Compliance Resources and Reporting

  Research Compliance Officer
  Biohazards and Public Health Committee
  Institutional Animal Care and Use Committee
  Institutional Review Board
  Radiation Safety Committee
				

Research Compliance Officer

The Research Compliance Officer is responsible for maintaining effective mechanisms by which individuals may report alleged violations of applicable laws, regulations, rules, policies and procedures. This includes the use of human subjects in research, animal welfare, control of biohazards and radiation safety. All reports will be kept confidential. The Research Compliance Officer may be contacted at (515) 294-3115; dament@iastate.edu

Biohazards and Public Health Committee

I. INTRODUCTION

The Iowa State University Biohazards and Public Health Committee (BPHC) is a University Standing Committee appointed by the Vice President for Research and Economic Development and Advanced Studies. The Committee also serves as the Institutional Biosafety Committee (IBC) in all matters involving recombinant DNA studies as required by the Federal Register, May 7, 1986 and amendments.

The Committee reviews and sets conditions for conducting studies involving recombinant DNA and transgenic animals or plants. It has the authority to require changes in operations that do not comply with the required conditions.

 The BPHC has the responsibility for reviewing the biological and public health safety programs at Iowa State University and sets policies that comply with federal, state, and local regulations and recommendations.

II. COMMITTEE REQUIREMENTS

A. Committee Composition

The BPHC (acting also as the IBC) shall be comprised of no fewer than six members so selected for their collective expertise, experience, and ability to assess the safety of recombinant DNA projects as well as potential biological and public health risks.

At least two members shall not be affiliated with the University except for their membership on the Committee. These two members will represent the surrounding community regarding public health and environmental protection. Eligible individuals for these two positions should be public health or environmental officials, or from other local government agencies, or active in local community, medical, health, or environmental concerns.

The ISU Biological Safety Officer (BSO) shall be a member of the Committee.

It is recommended that the BPHC appoint members, or use as consultants, individuals familiar with University commitments and policies, applicable law, standards of professional conduct, and community attitudes and environment. At least one member should be from a university laboratory technical staff and at least one member should be a representative of the ISU student body.

B. Government Notification

The BPHC shall identify each Committee member by a name in a report to the Federal Office of Recombinant DNA Activities (ORDA) and shall include relevant background information on members as required by ORDA.

C. General Procedures

No committee member may be involved (except to provide information) in the review or approval of a project that the member expects to be engaged in or has a direct financial interest in.

Committee meetings are open to the public except when the protection of personnel privacy and propriety interests are of overriding concern.

The University may establish additional Committee procedures as needed.

III. COMMITTEE FUNCTIONS

A. Recombinant DNA Compliance Review

The committee will review all DNA and other genetic modification project requests and will approve those which comply with the federal, state, and local regulations and guidelines.

Included in the above review will be an assessment of the following:

• Required containment levels
• Facilities, procedures, and practices
• The training and expertise of proposed project personnel

1. Required Actions

The committee will authorize only those genetic modification experiments that are explicitly covered by the NIH guidelines unless approval and containment requirements have been obtained from NIH. Containment levels will be set for each project reviewed.

Each principal investigator requesting a project review will be notified of the results of that review.

Any significant problems, violations, accidents, or illness that involve NIH guidelines will be reported promptly to ORDA. Significant accidents and illness that appear to be a hazard to public health will also be reported to the state and local public health departments.

B. Transgenic Animal Compliance Review

The committee will review all research proposals involving transgenic animal work. These proposals will be forwarded from the ISU Institutional Animal Care and Use Committee and Use.

The BPHC will determine:

• Compliance with the National Institutes of Health and the Animal and Plant Health Inspection Service guidelines
• Adequacy of designated laboratory facilities
• Adequacy of specified containment and/or confinement procedures
• The containment and/or confinement biosafety level under which the project must be conducted

C. Other Functions

Other functions and actions may be performed as delegated by the Vice President for Research and Economic Development and Advanced Studies.

D. Relationship of the BSO and the Department of Environmental Health and Safety (EH&S) with the BPHC

The BSO will have the responsibility of following the directives of the BPHC. The BSO also operates under the direction of EH&S which is responsible for a wide spectrum of safety and health programs at the University.

EH&S will maintain a comprehensive safety program and will implement the periodic surveys required for the BPHC to carry out its responsibilities. Included are safety surveys of laboratories, buildings and other areas where there may be biological and public health concerns.

EH&S has the authority to require changes in unsafe operations to assure compliance with applicable regulations and recommendations and to maintain reasonable standards of health and biological safety. Any significant problems, violations, accidents, or illnesses will be reported promptly to the appropriate university official and to the BPHC.

EH&S also coordinates employee participation in the Occupational Medicine Program which provides medical surveillance for ISU personnel working with materials or under conditions with recognized risks.

IV. COMMITTEE ACTIONS

A. Meeting Frequency

The committee shall meet as needed to conduct its required functions.

B. Quorum

The presence of a quorum shall be required for any action requiring a committee vote.

A quorum shall consist of any number of members over 50 percent of the current committee membership and shall include the chair. In the absence of the chair, the chair may designate another member to act as an alternate.

C. Meeting Minutes

Copies of all meeting minutes shall be kept in the office of the committee chair and at EH&S and shall be available for membership review at any time.

The University shall, upon request, make available to the public all minutes of meetings except when the protection of personnel privacy and proprietary interests are of overriding concern. If members of the public make comments on IBC actions, these comments shall be forwarded to the National Institutes of Health (NIH) along with any response from the IBC.

D. Committee Reports

Following the review of research requests or reported hazardous conditions; reports of approval or disapproval, comments, questions or requests will be sent to the responsible person or the department executive officer as appropriate.

E. Appeals

Actions by the committee may be appealed through the Vice President for Research and Economic Development and Advanced Studies. Guidance from specific regulations or standards will be used for final decisions. If any issue is still unresolved after university review, a review may be sought from an appropriate group outside of the university.

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Institutional Animal Care and Use Committee

The existence of an Institutional Animal Care and Use Committee is mandated by both the Animal Welfare Act and the PHS Policy. The committee answers to the institutional official responsible for the animal care and use program. At Iowa State the committee is named the University Institutional Animal Care and Use Committee (IACUC) and the institutional official is the Vice President for Research and Economic Development (Vice Provost). The membership of the IACUC is in compliance with the Animal Welfare Act and the PHS policy and which require a veterinarian with experience in laboratory animal medicine, scientists who use animals, a nonscientist and a community member not affiliated with the university.

To be in compliance with the Animal Welfare Act and the PHS policy the IACUC must fulfill the following responsibilities:

1. Review all proposed uses of live vertebrate animals in teaching, research and testing, including regular review of all ongoing projects. Changes in previously approved uses of animals must also be reviewed by the COAC.
2. Inspect the institution's animal facilities at least once every six months. Inspection reports must be prepared which specify deadlines for correction of cited deficiencies. Special note is taken of deficiencies which are not corrected. Under most conditions ongoing deficiencies must be reported to the USDA and the PHS
3. Review the institution's animal care and use program every six months.
4. Submit semiannual reports based on (2) and (3) above to the Vice Provost.
5. Submit an annual report to OPRR, detailing changes in the animal care and use program, changes in IACUC membership and the results of (2) and (3) above.
6. Review concerns involving the care and use of animals at the institution.

Make recommendations to the Vice Provost regarding the animal care and use program, university animal facilities and the care and use training programs available to university personnel.

In addition the IACUC must have the authority to suspend a previously approved animal related activity if the committee determines that the activity is not being conducted in compliance with the Animal Welfare Act, the PHS policy, or university policy.

Meetings of the IACUC are held monthly. A subcommittee meets weekly to review proposed uses of live vertebrate animals and special meetings are called by the Chair as needed.

Reporting Concerns Regarding the Care and Use of Animals

Concerns about the care and use of animals at ISU may be reported to the:

• ISU Confidential Hotline, hosted by Ethics Point, by phone at 866-384-4277 or https://secure.ethics.point.com  The web page is hosted on Ethic Point’s secure servers and is not part of the Iowa State University web site or intranet.  Reports may be anonymously submitted to Ethics Point.
• Institutional Official, Dr. John Brighton, 4-1785, brighton@iastate.edu
• Director of Research Assurances, Diane Ament, 4-3115, dament@iastate.edu
• IACUC Chair, Dr. Dan Morrical, 4-2904, morrical@iastate.edu
• Attending Veterinarian, Dr. Ronald Morgan, 4-8507, rlmorgan@iastate.edu
• Any IACUC member.  The names of current IACUC members may be found on the IACUC website at:  http://www.compliance.iastate.edu/ComplianceWeb/coacMembers.aspx

Noncompliance /Complaint Process

Upon notification to the Office of Research Assurances of noncompliance or complaint:

1. The Research Compliance Officer (RCO), the Chair of the COAC, the Attending Veterinarian and the IACUC Administrator will determine if immediate suspension of the project in question is required, while the complaint is addressed, in consultation with the Vice President for Research and Economic Development. This initial decision will be based on preliminary information and the seriousness of the situation. If applicable, the sponsor contract or grant award notice will be reviewed to determine requirements for notifying the sponsor.

2. The RCO, COAC Chair or the Attending Veterinarian will present the matter to the members of the COAC, when a quorum of the full committee is present. The COAC will determine if: (a) suspension is not merited; or (b) suspension is merited. In order to suspend a study a majority of the quorum of members present must vote in favor of the suspension.

   1. Suspension not merited:
      

      If suspension is not merited, the issue will be resolved between any combination of the following individuals: RCO, Chair of the COAC, Attending Veterinarian, COAC Coordinator, Principal Investigator, Principal Investigator’s Department Chair. These actions will be based on recommendations from the COAC members and in communication with the Vice President for Research and Economic Development. All communication will be documented.

   2. Suspension is merited:
      

      Notice of suspension effective immediately will be sent to: principal investigator, co-principal investigators, department chair, the Office of Sponsored Programs Administration, Sponsored Programs Accounting, and the Vice President for Research and Economic Development and the Associate Vice President for Research and Economic Development, Office of Laboratory Animal Welfare. The RCO will notify the Office of Laboratory Welfare.

The RCO will lead the investigation of the incident with the assistance from any combination of the following as appropriate: the IACUC Chair, the Attending Veterinarian, the IACUC Administrators and members of the COAC. Following completion of the investigation, a meeting will be called of the following individuals: RCO, the Chair of the COAC, the IACUC members, principal investigator, and the principal investigator’s department chair to discuss the nature of the situation and to determine if the situation merits a designation of serious or continuing non-compliance. All communication will be documented.

In order to make the determination of serious or continuing noncompliance it may be necessary to perform an audit of study records. The principal investigator will be required to produce: all data related to the study projects, applications for approval from the COAC, any study-related documentation including monitoring logs, etc.

1. Nonserious and Noncontinuing:
   

   If the incident appears to be isolated and in essence is a miscommunication or misunderstanding of a nonserious and noncontinuing nature, a letter from the RCO to the principal investigator describing a summary of the audit will be written. The RCO in communication with the Vice President for Research and Economic Development and Advanced Studies may determine the appropriate corrective action, based on recommendations made by the Chair of the COAC, the Attending Veterinarian, the IACUC Administrator, and members of the COAC, or require that the principal investigator describe corrective actions. This will be considered the final step if the incident is considered to be nonserious and noncontinuing. A copy of the letter will be sent to the principal investigator’s department chair and to Chair of the COAC. The RCO will notify the Office of Laboratory Animal Welfare of the final outcome.

2. Serious or Continuing:
   

   If the audit indicates noncompliance that is serious or continuing, corrective action will be determined by the RCO in consultation with the Vice Provost and the Associate Vice President for Research and Economic Development. The corrective action will be based on recommendations made by the Chair of the COAC, Attending Veterinarian and Administrator of the IACUC and members of the COAC. A copy of the letter will be sent to the principal investigator’s department chair, the dean of the principal investigator’s college, the Provost and other necessary individuals as determined by the Vice President for Research and Economic Development. The RCO will notify the Office of Laboratory Animal Welfare of the final outcome.

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Institutional Review Board

            At Iowa State University, the Institutional Review Board (IRB) reviews all research involving human subjects, including proposals to gather data from subjects for theses, dissertations, and other student projects. The committee has representatives from various areas within the university and includes a member from the community. The community member is asked to disclose any conflict of interest they may have with Iowa State University and that information will be kept in their file.

The IRB Committee has the authority to approve, require modifications or disapprove all human subject research activities at Iowa Statue University.

The full board review process is as follows. The Chair, designee, or any IRB member can set up a meeting. The IRB Committee meets once per month. A copy of each protocol to be reviewed is sent or delivered to the committee members for review before the scheduled meeting. The Administrator records the minutes of the meeting. Included in the minutes is the attendance, date, actions taken by the board, and the vote on actions taken. The Administrator then collects all copies of the protocols and shreds the excess copies.

Expectations and responsibilities of the IRB members are to attend each meeting; to be prepared to discuss each protocol and other agenda items; to use all of one’s area of expertise; to maintain confidentiality regarding any information contained in any review; to reveal any potential conflict of interest as soon as it arises; and to be familiar with the SOP and forms.

The IRB Committee will review protocols that have more than minimal risk. Following is the definition of minimal risk as defined in 45 CFR 46:

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

If an IRB member is an investigator on a protocol that is being reviewed by the Committee, they may be present to address any questions, and then the member is excused for the deliberation and vote by the remaining IRB members.

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The Iowa State University Radiation Safety Committee (RSC), is appointed by the Vice Provost as one of the standing committees of the University. The RSC shall have the responsibility to provide general review and audit of radiation safety programs at Iowa State University to determine compliance with Regulations and Licenses issued on the local, state, and federal level. The RSC shall likewise have the authority to require program changes, including termination of unsafe projects, to assure compliance with regulations and the maintenance of reasonable standards of health and safety.

The directives of the RSC will normally be carried out by the University Radiation Safety Officer (RSO). The RSO operates out of the Department of Environmental Health and Safety which has broad responsibilities for all safety and occupational health programs on the Iowa State University campus.

This Charter covers the Radiation Safety responsibilities of the RSC. General RSC items will be discussed first , then items which are specific to the use of radioactive materials and radiation producing equipment on campus, and finally, items which are specific to the UTR-10 Training Reactor.

II. GENERAL COMMITTEE REQUIREMENTS

A. Composition of the Committee

The RSC is composed of a representative from each of five colleges in the university in which research in the physical and life sciences and in engineering is conducted, plus three members with specific expertise in radiation protection. At least one of these members shall also represent university management. The college representatives are chosen from the Colleges of Agriculture, Engineering, Liberal Arts and Sciences, Family and Consumer Sciences, and Veterinary Medicine. One of the other three members shall be the university RSO. The chair of the committee shall be appointed by the Vice Provost. The terms on the committee for the RSO and chair are indefinite. All other terms are for three years with reappointments being determined by the Vice Provost.

B. Frequency of Meetings

The RSC meets at least once during each academic semester, at a time arranged by the chair for maximum attendance. Additional meetings may be called if circumstances dictate the need for them.

C. Quorum Requirements

            Five of the eight members of the RSC, including the chair or a designated alternate and the RSO or a designated alternate, shall constitute a quorum of the RSC.

D. Committee Reporting

Recommendations and minutes of the RSC meetings are sent to the Vice Provost. Copies of minutes which pertain to the UTR-10 Training Reactor are also sent to the chair of the Department of Mechanical Engineering. Any recommendations, comments or questions in the minutes regarding a specific project or program are sent to the person in charge of that project, and to the person having administrative authority for the department involved, when such action appears appropriate.

Permanent copies of the minutes of RSC meetings shall be retained by the university RSO in the files of the Department of Environmental Health and Safety.

E. Termination or Changes in Radiation Projects

The RSC shall have the authority to enforce changes in any radiation project in order to comply with regulations and to meet reasonable standards of safety and health. In the event that any radiation project endangers the health or safety of any individual, or presents a threat to the safety of property, the RSO shall have the authority to shut down and terminate such projects or operations. Upon taking such action the RSO must immediately notify the chair of the RSC and the chairs of the involved departments, college dean, and Vice Provost.

F. Appeals

Any individual may appeal the actions of the RSC through the Vice Provost. Where specific rules, regulations, or licenses apply, they will be used as guidance in making final decisions. If there is no concurrence after RSC and administrative review, issues will be referred to the appropriate off campus agency for review.

G. Relationship of the RSC and the RSO

The RSO is responsible for keeping the RSC apprised of all major actions taken to implement and enforce radiation safety rules and regulations on campus. The RSO shall implement and enforce directives of the RSC and coordinate the total radiation safety program to ensure proper and timely response to current problems.

H. Environmental Health and Safety

The RSC’s function of assuring safety surveys is implemented by the Department of Environmental Health and Safety. This department provides monitoring services for personnel and the UTR-10 Reactor and for reactor experiments and operations, receives and handles shipments of radioactive material, collects radioactive waste and performs other health physics functions.

III. RSC ACTIONS RELATIVE TO GENERAL USE OF RADIOACTIVE MATERIALS AND RADIATION PRODUCING EQUIPMENT AT IOWA STATE UNIVERSITY

A. Approval of Projects involving Radioactive Materials or Ionizing Radiation

Before an individual may use radioisotopes or ionizing radiation in experimental or routine procedures, approval must be obtained from the Radiation Safety Committee. This must include approval of the following:

1. The project itself on the basis of radiation protection only.
2. The facility for the amounts and types of radioisotopes or other radiation sources which will be used.
3. The training and background of the individual to handle the radioactive material or radiation which he or she intends to use.
   

This information shall be submitted to the RSC through the RSO. All projects and major additions or changes in projects, shall be reviewed by the RSO and the chair of the RSC. The chair of the RSC will determine if further committee review is necessary and act accordingly. All approvals for projects shall be granted by the chair of the RSC or his designated alternate. Minor additions or changes to projects will be reviewed and approved by the RSO or a designated alternate.

NOTE: A complete outline of information necessary to submit with a radiation project can be found in the Radiation Safety Manual.

B. Audit and Review of Radiological Safety Programs

The RSC shall assure itself through reports from the RSO, and through actual audits when necessary, that control of the radiation safety program is being maintained. This will include the following items and records maintained by the RSO:

1. Procurement and possession of radioactive material.
2. Transfer and shipment of radioactive material on and off campus.
3. Inventory lists to assure compliance with local possession limits, and with NRC licenses and regulations.
4. Appropriate surveys, leak tests, and monitoring of radiation projects to assure worker safety and compliance with regulations.
5. Personnel dosimetry records including bioassay results.
6. Disposal of radioactive waste materials.
7. Instruments and calibration records.
8. Renewal and changes in any federal, state, or other licenses held by Iowa State University that pertain to the use of radiation or radioactive materials.
9. Any other important records that may be required or deemed appropriate.
10. ALARA program.

IV. RSC ACTIONS RELATING TO THE UTR-10 TRAINING REACTOR

The Radiation Safety Committee is given authority to obtain access to the UTR-10 area and to all files relating to the UTR-10.

The Iowa State University Reactor Use Committee (RUC) is appointed as the review and audit committee for the UTR-10 Training Reactor operated by the Department of Mechanical Engineering of Iowa State University.

The RUC reviews and approves new experiments and proposed alterations to the reactor. The RUC shall also review and audit reactor operations for safety. Interviews and discussions by the RUC with the UTR-10 staff are a part of the audit process.

The RSC receives copies of all correspondence between the UTR-10 staff and the Nuclear Regulator Commission, current reports from the RUC, and all other pertinent letters and documents.

A. Composition and Qualifications

The RUC shall be composed of the reactor manager and a radiation health physicist, both ex officio (voting), and at least three other members having expertise in reactor technology. Committee members shall be appointed by the Radiation Safety Committee.

B. Operating Rules

1. The Reactor Use Committee shall meet a least semiannually and keep written records of its meetings. The committee shall report directly to the Radiation Safety Committee.
2. A quorum shall be three members. Members of the operations staff shall not be a voting majority.
3. Any action recommended by the RUC which may adversely affect the operations and/or safety of the university community shall be brought to the attention of the Radiation Safety Committee which shall have veto power over such a recommendation.
4. The RUC may appoint one or more qualified individuals to perform the audit function.
   

C. Review Function

The following items shall be reviewed by the Reactor Use Committee or a subgroup thereof:

1. Proposed changes in equipment, systems, tests, experiments, or procedures to determine that they do not involve an unreviewed safety question.
2. All new procedures and major revisions thereto having safety significance; proposed changes in reactor facility equipment, or systems having safety significance.
3. Tests and experiments in accordance with appropriate sections of the Safety Analysis Report for the UTR-10 Training Reactor.
4. Proposed changes in the technical specifications or the operating license.
5. Violations of the technical specifications or the operating license; violations of internal procedures or instructions having safety significance.
6. Audit reports.
7. Operating abnormalities having safety significance.
8. Reportable occurrences.
   

D. Audit Function

The audit function shall include selective (but comprehensive) examination of operating records, logs, and other documents. Where necessary, discussion with cognizant personnel shall take place. In no case shall an individual audit in an area for which he or she has operational responsibility. Deficiencies uncovered that affect reactor safety shall be reported immediately to the Radiation Safety Committee. A written report of the findings of audit shall be submitted to the Reactor Use Committee within 30 days after completion of the audit. The following items shall be audited:

1. Facility operations for conformance to the technical specifications and applicable operating license conditions, at least annually (interval between audits not to exceed 15 months).
2. The retraining and requalification program for operating staff, at least biennially (interval between audits not to exceed 30 months).
3. The results of actions taken to correct those deficiencies that might occur in the reactor facility equipment, systems, structure, or method of operations that affect reactor safety, at least annually (interval between audits not to exceed 15 months).
4. The reactor facility emergency and physical security plans and implementation procedures at least biennially (interval between audits not to exceed 30 months).
   

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