Slide 1 - Clinical and Translational Science Awards: Home

CTSA Clinical Management Workshop, June 24, 2008

Faculty Perspective:Challenges of Implementing Change

Sara Rockwell, PhD

Professor of Therapeutic Radiology and PharmacologyDirector, Office of Scientific AffairsYale University School of Medicine

Chair, Faculty Committee, Federal Demonstration PartnershipVice-Chair, Federal Demonstration Partnership


A Profile of Federal-Grant Administrative Burden among Federal Demonstration

Partnership Faculty

Report of the Faculty Standing Committee of the Federal Demonstration Partnership

Robert S. Decker, Ph.D., Principal Investigator Leslie Wimsatt, Ph.D.

Andrea G. Trice, Ph.D. Joseph A. Konstan, Ph.D.

Summary, full survey, all data are available on the FDP websitehttp://thefdp.org/Faculty_Committee.html

http://thefdp.org/Faculty%20burden%20survey%20report%20-%20complete.pdf


What is the FDP?

• The Federal Demonstration Partnership is a cooperative initiative among 10 federal agencies and ~100 institutional recipients of federal funds

• Its purpose is to reduce the administrative burdens associated with research grants and contracts

• Begun in 1988

• http://thefdp.org


~100 Academic Organizations are FDP members

• Many large research universities• Some smaller universities• 9 Emerging Research Institutions• State Schools and Private Schools• Some systems

UC, Nebraska, SUNY

• Many universities with medical schools• Some health oriented campuses and institutions

OHSU, Dana Farber Cancer Institute


Federal Agency Members of the FPD

• National Institutes of Health (NIH) • National Science Foundation (NSF) • Office of Naval Research (ONR) • Department of Energy (DOE) • Department of Agriculture (USDA) • Air Force Office of Scientific Research (AFOSR) • Army Research Office (ARO) • Army Medical Research and Material Command

(AMRMC) • National Aeronautics & Space Administration (NASA) • Environmental Protection Agency (EPA)


Affiliate Members of the FDP

• Council on Governmental Relations (COGR)

• National Council of University Research Administrators (NCURA)

• Society of Research Administrators International (SRA)

• Association of Independent Research Institutes (AIRI)


FDP Meetings – 3 per year

• Open meetings

• Other Agencies and Organizations are invited to participate or choose to attend

OMBOIGOther Federal AgenciesProfessional SocietiesCharitable Health Organizations


Each University designates 3 official representatives

• Administrative Representative

• Faculty Representative

• Technical Representative

• All representatives are encouraged to attend all meetings and to be active participants in FDP committees and activities.

• Universities may send other attendees.


The FDP provides a unique venue for faculty members to interact with university administrators and with federal agencies

• Platform for discussing faculty issues related to research administration

• Ability to have formal and informal discussions with federal decision makers

• Ability to identify issues and problems that span scientific disciplines, individual funding agencies and different schools

• Ability to participate in the development and performance of pilots and projects aimed at solving specific problems


Some past successes of FDP• Streamlined terms and conditions on NIH grants

• “Expanded authorities” University approval of rebudgeting University approval of NCE

• Increased budget flexibility Carry forward of NIH funds Modular NIH budgets

• Minimization of continuation proposals

• Most recent: ending requirement that NIH study section members get personal DUNS numbers and register as government contractors with CCR


Many problems and issues remain • Faculty Administrative Burden Survey was an

important step in identifying and attacking these problems

• Origin: requests for data on the administrative burdens of the faculty

Magnitude Nature Source

• The results of the survey have led to many discussions (including this one) and to several new initiatives


Survey Overview• All FDP research institutions were invited to

participate; 73 of 99 agreed (Some IRB problems)

• Institutions identified full time faculty members who were PIs or Co-PIs on active federally-funded research grants (23,325)

• Invitations, links to web-based survey, reminders sent to faculty in Fall of 2005

• 6,081 “valid” responses from the FDP faculty

• 90% PIs and 10% Co-PIs

• Mostly male (71%), white (92%), in sciences, from large research institutions

• Many with affiliated medical schools


Institution Funding Level

Under $10M-$100M11%

Over $200M67%

$150M-$200M10%

$100M-$150M12%


Principal Field of Research

Psychology or Social Sciences

4%

Other9%

Agriculture4%

Mathematics3%

Computer Science

3%Education

2%Biological/Life

Sciences35%

Engineering11%

Physical Sciences

13%

Health Sciences16%


Administrative Duties

Associate Dean2%

None64%

Chair5%Center Director

12%

Other17%


Academic Rank

Professor54%

Assistant Professor

22%

Associate Professor

24%


Tenure Status

No tenure system

5%Not on tenure

track6%

On tenure track22%

Tenured67%


Research Grants

Average number of grants to…

Federal

PI Co-PI

PI

Total Direct Cost Funding

Median Mean

Professors 2.0 1.0 $ 260,000 $ 560,320

Associate Professors

1.5 1.0 $ 200,000 $ 337,543

Assistant Professors 1.3 1.0 $ 150,000 $ 224,804


Time Spent on Work Activities

• 20% Teaching

• 58% Researcho Mentoring students & postdoctoral fellows (14%)

o Conducting research (44%)

• 9% Professional Serviceo Associations, societies (8%)

o Regulatory committees (1%)

• 11% Service (other)

• 3% Other Work Duties

*Total due to rounding (101%)


Time Spent on Federal Research42% of research time is actually spent administering the project

Active Research

58%

Post-Award Research

Administration20%

Pre-Award Research

Administration22%


Top Administrative Burdens(average for all respondents, including those who

reported no burdens in specific areas)*

1. Grant progress report submission

2. Personnel hiring

3. Project revenue management

4. Equipment and supply purchases

5. IRB protocol approvals and training*

6. Training personnel and students

7. Personnel evaluations

* For those who used human subjects or animals, IRB or IACUC was the #1 burden


Many burdens varied by federal agencyFederal Funding Agency Top burdens

All agencies (top 3 burdens)

• Grant progress report submissions• Personnel hiring• Project revenue management (all

but DOC)

DOI, DOD, DOE, EPA, USDA, NASA

• Equipment and supply purchases

EPA, ED, DOC, and DOI • Subcontracting and collaborations

HHS, ED, and NIH • IRB protocol approvals and training• IRB compliance issues • HIPPA compliance


Top burdens by federal agency (cont.)

Federal Funding Agency Top burdens

DOC and NIH • IACUC protocols and training

DOI • Cost accounting issues

NIH • Training personnel & students

USDA • Time & effort reporting


Burdensome tasks varied by faculty subgroup Burden Faculty Subgroup (s)

IRB protocols and training Medical institutionsPsychologyEducationSocial Sciences

Not on tenure trackOn tenure track – not tenuredNo tenure systemPrivate institutions

Female facultyUnderrepresented minoritiesAssociate/assistant professorsFaculty with administrative role


Burdensome tasks by faculty subgroup (cont.)Burden Faculty Subgroup (s)

Patent/copyright applications

Engineering

IRB compliance issues

Note that this is in addition to the burden of protocol development and training

Clinical facultyHealth SciencesPsychologyMedical institutionsEducation

Not on tenure trackNo tenure systemFemale faculty

HIPPA compliance Clinical facultyHealth SciencesMedical institutions


Burdensome tasks by faculty subgroup (cont.)

Burden Faculty Subgroup (s)

Subcontracting and collaborations

EngineeringEducation

Training personnel and students

Biological/Life SciencesMedical institutions

Asian/Pacific IslandersUnderrepresented minoritiesOn tenure track – not tenuredAssistant professors

IACUC protocols and training

Biological/Life SciencesMedical institutions


0

1

2

3

4

Grant Report Submissions( 1 = no burden 5 = worst burden)

Bars = different universities (schools with >100 respondents)Little variation between schools


0

1

2

3

4

Personnel Hiring ( 1 = no burden 5 = worst burden)

Bars = different universities (schools with >100 respondents)


0

1

2

3

4

Project Revenue Management ( 1 = no burden 5 = worst burden)

Bars = different universities (schools with >100 respondents)


0

1

2

3

4

IRB Protocol Approvals and Training ( 1= no burden 5 = worst burden)

Bars = different universities (schools with >100 respondents)Notable variation between schools


Institutional variations• For many administrative burdens there is

remarkably little variation among universities

• Some differences among universities; may reflect differences in scientific disciplines rather than differences in institutional policies or procedures

• Some differences may reflect institutional practices; these should be examined to find best practices

• Faculty at medical schools report more burdens and a greater cross section of burdens

• Faculty at ERI have special problems because of the lack of institutional support for research


There is variation in the impact of burdens• IRB hits hardest on medical schools, private schools,

social sciences, education, junior faculty, women and underrepresented minorities

• HIPPA hits hardest on medical schools, clinical faculty, health sciences

• Patent applications hit hardest on engineers

• Women, minorities, and junior faculty tend to report greater administrative burdens and less administrative support

• Some burdens, like reporting and personnel management, are remarkably consistent across faculty groups, universities and funding agencies


Burden vs. Existing Administrative Assistance

• Faculty report low levels of institutional support across all administrative tasks, with variations by disciplinary context very evident

• Most assistance = financial management Payroll, budget transfers, cost accounting issues, cost sharing

agreements, project revenue management Project revenue management remains a top burden

• Least assistance = research-related activities IRB, IACUC, COI monitoring, grant progress reports,

patent/copyright applications, intellectual property applications Grant progress report submission is the #1 reported burden

• Personnel evaluations 7th most burdensome of the 25 burdens 2nd lowest level of assistance


Support for research-related administration• 97% of faculty stated that at least some time they spend

managing Federal grants could be conducted by appropriate support personnel

• 95% of reporting faculty believed that they could devote 4-8 additional hours each to week to active research if they had more assistance with administrative tasks

• 76% of faculty would be willing to reallocate direct costs from their grants to pay for this research-related administrative support if this were allowed

• This administrative help would need to come from highly trained research staff, with expertise in the area of the research, who could help with administrative tasks directly related to the research such as preparation of IRB and IACUC protocols and reports, data management, scientific reports, staff training etc. They would be scientific staff acting as “project managers” rather than office staff.


No Single Culprit(The death of a thousand cuts)

Burdens come from several sources Federal regulations Agency implementation of regulations Differences in agency requirements Institutional requirements and implementation Audit fears and auditor interpretations and comments Inherent part of research Lack of administrative support

84% of the faculty members reported that the administrative burdens associated with their research have increased in recent years.


Burdens add up…

Considering only our respondents: About $97 million of the direct costs of federal grants is

spent on faculty salaries devoted to administration efforts directly related to those research grants

This survey considers only the grant-funded research administrative work of the PIs. It does not consider the work performed by

○ Other faculty investigators

○ Laboratory staff

○ Institutional administrative staff

○ Compliance committees

○ The PIs under support from other funding mechanisms


This survey does not consider the other research-related administrative tasks of the faculty, which are not project-specific and

therefore cannot be charged as direct costs on federal grants

• Writing and submitting new grants and competitive renewal applications

• Service on Study Sections

• Service on institutional compliance committees (IRB, IACUC, Biosafety, COI)

• Attending general mandatory training modules


The cost of the faculty time is divided

Sponsor sharePaid effort spent on administration of project (42%)

University shareEffort diverted from other tasks

Societal shareEffort diverted from actual research and teaching

Personal shareExtra effort added to job (and taken from family/life)


These burdens have impacts on trainees62% of the respondents felt that students are less likely to pursue academic research careers now than in the past

Multiple causes (workload, salary, funding competition, sense of job worth.)

“They see what we really do and they don’t want to do that.”

A particular challenge with American-born students

This echoes the concern voiced in many medical schools about the loss of physician scientists from the research pool


Conclusions from Survey • Faculty spend about 42% of their federal research time

(not their total paid time) on administration of the research

• No single overriding burden; pressure is on faculty from many sources (death of a thousand cuts)

• Significant costs are associated with these burdens

• Potential savings from decreasing burdens or providing faculty with more administrative support (very important in period of level/decreasing research funding)

• Potential gain from identifying and replicating best practices at agencies and funding institutions

• Potential gain from harmonizing requirements of different agencies


What is the message for the CTSAs?This problem merits attention from the CTSAs

• Many of the top burdens disproportionately affect clinical and translational research

• Problems impact the training and career development of young researchers

• Lack of institutional infrastructure to support research-related administrative activities is a problem – CTSAs can help provide these

• Coordinated efforts involving groups of organizations are needed to address some problems


Poster from YCCI • Outlines review/approval process occurring

during the development and implementation of a clinical protocol

Complex and daunting process Help from YCCI at several points Such help was reported to be rare in the FDP survey

• The process outlined on the poster does not include many of the elements that the PI is dealing with

Writing and submitting any grant applications associated with the protocol

Most personnel issues Reporting to sponsors, compliance committees Many training and compliance issues


Mandatory training of faculty an staff is a huge problem Training/activities related to my research projectsBiosafety Bloodborne Pathogen for Laboratory PersonnelBloodborne Pathogen for Lab and Clinic PersonnelBloodborne Pathogen Refresher Course*Biosafety Level 3 Regulatory Training for Animal Care & UseYARC Facilities OrientationRodent: Humane EuthanasiaMedical Surveillance for Animal HandlersState Controlled Substances Laboratory License*Federal Controlled Substances Laboratory License* Radiation Safety Orientation Radiation Safety Training SeminarRadiation Safety Training for Principal Investigators Radiation Safety Special Training Seminar Irradiator training (x-rays)Irradiator training (Cesium 137 irradiator)Radiation Safety Retraining*FBI background check and fingerprintingLaboratory Chemical SafetyTB testsHep B vaccine/titerTetanus immunization Human Subject Protection TrainingHIPAA for Research Staff Conflict of Interest in Human Subjects Research Developing a Repository Protocol Ethical Considerations in Human Embryonic Stem Cell Research Developing a Repository Protocol Assent and Pediatric Research

Other training/activity requirementsNot directly related to my researchTraining requirements assessment* Sponsored Projects Administration for FacultySponsored Projects Administration Self

AssessmentFire Extinguisher Training*Conflict of Interest/Commitment Disclosure* Sexual Harassment for SupervisorsHIPAA General Security TrainingTraining in use of Yale Credit CardTraining in use of various databases/IT systems

Because of work with federal agenciesDuns registration Central Contractor RegistrationVarious security clearances Various background checksNumerous additional COI disclosuresRegistration with Grants.gov and increasing

numbers of other databases


For Clinicians, there are additional requirements needed for credentialing by YNHH

Reading required training documentsMedical Staff BylawsMedical Staff Rules and RegulationsGuidelines or requirements for reference writersInfection Control/Standard Precautions Readings include:

Hospital infection control, standard precautions, bloodborne pathogens, TB control and airborne precautions. The post-test must be passed with a score of 75%.

HIPAA Privacy and Security Reading Materials. Post-Test also required.

Information on Interpreter ServicesImmunization /Test Records to comply with

OSHA/AHA/JCAHOIf applying for special privileges, requirements as noted in

individual “Criteria for Privileges” documents.Reading materials for Conscious Sedation Privileges. Test

must be passed. Proof of basic/advanced life support training in the past 4 years or has completed YNHH sponsored airway management training for Tier 1 or standard privileges. For Tier 2 privileges, the applicant must have the appropriate expertise as defined by an appointment in Anesthesia, Section of Emergency Medicine, or ICU Intensivist.

YNHH Policy on Medical Staff Health Medical Staff Policy on Focused Professional Practice

EvaluationMedical Staff Policy on Hand Hygiene and Contact

Precautions

Providing with the applicationCompleted application form. Check for FeeApplicant checklist Claim-Suit Report Form Written statement from the applicant

explaining his/her reasons for requesting privileges and what contributions he/she expects to make to the clinical and teaching mission of the hospital.

Clinical Privilege Delineation form based on clinical area of specialty

Copy of medical school diploma or ECFMG Certificate (for foreign medical school graduates)

All current licenses, including ConnecticutImmunization Documentation Form

including evidence of PPD in the past 12 months.

Hepatitis B declination, as appropriate.DEA certificates and Current CT narcotics

certificateCurrent malpractice insurance Identity verificationBoard CertificationsCopy of CVCompleted competency post-tests as

noted above. Medicare/CHAMPUS declaration


More things for physicians

In case you think credentialing is a one-time activity:

I was told that the re-credentialing process is essentially the same.

Other required training listed on the website*:

Medical Billing ComplianceCompliance Clinical Research

Training ModuleResearch Form trainingResearch Registration TrainingYMG Customer Service Training

(listed as “required, but not available”)

***I did not dig – I suspect there are many other requirements on the hospital side


And if a researcher has an appointment at our affiliated VA…

• Different rules• Different requirements• Additional requirements• Duplication of some training requirements• Duplication of many review/approval requirements

• This produces a large additional burden, with no obvious benefit to compliance, safety, or the quality of the research


Some thoughts on what CTSAs should do At our home institutions

• Provide infrastructure and resources to help researchers

• Look at CTSA processes and requirements in the context of the total administrative burden on translational researchers at their institution Where can processes be streamlined? Where can requirements and processes be harmonized? Which requirements and processes are unnecessary or

redundant? When can we avoid going to faculty for information by using

information already available in our institutional databases?

• Identify especially burdensome elements that add little value and work to change them


Some thoughts on what CTSAs should do At our home institutions

• Every proposed new procedure, requirement and process should be examined to ensure that it adds sufficient value Can the problem be addressed by using or modifying

an existing element?

• We should always question whether/how often retraining is necessary and what form “refresher” training should take Does it need to be a repeat of the original course?

Would advanced or area-specific training suffice or even be better?

What really needs to be done every year


Some thoughts on what CTSAs should doOn a national level

• Present to the agencies the potential benefits of harmonizing and streamlining administrative and compliance requirements/procedures Facilitating important translational research Increasing the impact of federal research dollars Improving the efficiency of the research enterprise

• Work on streamlining and harmonizing requirements and procedures Among CTSAs Among academic institutions Among federal agencies Help bring VA to the table

• Demonstrate the value of providing improved infrastructures that assist faculty and trainees who are performing translational research


Thanks !!

• The Members of the FDP Bob Decker and Joe Konstan (whose slides I have

used) Marv Paule Leslie Wimsatt and Andrea Trice Nancy Wray, Jerry Stuck and David Wright Scott Crawford, Survey Sciences Inc. Research Administrators from the FDP institutions (who

got the survey approved by their institutions and IRBs)

• Yale University

• The YCCI and the organizers of this meeting

Documents

Slide 1 - Clinical and Translational Science Awards: Home