Building an Effective

1
Building an Effective Compliance Program
Gretchen A. Brodnicki, J.D. Director of Research
Compliance Partners HealthCare System,
Inc. Patrick Fitzgerald Associate Dean, Research
Administration Harvard University
NCURA Region I Meeting
May 4, 2008
2
Todays Agenda

• Whats Research Compliance?
• Whats the Big Deal?
• The U.S. Sentencing Guidelines,
• Compliance Guidance and Developing
• a Research Compliance Program
• Compliance Hot Potatoes
• Research Compliance and Lab Safety

2
3
Whats Research Compliance?
Scientific Integrity Principle Ensures validity
of results/ Maximizes return on public
investment Conflict of Interest Conflict of
Commitment Research Integrity Data, Resource
Sharing, Cyber Security Public Access to
Publications
Welfare of Subjects and the Environment Principle
Provides safety/welfare of subjects and
environment Human Subjects Animal
Welfare HIPAA Environmental Health
Safety Select Agents Radiation Access
Cost Policy/ Financial Management Principle Ensur
es fair and reasonable costs to the
Government Cost Principles Salary Charges/Effort
Reporting Indirect Costs Cost Sharing Clinical
Trials Billing
Social and Political Requirements Principle Meets
National Social, Economic, Security
Interests SEVIS/Visas Export Controls Race,
Gender Handicap Equality and
Education Lobbying Debarment Drug Use
Adopted with permission from Geoff Grant
4
A Day in Our Lives

• Conflicts of Interest
• Gifts
• Vendor Relationships
• HIPAA
• Professional Behavior

• Grants Management
• Time Effort
• Cost Sharing
• Cost Transfers
• Grant Preparation
• Post Award
• Subcontract
• Ts, Ks, (ABCs)

4
5
A Day in Our Lives

• IRB
• Quality Assurance
• Data Monitoring
• INDs/IDEs/HDEs
• Informed Consent
• Scientific Misconduct
• Billing
• Coding
• Contracting

• Good Clinical Practice
• Federal Wide Assurance
• AAHRPP
• IACUC
• Lab Safety
• DHS
• BPHC
• Fire Department
• State

6
Whats the Big Deal?

• The False Claims Act
• Used to protect public against abuse and fraud in
  government contracts.
• Violations
• Knowingly submit
• Deliberately ignorant
• Recklessly disregard
• Consequences
• Triple Damages
• Suspension/Disbarment
• Criminal Charges
• Qui Tam

7
Whats the Big Deal?

• Investigations Settlements
• BIDMC 1999 (920K) 2004 (with Harvard)
  (3.3M)
• Northwestern 2003 (5.5M)
• Johns Hopkins/Bayview Med. Ctr 2004 (2.6M)
• U. of Alabama Birmingham 2005 (3.4M)
• Mayo Foundation 2005 (6.5M)
• Weill Med. College of Cornell 2006 (4.4M)
• U. of Connecticut 2006 (2.5M)
• U.S v. Poehlman - 2006
• Yale 2006 (ongoing)

8
What Happened?

• Nothing that couldnt happen anywhere else
• Good people misguided as to how to do the right
  thing
• Documentation, documentation, documentation

9
Research Compliance Program

• Arises from federal statutes and regulations
• Dedicated to aiding employees, investigators and
  the organization to do the right thing
• Helps maintain our focus in the midst of everyday
  pressures

10
Developing an Effective Research Compliance
Program

• United States Sentencing Commission - USSC 8A1.2
• Guidelines developed for mitigation of fines and
  penalties
• Became basis of all compliance programs
• OIG Hospital Compliance Guidance
• Federal Research Compliance Guidance coming soon!

11
Research Compliance Program The Partners Model

• Conforms with U.S. Sentencing Guidelines OIG
  Compliance Guidance for Hospitals
• Complements existing Partners and entity-based
  activities
• Complements activities of partners in the
  Research Enterprise

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Developing an Effective Research Compliance
Program

• 1. Written Policies and Procedures
• PHS Hospital Codes of Conduct
• PHS Policies
• Also Consider
• Guiding Principles for Researchers
• Guiding Principles for Management
  Administration of Sponsored Projects

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Developing an Effective Research Compliance
Program

• 2. Designate Compliance Officer and Compliance
  Committee
• PHS Office of Compliance Business Integrity
• (its not just about compliance!)
• PHS Audit Compliance Committee
• Hospital Compliance Committees

14
Research Compliance Program

• Structure
• PHS Director of Research Compliance
• Reports to PHS Director of Corporate Compliance
• Dotted Line Reporting to PHS Chief Academic
  Officer
• Research Compliance Associates for BWH/MGH
• Report to Hospital Compliance Officers
• Dotted Line Reporting to PHS Director of Research
  Compliance
• Research Compliance Committee
• Annual Report to PHS Audit Compliance Committee

15
Developing an Effective Research Compliance
Program

• 3. Conduct Effective Training and Education
• For all Research Staff
• Central Administrative Staff
• Department Administrators
• AND especially, INVESTIGATORS!

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Developing an Effective Research Compliance
Program

• 4. Effective Lines of Communication
• Confidential Help Line
• Non-Retaliation Policy
• Its not enough
• Culture
• Leadership
• Accessibility

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Developing an Effective Research Compliance
Program

• 5. Internal monitoring/auditing
• Internal Audit Program
• Grants Management
• Clinical Trials Billing
• Q/A in Clinical Trials
• For Cause
• Not-for cause
• Risk Assessment

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Developing an Effective Research Compliance
Program

• 6. Enforcing standards through disciplinary
  guidelines
• Legal Violations
• Policy Violations
• Action

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Developing an Effective Research Compliance
Program

• 7. Responding promptly/corrective action
• Detect
• Investigate
• Act

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Compliance Cycle
Policies/Procedures
Modify
Educate/ Train
Follow-up
Implementation
21
Compliance Cycle
Policies/Procedures
Plan
Act
Modify
Educate/ Train
Follow-up
Do
Study
Implementation
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Relationship Matrix
RVL/CSCR
Finance/ Patient Accounts
Research Management
IRBs (Partners, entities)
IACUCs
EHS
IBCs
ESCRO
Radiation Safety
Human Resources
Institutional Officials
OGC
Research Compliance Program
Relationships
Responsibilities
Designation of Compliance Officer(s) Responsible
for Research
Development Of Policies and Procedures
Enforcing Standards
Prompt Response Corrective Action
Communication/ HelpLines
Monitoring Auditing
Education And Training
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FY 07 HHS OIG Work Plan

• Cost Transfers
• Level of Commitment and Effort Reporting
• NIH Monitoring of Extramural Conflict of Interest
• University Administrative and Clerical Salaries
• Monitoring of NIH Research Grants
• Compensation of Graduate Students Involved in
  NIH-Funded Research

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HHS OIG FY08 Work Plan

• General Observations
• Increased emphasis on select agents,
  bioterrorism, and emergency preparedness
• Less emphasis on effort reporting, cost transfers
• Much greater emphasis on conflicts of interest,
  scientific misconduct

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HHS OIG FY08 Work Plan

• Specific Areas of Note
• Conflict of Interest
• Internal to NIH staff
• NIH - Extramural Affairs NIH Handling
• FDA Clinical Investigators
• Scientific Misconduct
• FDA Oversight and Action
• NIH Handling of Ethical Misconduct Related to COI
• Grants Management
• NCI Monitoring, Compliance with Cost Principles
• OHRP Review
• NIH Oversight of DSMBs

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Recently Adopted Policies
What Can We All Do

• Policy on Interactions with Pharmaceutical and
  Medical Device Companies (the P/D Policy new)
• Code of Conduct and Conflicts of Interest Policy
  (small revisions)
• Partners Policy on Consulting and Other Outside
  Activities
• All are available on Partners Policies and
  Procedures (PPP) site
• http//library.partners.org/PartProd/webserver/cus
  tom/trovedemoframeset.asp?HUhttp//www.partners.o
  rgP21w1024h768c32

• Understand the law
• Ask Questions
• Do the Right Thing
• Document, Document, Document

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Ostriches may feel safe
Ostriches may feel safe
but, they don't live longer!
but, they don't live longer!
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If You Build It, They Will Come!
Adopted with permission from Lynette Schenkel,
Director, Responsible Conduct of Research,
University of Oregon
29
Recently Adopted Policies
If You Build It

• Policy on Interactions with Pharmaceutical and
  Medical Device Companies (the P/D Policy new)
• Code of Conduct and Conflicts of Interest Policy
  (small revisions)
• Partners Policy on Consulting and Other Outside
  Activities
• All are available on Partners Policies and
  Procedures (PPP) site
• http//library.partners.org/PartProd/webserver/cus
  tom/trovedemoframeset.asp?HUhttp//www.partners.o
  rgP21w1024h768c32

• Circumstances of your hire
• For what are you responsible, who are you?
• With whom do you need to interact?
• With what committees do you need to work?
• Policy-Process-People
• Major Milestones

Adopted with permission from Lynette Schenkel,
Director, Responsible Conduct of Research,
University of Oregon
30
Recently Adopted Policies
Proactive or Reactive Hire?

• Policy on Interactions with Pharmaceutical and
  Medical Device Companies (the P/D Policy new)
• Code of Conduct and Conflicts of Interest Policy
  (small revisions)
• Partners Policy on Consulting and Other Outside
  Activities
• All are available on Partners Policies and
  Procedures (PPP) site
• http//library.partners.org/PartProd/webserver/cus
  tom/trovedemoframeset.asp?HUhttp//www.partners.o
  rgP21w1024h768c32

• Hot situation with which to deal?
• Settlement
• Audit
• Nasty News
• Catalyzing Events
• Culture

Adopted with permission from Lynette Schenkel,
Director, Responsible Conduct of Research,
University of Oregon
31
Recently Adopted Policies
Who Are You?

• Policy on Interactions with Pharmaceutical and
  Medical Device Companies (the P/D Policy new)
• Code of Conduct and Conflicts of Interest Policy
  (small revisions)
• Partners Policy on Consulting and Other Outside
  Activities
• All are available on Partners Policies and
  Procedures (PPP) site
• http//library.partners.org/PartProd/webserver/cus
  tom/trovedemoframeset.asp?HUhttp//www.partners.o
  rgP21w1024h768c32

• Scope of Responsibilities
• Human Subject Research
• Animal Research
• Safety (Coordinate with EHS)
• Chemical/Biological
• Export Control/Select Agents
• Conflicts of Interest/Commitment
• Possible Misconduct (Research Integrity Officer)
• Monitoring (Internal Auditing)
• Institutional Official

Adopted with permission from Lynette Schenkel,
Director, Responsible Conduct of Research,
University of Oregon
32
Recently Adopted Policies
With Whom Do You Interact?

• Policy on Interactions with Pharmaceutical and
  Medical Device Companies (the P/D Policy new)
• Code of Conduct and Conflicts of Interest Policy
  (small revisions)
• Partners Policy on Consulting and Other Outside
  Activities
• All are available on Partners Policies and
  Procedures (PPP) site
• http//library.partners.org/PartProd/webserver/cus
  tom/trovedemoframeset.asp?HUhttp//www.partners.o
  rgP21w1024h768c32

• Responsibility Matrix
• Identifies individuals
• Delineates who has
• Responsibility
• Support
• Authority
• Information
• Think about office that may not be represented by
  individuals on your matrix
• Operational versus Event Compliance

Adopted with permission from Lynette Schenkel,
Director, Responsible Conduct of Research,
University of Oregon
33
Recently Adopted Policies
Committees and Your Role

• Policy on Interactions with Pharmaceutical and
  Medical Device Companies (the P/D Policy new)
• Code of Conduct and Conflicts of Interest Policy
  (small revisions)
• Partners Policy on Consulting and Other Outside
  Activities
• All are available on Partners Policies and
  Procedures (PPP) site
• http//library.partners.org/PartProd/webserver/cus
  tom/trovedemoframeset.asp?HUhttp//www.partners.o
  rgP21w1024h768c32

• IRB
• IACUC
• IBC
• Lab Safety
• Radiation Safety
• Conflict of Interest/Commitment Committee (COICC)
• Research Integrity

Adopted with permission from Lynette Schenkel,
Director, Responsible Conduct of Research,
University of Oregon
34
Recently Adopted Policies
Committees and Your Role

• Policy on Interactions with Pharmaceutical and
  Medical Device Companies (the P/D Policy new)
• Code of Conduct and Conflicts of Interest Policy
  (small revisions)
• Partners Policy on Consulting and Other Outside
  Activities
• All are available on Partners Policies and
  Procedures (PPP) site
• http//library.partners.org/PartProd/webserver/cus
  tom/trovedemoframeset.asp?HUhttp//www.partners.o
  rgP21w1024h768c32

• Ex officio by virtue of the office
• Generally
• Non-voting
• Advisory
• Committee administrative staff
• Investigator (sleuth)

Adopted with permission from Lynette Schenkel,
Director, Responsible Conduct of Research,
University of Oregon
35
Recently Adopted Policies
Policy, Process, People

• Policy on Interactions with Pharmaceutical and
  Medical Device Companies (the P/D Policy new)
• Code of Conduct and Conflicts of Interest Policy
  (small revisions)
• Partners Policy on Consulting and Other Outside
  Activities
• All are available on Partners Policies and
  Procedures (PPP) site
• http//library.partners.org/PartProd/webserver/cus
  tom/trovedemoframeset.asp?HUhttp//www.partners.o
  rgP21w1024h768c32

• Policies Equal Authority
• Statutes
• Regulations
• Directives
• Standard Operating Procedures
• All receive the same treatment
• What/how many people do you need to carry out
  your responsibilities

Adopted with permission from Lynette Schenkel,
Director, Responsible Conduct of Research,
University of Oregon
36
Recently Adopted Policies
Major Milestones Six Months

• Policy on Interactions with Pharmaceutical and
  Medical Device Companies (the P/D Policy new)
• Code of Conduct and Conflicts of Interest Policy
  (small revisions)
• Partners Policy on Consulting and Other Outside
  Activities
• All are available on Partners Policies and
  Procedures (PPP) site
• http//library.partners.org/PartProd/webserver/cus
  tom/trovedemoframeset.asp?HUhttp//www.partners.o
  rgP21w1024h768c32

• Compliance Assessment
• High risk areas/vulnerabilities
• Policies
• Infrastructure
• Necessary personnel
• Budgets/goals
• Introduce yourself explain your function
• Find your faculty and administrative advocates

Adopted with permission from Lynette Schenkel,
Director, Responsible Conduct of Research,
University of Oregon
37
Recently Adopted Policies
Major Milestones One Year

• Policy on Interactions with Pharmaceutical and
  Medical Device Companies (the P/D Policy new)
• Code of Conduct and Conflicts of Interest Policy
  (small revisions)
• Partners Policy on Consulting and Other Outside
  Activities
• All are available on Partners Policies and
  Procedures (PPP) site
• http//library.partners.org/PartProd/webserver/cus
  tom/trovedemoframeset.asp?HUhttp//www.partners.o
  rgP21w1024h768c32

• Establish Missing Compliance Committees
• Strengthen Necessary Policies
• Create/Post Compliance Website
• Establish Your Communication Strategies
• Students
• Faculty
• Administrative Leadership

Adopted with permission from Lynette Schenkel,
Director, Responsible Conduct of Research,
University of Oregon
38
Compliance Hot Potatoes Identifying and
Assessing Your Risk
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Grants ManagementIn Every Grant Application

• Principal Investigator Assurance
• I certify that the STATEMENTS HEREIN ARE TRUE,
  COMPLETE and ACCURATE to the best of my
  knowledge. I am aware that any FALSE,
  FICTITIOUS, OR FRAUDULENT statements or claims
  may subject me to CRIMINAL, CIVIL OR
  ADMINISTRATIVE PENALTIES. I agree to accept
  responsibility for the SCIENTIFIC CONDUCT of the
  project and to provide the required PROGRESS
  REPORTS if a grant is awarded as a result of this
  application.

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Grants ManagementIn Every Grant Application

• Institutional Assurance
• I certify that the STATEMENTS HEREIN ARE TRUE,
  COMPLETE and ACCURATE to the best of my
  knowledge. I am aware that any FALSE,
  FICTITIOUS, OR FRAUDULENT statements or claims
  may subject me to CRIMINAL, CIVIL OR
  ADMINISTRATIVE PENALTIES. I agree to accept
  responsibility for the SCIENTIFIC CONDUCT of the
  project and to provide the required PROGRESS
  REPORTS if a grant is awarded as a result of this
  application.

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Sponsored Project ManagementResponsibilities

• Know the Terms of Your Award
• http//grants.nih.gov/grants/policy/nihgps_2003/in
  dex.htm
• Know What Activities/Changes NIH Must Pre-Approve
  (pg. 105 of NIH Grants Policy Statement,)
• i.e. 25 reduction in TE
• i.e. Transferring work off-site

42
Sponsored Project ManagementCost Principles

• OMB Circular A-21
• OMB Circular A-122
• OASC-3
• Direct Costs vs. FA Costs
• Direct those costs that can be identified
  specifically with a particular sponsored project,
  or that can be directly assigned to such activity
  relatively easily with a high degree of
  accuracy. OMB Circular A-21
• FA (Indirect) Costs Indirect costs are those
  that have been incurred for common or joint
  objectives, and thus are not readily subject to
  treatment as direct costs of research agreements
  or other ultimate or revenue producing cost
  centers. OASC 3

43
Sponsored Project ManagementCost Principles

• Must Manage the Sponsored Account
• Know the Federal Cost Principles - Every Charge
  Must Be
• Reasonable
• Allowable
• Allocable
• Conform with institutional policies
• Reconcile account regularly, monthly ideally
• Cost Transfers if not completed within 90 days,
  make sure they comply with federal requirements

44
Cost Transfers

• Cost transfers to NIH grants by grantees should
  be accomplished within 90 days.
• Transfers must be supported by documentation that
  fully explains how the error occurred and a
  certification of the correctness of the new
  charge by a responsible organizational official
  of the grantee.
• An explanation merely stating that the transfer
  was made 'to correct error' or 'to transfer to
  correct project' is not sufficient.

45
Cost Transfers

• Transfers of costs from one project to another
  or from one competitive segment to the next
  solely to cover cost overruns are not allowable.
  Grantees must maintain documentation of cost
  transfers, pursuant to 45 CFR 74.53 or 92.42
  record retention requirements and must make it
  available for audit or other review.

46
Cost TransfersNIH Grants Policy Statement

• Frequent errors in recording costs may indicate
  the need for accounting system improvements
  and/or enhanced internal controls.
• NIH also may require a grantee to take corrective
  action by imposing additional terms and
  conditions on an award(s)."

47
Cost TransfersUnacceptable Justifications

• To transfer costs from a sponsored project in
  deficit to another sponsored project for the sole
  purpose of eliminating the deficit
• To transfer costs to a sponsored project to spend
  the remaining funds
• Charging another sponsored project in
  anticipation of future funding
• Charging a sponsored project for a bulk purchase
  then moving costs to the appropriate fund(s)

48
Cost TransfersUnacceptable Justifications

• Absence of PI
• Shortage or lack of experience of staff
• The transfer of costs to cost centers with an
  unexpended balance for the purpose of expending
  the remaining funds
• The transfer of charges incurred after the end
  date of a project to another sponsored project
  cost center

49
Cost Sharing

• Cost sharing is that portion of a project not
  borne by the federal government OMB A-110
• Key Terms
• Mandatory
• Voluntary Committed
• Voluntary Uncommitted
• Regulatory References
• OMB Clarification (January 5, 2001)
• OMB Circular A-110, __.23
• A-21, J section (for allowability of cost)
• NSF Policy

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Who provides cost sharing?

• The recipient is responsible for all cost sharing
  required under the award.
• Cost sharing may be satisfied by collaborators by
  providing appropriate goods and services
  however, recipient still retains responsibility
  for meeting the awards cost-sharing expectation.

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Cost Sharing Criteria

• Necessary and reasonable to meet project needs.
• Verifiable with hard-copy or electronic
  documentation.
• Allowable under applicable cost principles.
• Not contributed to another federal award.
• Not paid from another federal award unless
  specified otherwise in the award document.
• Provided for in the budget when required by
  sponsor.

52
What can be offered to meet cost-sharing
requirement?

• Paid salaries and wages
• Other services
• Donated effort
• Supplies
• Equipment
• FA with Research Management and agency approval
  
• Whatever is offered must be auditable!

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What types of expenditures cannot be used to meet
cost-sharing requirement?

• Any expense the institution has defined as an
  indirect cost, such as administrative salaries,
  office supplies, and operations and maintenance
  expenses.
• Salary dollars in excess of regulatory salary
  caps.
• Unallowable costs, e.g., entertainment.

54
D
Types of Cost Sharing

• Mandatory required for submission of proposal
  and committed in the proposal.
• Voluntary Committed not a program requirement
  voluntarily committed in the proposal.
• Does it Matter? Once approved by the sponsor,
  the cost sharing is REQUIRED!

55
D
The Cost Sharing Cycle

• Starts with a commitment in a proposal
• Cost sharing commitment may be mandatory,
  voluntary, or inadvertent
• Inadvertent statements in a proposal that are
  interpreted as a commitment
• Once a proposal is awarded, all commitments
  become mandatory
• A condition of the award
• Must be documented and reported

55
56
D
Examples Mandatory Cost Sharing

• Program guidelines requires 50 cost-share for
  PIs effort requested in the budget.
• Program requires 50 cost-share for conference.
• Program requires 30 cost-share for all equipment
  requested in budget.

57
D
Examples Voluntary Committed Cost Sharing

• Voluntary committed PI describes in the
  proposal that Co-Investigator will devote 25
  effort but only requests funding for 10 effort.
• Voluntary committed PI describes
  Co-Investigator as making an in-kind
  contribution of x effort without requesting
  funding.

58
D
Cost Sharing the Proposal

• Typically mentioned in the budget section.
• A reference to cost sharing in any part of the
  proposal is considered a commitment.
• Do not confuse using leveraged funds with cost
  sharing or matching funds.

59
D
Cost Sharing the Award

• Cost-sharing specification in the award document
  makes cost sharing a requirement.
• Cost-sharing specification in a proposal
  referenced or incorporated in the award document
  makes cost sharing a requirement.

60
D
Unacceptable forms of Cost Sharing

• Using funds from one project to meet the cost
  sharing obligations of another
• Using cost categories that are unallowable as a
  chargeable expense to meet matching obligations
• Using unfunded salary for effort outside of MGH
  appointment

61
D
Cost Sharing Reporting

• Must be reported along with other project
  expenditures.
• Sponsor may have additional reporting
  requirements.
• Reporting periods may differ.

62
Cost Sharing Take Home Thoughts

• Dont make cost sharing commitments unless
  required by sponsor.
• And when you make a commitment, do so only at the
  required level or amount.
• Consult Grants Contracts Office early for cost
  sharing advice and additional approvals.
• In-kind effort contributions are real
  commitments with a cost to the department.
• If proposed, monitor, report and retain cost
  sharing records.
• Keep documentation in grant file.

63
Not Cost Sharing - Unallowable!Salary Over the
Cap

• Personnel costs represent the single largest
  category of expense charged to the federally
  sponsored awards. Accordingly, the government
  mandates that institutions receiving federal
  funds for sponsored programs maintain an effort
  certification process that complies with A-21 or
  OASC-3 requirements. 
• NIH Salary Cap Websites
• http//grants.nih.gov/grants/guide/notice-files/NO
  T-OD-05-024.html
• http//grants.nih.gov/grants/policy/salcap_summary
  .htm

64
Payroll Distribution and Certification(a/k/a)
Effort Reporting The Basics

• An institution can charge salary, wages and
  benefits to federally funded research projects
  provided that they are
• Reasonable
• Conform to established institutional payroll
  policies and
• Reflect no more than the percentage of time
  actually devoted to the project

65
Time EffortEffort Reporting

• Must submit monthly (quarterly/semi-annually)
  after-the-fact reports certifying that the
  distribution of activity listed on the
  pre-printed report accurately represents a
  reasonable estimate of actual work performed
• Verifies that work was performed
• Verifies that cost sharing was performed as
  promised in the proposal

66
Time EffortEffort Reporting, cont.

• Estimates must be broken down for each organized
  research project
• Estimates of time and effort expended must
  include an allocation between organized research
  and the following activities in terms of total
  effort devoted
• Patient Care
• Instruction and Training
• Administration

67
Time EffortEffort Reporting, cont.

• What does this mean?
• Grant 1 25 TE
• Grant 2 25 TE
• Other 50 TE
• A report which shows the above distribution means
  that the investigator spends half his or her time
  on research grants, and half his or her time on
  patient care and/or teaching and instruction,
  and/or administrative responsibilities.

68
Time Effort Organized Research

• What to include when estimating organized
  research activities
• Research conducted, analyzed and reported
  pursuant to a federal grant or contract (e.g.
  NIH, NSF or DoD)
• Writing an article to be published about the
  results of your research
• Non-federal research projects (e.g. a foundation
  grant or industry sponsored clinical trial)
• Writing a progress report for an existing grant.
• Holding a lab meeting with your staff.
• Attending a scientific conference held by an
  outside professional society
• Reading scientific journals to keep up to date
  with the latest advances in your field.

69
Time and EffortPercentages and Workload

• Effort (organized research patient care
  teaching administration) CANNOT exceed 100
• commitment of an individuals effort greater
  than 100 percent is not permitted..
• Commitment overlap occurs when a persons time
  commitment exceeds 100 percent, whether or not
  salary support is only requested for key
  personnel.no individuals on the project may have
  commitments in excess of 100
• NIH Grants Policy Statement (Dec. 2003)

70
Time EffortPercentages and Workload

• Not based on 40 hour workweek
• Person who works 40 hours per week who spends 20
  hours of his or her time and effort on organized
  research, spends 50 of his or her time on
  organized research and 50 of his her time on
  Other activities (patient care, teaching,
  administration
• Person who works 80 hours per week who spends 40
  hours of his or her time and effort on organized
  research, spends 50 of his or her time on
  organized research and 50 of his or her time on
  Other activities (patient care, teaching,
  administration)
• Be careful, however How long can one person
  keep up an 80 hour plus work week?

71
Time EffortWhy TEFRA Doesnt Cover It

• TEFRA is only a two-week snap shot in the course
  of a 3 month reporting period.
• The research Time Effort Report is an estimate
  of all of the work that an investigator does at
  the hospital (including research patient care,
  teaching and administration), but it aggregates
  all the non-research categories into one lump
  percentage  
• In general, however, the two reports should
  complement each other. By the nature of the two
  different accounting mechanisms required (i.e.
  hours vs. ), etc., it is unlikely that the
  numbers will exactly match. That is ok.
  Remember, the research TE report is only a good
  faith estimate of the work performed during the
  previous month.

72
Time Effort Special IssuesVoluntary Effort
Committed or Not

• Voluntary committed effort (said in grant
  application would dedicate 5, but did not
  request salary
• This MUST be included in Organized Research
• Other Significant Contributors
• Individuals who have committed to contribute to
  the scientific development or execution of the
  project, but are not committing any specified
  measurable effort to the project. These
  individuals are typically presented at effort of
  zero months or as needed
• PHS 398 Grant Application Instructions

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Time EffortSpecial Issues

• NIH Salary Cap and Cost Sharing
• Cap is raised each year
• Currently 186,600
• But different caps apply to different years (see
  attached Salary Cap Summary from NIH)
• If investigators salary is over the cap, another
  account must be identified to which the salary
  above the cap can be transferred or cost-shared.
• NEVER cost share to another federally funded
  account.

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Time EffortSpecial Issues, cont.

• Fellows/Trainees on F32s, T32s
• They are not considered employees and do not have
  to report their effort
• But, they are expected to spend full time effort
  on the grants
• only group whose full time effort is defined by
  40 hours per week
• They can moonlight, work on other projects
  unrelated to the research at MGH

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Time EffortSpecial Issues, cont.

• K Awards (Career Development)
• Intent is to support and protect a significant
  component of an individuals professional time
  for research activity
• Institutes manage these awards differently look
  to Institutes guidance
• 25-75 effort commitment based on total
  professional effort
• Limited salary cost sharing often required
• 11/03 revisions can get other award if in last
  2 years of mentored award and named PI (K01, K07,
  K08, K12, K22, K23, K25)

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Time EffortCertifying

• Should Investigators should certify as to own
  their effort?
• estimates of effortmust be prepared by the
  individual who performed the services or by a
  responsible individual such as a department head
  or supervisor having first-hand knowledge of the
  services performed on each research agreement.
  45 CFR Pt 74, App. E
• A-21 for Universities require that the signor
  have a suitable means of verification that the
  work was performed.

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Subrecipient Monitoring

• What is a subrecipient? A third-party
  organization performing a portion the sponsored
  projects
• Primes Responsibilities
• Advise subs of all applicable federal laws and
  regulations, and all appropriate flow-down
  provisions from the prime agreement
• Review of Progress Reports
• Review regular financial status
• Meet/monitor regularly
• Collect A-133 reports, get info about corrective
  actions
• Audit, if necessary

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Direct-Charging of Administrative and Clerical
Costs

• OMB Guidance on A-21 Revision to section F.6.b.
  (July 1993)
• In developing the departmental administration
  cost pool, special care should be exercised to
  ensure that costs incurred fro the same purpose
  in like circumstances are treated consistently as
  either direct or FA costs

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79
Direct-Charging of Administrative and Clerical
Costs

• The salaries of administrative and clerical
  staff should normally be treated as FA costs.
  Direct charging of these costs may be appropriate
  where a major project or activity explicitly
  budgets for administrative or clerical services
  and individuals involved can be specifically
  identified with the project or activity.
• Items such as office supplies, postage, local
  telephone costs, and memberships shall normally
  be treated as FA costs. OMB Circular A-21F6(b)

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Implications of F.6.b Guidance

• OMB Direct chargingmay be appropriate where a
  major project or activity explicitly budgets for
  administrative or clerical services
• Do we explicitly budget for these costs in the
  research proposal?
• Does the proposal include a written justification
  (i.e. why the necessary indirect costs are
  necessary for project performance)?
• Is this a major project as defined in Exhibit C
  of A-21?

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Administrative and Clerical Salaries for
Hospitals

• NIH Prohibition DOES NOT APPLY!!!!
• But be careful. Salaries can be direct charged
  (if not included as part of your FA rate) but
  still must be
• Reasonable
• Allowable
• Allocable
• Confirm with institutional policies

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Conflict of Interest

• NIH/NSF/AHA/ACS Requirements
• Institutions Must
• Review all disclosures
• Determine whether the financial interests are
  significant
• Determine whether there is a reasonable
  likelihood that the significant financial
  interests disclosed will directly and
  significantly affect the design, conduct, or
  reporting of the research
• Take appropriate action to reduce, manage, or
  eliminate potential conflicts of interest
• Report to the sponsor the existence of the
  conflict and provide assurances it will be
  managed.

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Conflict of Interest New Trends

• FY 06 Targeted OER Reviews
• Redefined investigator
• Most difficulty reporting conflicts after the
  project is underway
• January 2008 HHS OIG Report. Findings
• NIH could not provide an accurate count of
  financial conflict-of-interest reports
• NIH is not aware of the types of financial
  conflicts of interest that exist at grantee
  institutions
• Many Institutes primary method of oversight is
  reliance on grantee institutions assurances that
  regulations are followed.

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Other Non-Financial Compliance Risks
85
Research Integrity

• Plagiarism
• Falsification
• Fabrication
• Practical implications
• Identify your Research Integrity Officer
• Be Sure you have a policy and process for
  handling and reporting all complaints
• Role of ORI, and NSFs OIG

85
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Human Subjects Welfare

• Role of OHRP and FDA
• IRBs
• Informed Consent
• Institutional Officials
• Effect Upon Federally Funded Projects
• Data Safety Monitoring
• Clinical Trials Billing

86
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Animal Welfare

• Role of OLAW
• IACUCs
• Institutional Officials
• Use of Controlled Substances DEA
• Role of USDA
• Effect Upon Federally Funded Projects

88
Institutional Biosafety Committee (IBC)

• Review and oversight of nearly all forms of
  research utilizing recombinant DNA
• NIH Guidelines for Research Involving Recombinant
  DNA Molecules
• http//www4.od.nih.gov/oba/rac/guidelines/guidelin
  es.html
• Biosafety in Microbiological and Biomedical
  Laboratories (BMBL) 5th Edition
• http//www.cdc.gov/OD/ohs/biosfty/bmbl5/bmbl5toc.h
  tm

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Approach to Lab Compliance

• Lab Safety is related to but not the same as Lab
  Security
• Know who is authorized to work in your lab
• Know what materials your lab uses
• Assess the risk of those materials
• Prepare a lab security/evacuation plan
• Train your lab
• Not just researchers, administrators too
• Assign responsibilitieseveryone should have at
  least one

90
Approach to Lab Compliance

• Background checks
• ID badges
• Key card access
• P.S. Dont hold the doors open!
• Establish sign in/sign out procedures for lab
• Establish sign in/sign out procedures for access
  to chemical and Select Agents

91
Approach to Lab Compliance

• Secure Areas
• Use locks, passwords, key cards, id badges
• Never leave hazardous materials unattended
• Lock freezers, cabinets, equipment

92
Approach to Lab Compliance

• Know whats being ordered, shipped, used, stored
• Get rid of useless chemicals/materials
• Control access to materials
• Follow the rules for transporting and disposing
  hazardous materials and Select Agents and follow
  them
• Control the inventory and report missing items
• Keep meticulous records

93
Approach to Lab Compliance

• Establish and Emergency Plan
• Planning is the key to safety
• Everyone should have a roll
• Take into account hazardous chemicals and Select
  Agents
• Train and educate all personnel
• Notify officials of your plan

94
Approach to Lab Compliance

• Report Breaches
• Know who to contact
• Safety
• Biosafety
• Security
• PIs, administrators, all must be involved
• Train all lab staff
• Test the plans

95
What Can Our Institutions do to Ensure
Compliance?

• Maintain a culture of compliance
• Accept that we all are accountable, especially
  the Principal Investigator
• Monitor the high risk transactions, compliance
  with institutional policies
• Implement effective training programs
• Participate in development/revision of
  institutional policies
• Communicate current information
• Keep in mind that compliance starts at the
  beginning of a project, not the end

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What We All Can Do

• Understand the law
• Ask Questions
• Do the Right Thing
• Document, Document, Document

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Questions?

• Gretchen A. Brodnicki, J.D.
• Director of Research Compliance
• 617-954-9639
• gbrodnicki_at_partners.org
• Patrick Fitzgerald
• Associate Dean, Research Administration
• 617-495-4083
• pwf_at_fas.harvard.edu