Research Compliance: A Faculty Handbook
getting through the maze
INTRODUCTION
About the Handbook
This Handbook is intended to be an instructive guide for faculty and campus researchers. It has been designed to inform Berkeley campus faculty members (and other campus researchers) about key "research compliance" regulations mandated by the federal government and by the State of California that require oversight by the campus and additional activities on the part of the researcher.
Included in the Handbook are the following areas:
Research Compliance at Berkeley
The conduct of research at the University of California, Berkeley is governed by the rules and policies promulgated by several jurisdictions, the federal and state governments, the UC Office of the President, the Academic Senates of both the University of California system and the Berkeley campus, as well as the administration of UC Berkeley.
The Office of the Vice Chancellor for Research is responsible for the coordination of research oversight activities for the campus. Included in that authority is the assurance to federal and state regulators that the appropriate infrastructure is in place at Berkeley to safeguard the research enterprise.
The Vice Chancellor for Research has direct responsibility for assuring the humane use of animals in research, the safety of human subjects in research, the management of financial conflicts of interest that arise in research-related activities, and the management of misconduct in science. In addition, the Vice Chancellor shares oversight with Environment, Health & Safety for safety in research laboratories on the Berkeley campus.
Faculty Oversight Committees
http://research.chance.berkeley.edu/main.cfm?id=9
As mandated by federal and state regulations, faculty oversight committees have been established for the review of research-related activities. These committees are charged with the review of the appropriateness of the work to be done by means of a research protocol. All oversight committees are composed of a faculty chair and faculty-voting members. Administrative personnel dedicated to the work of the committee staff the committees.
The Research Protocol
The "research protocol" is a formal design for research involving human subjects or research animals that an investigator submits to an Institutional Review Board (IRB) or an Institutional Animal Care and Use Committee (IACUC) for review. A protocol generally has an objective, rationale, design, eligibility requirements, treatment regimen, and a description of research and data analysis methods. Protocols must conform to stringent federal regulations.
Use of University Facilities
APM-020,:Regulation 4, Special Services to Individuals and Organizations: http://www.ucop.edu/acadadv/acadpers/apm/apm-020.pdf
Regulation 4 states that "Research for the benefit of Federal, State, industrial or other projects is to be undertaken only under conditions approved in advance by the President [of the University]. …University laboratories, bureaus and facilities are not to be used for tests, studies or investigations of a purely commercial character…" It is incumbent upon every faculty member engaged in research on the Berkeley campus to be familiar with this regulation.
RESEARCH USING HUMAN SUBJECTS
The University of California is committed to the ethical principles for the protection of human subjects in research set forth in the Belmont Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979) (http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm).
The ethical principles are:
Human Subjects Research Defined
As established by federal regulations (45 CFR 46), human subjects research includes any systematic investigation designed to develop or contribute to scholarly knowledge which uses living humans or identifiable private information about living humans. Some examples of human subjects research projects conducted at UCB are:
Human subjects research does not include:
Even when student work involving human subjects does not constitute research, faculty members who assign or supervise the work are responsible for educating their students to safeguard the well-being of the subjects.
Institutional Review Board (IRB) — The Committee for Protection of Human Subjects (CPHS)
An Institutional Review Board (IRB), established pursuant to federal regulations, is a committee composed of scientists and laypeople who review all proposed campus human subjects research to ensure that the safety and welfare of subjects are protected. All human subjects research requires review and approval by an IRB prior to subject recruitment and data collection and prior to use of extant data or private information. The IRB at Berkeley is called the Committee for Protection of Human Subjects (CPHS).
CPHS is a joint IRB for both the Berkeley campus and the Lawrence Berkeley National Laboratory (LBNL), and members have the responsibility for reviewing all research involving human subjects conducted at Berkeley and LBNL, regardless of the source of funding. Conducted at or sponsored by means:
The Office for Protection of Human Subjects (OPHS)
The OPHS provides administrative support to the Committee for Protection of Human Subjects (CPHS). OPHS staff support CPHS by performing record-keeping duties and maintaining a database in order to document institutional compliance. The OPHS staff works with CPHS and researchers to address research protocol and compliance issues. In addition, OPHS serves as a resource for investigators and CPHS members. The OPHS staff has been delegated authority to determine the appropriate level of review required for each research proposal submitted for review.
The Review Process for Human Subject Studies
Federal regulations divide human subjects research into three categories according to the level of risk posed to subjects. Each level has a corresponding requirement for institutional approval or registration. Complete information about the federally defined exempt categories and a greater level of procedural detail is available via the CPHS website (http://cphs.berkeley.edu).
For all projects involving human subjects, researchers must submit an application for CPHS review or a Declaration of Exemption form. Researchers may also need approval from the Sponsored Projects Office or from other oversight committees, such as Radiation Safety, before the research project may commence.
The categories of review are as follows:
(1) Exempt Status: To qualify for this category, the research must fall into one of six exemption categories accepted by CPHS. These categories present the lowest amount of risk to potential subjects because they generally involve either collection of anonymous or publicly available data, or conduct of the least harmful research experiments. Examples of research that qualify for exempt status are:
Institutions are required to have a mechanism for the review of exempt status by someone other than the investigator. Although it is called "exempt," this type of research still requires registration with CPHS. At Berkeley, a "Declaration of Exemption" is reviewed by OPHS staff and the chair of CPHS. In addition, special conditions apply to inclusion of children in research qualifying for exempt status.
There are no deadlines for submission of exemption applications.
(2) Expedited Review: To qualify for this category, research must fall into one of the nine federally defined categories of research that may be reviewed through an expedited review procedure. These categories involve collection of samples and data in a manner that is not anonymous and that involves no more than minimal risk to subjects. Some examples of research qualifying for expedited review are:
Review via expedited procedures typically takes four to five weeks.
(3) Full Committee Review: This level of review is reserved for research proposals that involve risk that is greater than that encountered in daily life. Examples include:
Protocols requiring full committee review may take up to six weeks.
The Implementation of HIPAA and the Privacy Rule:
The Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA) took effect April 14, 2003. HIPAA regulates the protection of private health information for individuals. The law's Privacy Rule sets standards for the use and disclosure of all individually identifiable health information obtained from a covered entity. Berkeley's covered entities are the Tang Health Center, the Optometry Clinic, and the Psychology Clinic.
All forms of health information that are associated with any of 18 identifiers defined by HIPAA are considered to be protected health information (PHI) subject to HIPAA regulations. To access this information, all research studies must obtain either an individual's authorization to access their protected health information, granted by the provider of the PHI, or obtain an approval of a waiver of authorization. Use of data from the campus's covered entities must receive prior CPHS approval. For more information see http://cphs.berkeley.edu/content/hipaa/hipaa.htm.
Office for Protection of Human Subjects (OPHS)
101 Wheeler Hall MC 1340
Telephone: (510) 642-7461
Fax: (510) 643-6272
Web site: http://cphs.berkeley.edu
RESEARCH USING ANIMAL SUBJECTS
The University of California, Berkeley is committed to ensuring the humane care and use of all animals associated with its research and teaching programs and devotes considerable resources to carrying out this responsibility. As a premier research institution, Berkeley maintains a lively mix of research and teaching activities involving the use of animals across the full spectrum of scientific endeavor. The animal care and use program assists the campus in achieving its academic mission and commitment to public service by providing humane care and use of animals, facilitating research and education programs, and assuring compliance with applicable federal and state regulations, policies, and guidelines. UC Berkeley is a USDA-registered research facility, maintains a Public Health Service (PHS) Animal Welfare Assurance, and has been fully accredited by the Association for Assessment and Accreditation of Laboratory Animal Care, International (AAALAC) continuously since 1994. UCB maintains full compliance with the U.S. Public Health Service Policy on Humane Care and Use of Laboratory Animals, the National Research Council's Guide for the Care and Use of Laboratory Animals and the U.S. Department of Agriculture's Animal Welfare Act Regulations regarding the care and use of animals in a research setting.
Berkeley policies are designed to ensure strict compliance with federal law, regulations, and professional guidelines.
The Office of Laboratory Animal Care (OLAC)
OLAC is an academic service unit responsible for managing a centralized program of laboratory animal care. OLAC provides daily animal husbandry, veterinary care, provision of research services, surgical/anesthesia assistance and monitoring, purchase of all live vertebrates, purchase and disbursement of controlled substances, and training of research and technical personnel who use vertebrate animals in research or teaching. OLAC's Guide to Services publication is a wealth of information about the services this unit provides. The Guide to Services is available in hard copy from the OLAC office or may be accessed online at their website.
The Institutional Animal Care and Use Committee (ACUC)
ACUC is a federally mandated Chancellor's advisory committee responsible for oversight and evaluation of the campus's overall animal care and use program. Its functions include evaluation of the program; inspection of animal facilities and animal-study areas; submission of reports to responsible institutional officials; review of proposed uses of animals in research, testing, or education; and receipt and review of concerns involving the care and use of animals. The ACUC has the authority to approve, require modification in, or withhold approval of any proposed project, and to suspend any ongoing project that it determines is not being conducted in compliance with applicable laws, regulations, and guidelines.
The Review Process for Studies Using Animals
The Master Animal Use Protocol
Principal Investigators (PIs) are directly responsible for the humane treatment of animals used in their research, the training of all personnel using animals, and for compliance with all applicable laws, regulations, and guidelines, as well as University policies regarding live vertebrate animals. Before undertaking any activity involving live vertebrate animals, PIs must submit a Master Animal Use Protocol (AUP), describing the proposed activities in detail, to the ACUC for review and approval. Protocol forms, monthly submission deadlines, and other useful information are available on the ACUC website. It is also the responsibility of the PI to ensure that all personnel listed on the Master AUP receive the required training in animal care and use prior to the start of any animal activity.
The Master Animal Use Protocol describes all uses of live vertebrate animals proposed by an individual Principal Investigator for a one-year period. For investigators with multiple research projects, the Master AUP presents a cumulative description of all proposed animal species, numbers, and procedures to be used during the one-year period. The Master AUP must be reviewed and approved by the ACUC before the acquisition, housing, or use of animals. Detailed information about the Master AUP is posted on the ACUC website.
Training For Personnel Who Work With Animals
U.S. Animal Welfare Act Regulations and PHS Policy require institutions to provide training for all personnel engaged in animal research. This includes Principal Investigators, technicians, laboratory personnel, research fellows, students, and visiting scientists. A mandatory training seminar, Tier One Training, is coordinated by the ACUC and presented by OLAC. Tier One Training meets all the requirements for training as set forth in the federal regulations, including the following: animal welfare regulations, policies, and guidelines; animal protocol review and approval procedures; animal ordering; pre- and post-procedural care of animals; surgery training; proper use of anesthesia, analgesia, and tranquilizers; alternatives to animal use and ways to access information; OLAC Guide to Services; methods for reporting animal welfare concerns; how to access emergency veterinary care; proper handling and care of various species; and how to access additional training and/or information. Detailed information about Tier One Training is posted on the ACUC website.
The Occupational Health Program (OHP)
OHP is an additional component of UC Berkeley's animal care and use program. The OHP is coordinated by the Occupational Health Clinic (OHC), University Health Service, Tang Center. The requirements of the OHP are based on the guidelines of the National Research Council's Guide for the Care and Use of Laboratory Animals, and Occupational Health And Safety in the Care and Use of Research Animals. Detailed information about the OHP is posted on the ACUC website.
The Committee on Animal Research Space Assignment (CARSA)
CARSA reviews and recommends plans for accommodating animal housing space requests. CARSA is composed of academic senate members who are animal users and non-animal users, the Director of OLAC, the Chair of the ACUC, and the Assistant Vice Chancellor for Research. CARSA is advisory to the Vice Chancellor for Research, who has authority to make animal research space assignments. Animals cannot be housed without an approved Master AUP; however, approval of an AUP does not guarantee that animal housing space will be available for the proposed project. OLAC is responsible for the management of animal housing space on campus, and assigns space when it is available. If appropriate and adequate space is not available, the request for space is forwarded to CARSA for review.
For advice about research protocols or applicable laws, policies or regulations relating to the use of vertebrate animals:
Animal Care and Use Committee (ACUC)
Telephone: (510) 642-8855
Web site: http://www.acuc.berkeley.edu/
For advice about the acquisition and care of animals:
Office of Laboratory Animal Care (OLAC)
Telephone: (510) 642-9232
Web site: http://www.olac.berkeley.edu/
CONFLICT OF INTEREST IN RESEARCH
Conflict of interest has become a national concern as universities engage in increasingly complex relationships with other institutions, including corporations, nonprofit organizations, and agencies of the state and federal governments. As a public entity, the University of California falls under particular scrutiny.
Conflict of Interest Defined
A conflict of interest exists when a researcher's outside financial interests or obligations have the potential to bias a research project. The University of California recognizes that faculty and other investigators have a range of relationships with entities outside of the University. These relationships often provide useful components to the research effort. Sometimes, however, they can give rise to conflicts of interest. These conflicts most often relate to receiving funding for research projects while also having other sources of income from the same entity, such as salary, loans, or gifts, or ownership, investments, or positions held by the individual.
Conflict of interest situations can compromise the scientific integrity of a research project. They can be associated with a range of difficulties, including improper direction of a student or University employee's work, inappropriate delays or restrictions on publications, and the appearance of impropriety.
Disclosure of Conflict of Interest
Investigators at the University of California are subject to both State of California law and federal regulations on disclosure of financial conflicts of interest. Under these regulations, investigators must file disclosure forms when receiving gifts and with proposals to non-governmental agencies, federal Public Health Services agencies and the National Science Foundation, UC Discovery Grants programs, the American Heart Association, and the American Cancer Society.
In addition, the UC Berkeley Office for Protection of Human Subjects (OPHS) requires that when human subjects are used in research, individuals who have independent roles in projects and who are responsible for the design, analysis, conduct, or reporting of the results of research performed (or to be performed) under a human subjects protocol must disclose whether or not they have a financial interest in or association with the sponsor or the company supplying the materials, drugs, or devices for the project. If any individual has a conflict, the OPHS staff will forward the materials to the Conflict of Interest Committee (COI) for separate review.
The state, federal, and OPHS disclosure requirements differ as below. See http://researchcoi.berkeley.edu for details.
State of California Financial Disclosure: State of California law requires disclosure of financial interest in the sponsor if the proposal is for a research project to be funded by a non-governmental source, including research gifts. For contracts and grants, the disclosure form (Statement of Economic Interests for Principal Investigators: Form 700-U) should accompany the proposal and Proposal Review Form to the Sponsored Projects Office.
Federal Financial Disclosure: Federal regulations require investigators to disclose interests in outside entities that are "significant" and "related" to the research described in the proposal. Applicants to the National Science Foundation and Public Health Service agencies (including the National Institutes of Health) must disclose project-related financial interests for themselves and coordinate the disclosures of all other project investigators at the proposal submission stage. This requirement also applies to subcontracts from PHS/NIH or NSF or other agencies that have adopted the federal requirements (UC Discovery Grants, the American Heart Association, and the American Cancer Society).
OPHS Disclosures: required with all protocols submitted to CPHS in which there is a declaration of a conflict on the CPHS application form.
Filing Disclosures
Federal policy requires disclosure:
1. at the time of proposal submission,
2. as new investigators are added to the project, and
3. as investigator's financial interests change.
California State requires disclosure:
1. at the proposal submission stage,
2. when new funding is sought for the same project,
3. at the project close out, and
4. as investigator's financial interests change.
OPHS policy requires disclosure:
1. when submitting the application for human subjects CPHS Review, and
2. as investigator's financial interests change.
The Conflict of Interest Review Process
The faculty Conflict of Interest Committee (COI), which operates in conjunction with the Office of Research Administration and Compliance, is responsible for the review and assessment of financial disclosures related to research projects. The Committee seeks first to "manage" conflict of interest. Remedies may include modification of the research or project plan and monitoring of the project by independent reviewers. If the conflict is deemed "unmanageable," the Committee can require that the proposal be withdrawn or that the relationships that created the conflict be severed. For detailed information see http://researchcoi.berkeley.edu/coiguidelines.html.
Office of Research Administration and Compliance
2150 Shattuck Avenue, Suite 313, MC 5940
Telephone: (510) 642-8117
Fax: (510) 642-8236
Web site: http://researchcoi.berkeley.edu
LABORATORY SAFETY
Principal investigators (PIs) at UC Berkeley are responsible for ensuring that research performed under their leadership is conducted in a manner that protects laboratory personnel and the campus environment. The Office of Environment, Health & Safety (EH&S) assists PIs in complying with local, state, and federal regulations governing their research. The EH&S website (http://ehs.berkeley.edu) provides detailed information on over 50 topics pertaining to laboratory safety and compliance. A few of these topics are highlighted below.
Laboratory Safety Program
http://ehs.berkeley.edu/healthsafety/labsafety.html
EH&S assists departments with laboratories by providing hazard evaluations, work practice guidance, and training on:
Hazardous Materials Management
http://ehs.berkeley.edu/hazmat.html
Storage: PIs are responsible for overseeing proper storage of hazardous chemicals in their laboratories. EH&S provides detailed guidance entitled Safe Storage of Hazardous Chemicals Booklet (http://www.ehs.berkeley.edu/pubs/chemicalstoragebooklet.pdf) and Guidelines for Explosive and Potentially Explosive Chemicals - Safe Storage and Handling (http://www.ehs.berkeley.edu/pubs/guidelines/pecguidelines.html).
Disposal: The U.S. Environmental Protection Agency (EPA) regulates disposal of laboratory wastes. PIs are responsible for ensuring that employees and students working in their laboratory follow proper disposal procedures. EH&S provides hands-on assistance in this area. By filling out an electronic Material Packing List (e-MPL) on the EH&S web site, PIs can arrange for EH&S to pick up their unwanted hazardous materials and lab debris. The EH&S web site also describes disposal procedures for other hazardous materials, including radioactive or biohazardous materials, batteries, light bulbs, computer monitors, and refrigerators. PIs should contact EH&S if they have questions about proper labeling and storage of unwanted hazardous materials. Most chemicals cannot be disposed down the drain. Violations of this rule have resulted in regulatory fines. If you think you have a material that may be allowed down the drain, refer to the drain disposal guidelines on the EH&S web site, or contact EH&S.
Chemical Hygiene Plan: http://ehs.berkeley.edu/healthsafety/chp.html
The California Occupational Safety and Health Administration (Cal/OSHA) requires that all laboratories have a written Chemical Hygiene Plan (CHP) that includes laboratory-specific hazard and safety information. PIs can obtain a template CHP for their laboratory on the website.
Chemical Inventory: EH&S maintains an inventory of hazardous materials for the entire UC Berkeley campus and its field stations. PIs are responsible for ensuring that all hazardous materials they control are listed in their inventory. Chemical inventories are required by environmental, occupational, and Fire Code regulations and are kept in a secure central database prepared and maintained by EH&S.
Select Agents: see the section on "Post-9/11 Security Issues" in this handbook.
Training
http://ehs.berkeley.edu/training.html
The Office of Environment, Health & Safety offers compliance and safety training at no cost to most campus departments. Most training is specific to the work you perform in your job here on campus. Contact EH&S if you're interested in learning more about our training offerings or if you'd like training designed for your department.
Fact Sheets
http://ehs.berkeley.edu/pubs/factsheets.html
Laboratory employees and students may need guidance on other research safety and compliance topics. The web page above has over 80 Fact Sheets available, most of which cover a variety of laboratory safety and compliance practices.
Laboratory Self-Inspections
http://ehs.berkeley.edu/iipp/iippform3.html
Cal/OSHA requires that all workplaces be inspected for hazards at least annually. Therefore, the PI or a designee must perform and document an annual safety inspection of each laboratory. EH&S provides a laboratory self-assessment form at the URL above. This effort is coordinated campuswide by EH&S each fall, but supplemental self-inspections can be performed at any time.
Research Using Scuba Diving and Small Boats
http://pe.berkeley.edu/scubadiving
The Division of Diving Safety insures that all underwater diving conducted under the auspices of the University of California, Berkeley is done in accordance with the standards and policies established by the American Academy of Underwater Sciences (AAUS) and the Berkeley campus Diving Control Board (DCB). The program is administered by the Diving Safety Officer (DSO). A University scientific diver permit is required for anyone diving for science using University equipment, diving from University-owned property, or diving as a student or employee of the University. The Diving Safety Program (DSP) provides opportunities for students, faculty, and staff to pursue SCUBA certification or a scientific diver permit. There are fees associated with these services. Permits may be awarded by the DCB, based on recommendations by the DSO, through previous training and experience, completion of a scientific diver course, or through reciprocity with other institutions.
Researchers planning to use small boats (defined as being 26 feet in length and smaller) are advised to: take a boating safety course, file a float plan (http://pe.berkeley.edu/smallboats) for all research activities, and contact the DSO with questions.
Office of Environment, Health & Safety
Telephone: (510) 642-3073
Web site: http://ehs.berkeley.edu
Life-threatening Emergency
Telephone: 911
University Health Services Information
Telephone: (510) 642-2000
Office of Emergency Preparedness
Telephone: (510) 642-9036
University of California Police Department
Telephone: (510) 642-6760
Optometry Clinic (for safety glasses)
Telephone: (510) 642-2020
Each campus department has a Department Safety Coordinator (DSC) who is familiar with EH&S programs and departmental procedures for ensuring safety and regulatory compliance. DSCs can provide training on their department's Injury and Illness Prevention Program and the appropriate Building Emergency Plan. Cal/OSHA requires that all employees receive documented training on these documents. Contact EH&S if you need an introduction to your DSC.
RESEARCH MISCONDUCT
The Berkeley campus encourages and maintains the highest ethical standards in research. This means not just the avoidance of wrongdoing, but also the rigor, carefulness, and accountability that are hallmarks of good scholarship. All persons engaged in research at the University are responsible for adhering to the highest standards of intellectual honesty and integrity in research. Faculty and other supervisors of research activities have a responsibility to create an environment which encourages those high standards and integrity in research. Open publication and discussion, emphasis on quality of research, appropriate supervision, maintenance of accurate and detailed research procedures and results, and suitable assignment of credit and responsibility for research and publications are essential for fostering intellectual honesty and integrity in research.
One feature of this commitment is the University's response to allegations of misconduct. If proven, misconduct can result in a range of sanctions, depending on the circumstances involved. Detailed information on this subject is available on the campus Research website at http://research.chance.berkeley.edu/page.cfm?id=105.
Misconduct in Research Defined
"Misconduct in research" is a technical term defined by federal regulations. Institutions that accept research funding from federal agencies are required by the Office of Research Integrity to have policies and procedures in place for the management of incidents of research misconduct, which is defined as:
Fabrication, falsification, plagiarism or other practices that seriously deviate from those that are commonly accepted within the academic community for proposing, conducting or reporting research.
Reporting Misconduct
Any student, staff, faculty member, or individual outside of the University community may be a subject of a research misconduct inquiry. If an investigative committee determines that research misconduct has occurred, the Vice Chancellor for Research recommends to the Executive Vice Chancellor that the matter be adjudicated according to the University Policy on Faculty Conduct and the Administration of Discipline, June 14, 1974 (APM 016), including the Faculty Code of Conduct, August 26, 1988 (APM 015).
Any student, staff, faculty, individual outside of the University community, or a University committee such as the Institutional Review Board may report incidents of alleged research misconduct. Normally, allegations are addressed to the Vice Chancellor for Research, the dean of the school or college, or the director of the program which has primary affiliation with the individual being reported. These officials counsel the reporter. If the initial report of misconduct is oral, it must be put in writing before a preliminary inquiry can proceed.
In accordance with the campus policy, the proceedings of an inquiry into research misconduct are confidential to protect the members of the inquiry panel, the individual filing the allegation, the person accused, and the witnesses, to the maximum extent possible. All individuals are asked to refrain from discussing the matter with anyone, including faculty members, students, family members, and the media.
The Misconduct Investigation Process
The following outlines procedures to be followed once an allegation or other evidence of misconduct is received. A detailed account is provided on http://research.chance.berkeley.edu/page.cfm?id=105.
Preliminary Inquiry: The Vice Chancellor for Research and /or the Research Integrity Officer (RIO) assesses the reported incident to determine if it constitutes a bona fide allegation of research misconduct—i.e., does the alleged incident fit the definition of scientific misconduct and is the evidence provided in the report of the incident pertinent to the allegation being made? If it is concluded that a bona fide allegation of research misconduct has been made, the misconduct procedure enters its inquiry phase.
Inquiry: Upon receiving an allegation of research misconduct, the Vice Chancellor for Research appoints one or more persons to conduct an inquiry to determine whether there is sufficient substance to the allegation to warrant a formal investigation. The purpose of the inquiry is not to reach a final conclusion as to whether misconduct occurred or who was responsible. This preliminary phase of information gathering and fact-finding should take no more than 60 calendar days from the receipt of the allegation unless circumstances clearly warrant a longer period. If the inquiry finds sufficient evidence to warrant a formal investigation, the Vice Chancellor for Research promptly (within 30 calendar days) initiates the process as follows.
Investigation: An Investigative Committee is appointed to determine whether there exists probable cause that research misconduct has occurred, and, if so, to make recommendations with respect to the imposition of disciplinary sanctions. The investigation phase should be completed within 120 days from the appointment of the investigative committee, unless circumstances warrant a longer period. If the investigation stage is extended beyond 120 days, the reasons for doing so should be documented.
In the case of a faculty member, the investigative committee is appointed by the Vice Chancellor for Research (VCR). It will be constituted from members of the Academic Senate, and contain from one to three members. A larger committee may be appointed if in the opinion of the VCR it would facilitate the investigation.
RESEARCH SECURITY IN THE POST-9/11 ENVIRONMENT
The USA PATRIOT Act and related legislation have altered the landscape for research at U.S. universities. Driven by a concern that research-generated information and materials used in research experiments could be used by terrorists to attack the American population, the Federal government has extended its regulation of research activities at universities and private laboratories. The effects of this new regulatory regime will be felt especially by the biological sciences, and some branches of chemistry, computer science, and physics.
At present, the likely direct impact of the emerging regulatory environment will be in two areas: (1) new regulations with respect to how certain biological and chemical agents are handled in laboratories, and new restrictions on who may have access to laboratories that contain such agents; and, (2) restrictions written into federally funded contracts and grants that place limits on the publication of research results, and that impose citizenship requirements on participation in research programs. University research may also be indirectly impacted by the difficulties foreign graduate students, postdoctoral scholars, and research collaborators confront in gaining timely entry into the United States as a result of a slowdown in the visa issuing process.
The regulatory atmosphere since 9/11 remains volatile and subject to change. Faculty who work in fields likely to be affected by security-related regulations can find information about possible regulatory changes and read current directives in the Research Advocate from the campus Research Administration and Compliance Office (http://rac.berkeley.edu/ra/list.html) and on the EH&S website (http://ehs.berkeley.edu/healthsafety/selectagent.html).
Select Agents
Select Agents Defined
A Select Agent is one of approximately 40 viruses, bacteria, rickettsiae, fungi, and toxins that are considered to potentially pose substantial harm to human health. The list of select agents in 42 CFR 73 is available at: http://www.cdc.gov/od/sap/docs/salist.pdf. Certain strains of organisms and quantities of toxins are exempt from the regulations. For information about exemptions, contact the Campus Biosafety Office at 643-6562.
In order to comply with the USA PATRIOT Act of 2001 and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, UC Berkeley is required register the possession, use, and transfer of select biological agents and toxins. In addition, the PATRIOT Act creates a class of "restricted persons" who may not possess, ship, transport, or receive any biological agent or toxin that is listed as a select agent. Under the terms of the Act, these "restricted persons," who include criminals and aliens from certain countries, are now specifically prohibited from having access to select agents.
Campus Procedures for Select Agents: The EH&S office is responsible for administering UC Berkeley's compliance with federal regulations pertaining to select agents. (See http://ehs.berkeley.edu/healthsafety/selectagent.html.) EH&S has developed a select agent packet of checklists, forms and templates to help guide PIs who wish to conduct research with select agents. In order to lawfully possess select agents, PIs must contact the Campus Biosafety Office (643-6562) who will work with them to file an application to the appropriate federal agency.
Background checks: Staff authorized to work with or be in a facility holding select agents must pass background checks by the U.S. Department of Justice (DOJ). People from certain "countries of interest" as defined by the DOJ will not pass the background check and may not be authorized. Please check with the UCPD for information related to background checks.
Export Controls
http://research.chance.berkeley.edu/echome.cfm
http://www.spo.berkeley.edu/Policy/exportcontrol.html
Export control laws are federal regulations that control the conditions under which certain information, technologies, and commodities can be transmitted overseas to anyone, including U.S. citizens, or to a foreign national on U.S. soil for reasons of national security or protection of trade. The laws are implemented by both the Department of Commerce through its Export Administration Regulations (EAR) and the Department of State through its International Traffic in Arms Regulations (ITAR). Most exports do not require government licenses.
Export regulations apply whether or not the recipient is funded by a grant, contract, or other agreement, and apply whether or not the EAR or ITAR are explicitly cited in the award document. If a researcher accepts export-controlled technology or information from a government agency or from industry, the researcher is subject to ITAR or EAR regulations.
Fundamental Research Exclusion for Universities
Most UC Berkeley research activities are excluded from export controls because of a general exception for "fundamental research" under export control regulations. The term "fundamental research," as used in the regulations, includes basic or applied research in science and/or engineering at an accredited institution of higher learning in the U.S. where the resulting information either is ordinarily published and shared broadly in the scientific community or where the resulting information has been or is about to be published.
University research is disqualified as fundamental research if (1) the institution accepts any restrictions on the publication of the research other than limited prepublication reviews by research sponsors to prevent inadvertent divulging of proprietary information or to insure that publication will not compromise patent rights of the sponsor; or (2) the research is federally funded and specific access or dissemination controls regarding the resulting information have been accepted by the university or the researcher.
Publication Restrictions
UC Berkeley Policy Guidelines Governing Openness and Freedom to Publish: http://www.spo.berkeley.edu/policy/ucmemos/publish.html
University of California and campus policy preclude agreeing to publication restrictions, other than a short delay to permit a review for patent purposes. Exceptions to the publication policy may be granted only by the Chancellor under very limited circumstances.
The academic community is concerned that federal agency awards for research viewed as relevant to terrorism will incorporate grant and contract clauses requiring pre-publication review, and withholding from publication material the agencies consider to be "sensitive but unclassified." Official federal policy, post-9/11, has continued to encourage open basic research and has reaffirmed that "where the national security requires control, the mechanism for control of information during federally-funded fundamental research…is classification" (NSDD 189).
As of this moment, a new regime of publication regulation based on the "sensitive but unclassified" designation has not emerged, but university and academic associations widely believe that increased publication restrictions are in the offing.
Investigators presented with grant or contract provisions that restrict publication or require prior approval of either publication, dissemination of research results, or of project personnel should seek advice from the Sponsored Projects Office as soon as possible. The campus will make every attempt to work through issues of publication and other restrictions so as not to impede the research enterprise. Unfortunately, there may also be some situations in which, in spite of best attempts, the campus will not be able to procure a license or get research sponsors to drop unacceptable restrictions. While it is hoped that will occur on only the rarest of occasions, there may be some circumstances in which it will be necessary to decline research support.
Research Restrictions on Foreign Nationals
As defined by the federal government, the "export" of research may include transmitting technology to an individual other than a U.S. citizen or permanent resident within the United States. Even a discussion with a foreign researcher or student in a campus laboratory is considered a "deemed export." Export controls preclude the participation of all foreign nationals in research that involves covered technology without first obtaining a license from the appropriate government agency.
The above regulation may come into direct conflict with University of California policy which currently forbids discrimination in employment based on citizenship, including discrimination in access to and participation in University laboratories. It has been the practice of the Sponsored Projects Office to refuse to accept any extramural contract or grant that contains restrictive language with respect to either publication or employment.
APPENDIX: Regulations, Regulatory Agencies, and Policies
HUMAN SUBJECTS RESEARCH
Principles of Human Subject Protection
Federal Regulations
State of California Statutes
UC Systemwide Policies
UCB Campus Policies and Procedures
ANIMAL SUBJECTS RESEARCH
Federal Law, Regulations, and Policies
Guidelines and Accreditation Standards
UC System-wide Policy
UCB Campus Policies, Procedures, and Guidelines
LABORATORY SAFETY
Boating Guidelines, Information, and Courses
RESEARCH MISCONDUCT
Federal Regulations:
UC Research Policies:
UC Berkeley Policies
SECURITY AND RELATED ISSUES POST 9/11
Federal Policies and Regulations
University of California Policies
UC Berkeley Policies