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Research & Innovation » Sponsored Research » Desk Manual

7. Compliance Issues

Overview

The Research Integrity & Compliance is responsible for the development and administration of some of the key research-related assurance and compliance programs required by federal and state agencies and programs in order to conduct research at USF.

Activities of this Division include the administration of programs involving:


Research Integrity & Compliance Roles and Responsibilities PDF

Research Involving Human Subjects

Any employee, student, or agent of the USF (full-time, part-time, visiting, consulting, and/or without compensation) in connection with his/her USF assignment or using any property or facility of the USF or a USF-affiliated institution conducting research involving human subjects must obtain IRB approval or proof of exemption before initiating the study. If researchers are uncertain as to whether their project requires IRB approval, please refer them to an IRB staff member.

Written approval to conduct the study must be submitted to Sponsored Research from one of the following:

  • One of USF's two Institutional Review Boards (IRB) for the Protection of Human Subjects:
    • Medical IRB-01: All human research activities that fall under the Food and Drug Administration, that involve ingestion or placement of test articles, or that have some form of invasive procedure are reviewed by the Medical Institutional Review Boards.
    • Social and Behavioral IRB-02: All human research activities that involve procedures or data collection that are non-invasive in nature, including those research procedures other than those which involve the ingestion or placement of any investigational test article, are reviewed by the Social and Behavioral (SBR) IRB. Examples of human research activities reviewed by the SBR IRB include quantitative research, epidemiologic research, educational practices research, psychological research, and research stemming form areas within the arts and sciences such as anthropology, sociology, or engineering.
  • The Western Institutional Review Board (WIRB®) IF: the trial is a multi-centered, industry-sponsored and FDA regulated drug or IDE study; the investigator has not previously submitted the clinical trial to another IRB; the study does not involve the Veteran's Administration (i.e. use of VA facilities, equipment, or patients), is not in collaboration with an employee of the VA during his/her VA tour of duty; and is not used by an employee to fulfill VA responsibilities. Investigators may NOT use the WIRB for behavioral science research, non-therapeutic trials, or Phase I trials. Refer to the USF IRB Guidelines WIRB page
  • All Children's Hospital IRB: The USF Department of Pediatrics will provide a list of faculty eligible to conduct pediatric research projects at ACH to the USF Research Integrity & Compliance semi-annually.
  • An IRB at another institution with which USF has an Intra-Institutional Agreement

All USF and affiliate faculty, staff, and students who are involved in research using human subjects (regardless of which IRB reviews the study) must complete approved education in Human Subjects Protection annually and must submit a copy of the certificate of completion to the Research Integrity & Compliance.

Sponsored Research Involving Human Subjects

Sponsored Research will not release grant funds for research using human subjects unless a current copy of the IRB approval or exemption letter is on file. Under rare circumstances a limited amount of funding for a limited amount of time may be released for start-up activities prior to the collection of data on human subjects.

Permission to grant this type of exception must be obtained from the Associate Vice President for Research or Director of Sponsored Research and documented in the file.

Exception Requirements:

  • The PI must send an email or formal correspondence requesting the exception.
  • The PI must certify that no-human participants will be used until approval is received.
  • Sponsored Research will only open the award for 3 months.
  • A 3 month (maximum) budget will be released.
  • If additional time is needed, the process must be repeated.

The name of the project on the grant must be the same as the name on the IRB approval letter.

The PI of a grant using human subjects may be different from that of the PI on the IRB approval provided that he or she is included as an investigator on the IRB application and the scope of work is the same as that described in the IRB application.

IRB approval is typically granted for a maximum of one year. If the project extends beyond the approval period a copy of the approval extension must be kept on file and updated regularly for the duration of the study.

It is the responsibility of the PI to maintain current IRB approval records in the files. Under rare circumstances a study may remain open after the expiration of the IRB approval, IF all the human subjects' data have been collected and are in the analysis stage. Permission to grant this type of exception must be obtained from the IRB and documented in the file.

Although a copy of the signed letter of approval (or exemption) from the IRB is required for official documentation in the file, a record of the IRB approval process and timeframe is available to Sponsored Research Administrators in the InfoEd system and can be helpful in tracking the progress of the review process.

It is USF policy to assure that:

  • human beings exposed to research procedures are adequately protected;
  • the methods used to obtain "informed consent" are adequate and appropriate;
  • and the risks to the individual are outweighed by the potential benefits.

This policy is carried out in accordance with the Code of Federal Regulations, 45 CFR 46, and other pertinent federal, state, and local regulations.

The IRBs monitor all research conducted to ensure that medical, psychological, social, and other rights of individuals are safeguarded. At the present time, there are two separate IRB committees:

  • Medical IRB-01: All human research activities that fall under the Food and Drug Administration, that involve ingestion or placement of test articles, or that have some form of invasive procedure are reviewed by the Medical Institutional Review Boards.
  • Social and Behavioral IRB-02: All human research activities that involve procedures or data collection that are non-invasive in nature, including those research procedures other than those which involve the ingestion or placement of any investigational test article, are reviewed by the Social and Behavioral (SBR) IRB. Examples of human research activities reviewed by the SBR IRB include quantitative research, epidemiologic research, educational practices research, psychological research, and research stemming form areas within the arts and sciences such as anthropology, sociology, or engineering.

IRB applications, forms, and templates are available online.

The Principal Investigator (PI) must send the completed form and supporting documents to the Research Integrity & Compliance (campus mail stop MDC0035).

Results of the review by the Board will be sent to the PI and to Sponsored Research, usually within four to six weeks.

For further information, see Research & Innovation, Research Integrity & Compliance, Human Research Protections Program Policies and Procedures.

Also see: The USF IRB / Western Institutional Review Board (WIRB®) page.

Internal Form

The PI must make the determination whether or not the research involves human subjects.

If research activities involving human subjects are planned at any time during the proposed project period, either at the applicant organization or at any other performance site or collaborating institution (e.g., subcontractors, consultants), then the answer is "Yes" on the Internal Form, even if the research is exempt from regulations for the protection of human subjects.

If the answer is "No", no further information is required on the Internal Form.

If the answer is "Yes", then the PI must provide and complete the following entries:


HIPAA in Research

Federal privacy regulations of the Health Insurance Portability & Accountability Act (HIPAA) went into effect April 14, 2003. The regulations require that researchers and their institutions be in compliance with the HIPAA regulations, aka the HIPAA Privacy Rule.

If the PI is not certain HIPAA regulations apply to his/her research, a HIPAA Decision Tree PDF is available for reference.

Mandatory HIPAA Education:

USF Health faculty, staff, students, residents, and fellows who are in the USF Covered Health Care Component must complete HIPAA Education.

More information can be found at the HIPAA Compliance Program website.

Research Involving Animals

Investigators who intend to use vertebrate or warm-blooded animals in teaching, research, research training, experimentation, biological testing, or for related purposes must obtain approval from the Institutional Animal Care and Use Committee (IACUC) regarding the humane care and use of these animals.

Both federal Animal Welfare Act regulations (AWA) and the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy) require that the University appoint an Institutional Animal Care and Use Committee (IACUC).

The IACUC responsibilities are to oversee and evaluate the institution's animal program, procedures, and facilities to ensure they are consistent with the recommendations in the Guide for the Care and Use of Laboratory Animals, the AWA regulations, and the PHS Policy. Responsibility for enforcement of the Act has been delegated to the U.S. Department of Agriculture (USDA).

It is the responsibility of the IACUCs to implement current policy related to animal care and use and provide faculty with updated policy. 

USF IACUC applications are available for download online.

The completed form should be returned to the Institutional Animal Care & Use Committee, (campus mail stop MDC0035). Results of the review by the committee will be sent to the PI and a copy of the approval letter is sent to Sponsored Research.

For further information, see Use of Animals in Research, Teaching, or Testing, USF Policy 0-308 and IACUC Policies of Animal Care and Use.

The Research Integrity & Compliance provides the IACUC with administrative support services and assists the IACUC with its functions of oversight and evaluation of the animal care and use program.

USF's IACUC is part of the Comparative Medicine.

USF's Comparative Medicine is fully accredited by Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International as program #000434, and is managed in accordance with the Animal Welfare Regulations, the FDA Good Laboratory Practices, and the IACUC's Policies.

Comparative Medicine has assurance #A-4100-01 on file with Office of Laboratory Animal Welfare (OLAW)/PHS and maintains registration #58-R-0015.

Comparative Medicine veterinarians are Florida-licensed, members of the American Veterinary Medical Association (AVMA), and are specialty board certified by the American College of Laboratory Animal Medicine (ACLAM) and/or American College of Veterinary Preventive Medicine (ACVPM), and/or have research doctorates.

Comparative Medicine maintains institutional memberships with American Association for Laboratory Animal Science (AALAS), and Scientists Center for Animal Welfare (SCAW). All program staff are AALAS-certified, and many are either registered with the Society of Quality Assurance, and/or certified by the Academy of Surgical Research, or are State of Florida-certified veterinary technicians.

Required Training and Certification for Researchers Using Animals in Research

All personnel involved in animal care, use, or treatment must be certified by the IACUC as qualified to perform their duties. Researchers must submit a signed original request for certification to the IACUC, c/o Comparative Medicine, MDC0020, telephone 974-9796, fax 974-9432, e-mail CompMed@research.usf.edu.

For certification program information details and forms, see the IACUC Certification of Personnel page.

Internal Form

If research activities involving laboratory animals are planned at any time during the proposed project period, either at the applicant organization or at any other performance site or collaborating institution (e.g., subcontractors, consultants), then the answer is "Yes" on the Internal Form.

If the answer is "No", no further information is required on the Internal Form.

If the answer is "Yes", then the PI must provide and complete the following entries:

Status – enter "pending" or "approved".

Pending: No other information is required at the proposal stage. All information must be provided to the sponsoring agency and Sponsored Research prior to the award being made. This is often referred to as "Just in Time".

Approval Date: Provide approval date as provided in the letter from the IACUC to the PI. Approvals are granted for a three year period.

IACUC Number: the number as stated on the letter from the IRB to the PI

Will the animal data support an FDA submission? Yes or no

Would the data support FDA approval for marketing (patent, human use, etc.)?

Research Involving Radioactive Materials

PIs who intend to use radioactive materials, radiation-producing machinery, biohazardous chemicals, and/or infectious agents in support of their research are directed to contact the Research Integrity & Compliance, Radiation Safety Office, by telephone at 813-974-1194.

Applications for permit to use these materials shall be processed through the Research Integrity & Compliance, and approval granted by the Radiation Safety Committee. 

For further information, see Radiation Safety General Information PDF, Radiation Safety User Manual and Radioactive Disposal Fees (USF 0-307).

Internal Form

If research activities involving radioactive materials is planned at any time during the proposed project period, either at the applicant organization or at any other performance site or collaborating institution (e.g., subcontractors, consultants), then the answer is "Yes" on the Internal Form.

If the answer is "No", no further information is required on the Internal Form.

If the answer is "Yes", then the PI must provide and complete the following entries:

Status – enter "pending" or "approved".

Pending: No other information is required at the proposal stage. All information must be provided to the sponsoring agency and Sponsored Research prior to the award being made. This is often referred to as "Just in Time".

Approval Date: Provide approval date as provided in the letter from Radiation Safety to the PI.

Number: the number as stated on the letter from Radiation Safety to the PI.

The Radioactive Materials Lists (RAD) are maintained on Sponsored Research's "0" drive in the "Compliance" folder. The lists contain the PI name, Department, Permit Expiration date and the Permit Number.

Research Involving Biohazards (Recombinant DNA, Infectious Agents, or Biological Toxins)

PIs who intend to use infectious agents / biological toxins requiring BSL-3 containment or recombinant DNA molecules in support of their research are directed to contact the BioSafety Program in the Research Integrity & Compliance at 813-974-0954.

The use of infectious agents/biological toxins requiring BSL-4 containment is prohibited on the USF campus.

Applications to use these materials shall be processed through the Research Integrity & Compliance, and approval granted by the Institutional Biosafety Committee (IBC) prior to the initiation of the project.

A list of regulated agents can be found in Appendix B of the Registration Document.

For further information, see the Institutional Biosafety Manual. PDF

Internal Form

If research activities involving infectious agents / biological toxins or recombinant DNA molecules are planned at any time during the proposed project period then the answer is "Yes" on the Internal Form.

If the answer is "No", no further information is required on the Internal Form.

If the answer is "Yes", then the PI must provide and complete the following entries:

Status – enter "pending" or "approved".

Pending: No other information is required at the proposal stage. All information must be provided to the sponsoring agency and Sponsored Research prior to the award being made. This is often referred to as "Just in Time".

Approval Date: Provide approval date as provided in the letter from the IBC to the PI.

Number: the number as stated on the letter from the IBC to the PI.

Diving Safety

The purpose of these USF Scientific Diving Standards is to ensure that all scientific diving is conducted in a manner that will maximize protection of scientific divers from accidental injury and/or illness, and to set forth standards for training and certification that will allow a working reciprocity between other research facilities specifically organizational members of the American Academy of Underwater Sciences (AAUS).  Fulfillment of the purposes shall be consistent with the furtherance of research and safety. 

Internal Form

If diving is utilized by faculty, staff, or students participating in this proposed research at any time during the proposed project period then the answer is "Yes" on the Internal Form.

If the answer is "No", no further information is required on the Internal Form.

Definition:

If the answer is "Yes", then the Sponsored Research Administrator (SRA) will contact the Diving Safety Officer to obtain a copy of the approval letters for Diving Safety Certification on the principal investigators/researchers. The approval letters should be placed inside the Sponsored Research project folder and updated in the Sponsored Research data base.

More information can be found at the Scientific Diving Program website.

Conflict of Interest in Research

Conflict of interest in research is a situation in which designated officials reasonably determine that a significant financial interest or other personal considerations could directly and significantly affect the design, conduct, or reporting of the research.

Policy:

Federal regulations (42 CFR 50.601-607 and 45 CFR 94) require institutions to have in place policies and procedures that ensure objectivity in research by requiring that investigators on sponsored projects disclose any significant interest that may present actual or potential conflicts of interest with the project. Therefore, anyone who is responsible for the design, conduct, or reporting of a research project under the auspices of the University ("investigators"), must disclose for themselves and immediate family members (spouse or dependent children) financial or other interests that are, or may be perceived to be related to the project. 

USF Policy 0-309, Conflicts in Sponsored Research and  USF Regulations, 6C4-10.107 & 206, Faculty/Personnel Ethical Obligations: Conflicts of Interest and Outside Employment; Employment of Relatives; Seeking or Holding Public Office PDF apply to all sponsored research conducted or administered by USF, regardless of the source of funding.

The PI is responsible for reporting on the Internal Form when the proposal is submitted WHETHER OR NOT any potential financial conflict of interest exists for him/her or immediate family. S/he must also inform all "investigators" that they must report any financial relationship related to the project if they exist for themselves or immediate family.

If a potential COI is reported on the Internal Form or if the project is sponsored by the NIH, NSF or American Heart Association (AHA) or has federal flow through funding, the PI and all "investigators" must submit a completed Financial Relationships Disclosure Form with the proposal to the COI Coordinator, and the information must be updated with a new form annually.

For further information, refer to: Office of Research Compliance - Conflicts of Interest

Process (managed by COI Coordinator or program assistant):

At the Proposal/Initial Stage:

The Sponsored Research Administrators in Sponsored Research will monitor the Internal Forms and notify the Conflict of Interest Coordinator if 1) a COI has been identified on the form or 2) if an individual has received funding from the NIH, NSF, AHA or has federal flow through funding. In either of these cases, the Coordinator (or program assistant) will correspond with the investigators to obtain the proper documentation.

The forms and supporting documents will be collected by the COI Coordinator (or program assistant) and sent to a Conflict of Interest Administrator (COIA) for review and assessment. If the COIA determines that such interests may affect the design, conduct, or reporting of the project, steps will be taken to manage or eliminate the conflict and document FAST and the files. If a significant conflict exists the COIA will refer the case to a Conflict of Interest Committee for a final determination.  In the case of NIH, NSF and AHA Sponsored research the agencies will also be notified that a conflict has been identified and managed or eliminated.

At the Award Stage:

The COI Coordinator will be notified by the staff when an award has been made to an individual who has identified a COI on the Internal Form or who has received funding from the NIH, NSF or AHA. The Coordinator will check the file to see if FRDFs are filed. If the PI and "investigators" have not submitted the FRDF form the Coordinator will email them a reminder and form. Release of funds may be suspended until all forms are submitted.

Annual/Episodic COI Update:

The COI Coordinator (or program assistant) will identify faculty with an identified conflict of interest or NIH, NSF, AHA or federal flow through funding and send them an update reminder on an annual basis. In addition, if "investigators'" financial relationships change at any time during the study they must file another Financial Relationships Disclosure Form to update their status.

Internal Form

The PI must indicate on the Internal Form whether he or she or any immediate family members have any financial interest such as royalty, equity, or any other payments (e.g., consulting, salary, etc.) in the sponsor or other entities having financial interest in intellectual property, products or services that are subject of the proposed research.

If the answer is "No", no further information is required on the Internal Form unless the project is funded by the NIH, NSF, AHA or federal flow through money. 

If the project is funded by NIH, NSF, AHA or federal flow through money, the PI must submit a completed Financial Relationships Disclosure Form WHETHER OR NOT there is a financial interest.

If the answer is "Yes" then:

A Financial Interest Disclosure Form MS Word must be completed, signed by the investigator's supervisor or program leader, and submitted to the COI Coordinator in Sponsored Research along with the research proposal.

Forms received by the Sponsored Research Administrators should be sent to the COI Coordinator or program assistant in Sponsored Research for processing.

Note:  Failure to submit a Financial Relationships Disclosure Form will not delay the submission of a proposal to an agency. However, the form must be submitted and any conflict must be managed prior to the acceptance of the award.

Conflicts of Commitment

A Conflict of CommFlorida state law provides that no employee of a state agency "shall have interest, financial or otherwise, direct or indirect; engage in any business transaction or professional activity; or incur any obligation of any nature which is in substantial conflict with the proper discharge of his or her duties in the public interest." (Florida Statute, 112.311)itment arises when university members' involvements in outside activities substantially interfere with their primary commitments to the university: to teach, to conduct research and to meet related obligations to students, colleagues and the university.

Outside Activity means "any private practice, private consulting, additional teaching or research or other activity, compensated or uncompensated, which is not part of the employee's assigned duties for which the University has provided no compensation." 

The Florida Board of Education (FBOE) and the University do not intend to discourage an employee for engaging in outside activity in order to increase professional reputation, service to the community, or income. However, notification and an opportunity to discuss are necessary due to the special obligations and responsibilities of public employees bound by the State of Florida Code of Ethics and dual compensation regulations, in addition to the responsibility for full and competent performance of all duties pertinent to University employment."

If the PI has an outside activity (compensated or not) that could be perceived as conflicting with his or her proposed activity, an Outside Activity Form (OAF) must be filed. The purpose of this form is to provide for effective management of outside activities that have the potential for conflict of interest with USF duties.

Note: Faculty in USF Health must submit the Outside Activity Form with their annual contracts whether or not they have activities to report.

The form is valid for one fiscal year and needs to be renewed by July of each year or when the outside activities change. 

Faculty must file a new form for approval of new activities before they begin the activity. 

For further information, refer to:  USF Regulation, 6C4-10.107 & 206, Faculty/Personnel Ethical Obligations: Conflicts of Interest and Outside Employment; Employment of Relatives; Seeking or Holding Public Office PDF and USF Health Policy on Conflicts of Interest and Commitment .

Internal Form

If Outside Activity is indicated on the Internal Form (the PI checks "yes"), he or she must attach the OAF. The SRA reviews the OAF for completeness and required signatures.

If the form is complete, one copy is retained with the Sponsored Research copy of the proposal and an extra copy of the form is placed in the OAF binder located in the file room.

If the form is incomplete, or lacking signatures, the proposal is still submitted, however, the SRA will return the form to the PI to either route for signatures or complete the lacking information. The SRA will follow-up with the PI to make sure the form is returned.

Nepotism

Nepotism is favoritism granted to relatives or close friends, without regard to their merit. In the research context is means hiring a relative or close friend on the grant, contracting to do business for the grant with such a person/entity, or otherwise favoring such a person without regard to merit. In order to determine the "merit" issue any interaction with the research by relatives must be reviewed and approved by the Provost or the Vice President (for USF Health faculty) and documented in the Sponsored Research file.

For further information, refer to:  USF Regulation, 6C4-10.107 & 206, Faculty/Personnel Ethical Obligations: Conflicts of Interest and Outside Employment; Employment of Relatives; Seeking or Holding Public Office PDF

Internal Form

If any participating faculty, staff, or students have any relatives or related persons participating in this proposed research at any time during the proposed project period then the answer is "Yes" on the Internal Form.

If the answer is "No", no further information is required on the Internal Form.

If the answer is "Yes", then the PI must provide his or her Sponsored Research Administrator a memo signed by the Provost or Vice President determining how the nepotism has been mitigated.

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