• Conflicts of interest
• Disclosure to FDA by clinical investigators
• Laboratory and occupational safety standards
• Projects involving human subjects
• Using legend and investigational new drugs
• Working with animals

Disclosure to FDA by Clinical Investigators
Under 21 CFR Part 54, Financial Disclosure by Clinical Investigators, FDA requires that certain financial interests must be disclosed by the sponsor before a new drug application or pre-market approval application. This information must be collected and disclosed for the period of the clinical trial and one year after completion of the trial.

Some types of trials are excluded from coverage under the rules. For further information, consult the regulations.
 
Laboratory safety and occupational safety standards
PIs are responsible for protecting their personnel from hazardous conditions. If special hazards are identified after an award is made, the work may be suspended pending corrective action.

Environmental health and safety
While regulations vary with the situation, four requirements govern the use of any hazardous material:
• Spills and exposures must be reported.
• Containers must be labeled.
• Records must be kept.
• Workers must be trained, and that training must be documented.

The University's Department of Environmental Health and Safety (DEHS), (612) 626-6002, helps faculty certify compliance, provide training, and handle hazardous and radioactive materials. In addition, each unit must prepare a "chemical hygiene plan" that is filed with DEHS (some units will not approve a proposal application until this plan is signed). DEHS publishes much of its information on its Web site.

The University of Minnesota Chemical Waste Program has established a chemical and labware redistribution program. The program accepts chemicals and labware in good condition from various University laboratories. In turn, they are redistributed through the University system free of charge on a first-come, first-serve basis. For more information call 612.626.1859 or see Free Chemicals on their web site at www.dehs.umn.edu.

You may also dispose of unidentified/unlabeled chemicals for a nominal fee of $35 per item. Request forms are available at http://www.dehs.umn.edu/PDFs/formd.pdf. For more information call 612.624.6060 or see Unidentified Chemical Objects on their web site at http://www.dehs.umn.edu/hazwaste.htm.

If a hazardous unknown material spills, call the DEHS Spill Response Team (612.626.6002 weekdays, 911 other times) to report the spill.
 
All University Radiation Protection Advisory Committee
Research projects involving use of radioactive materials and ionizing or non-ionizing radiation producing equipment must comply with state and federal regulations. Contact the All University Radiation Protection Advisory Committee at (612) 626-6764 for information on permit requirements or see the DEHS Web site.
 
Training

• University departments are obligated to provide general health and safety training so all of their employees know how to work safely and to ensure that the environment is protected. They are also encouraged to designate a lab safety individual.
• Departments must also provide hazard-specific training for any employees who might be exposed to hazardous materials or agents while at work.
• Training must be documented for audit purposes; the Department of Audits reviews training records. Records may also be reviewed by state and local regulators.
• Departments must have an approved chemical hygiene plan on file.
• The Department of Environmental Health and Safety (DEHS) will assist departments in understanding applicable regulations and in developing training. This office will provide various materials, including:
  • a list of regulations pertaining to each type of hazardous material,
  • "fact sheets" about each regulatory training requirement,
  • "train-the-trainer" sessions on lab safety and hazardous waste management rules
  • "material safety data sheets" for specific hazardous materials.
• For more information, contact DEHS at (612) 626-6002. Check the DEHS Web site for training materials.

Using Legend and Investigational New Drugs for Clinical Research
Researchers using legend (prescription) and investigational new drugs must follow the University's policy and procedure on Using Legend and Investigational New Drugs for Clinical Research. This policy was developed in order to:

• promote the safe handling of drugs used in clinical research,
• reinforce the protections afforded human subjects who are administered drugs under research protocols,
• help detect and prevent diversion of drugs for unauthorized purposes, and
• assure compliance with applicable laws and internal requirements.

Working with animals
Before any work with animals begins, the protocol must have been approved by IACUC. These approvals are effective for one year. Any change from approved protocols must be reported immediately.

lnvestigators and staff must be properly trained to perform their research and teaching activities. It is the responsibility of the Principal Investigator to ensure that appropriate training has been received. The IACUC must have documentation of this training.

For information on training requirements, see the IACUC training webpage at: http://www.research.umn.edu/subjects/animals/training/index.html.

RSPP adheres to the policies and procedures outlined in the National Research Council's Guide for the Care and Use of Laboratory Animals, the principal manual governing care and use of research animals.
 
Single copies are available free-of-charge from the NRC's Institute for Laboratory Animal Resources at voice (202) 334-2590, fax (202) 334-1687, or e-mail ilar@nas.edu.
 
Multiple copies are available from the National Academy Press at (800) 624-6242.