Handbook of Operating Procedures

I. POLICY AND GENERAL STATEMENT

This policy identifies mandatory research training for faculty, staff, students, trainees, and visiting scholars and includes training for:

• Principal investigators (PIs) on all sponsored projects;
• Faculty with effort on sponsored projects, and other employees involved in the effort certification process;
• Faculty, staff, students, trainees, and visiting scholars conducting research involving human subjects;
• Faculty, staff, students, trainees, and visiting scholars conducting research involving animal subjects;
• Faculty, staff, students, 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.

这一政策描述的培训项目not intended to set forth all of the substantive laws and regulations applicable to research. Faculty, staff, students, trainees, and visiting scholars involved in research are required to comply with all laws and regulations pertaining to their research. TheOffice of the Executive Vice President & Chief Academic Officeris available to assist upon request.

This policy applies to all individuals performing research at The University of Texas Health Science Center at Houston (the “university”) regardless of the sources of funding for the research.

II. PROCEDURE

A. Research Compliance and Regulatory Issues

The university promotes high ethical and professional standards for the conduct of its research activities and supports adherence to relevant compliance and regulatory requirements and best practices, including research training requirements. This is achieved through a number of mechanisms including the following.

• Employees are required to complete biannual training about identifying and preventing or appropriately managing research conflicts of interest.
• To maintain objectivity in our research programs, faculty and A&P staff must complete annual financial disclosures so that potential conflicts may be identified and managed or prevented.
• University policy (HOOP 168 Conduct of Research) explicitly mandates that research and research training at the institution be carried out in accordance with the ethical standards and principles found in theIntroduction to the Responsible Conduct of Research,a publication developed by the Office of Research Integrity at the National Institutes of Health.
  • The office of the Executive Vice President & Chief Academic Officer ("EVP/CAO") will provide all principal investigators (PIs) and co-principal investigators (Co-PIs) a copy of the publicationIntroduction to the Responsible Conduct of Research. Also provided will be the names and contact information of key individuals throughout the institution as well as links to relevant policies and procedures. This information will be provided upon notice of initial funding of the award, or as a result of a transfer-in of an existing sponsored project. The Office of Sponsored Projects will provide the names of PIs and Co-PIs who require this information to the Office of the EVP/CAO for handling and monitoring.
  • The university provides, upon request, training sessions to provide more detailed information on responsible conduct of research. Contact the Office of the EVP/CAO (713-500-3082) to schedule a training session.
  • Individual schools may provide research training focused more specifically on the needs of their students and trainees.
  • Regardless of seniority or experience, faculty, staff, students, trainees and visiting scholars conducting research must receive appropriate training as indicated in this policy in order to conduct the specified research.

B. Effort Reporting

University faculty with effort on sponsored projects and other employees involved in the effort certification process may complete training on effort reporting on theEffort Reporting website.

C. Protection of Human Subjects

Individuals conducting research involving human subjects must complete approved training on the protection of human subjects regardless of the funding source for their research. SeeNIH Guide: Required Education in the Protection of Human Research Participants, NOTICE: 0D-00-039 (June 5, 2001) andNOT-OD-01-061 (September 5, 2001).

Training must be approved by theCommittee for the Protection of Human Subjects(CPHS). CPHS maintains a list of approved online and instructor-led courses on itswebsite. The training must be completed prior to the approval of protocols by the CPHS. Re-certification through continuing education is required every three years.

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, 2011. Investigators, technical personnel, trainees and visiting scholars 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 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. Training must be completed prior to the approval of animal protocols by the AWC. The university frequently offers the required courses in basic methodologies and aseptic surgical techniques. Individualized training may also be arranged through the university'sCenter for Laboratory Medicine Animal and Care. The current course schedule and registration information are available athttps://inside.uth.edu/animal-research/training/schedule.htm.

E. Environmental Health & Safety

1. Potentially Infectious Agents & Potentially Hazardous Chemicals

个人处理潜在的传染性ag)ents, such as human blood, body fluids, and known infectious agents, and all individuals working with potentially hazardous chemicals, such as toxins, pyrophorics, carcinogens, explosives, and nanoparticles, must receive training in basic hazard communication. This information is provided in the university Laboratory Safety Course and Bloodborne Pathogens Training which is offered at new employee orientation, regularly throughout the academic year, and online. PIs and personnel working in or overseeing a laboratory are required by the Chemical Safety Committee to complete an on-line Annual Laboratory Safety and Bloodborne Pathogens Refresher training. PIs are responsible for verifying that all laboratory personnel have completed the training as required.

2. Sources of Radiation

Individuals conducting work with sources of radioactive materials must complete a required six (6) hour radiation safety training class. Individuals able to provide documentation of previous equivalent training and experience in the areas covered by this mandatory training may be exempted from completing this course. See theUTHealth Radiation Safety Manualfor additional information. Individuals conducting work with radiation-producing devices, such as x-ray machines, must document their review of the Operating and Safety Procedures for the machine use(s) they utilize and any applicable training based on use, and must provide appropriate documentation of credentials for human use.

Individuals working with non-ionizing sources of radiation (such as lasers) are required to receive training in the safe handling of such devices. Individuals may also be exempted from the university training course if previous training documentation is provided that is sufficient to address the content of the university course.

Information on all of these courses can be obtained from theEnvironmental Health and Safety website. Customized courses for individuals and small groups are also available.

III. CONTACTS

• • Office of the Executive Vice President & Chief Academic Officer
  • 713-500-3082
  • //www.tjghsg.com/index/research.htm
  • //www.tjghsg.com/evpara/investigator-briefing.htm
• • Office of Sponsored Projects (Effort Reporting)
  • 713-500-3392
  • effort@uth.tmc.edu
  • //www.tjghsg.com/sponsored-projects-administration/Manage/effort-reporting/general-information
• • Committee for the Protection of Human Subjects
  • 713-500-7943
  • cphs@uth.tmc.edu
  • //www.tjghsg.com/cphs/
• • Animal Welfare Committee
  • 713-500-3041
  • //www.tjghsg.com/animal-research/awc.htm
• • Environmental Health & Safety
  • 713-500-8100
  • //www.tjghsg.com/safety/

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