Quality Assurance
All human subjects research conducted under the University’s jurisdiction is subject to quality assurance (QA) monitoring. The quality improvement program is designed as a proactive, collaborative, and educational process that supports researchers in maintaining compliance and promotes high-quality research practices.
Goals
The goals of the QA program are to a) protect the rights and welfare of human participants in all University research; b) promote best practices in ethical research; c) identify, prevent, and mitigate risk to participants, investigators, and the institution; d) improve the quality and rigor of research through ongoing education and support; and e) foster a culture of transparency and accountability of participant data.
Program Objectives
To achieve these goals, the QA program will:
- Verify adherence to IRB-approved protocols, consent materials, and study procedures
- Confirm proper documentation and conduct of informed consent and assent/parental permission
- Assess data security and confidentiality practices, including digital data management, storage, and de-identification
- Evaluate recruitment, screening, and compensation procedures
- Provide general guidance, targeted training, resources, and consultation to research teams throughout a project’s lifecycle
- Identify patterns or trends that may inform institutional improvements to policy or training
Routine Monitoring (not-for-cause)
The purpose of routine monitoring is to confirm compliance, to proactively identify and rectify potential issues, and to advise research teams. All human subjects research conducted at BC is subject to routine monitoring, including human subject research determined to qualify for “exempt”-level review. Studies selected for routine monitoring are chosen without cause and randomly, but emphasis may be placed on studies that meet the following criteria:
- Vulnerable populations (e.g., children, prisoners)
- Deception
- Waivers (e.g., waivers of consent)
- Greater than minimal risk
- Clinical trials
- Federally funded
- PIs with past findings of noncompliance
Selection for review does not imply noncompliance. Closed protocols or protocols in the data analysis-only phase will not be selected.
Directed Monitoring (for-cause)
Directed monitoring may occur in response to a specific concern or request, including when:
- There are reports or evidence of noncompliance or of unanticipated problems involving risk to participants or others
- In the judgment of the Vice Provost for Research (VPR), the BC IRB (by majority vote), the IRB Chairperson, the Director of the Office for Research Protections (ORP), and/or institutional officials
- The protection of human research subjects or the interests of the institution indicate the need for monitoring
Notification
PIs will receive written notice of selection via email and will be asked to schedule a site visit within two weeks of the notice’s receipt. PIs will be offered the opportunity to have a brief preliminary meeting over Zoom before the site visit, where they can meet with the QA team, learn more about the audit process, and to ask any questions they may have.
PIs will be asked to complete a QA Self-Assessment form found on InfoEd in advance of the visit, which will include uploading a blank version of the consent form(s) and all instruments currently in use. They will be asked to upload copies of completed consent forms to Box.com, using a link provided in the notification email. These consent forms and instruments will be compared to the approved versions.
All protocol submissions, including the initial submission and any continuing reviews or amendments, which are already on file in InfoEd, will be reviewed.
Areas of review include (but are not limited to) the following:
- IRB records and documentation
- Study team training and roles
- Compliance with IRB approved protocol
- Participant recruitment, selection, and payment procedures
- Informed consent/assent procedures and corresponding records
- Participant payment and corresponding records
- Data storage and retention practices
- Confidentiality and privacy practices, and process
The reviewer has the right to access any and all collections of research data, documents, and records maintained by the Principal Investigator or their team members concerning the research protocol that is the subject of the review.
Review Meeting
During the review meeting, the QA specialist will meet with the PI or a research team member designated by the PI. The PI may invite any research team members. The team should be prepared to answer questions such as those listed in the previously submitted Self-Assessment form. The QA specialist will provide recommendations on compliance-related issues, and any documented discrepancies between observed and approved activities will be discussed. The meeting is meant to be conversational and collaborative.
Follow-Up
Within two weeks of the meeting and information gathering, the QA specialist will provide a written report via email summarizing activities and findings to the PI. The report may include a summary of the purpose of monitoring, a description of the monitoring activities and scope, findings of noncompliance and/or areas of excellence, and suggested corrective and/or preventative actions, if applicable.
The QA specialist will share the draft with the PI and request feedback, particularly regarding any factual inaccuracies. A final version of the report will be sent to the PI, the VPR, the Executive Director of Research Administration, the IRB Chair, and the Director of ORP. A copy will be kept on file in accordance with applicable document retention policies or practices by the ORP.
If the PI is asked to make changes to the existing protocol or research practices, within two weeks of receiving the final report they should submit a letter via email to the IRB (irb@bc.edu) detailing how those changes will be addressed. If there are significant findings, the final report may be reviewed either by the IRB staff, the IRB chair, and/or the full IRB at the next meeting.