Post Approval Protocol Monitoring (PAPM)

The University of Maryland Baltimore County is required by federal regulation to exercise “appropriate oversight mechanisms” to insure that the institution’s policies and procedures designed for protecting the rights and welfare of human subjects are being effectively applied in compliance with the Office for Human Research Protections (OHRP) approved Federalwide Assurance (FWA).

In essence, the University is required to perform post approval protocol monitoring (PAPM) to protect research participants, to educate researchers about human subject protection issues and to improve the quality of research by detecting errors and/or omissions that might occur when performing research activities.  A report of the PAPM review will be provided to the members of the Institutional Review Board.

The ORPC make arrangements to meet personally with the investigator and/or research staff to examine the investigator’s protocol file. Investigators should plan to allow for least one (1) hour for the ORPC to conduct the review; while the investigator’s presence is not required, it will be helpful to be present to answer any questions. Student investigators and faculty advisors should meet prior to the review to make arrangements for a meeting time and access to the protocol files.

The ORPC will examine the following items in the protocol file:

  • The use of the IRB approved consent form (complete with the date stamp of approval).  A comparison will be made of the number of subjects recruited vs. the number of consent forms on file. Projects with IRB approved waivers or modifications of written consent must present evidence in the protocol file indicating how participants were informed about the purpose of the research project and the procedures conducted.  Secondary data analysis projects will be evaluated on the adequacy of confidentiality protection.
  •  The IRB approved measures and instruments
  • Copies of protocol correspondence between the investigator and the IRB, including evidence of the investigator(s) human participant use training (either UMBC IRB or CITI training).
  • Copies of continuation/renewal requests or progress reports
  • Reports of all unanticipated problems or adverse incidents and any follow-up to these incidents

Click here for sample list of information we will use to review your protocol.

The investigator’s data storage medium will be examined to determine if the appropriate measures are undertaken to ensure confidentiality and minimize risk to participants. Applicable items to be reviewed include the use of a secured location (lock and key system), an updated firewall or virus protection program and secure data tracking systems.

Maintaining confidentiality of data sources is important while the study is active. Data should be stored in a secured location and identified by code numbers only. A master list must be kept in a separate location from the data, with only the investigator and his/her designee responsible for access to the data.

If audio- and video-tapes have been used in the study, the recommended length of time to keeping tapes is three years beyond the completion of the study. However, data from audio- or video-tapes should be transcribed as soon as possible; once accomplished, these tapes should be erased or destroyed.

The results of the review must be kept in the investigator’s protocol file.  In addition, retention of signed consent forms and other relevant documents or the location of where these are maintained for at least five years past completion of the research activity for adult subjects and, for minor subjects, at least three years after reaching the age of 18, whichever is longer.

return to IRB info