In addition or as a supplement to regulations already noted in this Handbook, listed below are important regulations or policies of Federal sponsors and the Health Science Center.

9.1 Human Subjects 1

Because all human subjects research must be approved by the IRB, if there is any doubt as to whether IRB review is necessary, the IRB office should be contacted to make the determination. Prior to writing his/her first proposal, every prospective Investigator should familiarize him or herself with the issues related to human research and with the process by which IRB approval is obtained.

There are two related though separate entities involved in the review and approval of human research: the Institutional Review Board Office and the Institutional Review Board.

The Institutional Review Board and the Institutional Review Board Office share the common mission of facilitating the ethical conduct of human research. There are three general areas of concern for human research subjects that are assessed in the research review and approval process.

First, the respect for persons, including their autonomy to consent for research participation without coercion after being fully informed about the research process and procedures and their associated risks.

Second are risks and benefits to the subjects that will be involved in the research. A determination must be made that they represent an acceptable balance for human research to be approved. Also considered under this area is the scientific design of the proposed research, as it is unethical to do research on humans which does not have a reasonable chance of answering the posed research question.

Third is the concept of justice that involves issues of the populations targeted to the research and equal access to participate by all potential subjects. Discrimination regarding access on basis of sex, age, language spoken, ethnic or racial identity or economic status is not acceptable for research which has the potential to provide benefit to the subjects.

The Institutional Review Board convenes monthly to review all human research except for a few categories of minimal risk research which are approved administratively by the IRB Office. Protocols go through a pre-review process in which two board members identify items that need the Principal Investigator's attention prior to full board review. These reviewers are the Investigator's advocates and present the protocol at the full board meeting. The Investigator should work with the reviewers in addressing any concerns identified prior to the protocol going to the full board. Most protocols are conditionally approved with some further actions by the Investigator required for final approval.

The IRB Office provides administrative support and consultation to the IRB, but does not actively participate in IRB decisions regarding the approval of human research. The Office also serves as a liaison between investigators and the Board, providing guidance to investigators on protocol preparation and meeting requirements for final approval as identified by the Board.

The IRB Office has the institutional responsibility of monitoring the use of human subjects in research and documentation of the processes used to ensure the ethical use of human subjects. These processes have to meet extensive federal regulations and policies that are in place to protect the human research subjects' rights and ensure the ethical conduct of human research. As many of these apply to how the individual Investigator conducts the project, the IRB staff's responsibility extends to assisting each individual Investigator in meeting the regulations which apply to their research.

The IRB Office is the first point of contact in the human research review process. They will answer questions and provide assistance through the appropriate review path for the particular research protocol. The Office publishes an Investigator's Handbook that should be reviewed and read prior to starting the research review process. The Handbook describes many aspects of the approval requirements for various research activities and federal and Health Science Center policy that apply to ongoing research projects. A copy is available in the IRB Office (Room 225L) or by calling extension 7-2351. In addition to the Investigator's Handbook, the Office will also provide a copy of the Health Science Center's Multiple Project Assurance. The Assurance is, in essence, a contract between the Health Science Center and the National Institutes of Health defining how human research will be reviewed and conducted. It outlines the responsibilities of the institution and the Investigator relating to human research that must be met to maintain the IRB's ability to review federally funded human research. The Handbook and the Assurance as well as links to federal guidelines and policies regarding human research are available at the IRB web site which can be accessed at http://www.uthscsa.edu/irb.

9.2 Animal Subjects 1

All animals used for teaching, training, testing, research, and any related activity by faculty, staff and students in Health Science Center facilities must be used and cared for in accordance with all applicable provisions of the Animal Welfare Act, other federal statutes and regulations, accreditation guidelines, and institutional policies relating to the humane care and use of laboratory animals.

To accomplish this, the Health Science Center has established an Institutional Animal Care and Use Committee (IACUC) which oversees the animal care and use programs of the institution. The Department of Laboratory Animal Resources (DLAR) assumes responsibility for ensuring the best possible preventive, diagnostic and clinical care for animal subjects and for providing appropriate research support.

To ensure that the above goals are met, the Health Science Center requires that all research, teaching or testing programs that use laboratory animals be prospectively reviewed by the IACUC. Faculty members who intend to use either live or dead vertebrate animals for such purposes must submit an animal use protocol to the IACUC. No animals may be purchased or used without an approved animal protocol. Only the DLAR can purchase animals. The DLAR can be reached at x7-6166 or by accessing its web site at http://www.oerweb.uthscsa.edu/iphcula/lar.htm.

9.3 Recombinant DNA Research and Biohazards 1

The Principal Investigator is required to apply for approval in the areas of Recombinant DNA, In Vitro Biohazard Research or Clinical laboratory use and In Vivo Biohazard use. Application forms used by the BSC in approval/disapproval are available in the Institutional Safety Office.

The Biohazard Safety Handbook provides information to assist the Principal Investigator in completion of the application to use Recombinant DNA and other biohazards as well a the procedures for safe handling of biohazardous material.

Prior approval to utilize Recombinant DNA and biohazardous material is required for the sign off on the COP form.

Approval is required prior to the sign off of the Certification of Proposal.

9.4 Radiation Safety 1

In accordance with the license, the Radiation Safety Committee (RSC) has been established to make policy and review all use of radioactive material and protocols involving radiation. A Radiation Safety Handbook is provided for all persons working with radiation. The Handbook outlines the radiation safety requirements to meet training requirements, receive authorization, procure, use and dispose of radioactive material as well as requirements for radiation producing machines and human use of radiation. The Radiation Safety Committee meets bimonthly to review applications or protocols from principal investigators for use of radiation in the laboratory, clinical or medical research setting. Review of protocols may run parallel with IRB review.

Application forms are available from Radiation Safety; the Radiation Worksheet required for human use protocols available from the IRB.

Each investigator using radiation at the Health Science Center is making a commitment to comply with University policy, state and federal regulations. The Radiation Safety Office will review all applications and protocols prior to submission to the RSC.

VA Medical Center use of radioactive material or protocols involving radiation requires authorization from the VA Radiation Safety Committee. Contact the VA Radiation Safety Office at x 94-4035 for information regarding the radiation use at the VA.

The Radioactive Drug Research Committee (RDRC) registered with the Food and Drug Administration is provided to review human use protocols using a radioactive drug in lieu of the investigator obtaining an IND from FDA. The RDRC serves the Health Science Center, the VA Medical Center and the University Health System. Contact the Radiation Safety Office to determine if a human use radioactive drug protocol must be reviewed by the RDRC as well as the RSC.

The Radiation Safety Office may be reached at x7-2955.

9.5 Chemical Carcinogens and Toxic Chemicals 1

A Chemical Safety Handbook providing procedures for the safe handling and disposal of chemicals is distributed to every laboratory using chemicals.

Applications for approval by the CSC may be obtained from Institutional Safety. Contact Institutional Safety at x7-2955

9.6 Financial Conflict of Interest 1 *

1. University faculty research must have priority over all private-sector research with respect to all resources including facilities, equipment, services, and personnel.
2. The services that are to be provided to the outside company should be for stated periods of time rather than permanent.
3. The research being conducted in the University facilities must be within the research mission of at least one of the Health Science Center's departments.
4. The Health Science Center will receive reimbursement for all costs associated with each individual project. Such reimbursement shall include incremental costs incurred by the Health Science Center as a result of the use plus the appropriate indirect cost for sponsored projects.
5. The Health Science Center will not make its facilities available for services that are available from the private sector in the San Antonio area. This guideline would apply to the basic purpose for which facilities are used and not to all ancillary services.
6. All companies must have a sponsoring department that is willing to certify to at least the following:
   1. The department has the space available for the outside company to perform the project.
   2. The project will not take away from any of the department's functions or activities.
   3. The department will be responsible for all administrative details relating to the proposed company's use of the facilities, such as obtaining temporary parking permits through University Police, arranging for keys, etc.
   4. If University resources for which the Health Science Center has an obligation to a third party are to be used, the sponsoring department will appoint a faculty member who will be responsible for the conduct of the outside company relating to those resources.
7. All such arrangements should be subject to a business agreement to be negotiated by the Office of the Vice President for Administration and Business Affairs upon the recommendation of the sponsoring department and the appropriate dean, with final approval by the President.

All gifts from employees, students, alumni, and any gifts of less than $500 (whether solicited or not);

Memorials regardless of the purpose;

Gifts for scholarships, loan funds, endowment funds, special lectureship support, and designated equipment purchases; or

Other specific gifts as determined by the President.

Committee	Extension	Website
Animal Research	7-3722	http://www.oerweb.uthscsa.edu/iacuc.htm
Biohazard Safety	7-2955	http://www.uthscsa.edu/safety/
Chemical Carcinogens and Toxic Chemicals	7-2955	http://www.uthscsa.edu/safety/
Human Research (IRB)	7-2351	http://www.uthscsa/edu/irb
Radiation Safety	7-2955	http://www.uthscsa.edu/safety/