The UConn Storrs Monitoring Program for Research with Human Participants*

*Storrs and the regional campuses, the School of Social Work and the School of Law

  1. The goals of the Monitoring Program are:
    1. Protect the rights and welfare of human research participants by determining if a study is being conducted in compliance with federal regulations, state law, Institutional Review Board (IRB) policies and with the currently approved protocol and by correcting noncompliance through education.
    2. Assist investigators and the IRB by implementing a systematic, internal process for identifying areas of IRB and investigator non-compliance and working with investigators and the IRB to resolve those areas, thereby preventing situations that might increase risks to participants or lead to regulatory citations.
    3. Provide current information to investigators, students, and the IRB related to relevant regulations and policies governing the protection of human participants in research.

  2. Audit Categories:
    1. Routine: Studies selected for these audits will primarily be randomly selected, however, selection may include elements in 3. Selection of Studies, below. They will focus on compliance with the federal regulations and with IRB policies by reviewing IRB and Investigator files. They will include a review of: 1) the roles and responsibilities of research team members, 2) consent form elements and consent process; 3) participant recruitment and eligibility; 4) participant files for agreement with the approved protocol; 5) data collection and security; 6) adverse events (AE) and protocol deviations, and 7) other relevant aspects of the study.
    2. Informed consent: This type of review is intended to support researchers in conducting the informed consent process. It may include: 1) observation (when possible) of the consent process; 2) verification that the person consenting the subject is qualified and designated by the principal investigator (PI); 3) review of the consent form for IRB approval date and signatures; 4) documentation of consent, and confirmation that a copy was given to subject; 5) review of the consent form for required elements.
    3. For-cause: Under 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." This review is performed when concerns regarding compliance, protocol adherence, or subject safety are brought to the attention of the IRB or Office of Research Compliance. This is an on-site review that may include the elements described in Routine & Informed Consent.
    4. 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 audit by a sponsor or federal agency.

  3. Selection of Studies
      4. Protocols selected for monitoring will focus on, but not be limited to any of the following:
    1. Studies in which 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
    2. Studies that were given full board or expedited review by the IRB; or
    3. Investigator-initiated protocols, i.e., not peer-reviewed research; or
    4. Studies that include participants from "vulnerable populations" identified in 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
    5. Protocols that exhibit "for-cause" concerns; see description under Audit Categories above.
    6. Examples of other elements that may be considered include:
      • Adverse event reporting history,
      • Regulatory approval category,
      • Funding source,
      • Results of previous audits
      • Study topic

  4. Arranging the Audits
    5. Nothing in this policy will prevent the IRB or other university officials from intervening without notice where serious harm to subjects may be at risk or from taking any other reasonable action under the circumstances. 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:
    1. Routine: At least two weeks notice in advance of the audit.
    2. Informed Consent: At least one week notice in advance of the monitoring.
    3. For-cause: At least twenty-four (24) hours notice by a telephone call and email to the PI from the Institution Official or his/her designee.
    4. Investigator Initiated: A time will be arranged by mutual convenience.
  5. Audits May Include Some Or All Of These Elements:
    1. Review of roles and responsibilities of investigators and key personnel including verification of:
      • Persons authorized to consent participants
      • Persons authorized to conduct study procedures
      • Human participants protection training (CITI Program)
      • Review by any other university compliance committee, e.g., Conflict of Interest, when applicable
      • Other relevant study or IRB materials
    2. Review of Regulatory Compliance may include review of :
      1. Protocol file/regulatory documentation. The IRB Monitor reviews materials and determines whether the records meet regulatory and IRB guidelines.
      2. IRB Documentation. The IRB Monitor compares the PI's records with the IRB's records.
      3. Consent/Assent Forms. The IRB Monitor examines the Consent/Assent Forms/ Information Sheets used to enroll the participants to ensure that the appropriate form was used for the study and that the form had the current IRB stamped approval date on it. Where signed consent/assent was obtained, the IRB Monitor reviews whether the forms were properly signed and dated.
      4. Individual Participant Records. The PI may be asked in advance to randomly select a sample of participants' records for review. They are examined 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.

      5. Grant Application. If applicable, the grant application may be compared to the IRB approved protocol.

      6. The ORC/IRB File. IRB Meeting issues (quorum, diversity, expertise, conflict of interest); adequacy of review; IRB Minutes to assess requirements of IRB review.

      7. 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.

    3. Elements of Informed Consent/Assent:

      • Review of the required elements of informed consent according to the federal regulations and IRB requirements.

    4. 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 appropriateness of the consent process to meet the needs of vulnerable populations.
      • Steps taken to aid participants who possess barriers to understanding or lack of capacity to consent (language, reading level, etc.)
      • Steps taken to determine that the participant understands the research study purpose, risks, benefits, voluntary participation, withdrawal, confidentiality, costs/compensation, contacts for questions or injuries.

    5. Subsequent publications resulting from IRB approved protocols may also be reviewed.

  6. Report of Findings
    1. The IRB Monitor will report serious violations immediately to the IRB Chair and to the Institutional Official or his designee. In concert, they will determine whether regulations or policies require reporting the findings to external agencies or to individuals within the institution, including the Department Head or Dean.

    2. A Summary Report of Routine Audits will be drafted by the IRB Monitor and sent to the PI for his review. The PI may discuss with the IRB Monitor any problems he has with the report and add his comments to it before signing it. When indicated, the PI will be invited to create his own corrective action plan. The IRB Monitor will sign the report and submit it to the Associate Vice Provost for Research (AVPR). The originals will be filed in the IRB Monitor's file for quality improvement purposes. Copies will be provided to the PI, the IRB Chair, and the AVPR. At least quarterly, the IRB Monitor will present a list of Routine Audits at a regularly scheduled IRB Meeting. The Summary Report will also include a:

      • Statement describing the type of review, the date, location and procedure followed, who was in attendance and the PI's response;
      • Description of the PI's overall compliance;
      • Description of any noncompliance, (policies, regulatory or legal) or other deficiencies (as in documentation, etc.);
      • Recommendations of the IRB Monitor re: education for PI and/or research assistants, record keeping, etc.;
      • PI corrective action plan when necessary;
      • Optional section for PI comments;

    3. 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 on at regularly scheduled IRB Meetings.

    4. 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.

    5. 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.

    6. The IRB Monitor will see to it that common problems noted during Routine Audits will be the subject of additional general training efforts at the university.

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