Post Award Financial Management
What are direct costs?
Includes costs that directly benefit the grant-supported project or activity
(Salaries, Travel, Equipment, Supplies)
What is an audit?
A systematic review or appraisal made to determine whether internal accounting and other control system provide reasonable assurance.
What is NOT considered research misconduct?
Research misconduct does not include honest error or differences of opinion
What does HRPP stand for?
Human Research Protection Program
Who initiates the trial request for IITs?
The investigator and NOT by the company or sponsor.
What are examples of some prohibited costs?
Business class travel, flowers, gifts and awards, good/services for personal use, lobbying, membership in airline travel clubs, selling or marketing products or services, social events, alcoholic beverages, fundraising, antiques, bad debt write offs...
What do audits review?
Financial operations are properly conducted.
Financial reports are timely, fair, and accurate.
The entity has complied with applicable laws, regulations, and other grant terms.
Resources are managed and used economically and efficiently.
Desired results and objectives are being achieved effectively.
What IS research misconduct?
Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research or in reporting research results.
What is Federal Wide Assurance (FWA)
An institutions commitment to comply with the federal regulations governing human subjects research
OHRP-for cause/not for cause audits
FDA-biomedical research monitoring program
What are professional degrees for investigators versus research degrees?
Professional degrees: MD, DO, PharmD, DNP
Research Degrees: PhD
What is needed on a receipt for a business meal expense report?
Date of expense, last 4 digits of the card used, itemized receipt, list of attendees, and name of restaurant.
When is an external audit required?
Annual audits are required for an institution that expends $750,000 or more per year
Policy Obstacles to Integrity (highlighted on this slide)
What are the Belmont Ethical Principles?
Beneficence, Justice, Respect for persons
What is eSMART?
Consistency for study teams without a Clinical Trial Management System (CTMS)
eSMART houses VUMC clinical trials study data
What is effort?
Effort refers to the portion of time spent on a particular activity expressed as a percentage of the individual’s total activity for the institution.
(Effort is the greatest direct cost)
What are some common internal audit findings?
Not sufficient documentation. (Direct charges, effort allocations.)
Policies and Procedures
Approvals (Cost transfer and effort certification statements)
Governance(Ensure adherence to contract requirements, department guidelines and Institutional policies)
What is the first step in reporting research misconduct?
Start with your supervisor
What is a Non-human subject?
To qualify for Non-Human Research the data/specimens cannot contain any link or identifer that would connect the information back to a human being
What are some examples of early career NIH funding awards?
K awards (K01, K08, K23)
R21 or R03
First R01
What are synonyms for indirect costs?
IDC, F&A, Facilities and Administrative Costs
What are some best practices for prepare for a potential audit?
Retain all necessary documentation, Ensure strong internal controls, Review all relevant policies and procedures, Address any previous audit findings or issues, Prepare key personnel for potential interview questions.
What are some practices for preventing misconduct?
Reduce the number of likely offenders
Harden targets by limiting and documenting access
Increase capability and/or number of internal controls (people or systems)
What are the required elements of an IRB?
•Five members, of both sexes, from varied professions;
•One member whose primary concerns are in nonscientific areas;
•One member whose primary concerns are in scientific areas;
•One member who is not otherwise affiliated with the institution;
•Members with expertise in all areas of reviewed research and can invite experts with competence in areas out of the expertise of the Committee;
•Diversity of backgrounds and racial and cultural diversity;
•Sensitivity to community attitudes;
•And knowledge of regulations, laws, institutional commitments, and standards of professional conduct.
What is a payline?
Overall impact score or percentile that establishes cut-off range for proposals under consideration for funding