designated representative of the grantee organization in matters related to the award and administration of its NIH grants, including those that require NIH approval or changes in award terms and conditions The signature of the authorized institutional official is required for all official correspondence to NIH Authorized Institutional Official This individual's signature on the grant application further assures that the applicant organization will be accountable both for the appropriate use of funds awarded and for the performance of the grant-supported project or activities resulting from the application The authorized institutional official is accountable both for the appropriate use of funds awarded and for the performance of the grant-supported project or activities resulting from the application Principal Investigator The Principal Investigator (PI) is the member of the grantee team responsible for ensuring compliance with the financial and administrative aspects of the award NIH encourages the PI to maintain contact with the NIH Program Official with respect to the scientific aspects of the project NIH also encourages the PI to maintain appropriate contact with the Grants Management Officer concerning the business and administrative aspects of the award Principal Investigator The PI works closely with designated officials within the grantee organization to: create and maintain necessary documentation, including both technical and administrative reports prepare justifications ensure that Federal support of research findings is appropriately acknowledged in publications, announcements, news programs, etc. comply with organizational as well as Federal requirements What if I have a Question? Can my question be answered at my institution? Can my question be answered by written policy or regulations? Should my question be answered by an office at NIH? Should I call the Grants Management Specialist or Program Official indicated on the Notice of Grant Award? For Policy Questions IfI tried the above sources and still have a general policy question unanswered, call the Division of Grants Policy, Office of Policy for Extramural Research Administration (OPERA), 301-435-0949 Information Sources MUSC’s Office of Research and Sponsored Programs Notice of Grant Award (terms of award) NIH Grants Policy Statement NIH Guide for Grants and Contracts NIH Office of Extramural Research Homepage Welcome Wagon Letter Grants Information at firstname.lastname@example.org Administration for Faculty/PIs Diane Dean Kathleen Shino Greg Pryor Overlap Scientific Overlap occurs when: substantially the same research is proposed in more than one application or is submitted to two or more different funding sources for review and funding consideration, or a specific research objective and the research design for accomplishing that objective are the same or closely related in two or more applications or awards, regardless of the funding source Overlap Budgetary overlap occurs when duplicate or equivalent budgetary items are requested in an application but are already funded or provided for by another source Commitment overlap occurs when any project personnel has time commitments exceeding 100 percent Program Income Program income is gross income that is directly generated by the grant-supported activity or earned as a result of the award It can be earned by a grantee, a consortium participant, or a contractor under a grant Program Income Program Income includes, but is not limited to: income from fees for services performed use or rental of real or personal property acquired under the grant sale of commodities or items fabricated under an award license fees and royalties on patents and copyrights Program Income The requirements for accountability of program income are stated in the terms of award Unless otherwise specified in the terms and conditions of the award, NIH grantees are not accountable for program income accrued after the period of grant support Change in Scope Change in Scope is a change in direction, type of training, or other areas that constitute a significant change from the aims, objectives, or purposes of the originally approved project Change in Scope Requires Prior Approval Actions likely to be considered a change in scope include, but are not limited to, the following: Change in the specific aims approved at the time of award. Substitution of one animal model for another. Any change from the approved use of animals or human subjects. Shifting the research emphasis from one disease area to another. Applying a new technology; i.e., changing assays from those approved to a different type of assay. Transferring the performance of substantive programmatic work to a third party through a consortium agreement, by contract, or any other means. Change in Scope Requires Prior Approval Actions likely to be considered a change in scope (cont’d): Change in key personnel whose expertise is critical to the approved project Significant rebudgeting whether or not the particular expenditure(s) requires prior approval Incurrence of patient care costs if not previously approved by NIH or if a grantee desires to rebudget additional funds into or rebudget funds from the patient care category. Expanded Authorities Provisions Extension of project period without additional funds Carryover of unobligated balances Additive cost alternative for use of program income Waiver of certain cost-related prior approvals Preaward costs Prior Approval Change in Status, Including Absence of PI and Other Key Personnel Must notify NIH if the PI or other key personnel named in the NGA will: withdraw from the project entirely be absent 3 months or more reduce time devoted to the project by 25% or more Must request approval of a substitute PI/key person Must notify the awarding office GMO in writing if grantee wishes to terminate because it cannot make suitable alternate arrangements Prior Approval Change of Grantee Institution Required for the transfer of a grant-supported project from one institution to another Request must include: Relinquishing Statement Final Invention Statement and Certification Grant Application (PHS 398) from the proposed grantee All permanent benefits attributable to the original grant can be transferred, including equipment NIH may request additional information Prior Approval Restrictions on NGA Deviations from special terms or conditions stated in the NGA or from the terms and conditions included in the NIH Grants Policy Statement Activities disapproved or restricted as a condition of the award A Rule of Thumb Whenever you are contemplating rebudgeting or other postaward changes and you are uncertain about the need for prior approval, consult, in advance, with: MUSC Office of Research and Sponsored Programs Written policies and regulations NIH awarding component GMO Closeout Final Reports Failure to submit timely final reports may affect future funding to the organization Final Financial Status Report (FSR) Final Invention Statement and Certification Final Progress Report Grants Questions? Diane Dean Assistant Grants Policy Officer, Office of Policy for Extramural Research Administration, OER, NIH 301-435-0930 email@example.com Kathleen Shino Grants Management Specialist, National Cancer Institute, NIH 301-496-8635 firstname.lastname@example.org Contracts, Grants and Cooperative Agreements Grants and Cooperative Agreements are forms of “assistance:” With Grants the Government is a PATRON With Cooperative Agreements the Government is a PARTNER Contracts, however, are for “acquisition:” And the Government is a PURCHASER What about Contracts? A legal instrument Purpose of the transaction is to acquire goods or services for the direct benefit or use of the Government Government-initiated Statement of Work Government identifies evaluation criteria Government requires competition Anything else? The Government Project Officer is responsible for monitoring the technical aspects of the work In a cost-reimbursement contracting regular financial reporting is critical to monitoring progress and performance as well as expenditures Contracts Questions? TALK to your cognizant Contract Specialist or Contracting Officer Greg Pryor Procurement Analyst Division of Acquisition Policy and Evaluation Office of Acquisition Management and Policy OD, NIH 301-496-3432 email@example.com Financial Management of Sponsored Projects Michael D. Payne What is Financial Management? Means different things to different people Responsible accounting, monitoring and reporting of sponsored project expenses Why Financial Management? (continued) Accountable to: taxpayers congress Getthe most research for the funds provided Why Financial Management? (continued) Good financial management ensures that: grant/contract funds are expended for their intended purpose only reasonable, allowable, allocable and consistently applied (direct/indirect) expenses are charged to sponsored projects Why Financial Management? (continued) Most NIH awards provide for cost reimbursement (as opposed to fixed price) arrangements What does Cost Reimbursement Mean? Reasonable, allowable, allocable and consistently applied costs will be reimbursed based on actual costs incurred Includes F&A costs reimbursed based on negotiated rate agreement Accounting Separate account for each project Costs charged in accordance with the cost principles (A-21), GPS, A-110, CAS, NGA/contract document Good source documentation Accounting (continued) Program Income identified Cost sharing accounted for NIH salary rate limitation not exceeded Monitoring Good oversight of project expenses Compare actual expenses with budget Cash draw downs consistent with budget Monitoring (continued) Prior approvals obtained when necessary Minimal cost transfers Good oversight of subrecipient expenses Reporting Accuratereporting of project costs to appropriate sponsors Timely reporting of project costs Timely close out of expired grants/contracts What‟s at Risk? Audit Findings/Cost Disallowances/Refunds Special Terms and Conditions on NGAs Requirement for Corrective Action Plan What‟s at Risk? (cont.) Special Monitoring by NIH Temporary Withholding of Payments Withholding of Future Awards Possible criminal/civil/administrative penalties in cases of fraud Recommendations Read and understand the award‟s financial terms and conditions Read and understand Federal and University policies Read and understand cost principles A-21 Work with University‟s ORSP and NIH‟s grant/contract officials Conclusion Mutual benefit to have in place good financial management systems and policies and procedures that are consistently followed We‟re here to work with you on a proactive basis to help you achieve/maintain outstanding financial management of sponsored projects Questions? Michael D. Payne Director, Division of Financial Advisory Services Office of Acquisition Management and Policy, OD, NIH 301-496-4401 firstname.lastname@example.org Financial Management of Sponsored Projects The Institutional Perspective... Conflict of Interest Greg Pryor The Regulations For Grants: 42 CFR Part 50 Subpart F “Responsibility of Applicants for Promoting Objectivity in Research” For Contracts: 45 CFR Part 94 “Responsible Prospective Contractors” Involves: PHS $, Research and Investigators These Regs. do not apply to Phase I SBIR & STTR Conflict of Interest Regulations Regulations which promote Objectivity in Research by requiring the establishment of Institutional Standards to: Ensure there is no reasonable expectation that design, conduct or reporting of PHS funded research is biased by a conflicting financial interest of an Investigator. Conflict of Interest Regulations - Overview - What the regulations require. Who is affected by the regulations. Where the regulations are intended to operate. How the regulations are supposed to operate. C.o.I. Overview Topics The BIG Picture Key Vocabulary: 4 Definitions in the Regs. Seven + components/requirements of the regulations Institutional actions to Manage, Reduce or Eliminate C.o.I. What PHS can do in cases of noncompliance with the regulations C.o.I. - The BIG Picture since 10/1/95: Institutions Must: Maintain a written, enforced Financial C.o.I. Policy for Research Investigators Inform Investigators of the Policy, the Reporting Responsibilities and the Regulations Report to awarding offices (NIH I/Cs) the existence of C.o.I.s and how the C.o.I.s are M.R.E.ed C.o.I. Vocabulary 1. Investigator: P.I. and Anyone Responsible for the Design, Conduct or Reporting of PHS Funded Research. Includes Investigator’s Spouse & Dependent Children for Reporting Financial Interests. (PHS includes: NIH, FDA, CDC, etc.) 2. Significant Financial Interest (SFI): Anything of Monetary Value. But note Numerous Important Exclusions listed in the Regulations! (generally any remuneration from the applicant organization is excluded from the definition of SFI) C.o.I. Vocabulary (Continued) 3. Financial Disclosure Statement : A Listing of Investigators‟ SF Interests and those of her/his spouse and dependent children: (i) that would be affected by the research; and (ii) in entities whose financial interests would be affected by the research. (e.g., stocks) Financial Disclosure Statements: Are to be updated annually or as new SFIs occur C.o.I. Vocabulary (Continued) 4. Conflict of Interest: Exists when the Institutional Designated Official reasonably determines that a S.F.I. could Directly & Significantly affect the design, conduct or reporting of the PHS funded research. The Seven + Institutional Requirements (the Process) 1. Maintain an Enforced, Written C.o.I. Policy which complies with the regulations. 2. Designate an Official (D.O.) to solicit & review Financial Disclosure Statements from Investigators planning to participate in the research. 3. By the time of application submission assure that the D.O. has received Financial Disclosure Statements from Investigators. The Seven Institutional Requirements (the Process - continued) 4. Provide the D.O. with guidelines to identify C.o.I.s & take appropriate action to Manage, Reduce or Eliminate them 5. Maintain records of all Financial Disclosure Statements & Institutional actions regarding each C.o.I. 6. Establish enforcement mechanisms & provide sanctions where appropriate. 7. Certify to 1.- 6. Above in each application. The Seven+Institutional Requirements (the Process-continued) 7. A. Report to the awarding component (NIH I/Cs) C.o.I.s prior to spending funds under an award and M.R. or E. the C.o.I. (No details sent to NIH at this point) 7. B. Upon request from awarding component, must make information available re. all C.o.I.s & how C.o.I.s have been M.R. or E.ed. 7. C. Otherwise comply with the regulations. Managing, Reducing or Eliminating Financial Conflicts of Interests at the Institution (These are examples offered in the Regs.) Institutions may: Publicly Disclose the S.F.I. (most common) Monitor research by independent reviewers Modify research plan Divest the S.F.I. Sever relationship(s) that create conflict(s) When Failure to Comply has Biased Design, Conduct or Reporting of Research Institution must promptly notify awarding component of corrective action taken or to be taken. Awarding component may take action or refer back to the Institution for further action perhaps with directions about what to do. Awarding component may review all records pertinent to compliance & may determine to suspend funding until the matter is resolved. In the Case of Biased Clinical Research to Evaluate the Safety, or Effectiveness of a Drug, Medical Device or Treatment TheInstitution must require the investigator(s) involved to disclose the conflicting interest in each public presentation of the results of the research. (This is a legislative requirement) Summary 42 CFR Part 50 Subpart F - Grant 45 CFR Part 94 - Contracts Since 10/1/95 Institutions must maintain a written, enforced C.o.I. policy for Research Investigators Investigators, S.F.I.s, F.D.S.s, C.o.I. 7+ Institutional requirements Institutional Activities to M.R. or E. C.o.I. Future $CoI Developments On 8/15-16/00 HHS will hold public discussions in at the NIH to determine new ways to manage CoIs so that research subjects are appropriately informed and to further ensure that research results are analyzed and presented objectively How $CoI is dealt with as it affects researchers, IRB members and Institutions will be discussed Expecting 600 attendees See http://aspe.hhs.gov/sp/coi/index.htm Where to get More Information Frequently asked questions re. C.o.I.+ the regulations appear in 7/3/96 Federal Register http://www.nih.gov/grants/policy/coifaq.htm Greg Pryor Phone (301) 496-3432; Fax (301) 402-1199 email@example.com Division of Acquisition Policy and Evaluations, Office Acquisition Management and Policy, Office of the Director, NIH Conflict of Interest The Institutional Perspective... Extramural Intellectual Property: Invention Reporting Policy and Procedures George Stone, Ph.D. Stewardship of Federal Funds How funds will be expended Fiscalmanagement Programmatic assessment How research will be conducted Research integrity Conflict of interests How research outcomes will benefit the public (both directly and indirectly) Encourage application of intellectual property Share outcomes to spawn new research ideas Government-Supported Intellectual Property…pre-1980 Any intellectual property derived through Federal funding agreements could be claimed by the Government F.A.R. 52.227-13 Not uniformly exercised across the Government Result = no commercialization/application incentive Bayh-Dole Act Of 1980 Gave Grantee Organizations/Contractors Title to Inventions Arising From Federal Funding Agreements Required pursuit of tech. transfer opportunities Government retains license to practice the invention Result = Commercialization/application of Federally funded inventions Implementation of Bayh-Dole: 37 Code of Federal Regulations, Section 401.14 Defines Terms, Parties Prescribes Order of Disposition of Rights Grantee org. Gov‟t. Inventor(s) Prescribes Chronology of Reporting Requirements for Grantee/Contractor Organization http:/iedison.gov/timeline.html Prescribes Basis for & Extent of Government Action to Retain Rights Grantee/Contractor Organization Responsibilities in Invention Reporting NIH Grants Policy Statement - Section II: Administrative Requirements (per 37CFR, 401.14) Organization to Implement Employee Agreements Investigator to relinquish rights Investigator to report “subject” invention(s) in timely way as needed (review annually) Organization to disclose each invention within 60 days of reporting by investigator Organization to Resolve Title within 2 years Organization to File Patent within 1 yr. of election NIH Grantees/Contractors Responsibilities…cont. Organization to Provide License to the Govt. upon title election Organization to indicate Govt. Support on Patent with patent appl. Organization to share royalties with inventor(s) when available Organization to ensure Small Businesses given preference in licensing where feasible Organization to ensure Product Manufacturing in U.S. required unless by waiver NIH Responsibilities in Invention Reporting 37 CFR, Section 401.14 Maintain Confidentiality for Benefit of Grantee/Contractor/Inventor Ensure Government License to Invention Include Patent Rights Clause (by reference) in All Funding Agreements Require Periodic Reporting On Utilization Facilitate Transfer of Technology GrantPermission For Assignment of Rights Waive Requirement For U.S. Manufacture NIH Responsibilities…cont. Ensure Equal Access to Intellectual Property “March In” to Provide License to Responsible Applicant Restrict Title In Exceptional Circumstances Encourage wide distribution of Research Tools Ensure Compliance of 37CFR;401.14 Oversight of Grantee Organization Reporting Education of Grantee Organization Community Didactic Content to inform investigators & grantee/contractor organizations 37CFR 401 Invention Policy Issues Invention Reporting Procedures/forms Submission of Invention Report Records via Secure, Interactive Web-Based System Production Deployment - Oct. „97 Single interface to report inventions sponsored by 13 Federal agencies IEdison url = http://www.iedison.gov Examples of Research Tools Useful In Commercial Applications D2 dopamine receptor screening Immortalized liver cells disease model ERKO mice screening basement membrane reagent sales G protein antibodies reagent sales HIV protease screening NIH Director‟s Working Group Recommendations For NIH Promote free dissemination of research tools without legal entanglements Further use of UBMTA Develop guidelines for extramural MTAs and licensing Review and strengthen current policies Establish “research tools forum” New Guidelines For Recipients Of NIH Grants & Contracts Guidelines published in Federal Register Vol. 64, #100, pp. 28205-28209 (May 25, 1999) Principles for: ensuring academic freedom and publication minimizing administrative impediments implementing Bayh-Dole Act disseminating research resources Sources Of Information On NIH Research Tools And Policy NIH Director‟s Forum - www.nih.gov/welcome/forum/ Working Group Report - www.nih.gov/news/researchtools/index.htm Research Tool Guidelines - www.nih.gov/od/ott/RTguide.htm NIH Office of Technology Transfer - www.nih.gov/od/ott Questions? George Stone, Ph.D. Chief, Extramural Inventions and Technology Resources Branch, Office of Policy for Extramural Research Administration, NIH 301-435-0679 firstname.lastname@example.org Data and Safety Monitoring of Clinical Trials Dennis O. Dixon, Ph.D. Data and Safety Monitoring of Clinical Trials -- Background Stop any trial as soon as objectives have been met Avoid exposure of volunteers to excessive risk Data and Safety Monitoring of Clinical Trials – Recent Changes All NIH-supported trials require monitoring (6/98) IRBs must be notified of the outcomes of data and safety monitoring board reviews (6/99) All trials need to follow monitoring plans (6/00) Data and Safety Monitoring of Clinical Trials – Some Approaches Independent Board, explicit guidelines Internal committee Designated medical monitor Data and Safety Monitoring of Clinical Trials – Scope of Reports Recent and cumulative enrollment and retention Data collection and quality control Summary of toxicity and interpretation Summary of treatment responses and interpretation Data and Safety Monitoring of Clinical Trials – IRB Role Determine which research activities require continuing review more frequently than every 12 months Review progress reports submitted by investigators Questions? Dennis O. Dixon, Ph.D. Chief, Biostatistics Research Branch Division of Acquired Immunodeficiency Syndrome National Institute of Allergy and Infectious Diseases, NIH 301-496-0694 email@example.com Intellectual Property: Invention Reporting Policy and Procedures The Institutional Perspective... NIH Proactive Compliance Site Visit Risks Associated with Noncompliance The NIH Perspective... False Claims Act / Qui Tam False Claims Act (FCA) Allows an individual, known as the “relator” to file suit on behalf of the US alleging that false or fraudulent claims have been submitted to the government. The government has a period of time to investigate the allegations to determine whether to take over the suit or to allow the relator to pursue it alone. Qui Tam (a provision of FCA) Persons who file qui tam suits may recover from 15 to 25% of the settlement or judgment if the US litigates the case, or up to 30% if they pursue it on their own. Since the FCA was amended in 1986, the number of qui tam suits have risen from 33 (1987) to 534 (1997) Whistleblowers have received about $300M with additional awards pending. RISKS ASSOCIATED WITH NONCOMPLIANCE: What can grantees lose? Administrative economies and privilege Confidence Credibility Monetary considerations Respect Self-determination Trust COMPLIANCE ISSUES Risky Business... From the Chronicle of Higher Education: for falsifying information on a Federal grant application (listing of corporate sponsors) Professor at UW- Madison 3-months jail sentence $10,000 fine Possible Implications of Noncompliance: Corrective Actions Special Terms and Conditions of Award Loss of Expanded Authorities Cost Disallowance Suspension/Termination of Award Improved Systems and Policies NIH Proactive Compliance Site Visit Risks Associated with Noncompliance: The Institutional Perspective NIH Proactive Compliance Site Visit To receive credit for attending this seminar you must have registered… did you?
Pages to are hidden for
"Compliance"Please download to view full document