Texas Tech University

IBC Requests for Clarification or Deviation

While our policies are written to provide flexible approach to biosafety, not all situations can be anticipated and what may seem clear to the Committee, may not be not be so to everyone.  The Institutional Biosafety Committee has adopted the framework below to provide an avenue for researchers to petition the IBC for a clarification to or a deviation from current biosafety policy.

Request for Clarification

If a principal investigator (PI) would like clarification regarding a Texas Tech University policy/procedure in the University Laboratory Safety Manual (LSM) - Biological Safety Manual, they will need to submit the request in writing to the Institutional Biosafety Committee (IBC). The IBC's evaluation and response to the Request for Clarification will be communicated in writing to the PI in the form of a memorandum from the IBC chair.

Conditions

  • The Request for Clarification is to be emailed to the IBC at the institutional email address (ibc.ehs@ttu.edu  ) no less than 5 business days before a scheduled meeting to be placed on the upcoming meeting's agenda. If the request is not received 5 business days prior to the meeting, the request may not be considered until the following meeting if the agenda is already full.

The written Request for Clarification will need to address the following:

  1. The policy(s) or procedure(s) for which clarification is needed as written in the LSM.
  2. The concerns, comments, and/or the point(s) needing clarification and why clarification is necessary, citing reputable references or peer-reviewed literature as needed.
  3. Suggestions for amending the policy(s) or procedure(s) in question; and
  4. Whether they wish to address the committee in-person regarding this matter so the coordinator can inform the IBC chair.

Request for Deviation

If a principal investigator (PI) desires to deviate from Texas Tech University policy(s)/procedure(s) outlined in the University Laboratory Safety Manual - Biological Safety Manual, they will need to submit the request in writing to the Institutional Biosafety Committee (IBC). The IBC's evaluation and response to the Request for Deviation will be communicated in writing to the PI in the form of a memorandum from the IBC chair.

Conditions

  • The Request for Deviation is to be emailed to the IBC at the institutional email address (ibc.ehs@ttu.edu  ) no less than 5 business days before a scheduled meeting to be placed on the upcoming meeting's agenda. If the request is not received 5 business days prior to the meeting, the request may not be considered until the following meeting if the agenda is already full.
  • Deviations may not be implemented until approved by the IBC.
  •  The IBC may request additional information or clarification regarding a request during their evaluation process.
  • Requests which impact an IBC protocol will be appended to the protocol as an amendment.  If this deviation will be universally incorporated into their lab practices, the PI will need to submit an updated Work Area Safety Plan (WASP) reflecting this change with their deviation.

The written Request for Deviation will need to address the following:

  1. The agent(s) and/or hazard(s) in use and/or impacted by the proposed deviation.
  2. The IBC Protocol number(s) and laboratory location(s) impacted by the proposed deviation.
  3. How the PI intends to modify the IBC-approved SOP(s) or policy.
  4. A final copy of their proposed SOP(s) or lab-specific policy.
  5. A written justification as to why the IBC-approved SOP or policy is not appropriate that indicates the specific deviations from the IBC-approved SOP or policy, citing reputable references and/or peer-reviewed literature to support their position for the needed change; and
  6. Whether they wish to address the committee in-person regarding this matter so the coordinator can inform the IBC chair.