Research Compliance

Guide to Research at USC

The following is a quick reference tool that highlights some of the important USC policies related to sponsored projects.  Please refer to this checklist both in the proposal preparation stage and throughout the course of your research.  At the end of this guide, you will find a list of important research contacts in the university.

Please contact the Office of Research Advancement (www.usc.edu/research, or 213-740-6709), for any general questions on research within USC, and contact the Office of Compliance (http://www.usc.edu/admin/compliance/ or 213-740-8258) for any general questions on research compliance.

I.            Proposal Submission

A Proposal Activity Record (PAR, http://dcg.usc.edu/IPFP/index.cfm) must be submitted to the Department of Contracts and Grants with any externally sponsored proposal.  The PAR summarizes how the proposed research will affect the university, from the perspectives of budgets, space, research regulations and policies.  The PAR form also identifies whether your proposal is subject to review by one of USC’s regulatory committees or by our Disclosure Review Committee. 

A.          Regulatory Research Committees

If your proposal is subject to review by a regulatory research committee, committee approval is required before research can commence and before an account is established.  Investigators should contact the applicable committees before, or soon after, a proposal is submitted, to avoid delays in starting research.  The USC regulatory research committees are as follows:

Human Subjects: Institutional Research Board (IRB) (human subjects research).  Visit http://www.usc.edu/admin/provost/oprs/, or phone (323) 223-2340 for Health Science Campus or (213) 821-5272 for University Park Campus.

Stem Cells (Adult or Embryonic):  Embryonic Stem Cell Research Oversight Committee (ESCRO).  Phone (323) 442-1607 or email gpetrov@usc.edu.

Animals:  Institutional Animal Care and Use Committee (IACUC).  Visit www.usc.edu/hsc/dar/iacuc/forms/ or call (323) 442-1689.

Biological Agents and Regulated Carcinogens:  Institutional Biosafety.  Visit http://capsnet.usc.edu/LabSafety/BioSafety or call (323) 442-2200.

Radioactive Materials:  Radiation Safety Committee (research involving the use of radioactive materials), http://capsnet.usc.edu/LabSafety/RAD, or call (323) 442-2200.

Select Agents (as identified at www.cdc.gov/od/sap/docs/salist.pdf): Contact the Laboratory Safety Office at 323-442-2200.

B.          Conflicts of Interest and Commitment

Any potential conflict of interest in research must also be identified on the PAR.  You must also fully disclose the potential conflict by completing a Statement of Outside Interests Related to Research.  Research cannot commence until a decision is made by the Conflict of Interest Review Committee (CIRC), which may require that you follow a conflict management plan.  Conflicts that arise during the course of research must also be disclosed when they first appear, and also require an approved management plan.  Conflicts of commitment must be disclosed through your supervisor and Dean.  Call the Office of Compliance at (213) 740-8258 for further information.

Resources

http://ooc.usc.edu/ResearchCompliance/ConflictsOfInterest/documents/COIPolicy.pdf  (Conflict of Interest in Research Policy)

http://ooc.usc.edu/ResearchCompliance/ConflictsOfInterest/documents/StatementofOutsideInterests-pdf_000.pdf (Statement of Outside Interests Related to Research)  

http://policies.usc.edu/policies/conflictadmin110102.pdf  (Conflict of Commitment)

II.           Account Establishment

The Department of Contracts and Grants negotiates the terms of all sponsored research agreements with sponsoring organization. 

A.          Pre-Award Costs/Advanced funding

Pre-award costs and advanced funding enable investigators to incur costs on a sponsored project before the university has actually received award funds. 

Pre-award costs are used for costs incurred up to 90 days before the official start date of an award, but only where there is a programmatic justification to do so. 

Advanced funding is used to incur costs after the official start date of the award, but prior to the university actually receiving the award funds. 

Both pre-award costs and advanced funding require authorization from the investigator’s dean (school of primary appointment), because the Dean’s account is at risk until the award is received.  For further information, visit the Department of Contracts and Grants website at http://dcg.usc.edu/, or call (213) 740-7762 (University Park Campus), or (323) 442-2396 (Health Sciences Campus).

B.            Account Creation

The Department of Contracts and Grants first prepares a Notice of Award (NOA), which contains a summary of the terms and conditions of the award, and sends it to the Principal Investigator.  It is important to review this document and maintain a copy in your files.  The Department of Contracts and Grants then establishes an account related to the sponsored project.  Until the account is established, the PI cannot charge costs against the award.  For further information, visit the Department of Contracts and Grants website at http://dcg.usc.edu/, or call (213) 740-7762 (University Park Campus), or (323) 442-2396 (Health Sciences Campus).  

III.          After Research Commences

A.          Effort Reporting 

Faculty and research staff are responsible for reporting and certifying monthly percentage effort charged to a sponsored project in a timely manner. Certification also includes making corrections and adjustments if there are differences between estimates and actual effort.  Certification processes vary among schools, but are overseen by USC’s Office of Financial Analysis.  Visit http://fbs.usc.edu/depts/ofa/, call (213) 821-1937 or contact your own department coordinator. 

The University is testing an on-line effort reporting system designed to streamline the certification process.

B.           Cost transfers 

A cost transfer is a mechanism used to transfer payroll and non-payroll transactions from one sponsored account to another when a sponsored account was erroneously charged.  Cost transfers should be made within 90 days of when the original charge was incurred, and no later than 15 days after the termination date of the budget period.  All cost transfers must be fully documented.  USC’s Sponsored Projects Accounting (SPA) oversees the cost transfer process.  Visit http://fbs.usc.edu/depts/spa/ or call (213) 740-5381 for more information.

C.           Subrecipient monitoring

All subcontractors must sign a subcontract that includes a detailed statement of work. Investigators are required to monitor subcontractors to ensure that they are complying with the terms of the award.  These monitoring duties include confirming that the subcontractor is satisfying the statement of work, and that the invoices submitted by the subcontractor are reasonable, allocable, and allowable on the project.  For assistance on issues related to subrecipient monitoring, please contact the Department of Contracts and Grants (http://dcg.usc.edu/) or the Office of Financial Analysis (http://fbs.usc.edu/depts/ofa/).

D.          Program Income

Program income is gross income earned by a grantee that is directly generated by the project or activity or earned as a result of the award, other than income resulting from royalties or licensing fees.  All program income must be reported on the financial status report. 

E.           Use of Consultants

Before an independent contractor or consultant provides professional advice or a service in connection with a sponsored project, the appropriate independent contractor agreement – either short form or long form -- must be signed.  Please visit the Office of Disbursement Control at http://fbs.usc.edu/depts/DC/object.aspx?object_id=1571  for more information on what form should be used in a particular situation. University faculty are not eligible to receive compensation for consulting within the university.

F.           When to Notify Regulatory Research Committees 

Investigators must inform regulatory research committees of any changes that relate to studies under their jurisdiction, such as:

• Adverse events
• Changes to study personnel
• Protocol changes
• Changes in funding sources

If you are unclear as to whether to report a change, consult the applicable committee.

G.           When to Update Conflict of Interest Disclosure: 

Any change in a financial or other interest related to research must be disclosed to the DRC, regardless of whether a disclosure was made at the outset of the research.  These include changes in the:

• Percentage of ownership in outside entities with a financial interest in research;
• Amount of consulting performed on behalf of an outside entity;
• Role of an investigator in an outside entity (i.e., from consultant to managerial role).  

IV.         Closeout

A.          Reporting

Investigators are required to satisfy all final reporting requirements, which includes notifying the sponsor that the research has been completed, submitting final reports, and disclosing project results and expenditures.  USC’s Sponsored Projects Accounting (SPA) office is charged with fiscal oversight of the project closeout process.  Visit http://fbs.usc.edu/depts/spa/ or call (213) 740-5381 for more information.

B.           Intellectual Property 

Under USC Policy and consistent with both federal and state laws, all intellectual property (as a limited example, patentable inventions) resulting from government and industry sponsored projects, or substantial use of university resources, must be disclosed to USC Stevens.  USC Stevens assists faculty, staff and students with intellectual property matters in many ways, including obtaining and maintaining patents, identifying potential licensees and partners, consulting on start-up activities and strategies, and negotiating related agreements. In addition, USC Stevens provides services for transferring technologies to other non-commercial and non-profit research institutes.  Visit http://stevens.usc.edu/ or call (213) 821-5000 for more information.

V.          Scientific Integrity

Investigators should be responsible and ethical in their research, and promote high ethical standards among their colleagues and mentees.  USC’s policy on scientific misconduct  (http://policies.usc.edu/policies/scientificmisconduct061203.pdf) designates the responsibilities of all investigators, which include the following.

A.          Data Management 

Data can include laboratory notebooks, notes, preliminary analyses, as well as any other records that are necessary for the reconstruction and evaluation of results of research, regardless of the form or media on which they are recorded.  Generally speaking, USC owns all research data created in the course of research conducted at the university. 

B.           Authorship

Generally speaking, authorship credit should be given to those who have made significant contributions to the conception and design, or analysis and interpretation of data, or both; to drafting of the manuscript or revising it critically for intellectual content; or on final approval of the manuscript.  Principal authorship and other publication credits should accurately reflect the relative scientific or professional contributions of the individuals involved, regardless of their relative status. 

VI.         Education Requirements

A.          WEBBA training 

All staff members must complete mandatory WEBBA System Training, which provides an introduction to the Budget Administration (WEBBA) System, within 30 calendar days of receiving their BA system access, or their access will be frozen until they complete the training.  For further details, go to: www.usc.edu/dept/finserv/dirtrng/handsontraining.html.

B.           Grants Management Education 

All principal investigators, co-investigators and research administrators must complete one of the two courses in Grants Management Education program to obtain access to sponsored projects funds or the budget administration system.  To register, go to www.ooc.usc.edu/ResearchCompliance/index.cfm and click on the link titled “Grants Management Education Program.”

C.           Human Subjects Education

All personnel engaged in human subjects research must complete the CITI on-line human subjects education course.   Go to: www.usc.edu/admin/provost/oprs/citi, or contact the Office for Protection of Research Subjects at (213) 821-1154, or oprs@usc.edu.

D.          Animal Use 

All Principal Investigators, staff, and students working in laboratory animal facilities and/or handling animals or animal tissues must complete initial training and yearly refresher training thereafter, by the Department of Animal Resources.  Visit www.usc.edu/hsc/dar/ or phone (323) 442-1689.

E.           Radiation Safety

All individuals who work with or in the vicinity of radioactive material or radiation-producing machines must undergo appropriate training. This training is required by the Radiation Safety Committee and administered by Environmental Health and Safety.  Visit http://capsnet.usc.edu/LabSafety/RAD, or call (323) 442-2200.

F.           Institutional Biosafety

All investigators and laboratory personnel who engage in research involving potentially hazardous biological agents, agents including but not limited to infectious agents, human and non human primate materials (including established cell lines), known regulated carcinogens, select agents, recombinant DNA and studies involving human gene transfer must undergo appropriate training.  This training is required by the Institutional Biosafety Committee and administered by Environmental Health and Safety. Visit http://capsnet.usc.edu/LabSafety/biosafety, or call (323) 442-2200.

G.           Research Advancement

The Office of Research Advancement offers courses in grantsmanship, including specialized courses on proposal writing for foundations, corporations, NIH, and Department of Defense.  Information can be found at: http://www.usc.edu/research/for_researchers/training/, or phone 213-740-6709.