Compliance, Training, and Research Policies
Summary and quick links
Compliance
Research involving human subjects or animals
Recombinant DNA and pathogens
Other biohazardous materials
Responsible conduct of research
Conflict of interest
Confidentiality
Reporting misconduct
Clinical study-specific documentation
Publication of clinical trials to Web sites
Record keeping and record retention
Obtaining required approvals (under construction)
Terms and conditions of your award
Federal circulars and regulations pertaining to grants and contracts
Federal acts and other considerations
New! NIH policy on public access to research results
Detailed Health Sciences Library site
Shorter "what must I do" page (Office for Research site)
Training
Office of Environmental Health and Safety
Institutional Biosafety Committee
Institutional Animal Care and Use Committee
Institutional Review Boards
Other required training
Human subjects research. The University has two Institutional Review Boards (IRBs) that share a common Web site. The IRB for the Social and Behavioral Sciences (IRB-SBS) reviews and oversees non-medical, behavioral research studies. The IRB for Health Sciences Research (IRB-HSR; formerly known as the Human Investigations Committee) oversees all other studies involving human subjects, representing 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 Institutional Animal Care and Use Committee (IACUC) reviews and oversees the use of animals in research and teaching at the University. The IACUC provides training in handling research animals, insures participation in the occupational health and safety program by users of animals, and conducts inspections of animal use facilities. The IACUC Web site also lists protocol submission deadlines. The Center for Comparative Medicine operates vivaria and provides veterinary support. Current per diem rates are given 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 any human specimens. The IBC also inspects laboratories that have registered for one or more of these activities.
Biohazardous materials (bloodborne pathogens, radiation, hazardous chemicals, shipping biological materials, etc.). The UVA Office of Environmental Health and Safety maintains comprehensive programs for the management of potential hazards that may be encountered during research activities. Their Web site includes current health and safety policies and information on ordering radioactive materials. Click here for UVA 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 acknowledgement in research publications to the originators of ideas, methods, and findings. These areas are of special concern for investigators:
- Authorship. JAMA (see "Authorship Criteria and Contributions") and the International Committee of Medical Journal Editors have developed authorship policies. Discussions concerning authorship should begin when first planning a project: agree on authorship vs. individuals to be acknowledged, including the order of authors and each author’s responsibility on the project and in preparing the resulting manuscript. Authors assume responsibility for the integrity of the work as a whole. Before the manuscript is submitted, each author should read and approve the it and agree to take public or legal responsibility for its content. Please refer to the SOM policy on authorship (internet; policy 2.700).
- Conflict of Interest. Refer to the section below.
- Financial. Costs of investigational procedures or subject visits on clinical studies should not be borne by patients or third party payers. Similarly, public funds (both external awards and 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. Prior to initiating a project, investigators should establish an analytic plan and agree on methodologies (e.g., lab standard operating procedures, exclusion of outlier data). Once the data are collected, verified, and locked, any changes in analytic methodology should be reported as post hoc and exploratory.
Images. Computer manipulation of images may be used appropriately or inappropriately by investigators preparing images for publication or presentations. See Rossner and Yamada, J. Cell Biol., 2004, 166:11-15 (PDF accessible from the UVA domain). Consider developing a policy for your research group along these lines (adapted from the Southwest Environmental Health Science Center):
- Scientific content may not be knowingly altered in any image.
- Limited enhancements for clarity, aesthetic reasons, or to eliminate physical artifacts are permitted.
- 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 must take training in RCR; this generally takes the form of completing BIMS 710, “Research Ethics.” Also consider the following sources on this subject:
- “On Being a Scientist: Responsible Conduct in Research” (National Academy Press, Washington, D.C. 1995)
- Steneck , NH , “ORI Introduction to the Responsible Conduct of Research” (Office of Research Integrity, NIH).
- Educational resources on RCR at the NIH Office of Research Integrity.
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.
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. The Commonwealth of Virginia defines “financial interest” as ownership/liability of 3% of company assets or property used by a company; or income/salary/other compensation totaling $10,000 annually. UVA COI policy is not meant to discourage ownership, consulting, or other activities related to the corporate sector. Rather, if such a conflict exists, the University is required to remove, mitigate, or manage the conflict. The President can sign a waiver of COI under the Virginia COI statute when a UVA contract (e.g., NIH SBIR subcontract or purchase from a faculty-owned company) is involved. See the UVA FAQs on conflict of interest for more information.
Potential conflicts relating to research activities are reviewed by the UVA Conflicts of Interest Committee prior to acceptance of external funding or initiation of clinical research. The process is initiated by the individual disclosing the conflict (contact Dr. Steven Wasserman) to one's Chair or Director and Dean's Office for review. It is then forwarded to the COI Committee, which recommends acceptance, rejection, or acceptance with conditions on the award, gift, or research activity. The latter might include the institution of a COI management plan (which may include data review to ensure unbiased analysis/interpretation, appointment of an ombudsman to protect the educational and professional needs of trainees, etc.).
COI and human subjects research. The use of human subjects in research by individuals with COI warrants additional scrutiny. Refer to the DHHS Office for Human Research Protections guidance document on financial COI in human subjects research. The PI must disclose the conflict to the IRB when submitting a research protocol, regardless of the funding source for the study itself. The IRB will work in collaboration with the COI Committee to ensure appropriate review of the COI prior to protocol approval.
FASEB has created a comprehensive Web site containing resources to help academic investigators and administrators understand and manage conflicts of interest due to industry relations.
Update. The SOM is developing a new policy on COI in research, training, and patient care. See the presentation of the COI Task Force to the Dean of January 2008.
SOM contacts to discuss conflict of interest: Steven S. Wasserman, Assistant Dean for Research; Stewart Craig, Director, Grants & Contracts.
Confidentiality. Investigators gain access to confidential or privileged information from many sources: review of proposals and manuscripts; human subjects research; consulting agreements with industry; personnel records of your 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.
Occasionally, you may be asked to sign a Confidential Disclosure Agreement (CDA) prior to being given access to such information. If you are performing these activities in conjunction with your position at UVA, forward such documents to the Office of Grants and Contracts for review prior to signing.
Reporting misconduct. If you suspect misconduct in research, report it to the Office of the Vice President for Research and Graduate Studies. Initial, informal discussions with the Research Integrity Officer (924-3606) may help clarify whether the suspected behavior meets the definition of research misconduct. If it does, the Officer will refer you to other officials with responsibility for resolving the problem. UVA is aware that misconduct by a superior or supervisor may be difficult to report. The University 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.
Publication of clinical trials to Web sites. The University requires that corporate sponsors of research contracts publish their clinical trials on a public site. NIH encourages that all trials be listed. Furthermore, U.S. Public Law 110-85 (effective October 2007) expanded the requirements for clinical trials registration. Specifically, the sponsor of the IND/IDE or PI must register all trials of drugs and biologics subject to FDA regulation (other than Phase 1) and trials of device (except for small feasibility and pediatric postmarket surveillance). The information that must be posted also has been expanded to include study results. The Clinical Trials Office can assist with posting a study on ClinicalTrials.gov. Finally, The International Committee of Medical Journal Editors will require that all Phase 1 clinical trials published in their journals must be registered at a public site, effective July 1, 2008.
Record keeping and record retention
The School of Medicine has developed a guidance document describing the State retention and destruction policies for commonly encountered documents. It has been approved by the Library of Virginia, which administers the Virginia records management program. Please also see the School of Medicine policy on records management. Storage of any documents containing information covered by HIPAA or FERPA in unsecured areas is no longer 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.
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. Other sponsors may have different requirements. The Commonwealth of Virginia requires retention of at least five years, or in accordance with grant/contract stipulations - whichever is longer. See the SOM guidance document for clarification on specific research records.
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 forms of 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 and Graduate Studies.
- 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 http://www.fda.gov/cder/guidance/959fnl.pdf).
- Protection. Data records should be backed up, with a copy stored off-site. Protection of data also requires the establishment of 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 (i.e., protecting intellectual property rights, priority in publication, or the privacy of research subjects) with the benefits of sharing data (to foster collaborative research, allow replication of experiments, or satisfy funding agency requirements). It is generally agreed that prior to publication, investigators 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. All 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 all 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. Don't underestimate the benefits of retaining data: the gene sequence of pandemic Spanish influenza in (published in 2005) was derived, in part, from preserved lung tissue stored at the Armed Forces Institute of Pathology since 1918.
Clinical study-specific documentation. 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 has been discontinued. Again, regulatory requirements or contractual agreements with the sponsor may extend this requirement. Also note that federal HIPAA regulations require that consent forms be retained for 6 years after the end of the clinical study.
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
- zbudget 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. The NIH Notices of Award (NOA) also reference agencyregulations, the Code of Federal Regulations, or the Federal Acquisition Regulation (FAR). The NOA may also place restrictions on your award: for example, if your project moves into human or animal studies during the second project year, you will be restricted from such activities until IRB/IACUC approval has been forwarded 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.
Obtaining required approvals. This section is under construction.
Federal circulars and regulations pertaining to grants and contracts. The Federal Acquisition Regulation (FAR) codifies policies for the acquisition of supplies and services by federal executive agencies. Circulars governing the practices of federal agencies and those agencies’ regulations are maintained by The Office of Management and Budget (OMB). Of particular interest are:
- Circular A-21: financial management procedures relevant to federal agreements with academic institutions and represent the “Cost Accounting Standards” for federal awards. A summary of Circular A-21 and its implementation at UVA can be found at the Office of Sponsored Programs.
- Circular A-110: award of grants and contracts, post-award requirements, and property standards.
Federal acts and other considerations
Code of Federal Regulations (CFR). The CFR (searchable version) is comprised of general and permanent rules established by the Executive branch of the Federal Government. The CFR titles associated with biomedical research are:
- Title 7 - Department of Agriculture. 7 CFR Part 331 (with 9 CFR Part 121) governs possession, use, and transfer of biological agents and toxins that may pose a threat to animal or plant health, or to human safety.
- Title 9 - Animals and Animal Products. 9 CFR Part 2.31 mandates and describes the minimum activities required of Institutional Animal Care and Use Committees.
- Title 21 - Food and Drugs (Food and Drug Administration). 21 CFR Part 56 mandates and describes the minimum activities required of Institutional Review Boards (IRBs). 21 CFR Part 312 and 21 CFR Part 812 describe Investigational New Drug Applications and Investigational Device Exemptions, respectively.
- Title 37 - Patents, Trademarks, and Copyrights (U.S. Patent and Trademark Office).
- Title 42 - Public Health. 42 CFR Part 1 governs the Department of Health and Human Services (including the National Institutes of Health). 42 CFR Part 1003 establishes rules regarding possession, use, and transfer of select agents and toxins posing a threat to human health.
- Title 45 - Public Welfare. Protection of human subjects.
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Title 48 - Federal Acquisition Regulations (see above).
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 and Waste Training. This course is available in on-line format.
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BSL-3 Training. This is required for laboratory personnel who work in BSL-3 areas. Contact EHS (982-4911) for details.
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 (schedule). 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. Biennial refresher classes are required.
Training offered by the Institutional Animal Care and Use Committee
- Animal Research Orientation Seminar. This session is required of all new animal users (details and schedule of classes).
- Laboratory Animal Training Association (LATA) training modules. These mandatory, on-line modules are tailored to your particular research program (see description).
- Rodent Survival Surgery. For individuals who will be performing rodent surgery, the ACUC recommends that you complete this electronic training. Click here for details.
- 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, plf6z@virginia.edu) 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. See their Web site describing these offerings.
Training offered by the Institutional Review Boards (IRBs)
The IRB-HSR and the IRB-SBS 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.
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 and Communication, and can be accessed here. Please 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. Please ask your local administrator for instructions on how to access this module.