Post Approval Monitoring (PAM) Policy
It is the responsibility of all research investigators to uphold the rights and welfare of human subjects in research. Federal regulations require that after an Institutional Review Board (IRB) reviews and approves research there must be procedures in place for monitoring compliance with human subjects requirements. The University has the responsibility to ensure that the research is being conducted as stated in the IRB protocol. To assist in this endeavor, the Provost and Academic Vice President has endorsed the creation of the Post Approval Monitoring (PAM) Committee. A sub-committee of the IRB, the PAM Committee was formed to make for-cause and not-for-cause audits to ensure that the campus community meets University and federal regulations for the protection of human subjects in research. Notably, the post-approval monitoring process is designed to benefit the research team by providing education and training to assist researchers in complying with the regulations and to be prepared for external audits by granting, regulatory, and accreditation agencies.
a. PAM Membership
The PAM Committee consists of academic faculty with research experience who serve as voting members on the IRB and the Compliance Specialist from the Office of Sponsored Projects.
b. Key Terms
A for-cause audit is an inquiry of a research investigator that is initiated at the request of the IRB to obtain (or verify) information necessary to ensure compliance with University and federal regulations.
A not-for-cause audit serves as a necessary part of the quality assurance process, by educating researchers about information necessary to ensure compliance with University and federal regulations. A not-for-cause audit identifies areas in research compliance that needs improvement and education across the campus community.
A serious and continuing noncompliance is the result of a review of research records where there are severe problems and violations of University and federal regulations.
A nonserious and noncontinuing noncompliance is the result of a review of research records where there is an isolated problem or misunderstanding of University or federal regulations.
a. Monitoring Process
The PAM Committee employs various methods to monitor post approval research activities. This may include, but is not limited to, observation of recruitment procedures to potential participants, observation of the consent process with participants, observation of the data collection process, inspection of the research facilities and data analysis and storage areas. Further, the PAM Committee is responsible for contacting participants regarding their research experience, if necessary.
b. Selection Process
A for-cause audit is generally based on a concern, complaint, or an allegation that was brought to the attention of the Compliance Specialist or a member of the IRB, any situation where the IRB or PAM Committee has concerns that the research process might not be proceeding according to the approved IRB protocol, protocols that involve complicated procedures, and/or research teams with minimal experience administering consent or research procedures. Whereas, Principal Investigators (PI) are randomly selected for not-for-cause audits from the list of all PIs who have submitted an expedited or full review project within the past 36 months. The PAM Committee may also select various topics for monitoring across several protocols, such as investigating effective recruitment or informed consent procedures, or for the assessment of best practices to enhance the protection of human research participants.
Research records must be accessible for inspection and copying by authorized representatives of the University or the federal government at reasonable times and in a reasonable manner. Researchers will receive notification of an audit no later than two weeks before the audit. A meeting or on-site review will be scheduled at the earliest convenience of the PAM Committee and the PI.
During an audit the PAM Committee will document the following for each of the PI's research projects:
1. Research records are stored in a secure location, as specified in the IRB protocol.
2. Research records are organized and labeled to allow the identification of specific information within the records by someone who was not involved with the original project.
3. Regulatory materials and documents are readily available for review. At a minimum these materials include the following:
· The IRB approved protocol(s), which include the IRB tracking number. (Please note: each approved protocol needs to be retained, e.g., original IRB form and all Review and Monitoring Forms).
· Correspondence from the IRB including approval letter(s).
· Signed informed consent, assent, or parental permission documents.
· Copies of all of the recruitment materials, if applicable.
· Copies of all other written information given to subjects, e.g., supplemental materials.
· Electronic or hard-copy data materials and/or files.
· Letter(s) of support from an outside entity, if applicable.
· Grant contract or agreement between the PI and the funding agency, if applicable.
4. Research records are stored in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
5. Research has been conducted as stated in IRB protocol.
6. Research related activity has been conducted within the approval dates.
7. Unanticipated problems involving risks to subjects have been reported to the IRB.
Once the findings from the audit are reviewed, the PAM Committee will provide the PI with a summary of how they conducted the review, their findings, and their recommendations for corrective actions, if applicable. The audit process provides an opportunity to help PI's identify areas of their post approval research design which need improvement. Education and training is a fundamental piece of the post-approval monitoring process.
b. Corrective Actions
The PAM Committee can put the PI on a cycle of monthly records review to assess whether the PI has effectively implemented the corrective action plan. There may be more severe sanctions for serious and continuous noncompliance. The PAM Committee reports all serious noncompliance to the Institutional Official (Provost and Academic Vice President) and to the members of the IRB for inquiry.