Post Approval Monitoring Overview

The University at Albany (UAlbany) research compliance bodies administered by the Office for Regulatory and Research Compliance (ORRC) have statutory responsibility for review and oversight of research, teaching, or testing activities they have approved.

Institutional Review Board (IRB) and Institutional Animal Care and Use (IACUC) approvals for activities are invariably contingent upon performance or execution of the activities exactly as they are approved.  Accordingly, any changes or modifications must be submitted, reviewed and approved by the applicable committee prior to initiation of the new or altered activity.

Additionally, UAlbany must ensure that the ongoing research process accurately reflects approved protocols. There are several mechanisms used to accomplish post-approval monitoring (PAM), including annual reviews, continuing reviews, semiannual reviews, spot monitoring, complaint investigations, etc.

The ORRC has a PAM program which can include announced in-laboratory visits to assess compliance with approved protocols. The over-arching intent of the oversight program is to help protect the interests of the university and our researchers. This is done by helping researchers achieve compliance, rather than to find non-conformance.

Accordingly, your activity may be visited or reviewed as part of our oversight/compliance program. If you have questions about the PAM program, please contact ORRC.

IRB - Human Subjects Research Post-Approval Monitoring Program

The purpose of this program is to ensure that scientific, ethical and regulatory requirements are followed in all IRB approved protocols. The program is also designed to improve the quality of research by detecting errors and/or omissions that might occur when performing research activities. This also gives investigators an opportunity to ask questions and receive information about regulations and issues regarding the protection of human subjects.

Non-compliance with federal regulations can result in suspension of research protocols, the loss of the privilege of using human participants in research at UAlbany, the loss of federal research funding across the entire institution or imposition of more severe penalties.

All studies, even those determined to qualify for an exemption from IRB review, are subject to post approval monitoring.  Not all studies will be selected. The majority of studies reviewed are selected with an emphasis on the following:

  • vulnerable population;
  • off-site research;
  • student investigators; and
  • studies involving possible conflicts of interest.

Receiving notification that a study has been selected for a monitoring does not imply that wrongdoing is suspected in the conduct of the study. Post approval monitoring of randomly selected or specifically targeted protocols help the IRB to assess investigator compliance.

The Research Compliance Officer (RCO) serves UAlbany as the compliance liaison between the research and instructional community and the IRB. The RCO is also the University’s Institutional Official for human subjects research.

The PAM Administrator reports to the Research Compliance Officer and is employed within ORRC.

The PAM Administrator will be a primary resource in assessing and facilitating compliance by providing quality assurance/quality improvement activities with regard to research involving human subjects.   These activities are designed to assess and improve UAlbany’s human subjects research program as a whole by identifying areas requiring further attention.

Training will also be made available, as needed, to rectify deficiencies. Timelines will be established for remediation of action items, and follow-up monitoring and mentoring will be provided in all cases where deficiencies are identified.

The IRB will receive periodic reports of the activities and findings of the PAM program by the RCO.

IACUC - Vertebrate Animals in Research or Teaching Post-Approval Monitoring Program

UAlbany is committed to providing humane care and treatment of animals used in research and teaching by faculty, staff, and students. As a Registered Research Facility with the United States Department of Agriculture-Animal and Plant Health Inspection Service (USDA-APHIS-AC), and as a research facility with an approved Assurance on file with the Public Health Service’s (PHS) Office of Laboratory Animal Welfare (OLAW), the IACUC serves as a mandated surrogate for and reports to both USDA-APHIS-AC and OLAW.

Non-compliance with federal regulations can result in suspension of research protocols, the loss of the privilege of using animals in research at UAlbany, the loss of federal research funding across the entire institution or imposition of more severe penalties.

Thus, PAM of previously approved animal activities provides assurance to the IACUC and to the institution that researchers, instructors, and research and teaching support staff are conducting their activities in accordance with their respective IACUC approved protocols, and are thus complying with applicable local, state, and federal regulations.

Post approval monitoring of randomly selected or specifically targeted protocols will help the IACUC to assess investigator compliance.

The RCO serves the University as the compliance liaison between the research and instructional community, the IACUC, and the University’s Institutional Official for animal use (the Vice President for Research). 

The PAM Administrator reports to the RCO and is employed within the ORRC.

The PAM Administrator will be a primary resource in assessing and facilitating compliance by providing inspections (audits) of, but not limited to, research records, laboratories, animal handling, procedural techniques, and animal facilities.  These audits will be utilized as a tool to assess and improve the University at Albany’s animal care and use program as a whole by identifying areas requiring further attention.

Training will also be made available, as needed, to rectify deficiencies. Timelines will be established for remediation of action items, and follow-up monitoring and mentoring will be provided in all cases where deficiencies are identified.

The IACUC will receive periodic reports of the activities and findings of the PAM program by the RCO.

For additional information on the PAM program, please contact ORRC at compliance@albany.edu.