The University of Connecticut Monitoring Program for Research with Human Participants

 

Goals

Monitor research and IRB practices, provide current information to investigators, students, and the IRB and correct noncompliance through education, thereby improving research compliance and preventing situations that might increase risks to research participants or lead to regulatory citations.

Audit Categories

  • Routine:  Studies will primarily be randomly selected by the IRB Monitor; however, selection may include elements in Selection of Studies, below.It will include a review of the IRB’s file, the regulatory file of the PI, the Consent Forms and process and sample subject files.

  • Informed consent: Usually requested by the IRB, this audit is intended to support researchers in conducting the informed consent process. It may include: observation (when possible) of the consent process and/or a thorough review of the process including training of people obtaining consent and review of the consent forms signed by the participants.
  • For-cause:  Under 45 CFR 46.113 requirements, this review is performed when concerns regarding compliance, protocol adherence, or subject safety are brought to the attention of the IRB or the IRB Monitor. This is an on-site review that may include all of the elements described under Routine and Informed Consent audits above.
  • Investigator Initiated:  A PI may request an on-site review to help keep records and procedures in compliance with federal regulations and institutional policies or to prepare for an external audit by a sponsor or federal agency.

Selection of Studies

Protocols selected for monitoring will focus on, but not be limited to studies where:

  • the probability and magnitude of anticipated harm or discomfort, (including loss of privacy or confidentiality) are greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests; or
  • full board or expedited review were given by the IRB; or
  • no peer-review was given; or
  • participants from “vulnerable populations” are included See: 45 CFR 46, subparts B, C, and D (pregnant women/fetuses/neonates, prisoners, and children), or other populations vulnerable to coercion or undue influence including:  the mentally disabled, economically or educationally disadvantaged persons under 45 CFR 46.111(b), or others considered vulnerable by the University; or
  •  “for-cause” concerns are exhibited; see above.
  • other factors that may be considered include:
    • Adverse event or Protocol Deviation reporting history
    • Regulatory approval category
    • Funding source
    • Results of previous audits
    • Study topic

Audit Notice

Except in cases where the safety of subjects is a concern, written notification of an audit will be sent from the Institutional Official or his designee. The IRB Monitor will contact the PI to arrange a visit to the department within the following estimated timeframes:

  • Routine:  At least two weeks notice in advance of the initial meeting of the audit.
  • Informed Consent:  At least one week notice in advance of the monitoring.
  • For-cause:   At least twenty-four (24) hours notice by a telephone call and email to the PI from the Institutional Official or his/her designee.
  • Investigator Initiated: A time will be arranged by mutual convenience.

Audit Elements

(See Monitoring Review Form)

  • Review of roles and responsibilities of investigators and key personnel
  • Review of Regulatory Compliance may include review of :
    1. Protocol file/regulatory documentation.
    2. IRB Documentation.
    3. Consent/Assent Forms.
    4. Individual Participant Records. A random sample to determine if :
      • The participants met the inclusion/exclusion criteria for the study.
      • Study related procedures are performed according to the protocol.
      • Study related procedures are scheduled and performed per the study time line.
      • Data is recorded and stored securely as described in the Consent Form.
      • Adverse Events have been reported according to institutional policy.
      • Payments were made to participants as described in the protocol.

  • Grant Application, if applicable; the grant application may be compared to the IRB approved protocol.
  • The ORC/IRB File. IRB Meeting issues (quorum, diversity, expertise, conflict of interest); adequacy of review.
  • IRB file to determine whether it contains all correspondence/amendments and adverse events the investigator submitted; to determine whether continuing review was completed as required by the IRB based on the risks presented by the study.
  • Elements of Informed Consent/Assent documents:
    Review of the required elements of informed consent according to the federal regulations and IRB requirements.
  • Informed Consent/Assent Process. Includes review of :
    • The timing of recruitment and screening in relation to informed consent.
    • The appropriateness of the person obtaining consent.
    • The consent process to meet the needs of vulnerable populations.
    • Steps to aid participants with barriers to understanding or lack of capacity to consent (language, reading level, etc.)
    • Steps to see if the participant understands the research purpose, risks, benefits, voluntary participation, withdrawal, confidentiality, costs/compensation, contacts for questions or injuries.
  • Subsequent publications resulting from IRB approved protocols may also be reviewed.

Report of Findings

  • It is anticipated that in most cases serious violations involving risk of injury to participants will have already been reported to the IRB. However, if an audit demonstrates that a serious violation involving risk of injury to participants has not been reported, it will be reported immediately to the IRB Chair and to the Associate Vice Provost for Research (AVPR).

  • For Routine Audits, a Summary Report will be drafted by the IRB Monitor and sent to the PI for his review and comments. When indicated, the PI will be invited to create his own corrective action plan. The PI and the IRB Monitor will sign the report and submit it to the AVPR.  The originals will be filed in the IRB Monitor’s file for quality improvement purposes and not in the IRB protocol file. A copy will be provided to the PI; the IRB Chair, and the AVPR will review and sign it. Copies will not be provided to the full IRB but the IRB Monitor will periodically present a list of Routine Audits at a regularly scheduled IRB Meeting. For a more detailed description, select The Summary Report.

  • For Cause and Consent Audits will usually be requested by the IRB. Summary Reports for these types of audits will generally contain the same types of information described above and will be reported at regularly scheduled IRB Meetings.

  • The Summary Report for the Investigator-initiated audits will contain the same information as the Routine Audits but a copy of the report will only go to the PI. The IRB Monitor will keep a copy for quality improvement purposes.

  • Recommendations for the IRB and for the IRB staff will be made to the Associate Director of the ORC/IRB or to the IRB Chair as appropriate.

Regulatory Authority and References

  • The UConn Federal-Wide Assurance Agreement with the OHRP. The agreement's Terms of Assurance stipulates that the university must have procedures that "include formal mechanisms for monitoring compliance with human subject protection requirements.

  • DHHS, 45 CFR 46.109(a). "An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy."

  • DHHS, 45 CFR 46.109(e) and FDA, 21 CFR 56.109(f). "An IRB shall conduct continuing review of research ...and shall have authority to observe or have a third party observe the consent process and the research."

  • DHHS, 45 CFR 46.111(a)(6) and FDA, 21 CFR 56.111(a)(6). An IRB is required to ensure "when appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects."

  • DHHS, 45 CFR 46.113. "An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects."