Regulatory Compliance

Administrative officials must ensure that all employees under their direction comply with applicable laws, regulations, and special restrictions. Noncompliance with state and federal regulations can result in the loss of funding for an individual principal investigator, a department, and even UC Berkeley as a whole, as well as possible loss of licenses and accreditation. Individuals who willfully violate laws, regulations, or restrictions while conducting University activities may be held personally responsible.

Specific regulatory oversight responsibilities include:

Staying abreast of changing legal and regulatory requirements. See the Sponsored Project Office’s web site (http://www.spo.berkeley.edu/) for information on regulatory changes that effect sponsored research;
Ensuring that staff are appropriately trained (see Externally Required Training for Personnel on Research Projects section below) and complying with all applicable financial and operational requirements;
Reporting suspected fraudulent or illegal business transactions immediately to Audit and Advisory Services (http://www.audit.berkeley.edu);
Reporting to sponsoring entities according to the specific reporting requirements. In general, most sponsoring entities require adherence to generally accepted accounting principles (GAAP). Additionally, federal agencies and entities which serve as conduits for federal funds require adherence to the Office of Management and Budget Circulars (OMB) and/or Federal Acquisition Regulations (FAR). Two primary circulars are OMB Circular A-21, which provides cost principles for educational institutions, and OMB Circular A-110, which provides uniform administrative requirements for grants and other agreements with institutions of higher education, including financial reporting requirements. Extramural Funds Accounting (http://extramuralfundsaccounting.berkeley.edu/) provides financial and accounting services for private gifts, endowments, contracts and grants awarded to UC Berkeley; and
Keeping data and financial reporting systems available for internal and external audits in accordance with the records retention policies and procedures found at http://www.ucop.edu/ucophome/policies/bfb/rmp5a.html. The Office of the Controller coordinates external audits. The Controller can be reached via e-mail at controller@berkeley.edu or on the web at http://controller.berkeley.edu/.

Additional compliance information may be found in this Guide under Animal Subjects, Environment and Workplace Safety, Hazardous Materials Management, Health and Safety, Human Subjects, and Laser and Non-Ionizing Radiation Safety.

Externally Required Training for Personnel on Research Projects

Governmental regulatory agencies, funding entities, accrediting bodies, and other entities external to UC Berkeley have established mandatory training requirements for persons involved with certain types of research. Departmental administrative officials are responsible for ensuring that their researchers have completed this required training.

The required training can focus on ensuring that live research subjects, including humans or other vertebrate animals, are not mishandled or otherwise put at risk during the study. Other required training, such as that regarding radiation hazards or blood borne pathogens, is designed to ensure researchers understand the proper precautions needed to protect themselves during their work.

In each case where training is required, there are potentially significant consequences for noncompliance in addition to the risk to researchers and their subjects. These consequences can include monetary fines to the researcher’s department and withdrawal of funding to complete the study. Flagrant violations of these requirements may even result in loss of funding or accreditation to UC Berkeley as a whole.

Faculty research oversight committees and staff offices have developed training programs to facilitate compliance with these various requirements. The Office of the Vice Chancellor for Research (http://www.spo.berkeley.edu/guide/researchtraining.html) has prepared a matrix that summarizes the various types of research that require documented training and provides links to campus groups who can provide the training.