I.  Bylaws of the Radiation Control Committee

    A.  Authorized Purpose of the Committee
    B.  Organizational Details of the Committee
    C.  Responsibilities of the Radiation Control Committee
    D.  Human Uses Subcommittee
    E.  Appeals
 
 
 
 
 
 
 
 
 
 
 
 
 

A. Authorized Purpose of the Radiation Control Committee  top

The President delegates to the Radiation Control Committee the responsibility for ensuring that ionizing radiation, radiation producing machines and radioactive sources are used safely on the University of New Mexico campus and in such other locations as might be employed by University faculty and staff.  The Committee shall establish such guidelines, rules and regulations as are required to meet this responsibility.  The Committee shall also be responsible for meeting all requirements regarding the broad scope license to use radioactive materials issued to the University by the New Mexico Environment Department (NMED).

The Committee shall report directly to the Associate Provost for Research.

B. Organizational Details of the Committee  top

    1. Name

        The name of this committee is the Radiation Control Committee.  This name is abbreviated “RCC”.

    2. Membership

The membership of the RCC will consist of no fewer than five regular members.
These members shall be knowledgeable in the field of radiation control and safety, or have some special interest that may enhance the committee membership, and shall be members of the faculty or staff of the University of New Mexico, or retained for special UNM services.  The Committee may designate non-voting ex officio members.  See Attachment B for suggested representation for membership.

Appointments to membership will be made by the Associate Provost for Research for a two-year term.  The Committee shall make recommendations for appointment to the Associate Provost for Research.  Terms are overlapping so that approximately one-half of the membership retires each year.  A member may be reappointed for more than one term.

1. One regular member of the RCC will be appointed as Chairman and one member appointed as co-Chairman by the Associate Provost for Research.
2. The Chairman of the RCC serves as the administrative officer in promulgating the policies, procedures, standards, and rulings of the Committee.
3. The Chairman shall preside over meetings of the RCC and shall have the power to call special meetings of the Committee.  The co-Chairman shall preside over meetings when the Chairman is absent.
4. In the absence of the Chairman and the co-Chairman for a meeting, one of the regular members of the Committee shall serve as Acting Chairman.  The selection of the member to serve as Acting Chairman shall be made by majority vote of the regular members present, and shall be duly recorded in the minutes.

A quorum will consist of four (4) voting members, one of whom must be an M.D.  A quorum must be indicated by noon on the day of each RCC meeting for a meeting to take place.

The RCC shall normally meet at least quarterly during the calendar year and more frequently if necessary.  Dates, times, and places of regular meetings will be set by the Chairman.

1. The Chairman or co-Chairman of the RCC is authorized to act for the Committee between meetings in cases of minor modifications of existing programs upon recommendation of the Radiation Safety Officer, i.e., adding or deleting a radionuclide, increasing the possession limit for a radionuclide already approved, or expanding a research project.  Such actions will be reported to the RCC at the next meeting.
2. The Radiation Safety Officer is delegated to act for the RCC between meetings in routine matters of follow-through on conditionally approved programs.

The Radiation Control Committee shall establish subcommittees as necessary to more effectively fulfill its responsibility.  One subcommittee currently exists to assist the Radiation Control Committee.  This is the Human Uses Subcommittee (HUS).  Responsibilities of this Committee are outlined in sections I. D.

C. Responsibilities of the Radiation Control Committee  top

In fulfilling its authorized purpose, the Radiation Control Committee is charged with the following responsibilities and duties:

1. To establish policy and disseminate rules for radiation control and safety applicable to the faculty, staff, students, and visitors at the University of New Mexico.
2. To assure that the University has a Radiation Safety Officer to carry out the duties delegated by the Radiation Control Committee and to satisfy the requirements of the licensing agencies.
3. To serve as the University’s liaison with the New Mexico State Environment Department and the United States Nuclear Regulatory Commission in matters of registration, licensing, and radiation control.
4. To prescribe special conditions, requirements, and restrictions as may be deemed necessary to minimize hazards arising from the operation or use of all sources of ionizing radiation on the University campus and other UNM-operated properties and other locations where radioactive materials are used under the University’s license.
5. To review:
1. Proposals for the use of sources of ionizing radiation in programs under the jurisdiction of the University from the standpoint of good radiation safety practices.
2. Actions of the University departments or divisions, or representatives or committees thereof, in matters pertaining to good radiation safety practices.
3. User’s training and experience and determine who should take the Introduction to Radiation Safety Course.
6. To advise the University Architect and any Department, College, or School in the planning of a new or remodeled facility in which the use of sources of ionizing radiation is anticipated; to review and approve the final preliminary drawings, specifications, and contract drawings for adequate design to facilitate good radiation safety practices and control as deemed appropriate by the Committee.
7. To ensure periodic inspections and radiation surveys by the RSO, announced or unannounced, of any University facility for the purpose of assuring the safety of radiological operations within the facility.
8. To order immediate shutdown or cessation of work in any facility where the RCC considers that health hazards exist to the extent of endangering life and/or property.
9. To review and issue directives for correction of violations of applicable regulations or University rules and policies.
10. To keep a written record of all meeting actions taken by the RCC in fulfilling its authorized purpose.

1. The RCC has delegated, to the HUS, jurisdiction over patient protection with regard to routine and investigational uses of various forms of radiation in and on humans.
2. Proposals for the use of ionizing radiation in humans are reviewed by the HUS with special consideration to patient protection, informed consent, and possible hazards.
3. Appointments to the HUS are by the Associate Provost for Research.  A term of service is for two years with approximately one-half of the membership retiring each year.  A member may be appointed to serve more than one term.
4. The HUS will meet when there is sufficient business to justify a meeting.  A quorum will consist of one-half the membership provided that at least three (3) M.D.’s are present.
5. Criteria for Qualifications of User Physicians

Application to become a user physician for human use shall be made to the HUS.  The applicant’s credentials will be evaluated by the HUS.  Unanimous approval by all HUS members is necessary before a physician is authorized for investigational radiation use in or on humans.  Other HUS business also requires approval by unanimous approval. The RCC will be advised of HUS approvals.
6. Records of all human use authorizations and the minutes of HUS meetings will be maintained by the Radiation Safety Division.
7. Guidelines for Investigational Uses of Radionuclides in Humans

 

 

a. General Statements

 
1) Any use of radionuclides will be termed “investigational” if not considered as a well established procedure by the RCC.  The investigator is encouraged to consult with the RCC.
2) Any physician wishing to pursue an “investigational” use of radionuclides in humans must be approved as a qualified user physician.
3) The proposed investigational use must have been previously tested in an animal model as evidenced by:
 
a) literature citations or personal communications regarding unpublished experiments, or
b) personal experience by the investigator(s) with animal studies that specifically relate to the proposed human use.


b. Specific Statements Required in Application

1) Purpose of study; including
 
a) rationale for investigation, including statement of risk vs. benefit
b) previous related investigation in animals or humans
2) Materials to be used; including
a) radionuclide(s) or radiopharmaceutical(s), including
(1)  method of preparation, or source of supply
(2)  detailed assurance of quality control
(3)  method of calibration of doses
b) complimentary drugs administered, if any
c) type(s) of patients and control subjects to be studied, and number(s)
3) Experimental Methodology, including
a) radionuclide storage, administration, and waste disposal
b) instrumentation to be used
c) data to be obtained, specifically regarding
 
(1)  data format and manipulation, and
(2)  time frame of study (individual and total)


d) data reduction and presentation methods
e) statistical processes to be used

4) Radiation Dosimetry, including
 
a) fate of administered radionuclide(s) or radiopharmaceutical(s)
(1)  effective half-life (total body)
(2)  organ or tissue deposition (localization) with organ specific effective half-life
b)  total effective dose equivalent and total organ dose equivalent per unit activity (e.g., mCi, kBq)
c)  total radionuclide or radiopharmaceutical dose to be administered, total effective dose equivalent and total organ dose equivalent to be delivered, and rationale for using administered doses.
 
5)  Toxicity or adverse reactions
6)  Plan for reporting results, including interim reporting if long term, using the  following format:
 
a)  A statement of the purpose of the investigation
b)  A summary of the results, including
(1)  The radionuclide administered, its chemical form, and route of administration
(2)  The number of patients involved in the study, their ages, sex, and clinical diagnosis before administration of the radiopharmaceutical
(3)  Dosage schedule used
(4)  Complimentary drugs administered, if any
(5)  The method of preparation of the radiopharmaceutical, if it was not obtained in a prepackaged, precalibrated, sterile, and pyrogen-free form from a pharmaceutical supplier
(6)  Special radiation detection instrumentation used
(7)  A statement of organ distribution and an estimate of biological half-life of the administered radionuclide as determined during the course of the study.  The rationale behind these estimates or methods used to make the determinations.
(8)  A synopsis of the toxicity data obtained
(9)  Brief clinical histories of all patients exhibiting any adverse reactions to any radiopharmaceutical administered.  The investigator should describe the reaction and include his interpretation of the nature and cause of the reaction.
c)  An evaluation by the investigator of the safety and efficacy of the diagnostic or therapeutic procedure.  This evaluation should include a statement on side effects, toxicity, and ineffectiveness.  In the case of diagnostic procedures, the investigator should state whether or not the resultant diagnosis was confirmed by other methods.


c. Consent Forms

Consent forms should follow the format approved by the HUS (Attachment F).  Radiation dose to a patient should be explained in terminology familiar to the patient and compared to an equivalent dose (e.g., from background radiation).

Actions taken by the Radiation Control Committee may be appealed by the individual, department, or division concerned to the President of the University (via the Associate Provost for Research) for final decision, with the knowledge and consent of the Dean or Director of the College, School or Department involved.
Complaints regarding radiological practices can be made to any committee member who shall then bring the complaint to the full committee for consideration and possible action.  Complaints shall be considered as confidential if so requested by the complainant.