Purpose

The goal of the Post Approval Monitoring (PAM) inspection process for Environmental Health and Safety (EHS) Biosafety staff is to collaboratively facilitate safe and compliant research.

PAM inspections are also utilized to meet the requirement of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules that periodic inspections are conducted to ensure that the laboratory standards and containment conditions required by the IBC are rigorously followed [Section IV-B-3-c-(1)]. 

Who is eligible to receive a PAM inspection?

Any Principal Investigator (PI) with an active IBC protocol is eligible to receive a PAM inspection. Typically, EHS Biosafety staff prioritize protocols classified by the NIH Guidelines as III-A through III-E.

When are PAM inspections scheduled?

PAM inspections are scheduled no earlier than six months after approval to ensure that the PI has ample opportunity to train their staff and begin their operations and may recur approximately every three years. The exact timing will be determined based upon EHS Biosafety staff and PI (or designee) availability.

EHS Biosafety staff will work with the PI to schedule a convenient time. Temporary postponement of the PAM inspection may be requested to avoid conflicts or if the work has not yet started.

What is the PAM inspection process?

• EHS Biosafety staff will contact a PI via email to schedule a PAM inspection. If the PI remains unresponsive after several email attempts, Biosafety staff will attempt to contact the PI in-person. If the PI does not respond after one month (and a minimum of four attempts), the request will be elevated to EHS and departmental leadership.
• An EHS Biosafety staff member will read the IBC protocol(s) under the PI’s name prior to the inspection to familiarize themselves with the work described.
• The EHS Biosafety staff member will meet the PI (or designee) to review approved materials, facilities, practices, and personnel.
• The EHS Biosafety staff member will meet with the researchers conducting work in the laboratory to review work practices and incident response procedures.
• If modifications to the IBC protocol(s) are needed, the EHS Biosafety staff member will work with the PI (or designee) to ensure that changes are made and submitted in a timely manner.
• Results of the PAM inspection will be summarized at the next convened IBC meeting.

What happens if noncompliance is found?

If IBC noncompliance is identified, the priority for EHS Biosafety staff is to work with the PI and research team to get them back into full compliance. Punitive measures, which often worsen communication and relationships, are typically utilized only as a last resort for noncooperation and/or repeated or deliberate noncompliance. These will be decided by the IBC at a convened meeting and will be communicated to the IBC Institutional Official (IO) by the committee chair.  

Note that some forms of noncompliance, as outlined in the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules [Section I-D], must be reported by EHS to the NIH Office of Science Policy. Their focus historically has also been to ensure safety and compliance and not to punish, but actions for severe noncompliance could include suspension, limitation, or termination of financial assistance for an NIH-funded research project and/or of NIH funds for all other recombinant or synthetic nucleic acid molecule research at this institution.