Policy Number: 95
I. POLICY AND GENERAL STATEMENT
This policy identifies mandatory research training for faculty, staff, trainees, and visiting scholars and includes training for:
- Principal investigators (PI) on all sponsored projects;
- Faculty with effort on sponsored projects, and other employees involved in the effort certification process;
- Faculty, staff, trainees, and visiting scholars conducting research involving human subjects, inclusive of human derived materials or human derived data;
- Faculty, staff, trainees, and visiting scholars conducting research involving animal subjects;
- Faculty, staff, trainees, and visiting scholars conducting research involving environmental health and safety concerns, in the forms of potentially infectious agents, potentially hazardous chemicals, and sources of ionizing and non-ionizing radiation.
The training programs described in this policy are not intended to set forth all of the substantive laws and regulations applicable to research. Faculty, staff, trainees, and visiting scholars involved in research must seek counsel from the Office of Academic and Research Affairs as the need for additional information arises in order to conduct safe and responsible research.
This policy applies to all researchers regardless of the sources of funding for their research.
A. Research Compliance and Regulatory Issues
All university employees who serve as PIs on sponsored projects must complete training on research compliance and regulatory issues (Investigator Responsibility Briefing). Re-certification through continuing education is required every three years, and courses taken to satisfy the re-certification requirement must be approved by the Executive Vice President for Academic and Research Affairs.
B. Effort Reporting
All university faculty with effort on sponsored projects and other employees involved in the effort certification process must complete approved training on effort reporting. Re-certification through continuing education is required every three years, and courses taken to satisfy the re-certification requirement must be approved by the Executive Vice President for Academic and Research Affairs.
C. Protection of Human Subjects
All investigators participating in research involving human research subjects, human derived materials, or human derived data must complete approved training on the protection of human research subjects regardless of the funding source for their research. See NIH Guide: Required Education in the Protection of Human Research Participants, NOTICE: 0D-00-039 (June 5, 2001) and NOT-OD-01-061 (September 5, 2001). For the purposes of this policy, investigators include: PIs; laboratory personnel working with human-derived data or samples and/or contributing to study design; study coordinators; study nurses; subcontractors/consortium arrangement recipients; and consultants.
Training must be approved by the Office of Research Support Committees (ORSC). ORSC maintains a list of approved online and instructor-led courses on its website. The training must be completed prior to the approval of protocols by the Committee for the Protection of Human Subjects, and investigators must provide the ORSC a certificate documenting the training has been completed. Re-certification through continuing education is required every three years, and courses taken to satisfy the re-certification requirement must be approved by the ORSC.
D. Care and Use of Animals in Research
Animal Welfare Regulations and Public Health Service Policy require institutions to ensure that all people caring for or using animals are qualified/trained to do so. See 9 CFR, Subchapter A, Animal Welfare, Part I (Animal Welfare Act implementing regulations): Public Health Service Policy (PHS Policy) for the Humane Care and Use of Laboratory Animals; Guide for the Care and use of Laboratory Animals, NCR, 1996. Investigators, technical personnel, trainees and visiting principal investigators who perform anesthesia, surgery or other experimental manipulations must be qualified through training or experience to accomplish these tasks in a humane and scientifically acceptable manner.
The university provides for formal or on-the-job training to facilitate effective implementation of the program and humane care and use of animals. Faculty with approved animal use protocols must assure the Animal Welfare Committee (AWC) --- also known as the Institutional Animal Care and Use Committee (IACUC) --- that personnel will be or are adequately trained. The university offers the required courses in basic methodologies and aseptic surgical techniques frequently and individualized training may also be arranged through the university's Center for Laboratory Medicine Animal and Care.
E. Environmental Health & Safety
1. Potentially Infectious Agents & Potentially Hazardous Chemicals
All individuals working with potentially infectious agents, such as human blood, body fluids, known infectious agents, etc. and all individuals working with potentially hazardous chemicals, such as toxins, reactives, ignitables, etc. must receive training in basic hazard communication and control. This information is provided in the university Laboratory Safety Course which is offered both at new employee orientation and regularly throughout the academic year.
2. Sources of Radiation
All individuals conducting work with sources of ionizing radiation (either radioactive materials or radiation producing devices such as x-ray machines) must complete the required 6 hour radiation safety training class. PIs able to provide documentation of previous training and experience in the areas covered by this mandatory training can be exempted from attending this course (see UTHealth Radiation Safety Manual for additional information).
Individuals working with non-ionizing sources of radiation (such as lasers) are required to receive training in the safe handling of such devices. PI's may also be exempted from the university training course if previous training documentation can be provided that is sufficient to address the content of the university course.
Information on all of these courses can be obtained from the Environmental Health and Safety website, http://www.uth.tmc.edu/saftety/index.html. Customized courses for individuals and small groups are also available.
|Office of Academic and Research Affairs||713-500-3082||http://www.uthouston.edu/index/research.htm|