View
217
Download
1
Tags:
Embed Size (px)
Citation preview
SRA Departmental Administrators Certification Course(DA-201)
Keys To Success In Management:
• Pride In One’s Organization
• Enthusiasm For Its WorkTom Peters
A Passion For Excellence
Classic Management Challenge
“How To Make Ordinary People Do Extraordinary
Things”
Peter Drucker In HBR Likens Managers To Conductors Of
Symphony Orchestras“A Great Orchestra Is Not Composed Of Great Musicians But Of Adequate Ones Who Produce At Their Peak”
Why Does The Same Group Of Musicians Perform Poorly Under One Conductor
And Superbly Under Another?
“The Great Leaders Are Like The Best Conductors – They Reach Beyond The Notes To Reach The Magic In The Players.”
Blaine Lee
The Power Principle
Drucker Says:
“The Key To Greatness Is To Look For People’s Potential
And Spend Time Developing It”
So How Are You Doing As A Manager?
or
“In the real world, Research Administrators strive to provide quality support to the research enterprise while following all of the applicable policies and rules. It’s not always as easy as it sounds!”
Department Chair
Sponsored Programs Office
Purchasing Office
Funding Agencies
Dean’s Office Students
To Succeed, We Can’t Just Be Reactive, We Must Be Proactive!
What Does It Mean To Be Proactive?
• Have A Plan.
• Study The Art
Of Management
• Observe Successful People!
Lessons From Great Leaders
“A Good Plan Executed Right Now Is Far Better
Than A Perfect Plan Executed Next Week.”
George S. Patton
“She Didn’t Know It Couldn’t Be Done, So She Went Ahead And Did It.”
Mary’s Almanac
Lessons From Great Leaders1. Don’t Be Afraid To Take Action
“Failure Is The Opportunity To Begin Again, More Intelligently.”
Henry Ford
“I Have Not Failed. I’ve Just Found 10,000 Ways That Won’t Work.”
Thomas Alva Edison
“The Only Man Who Makes A Mistake Is The Man That Never Does Anything.”
Theodore Roosevelt
Failure–Tolerant Organizations• Encourage Intelligent Risk Taking• View Failure As A Pre-Requisite For
Invention• View Failures As Outcomes To Be
Examined, Understood, And Built Upon• Focus On Increasing Their Organization’s
Intellectual Capital • Create A Culture Of Collaboration Rather
Than Competition.Richard Farson and Ralph Keyes
The Failure-Tolerant Leader
• Jack Welch, Former Head Of GE
“We Reward Failure.”
• Thomas Watson, Sr., Former Head Of IBM
“The Fastest Way To Succeed Is To Double Your Failure Rate.”
Peter Doherty, 1996 Nobel Prize Winner“A Good Researcher Failed Every Time But The Last One.”
• Spencer Silver’s “Failure” Imperfect Adhesive resulted In 3M’s Post-It Notes
Lessons From Great Leaders1. Don’t Be Afraid To Take Action
2. Foster An Environment That Allows People To Fail Intelligently
“I Not Only Use The Brains I
Have, But All I Can
Borrow.”
Woodrow Wilson
“The Best Executive Has The Sense Enough To Pick Good Men, And The Self-Restraint Enough To Keep From Meddling.”
Theodore Roosevelt
“Never Tell People How To Do Things. Tell Them What To Do And They Will Surprise You With Their Ingenuity.”
General George S. Patton
Lessons From Great Leaders1. Don’t Be Afraid To Take Action
2. Foster An Environment That Allows People To Fail Intelligently
3. Hire Good People, Point Them In The Right Direction, Provide Motivation, but Don’t Micro-Manage
“Individual Commitment To A Group Effort – That Is What Makes A Team Work, A Company Work, A Society Work, A Civilization Work.”
Vince Lombardi
• Teamwork – A Worthy Goal!
• But Not All Groups Become Teams
• What Makes A Group Become A Team?
“A Team Is A Small Number Of People With Complementary Skills Who Are Committed To A Common Purpose, Set Of Performance Goals, And Approach For Which They Hold Themselves Mutually Accountable.”
Jon R. Katzenbach And Douglas K. Smith
The Discipline Of Teams
“A Team Is A Small Number Of People With Complementary Skills Who Are Committed To A Common Purpose, Set Of Performance Goals, And Approach For Which They Hold Themselves Mutually Accountable.”
Jon R. Katzenbach And Douglas K. Smith
The Discipline Of Teams
“A Team Is A Small Number Of People With Complementary Skills Who Are Committed To A Common Purpose, Set Of Performance Goals, And Approach For Which They Hold Themselves Mutually Accountable.”
Jon R. Katzenbach And Douglas K. Smith
The Discipline Of Teams
“A Team Is A Small Number Of People With Complementary Skills Who Are Committed To A Common Purpose, Set Of Performance Goals, And Approach For Which They Hold Themselves Mutually Accountable.”
Jon R. Katzenbach And Douglas K. Smith
The Discipline Of Teams
“A Team Is A Small Number Of People With Complementary Skills Who Are Committed To A Common Purpose, Set Of Performance Goals, And Approach For Which They Hold Themselves Mutually Accountable.”
Jon R. Katzenbach And Douglas K. Smith
The Discipline Of Teams
“A Team Is A Small Number Of People With Complementary Skills Who Are Committed To A Common Purpose, Set Of Performance Goals, And Approach For Which They Hold Themselves Mutually Accountable.”
Jon R. Katzenbach And Douglas K. Smith
The Discipline Of Teams
Lessons From Great Leaders1. Don’t Be Afraid To Take Action
2. Foster An Environment That Allows People To Fail Intelligently
3. Hire Good People, Point Them In The Right Direction, Provide Motivation, but Don’t Micro-Manage
4. Encourage The Development Of Effective Teams
“The Difference Between A Boss And A Leader: A Boss Says, ‘Go!’ – A Leader Says, ‘Let’s Go!’”
E. M. Kelly
Growing Disciples
What Does It Mean To Lead By Example?
Lessons From Great Leaders1. Don’t Be Afraid To Take Action
2. Foster An Environment That Allows People To Fail Intelligently
3. Hire Good People, Point Them In The Right Direction, And Stay Out Of Their Way
4. Encourage The Development Of Effective Teams
5. Lead By Example!
Tim’s Definition of Management:
The Process of Intentionally Guiding An Organization Toward The Successful Fulfillment Of Its Mission, Within A Given Set Of Environmental Constraints,By Setting And Achieving Specific Goals.
The Process of Intentionally Guiding An Organization Toward The Successful Fulfillment Of Its Mission, Within A Given Set Of Environmental Constraints,By Setting And Achieving Specific Goals.
Tim’s Definition of Management:
What Constraints Do We Face?
Money
What Constraints Do We Face?
Money People
What Constraints Do We Face?
Money People
Facilities
What Constraints Do We Face?
Money People
Facilities Time“The thing I lose patience with the most is the clock. Its hands move too fast. Time is really the only capital that any human being has, and the one thing that he can’t afford to
lose.”
Thomas Edison
Environment Constraints
1.Resources
Environment Constraints
1.Resources2.Rules
Environment Constraints
1.Resources2.Rules
3.Organizational Culture
Spending Too Much Time Focusing on
Constraints Is A Waste!
“Great Managers Focus On Solutions, Not Limitations.”
Remember Tim’s Definition
of Management
The Process of Intentionally Guiding An Organization Toward The Successful Fulfillment Of Its Mission, Within A Given Set Of Environmental Constraints,By Setting And Achieving Specific Goals.
Harvard Parking Story 1950’s – 2 UNC Grads To Harvard
One in Wheel Chair
Arrived In Boston One Evening•No Parking By Dorm•Parked By Front Door To Unload
Campus Police Came•Returned With Workman – Painted Yellow Line
Understanding Mission:
“As Long As You And Your Roommate Are Students In Good-
Standing At Harvard, This Parking Place Is For
You!”
He Felt Empowered To Make A Decision That Supported This Mission.
Some Pretty Incredible Managers – Even “Campus Cops” Knew And Supported The MISSION.
He Understood Harvard’s Mission: Supporting Education
Remember The Man Who Worked For Ringling Brothers Circus
All Dusty And Somewhat Smelly Worked For 32 Years Following The Elephants With A Broom And Large Dust Pan To Keep The Streets Clean
When Asked Why He Didn’t Get Into Another Line Of Work He Replied, Indignantly
“WHAT, AND GIVE UP SHOW BUSINESS?” He Knew What Business He Was In.
It Wasn’t About Cleaning Up After Elephants.
He Was In Show Business!
He understood The Mission.
Visits To UNC-CH VR Lab
“Your Job Is To Support (Enable) What You Are About To Experience.”
NEW PERSPECTIVE Focus On The Mission!
“What Is Your Job?”• Process Travel Forms• Pre-Audit Contract and
Grant Expenditures• Track Effort-Reporting
CircusEmployee
HarvardCop
MISSION
Research Support
Staff
Pride Enthusiasm
Focus
Efficiency vrs. EffectivenessA Balancing Act!
Efficiency – Producing The Greatest Quantity Of Work For Each Unit Of Resource Expended (Or Producing A Unit Of Work For The Smallest Possible Expenditure Of Resources)
Effectiveness – Successfully Accomplishing The Goals/Objectives Of The Organization.
Fulfilling Its Mission!
Efficiency Is Important Resources Are Limited – We Must Use
Them Intelligently
But - An Efficient Organization Is Not Necessarily An Effective Organization
When Sub-Units Strive To Develop Efficient Approaches To Accomplishing Their Work, They Often Ask The Following Questions:
– How Can We Organize Ourselves To Get Our Work Done Most Efficiently?
Sub-Unit Optimization
– What Policies/Procedures Do We Need To Put Into Place To Help Us Get Our Work Done?
What’s Wrong With These Questions?
• They Focus Inward On Getting Their Work Done Rather Than Focusing On How To Accomplish The Goals Of The Organization.
Example: UNC Survey Due May 15
Sub-Unit Optimization
Better Question:
How Can We Best Organize Ourselves To Accomplish The Work That We Are Assigned In A Manner That Best Supports The Goals Of The Enterprise?
Paradoxical Question
• Should We Intentionally Create Sub-Unit Inefficiencies In Order To Best Support The Goals/Mission Of The Enterprise?
Remember Tim’s Definition of Management
The Process of Intentionally Guiding An Organization Toward The Successful Fulfillment Of Its Mission, Within A Given Set Of Environmental Constraints,By Setting And Achieving Specific Goals.
Rules For Effective Goal Setting
1.Set Goals That Are Important/Challenging
• Related To Mission
• Significant
• Push You To Achieve
• Highly Motivated
• Focus On What You Want – Not What You Don’t Want
• Keep A Mental Image of Success
• Stay Away From Negative Thinking
“Obstacles Are Those Frightful Things You See When You take Your Eyes Off The Goal.”
Henry Ford
2.State Your Goals In Positive, Not Negative, Terms!
“Dreams Are Just Thoughts. They Become Tangible Goals When We Write Them Down.”
3.Write Your Goals Down.
• Helps To Crystallize Thinking
• Be Precise
• Helps Spot Contradictory Goals
• Increases Commitment
“Goals Are Just Dreams With Deadlines.” Diana Scharf Hunt
Creating Deadlines Is A Powerful Management Technique
4.Make Your Goals Time Specific
5.Review Your Goals Regularly!
• My Approach: Plastic-Covered Sheet In Telephone Book Drawer
• Reviewing Keeps You Focused
• Be Willing To Modify/Clarify When Appropriate
6.Don’t Give Up. Continue Until You Achieve Your Goals!
The Process of Intentionally Guiding An Organization Toward The Successful Fulfillment Of Its Mission, Within A Given Set Of Environmental Constraints,By Setting And Achieving Specific Goals.
Remember Tim’s Definition of Management
What Is Your Approach To Management?
Intentionality in Management
• Management By Wandering Around• Total Quality Management
• Responsible Delegation Techniques
• Understanding Motivation
Management By Wandering Around
Management By Wandering Around
• Get Out From Behind Your Desk• Spend Time In The
Labs/Classrooms/Building• Walk The Halls• Be A Keen Observer• Ask People Questions
• You Will Be Surprised By What You Learn!
• On Occasion Go To Other People’s Office For Meetings (Don’t Always Have Them Come To You)
• If Possible, Locate Your Office In The Highest Possible Traffic Area
Be Accessible
• If Possible, Arrange Your Office So You Don’t Sit Behind Your Desk When Meeting People
Management By Wandering Around
TQM: What’s Worth Remembering
W. Edwards Deming (Management Consultant -Ideas Were Rejected In The US – Promoted a Quality Approach In Japanese Manufacturing)
• Pre-Quality (Poor Quality, Cheap “Knock-Offs”)
• Post-Quality (Finest Electronics and Cars In The World)
Baldridge Award in US
TQM Core Principles
What Can We Do To Get Better?• Banish Complacency• Set Heroic Goals – “Raise The Bar”
Commitment To Continuous Improvement• “Excellence Is A Game Of Inches.” Tom
Peters
Treat Mistakes Like “Diamonds”• Rare/Opportunities To Learn• H-P (Can’t Get Raise If You Haven’t Made
Mistakes – If No Mistakes, You Aren’t Doing Anything)
Responsible Delegation
A Manager Must Learn To Delegate Responsibility And Authority In Order To Build An Effective Team!
1. Time To Look At “Big Picture”/Plan2. Greater Staff Involvement = Higher
Morale/Investment3. More Gets Done When Manager Isn’t “Funnel”4. Creativity
Payoffs
Responsible Delegation
1. Inconsistent Application of Policy2. Strain When Manager Feels That An
Employee Is Doing Something Wrong And Has To Confront Him/Her
3. Accountable For Decisions You Don’t Make
4. Asking Employees To Do Too Much – They May Be Resistant (“Don’t Dump on Me”)
5. “I Could Have Done It Myself Faster”6. “Loose Touch With Operations”
Risks/Problems
Reward People For Solving Problems Without Coming To See You First!
Unconventional Weekly Staff Meetings Agenda – “The Problems You Faced
And The Decisions You Made And, If You Got Help, Who Helped You.”
Builds A Team That Works Together!
Harvard Business Review Case Study: MacGregor
McGregor Played A Lot Of Golf!
Employee Motivation is Based Upon:
MOTIVATION
A B C
Employee Motivation is Based Upon:
MOTIVATION
A B CA= Does My Job Contribute To My Personal Goals?
Employee Motivation is Based Upon:
MOTIVATION
A B CA= Does My Job Contribute To My Personal Goals?
B= Am I Confident In My Abilities To Do My Job?
Employee Motivation is Based Upon:
MOTIVATION
A B CA= Does My Job Contribute To My Personal Goals?
C= If I Do A Great Job, Will I Be Recognized And Rewarded?
B= Am I Confident In My Abilities To Do My Job?
Compliance for Departmental Administrators
DA 201
Institutional Compliance is:
A A commitmentcommitment to obey federal and state laws and to obey federal and state laws and sponsor policies, and follow internal policies and sponsor policies, and follow internal policies and proceduresprocedures
An An ongoing operational programongoing operational program to prevent, to prevent, detect, and correct wrongdoingdetect, and correct wrongdoing
A A system of internal control and proceduressystem of internal control and procedures to to evaluate operational practices, minimize legal and evaluate operational practices, minimize legal and business risk and implement corrective actionbusiness risk and implement corrective action
Objectives
Importance of programImportance of program What is requiredWhat is required ResponsibilitiesResponsibilities How departmental administrators can How departmental administrators can
participateparticipate
Why is Institutional Compliance Necessary? Complex statutory and regulatory Complex statutory and regulatory
environmentenvironment Increased government scrutinyIncreased government scrutiny Government and sponsors look favorably Government and sponsors look favorably
upon institutions with effective compliance upon institutions with effective compliance programsprograms
Compliance
Need to know the rules to help the Need to know the rules to help the investigatorsinvestigators
At departmental level, you are more likely At departmental level, you are more likely to hear of problems earlyto hear of problems early
Issues of noncompliance inevitably come Issues of noncompliance inevitably come back to haunt the department and its back to haunt the department and its administrationadministration
First line of defense against non-complianceFirst line of defense against non-compliance
Compliance
Compliance does not mean “no”Compliance does not mean “no”
Benefits of a Compliance Program Demonstrates commitment to ethical and lawful Demonstrates commitment to ethical and lawful
behaviorbehavior Instills a culture that promotes integrity and Instills a culture that promotes integrity and
ethical behaviorethical behavior Proactively identifies risks before they become Proactively identifies risks before they become
major issuesmajor issues Enhances employee awareness of conduct that is Enhances employee awareness of conduct that is
unacceptableunacceptable Reduces organizational exposure to civil and Reduces organizational exposure to civil and
criminal liabilitycriminal liability
Risk Assessment (Outline)
Protection of Human Subjects Protection of Human Subjects Care and Use of Animals in ResearchCare and Use of Animals in Research Stewardship of Federal FundsStewardship of Federal Funds Conflict of InterestConflict of Interest Environmental Health and Safety IssuesEnvironmental Health and Safety Issues
Management’s Responsibilities
Commitment
You must be able to communicate (sell)You must be able to communicate (sell) What is expected of themWhat is expected of them Why it is required (federal, state, local & Why it is required (federal, state, local &
sponsor)sponsor) Where hazards, controls, and safe work Where hazards, controls, and safe work
practices exist in the workplacepractices exist in the workplace When requirements change or newly adoptedWhen requirements change or newly adopted Whom to contact for questions and assistanceWhom to contact for questions and assistance What are the required resources What are the required resources
Risk Assessment (Outline)
Protection of Human SubjectsProtection of Human Subjects Care and Use of Animals in ResearchCare and Use of Animals in Research Stewardship of Federal FundsStewardship of Federal Funds Scientific MisconductScientific Misconduct Conflict of InterestConflict of Interest Application of Intellectual PropertyApplication of Intellectual Property Environmental Health and Safety IssuesEnvironmental Health and Safety Issues
Human Subjects in Research
Medical War Crimes - WWII Experiments were unprecedented in scope and Experiments were unprecedented in scope and
degree of harmdegree of harm ““Medical Experiments” were performed on Medical Experiments” were performed on
thousandsthousands 16 of 23 Physicians and Administrators found 16 of 23 Physicians and Administrators found
guiltyguilty 1947 verdict included rules for “Permissible 1947 verdict included rules for “Permissible
Medical Experiments” known as the “Nuremberg Medical Experiments” known as the “Nuremberg Code”Code” Voluntary consentVoluntary consent Benefits outweigh risksBenefits outweigh risks Ability of subjects to terminate participationAbility of subjects to terminate participation
Human Subjects in Research
Jewish Chronic Disease Hospital (1963) Injection of foreign, live cancer cells into Injection of foreign, live cancer cells into
hospitalized patients with various chronic hospitalized patients with various chronic debilitating diseasesdebilitating diseases
Oral consent did not include discussion of Oral consent did not include discussion of cancer cellscancer cells
Researcher found guilty of fraud, deceit and Researcher found guilty of fraud, deceit and unprofessional conductunprofessional conduct
Human Subjects in Research
The Willowbrook Study (1963-66) NY institution for “mentally defective” NY institution for “mentally defective”
childrenchildren Study to gain an understanding of the Study to gain an understanding of the
natural history of infectious hepatitisnatural history of infectious hepatitis Newly admitted children were deliberately Newly admitted children were deliberately
infected so scientists could work on a infected so scientists could work on a vaccinevaccine
Human Subjects in Research
Tuskegee Syphilis Study Notorious example of prolonged and Notorious example of prolonged and
knowledgeable violation of a vulnerable groupknowledgeable violation of a vulnerable group 1932 through 1972 USPHS - study to the natural 1932 through 1972 USPHS - study to the natural
history of untreated syphilishistory of untreated syphilis 400 men participated – spinal taps were presented 400 men participated – spinal taps were presented
as “special free treatment”as “special free treatment” 1940 penicillin found effective in the treatment1940 penicillin found effective in the treatment
Human Subjects in Research
Timeline of Events
NIH – Human Participant Protections Education for Research Teams
Human Subjects in Research
Timeline of Response
NIH – Human Participant Protections Education for Research Teams
Human Subjects in Research
Declaration of Helsinki (1964, revised 2000)
Distinction – Therapeutic vs. Non-Distinction – Therapeutic vs. Non-TherapeuticTherapeutic
Informed Consent – Central RequirementInformed Consent – Central Requirement Need for protocol, reviewed byNeed for protocol, reviewed by
independent committeeindependent committee
Human Subjects in Research
Federal Protections Begin Result of the Tuskegee Study exposureResult of the Tuskegee Study exposure National Research Act of 1974National Research Act of 1974
Codify policy for protection of human Codify policy for protection of human subjects (45 CFR 46)subjects (45 CFR 46)
Established Institutional Review Board as Established Institutional Review Board as authorizing bodyauthorizing body
Only applies to federally funded or FDA regulated Only applies to federally funded or FDA regulated research research
Human Subjects in Research
Belmont Report (1979) Cornerstone of ethical principles upon which the Cornerstone of ethical principles upon which the
federal regulations are basedfederal regulations are based Respect for PersonsRespect for Persons
Individual AutonomyIndividual AutonomyProtection of individuals with reduced Protection of individuals with reduced
autonomyautonomy BeneficenceBeneficence
Maximize benefits and minimize harmsMaximize benefits and minimize harms JusticeJustice
Equitable distribution of research costs and Equitable distribution of research costs and benefitsbenefits
HIPAA - Privacy Rule (4/14/03) (Health Insurance Portability and Accountability Act)
National health information privacy protectionNational health information privacy protection Applies to health plans and providers who conduct Applies to health plans and providers who conduct
electronic financial transactionselectronic financial transactions Applies to personally identifiable health Applies to personally identifiable health
information communicated electronically, on paper, information communicated electronically, on paper, or orallyor orally
Affords patients rights to education about privacy Affords patients rights to education about privacy safeguards, access to their medical records, and a safeguards, access to their medical records, and a process for correction of recordsprocess for correction of records
http://privacyruleandresearch.nih.govhttp://privacyruleandresearch.nih.gov//
HIPAA – Security Rule (4/21/05)
The standards define The standards define administrativeadministrative, , physicalphysical, and , and technical safeguardstechnical safeguards to protect the confidentiality, to protect the confidentiality, integrity, and availability of electronic protected integrity, and availability of electronic protected health information (EPHI)health information (EPHI)
Protect against any reasonably anticipated threats or Protect against any reasonably anticipated threats or hazards to the security or integrity of such hazards to the security or integrity of such informationinformation
Protect against any reasonably anticipated uses or Protect against any reasonably anticipated uses or disclosures of such information that are not disclosures of such information that are not permitted or required under the privacy rulepermitted or required under the privacy rule
Ensure compliance by its workforceEnsure compliance by its workforce
Human Subjects in Research
What Can the Administrator Do?
Become familiar with the requirements for Become familiar with the requirements for research involving human subjects research involving human subjects
Maintain rapport with IRB administratorsMaintain rapport with IRB administrators Assist investigator in applying for IRB approvalAssist investigator in applying for IRB approval Ensure training requirements are met for key Ensure training requirements are met for key
personnelpersonnel Become familiar with HIPAA regulations, and Become familiar with HIPAA regulations, and
assist PI in compliance with privacy regulationsassist PI in compliance with privacy regulations
Human Subjects in Research
Resources
DHHS Office for Human Research ProtectionsDHHS Office for Human Research Protections http://ohrp.osophs.dhhs.gov/http://ohrp.osophs.dhhs.gov/
IRB RegistrationIRB RegistrationAssurance FilingAssurance FilingPolicy GuidancePolicy GuidanceCompliance OversiteCompliance OversiteEducational MaterialsEducational MaterialsWorkshopsWorkshops
Human Subjects in Research
Resources
45 CFR 46 – Protection of Human Subjects45 CFR 46 – Protection of Human Subjects http://ohrp.osophs.dhhs.gov/http://ohrp.osophs.dhhs.gov/
humansubjects/guidance/45cfr46.htmhumansubjects/guidance/45cfr46.htmTo what does the policy applyTo what does the policy applyDefinitionsDefinitionsSubpart A – “Common Rule”Subpart A – “Common Rule”Subparts B-D – Vulnerable populationsSubparts B-D – Vulnerable populations
Human Subjects in Research
Resources
Belmont ReportBelmont Report http://ohrp.osophs.dhhs.gov/http://ohrp.osophs.dhhs.gov/
humansubjects/guidance/belmont.htmhumansubjects/guidance/belmont.htm Declaration of HelsinkiDeclaration of Helsinki
http://www.wma.net/e/policy/17c.pdfhttp://www.wma.net/e/policy/17c.pdf Nuremberg CodeNuremberg Code
http://www.dreamscape.com/morgana/http://www.dreamscape.com/morgana/ nurmberg.htmnurmberg.htm
Risk Assessment (Outline)
Protection of Human Subjects Protection of Human Subjects Care and Use of Animals in ResearchCare and Use of Animals in Research Stewardship of Federal FundsStewardship of Federal Funds Scientific MisconductScientific Misconduct Conflict of InterestConflict of Interest Application of Intellectual PropertyApplication of Intellectual Property Environmental Health and Safety IssuesEnvironmental Health and Safety Issues
Care and Use of Animals in Research
Public Involvement
1962 – 1962 – Silent SpringSilent Spring, by Rachel Carson, by Rachel Carson 1966 – LIFE magazine article1966 – LIFE magazine article
Care and Use of Animals in Research
Public Involvement 1982 – Silver Spring Monkey case1982 – Silver Spring Monkey case
Deafferentation StudyDeafferentation Study Infiltration of labInfiltration of lab Photos and affidavitsPhotos and affidavits Search warrant and seizureSearch warrant and seizure PETA on the mapPETA on the map
Care and Use of Animals in Research
Public Involvement
1983 –Head Trauma in Monkeys1983 –Head Trauma in Monkeys Animal Liberation Front burglaryAnimal Liberation Front burglary
6 years of research materials6 years of research materials60 hours of videotape60 hours of videotapeResearch animalsResearch animalsExtensive facility and equipment Extensive facility and equipment
damagedamage
Care and Use of Animals in Research
Government Involvement
1962 – NIH Contract – first 1962 – NIH Contract – first GuideGuide 1966 – Laboratory Animal Welfare Act 1966 – Laboratory Animal Welfare Act
Covers warm blooded animals used in Covers warm blooded animals used in teaching, research and testingteaching, research and testing
Excludes rats, mice and birdsExcludes rats, mice and birds Enforced by the USDAEnforced by the USDA Annual InspectionsAnnual Inspections
Care and Use of Animals in Research
Government Involvement
1985 – Health Research Extension Act1985 – Health Research Extension Act 1985 - Public Health Service Policy1985 - Public Health Service Policy
Covers live vertebrate animals when PHS Covers live vertebrate animals when PHS funds (NIH, NSF, HRSA…) are involvedfunds (NIH, NSF, HRSA…) are involved
Enforced by the Office of Laboratory Enforced by the Office of Laboratory Animal Welfare (OLAW), NIHAnimal Welfare (OLAW), NIH
Care and Use of Animals in Research
Government Involvement
PHS Policy and AWA establish the PHS Policy and AWA establish the Institutional Animal Care and Use Institutional Animal Care and Use Committee as the authorizing bodyCommittee as the authorizing body
IACUC ResponsibilitiesIACUC Responsibilities MembershipMembership Review proposed studiesReview proposed studies ReportReport
Care and Use of Animals in Research
Government Involvement
PHS through the PHS through the GuideGuide requires: requires: Occupational Health Program for Animal Occupational Health Program for Animal
WorkersWorkers Training for Animal WorkersTraining for Animal Workers
Care and Use of Animals in Research
What Can the Administrator Do?
Become familiar with the requirements of research Become familiar with the requirements of research involving animalsinvolving animals
Maintain a rapport with IACUC administratorsMaintain a rapport with IACUC administrators Assist investigator in applying for IACUC Assist investigator in applying for IACUC
approvalapproval Ensure IACUC approval is obtained Ensure IACUC approval is obtained Ensure training requirements are met for animal Ensure training requirements are met for animal
workersworkers
Care and Use of Animals in Research
Resources Office of Laboratory Animal WelfareOffice of Laboratory Animal Welfare
http://grants1.nih.gov/grants/olaw/olaw.htmhttp://grants1.nih.gov/grants/olaw/olaw.htmPHS Policy TutorialPHS Policy TutorialIndex to OLAW GuidanceIndex to OLAW GuidanceOLAW LISTSERVOLAW LISTSERVTraining MaterialsTraining Materials
Care and Use of Animals in Research
Resources Guide for the Care and Use of Laboratory Guide for the Care and Use of Laboratory
Animals (1996)Animals (1996) http://www.nap.edu/readingroom/books/http://www.nap.edu/readingroom/books/
labrats/contents.htmllabrats/contents.html Institutional Policies and Responsibilities Institutional Policies and Responsibilities Animal Environment, Housing, and Animal Environment, Housing, and
Management Management Veterinary Medical Care Veterinary Medical Care Physical Plant Physical Plant
Care and Use of Animals in Research
Resources PHS Policy on Humane Care and Use of PHS Policy on Humane Care and Use of
Laboratory AnimalsLaboratory Animals http://grants1.nih.gov/grants/olaw/http://grants1.nih.gov/grants/olaw/
references/phspol.htmreferences/phspol.htmApplicabilityApplicabilityDefinitions Definitions Implementation by InstitutionsImplementation by InstitutionsImplementation by PHSImplementation by PHS
Care and Use of Animals in Research
Resources
Association for Assessment and Association for Assessment and Accreditation of Laboratory Animal Care, Accreditation of Laboratory Animal Care, International (AAALAC, International)International (AAALAC, International) http://www.aaalac.org/http://www.aaalac.org/
Represents qualityRepresents qualityPromotes scientific validityPromotes scientific validityRecruiting toolRecruiting tool
Risk Assessment (Outline)
Protection of Human Subjects Protection of Human Subjects Care and Use of Animals in ResearchCare and Use of Animals in Research Stewardship of Federal FundsStewardship of Federal Funds Scientific MisconductScientific Misconduct Conflict of InterestConflict of Interest Environmental Health and Safety IssuesEnvironmental Health and Safety Issues
Stewardship of Federal Funds
How? How? How? How Funds will be ExpendedHow Funds will be Expended
Fiscal managementFiscal management Charging practicesCharging practices
How Research will be ConductedHow Research will be Conducted Research integrityResearch integrity Conflict of InterestConflict of Interest
How Research Outcome will Benefit the PublicHow Research Outcome will Benefit the Public Encourage application of intellectual propertyEncourage application of intellectual property Share outcome to spawn new researchShare outcome to spawn new research
Stewardship of Federal Funds
OMB Circulars
OMB A-110OMB A-110 Standard for obtaining consistency and Standard for obtaining consistency and
uniformity among Federal agencies uniformity among Federal agencies Applicable to institutions of higher Applicable to institutions of higher
education, hospitals, and other non-profit education, hospitals, and other non-profit organizationsorganizations
Stewardship of Federal Funds
OMB Circulars
OMB A-21OMB A-21 Cost Principles for Educational Cost Principles for Educational
InstitutionsInstitutions OMB A-122OMB A-122
Cost Principles for Non-Profit Cost Principles for Non-Profit OrganizationsOrganizations
Stewardship of Federal Funds
OMB Circulars
OMB A-21 and A-122OMB A-21 and A-122 Define the financial framework for Define the financial framework for
administering federally sponsored researchadministering federally sponsored research Describe the basis for calculating facilities Describe the basis for calculating facilities
and administrative costs (F&A; indirect)and administrative costs (F&A; indirect) Provide guidance for determining how to Provide guidance for determining how to
charge specific, common costscharge specific, common costs
Stewardship of Federal Funds
Where Can Things Go Wrong?
During Post-AwardDuring Post-Award Direct ChargingDirect Charging Cost TransfersCost Transfers Effort ReportingEffort Reporting Cost SharingCost Sharing
Stewardship of Federal Funds
Direct Charges Must Measure Up
The yard (meter) stickThe yard (meter) stick ReasonableReasonable AllocableAllocable ConsistentConsistent AllowableAllowable
Stewardship of Federal Funds
Universal Truths
Brush your teeth before bedBrush your teeth before bed An apple a day keeps the doctor awayAn apple a day keeps the doctor away Don’t swim for 1 hour after eatingDon’t swim for 1 hour after eating Look both ways before you cross the streetLook both ways before you cross the street I before E except after CI before E except after C Reasonable, Allocable, Consistent and Reasonable, Allocable, Consistent and
AllowableAllowable
© 2001 Arthur Andersen
Stewardship of Federal Funds
Reasonable
Prudent Person Rule (A-21 & A-122)Prudent Person Rule (A-21 & A-122) ““A cost may be considered reasonable if A cost may be considered reasonable if
the nature of the goods or services the nature of the goods or services acquired or applied, and the amount acquired or applied, and the amount involved therefore, reflect the action that involved therefore, reflect the action that a prudent person would have taken under a prudent person would have taken under the circumstances prevailing at the time the circumstances prevailing at the time the decision to incur the cost was made.”the decision to incur the cost was made.”
Stewardship of Federal Funds
Allocable A cost is allocable to a Federal award if it is treated A cost is allocable to a Federal award if it is treated consistentlyconsistently
with other costs incurred for the same purpose in like with other costs incurred for the same purpose in like circumstances and if it:circumstances and if it:
Is incurred specifically for the award;Is incurred specifically for the award; Benefits both the award and other work and Benefits both the award and other work and
can be distributed in reasonable proportion; or can be distributed in reasonable proportion; or Is necessary to the overall operation of the Is necessary to the overall operation of the
organization, although a direct relationship to organization, although a direct relationship to any particular cost objective cannot be shown.any particular cost objective cannot be shown.
Stewardship of Federal Funds
Consistent and Allowable ConsistentConsistent
Similar cost incurred in like circumstances Similar cost incurred in like circumstances must be treated consistentlymust be treated consistently
AllowableAllowable Not otherwise specified as unallowableNot otherwise specified as unallowable ““The fact that a cost requested in a budget is The fact that a cost requested in a budget is
awarded, as requested, does not ensure a awarded, as requested, does not ensure a determination of allowability. The determination of allowability. The organization is responsible for presenting organization is responsible for presenting costs consistently and must not include costs costs consistently and must not include costs associated with their F&A rate as direct associated with their F&A rate as direct costs.”costs.”
• NIH GPS (03/01) NIH GPS (03/01)
Stewardship of Federal Funds
What Can the Administrator Do?
Become familiar with the OMB Circulars Become familiar with the OMB Circulars and Institutional Policiesand Institutional Policies
Assist investigator during the budget Assist investigator during the budget formulationformulation
Review the budget Review the budget Develop tests for departmental Develop tests for departmental
administrators administrators Perform internal targeted reviewsPerform internal targeted reviews
Stewardship of Federal Funds
Resources Office of Management and BudgetOffice of Management and Budget
OMB A-110OMB A-110
http://www.whitehouse.gov/omb/circulars/http://www.whitehouse.gov/omb/circulars/a110/a110.htmla110/a110.html
OMB A-122OMB A-122
http://www.whitehouse.gov/omb/circulars/http://www.whitehouse.gov/omb/circulars/a122/a122.htmla122/a122.html
OMB A-21OMB A-21
http://www.whitehouse.gov/omb/circulars/a02http://www.whitehouse.gov/omb/circulars/a021/a0211/a021
. html. html
Stewardship of Federal Funds
Resources
NIH Grants Policy StatementNIH Grants Policy Statement http://grants.nih.gov/grants/policy/http://grants.nih.gov/grants/policy/
nihgps_2001/nihgps_2001/
Risk Assessment (Outline)
Protection of Human Subjects Protection of Human Subjects Care and Use of Animals in ResearchCare and Use of Animals in Research Stewardship of Federal FundsStewardship of Federal Funds Scientific MisconductScientific Misconduct Conflict of InterestConflict of Interest Environmental Health and Safety IssuesEnvironmental Health and Safety Issues
Scientific MisconductScientific Misconduct
SCIENCE IS A COMMUNITY SCIENCE IS A COMMUNITY BASED ON TRUSTBASED ON TRUST
““Most Americans see a strong science as Most Americans see a strong science as essential to a successful future. Yet that essential to a successful future. Yet that generous social support is based on the generous social support is based on the
premise that science will be done premise that science will be done honestly and that mistakes will be honestly and that mistakes will be
routinely identified and corrected.”routinely identified and corrected.”
President, National Academy President, National Academy of Sciences, 1989of Sciences, 1989
Scientific MisconductScientific Misconduct
Scientific MisconductScientific Misconduct
INTEGRITYINTEGRITY
1.1. The condition of having no part or element The condition of having no part or element taken away or wanting; undivided or taken away or wanting; undivided or unbroken state; material wholeness, unbroken state; material wholeness, completeness, entirety.completeness, entirety.
2.2. The condition of not being marred or The condition of not being marred or violated; unimpaired or uncorrupted violated; unimpaired or uncorrupted condition; original perfect state; soundness.condition; original perfect state; soundness.
The Oxford English Dictionary, 1933The Oxford English Dictionary, 1933
““The right to search for truth The right to search for truth
implies also a duty; implies also a duty;
one must not conceal any partone must not conceal any part
of what one has of what one has
recognized to be true.”recognized to be true.”
- AlbertAlbert EinsteinEinstein
Scientific MisconductScientific Misconduct
PHS Reportable Misconduct:PHS Reportable Misconduct:
Fabrication, falsification, plagiarism, or other Fabrication, falsification, plagiarism, or other practices that seriously deviate from those that practices that seriously deviate from those that are commonly accepted within the scientific are commonly accepted within the scientific community for proposing, conducting, or community for proposing, conducting, or reporting research. It does not include honest reporting research. It does not include honest error or honest differences in interpretation or error or honest differences in interpretation or judgment of data.judgment of data.
Scientific Misconduct
DATA COLLECTION, MANAGEMENT AND RECORD KEEPING
Scientific MisconductScientific Misconduct
Data Collection and PresentationData Collection and Presentation
TrimmingTrimming
CookingCooking
ForgeryForgery
PlagiarismPlagiarism
““Trimming: the smoothing of Trimming: the smoothing of irregularities to make the data irregularities to make the data look extremely accurate and look extremely accurate and precise.”precise.”
““-Honor in Science” Sigma Xi (1986)-Honor in Science” Sigma Xi (1986)
Scientific MisconductScientific Misconduct
““Cooking: retaining only Cooking: retaining only those results that fit the those results that fit the theory and discarding theory and discarding others.”others.”
““-Honor in Science” Sigma Xi (1986)-Honor in Science” Sigma Xi (1986)
Scientific MisconductScientific Misconduct
““Forging: inventing some or all Forging: inventing some or all of the research data that are of the research data that are reported and even reporting reported and even reporting experiments to obtain data that experiments to obtain data that were never performed.”were never performed.”
““-Honor in Science” Sigma Xi (1986)-Honor in Science” Sigma Xi (1986)
Scientific MisconductScientific Misconduct
Plagiarism is the Plagiarism is the misappropriation of another misappropriation of another individual’s thoughts, ideas, or individual’s thoughts, ideas, or writings and claiming them as writings and claiming them as one’s own.one’s own.
Scientific MisconductScientific Misconduct
Scientific MisconductScientific Misconduct AccountabilityAccountability
The laboratory notebook The laboratory notebook represents the final authority on represents the final authority on data collection, manipulation, and data collection, manipulation, and presentation.presentation.
Scientific MisconductScientific Misconduct
AuthorshipAuthorship
Authorship on a scientific paper Authorship on a scientific paper should be limited to those should be limited to those individuals who have contributed individuals who have contributed directly to the design and directly to the design and execution of the experiments and execution of the experiments and who have participated in the who have participated in the preparation of the manuscript.preparation of the manuscript.
Risk Assessment (Outline)
Protection of Human Subjects Protection of Human Subjects Care and Use of Animals in ResearchCare and Use of Animals in Research Stewardship of Federal FundsStewardship of Federal Funds Scientific MisconductScientific Misconduct Conflict of InterestConflict of Interest Environmental Health and Safety IssuesEnvironmental Health and Safety Issues
Conflict of Interest
A Body with Many Heads Public ExpectationsPublic Expectations
Protect SubjectsProtect Subjects Preserve TrustPreserve Trust Promote ProgressPromote Progress
Bioethicists ConcernsBioethicists Concerns Profits may cloud scientific integrityProfits may cloud scientific integrity Experiments may be pushed that might Experiments may be pushed that might
not be safenot be safe
Conflict of Interest
It’s About Public Trust
Longstanding interest in objectivity in Longstanding interest in objectivity in research and financial conflict of interestresearch and financial conflict of interest
Key Question: “Is the situation likely to Key Question: “Is the situation likely to interfere or interfere or appearappear to interfere with the to interfere with the independent judgment one is supposed to independent judgment one is supposed to show as a professional performing official show as a professional performing official duties?duties?
Conflict of Interest
Significant Financial Interest
Anything of monetary value, including but Anything of monetary value, including but not limited to, salary or other payments for not limited to, salary or other payments for services; equity interests; and intellectual services; equity interests; and intellectual property rightproperty right
> $10,000 or > 5% ownership interest for > $10,000 or > 5% ownership interest for any one enterprise or equityany one enterprise or equity
Conflict of Interest
1999 – University of Pennsylvania 1999 – University of Pennsylvania Researchers testing new way to replace Researchers testing new way to replace
defective genes to treat enzyme disorders. defective genes to treat enzyme disorders. 18 year old Jesse Gelsinger died from the 18 year old Jesse Gelsinger died from the gene therapy studygene therapy study
The university held equity in the company The university held equity in the company developing the drug, and the lead doctor developing the drug, and the lead doctor held one-third of its shares of stockheld one-third of its shares of stock
Conflict of Interest
Significant Financial Interest Disclosure of Significant Financial InterestDisclosure of Significant Financial Interest
Funding by NIH or NSFFunding by NIH or NSF Includes faculty, spouse, dependent Includes faculty, spouse, dependent
childrenchildren Declarations are made annually or as new Declarations are made annually or as new
significant financial interests are obtainedsignificant financial interests are obtained
Conflict of Interest
Significant Financial Interest Interest must beInterest must be
Managed;Managed; Reduced; orReduced; or EliminatedEliminated
Management PlanManagement Plan Include brief, general explanation of Include brief, general explanation of
actions taken butactions taken butExcludeExclude personal financial data personal financial data
NIH GMO notified; NSF notified only if can’t NIH GMO notified; NSF notified only if can’t managemanage
Conflict of Interest
Significant Financial Interest National Institutes of Health researchersNational Institutes of Health researchers 900 current and former scientists collected 900 current and former scientists collected
$8.9 M in royalties for drugs and inventions $8.9 M in royalties for drugs and inventions they discovered while working at NIHthey discovered while working at NIH
Until recently, no disclosure required to Until recently, no disclosure required to clinical trials subjectsclinical trials subjects
Conflict of Interest
Significant Financial Interest GI physician (M. Wolfe) at Boston University asked GI physician (M. Wolfe) at Boston University asked
to review data comparing Celebrex with two older to review data comparing Celebrex with two older arthritis medicationsarthritis medications
Favorable JAMA reviewFavorable JAMA review One year later, while serving on FDA advisory One year later, while serving on FDA advisory
committee, Wolfe reviewed data again and found committee, Wolfe reviewed data again and found the study ran for 1 year, not 6 months, and benefits the study ran for 1 year, not 6 months, and benefits of Celebrex goneof Celebrex gone
Pharmaceutical company suppression of negative Pharmaceutical company suppression of negative datadata
Conflict of Interest
What Can the Administrator Do?
Become familiar with PHS requirements Become familiar with PHS requirements and Institutional policyand Institutional policy
Assist Investigator in disclosing significant Assist Investigator in disclosing significant financial interestsfinancial interests
Notify Grants Management when Notify Grants Management when appropriateappropriate
Ensure annual disclosureEnsure annual disclosure
Conflict of Interest
Resources
Conflict of Interest (NIH, OER)Conflict of Interest (NIH, OER) http://grants1.nih.gov/grants/policy/http://grants1.nih.gov/grants/policy/
emprograms/overview/ep-coi.htmemprograms/overview/ep-coi.htmNIH Grants Policy StatementNIH Grants Policy StatementFAQsFAQs
Conflict of Interest
Resources
PHS Policy (42CFR50)PHS Policy (42CFR50) http://www.access.gpo.gov/nara/cfr/http://www.access.gpo.gov/nara/cfr/
waisidx_01/42cfr50_01.htmlwaisidx_01/42cfr50_01.htmlApplicabilityApplicabilityDefinitionsDefinitionsInstitutional ResponsibilitiesInstitutional ResponsibilitiesManagement of Conflicting InterestsManagement of Conflicting Interests
Conflict of Interest
Resources
New England Journal of MedicineNew England Journal of Medicine Volume 346:285-287 Jan. 24, 2002Volume 346:285-287 Jan. 24, 2002
Association of American Medical Association of American Medical Colleges Task Force report discussionColleges Task Force report discussion
BackgroundBackground
Conflict of Interest
Resources
GAO (2001): Report on Conflict of Interest GAO (2001): Report on Conflict of Interest in Biomedical Researchin Biomedical Research Study of UniversitiesStudy of Universities
http://www.aau.edu/research/GAO.pdf http://www.aau.edu/research/GAO.pdf
Conflict of Interest
Resources
DHHS (5/05/2004): Financial Relationships DHHS (5/05/2004): Financial Relationships and Interest in Research Involving Human and Interest in Research Involving Human Subjects: Guidance for Human Subject Subjects: Guidance for Human Subject ProtectionProtection Issues for Institutions, Investigators and Issues for Institutions, Investigators and
IRBsIRBshttp://www.hhs.gov/ohrp/http://www.hhs.gov/ohrp/
humansubjects/finreltn/fguid.pdfhumansubjects/finreltn/fguid.pdf
Risk Assessment (Outline)
Protection of Human Subjects Protection of Human Subjects Care and Use of Animals in ResearchCare and Use of Animals in Research Stewardship of Federal FundsStewardship of Federal Funds Scientific MisconductScientific Misconduct Conflict of InterestConflict of Interest Environmental Health and Safety IssuesEnvironmental Health and Safety Issues
Environmental Health and Safety
Regardless of who funds the workRegardless of who funds the work The Institution is absolutely responsible for:The Institution is absolutely responsible for:
Health and Safety of faculty, staff and Health and Safety of faculty, staff and students students
Environmental ComplianceEnvironmental Compliance
Environmental Health and Safety
Safe workplace is obligation of grant awardSafe workplace is obligation of grant award
Environmental Health and Safety
Major Federal Laws and How they affect research
Occupational Safety and Health ActOccupational Safety and Health Act Select Agent Laws and regulationsSelect Agent Laws and regulations Hazardous Waste Law (RCRA)Hazardous Waste Law (RCRA) Toxic Substances Control ActToxic Substances Control Act
Environmental Health and Safety
Major Federal Laws and How they affect research Occupational Safety and Health Occupational Safety and Health
ActAct Agency: U. S. Occupational Agency: U. S. Occupational
Safety and Health AdministrationSafety and Health Administration Chemical Hygiene Plans Chemical Hygiene Plans
(OSHA 29 CFR 1910.1450)(OSHA 29 CFR 1910.1450) control exposure to control exposure to
hazardous chemicalshazardous chemicals additional requirements for additional requirements for
particularly hazardous particularly hazardous chemicalschemicals
required for select agent required for select agent toxinstoxins
IMPORTANCE OF SECURITYTime Line of Using Select Agents
Bubonic Plague Samples Missing in Texas
2000
1339-1351
1763
1994-1995
1977
Six more arrested in London Ricin poison find
20012003
2003
Environmental Health and Safety
Select Agent Laws and regulations Biological or chemical Biological or chemical
that are potential that are potential weapons of mass weapons of mass destruction.destruction.
ExamplesExamples
RicinRicin AnthraxAnthrax SmallpoxSmallpox Ebola VirusesEbola Viruses
Ricin
Anthrax Spores
Environmental Health and Safety
Major Federal Laws and How they affect research
Select Agent Laws and regulationsSelect Agent Laws and regulations Security Security
Physical Security - locked storage Physical Security - locked storage areas, locked labs, locked buildingsareas, locked labs, locked buildings
Inter and Intra facility transfersInter and Intra facility transfersRisk assessment for PI and lab staffRisk assessment for PI and lab staffFacility risk assessment and security Facility risk assessment and security
plansplans
Environmental Health and Safety
Major Federal Laws and How they affect research Resource Resource
Conservation & Conservation & Recovery Act (i.e. Recovery Act (i.e. Hazardous Waste Law Hazardous Waste Law (RCRA)(RCRA)
Agency: US Environmental Agency: US Environmental Protection AdministrationProtection Administration
Environmental Health and Safety
Radiation Safety
Standards for Protection Against RadiationStandards for Protection Against Radiation Occupational Exposure LimitsOccupational Exposure Limits Exposure Limits to Members of the Exposure Limits to Members of the
PublicPublic Release Limits to the EnvironmentRelease Limits to the Environment
What Can the Administrator Do?
Maintain rapport with the Safety department Maintain rapport with the Safety department Be aware of approval processes for chemical, Be aware of approval processes for chemical,
biological, and radioactive materialsbiological, and radioactive materials Identify hazards to Safety before grant submitted. Identify hazards to Safety before grant submitted.
May be able to address hazard reduction in grantMay be able to address hazard reduction in grant Ensure approvals are obtained Ensure approvals are obtained Ensure training requirements are met for all Ensure training requirements are met for all
personnel personnel Be aware of PI and Institutional responsibilities and Be aware of PI and Institutional responsibilities and
associated processes and documentationassociated processes and documentation
Environmental Health and Safety
Resources
Biosafety in Microbiological and Biosafety in Microbiological and Biomedical Laboratories (BMBL)Biomedical Laboratories (BMBL) DHHSDHHS CDCCDC NIHNIH
http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm
Environmental Health and SafetyResources NIH Guidelines for Research Involving NIH Guidelines for Research Involving
Recombinant DNA MoleculesRecombinant DNA Molecules DHHSDHHS NIH (OBA)NIH (OBA)
http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html
Research Compliance in Perspective
How Many Times Have You Heard?
““But other research institutes and But other research institutes and Universities allow…”Universities allow…”
Managing an Institutional Compliance Program
Challenges Research is performed and administered Research is performed and administered
throughout the institution throughout the institution Departmental Administrators have other Departmental Administrators have other
responsibilitiesresponsibilities Inability to segregate instruction, research, and Inability to segregate instruction, research, and
patient care makes administration complexpatient care makes administration complex Knowledge of regulations and expectations are Knowledge of regulations and expectations are
limitedlimited Training on research compliance is often Training on research compliance is often ad hocad hoc
and not performed effectivelyand not performed effectively
Engaged ManagementHow to delegate responsibility and authority while still staying
in control
The Problem
Once an organization grows larger than a single person can manage, then management has to be delegated.When management tasks are split among many people, the need for coordination arises
The Challenge of Coordination
What has been delegated to whom?Am I supposed to write the report or is my boss?
What is each person’s level of authority?Am I supposed to make the decision or not?
What is the expectation for follow up and task completion?
What is the due date for the project?
Intra Organizational Communication
Between supervisor and supervised
Between peers in an organization
A consistent message for all branches of an organization
Who Does What?
The Supervisor needs to assign tasks (delegate) in a way that optimizes organizational productivity.Usually related areas of management responsibility are grouped for efficient delegation.
You don’t ask an accounting manager to handle a facilities task!
Principles of Engaged Management
1. Regular communication2. Progress reporting3. Goal-setting4. Problem identification5. Managerial support6. Mutual understanding of workload
and tasks
Regular Communication
The Monthly Management Report1. On time, every time.2. Three Sections:
• Accomplishments• Priorities (in priority order)• Need for support
Progress Reporting
1. What was accomplished.2. Who participated (peers,
subordinates, supervisor)3. Serves as a reminder at annual
performance review time4. Provides the opportunity to “toot
your own horn”.
Goal Setting1. Short-term goals2. Longer-term goals3. Forces employee to think about how
to allocate their time.4. Provides supervisor the discretion to
prioritize tasks differently as organizational demands change.
Problem Identification
What high priority goals seem to never get accomplished?What are the impediments to completion?Was the task inappropriately delegated?
Wrong person?Wrong department?Wrong time?
Managerial SupportShould the task have been delegated to this person?Are resources needed for completion?Does the delegator need to arbitrate?Would this task be more easily solved with a “team” approach?Is the level of authority appropriate?
Level of AuthorityEvery item has an appropriate level of
authorityType 1 – “Handle it, but keep me informed.”Type 2 – “You are responsible, but come to me for direction and support.”Type 3 – “I will take primary responsibility for this item, but it affects your area so you work with me as a team on it.”
Type 1
“Handle it, but keep me informed.”
Example: There is a water leak in a laboratory. The facilities manager is empowered to solve the problem, but by letting her supervisor know of the problem and its progress to resolution, the supervisor is not “blind sided”.
Type 2“You are responsible, but come to me for
direction and support.”
Example: A new PI wants a lab modified at a cost of $10,000. The facilities manager understands the problem, collects information, examines alternatives, but gets her supervisor to provide direction and participate in the decision.
Type 3“I will take primary responsibility for this
item, but it affects your area so you work with me as a team on it.”
Example: The Dean has decided to build a new building. The supervisor will have this as a long-term project, and the facilities manager will be an active participant and provide staff support to the supervisor.
Level of Authority Problems
Many problems arise because either an employee fails to exert authority when they should, or oversteps her/his authority.When in doubt, ASK!Level of Authority grows with time in job and as the employee grows in experience and judgment.
Mutual Understanding
Employee and supervisor gradually understand each other’s jobs, pressures, demands, and needs.Communication is regular and open.No surprises!Better decisions result when both parties are engaged in the management of the area.
The Monthly MeetingOn-site or off-site at employee’s option. Bring the report!Guaranteed private time. (“My boss cares about me!”)“How do you feel about your job, your career, the workload, your peers, your staff.“What can I do as your supervisor to make your job easier, or increase your job satisfaction?”
Additional Management Tools
ReportsWorkload statisticsCapacity planningTrendsTroubling e-mailsRequisitions!
Adapt the Tool to the People
One size doesn’t fit allFermentation manager VS MIS DirectorDegree of detail and frequency of reportingReport contentInclude reports of sub-organizational units
When the System Fails
People who refuse to be accountablePeople who refuse to be managedPeople who can’t plan, organize, or prioritize
Do’s
Insist on a consistent application of the programRead the reportsAsk questions / understandPut yourself in the other person’s shoesRecognize and reward progressSeek meaningful ways to be supportive
Instructions for Skill Practice Activity• Participants will work in groups of 3
• Each person will alternate between A, B and C• A = Principal• B = Respondent• C = Observer
• A’s will go first, followed by B’s with C’s going last
Practice 3 Key Points
• Participants will be asked to practice 3 key points from the HR session
– Evaluating Performance
– Delegation
– Scientist and the Human Resource
• Allow 9 minutes for each key point – each participant will have 3 minutes and then rotate their role
• The presenters will review the 3 key points when the participants have finished
1) Evaluating Performance
Three months ago you hired a new mailroom clerk and he is not working out as well as you expected. He started out fine but you find that he has called in sick the last two Mondays and has had to leave early on a number of days. You want to schedule a meeting with him to review his performance but feel a bit reluctant to do so because he is such a nice person and you do not want to antagonize him. What you do not realize is that your mailroom clerk has a very sick parent to care for.
2) Delegation
You have been asked to review a collaboration agreement that must go out tomorrow but are in the middle of finalizing your departmental budget that you promised to give to your finance officer by tomorrow at noon. It is your birthday today and a big party is planned for you this evening. There is only one other person who you can give any one of these jobs to in your department. He is in the middle of an important project and you have already spoken to him about being late in submitting it to you. What do you do?
3) Scientists and the Human Resource
Dr. Roy, your institution’s most senior research scientist appears at your desk on Monday morning with a new research associate whom he has just hired. He has not advised anyone at your institution about this and wants to charge his salary to a grant account that was closed two months ago. How do you respond to him and what steps do you take to straighten things out?
Intellectual Property & Technology Transfer
AgreementsA Glimpse into the Wild World of
Technology Transfer
Topics
• Invention Reports
• Confidential Disclosure Agreements (CDAs / NDAs)
• Material Transfer Agreements (MTAs)
• License Agreements
• Option Agreements
• Recap and Practical Matters
Invention Reports
Invention Reports• Report at Time of Invention – Does
Not Require “Reduction to Practice”• Obtain Written Assignments at Time of
Invention Report• Report Internally Prior to Public Disclosure
(Discussions, Collaborations, Publications, Proposals) – One Year Trigger
• Invention Report Helps to Support “First to Invent” Doctrine (U.S.)!
• Make Report as Broad / All-Encompassing as Possible – Don’t be Constrained by Patentability
Anatomy of an Invention Report
• Front Page Needs to be “at a Glance”– Report Date– Inventorship (Legal Name, Affiliation, Home
Address, Contact Info, & Citizenship) – MUST be Correct!
– Sponsorship (Sponsor Name, Contract/Grant #, Funding Period/ Dates, PI)
– Invention Title
Anatomy of an Invention Report
• Invention Abstract
• Prior Art (Patents, Publications, Commercially Available Products & Services) – What Else is Out There & How & Why Yours is Better
• Detailed Invention Description – Broaden!
• Figures & Drawings
• Supporting Data / Reduction to Practice
Anatomy of an Invention Report
• Public Disclosures – Prior & Planned
• Regulatory Approval Requirements – Does This Invention Require Regulatory Agency Approval, e.g., EPA, USDA, FDA, OSHA?
• Market Assessment – Potential Markets, Competition, Potential Licensees
• Personal Objectives - File Only, Desire Utility Patent, Commercialize Via License / Start-Up – If Start-Up, What Role?
Anatomy of an Invention Report
• Signatures with Dates– Inventors– Witness – Needs to be Familiar with or
Understand Underlying Technology– Department Chairperson (Optional)– Office of Recordation
Anatomy of an Invention Report
• Inventor Request for Waiver of Rights– For inventions created external to institution, or
without significant institutional resources– Inventor signatures Required
• List of Faculty Knowledgeable About Subject Matter Technical “Due Diligence”
Confidential Disclosure Agreements(CDAs)
Confidential Disclosure Agreements(CDAs)
• Also called Nondisclosure
Agreements (NDAs)
• One Direction Vs. Mutual (2-Way)
• One Party Vs. 2 Party Agreements
• One Mutual CDA Between 3 Parties is NOT the Same as Three 2-Party CDAs!
• Motivation for Institution is to Prevent Public Disclosure (Loss in Patent Rights)
Confidential Disclosure Agreements(CDAs)
• Motivation for Industry is to Protect Proprietary Information – Publication Restrictions!
• Require PI to Sign Letter of Understanding & Compliance – Needs to Educate ALL Who Are Involved in Handling Confidential Info
• Track / Monitor Dates – Issue Memo to PI When CDA is Terminated
• Watch out for: (a) Disclosure of Company’s Name, (b) Company’s “Business” (Strategies, Plans, Customers, Employee Names, etc.), (c) use of Company Info in Multi-Partner Proposals and Publications
Anatomy of a CDA
• Recitals – You have Rights, We Have Rights, You want Institution to Perform Research, What Defines “Confidential Information”
• Purpose of Confidential Info Disclosure = Research Only! No Other Purpose
• No Express or Implied License to Use Info
Anatomy of a CDA
• Info Provided to be Returned or Destroyed Upon Written Request
• Recipient to Use “Best Efforts to Preserve” – Remember that Faculty / Students/ Researchers Far More Likely to Slip Up Than Industry Counterpart!e.g. “Recipient shall use its best efforts to preserve the confidentiality… and shall use not less than reasonable care with respect to such Confidential Information…”
Anatomy of a CDA
• CAN Disclose the Following: (a) Available to Public, (b) Becomes Part of the Public Domain Through no Fault of Recipient, (c) Previously Lawfully Disclosed to Recipient, (d) Previously Developed Independently by Recipient – Require (c) and (d) to include “… as Proven with Written Records”
• Jurisdiction – Agreement Governed by Laws of Institution’s State (Usually State Law Requirement – Only Alternative is to Remain “Silent” on Issue)
Anatomy of a CDA
• Term of Agreement and Confidentiality Requirement - Shorter the Better for Institutions
• Assignment of Rights by Company Requires Institution’s Written Consent
• Agreement is Binding on all Employees of Company / Institution
• Typical “No Reps or Warranties”• Approved Signatures – Who’s Approved to Sign at
Your Institution?
Material Transfer Agreements(MTAs)
Material Transfer Agreements(MTAs)
• Usually for Exchange of Biological Materials / Animals – BUT Can Apply to Other Materials
• Most Institutions Have Different Agreements for Incoming and Outgoing Materials
• Know Who is Authorized to Sign for Your Institution – Faculty Typically See Review as “Red Tape” and May Sign to Expedite Receipt of Material
• Preserve Publication Rights!• Watch out for “Built-in” IP License / Assignment • Standardize Templates and Publish on Web to Expedite
Process & Prevent Negotiations Challenges
Anatomy of an MTA(For Outgoing Materials)
• Define Material to be Transferred (and Include all Derivatives, Modifications, and Improvements)
• Define Ownership of Material – Institution!• Recipient Agrees NOT to Transfer to Others
Without Institution’s Consent• Recipient Has Right to Use (& File Patents
for) Substances Created Using Materials ONLY IF Substances are NOT Derivatives / Modifications
Anatomy of an MTA(For Outgoing Materials)
• Modifications / Derivatives MAY be Distributed to Not-for-Profit or Government Agencies without Provider Approval ONLY for Research Purposes
• Modifications / Derivatives for Commercial Use Require License from Provider
• No Inherent License Rights
• Define Who Owns Resulting IP (“Yours, Mine, Ours”)
Anatomy of an MTA(For Outgoing Materials)
• MTA does NOT Alter any Previously Granted Rights to Material
• Provider’s Obligation to Fully Disclose ANY Health or Safety Risks / Precautions Known to be Associated with Materials
• Typical “No Reps or Warranties”
• Recipient Assumes ALL Liability for Use
• Jurisdiction of Law
Anatomy of an MTA(For Outgoing Materials)
• Recipient Agrees to Comply with ALL Laws and Regulations (Human / Animal Subjects, Export Control, etc.)
• Agreement Termination Provisions – Time + How to Dispose of Materials
• Fees Required – If Any
• Signatures
License Agreements
License AgreementsThe “Bread & Butter” of Tech Transfer
• Licenses & Assignments are Different
• Provide the Ability to Manufacture & Sell
• Exclusive Vs. Nonexclusive
• Perpetual Vs. Timed
• Worldwide Vs. Licensed
Territory
• Unlimited Use Vs. Field of Use
• Right to Sublicense
License AgreementsThe “Bread & Butter” of Tech Transfer
• Institution’s Internal Right to Use
Madey Vs. Duke University
• Institution’s Right to Publish
• Compensation Choices: Royalties, Fees, Equity, % of Profits, Good & Services (Barter)
• Patent Prosecution & Maintenance – Who Manages & Who Pays?
License AgreementsThe “Bread & Butter” of Tech Transfer
• Auditable Financial Records
• What Happens in the Event of Bankruptcy?
• How do you Handle Patent Infringers or an Infringement Case Against Licensee / Institution?
• Commercialization Plan / Milestones
• What are “Clawback Provisions”?
License AgreementsThe “Bread & Butter” of Tech Transfer
• Guard Against “Shell Game” & Other Tricks– All Products Sold Through Sublicensees– Collateralization of License for Debt– Sale / Merger of Company– Transfer of Rights to Subsidiaries– Definition of “Net Sales”– Definition of “Bundling”– Technology Workarounds
Anatomy of a License Agreement
• Recitals - “Soft Objectives” & SOPs• Definitions – Need to Clearly & Distinctly Define
Agreement Terms:– “Licensed Products and Processes”
– “Invention Rights” – Derivatives/Improvements Included?
– “Know How”
– “Net Sales Revenue” (Gross Sales Revenue Even Better!)
– “Licensed Field of Use”
– “Licensed Territory”
– “Internal Use”
Anatomy of a License Agreement• License Grant
– Exclusive or Nonexclusive– Perpetual or Time-Based– Field of Use– Right to Sublicense– Institution’s Right to Internal Use – Institution’s Right to Publications– Cross-license Rights– Force Any Additional Research Requirement to be
Governed by Separate Agreement(s)– Preserve Government Rights (Bayh-Dole, FAR/DFARS)– Ensure Compliance with all Regs (e.g. Export Control)
Anatomy of a License Agreement
• Licensee Acknowledgement of Understanding– Add Clause that States that
Licensee Fully Investigated
Inventions / Invention Rights
- is Satisfied that Everything
is Accurate, Complete & Understood
Anatomy of a License Agreement
• Compensation– Fees:
• How Much are Fees, and How
are They to be Paid? (Initial, Maintenance Fees)
– Royalties:• What Royalty %? Based on Gross/Net Sales? When
Payable? If Bundling Involved, Definition is Critical – How Does One Calculate the Right Amount?
• Sublicense Royalty Terms (%, When, How, Who Collects?)
Anatomy of a License Agreement• Compensation
– Equity:• Previously not Part of
License Compensation – Becoming More Prevalent
• Understand Who Holds Equity for Institution• Voting Vs. Nonvoting Stock• Common Vs. Preferred Stock• Membership Units Vs. Shares• Warrants / Options / Put• Board Representation – Observer Only Vs. Voting
Anatomy of a License Agreement
• Patent Prosecution– Who Manages Filings, Prosecution & Maintenance?– Who Assumes the Costs?– Define How to Handle Termination of Agreement or
Abandonment of Rights
• Record Keeping and Reporting– Where are Records to be Stored?– Permit Inspection / Audits by Institution (or Designee)– Reporting Requirements for Commercialization Plan– Financial Reports Should be Sent to Institution Quarterly– Specify Penalty for Late Payments
Anatomy of a License Agreement• Statement to Prevent Public Disclosure
– Applies to Unpatented Technologies and CIPs / Divisionals (Derivatives / Improvements / Enhancements)
– Could Lose Patent Rights w/ Public Disclosure!– Use CDAs or Patent Filings Prior to Public Disclosure
• Adherence to Commercialization /Milestone Plan– Initial License Fee ($)– Delivery of Written Commercialization / Business Plan (w/
Identifiable Milestones)– Deadline for First Commercial Sale– Annual License Maintenance Fee– Failure of any Above Results in “Clawback”
Anatomy of a License Agreement
• Patent Markings – Ensure all Commercial Products are Marked w/ Patent (or Patent Pending) Numbers
• Termination Provisions – Who Can Terminate, When, and What are Ramifications of Termination?– Nonpayment by Licensee
– Evidence of “Shell Game”
– Bankruptcy / Dissolution of Company
– How to Handle Inventory of Licensed Products AFTER Termination of License Agreement
Anatomy of a License Agreement
• Patent Infringement– Decide Who Manages Process
and Who Pays– Decide How to Handle any
Resulting Awards
• Prohibition of Use of Institution’s Name – All Licensees WANT to Publicize Relationship w/ Institution to Provide Credibility, Stability, Reputation Enhancement, Validation
Anatomy of a License Agreement
• Typical Warranties and Reps, Succession & Assignability, Indemnification
• Require Licensee to Have General Liability Insurance as Precautionary Measure – Mostly for Start-ups / Small Companies – Usually $1M per Claim, $3M in Aggregate
• Typical Notice Statement, Jurisdiction of Law, Compliance w/ Laws – e.g. Government IP Rights and Export Restrictions
Anatomy of a License Agreement
• Signatures
• Attachment / Exhibit A :
Description of Invention(s)
& Patent(s)
• Attachment / Exhibit B :
Format for Commercialization / Business Plan Required
Option Agreements
Option Agreements
• Can be Separate Agreements or Embedded in Research Agreements
• Provides Period of Exclusivity While Technology is Being Evaluated
• Can Provide:– Right of First Refusal– Automatic Licensing Terms (Exclusive /
Nonexclusive) – OR – Ability to Negotiate on “Commercially Reasonable” Terms
Option Agreements
Example 1: Option Embedded in Research Agreement
Company Option. Pursuant to the terms of this Agreement, and provided that Company is not otherwise in default of this Agreement or any Task Statement hereunder, Company shall have the option, for Project Inventions, to an exclusive license as described in this Section X (the “Option”).
Option Agreements
• Example 2: Separate Option (or “Exclusivity”) Agreement
– Company pays $50,000 cash for Right of Exclusivity for a Period of 6 Months (to Evaluate Technology)
– At End of Exclusivity Period, Company has Ability to Exercise Option (Usually 30 – 60 Day Window) for an Exclusive License to Technology at the Following Terms…
Recap and Practical Matters
Recap and Practical Matters
• Report Inventions BEFORE Public Disclosure• Obtain Written Assignments• Broaden Invention Disclosures to Increase Inherent
Value • Multiple 2-Party CDAs NOT Same as 1 Mutual
CDA Among the Parties• Use CDAs to Preserve Patent Rights• Educate PIs on Ramifications of CDAs and Solicit
Their Help in Educating Others on Project
Recap and Practical Matters
• Provide Heads-Up When CDA Terminates• Use MTAs, but Watch out for Inherent IP Rights
(Loss) or Publication Restrictions• Consider Export Control Issues for all Material
Exchanges• Typically Different MTAs for Incoming and
Outgoing Materials & For-Profit Vs. Not-For-Profit Use
• No MTA is ALWAYS Better than Bad MTA!
Recap and Practical Matters
• Understand Difference Between Licenses & Assignments
• Preserve Institution’s Right to “Internal Use” and Publications
• Every “Deal” is Different – Standard License Templates Will NOT Usually Work
• Know the Pros & Cons of Having Licensee Control Patent Prosecution Vs. Institution
• Provide Clawback Capability in Licenses
Recap and Practical Matters
• Watch out for Shell Game & Other Tricks by Licensees
• Use Option Agreements / Clauses to Prevent Problems Down the Road – Establish Pipeline!
• Use Option Agreements / Clauses to get Paid for Period of Exclusivity – Time = CASH!
• Always Seek Advice from Tech Transfer / Legal Advisors Within Institution When Uncertain
• DON’T be Afraid of IP – It’s NOT as Scary as it Seems!
Financial Reporting or Financial Reporting or “Financial Reports Even a “Financial Reports Even a Scientist Can Understand”Scientist Can Understand”
This session will explore creative ways to present the "right data" at the "right time" in the "right format" to a wide variety of audiences, e.g., PI's, department Chair, various central institution offices.
The "Sunshine System" a series of tools developed to download central financial data to build a "Sunshine" system (rather than a "shadow" system) will be discussed.
Learn how to provide graphical financial data to PIs and top management, and compliance data to research administrators. See how inexpensive PC databases can be used to generate "anywhere, anytime" graphical reports from your department via the Web.
Financial Reporting Includes
1. Budgets2. Expenditures (Actual Costs and Encumbrances)3. Balance to Spend4. Forecasting (Burn Rate Chart)5. Budget Carry Forwards and Other Issues6. Reporting Tools7. Integrating Financial and Non-Financial Data
1. Which Budget? Budget for the project period. Budget for the fiscal year. Budget for the fiscal year + unexpended
carry forward. Budget for the direct cost portion only or
budget for the Direct + Indirect. Budget for the funded portion + the cost
share portion.
2. Best Practices for Budgets Know which accounts will allow unexpended
balances to carry forward versus those that won’t because you will manage these accounts differently.
When two or more accounts are equally appropriate for an expenditure, charge the expense to the account that does not permit carry forward!
2. Which Expenditures? Current period expenditures. Expenditures for the fiscal year or project
year? Expenditures for the fiscal year +
Encumbrances. If salaries are encumbered, HOW? Are “time benefits” (e.g. vacation time)
accrued?
Unanticipated Source of FundsUnanticipated Source of Funds
FROM THE DESK OF IKE EGO UNION BANK OF NIGERIA telephone FROM THE DESK OF IKE EGO UNION BANK OF NIGERIA telephone numbers 234-1-7766371 numbers 234-1-7766371
ATTENTION: DEAR, ATTENTION: DEAR,
STRICTLLY A PRIVATE BUSINESS PROPOSAL I AM IKE EGO, THE STRICTLLY A PRIVATE BUSINESS PROPOSAL I AM IKE EGO, THE MANAGER, BILLS AND EXCHANGE AT THE FOREIGN MANAGER, BILLS AND EXCHANGE AT THE FOREIGN REMITTANCE DEPARTMENT OF THE UNION BANK OF NIGERA REMITTANCE DEPARTMENT OF THE UNION BANK OF NIGERA PLC. I AM WRITING THIS LETTER TO ASK FOR YOUR SUPPORT PLC. I AM WRITING THIS LETTER TO ASK FOR YOUR SUPPORT AND COOPERATION TO CARRY OUT THIS BUSINESS AND COOPERATION TO CARRY OUT THIS BUSINESS OPPORTUNITY IN MY DEPARTMENT. WE DISCOVERED AN OPPORTUNITY IN MY DEPARTMENT. WE DISCOVERED AN ABANDONED SUM OF $15,000.000.00 (FIFTEEN MILLION UNITED ABANDONED SUM OF $15,000.000.00 (FIFTEEN MILLION UNITED
STATES DOLLARSSTATES DOLLARS . . . . . . . . . . . .
IN AN ACCOUNT THAT BELONGS TO ONE OF OUR FOREIGN IN AN ACCOUNT THAT BELONGS TO ONE OF OUR FOREIGN CUSTOMERS WHO DIED ALONG WITH HIS ENTIRE FAMILY OF A CUSTOMERS WHO DIED ALONG WITH HIS ENTIRE FAMILY OF A WIFE AND TWO CHILDREN IN NOVEMBER 1997 IN A PLANE WIFE AND TWO CHILDREN IN NOVEMBER 1997 IN A PLANE CRASH. SINCE WE HARD OF HIS DEATH, WE HAVE BEEN CRASH. SINCE WE HARD OF HIS DEATH, WE HAVE BEEN EXPECTING.HIS NEXT-OF-KIN TO COME OVER AND PUT CLAIMS EXPECTING.HIS NEXT-OF-KIN TO COME OVER AND PUT CLAIMS FOR HIS MONEY AS THE HEIR, BECAUSE WE CANNOT RELEASE FOR HIS MONEY AS THE HEIR, BECAUSE WE CANNOT RELEASE THE FUND FROM HIS ACCOUNT UNLESS SOMEONE APPLIES THE FUND FROM HIS ACCOUNT UNLESS SOMEONE APPLIES FOR CLAIM AS THE NEXTOF-KIN TO THE DECEASED AS FOR CLAIM AS THE NEXTOF-KIN TO THE DECEASED AS INDICATED IN OUR BANKING GUIDELINES. UNFORTUNATELY, INDICATED IN OUR BANKING GUIDELINES. UNFORTUNATELY, NEITHER THEIR FAMILY MEMBER NOR DISTANT RELATIVE HAS NEITHER THEIR FAMILY MEMBER NOR DISTANT RELATIVE HAS
EVER APPEARED TO CLAIM THE SAID FUND. . . . .EVER APPEARED TO CLAIM THE SAID FUND. . . . . Send your reply through; [email protected] your reply through; [email protected]
2. Best Practices for Expenditures Understand exactly how expenditures are
charged to your accounts.– Labor– Non-recurring costs (e.g. tuition remission)– Summer salaries
Know “hidden costs” during account close-out (accrued vacation time).
2. Classification of Costs2. Classification of Costs
Costs
Allowable Unallowable
Direct
Costs
Indirect
Costs
2. Best Practices - Expenses Develop a “cheat sheet” for your PIs and others to
tell them how to code real-life costs in the system so that costs are accurate.
Clearly define how to handle unallowable costs. Know which costs are unallowable and isolate them from allowable costs. Use separate POs, requisitions, object codes, and even account numbers.
Be ready to show auditors that unallowables are segregated!
3. Balance to Spend
What does EVERY PI want to Know?
3. Balance to Spend
How Much Money is Left?
3. Balance to Spend Thinking Deeper
How much money is left? Will the budgeted funds last to the project
end date? Can overdrafts in one expense area be
covered by surpluses in another area? Is the expenditure rate increasing or
decreasing?
3. Balance to Spend Thinking Deeper
To answer these questions you will need more information than you typically see
in a “Project Status Report”!
3. Project Status Report Budget Actual expenses, this period Actual expenses, year-to-date
(whatever that means!) Encumbrances Free Balance
O/C Description Budget Actual Encumbrance Free Balance
11000 Salaries & Wages 200,000 53,582 41,567 104,851
12000 Fringe Benefits 60,000 14,629 11,444 33,927
13000 Supplies 35,000 17,244 1,500 16,256
17000 Travel 8,000 5,344 2,656
18000 Equipment 40,000 - 40,000
Total 343,000 90,799 54,511 197,690
3. The Project Status Report3. The Project Status Report The typical financial reporting tool a system The typical financial reporting tool a system
provides for a PIprovides for a PI Answers the question “How much money is left?”Answers the question “How much money is left?” Budget/Actual/Encumbrance/Free BalanceBudget/Actual/Encumbrance/Free Balance Backup reports for actual and encumbrance Backup reports for actual and encumbrance
detaildetail This is an important tool. But not the only tool!This is an important tool. But not the only tool!
3. Project Status Report Problems3. Project Status Report Problems Doesn’t differentiate between one-time Doesn’t differentiate between one-time
costs and recurring (tuition remission, costs and recurring (tuition remission, equipment)equipment)
Typically doesn’t consider trendsTypically doesn’t consider trends Doesn’t account for companion funding Doesn’t account for companion funding
(cost sharing)(cost sharing) Doesn’t account for budget increments Doesn’t account for budget increments
(non-competing renewals)(non-competing renewals)
3. The “Burn Rate” Approach Balance remaining is adjusted for known,
unexpended amounts Balance to Spend is compared to the “burn
rate” to see if the time the money will last matches the time the grant is to run.
Projected unexpended balance is compared to agency guidelines for maximum carry forward.
O/C Description Budget Actual Encumbrance Free Balance
11000 Salaries & Wages 200,000 53,582 41,567 104,851
12000 Fringe Benefits 60,000 14,629 11,444 33,927
13000 Supplies 35,000 17,244 1,500 16,256
17000 Travel 8,000 5,344 2,656
18000 Equipment 40,000 - 40,000
Total 343,000 90,799 54,511 197,690
Months 12 3
Burn Rate 28,583 30,266
4. Forecasting
Where your accounts are TODAY is irrelevant!
Where are they going to be at the project completion date?
4. Using Burn Rate for Forecasting Is forecasting a part of your management
system? For many organizations it is not. What do your management reports tell you
and do your PIs understand them? Who are the “financial wizards” at your
organization and what tools do they use? It is simple to use burn rates to forecast!
O/C Description Budget Actual Actual to Completion Free Balance
11000 Salaries & Wages 200,000 53,582 214,328 (14,328)
12000 Fringe Benefits 60,000 14,629 58,516 (13,145)
13000 Supplies 35,000 17,244 68,976 (51,220)
17000 Travel 8,000 5,344 21,376 (18,720)
18000 Equipment 40,000 - 40,000 -
Total 343,000 90,799 403,196 (97,413)
Months 12 3
Burn Rate 28,583 30,266
4. Burn Rate Chart Uses Project Status Report data,
supplemented with … Burn rates applied to future months Start and End dates are clearly recognized A visual tool that “even a Scientist can
understand”!
Burn Rate
-
50,000
100,000
150,000
200,000
250,000
300,000
350,000
Jan-01 Feb-01 Mar-01 Apr-01 May-01 Jun-01 Jul-01 Aug-01 Sep-01 Oct-01 Nov-01 Dec-01
Incr Budget Cum Exp Proposal Budget Total Budget Cum + Proj
End Date
Maximum Aw ard Amount
Incremental Funding
Project Budget
Actual Expense
4. The “Burn Rate” Chart4. The “Burn Rate” Chart Primary graphical financial toolPrimary graphical financial tool Produced automaticallyProduced automatically Shows past, present, and futureShows past, present, and future Accepted by PIs as tool of choiceAccepted by PIs as tool of choice Encourages labor projectionsEncourages labor projections Shows: remaining funds, historical spending Shows: remaining funds, historical spending
pattern, increments, projections, and pattern, increments, projections, and contract end date.contract end date.
4. The “Burn Rate” Chart (2)4. The “Burn Rate” Chart (2) ““Am I burning funds too quickly or too Am I burning funds too quickly or too
slowly?”slowly?” ““When will I need a funding increment?”When will I need a funding increment?” ““Does the financial burn rate match the Does the financial burn rate match the
planned statement of work?” (“Do I need an planned statement of work?” (“Do I need an NFE?”)NFE?”)
““Am I still in the ‘ramp up’ phase, or have Am I still in the ‘ramp up’ phase, or have expenditures stabilized?”expenditures stabilized?”
5. Budget Carry Forwards and Other Issues
Know that your project accounts have different “years” from the unrestricted accounts and make sure spreadsheets recognize this difference.
5. Budget Control Best Practices Know project start and end dates and track
budgets at least monthly. Be sure all costs are allowable to the
project. Cost transfers require clear documentation. Labor certification is a MUST. Monitor costs closely in last 90 days.
5. Budget Carry Forward Restricted VS Unrestricted – accounts need
to be treated differently Agency Allowable guidelines (25% rule?) Understand exactly how your financial
system handles this transaction. Understand how financial reports reflect this
phenomenon.
6. How Do We Get from PSR to Burn Rate Charts?
Manual System Shadow System “Sunshine” System
6. Manual System
Spreadsheets are created from Project Status Reports or other information.
Work grow in proportion to the number of accounts tracked
Work has to be repeated each month Possibility for errors
““SHADOW” SystemSHADOW” System Many research departments maintain Many research departments maintain
separate recordsseparate records Very common where on-line access is limitedVery common where on-line access is limited Viewed as easier for control of labor and other Viewed as easier for control of labor and other
costscosts Involves DUPLICATE record-keeping andInvolves DUPLICATE record-keeping and Redundant data entry, but may be worth the Redundant data entry, but may be worth the
cost!cost!
Research Department
Research Department
Duplicate Input
InstitutionFinancialSystem
Shadow SystemShadow System
Standard ReportsSpecial Reports
Reconcile Reports
Making a Good Thing even Better!Making a Good Thing even Better! Goals of Departmental Financial Tracking Goals of Departmental Financial Tracking
SystemSystem– No redundant entry of dataNo redundant entry of data– Enrich central data with local knowledgeEnrich central data with local knowledge– Integration of Labor projection databaseIntegration of Labor projection database– Project status even a Ph.D. can understand!Project status even a Ph.D. can understand!– Rollups by “group”, division, and InstituteRollups by “group”, division, and Institute– Data accessible to anyone, anywhereData accessible to anyone, anywhere
6. Tools Necessary to Accomplish 6. Tools Necessary to Accomplish the Objectivethe Objective
– Access to Institutional dataAccess to Institutional data– Departmental data in a suitable formatDepartmental data in a suitable format– A tool to integrate data from multiple sources, A tool to integrate data from multiple sources,
probably a simple database such as ACCESSprobably a simple database such as ACCESS– A tool to export integrated data to spreadsheets A tool to export integrated data to spreadsheets
and graphs such as EXCELand graphs such as EXCEL– WEB technology for any-platform accessWEB technology for any-platform access
““Sunshine” System ModelSunshine” System Model Data is entered only once.Data is entered only once. No reconciliation among systems is requiredNo reconciliation among systems is required Local data makes central data more valuableLocal data makes central data more valuable Institute is free to design reports that are locally Institute is free to design reports that are locally
meaningfulmeaningful Opens opportunities for local customization and Opens opportunities for local customization and
integration to local technology infrastructureintegration to local technology infrastructure
Research Department
Research Department
UniversityFinancialSystem
LocalData
LocalData
TM
Standard Reports Web Reports E-MailGraphsSpecial Reports
“SunshineSystem”TM
Monthly Data Download
“Official Data”
Input Transactions
0
10
1stQtr
3rdQtr
0
10
1stQtr
3rdQtr
Advantages to PIAdvantages to PI Doesn’t need a central account/password Doesn’t need a central account/password
(local security protocol)(local security protocol) Doesn’t need to know central account Doesn’t need to know central account
numbersnumbers Can access project data from office, home, Can access project data from office, home,
hotel, virtually anywhere!hotel, virtually anywhere! Doesn’t have to use any “standard” Doesn’t have to use any “standard”
hardware or softwarehardware or software
7. Integrating Financial Data with 7. Integrating Financial Data with Operational DataOperational Data
Grant funds VS Unrestricted fundsGrant funds VS Unrestricted funds Space Occupied VS Indirect Cost RecoverySpace Occupied VS Indirect Cost Recovery Grant applications VS prior yearsGrant applications VS prior years ““Book-to-Bill” ReportBook-to-Bill” Report
GRANTS SUBMITTED/AWARDED BY FISCAL YEAR
49
12
89
25
87
17
69
17
102
22 23
10
20
40
60
80
100
120
FY98 FY99 FY00 FY01 FY02 FY03
47.1
0.9
45.8
0.1
0
20
40
60
Thru 12/31/2001 Thru 12/31/2002
Comparison of Direct grants to SKCC Funds
0
50,000
100,000
150,000
200,000
250,000
300,000
350,000
0 100,000 200,000 300,000 400,000 500,000 600,000 700,000 800,000
Grant Volume
SKC
C F
unds
Space vs 2000 Actual IDC Recovery
$-
$100,000
$200,000
$300,000
$400,000
$500,000
$600,000
$700,000
0 500 1000 1500 2000 2500 3000 3500
Square Feet
Act
ual I
ndire
ct R
ecov
ery
Sponsored Research Direct Base Cumulative
0
1,000,000
2,000,000
3,000,000
4,000,000
5,000,000
6,000,000
7,000,000
8,000,000
9,000,000
Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep
-
5,000,000
10,000,000
15,000,000
20,000,000
25,000,000
J an-
00
Feb-
00
Mar-
00
Apr-
00
May-
00
J un-
00
J ul-
00
Aug-
00
Sep-
00
Oct-
00
Nov-
00
Dec-
00
J an-
01
Feb-
01
Mar-
01
Apr-
01
May-
01
J un-
01
J ul-
01
Cumulative Grant Income
Cumulative Grant Expenditures
Book-to-Bill Report
Conclusions The surest way to be recognized as a savvy
Research Administrator is to exhibit strong financial management.
Today you can find an impressive set of resources to help you: computer tools, management techniques, helpful colleagues, training programs, and web sites.
Using these tools, you can create financial reports even a scientist can understand!
Financial Planning and Shadow Accounting
Arguing with an Auditor is LikeWrestling with a Pig in Mud...
After a while, you realize the pig ENJOYS it!
The Importance of Financial Planning at the Departmental Level Cannot be Overstated!
Question 1: Where are we now?Question 2: Where are we going?
Financial Planning
Question 1: Where are we now?
Critical need for accurate, detailed and current view of financial status (by project and department-wide)
• If institutional accounting records provide this – fine!
• If not, you need a departmental system (“shadow accounting”).
Financial Planning
Question 2: Where are we going?Projecting expenditure/revenue forecasts into the future (for fiscal year)
• Special attention to personnel– Plan to cover soft money people for year– Note institutional policy for “layoffs”
Name Funding Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May JunWashington, G. GRIP 24% 14th
Lincoln, A. DOE-F 15%GRIP 60% 14thMIP 10%STC/Teleimmersion 15%
Jefferson, T. DOE-F 12.5%I-FLOW 50%NANO 25%STC/Teleimmersion 12.5%DOE-F 50%STC/Teleimmersion 50%100%
Clinton, B. GRIP 100% 14th
Ford, G. DOE-F 20%STC/Teleimmersion 13%
Eisenhower, D. MIP 100%
Johnson, L. STC/Teleimmersion 100%
Truman, H. GRIP 100% 14th
Reagan, R. MIP 100%
Roosevelt, F. DOE-F 30%I-FLOW 20%NANO 10%MIP 10%STC/Teleimmersion 30%
Personnel Funding Chart
Name Funding Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May JunLarry DOE-F 20%
STC 8%MCNC 5%STC 28%MCNC 33%ITR-F 14%(NEW)DOE-F 14%ITR-Brown/Welch 5%ITR-F 38%(NEW)DOE-F 38%
Curley TRUST 20%STC 60%STC 35%MCNC 5%GRIP 20%ONR-Bishop 20%ITR-F 20%(NEW)DOE-F 5%ITR-N 35%KECK-OVHD 35%ONR Bishop 10%ITR-F 40%(NEW)DOE-F 30%
Moe TRUST 10%STC 72%MCNC 18%STC 32%DOE-M 100%ONR-Bishop 20%GRIP 23.5% (NEW)DOE-F 33%ITR-Brown/Welch 23.5%
Personnel Funding Chart
Question 2: Where are we going?Projecting expenditure/revenue forecasts into the future (for fiscal year)
• Special attention to personnel– Plan to cover soft money people for year– Note institutional policy for “layoffs”
• Special attention to fixed expenses– Equipment (or software) maintenance
contracts, rent
Financial Planning
Do You Need A Departmental System?
Remember, central systems are first designed to meet institutional needs
Department needs are secondary Central systems often don’t provide
everything that is needed to “run a department”, for example:• Store backup for purchase quotes (your auditors
will want to see these)• Store vacation and sick leave data• Give you the flexibility to produce the reports that
you need• ENCUMBER SALARIES THROUGH BUDGET PERIOD
Are Central Records Systems Adequate?
“Relying upon poor data from a central system to manage the financial affairs of your department is like relying upon the tide to steer your ship.”
It Just Doesn’t Make Sense!
Shadow Accounting Systems“A shadow accounting system is a set
of records maintained at a local level independent of the official records”• Have existed in some form probably
forever• PIs keeping account balances in lab
books• Personal computers fostered an
explosion of shadow systems
When To Implement A Shadow Accounting System? When central records
• Do not provide enough detailed information,
• The information is not readily available in a usable form,
• When there is too much lag time between incurring an obligation and it being posted to the central records, and
• If the benefits (dollars and time) out weigh the costs!
Additional Advantages Tracking Extra Data on Transactions
• Purpose of expense, e.g., graduate student education fund, faculty recruiting
• Category of expense, e.g., supplies for particular class
Maintaining sub accounts internally for a single central account• Departmental “earmarks” for gift or
institutional accounts• May be easier to keep in one account (less
institutional hassle and paperwork)
“Dos” Do be sure to enter transactions into your
system before they “leave your office” (paper or electronic)
Do be sure that your records are secure and stored in a safe form and location
Do perform a regular, thorough reconciliation to official records using a reconciliation worksheet
Do print and store reports in a form that are useful in audit situations
Do train more than one person on the proper use of the system.
“Don’ts” Don’t assume that magnetic files will
always be available for printing the report the auditor is going to request!
Don’t assume that just because you recorded the transaction correctly in YOUR system, that it got posted correctly in THEIR system!
Don’t assume that the person who uses the system today will ALWAYS be around tomorrow!
Goal
Financial Reconciliation Process
Step 1
Obtain central data (financial reports and transaction data) in a form that you can match with the shadow system (typically by account for a particular accounting period)
Financial Reconciliation Process
UNC Central Report
UNIVERSITY OF NORTH CAROLINA - CHAPEL HILL FINANCIAL RECORDS SYSTEM
FBM090 - C2 SUMMARY ACCOUNT STATEMENT FOR 08/31/00 DIST# REPORT DISTRIB = 3276 INTERACTIVE GRAPHICS FOR MOLECULAR STUDIES & MICROSCOPY
REPORT PAGE 2531 PROGRAM ID FBM0929 ACCOUNT PAGE 1
ACCT: ATTRI
5-31136 0-110-32761
TO:
CB 3175, SITTERSON
SPON:NAT CTR FOR RES RESR BUD PD:051500-051401 AWARD: $855,675.00 CON#:5-P41-RRO2170-17 CAN#: PRJ PD:050184-051401 FROE:OOOO FR:081201 PY:530846 SPON CODE:DHHS TR:081201 PRIME #:531136 OVHD-ON:H 4500 OFF: SUB -------- BUDGETS -------- -----------------
- ACTUALS ------------------ OPEN BALANCE
CODE DESCRIPTION ORIGINAL REVISED CURRENT MONTH FISCAL YEAR PROJECT YEAR COMMITMENTS AVAILABLE 1001 C/G PERSONNEL 395,190.00 255,069.96 255,069.96 1112 EPA NON-TEACH - 54,859.36 21,120.22 35,799.04 54,859.36 1113 EPA NON-TEACH - 9 365.19 2,369.00 4,034.78 9,365.19 1117 MO STU/OTHER NON 42:792.35 15,888.63 25,264.44 42,792.35 EPA NON-TEACH SA 107,016.90 39,377.85 65,098.26 107,016.90 1212 SPA ON CAMPUS 31,377.76 2,420.16 4,791.55 7,694.83 23,682.93 1251 SPA SEVER WAGES 15.38 4.84 9.58 15.38 SPA EMPLOYEE SAL 31,393.14 2,425.00 4,801.13 7,710.21 23,682.93 1411 NON-STUDENT WAGE 300.00 300.00 300.00 300.00 1451 STUDENT WAGE 1,410.00 468.75 915.00 1,410.00 TEMP EMPLOYEE WA 1,710.00 768.75 1,215.00 1,710.00 TOTAL PERSONNEL 395,190.00 395,190.00 42,571.60 71,114.39 116,437.11 23,682.93 255,069.96 1800 STAFF BENEFITS 60,086.00 41,545.31 41,545.31 1812 SOCIAL SECURITY 5,483.63 1,410.22 2,520.07 4,292.87 1,190.76 1813 SOC SECUR - HOSP 1,433.46 406.44 704.25 1,154.98 278.48 1822 STATE RETIREMENT 4,087.85 759.83 1,301.56 2,401.63 1,686.22 1831 MED INSURANCE OT 413.28 118.00 236.00 413.28 1832 MEDICAL INSURANC 738.68 128.25- 214.81 738.68 1833 HMO/HEALTH PLANS 2,596.30 281.97 582.74 898.37 1,697.93 1836 MEDICAL INS GRAD 469.02 207.99 469.02 469.02 1872 TIAA RETIREMENT 2,194.84 684.17 1,444.65 2,194.84 1873 TIAA-HEALTH PLAN 531.69 416.85 474.66 531.69 1876 ORP FIDELITY 359.10 359.10 359.10 359.10 1892 COMPOSITE BENEFI 232.84 85.13 142.21 232.84 STAFF BENEFITS 60,086.00 60,086.00 4,601.45 8,449.07 13,687.301, 4,853.39 41,545.31 1920 PROF CONSULTING 5,500.00 5,500.00 5,500.00 2000 SUPPLIES & MATER 9,500.00 7,384.00 7,384.00 2311 EDUCATIONAL SUPP 2,116.00 1,644.24 1,753.67 1,809.66 306.34 SUPPLIES / MATER 9,500.00 9,500.00 1,644.24 1,753.67 1,809.66 306.34 7,384.00 3100 TRAVEL 8,317.00 5.90- 5.90-
FR04B/PCB-08 Rev.,PCB-02:9
UNC Central ReportDATE RUN 09/08/00 UNIVERSITY OF NORTH CAROLINA - CHAPEL HILL REPORT PAGE 2539TIME RUN 11:09:05 FINANCIAL RECORDS SYSTEM PROGRAM ID FBM092FBM091 REPORT OF TRANSACTIONS FOR 08/31/00 ACCOUNT PAGE 5
DIST# REPORT DISTRIB = 3276INTERACTIVE GRAPHICS FOR MOLECULAR STUDIES & MICROSCOPY
FR04C/PCB-0890
ACCT: 5-31136 TO:
DEPT: 3276 CB 3175, SITTERSONSUB 2ND J.E. OFFSET BUDGET CURRENT BATCHCODE DESCRIPTION DATE TC~ REF. REF. ACCOUNT ENTRIES REV/EXP COMMITMENTS REF. DATE1876 J W Smith 08/31 042 M02 REG 179.55 APRM02 00083
J W Smith 08/31 042 M02 119 8.55 APRM02 00083J W Smith 08/31 042 JE2412 171.00 APRM02 00083
1876 CM TOTAL ORP FIDELITY 359.101892 PAYROLL RESERVE (16) 08/11 042 B03 REG 2.91 APRB03 00081
PAYROLL RESERVE (16) 08/25 042 B04 REG 3.47 APRB04 00082PAYROLL RESERVE (16) 08/31 042 M02 REG 78.75 APRM02 00083
1892 CM TOTAL COMPOSITE BENEFITS 85.131920 CNA 08/15 020 2000509 5,500.00 CGOL99 000811920 CM TOTAL PROF CONSULTING
FEES 5,500 00
2000 CNA 08/15 020 2000509 9,500.00 CGOL99 000812000 CM TOTAL SUPPLIES & MATERIALS2311 IEEE MAGAZINES 08/11 050 K399887 1,115.00 CGLLL 00081
IEEE INC 08/18 048 K399887 920261 1,115.OO 1,115.00- APC419 00081TAPE RESOURCES INC 08/10 050 K409250 519.30 CGLLL 00081TAPE RESOURCES INC 08/17 048 K409250 916738 519.30 519.30- APC415 00081DELL MARKETING LP 09/06 050 K434469 306.34 DP5003 00090D Davis 08/14 050 K435666 7.73 CGLLL 00081D Davis 08/22 048 K435666 921540 7.29 7.73- APC425 00082NEWARK ELECTRONICS 08/11 050 K435730 2.65 CGLLL 00081NEWARK ELECTRONICS 08/18 048 K435730 920163 2.65 2.65- APC419 00081
2311 CM TOTAL EDUCATIONAL SUPPLIES 1.644.24 306.34
3100 CNA 08/15 020 2000509 8,317.00 CGOL99 000813100 CM TOTAL TRAVEL 8,317.00
3121 R M Hall 08/24 048 T012732 923834 210.00 996.00- APC430 00082F P Albright 08/16 048 T012747 915818 349.79 349.79- APC413 00081C Wall 08/23 048 T012751 922967 206.00 206.00- APC428 00082C Wall 08/28 050 T012751 474.00- ENC912 00082
3121 CM TOTAL OUT/STATE TRANS-AIR 765.79 2.025.79-
3122 R M Hall 08/24 048 T012732 923835 63.85 APC430 00082F P Albright 08/16 T012747 915818 87.75 APC413 00081
3122 CM Total OUT/STATE TRAN-GROUN 151.603124 R M Hall 08/24 048 T012732 923835 570.55 APC430 00082
F P Albright 048 T012747 915818 692.65 APC413 00081C Wall 08/16 048 T012751 922967 232.77 APC428 00082
3124 CM TOTAL OUT/STATE SUB-LODGIN 10495.97
Financial Reconciliation Process
Step 2
Prepare shadow data (financial reports and transaction data) in the matching format as the central data.
Computer Science Department Report
Selection Criteria: Account Budget Report Report Run On: 10/10/00 11:00:47JAM Account=5-00000 Account 5-00000 PI Name Donald Duck Current Budget Period 5/15/00 5/14/01 NIH - GRIP – PRIME Budget Code Description Budget Encumbered Expensed Balance 1000 Personnel 395,190.00 30,192.39 116,437.11 248,560.50 1800 Faculty/Staff Benefits 60,086.00 4,621.33 13,687.30 41,777.37 1900 Con sultants/Temporaries 5,500.00 5,500.00 2000 Supplies & Materials 9,500.00 3,345.28 1,809.66 4,345.06 3100 Travel 8,317.00 4,542.90 5,317.90 (1,543.80) 3130 Foreign Travel 2,900.00 756.43 2,143.57 3200 Communication 500.00 16.28 45.92 437.80 3400 Printing/Binding 24.72 (24.72) 3800 Computer Services 49,858.00 9,399.48 6,356.34 34,102. 1 8 3900 Miscellaneous 600.00 463.25 136.75 4400 Maintenance Contracts 10,000.00 9,606.72 393.28 5000 Equipment 38,000.00 38,000.00 6500 Educational Grants 13,153.00 13,153.00 8900 Indirect Costs 243,764.00 178,559.62 65,204.38 0.00 8982 Restricted Funds 18,307.00 18,307.00 0.00
I Total for Account: 5-00000 855,675.00 258,591.00 210,103.01 386,980.
Selection Criteria:Object Code=231 1, Object Set=UNC, Account=5-31136 Account Breakdown Report Report Run On:10/11/00 2:16:50PM
Account
Budget Code 2000
5-31136 NIH - GRIP - PRIME
Supplies & Materials
5/12/00 6/30/00 VISA CARD CHARGES NONE JET VISA04 NONE 1,862.90 55.99
5/19/00 8131/00 GUTHOLD - IEEE REPRINTS K399887
NONE 1,115.00
5/31/00 8/31/00 TAPES/FUJI/SONY/PANASONIC TAPERESC HARRISC K409250 NONE 519.30
6/29/00 7131/00 INV# 1747678 NEWARK HARRIS( K422113 NONE 28.30
6/29/00 7/31/00 INV# 1775603 NEWARK HARRIS( K422137 NONE 29.30
6/29/00 7/31/00 INV# 1798294 NEWARK HARRIS( K422144 NONE 4.20
6/29/00 7/31/00 INV# 1753606 NEWARK HARRISC K422145 NONE 47.63
7/18/00 HDA APPLE K430340 NONE 286.20
7/20/00 INV# 387776 MARKERT HARRIS( K431865 NONE 246.917/26/00 8/31/00 INV# 410860217 DELL STONEM k434469 NONE 306.347/31/00 8131/00 REIMBURSE FOR FREEDM, K435666 NONE 0.44 7.29
REFRESHMENTS FOR NIH SITEVISIT
7/31/00 8/31/00 YELLOW LED'S/K411941NEWARK HARRIS( K435730 NONE 2.658/9/00 MINI-CIRCUITS INV# 792054 BRUMBA K440673 NONE 457.888/9/00 MINI-CIRCUITS INV# 796875 K440683 NONE 170.708/30/00 INV# P49056420103MICROWA K451954 NONE 149.00
9/22/00 VISA CARD CHARGES NONE NONE VISA03 NONE STINE 116.58
Total for Budget Code 2000 0.00 3,596.95 1,809.66
Balance Available for Budget Code 2000 (5,406.61)
3,596.95 1,809.66
Step 3Compare differences in expenditures/balances by object code between central and departmental financial reports
• This will alert you to particular areas of discrepancy
Summary of Discrepancies
Central Records Departmental Records Difference
Personnel 255,069.96 248,560.50 6,509.46
Supplies 7,384.00 4,345.06 3,038.94
Travel 2,137.67 593.87 1,543.80
Financial Reconciliation Process
Step 4
Best approach - compare all transactions for the period and “check off” those that match.
Compromise approach (use in situations where volume is enormous and accounting staff resources are limited) - compare all transactions for the period in the object codes where discrepancies were noted in the comparison of financial reports.
Financial Reconciliation Process
Every discrepancy must be researched
and explained!
IMPORTANT
What Are Likely Explanations For These Discrepancies?
Timing errors
Posting errors
Processing errors (the form is still sitting on your desk!)
Reconciliation Confirm the timing items by inquiry to
the central system. If you can’t find them, you will need to do more research.
Confirm posting errors to the central system and get them fixed.
Correct departmental processing errors. Keep a list of items that should be
corrected in the next accounting cycle.
Reconciliation Unmatched central items “got past
you” and need to be recorded in the shadow system, or explained out in a reconciliation worksheet.
Cost SharingAnd Effort Reporting
Departmental and Central Office Shared Responsibilities
Issues
• Cost share defined
• Allowable and unallowable cost share
• Identification of sources
• Identification of responsible persons
• Regulations
• Audits and repercussions
Cost sharing or matching is that portion of the project or program costs not borne by the sponsor
Definition
Types of Cost Sharing
• Mandatory, required, condition of award
• Voluntary Committed, offered, excess of mandatory, not a condition to be considered for the award
• Voluntary Uncommitted, effort or expenditures that are in excess of committed and budgeted
Special Notice!
Commitments in proposals become requirements upon award.
Cash vs. In-kind
• Cost share from University sources are considered cash
• Value of non-cash contributions provided by a third party are considered in-kind
Budget Example
Expense Categories Insitution Agency
PI Salary ($90K) 20,000Colleague Time 0Consultant 5000Graduate Students (5) 75,000Supplies 30,000Travel 5,000Printing 2,000F & A 66,000
Total Budget 5,000 198,000
Submitted to AgencyBudget
Budget Example
Expense Categories Insitution Agency Insitution Agency
PI Salary ($90K) 20,000 22,500 20,000Colleague Time 0 2,000 0Consultant 5000 5,000Graduate Students (5) 75,000 7,000 75,000Supplies 30,000 2,000 30,000Travel 5,000 5,000Printing 2,000 300 2,000F & A 66,000 19,400 66,000
Total Budget 5,000 198,000 58,200 198,000
Submitted to Agency Real BudgetBudget
Examples of Cost Sharing
• Employee time, including fringe benefits
• Equipment
• Volunteer time or other contributed items
• Unrecovered F&A, if approved by sponsor
• Subrecipient cost-sharing
• Directly related supplies and services
Sources of Cost Sharing
• University funds
• Unrecovered Facilities and Administrative (F & A) costs
• Third party contributions
• Other sponsored projects
Responsible Persons
• Shared responsibilities
– Principal investigator
– Department administrator (liaison)
– Central office
When to Include Cost Sharing
• Mandated by sponsor
• Contribution is necessary to ensure success of competitive proposal
The amount included as cost sharing should be a reasonable level, considering burden placed on Institution resources.
Finding Cost Share
Some acceptable items include:
– Salaries and fringes
– Lab supplies
– Travel
– Unrecovered F&A
Unallowable Cost Share
• Items normally treated as indirect
• Specifically unallowable costs
• Cost share used on other projects
Effect on F & A
• The amount of cost share contributed by an institution has an inverse effect on its facilities and administrative cost reimbursement rate
• How?
Cost Share / F&A Relationship
0
10
20
30
40
50
60
1 2 3 4 5 6 7 8 9
Cost Share in hundred thousands
Rate
Cost Share/F&A Relationship
Cost Share in 100’s of thousands
Rat
e
Cost Share or F&A
Items generally considered indirect cannot be cost share. These include:– Department Administration – Space– Utilities– Equipment, usually– Library resources
Timing
• Cost share must be expenditures incurred or services rendered during the period of award
• Some agencies expect / require expenditures to occur at same pace as federal dollars
Where to Find the Regulations
• OMB A-110, Subpart c.23
• NSF Grants Policy Manual, Section 330 and General Conditions, Section 21
• Office of Education (EDGAR), Section 74.23
• Other agency guidelines, including RFPs
Cost Sharing Criteria
• Verifiable from Official University Records
• Not cost sharing for other sponsored programs
• Necessary and reasonable for accomplishing project
• Allowable cost, as defined in OMB A-21• Incurred during effective award dates
Repercussions of Unmet Cost Share
• Identify amount and proportion unmet
• Identify programmatic effect
• Notify agency immediately
• Agency may require repayment of a proportionate share of grant funds
Note: Unsatisfactory documentation may be treated as unmet cost share
Audits of Cost Share
• OMB A-133 audits
• Program audits
• Project financial audits
• Agency Inspector general audits
Common Audit Findings• Failure by institutions to identify cost sharing
in their accounting systems• A lack of written policies and procedures• No method exists for valuing contributed
effort as cost sharing• Incorrect valuation of in-kind cost sharing• No annual certification when cost sharing
exceeds $500K• Unallowable costs claimed as cost sharing
Sharon Kiser:
Source: Federal Grants News 3/02 – quotes from NSF Inspector General
Sharon Kiser:
Source: Federal Grants News 3/02 – quotes from NSF Inspector General
Documentation
• Mandatory Cost Share must be documented
• Must be readily identifiable in the official records of the Institution
• Method of documentation is determined by type of award and type of cost share
• Inadequate documentation may result in disallowance
In Summary
• Cost share when mandatory
• Be conservative in valuing for budget
• Track and document timely
• Provide information to Sponsored Programs for Official Records
Time and Effort Reporting
What is Effort Reporting?
• Process prescribed by federal government to verify that salaries charged to federally sponsored projects represent work performed
• Verification that cost sharing was performed as budgeted in proposal
What Governs Effort Reporting?
OMB A-21 , Section J.8, Compensation for personal services
Compensation covers all amounts paid during the period of performance under sponsored agreements– Based on documented payrolls– Reliance is placed on tolerable degree of estimates– No single best method for documenting
Understanding 100%
What is 100%?
40 Hours per week?
24 / 7 ?
Other?
Certification
• Details of certification– Reflect distribution of Activity (Effort)– May be After the Fact– Reasonably reflect compensation by Activity– Reflect Activity for EACH SPONSORED
AGREEMENT – Timing – for professionals, no less than every six
months– Time cards qualify as documentation
Who certifies?
Effort must be confirmed by responsible
persons with suitable means of verification
that the work was performed. Confirmation
by the employee is not required.