Principal Investigator's Quick Reference Guide for Research Compliance

As a reminder, Research Administration is here to excel as a value-added partner in the UTMB research enterprise. We strive to facilitate the UTMB research mission, from funding identification through project completion, by: Providing research-specific resources and education; promoting the responsible conduct of research; and advising and assisting with administrative policies and regulations.

While awards are made to UTMB on behalf of the PI, the principal investigator (PI) is responsible for specific elements of the process: Providing the scientific direction of the research program; ensuring research is conducted ethically and in accordance with the award terms and conditions; and ensuring the proper financial stewardship of the research program, including the allowability, allocability and reasonableness of all expenditures.

This quick reference guide is intended to supplement the roles and responsibilities documents and policies.

 

PI Quick Reference Guide

Research misconduct is contrary to the interests of science, UTMB, the State and Federal government, and to the health and safety of the public. The faculty, staff, and students of UTMB have an affirmative duty to ensure the integrity of all science conducted at UTMB or by UTMB personnel, and primary responsibility for responding to and reporting allegations of research misconduct to the Scientific Integrity Official at UTMB.

Misconduct in science or research means fabrication, falsification, plagiarism, or other practices that materially deviate from those that are commonly accepted within the academic community for proposing, conducting, or reporting research. It does not include honest errors or honest differences in interpretations or judgments of data. 

To assist you in the proper management of your responsibilities as a PI, it might be helpful to have the following definitions.

Co-Investigator
An individual involved with the PI on the   scientific development or execution of a project. A Co-I typically devotes a specified percentage of time to the project and is considered “key personnel.” He/She does not affect the PI’s roles and responsibilities.

Equipment
Non-expendable item having a useful life of more than one year and an acquisition cost of $5,000 or more.

Key Personnel
Individuals identified by the PI who contribute to the scientific development or execution of a project in a substantive, measurable way. “No effort” or “as needed” is not an acceptable level of involvement for key personnel.

PI/Program Director/Project Director
Individual  designated by UTMB to direct the project or activity being supported by the grant. He/She is responsible and accountable to UTMB for the proper conduct of the project or activity.

Program Income
Gross income earned by the grantee that is directly generated by the grant-supported project or activity, or earned as a result of the award.

Program Official
The sponsor official responsible for the programmatic, scientific, and/or technical aspects of a grant. This person is your advocate within the sponsor organization.

Research Misconduct
Fabrication, falsification, or plagiarism in proposing, performing, or reporting research or results.

Terms and Conditions of Award
All legal requirements  imposed on a grant by the sponsor, whether based on statute, regulation, policy or other documentation referenced in the grant award, document itself.

UTMB Signing Officials are employees of Research Administration who have the authority to sign grant applications on behalf of the university. The UTMB Authorized Official Signature on a grant application:

  • Certifies that UTMB will comply with all applicable assurances and certifications referenced in the application.
  • Assures that UTMB will be accountable for both the  appropriate use of funds awarded, and for the performance of the grant-supported project or activities resulting from the applications.
  • Attests that all information contained in the application is true, complete, and conforms to federal and organization requirements.

 

Annual and routinely updated Conflict of Interest Disclosure Forms are required from:

  • All faculty engaged in organized research activities.
    Members of  institutional research-related review committees.
  • Staff members who negotiate or execute research-related agreements on behalf of UTMB.
  • Any individual who, regardless of title or position, is responsible for the design, conduct or reporting of research, including the PI, Co-I, faculty agent, research tech, research nurse, fellow, or administrators who participate in research.
Conflict of Interest training, available online through UTMB Learn, is required every 4 years.

Read the Conflict of Interest Policy, and contact the Conflict of Interest Office with any question.

 

Direct costs are those costs that can be identified specifically with a particular sponsored project and that can be directly assigned to such activities relatively easily with a high degree of accuracy.

Direct costs:

  • Must be specifically identified with a particular project – Charge it where you use it.
  • Must be allocable (i.e., costs must be charged in proportion to their benefit to a particular project).
  • Must be reasonable (i.e., charging costs to a particular project must be done conservatively and reflect the actions of a prudent person).
  • Must be allowable (i.e., certain costs, such as entertainment, generally may not be charged to a federal grant).
  • Must be timely (cost transfers should occur as soon as an error is discovered but no later than 90 days after original charge was incurred).
  • Must conform to any limitations or exclusions in sponsored agreements. (See OMB Uniform Guidance.)

Also, costs normally included in the institution’s research F&A cost rate (i.e., administrative staff or office supplies), CANNOT be directly charged to a federal grant. (See Institutional Handbook of Operating Procedures Policy 4.5.2 Consistent Treatment of Cost).

Also known as indirect costs, F&A costs are those costs that are incurred for common or joint objectives and therefore cannot be identified readily and specifically with a particular sponsored project (2 CFR, Part 200.414). Examples include costs such as lab space, housekeeping, utilities, libraries, and general administration.
  • The Facilities & Administrative Cost Rate is negotiated with the DHHS, Division of Cost Allocation.
  • Be familiar with UTMB's current F&A Rates (Facilities & Administrative Cost Rate Agreement)
  • The PI must use the applicable F&A rate in all competitive and non-competitive proposals submitted unless specifically prohibited or altered by the sponsor.

A cost transfer occurs when an expense is transferred from one
PeopleSoft Chartfield to another, or from one account (object code) to another when an error has occurred.

  • Cost transfers must comply with principles of direct costs and UTMB Cost Transfer Policy.
  • Transfers are a means of correcting errors, NOT managing project funds.
  • Transfers must be supported with full, detailed explanation, not just what was done, but also why the transfer was necessary.
  • Transfers must be completed within 90 days after the original charge was incurred; tardy transactions require an explanation for lateness and must be approved by the Department Chair.
  • Costs allocable to several projects CANNOT generally be charged solely to a single project.
  • Costs not allocable to a project CANNOT be charged or transferred to that project temporarily.
The portion of the costs of a federally assisted project not borne by the Federal Government. Matching or cost sharing may be required by statute or program regulation. Costs used to satisfy matching or cost sharing requirements are subject to the same policies governing other costs under the approved budget.

These costs are committed in the proposal as a requirement of the sponsor/program or as volunteered, and thus committed, by the PI/Department.

  • If proposed, cost sharing MUST have an approved internal funding source, departmental authorization on the Proposal Routing Form, and approved by the Provost Office (Cost-Sharing Approval Form).
  • Unallowable costs CANNOT be included in the portion of costs shared by the university.
  • The cost sharing portion of a project CANNOT be funded from another federal project.
  • Costs benefiting another project CANNOT be included as cost sharing.
  • Costs resulting from a sponsored project overdraft at expiration represent project costs borne by UTMB and are considered as cost sharing, although they may not be used to fulfill a cost share commitment.
  • Proposal that have cost sharing will be reviewed by Entity CFO’s prior to institutional signatures.
  • See OMB Uniform Guidance and UTMB's Budget Guidelines for additional guidance.

The NIH (plus AHRQ and SAMHSA) limits the amount of direct salary charged to its grants.

  • Compensation for individuals on NIH grants cannot exceed a stipulated rate of pay per year or per academic appointment.
  • Current NIH salary cap information.
  • Federal regulations require salary and effort certification on federally sponsored projects.
  • UTMB employees certify effort with an after-the-fact confirmation, using the online UTMB Effort Reporting System.
  • Effort for all individuals (faculty and classified staff) working on sponsored projects is certified on a semi-annual basis.
  • Effort reports for faculty are to be certified by the faculty   member.  Effort reports for all classified staff are to be certified by a primary individual with suitable means of verification that the work was performed.
  • Effort calculation is not based upon a 40-hour work week; all hours worked in UTMB-related activities must be included as a percentage of effort.
  • For information about federally mandated effort reporting requirements and UTMB policies and procedures, contact the Effort Reporting team or visit the website.
Who can apply for a grant? Before developing your proposal, understand who may and may not apply for sponsored project funding through the Office of Sponsored Programs.

To achieve its aims of providing higher education, providing patient care, advancing knowledge, and contributing to the welfare of the State, UTMB accepts external funding in support of research and sponsored activities when the project:

  • Provides the faculty member with the opportunity to gain experience and knowledge of value to his/her teaching and/or research activities.
  • Is a suitable sponsored activity through which the faculty member may make worthy contributions to knowledge.
  • Provides appropriate public service to the community.
  • Provides an opportunity to enhance a student educational objective(s).
Read more about who is eligible  to submit a proposal to an external funding agency and serve as PI.

Everyone listed as an author should have made a substantial, direct, and intellectual contribution to the work. Please read UTMB Suggested Authorship Guidelines.

UTMB's Institutional Animal Care and Use Committee (IACUC) supports the use of animal research when conducted in a responsible, humane manner for medical and scientific research. All research involving vertebrate animals must be reviewed and approved by the IACUC.

  • New animal protocols may be submitted for IACUC review via the InfoEd system at any time. Deadlines for the submissions to be reviewed at a specific meeting are listed on the IACUC website.
  • Personnel must complete designated training, have Occupational Health clearance and placed on a protocol prior to working with animals. 

UTMB is committed to protecting the rights and welfare of human subjects who choose to participate in biomedical or socio-behavioral research. UTMB has an organized and systematic program in place for the protection of research subjects that includes a commitment to the principles and guidelines for protecting research subjects contained in the Belmont Report. UTMB maintains a Federalwide Assurance (FWA), FWA#00002729, with the Department of Health and Human Services’ Office of Human Research Protection (OHRP). This Assurance is updated periodically and commits the University to abiding by all federal regulations and guidelines as set forth under 45 CFR 46 with respect to its research activities involving human subjects.

All research involving human subjects must be reviewed and approved by the Institutional Review Board (IRB).

  • Human protocols are accepted on a rolling basis for IRB review. UTMB has two IRB committees, each meeting once a month. The placement of items on the IRB agenda is determined based on the order in which it is received and the number of members scheduled to be present.
  • Human subject protocols require training of PIs and research staff.  Training is available through CITI Program
Privacy rules apply to research just as they do to health care systems. Please refer to the Office of Institutional Compliance for current HIPAA privacy guidelines
The Office of Clinical Research can provide guidance and resources for clinical research billing. 
Environmental Health & Safety (EHS) works to protect the health & safety of faculty, staff, students, patients,and visitors at UTMB as well as ensure compliance with local, state, and federal regulations. They work with researchers to ensure compliance with all regulations related to biological & chemical safety, environmental safety and radiation safety.

Investigators should contact EHS for information regarding the use and potentially required reviews of select agents, recombinant DNA, infectious agents, hazardous chemicals or biochemicals and radioisotopes.

Related Review Committees

INSTITUTIONAL BIOSAFETY COMMITTEE
CHEMICAL SAFETY COMMITTEE
RADIATION SAFETY COMMITTEE

The Office of Technology Transfer manages UTMB's intellectual property assets, while promoting and encouraging scientific research. Contact the office for guidance on identifying, protecting, marketing and licensing UTMB intellectual property. The office also drafts and negotiates material transfers, confidential disclosures, licensing, and agreements with industry, including SBIR-funded agreements. Investigators also have resources for identifying competing and complementary technologies of interest, developing business plans, establishing entities, as well as identification of commercial partners and cultivation of industrial relationships.