The person submitting the Protocol must be the principal investigator (PI) and have faculty rank. PIs are responsible for biohazardous or recombinant agents use by their students and staff. Texas A&M International University policy requires the submission and approval of an IBC Protocol Application for all activities involving the use of biohazardous or recombinat agent research at TAMIU.
Prior to the initiation of any biohazardous or recombinant agent research at TAMIU, the IBC has the responsibility to review and approve, require modifications to, or withhold approval to a biohazardous or recombinant agent Protocol and to inspect all of the biohazardous or recombinant agent facilities annually.
The TAMIU IBC meets a minimum of twice yearly. Submit the forms to the IBC as soon as the need is anticipated and all protocols must be submitted to the IBC no later than 10 days before the meeting (contact IBC chair to find out the next meeting date). The IBC cannot expedite the review of an application because the investigator failed to submit it in time. It is the responsibility of the principal investigator (PI) to submit a protocol with sufficient lead-time to meet all University and agency deadlines.
1. Complete the IBC Protocol Application and submit it to firstname.lastname@example.org
2. All personnel listed on the protocol form need to complete the TAMIU Medical Health Questionnaire
3. Submit both the signed application form and page 3 of the TAMIU Medical Health Questionnaire to Dr. Michael Kidd, (LBVSC 312B).
4. All personnel listed on the application form who will enter the biosafety facility must complete CITI IBC Training, submit the TAMIU Medical Health Questionnaire (page 2 only) to the principal investigator of the IBC Protocol Application, and have a current vaccines (if applicable) prior to the initiation of any biohazardous research.
5. Any new personnel joining the lab must be added to the protocol using the IBC Amendment Form, complete CITI IBC Training, submit the TAMIU Medical Health Questionnaire as described above and have current vaccines (if applicable) prior to the initiation of any biohazardous research.
1. All protocols are reviewed by the entire committee.
2. After review one of three outcomes is possible: approval with no modifications, conditional approval pending revisions, or disapproval.
a. Approval with no modifications - The protocol meets all standards and is approved without modifications by full committee
b. Modifications required to secure approval - This is conditional approval with final approval by IBC Chair (or designated member) or by Full Committee once PI has completed revisions necessary for approval. PI is notified in writing of the required changes that must be made to the protocol before approval will be granted. Full Committee may defer approval of the required changes to the designated-member review method.
c. Disapproval – The reasons for disapproval are given to the PI, who may submit a Revised Protocol.
3. Upon approval the PI will receive written notification and is responsible for submitting annual review on the anniversary date of the approval and resubmission prior to the third anniversary. Failure to submit the renewal in time for review prior to the third anniversary will result in a lapse of approval.
4. Note: Any revisions requested during the review process become a part of the official protocol file.
Any changes in the protocol procedures, biohazards and/or agents, or personnel requires the submission of the IBC Amendment form. In addition to the amendment form, for additions of new personnel, the TAMIU Medical Health Questionnaire must also be submitted, completion of the CITI IBC Training and current vaccines (if applicable) are all required prior to the initiation of any biohazardous research by the new personnel. The IBC Chair will then:
a. Notify all members of the IBC in writing that an amendment has been submitted. This written notification shall contain, at a minimum the title of the study and the number of the amendment.
b. The IBC chair will forward a copy of the amendment and parent protocol to any member of the IBC who requests such information.
Members of the IBC may request:
a. A copy of the written amendment and supporting documentation.
b. Submission of the amendment to the full committee at the next scheduled meeting.
If full committee review is not requested by any member of the IBC after distribution of the amendment within 10 business days, the review may be carried out using an designated-member review method.
Designated-Member Review Method: the Chair, or one or more experienced reviewers designated by the Chair from among the members of the IBC, shall carry out the review. Any IBC member who has a conflicting interest shall not participate in the review of that amendment except to provide information requested by the IBC. The IBC Expedited Reviewer(s) or Subcommittee shall have the same responsibilities and authority as that of the full IBC except disapproval.
III. Training - Required
IV. IBC Members
VI. TAMIU IBC Policy and Procedures Manual (available from IBC Chair)
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