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McLean Hospital

Research Town MeetingApril 25, 2011

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AGENDA

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IRB Update

Jim Hudson

New Emphasis on Pre-Review

• Goal: resolve as many substantive issues as possible prior to the meeting to – avoid deferrals – speed up approvals

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Pre-Review

• What WE do:– Identify issues in time period after submission but

before meeting– Communicate with PIs or staff to discuss and make

changes before meeting– As issues arise during meeting, discuss with PI if

necessary to clarify

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Pre-Review

• What YOU (PIs and staff) can do:– Be available for pre-review discussions and work

quickly to provide new material requested– Identify prior to submission any issues that are likely to

pose difficulties•Seek consultation from IRB office•Consider submitting some materials earlier than deadline for extensive pre-review

– Have someone, preferably PI, available to answer questions during meeting

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Administrative Notes

• Scheduled for accreditation site visit in May• Preparing for e-IRB• Reminder: use newest version of forms from

website for each submission

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Strengthening McLean

Research Administration Update

Peter Paskevich

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The Broader Context of Grants Management

• Increased Regulatory Demands• Rapidly Changing Rules & Tools• Increased Demand for Documentation and Compliance• Increased Funding Challenges• Variance in Personnel who Manage Grants at McLean

Background

Duties

Skill Levels• Limited Formal Training Opportunities for Grants Managers and

Junior Investigators• Opportunities for Improvement (Good Better Best!)

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Strengthening Research Administration FY 2011 Goals

1. Clarify and differentiate roles and responsibilities of McLean:

a) Principal Investigators (PIs)

b) Grant Administrators (GAs)

c) McL Research Administration (McL RA)

d) PHS Research Management / PHS Research Finance

2. Facilitate & ensure grant administrators’ competence

3. Leverage McLean’s new divisional structure to improve research administrative functions

4. Evaluate re-assignment of roles to PHS RM to take advantage of centralized expertise and economies of scale

5. Continue implementation of electronic systems to improve effectiveness and efficiency (eIRB, eIACUC, InfoEd PD)

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Principal Investigator’s Responsibilities

A PI is responsible for:

• Scientific Integrity of a project and for managing all aspects of the project to fulfill scientific goals.

• Effort and Salary: ensuring that salary payments to investigators and staff charged to a particular project are commensurate with their contributions (effort) to that project.

• Financial Oversight: the PI is ultimately responsible for managing sponsored funds, including:

– Reviewing grant financial statements on a regular basis to ensure that expenses are allowable, allocable and reasonable and overspending does not occur.

– Reviewing and approving invoices from collaborators under subcontracts and for monitoring their technical performance to ensure project goals are met.

– Pro-actively addressing and resolving deficits

• Conflict of Interest (COI)

– Being familiar with the Partners Conflict of Interest Policy

– Filing disclosure forms in accordance with the policies of PHS, HMS, extramural research sponsors (e.g., NIH, NSF DoD)

– Ensuring that project personnel are familiar with the COI policy.

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Grant Administrator’s Responsibilities

• Timely and accurate assistance to the PI by providing information and preparing materials for:

– Pre-award documents, progress reports, invention reports and close-out reports – Budgets, cost sharing/matching requirements, cost transfers– Sponsor prior approval– Subcontract invoices

• Processing and reviewing charges to grant accounts to ensure only allowable and allocable expenses are charged to sponsored projects.

• Reconciling expenses and income of the grant against expected amounts and ensuring that all errors are corrected on a timely basis.

• Providing effort reporting information to PI and other investigators with salaries charged to grants and processing salary distributions reflecting the correct effort.

• Knowing the standard rules for carry forward of unspent grant funds and for informing and working with McL Research Administration, Partners Research Management/Finance when the PI has requested that funds be carried forward.

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McLean Research Administration’s Responsibilities

1. Responsible for the daily Research Operations • Pre-award, Post-Award, Compliance, Personnel• Routine oversight, administration and reporting on all pending and awarded research grants and

contracts• Provide guidance on pre and post award policies and regulations to Principal Investigators and Grant

Administrators.

2. Financial Oversight• All annual operating budgets and capital budget • Responsible for working on deficit resolution plans with administrators and PI’s while ensuring that

grants /contracts are expensed in a manner that is fiscally prudent and in full compliance with all federal, state, local, institutional and granting agency regulations, terms, and conditions

• Monitors all Intellectual Property revenue that result from royalty and patents and distributes funds as needed

3. Personnel– Review and approval of new hires – PeopleSoft Manager Self Service transactions

4. Up to date with Regulations• Ensure all Principal Investigators maintain a current Massachusetts Controlled Substance

Registrations• Annual OMB Circular A-133 Audit and Inspections (USDA, Lab Safety, Belmont Health Department)• Responsible for the institutional permits: Division of Fisheries & Wildlife, USDA Annual Report,

Belmont Health Department (recombinant DNA permit), DHHS/OLAW Annual Report.

5. Compliance• Ensure compliance with all fiscal policies of Partners HealthCare Systems, with particular attention to

the Sundry Fund Policy, and the Overdraft and Deficit Monitoring Policy. • Ensure reported time and effort is consistent with grant / contractual obligations

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PHS Research Management / Research Finance’s Responsibilities

• Operations– Liaise with other groups to understand current financial processes and systems in place and

provide recommendations for improvements. – Support A-133 audit and other audits. – Establish finance best practices, design and document divisional cost allocation

methodology.

• Financial Reporting– Assist in monthly accounting close, including detailed expense and labor cost

review/validation– Identify and resolve accounting discrepancies within research funds.– Prepares Financial Status Reports (FSRs) for federal, fed-other and non-federal awards – Performs salary adjustments for terminated employees only – Performs residual balance transfers – Activates and Closes funds – financial aspects – Reviews and processes Journal Entries

• Billing and Collection– Manages billing and collections for all grants, contracts and industry sponsored projects– Manages and monitors accounts receivable – Performs daily posting and reconciliation of research cash,  including checks and wire

payments – Reviews and verifies incoming subcontract invoices – Uses Letter of Credit (LOC) process to bill for and receive funds from NIH and other federal

sponsors

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Facilitating & Ensuring Grant Administrator’s Competence

• Goal: Ensure that each research grant administrator (GA) at McLean Hospital has the requisite knowledge and skills to perform his/her duties, through training and evaluation.

• Plan – Develop GA Core Competency Program (training & assessment)– Standardize job descriptions, job titles and workforce competency

documentation• based on PHS RM templates that reflect competency

requirements.• including a dotted line reporting from GAs to McL RA

• McLean Research Administration in collaboration with McLean Human Resources and PHS Research Management

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Facilitating & Ensuring Grant Administrator’s Competence

1. GA Core Competency Program (training & assessment)– Grant Administrators

• ~30 McLean staff to whom PIs delegate research-related tasks

– Content• Policies• Transactions• Customized to reflect McLean policies and procedures

– Assessment to be administered through HealthStream with automatic feed to PeopleSoft

– Expectations• GAs must successfully complete assessments in order to perform tasks

noted above• Target date to be finalized in conjunction with McLean Human Resources &

PHS Research Management

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Standardizing GA Job Descriptions and Titles

2. Standardize GA job descriptions and titles

– 3 levels: GA I, GA II & Sr. GA

– GAs’ dotted line reporting relationship to Research Administration

– Input from Research Administration on the annual performance evaluations through new evaluation forms

– Involvement of Research Administration with PIs/divisions in hiring, training and professional development

Challenges ahead…– Distinguishing GA duties as separate job would likely result in reclassification of

the other support duties to non-exempt status

More to follow…..

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Proposed GA Reporting Relationships [Schematic]

Associate Director, RA

GA-III

GA-Is GA-IIs

Sr. Vice President, RA

Division Chief

PIs / Labs PIs / Labs

GA-III will have dual reporting relationship – to division chief and to Associate Director of Research Administration

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Who Benefits??? Everyone!

• GAs

– Access to a new comprehensive training program,

– Improved job descriptions with a clearer set of roles and responsibilities as well as reporting structure

• PIs

– Improved grants management support

– Relief from administrative tasks

• McLean

– Ensuring best practices and compliance (Good Better Best!)

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Leveraging Divisional Structure

Leverage McLean’s new divisional structure to improve research administrative functions

1. Background/Context– 49% of PIs and 59% of research awards associated with existing divisions (Alcohol and

Drug Abuse; Psychotic Disorders; Basic Neuroscience) and the Neuroimaging Center– 3-4 additional divisions to be established over next several years

2. Proposal: Divisional Grant Administrator – Each division shall have a divisional grant administrator.

– Division chiefs responsible for ensuring that PIs within division are knowledgeable, competent and compliant, with support from McL RA

– Oversight and support for non-divisional-based PIs and GAs provided by McLean Research Administration

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Re-assignment of Research Administration Roles

Proposed transfer of function from McL RA to PHS RM to take advantage of centralized expertise and economies of scale

1. Industry-sponsored clinical research: Draft and negotiate agreements and budgets; prepare Medicare coverage analyses when required

2. Post Subcontracts-in: Review and negotiate agreements & amendments

3. Post Subcontracts-out: Draft and negotiate agreements and amendments

4. Post Award: Financial management support to PIs and GAs. Projected Volume: $40 million

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Electronic Systems

Continue implementation of electronic systems to improve effectiveness and efficiency

Proposal: Further implementation of e-systems at McLean

– eIRB (1st priority)

– eIACUC (2nd priority)

– InfoEd Proposal Development

Next Steps– Calculate change in PHS allocation to McLean (PHS)

– Assess staffing requirements for implementation and training; evaluate financial implications (McL RA; PHS RM; PHS Res Apps)

– If decision to proceed

• Develop implementation plan (McL RA; PHS RM; PHS Res Apps)

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We are delighted to announce the selected members as part of the RAAC:

Administrators Principal Investigators

Jennifer Clark Sabina Berretta

Dawn Morrissey Marc Copersino

Valerie Robbins Brent Forester Nancy Mello Marisa Silveri

Response received from Principal Investigators and Administrators was overwhelming.• Highlights the need to integrate and communicate McL Research Administration’s many new initiatives with the research community. Purpose : Advise McL Research Administration• on how we can better communicate important information •on the need for training or re-training as systems and requirements evolve. One year appointment •anticipate adding new members as others rotate off•invited guests to each committee meeting (to ensure adequate representation)List kept of everyone who volunteered, for participation at a future date.Meet once every quarter (first one is tomorrow!)

Research Administration Advisory Committee (RAAC)

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Hiring Practices Post OFCCP* Audit

Jean Mansfield

* Office of Federal Contract Compliance

•Equal employment opportunity (EEO) laws prohibit job discrimination in the workplace.

History

•All of these laws apply to current employees as well as employment selection practices.

•The Equal Employment Opportunity Commission (EEOC) is the federal agency responsible for enforcing federal laws

prohibiting employment discrimination on the basis of:•Race•Color

•Religion•Gender (including pregnancy)

•National origin•Age (40 or older)

•Disability•Genetic information

•Etc.

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History

• The Office of Federal Contract Compliance Programs (OFCCP) reviews employers doing business with the federal government for compliance with Affirmative Action/Equal Employment laws & regulations

• Annually, McLean files an Affirmative Action Plan (AAP) and reports data for each of our jobs, comparing our workforce diversity to community diversity

• Under the current administration, the agency has increased efforts to ensure compliance.

• Why does McLean have to comply?

McLean Hospital is a Federal Government contractor!

1. Source: Society for Human Resource Management (SHRM); 10/22/2010 Slide 26

OFCCP EXPECTATIONS

• Accurate reporting• Analysis of data and development of an action

plan to address under represented groups• Demonstration of implementation of action plan• Employer must be able to support report data:

– By producing each employment application if requested

– By documenting criteria used to make interview/hire/fire/promotion decisions

– By producing documentation that criteria was applied fairly and consistently

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Considerations for RecruitingThere can be no Disparate Treatment or Impact in:

• Job descriptions, Advertising, Interview process, Hiring

• Disparate Impact, as defined under EEO law, is a less favorable effect for one group than for another. Disparate impact results when rules applied to all employees have a different and more inhibiting effect on women and minority groups than on the majority.

We receive 6,000+ expressions of interest in employment at McLean Hospital every quarter!

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2009 OFCCP AUDIT• McLean Hospital began a compliance review by

the OFCCP in December 2009. • Data was submitted for review (information on

applicants and employees: who was interviewed, who was hired, promoted, terminated, etc.)

• The OFCCP requested additional information on candidates who applied for 4 specific job codes in Research and Patient Care.

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2009 OFCCP AUDIT• The information auditors sought included:

– PROOF we hired the most qualified candidate for each job. Auditors wanted us to review 12,000 applicants and provide information about their years of experience (direct and general), assuming this was used as hiring criteria

– Did we review and route resumes consistently (“first in, first reviewed”)?

– If two candidates had similar qualifications, did we interview them both?

– Does it appear that we are selecting candidates based on criteria other than their qualifications for the job?

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2009 OFCCP AUDIT• The audit was closed in September 2010.

• McLean was given a “Notice of Violation” for recordkeeping.

• In our “Conciliation Agreement” we agreed to correct our recordkeeping deficiencies AND report on a bi-annual basis.

• Agreement included a statement: “McLean commits that these violations will not recur.”

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Audit Anecdotes• What has happened at other institutions:

– Managers are questioned individually about every applicant for a job opening and are required to provide a reason for hiring/not hiring or interviewing/not interviewing.

• From the Department of Labor’s own website: Depending on the circumstances, violations also may result in cancellation, suspension, fines or termination of [federal] contracts, withholding of progress payments, and debarment

DID WE PROVIDE AN EQUAL OPPORTUNITY TO EVERYONE AND IS THERE EVIDENCE OF DISCRIMINATION?

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The Rules apply for all Employment Actions• The basis for determining affirmative action targets is

census data. We utilize this data to compare the makeup of our employee population to the makeup of the general population.

• As we fill open positions and work with our current staff, are we making a dedicated effort to recruit and retain a diverse workforce?

• Documentation in the employment process (from hiring to firing) is critical.

• HR has implemented hiring processes to ensure that we are in full compliance with OFCCP regulations….

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Posting Positions

• Submit an online requisition through PeopleSoft • Provide recruiter with accurate, updated job

description including:– Education

– Licensure

– Experience as appropriate

• HR Reviews and Approves before posting • Minimum posting for 5 days

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Reviewing Candidates

• Recruiter routes qualified candidates

• Hiring manager reviews each candidate

• Hiring manager must return comments on ALL candidates routed – retain your notes in event of audit!

• Position may be reposted after 5 days if all applicants have been considered and comments have been forward to recruiter

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Interview Candidates

• Contact the candidates directly or ask the recruiter to set up an interview

– HR interviews provide information regarding benefits, salary range and employment requirements

• Information to track:– Candidate’s name – Interview date – Individual(s) who interview the candidate – Type of interview (phone/in person)– Interview notes from each interviewer (must be job related –

retain in event of audit!)

• DO NOT send candidate to HR for CORI at this time!

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Preparing for Offer

• Recruiter checks references for candidate– Department may check references, but please obtain official reference form from HR

• Letter of recommendation (if provided)– Recruiter or hiring manager must confirm with the individual who wrote the reference

• Recruiter completes salary calculation and reviews with hiring manager

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Making Job Offer (HR)

• Recruiter extends the offer, but candidate may NOT start until:–Successful CORI check –Successful National Background check –Candidate receives medical clearance

• Recruiter sends conditional offer letter and email with directions for completing hiring requirements (background check, Occupational Health)

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Completing Hiring Requirements

• Candidate completes CORI form in person in HR office, Hire Right national background check form online, and Occupational Health requirements

• Once all have cleared, coordination occurs for start and orientation date

• Hiring Manager sends recruiter information regarding each candidate interviewed including:

– Name – Date of interview – Persons who interviewed the candidate – Type of interview (phone/1st interview/2nd interview)– Comments regarding why candidate was not chosen – speak to

your recruiter for guidance

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Employee’s First Day

• New employee visits HR to complete final paperwork

• New employee attends orientation

• New employee reports to Security for completion of ID badge

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REMEMBER

• Under no circumstances may an employee start before: –Reference checks have been completed –CORI and National Background Checks

are complete–Medical clearance has been obtained

• If you have any questions, please check with your recruiter

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Update on the Basic Neuroscience Faculty

Search

Research SpaceJoe Coyle

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Research Vision Update

Scientific Advisory Board

Scott Rauch

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Scientific Advisory Board

• To be established and then convened at least annually

• To advise the President and Board of Trustees

• Members:• Steven E. Hyman - Chair (Harvard/HMS)• Eric Nestler (Mt. Sinai)• Danny Pine (NIMH Intramural)• Barbara Rothbaum (Emory)

Research Vision Update

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Open Forum