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Jekyll and Hyde: Balancing Research Development and Compliance Kris A. Monahan, Providence College Joseph Tomaras, Bates College Mabel Chee, Borough of Manhattan Community

Jekyll and Hyde: Balancing Research Development and Compliance Kris A. Monahan, Providence College Joseph Tomaras, Bates College Mabel Chee, Borough of

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Page 1: Jekyll and Hyde: Balancing Research Development and Compliance Kris A. Monahan, Providence College Joseph Tomaras, Bates College Mabel Chee, Borough of

Jekyll and Hyde: Balancing Research Development and

ComplianceKris A. Monahan, Providence College

Joseph Tomaras, Bates CollegeMabel Chee, Borough of Manhattan

Community College

Page 2: Jekyll and Hyde: Balancing Research Development and Compliance Kris A. Monahan, Providence College Joseph Tomaras, Bates College Mabel Chee, Borough of

Session Objectives• Learn to identify compliance risks before they

become emergencies. • Develop strategies for integrating compliance

training into pre-award development activities.• Identify skills of interpersonal communication to

help maintain healthy working relationships even in worst-case scenarios.

Page 3: Jekyll and Hyde: Balancing Research Development and Compliance Kris A. Monahan, Providence College Joseph Tomaras, Bates College Mabel Chee, Borough of

Identifying Compliance RisksReview the environment and ask questions to determine risks:Any changes in regulations/policies/requirements? For example, Grants Reporting Information Project: www.recovery.gov/About/board/Documents/Grant%20Reporting%20Information%20Project%20Report_June%202013.pdf

How will institution demonstrate compliance?Who needs the information and how will it be used?

Page 4: Jekyll and Hyde: Balancing Research Development and Compliance Kris A. Monahan, Providence College Joseph Tomaras, Bates College Mabel Chee, Borough of

Compliance RisksI. Research ComplianceProtection of Human Subjects Animal Care & Use Biohazards & Biosafety

Responsible Conduct of Research Conflict of Interest Research in a Foreign Country

Data Management

II. Award Compliance

Types of Awards Terms and Condition of Award

Performance Obligations Reporting Requirements

Reporting Cost Sharing Management

Allowable Costs Intellectual Property

Hiring and Contracting Policies Subcontracts vs. Consulting

Export Control Evaluation

Effort Reporting

Page 5: Jekyll and Hyde: Balancing Research Development and Compliance Kris A. Monahan, Providence College Joseph Tomaras, Bates College Mabel Chee, Borough of

Strategies

• Lead Time• Checklists• Demonstrate Value

Page 6: Jekyll and Hyde: Balancing Research Development and Compliance Kris A. Monahan, Providence College Joseph Tomaras, Bates College Mabel Chee, Borough of

Lead Time

• Balance between nimble, customer service orientation, & need to vet outgoing proposals

• Commit to reading/reviewing all proposals (even the biochemistry ones!)

• Communicate reasonable expectations for turnaround

Page 7: Jekyll and Hyde: Balancing Research Development and Compliance Kris A. Monahan, Providence College Joseph Tomaras, Bates College Mabel Chee, Borough of

Checklists

• Populate based on likely risks @ your institution, e.g.• Cost Sharing (& documentation)• Allowability of costs• PI effort commitments• Human Subjects / Vertebrate Animals

Page 8: Jekyll and Hyde: Balancing Research Development and Compliance Kris A. Monahan, Providence College Joseph Tomaras, Bates College Mabel Chee, Borough of

Checklists

• Likely risks (continued)• Subawards• Research in foreign countries• HR Issues (hiring; leave/benefits for project staff)• Facilities security, safety, or suitability for new

equipment• Conflict of Interest

Page 9: Jekyll and Hyde: Balancing Research Development and Compliance Kris A. Monahan, Providence College Joseph Tomaras, Bates College Mabel Chee, Borough of

Ways to Demonstrate Value• You found the funding opportunity• You noticed a key requirement in the RFP• You trouble-shot a knotty budget issue• You found a weakness in the project narrative• You offered edits—and they were good!• You helped the PI make the case for institutional

resources/support

Page 10: Jekyll and Hyde: Balancing Research Development and Compliance Kris A. Monahan, Providence College Joseph Tomaras, Bates College Mabel Chee, Borough of

General Rules

If possible, demonstrate your value BEFORE alerting a PI to compliance concerns.

Frame concerns as a shared challenge to be met cooperatively, rather than a violation of ethics or

institutional policy.

Page 11: Jekyll and Hyde: Balancing Research Development and Compliance Kris A. Monahan, Providence College Joseph Tomaras, Bates College Mabel Chee, Borough of

Case Example #1PI is applying for a Federal student scholarship grant w/ several eligibility restrictions. If awarded, he will need timely information re: entering students from Admissions & Financial Aid. If he does not seek the

information, expenditures could be disallowed. If he seeks it but does not receive it promptly, he may not

be able to spend funds on time.

Page 12: Jekyll and Hyde: Balancing Research Development and Compliance Kris A. Monahan, Providence College Joseph Tomaras, Bates College Mabel Chee, Borough of

Case Example #2

PI has assisted a small company in obtaining an SBIR grant from DARPA. Company now wants to subcontract to PI. Company wants royalty-free

exclusive license on all IP to be developed. On an FCOI disclosure form filed on his NIH grant, PI

lists this company as owned by his wife.

Page 13: Jekyll and Hyde: Balancing Research Development and Compliance Kris A. Monahan, Providence College Joseph Tomaras, Bates College Mabel Chee, Borough of

Case Example #3

PI wants to conduct research surveying current & former sex workers in Cambodia. He is

applying for an NSF grant; if awarded, more than 50% of total award will be subcontracted to

an NGO in Phnom Penh. Your institution has never worked with a foreign subawardee before.

Page 14: Jekyll and Hyde: Balancing Research Development and Compliance Kris A. Monahan, Providence College Joseph Tomaras, Bates College Mabel Chee, Borough of

Interpersonal Skills NeededDefinition of 'Interpersonal Skills'

"The skills used by a person to properly interact with others. In the business domain, the term generally refers to an employee's ability to get along with

others while getting the job done. Interpersonal skills include everything from communication and listening skills to attitude and deportment. "

Source Investopedia

Page 15: Jekyll and Hyde: Balancing Research Development and Compliance Kris A. Monahan, Providence College Joseph Tomaras, Bates College Mabel Chee, Borough of

TELL US!

What are the characteristics of a successful research administrator who can balance promoting compliance with encouraging

proposal submission?

Page 16: Jekyll and Hyde: Balancing Research Development and Compliance Kris A. Monahan, Providence College Joseph Tomaras, Bates College Mabel Chee, Borough of

Characteristics of Successful Research Administrator

Political LeadershipEffective and Proactive CommunicatorResponsive to InputGarners Support/Gains Trust

Page 17: Jekyll and Hyde: Balancing Research Development and Compliance Kris A. Monahan, Providence College Joseph Tomaras, Bates College Mabel Chee, Borough of

Characteristics of A Successful Research Administrator

Managerial/Administrative LeadershipBalances PrioritiesFosters Shared LeadershipMaintains AccountabilityEncourages InnovationContinuous Improvement of Leadership

Page 18: Jekyll and Hyde: Balancing Research Development and Compliance Kris A. Monahan, Providence College Joseph Tomaras, Bates College Mabel Chee, Borough of

Self-Reflection

What is one thing you can do differently or more effectively to balance research

development with compliance?

Page 19: Jekyll and Hyde: Balancing Research Development and Compliance Kris A. Monahan, Providence College Joseph Tomaras, Bates College Mabel Chee, Borough of

ResourcesNCURA Resources*Report on Research Compliance: http://www.reportonresearchcompliance.com/

*Research Administration Training and Compliance at the Department Level for a Predominantly Undergraduate Institution

Beryline Temples, Paula Simons, and Timothy N. Atkinson, University of Central Arkansas, Vol. 19, No. 1 - 2012

National Institute of Health

http://grants.nih.gov/grants/compliance/#glance

http://www.youtube.com/user/NIHgrants

National Science Foundation

http://www.nsf.gov/bfa/dias/policy/guidance.jsp

Page 20: Jekyll and Hyde: Balancing Research Development and Compliance Kris A. Monahan, Providence College Joseph Tomaras, Bates College Mabel Chee, Borough of