Institutional Biosafety Committee

Submit all RDRQs, Select Agent/BBP notification, IAQs, and supporting documentation to ibc@reed.edu

Table of Contents

Purpose
What needs to be reviewed?
1) Pre-submission of RDRQ form
2) Review process
3) Amending an Existing Protocol
4) Reviews and renewals
5) Infectious Agents (including Select Agents) and Blood Borne Pathogens

Purpose

In compliance with the National Institute of Health (NIH) Guidelines for Research Involving Recombinant DNA Molecules, (NIH Guidelines), and the Code of Federal Regulations for Select Agents and Toxins, Reed College has instituted an Institutional Biosafety Committee (IBC).

The IBC is charged with reviewing, approving, and regulating all work on or with recombinant DNA molecules, Select Agents and Toxins, and other infectious agent activities performed at Reed College, or by Reed College employees working off-site on behalf of Reed College. The IBC will meet as appropriate to review and approve protocols, but at minimum of yearly to review annual reviews.

The committee will include "no fewer than five members so selected that they collectively have experience and expertise in recombinant DNA technology and the capability to assess the safety and containment of recombinant DNA research to identify any potential risk to public health or the environment".

What needs to be reviewed?

All research utilizing recombinant DNA or synthetic nucleic acid molecules must adhere to the NIH guidelines. Ensuring compliance with these guidelines is the responsibility of the principal investigator (Sec. IV-B-7-a, NIH guidelines). Biohazardous material (i.e. human tissue and fluid) and infectious agent work also requires IBC notification via email even though they are not regulated by the NIH guidelines. To determine what research requires IBC review, referred to Sec III of the NIH guidelines or contact the IBC.

1) Pre-submission of RDRQ form

• Read this webpage and the NIH guidelines.
• Submit an Initial Classification Form to ibc@reed.edu for assistance with determining exempt vs. non-exempt work.
• Download and complete RDRQ form.
• Ensure that personnel listed on the RDRQ have read and understand their responsibilities as it applies to the proposed research.
• Ensure that personnel listed on the RDRQ are up to date on appropriate training.
  • BBP (if needed provided by EHS, required annually)
  • Biosafety Training and NIH guidelines
    • It is the PIs responsibility to make certain that prior to engaging in research involving known or potential pathogens all laboratory and support personnel are properly trained in the practices and techniques required to ensure safety, and to supervise the safety performance of those involved ensuring that the required safety practices and techniques are employed.

2) Review process

Non-exempt Protocols

All non-exempt rDNA work must be reviewed by the IBC. The reviewer will verbally summarize the RDRQ to the IBC, request revisions (if deemed necessary), give recommendation for approval status (i.e. provisional approval), and then the full IBC will vote to approve the new protocol based upon reviewer recommendations.

Possible Outcomes

• Approved
  The RDRQ submission satisfactorily addresses all issues and the submission is fully approved, no modification is necessary on the part of the principal investigator.

• Provisionally Approved
  Minor issues remain that must be addressed by the principal investigator prior to approval. The revised RDRQ is reviewed by the primary reviewer and may be approved outside of the full IBC if changes are deemed satisfactory. Multiple revisions are allowed and may be necessary in some cases.

• Tabled
  Significant issues remain requiring full IBC review upon the principal investigator's response to the requested revisions.

• Rejected
  The RDRQ is not approved and has not been recommended for further consideration by the IBC.

Requested Revisions completed and approved by primary IBC reviewer

All requested revisions from the reviewer will be forwarded to the principal investigator. Once all requested revisions have been implemented, the reviewer will determine if approval is granted or full committee review is needed. The reviewer will forward the revised RDRQ to the IBC for reference.

Biosafety Office (BSO) review

Upon the primary reviewer's approval of the new protocol, the submission can be forwarded to the Biosafety Officer (BSO) to conduct a lab inspection (if necessary).

Final approval notification

If all relevant training (i.e. NIH Guidelines, Blood borne Pathogens, Biological Safety, etc.) is complete and the RDRQ has been approved, the IBC will forward final approval to the principal investigator and that research may commence.

Exempt Research Review

A completed Initial Classification Form must be on file for all exempt rDNA work at Reed College. Exempt work does not need prior approval before commencing but notification and form must be completed.

Biosafety Office (BSO) review

The BSO will review the completed Form to ensure that the proposed research falls under Sec. III-F of the NIH Guidelines. The Biosafety Office (BSO) will conduct a lab inspection (if necessary). The BSO will sign the RDRQ once they have ensured that the research falls under Sec III-F and all required training is complete.

3) Amending an Existing Protocol

Any change to an existing IBC protocol must be submitted for review to the IBC.

Amendments (major and minor) to protocols approved on the current RDRQ should be made directly to the RDRQ form and incorporated into the body of the protocol. Please use the strikethrough tools and track changes.

A comprehensive description of the proposed change is necessary for the amendment to be given full consideration. This should be added to the project summary section.

4) Reviews and renewals

Every 5 years' non-exempt protocols must be resubmitted for full committee review.

All previously approved, non-exempt research requires an annual review to assess any changes that have been made during the previous year. If a change has occurred, an amendment is required. If no changes have occurred, simply checkmark the box at the top of the form that reflects this years' review number and date. All forms must be resigned by the Principal Investigator/Head of Lab.

A study may be terminated at any time, although notification of research termination is usually given at the time of annual or five-year renewal.

5) Infectious Agents (including Select Agents) and Blood Borne Pathogens

Notification to the IBC must be given via email if work is to be conducted with Infectious Agents or Blood Borne Pathogens. If needed, the IBC may request that an Infectious Agent Questionnaire (IAQ) or a project summary be returned for review. Work may not commence until approval is given.

Submit all Initial Classification Forms, RDRQs, Infectious Agent/BBP notifications, IAQs, and supporting documentation to ibc@reed.edu