Regulatory Review and Compliance

Compliance

The School of Medicine is committed to conducting sponsored research in accordance with all relevant ethical, legal, and regulatory obligations. We have structured several compliance programs and initiatives to ensure effective monitoring, auditing, training, education, and communication regarding compliance issues. 

Human subjects research

The Institutional Review Board for the Social and Behavioral Sciences (IRB-SBS) reviews and oversees non-medical, behavioral research studies.  The IRB for Health Sciences Research (IRB-HSR) oversees all other studies involving human subjects, including the majority of human use protocols performed by the School of Medicine.  Investigators who are new to clinical research or who wish to perform unfamiliar studies should contact the IRB-HSR prior to submitting a protocol.  The  Clinical Trials Office can facilitate the conduct of clinical studies by assisting with budget and proposal preparation, study coordination and management, and regulatory functions such as quality assurance/quality control.

Animals in research

The Animal Care and Use Committee (ACUC) reviews and oversees the use of animals in research and teaching at the University.  The ACUC provides training in handling research animals, insures that individuals using research animals participate in the WorkMed (occupational health and safety) program, and conducts inspections of animal use facilities.  The ACUC has specific protocol submission deadlines.  The Center for Comparative Medicine operates UVA vivaria and provides veterinary support.   Current per diem rates are listed on the CCM web site.

Recombinant DNA and pathogens

The Institutional Biosafety Committee (IBC) oversees the use of recombinant DNA, organisms requiring at least Biosafety Level 2 conditions, and of human specimens.  The IBC also inspects laboratories that have registered for one or more of these activities.

Biohazardous materials

The Office of Environmental Health and Safety maintains comprehensive programs for the management of potential hazards (bloodborne pathogens, radiation, hazardous chemicals, shipping biological materials, etc.) that may be encountered during research activities.  Refer to their web site for current health and safety policies and information on ordering radioactive materials and provides information on training requirements, programs, and on-line training.

Responsible conduct of research (RCR)

UVA expects the highest standards of teaching, research, and public service from its faculty and staff.  Biomedical research requires both personal integrity and public trust to continue to flourish.  UVA investigators should:  openly exchange their findings via scientific publications; provide unique research materials to qualified academic investigators; maintain detailed records of research procedures and results; fairly assign authorship or acknowledgment in research publications to the originators of ideas, methods, and findings.  These areas are of special concern for investigators:

• Authorship. Refer to SOM authorship policy and International Committee of Medical Journal Editors recommendations on authorship.  Recommended best practices:
  • Initiate discussions concerning authorship when first planning a project:  agree on authors and individuals to be acknowledged, including the order of authors and each author’s responsibility on the project and in preparing resulting manuscript(s).
  • Since authors assume responsibility for the integrity of the entire publication, each author should read and approve the final manuscript and agree to take public or legal responsibility for its content.
  • The  SOM authorship policy prohibits the use of ghost authors on scholarly publications and prohibits faculty from serving as ghost authors on other authors’ publications.
• Conflict of Interest. Refer to the section below.
• Financial sources/billing for clinical research activities. Costs of investigational procedures or subject visits on clinical studies should not be borne by patients or third party payers, unless allowed by policy.  Similarly, public funds (e.g., external awards, University facilities/staff) may not be used to support industry-funded studies without prior institutional approval.  The Clinical Trials Office can help investigators and clinical study personnel determine which charges to insurers are allowable.
• Data integrity. The investigative team should establish an analytic plan and agree on methodologies (e.g., laboratory SOPs, exclusion of outlier data) at the start of their project.  Once the data are collected, verified, and locked, any changes in analytic methodology should be reported as post hoc and exploratory.
• Plagiarism.  Funding agencies and journals routinely compare submitted proposals and manuscripts to libraries of prior proposals or publications.  Submissions considered similar or identical to previously-published documents will be rejected and their authors are at risk for corrective actions under applicable regulations.
• Images. Avoid inappropriate manipulation of images when preparing them for publication or presentations (cf. Rossner and Yamada, J. Cell Biol, 2004, 166:11-15).  Consider following these simple guidelines within your research group (adapted from the Southwest Environmental Health Science Center):  scientific content may not be knowingly altered in any image; limited enhancements are permitted for clarity, aesthetic reasons, or to eliminate physical artifacts; and any manipulations must be described in resulting publications and presentations.
• Training in RCR. Graduate students in the Biomedical Sciences Graduate Programs (BIMS) and individuals supported by NIH training grants or career development awards are required to be trained in RCR, by completing BIMS 7100, “Research Ethics.” Additional sources on RCR:
  • “On Being a Scientist:  Responsible Conduct in Research” (National Academy Press; free download)
  • DHHS Office of Research Integrity materials:
    • “ORI Introduction to the Responsible Conduct of Research” (Office of Research Integrity, DHHS)
    • Educational resources (ORI site; select “RCR Resources”)
    • “The Lab: Avoiding Research Misconduct” (video simulation allowing users to assume the role of a graduate student, postdoc, research administrator, or PI and make decisions that affect the integrity of research)
• NIH “Update on the Requirement for Instruction in the Responsible Conduct of Research,” providing recommendations on RCR training required for NIH training, career development awards, research education grants, and dissertation research grants.

Reporting misconduct

If you suspect misconduct in research, UVA research misconduct policy requires that you report it to the Vice President for Research.  Informal discussions with the Research Integrity Officer (RIO, Dr. David Hudson; 924-3606) may help clarify whether the suspected behavior meets the definition of research misconduct.  If it does, the RIO will refer you to other officials with responsibility for resolving the problem.  It is difficult to report misconduct by a superior or supervisor; however, the research misconduct policy states that individuals who report allegations of misconduct or of inadequate institutional response thereto must be protected in terms of the terms and conditions of their employment or other status at the University of Virginia and requires that UVA protect the privacy of those who report misconduct in good faith, to the maximum extent possible.

Conflict of interest (COI)

COI regulations govern situations in which financial considerations may compromise an individual’s conduct or reporting of research, or his/her procurement decisions on behalf of the University.  This section specifically refers to conflicts of interest that relate to research activities.  Financial interests generally are not the same as financial conflicts of interest. Federal regulations and UVA policies recognize that faculty may have financial interests in corporate sponsors or in entities whose business interests relate to their research.  For example, the Commonwealth of Virginia defines “significant financial interest” as ownership/liability of 3% of company assets or property used by a company; or income/salary/other compensation totaling $5,000 annually.  Public Health Service (PHS) Objectivity in Research Policy uses the following thresholds for the definition of significant financial interests:  combined income/equity >$5,000, any ownership interest in a non-publicly traded company, travel reimbursed or sponsored by an external entity other than academic institutions or government agencies.  The PHS policy requires that institutions assess the relatedness of a significant financial interest to PHS-funded research in deciding whether there exists a financial conflict of interest requiring institutional review/management.

UVA and Health System COI policies are not meant to discourage ownership, consulting, or other external activities.  Rather, if a financial interest rises to the level of COI, the University must eliminate, reduce, or manage the conflict.  When grants or contracts involve employees with financial COIs (e.g., NIH SBIR subcontract or procurement from a faculty-owned company), the UVA Conflicts of Interest Committee will review and, if recommended by the committee, the president will sign a waiver of COI to satisfy the Virginia COI statute.

Developing and obtaining approval for a waiver.  Because the COI landscape is so complex, we recommend that you speak first with Danny Burdine, Director of Research Operations.  The two of you will craft a request for exemption from conflict of interest that includes a proposed management plan for the conflict and may include data review to ensure unbiased analysis/interpretation, appointment of an ombudsman to protect the professional goals of trainees, requiring disclosure of financial interests in all resulting publications, etc.  The request for exemption is then forwarded to your Chair and Dean’s Office for review using a request for exemption of COI form.  Most of the waiver requests that are developed via this procedure are approved by the institution.  The UVA COI Committee meets the third Wednesday of the month.  Requests for waivers are due to the committee on the first Wednesday of the month to allow for a pre-review, responses to follow-up questions generated during pre-review, and distribution of materials to the committee prior to its meeting.

COI and human subjects research.  Participation in human subjects research by individuals with significant financial interests warrants substantial scrutiny.  The School maintains the “rebuttable presumption” that an individual with a significant financial interest (defined as annual income >$10,000 or ownership interest >3%) may not participate in human subjects research, unless approved by the institution.  Only under tightly controlled circumstances may this presumption be rebutted, after review by the UVA COI Committee but prior to approval of the protocol by the IRB.  Refer also to DHHS Office for Human Research Protections guidance document on financial COI in human subjects research.  In addition, the IRB must be notified immediately if a financial conflict arises during the course of a research protocol.

Training on conflict of interest.  The Public Health Service Policy on Objectivity in Research requires that all Investigators on PHS awards (defined as “the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which may include, for example, collaborators or consultants”) must complete training in COI before expending any funds on such awards.  UVA uses the CITI COI training module to satisfy this requirement.  See also our instructions for creating an account and logging onto the CITI site.  Investigators must be re-trained no less than every four years to remain in compliance with the PHS policy.

Export Controls

The federal government restricts certain activities involving the export of certain technologies to specific countries and transfers to citizens or companies within those countries.  Note that a visitor to UVa from a sanctioned country who learns about restricted technology is considered a deemed export of that technology.  See the UVA Office of Export Controls web site for additional information and contact that office if you have questions concerning what can be transferred and whether a federal license would be required before a transfer can be effected.

Confidentiality

Investigators gain access to confidential or privileged information from many sources:   review of proposals and manuscripts; human subjects research involving personal identifiers; consulting agreements with industry; personnel records of research staff; etc.  UVA employees must maintain the highest level of confidentiality in all aspects of their research.  All School of Medicine employees are required to complete training on HIPAA privacy, which governs protected health information.

If you are asked to sign a Confidential Disclosure Agreement (CDA, or Nondisclosure Agreement) for activities in conjunction with your position at UVA, forward the agreement to the Office of Grants and Contracts for review prior to signing.

Records management

Records management at UVA is overseen by the Records Management Office (Caroline Walters, Records Officer). Storage of documents containing information protected under HIPAA or FERPA in unsecured areas is not permitted.  Secure areas include locked file cabinets, locked rooms with restricted access, or HIPAA- and FERPA-compliant storage facilities such as the Library of Virginia State Records Center.  Electronic records must be protected with a similar level of restricted access.  See UVA policy IRM-015, governing the electronic storage of highly sensitive data.

Grant & contract records. NIH Grants Policy Statement requires that documents associated with research awards be retained for at least three years after the annual (for SNAP awards, the final) financial report has been filed.  Individual sponsors or projects may have different requirements.  The Commonwealth of Virginia requires retention of at least five years after grant closeout, or in accordance with grant/contract stipulations – whichever is longer.

Research data. This includes maintaining complete and accurate records for data analysis and other records relating to the conduct of the project, such as the documents on financial management and the development of intellectual property under the project.  The following are critical to the responsible conduct of research:

• Ownership.  All data resulting from University sponsored projects or substantial use of University resources are the property of the University.  Investigators who leave UVA may transfer the data to another institution, if approved by the Vice President for Research.
• Collection.  Data may be collected electronically, manually, by recorded interview, etc.  The original record and subsequent transcriptions of those data must be accurate and reliable.  Your research group should agree upon data recording and transcription standards.  Such Standard Operating Procedures (detailed instructions permitting uniformity in performing specific procedures) can help maintain consistency across members of a research group.  Collection and transcription of clinical research records are governed by Good Clinical Practice (see FDA Clinical Trials Guidance Documents ).
• Security.  Back up all data to an off-site location.  Ensure protection of data by establishing rules for authorized access to clinical data and ensuring that such data are used only as approved by the IRB.
• Sharing.  Investigators must balance the reasons not to share their data (i.e., protecting intellectual property rights, priority in publication, privacy of research subjects) with the benefits of sharing data (to foster collaborative research, allow replication of experiments, or satisfy funding agency requirements).  Prior to publication of their research results, investigators generally are not required to share proprietary materials.  After publication, unless constrained contractually, investigators should share research materials with their colleagues at other institutions.  Certain journals require that authors share the materials described in their publications with members of the scientific community, for noncommercial purposes.  This can be effected via a Material Transfer Agreement.
• Retention.  UVA data must be retained to confirm research findings, establish priority of inventorship, for investigation of research misconduct, and (for clinical trials) for use in the FDA licensure process.  The UVA Laboratory Notebook and Recordkeeping Policy states that raw data must be retained for at least five years after publication or termination of research support, whichever comes first, unless otherwise required by contract, law, or regulation.

Clinical study documents.  FDA regulations require that clinical study documents be retained until at least 2 years after the last approval of a marketing application if there are no pending or contemplated marketing applications, or at least 2 years have elapsed since clinical development of the product was discontinued.  Regulatory requirements or contractual agreements with the sponsor may extend this requirement.  Federal HIPAA regulations require that consent forms be retained for 6 years after the end of the clinical study.

Managing  your records.  The Records Management Office maintains an on-line system called University Records Management Application (URMA), that ties records to the responsible office, calculates the disposition dates automatically, provides a mechanism to easily transfer the storage of physical records to approved storage locations, and streamlines the “Certificate of Records Destruction” process required by the Virginia Public Records Act

Terms and conditions of your award

The terms and conditions of an award delineate the obligations of the sponsor, University, and Principal Investigator.  These may include the following:

• award amount and payment methods and schedule
• budget and project period
• responsible personnel (e.g., PI and agency project officer)
• scope of work
• scientific, financial, and other reporting requirements
• mechanisms for effecting post-award modifications
• ownership and management of intellectual property
• publication rights
• confidentiality requirements

The specific terms and conditions vary among sponsors and award types.  NIH Notices of Award (NOAs) also reference agency regulations, the Code of Federal Regulations, or the Federal Acquisition Regulation (FAR).  An NOA may also place restrictions on an award:  for example, if the project will move into human or animal studies during the second project year, the PI must first forward IRB/ACUC approval for the study to NIH.  Projects involving the use of select agents will be restricted until the PI has registered with CDC or USDA.

The Principal Investigator is responsible for reviewing and understanding the requirements of his or her award.  Refer any questions to your research administrator or the Office of Grants and Contracts.

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Training

Training offered by the Office of Environmental Health and Safety (EHS)

• • Radiation Safety.  New users of radioactive materials must attend classroom-based training (schedule of classes).  Annually thereafter, users must take an on-line refresher course on Radiation and Chemical Safety.
  • Chemical Safety.  See links to on-line training.

  • BSL-2 and BSL-3 Training.  For laboratory personnel working in these research environments.

Training offered by the Institutional Biosafety Committee

• • • • Bloodborne Pathogen and Biosafety Training.  Laboratory and other personnel are provided with a review of exposure control, biosafety and infectious waste disposal practices.   Initial training is in the classroom.  On-line refresher courses are required annually thereafter.
      • Shipping Infectious Substances & Diagnostic Specimens.  Personnel who ship infectious substances (e.g., diagnostic specimens, microorganisms, human-derived materials) must complete a training program – see links on shipping and transporting.   Biennial refresher classes are required.

Training offered by the Animal Care and Use Committee

• • • • Animal Research Orientation Seminar. This session is required of all new animal users (details and schedule of classes).
      • ACUC on-line training modules. These mandatory, on-line modules are tailored to your particular research program, and include animal handling, rodent survival surgery, refresher modules for Principal Investigators, large animal surgery, and Laboratory Animal Training Association (LATA) Modules.
      • Animal protocol writing workshop. This optional workshop, offered quarterly, provides hints for writing a successful protocol.  Phone 924-0238 to register.  Dr. Patricia Foley (924-1884, [email protected]) can help new investigators to strengthen their protocols and help in writing the animal use sections of grant proposals.
      • Other voluntary programs are available from the ACUC, whose web site describes these offerings.

Training offered by the Institutional Review Boards (IRBs)

The IRB for Human Subjects Research and the IRB for Social and Behavioral Sciences offer on-line training on the major principles of conducting human subjects research that are consistent with legal and regulatory requirements.  They also provide several non-required seminars and classes for investigators and clinical coordinators.

Other required training

Computer and data security

All new SOM employees must complete this training module, which should take no more than 15 minutes.  This general training module that includes the federal HIPAA requirement is administered by UVA Information Technology Services, and can be accessed here.  Retain a printed copy of the last page, indicating that you have completed the training.

HIPAA privacy

All new SOM employees must complete this training module, which should take approximately 20 minutes.  The module is found at the UVA Health System NetLearning site.  Ask your local administrator for instructions on how to access this module.

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