Policies

Introduction

University of Portland recognizes the importance of conducting a broad spectrum of investigative research as well as classroom and laboratory educational activities that require the use of recombinant or synthetic nucleic acid molecules technology or infectious agents, and/or involve human tissue or body fluids, or involve animals that may carry zoonotic disease. Cognizant that these activities may be accompanied by some risks, the University requires that these activities be reviewed and approved by an Institutional Biosafety Committee (IBC) to ensure that they are conducted in a safe and appropriate manner, and in accordance with the current editions of the National Institute of Health Guidelines For Research Involving Recombinant or Synthetic Nucleic Acid Molecules, the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories, and the Occupational Safety & Health Administration (OSHA) Standards for Bloodborne Pathogens. Adherence to this policy shall not exempt investigators employing recombinant or synthetic nucleic acid molecules or infectious agents in their research from compliance with other applicable laws, regulations or policies (e.g. research with human subjects, vertebrate animals, or radioactive materials). The appropriate paperwork must also be filed with the Institutional Review Board (IRB) for the protection of human subjects, the Institutional Animal Care and Use Committee (IACUC), and the Radiation Safety Officer. IBC and IACUC approval must be obtained prior to or concomitant with IRB review.

Definitions

• Recombinant or synthetic nucleic acid molecules are defined as either (i) molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate inside a living cell, or (ii) DNA molecules that result from the replication of those described in (i) Synthetic DNA segments likely to yield a potentially harmful polynucleotide or polypeptide (e.g. a toxin or pharmacologically active agent) shall be considered as equivalent to their natural DNA counterpart. If the synthetic DNA or RNA segment is not expressed in a living cell as a biologically active polynucleotide or polypeptide product, it is exempt from this policy.

• Infectious agents are defined as those biological agents, both pathogenic and non-pathogenic, known to infect human as well as selected animal agents that may pose theoretical risks if inoculated into humans.

Applicability

This policy is applicable to all research, teaching, and outreach activities involving recombinant or synthetic nucleic acid molecules or infectious agents that are conducted at or sponsored by (or under the aegis of) University of Portland. No activity involving the construction or handling of recombinant or synthetic nucleic acid molecules or the use of infectious agents or potentially infectious cells or organisms shall be initiated without the review and approval of the IBC Application for Work with Biological Agents by the University of Portland Institutional Biosafety Committee.

Institutional Biosafety Committee

An Institutional Biosafety Committee (IBC) comprised of University faculty and staff appointed by the Provost and at least two outside community members shall fulfill the responsibilities described in this policy and in the Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, Biosafety in Microbiological and Biomedical Laboratories, and OSHA Standards for Bloodborne Pathogens.

A. Committee Membership

The IBC members shall be selected so that they collectively have experience and expertise in recombinant or synthetic nucleic acid molecules and technology, infectious organisms and the capability to assess the safety of such activities and any potential risk to public health or the environment. At least two members shall not be affiliated with University of Portland (apart from membership on the IBC) and shall represent the interest of the community area with respect to the health and protection of the environment. The Administrative Liaison, under the direction of the Provost, shall also be a member.

B. Meetings

The IBC shall meet as needed, with a schedule of meetings shall be publicly posted when feasible. Meetings will be open to the public consistent with protection of privacy and proprietary interests. A quorum for conducting business shall consist of 2/3 of the current members except that at least one member not affiliated with University of Portland (apart from serving the IBC) must be present. Members may be present in person, by teleconference, or by videoconference. The meetings will follow recognized parliamentary procedure.

C. Reports

The IBC will report publicly to the University community concerning the performance of its assigned functions by making available a copy of the approved minutes of each IBC meeting. Copies may be obtained from the Provost’s Office or from the Chair of the IBC.

The IBC may redact proprietary or private information captured in the minutes and other publicly accessible documents, but will do so judiciously and consistently for all documents requested by the public. The definition of “public” shall be interpreted in its broadest sense – as referring to all peoples and entities. The criteria used in determining which information will be redacted include, but are not limited to:

• Trade secret information and other confidential commercial information.
• Home telephone numbers and home addresses of IBC members.
• Specific information whose disclosure would directly compromise institutional or national security.

In addition to any redacted report, minutes or other documents made necessary to protect the information set forth above, the IBC shall also maintain a full report without redactions that shall not be publicly available.

D. Conflicts of Interest

Members of the IBC shall not participate in the review and approval of applications under consideration by the IBC when a conflict of interest exists. Conflicts of interest include, but are not limited to, the following:

• The IBC member is currently engaged, or expects to be engaged, in the research project under review, as defined in the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines.)
• The IBC member has a direct financial interest in the Principal Investigator or the entity funding the research proposed by the Principal Investigator, as defined by the University and/or NIH Guidelines.
• The IBC member and the Principal Investigator of the application under consideration share a familial relationship.
• The IBC member has other reasons to feel that he/she cannot render an independent assessment of an application.

The IBC member shall disclose the conflict of interest at the following time:

• When the IBC member is contacted to participate in the review of a project from a Principal Investigator with whom the IBC member has a conflict of interest.
• Prior to the discussion at a convened meeting of a project for which the IBC member has a conflict of interest.
• Immediately upon discovery of the conflict of interest if at other than the aforementioned times.

An IBC Vice-Chair will be appointed to manage committee business in the event that the Chair has a conflict of interest. Although an IBC member shall be recused from voting on the final disposition of projects for which she/he has a conflict of interest, the IBC member shall nevertheless remain eligible to provide information related to the review of the proposal to the IBC. In such cases, the IBC member may participate in the meeting during which his/her project is being reviewed, but will be excused from the portion of the meeting during which formal adjudication and voting occurs.

Forms and Procedures

Each investigator/instructor using recombinant and synthetic nucleic acid molecules or infectious organisms or potentially infectious cells or organisms is required to submit The Institutional Biosafety Committee (IBC) Application for Work with Biological Agents, as described below.

If an adjunct faculty member is the instructor of record for a course or project that requires IBC review, a full-time faculty member should serve as joint Principal Investigator and be listed on the application as joint Principal Investigator.

Work requiring submission of the IBC Application for Work with Biological Agents includes:

• Research/Teaching Involving Recombinant or Synthetic Nucleic Acid Molecules: for those investigators/instructors employing recombinant or synthetic nucleic acid molecules and technology, including the construction or use of transgenic animals or plants and transfection or transduction of cell lines.
• Research/Teaching Involving Cell Lines Designated BSL2 or Higher: for those investigators/instructors using cell lines designated BSL2 or higher.
• Research/Teaching Involving Infectious Agents: for those investigators/instructors employing infectious agents in their research and teaching.
• Research/Teaching Involving Human Tissue or Body Fluids: for those investigators/instructors employing human tissue or body fluids or human cell cultures.
• Research/Teaching Involving Wild-Caught or Random Source Animals or Animal Tissues: for those investigators/instructors employing animals that may carry zoonotic disease.

An annual renewal form must be submitted each year for each approved application In addition, any substantive changes in procedures or type of recombinant and synthetic nucleic acid molecules, infectious agents or potentially infectious cells or organisms should be reported to the IBC as an amendment. Any additions or changes to personnel involved in the project, including students, should be reported to the IBC as an amendment. A new IBC Application for Work with Biological Agents must be completed every three years (every five years for classroom projects.)

Review Procedures

When an application is submitted, a copy will be sent to all committee members via electronic mail.

• The committee chair will designate a primary and secondary reviewer who are responsible for reading the application most closely and for presenting the proposal to the group at the meeting. Through the chair and on behalf of the committee, the primary and secondary reviewer will ask the Principal Investigator to respond to questions and requests for revisions or clarifications.
• Designated Review by two committee members is appropriate if:
  • There are no substantive changes to the project at the time of annual review.
  • The Principal Investigator wishes to add an addendum to procedures or agents with biosafety concerns similar to those already approved.
• IBC meetings will be scheduled monthly through the Fall and Spring semesters. If there are no proposals to review then the meeting will be canceled on the Friday prior to the meeting. For a proposal to be reviewed it will need to be received at least two full weeks prior to a pre-scheduled meeting. The meeting schedule will be published on the IBC website by the first week in September.
• The Principal Investigator will be invited to attend the IBC meeting to answer questions and provide information to the committee, but is not obligated to attend. The Principal Investigator will be excused from the portion of the meeting during which formal adjudication and voting occurs.
• Once the committee is satisfied that the project is in compliance with the policies and guidelines noted in Section VI, A (below), they should recommend approval of the project to the committee chair. The chair, on behalf of the committee, sends the Principal Investigator official notification that she or he may begin the research described in the application and reports the project’s approval at the next full committee meeting.

Functions and Responsibilities of the IBC

A. On behalf of University of Portland, the IBC shall review all applications to assure compliance with this policy and the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, the CDC Biosafety in Microbiological and Biomedical Laboratoriess, and the OSHA Standards for Bloodborne Pathogens.

B. On behalf of University of Portland, the IBC shall conduct periodic self-studies of the effectiveness of University policy on biosafety and the implementation procedures, reporting the results to the Provost and recommending any needed revisions. This will involve responsibility for:

1. Reviewing applications for the appropriateness of biosafety procedures and assignment to the proper biosafety containment levels of experiments.
2. Reporting within 30 days to the University Environmental Health and Safety Office and the Administrative Liaison identified problems with or violations of the guidelines and research-related accidents or illnesses; the IBC along with the Administrative Liaison, under the direction of the Provost, has responsibility for communication with external sponsoring and monitoring agencies.
3. Participating with the University Environmental Health and Safety Office in the development of emergency plans to deal with accidental spills and personnel contamination resulting from research.
4. Insuring through periodic inspections that laboratory standards are rigorously followed.
5. The Chair shall be responsible for signing external grant applications that may require approval from the IBC before the grant can be submitted or funded.

C. On behalf of University of Portland, the IBC may investigate issues and reports of unanticipated problems or serious or continuing non-compliance, and undertake a range of possible actions in response. These include but are not limited to: suspension of project; termination of project; IBC consultation with institutional officials, including the Faculty Personnel Committee.

Investigator's Responsibilities

The Principal Investigator is responsible for reviewing this policy and complying with its requirements. Specifically, he/she will:

A. Submit The Institutional Biosafety Committee (IBC) Application for Work with Biological Agents, annual review forms, and amendments for any modifications to the project. The committee will use these documents to determine whether the research is subject to Section III-A, III-B, III-C, III-D, III-E of the NIH Guidelines, or is exempt research. The IBC Chair is available to assist the Principal Investigator in completing this application.

This application (see Section V, above) includes:

1. Proposing physical and biological containment levels in accordance with the NIH Guidelines when registering research with the IBC.
2. Proposing appropriate microbiological practices and laboratory techniques to be used for the research.

B. Meet all the requirements of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, the CDC Biosafety in Microbiological and Biomedical Laboratories, and the OSHA Standards for Blood borne Pathogens prior to initiating research subject to the NIH Guidelines.

C. Under certain unusual circumstances:

• Seeking the NIH Office of Biotechnology Activities’ (OBA) determination of containment for experiments that require case-by-case review.
• Petitioning the OBA, with notice to the IBC, for proposed exemptions from the NIH Guidelines.
• Seeking NIH approval, in addition to IBC approval, to conduct experiments specified in Sections III-A and III-B of the NIH Guidelines.

D. Make available to laboratory staff and students copies of the IBC application and other protocols that describe potential biohazards and the specific precautions to be taken.

E. Provide appropriate instruction and training in practices and techniques necessary to ensure laboratory safety.

F. Supervise the laboratory staff to ensure that appropriate safety techniques and procedures are employed.

G. Report in writing to the IBC any significant problems or deviations pertaining to the operation and implementation of containment practices and procedures.

Issues that Must be Reported to the IBC

Adverse Events

An adverse event is defined by NIH as any untoward or unfavorable medical occurrence in a human study participant, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participants’ involvement in the research, whether or not considered related to participation in the research.

Any faculty member who is part of an approved IBC proposal is responsible for reporting an adverse event that has not yet been reported. Written notification must be promptly sent to both the IBC email (ibc@up.edu) and the Environmental Health and Safety Officer’s email (ehs@up.edu) summarizing the adverse event. Adverse events must be reported within 24 hours of occurrence.

Adverse events may result in required modifications, suspension, or termination of the IBC approved protocol.

Serious Adverse Events

Serious Adverse Event (SAE) are defined by the NIH as any adverse event that:

• Results in death;
• Is life threatening, or places the participant at immediate risk of death from the event as it occurred;
• Requires or prolongs hospitalization;
• Causes persistent or significant disability or incapacity;
• Is another condition which investigators judge to represent significant hazards.

Serious Adverse Events must be reported to Campus Safety by telephone (503.943.4444) immediately following occurrence and must be reported to the IBC email (ibc@up.edu), Environmental Health and Safety Officer (ehs@up.edu), and the Office of the Provost (provost@up.edu) via email within eight hours of occurrence. If a Serious Adverse Event occurs, research under the IBC protocol must be suspended until revised protocols are developed and approved by the IBC.

Eliminating an Immediate Hazard

Any immediate hazards that present a threat to life or physical safety, such as those that could result in a serious adverse event, should be immediately reported to Environmental Health & Safety (ehs@up.edu) and Campus Safety (503.943.4444). Research personnel must coordinate with Environmental Health and Safety to work with appropriate campus and emergency services personnel. The IBC must be notified of the hazard in writing, within 24 hours. Written notification must be sent to the IBC email ibc@up.edu                                                          

Unanticipated Problems

An unanticipated problem is defined as any incident, experience, or outcome that meets the following criteria:

• Unexpected (in terms of nature, severity, or frequency) given the research procedures that are described in the IBC approved protocol and informed consent document.
• Related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research).
• Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

Every member of the research team is responsible for reporting an unanticipated problem not previously addressed in the research proposal. Written notification must be promptly sent to both the IBC email (ibc@up.edu) and Environmental Health and Safety (ehs@up.edu) summarizing the unanticipated problem.

Unanticipated problems with a study may result in required modifications, suspension, or termination of the IBC approved protocol.

Noncompliance

Noncompliance is defined as failure to adhere to UP IBC policy and NIH policy as well as the protocols outlined in the research personnel’s accepted research proposal. This includes failure to submit a yearly protocol review.

Failure to adhere to NIH and IBC regulations will be documented in IBC records. Serious or continuing noncompliance is reported to the Provost’s office, Environmental Health and Safety, and the academic supervisor. The third failure to follow UP IBC policy constitutes continuing noncompliance.

Noncompliance that results in harm to research personnel constitutes serious noncompliance. Three incidents of serious failures to adhere to the NIH and University’s IBC regulations, three incidents of continuing noncompliance, or a combination of three incidents of  serious and continuing noncompliance will result in prohibition from conducting research that would require IBC approval while a UP employee.

Prior failures to adhere to NIH and IBC policies will result in more frequent continuing review.

Every member of the research team is responsible for reporting when an IBC approved protocol is not  being followed. Written notification must be sent within 24 hours to both the IBC email (ibc@up.edu) and Environmental Health and Safety (ehs@up.edu) summarizing how the approved protocol is not being followed, or the individual can fill out the IBC Compliance Reporting Form.

When a noncompliance report is filed the Environmental Health and Safety Officer and Chair of the IBC work with appropriate campus personnel to address the safety concern.

All issues reported to the IBC will be acknowledged by email, with any further follow-up noted, if known.

Noncompliance Appeals

Researchers may appeal consequences for noncompliance by submitting a written appeal to the IBC and Provost. All appeals for noncompliance are presented to the Provost’s Council for review. The Provost will communicate, in writing, the decision of the Provost’s Council.

Send questions about these policies to IBC@up.edu.