Section 8: IRB Records and Protocol Monitoring

The Trinity College IRB office maintains the following records in electronic or hard copy for each study: copies of all research proposals reviewed; scientific evaluations, if any, that accompany the proposals; approved sample consent documents; progress reports submitted by investigators; reports of injuries to subjects or other adverse events; minutes of IRB meetings; records of continuing review activities; copies of all correspondence between the IRB and the investigators; a list of IRB members; written procedures for the IRB; statements of significant new findings provided to subjects; recruitment flyers or postings; and notifications of IRB decisions and outcomes.
These records shall be retained for at least three years, and records relating to research that is conducted shall be retained for at least three years after completion of the research. Records related to HIPAA authorization forms or HIPAA waivers are retained for a minimum of six years from the date of their creation or the expiration date, whichever comes later. Investigators should maintain duplicate files for their own records and for use during IRB audits while the study is still in progress and for three years after closure of the study.
The IRB office maintains records of IRB convened meetings: agendas, minutes, protocol status reports, applications reviewed with attachments, and other related material. Copies of inquiries and miscellaneous correspondence are also maintained by the IRB.
The minutes of meetings will include standard information such as attendance record; a summary of protocol discussions and the controverted issues; motions, actions and outcomes determined by the IRB; and the votes in favor of approval, disapproval or abstentions. The IRB office also maintains IRB member records to include curricula vitae of current members and a roster of names, affiliations, representation capacities, experience certifications, and terms of appointment with expiration dates.

8.1 Audits of Approved Protocols

Federal rules require that IRBs conduct self-monitoring activities in order to insure that investigators comply with regulations and carry out protocols as approved by the IRB. Verification can take place by observing research in progress, especially the enrollment and consenting of participants, auditing of research records on a random basis, and by establishing procedures for the receipt and proper review of complaints from participants in the research. The Trinity College IRB adheres to these methods of verification and also conducts periodic reviews to determine if protocols are implemented as approved. Data reviewed at the time of audits may include:
  • the currently approved protocol;
  • recruitment procedures as implemented;
  • status of participant enrollments;
  • individual subject records;
  • consent and assent forms as implemented and filed;
  • modifications to protocols;
  • the reporting of adverse events, if any.
All adverse events that are attributable to study procedures will require an audit of the respective protocol to determine compliance and to evaluate whether changes in procedures or in the consent form are warranted or if the study should be suspended until further inquiry can be conducted.

8.2 IRB Non-compliance Inquiries and Reporting of Findings

The IRB may become aware of possible non-compliance by any of several venues. These may include:
  • complaints or concerns from research participants, research staff or employees of the unit;
  • audit findings;
  • continuing reviews for re-approval;
  • adverse event reports submitted by investigators; or
  • quality improvement reviews conducted by the IRB.
Reports of possible non-compliance may be forwarded to the Trinity College IRB by contacting:
  • the IRB administrative office  [];
  • the IRB Chair [link];
  • the IRB Administrator [link].
Anyone, regardless of affiliation, who suspects non-compliance may submit a complaint or concern. The person submitting the report may be asked to describe the problem or the concern in writing, unless the person chooses to remain anonymous.

Upon receipt of a report, the IRB Chair will evaluate the concern and determine next steps. Minor violations may be disposed of administratively following an initial inquiry by the Chair or an IRB subcommittee. All serious or continuing noncompliance with regulations or the determinations of the IRB will be reported promptly to the IRB members at a full review meeting and to other college officials, the federal Office of Human Research Protections (OHRP), and the federal Department or Agency Directors as applicable.

Examples of non-compliance include:
  • serious violations discovered after completion of a protocol audit;
  • instances where non-exempt research was conducted without IRB review and approval or without appropriate informed consent procedures;
  • implementation of significant modifications without IRB prior approval;
  • instances of repeated or multiple problems with noncompliance by principal investigators even after IRB warnings.
Allegations or any evidence of serious non-compliance will constitute sufficient cause for the IRB to initiate a protocol audit or investigation upon written notification to the principal investigator. Audits or investigations may be conducted by the IRB Chair or a subcommittee of the full IRB in a manner that will protect human subjects and provide the investigator with due process, including the right of appeal. The seriousness of the allegations and any preliminary evidence will determine whether a temporary suspension of the research should be imposed by the IRB pending a full inquiry and a final determination at a convened meeting.

Suspensions and final reports detailing the implementation of corrective actions must be reported to the Dean of the Faculty and other College and Federal Officials depending on the seriousness of the violations after the IRB has determined that noncompliance has occurred. Notification to the Dean of the Faculty or other officials as appropriate will include the following pertinent information:
  • name of principal investigator;
  • the project title;
  • protocol and grant numbers;
  • detailed description of the non-compliance; and
  • actions taken or planned to address or correct the violations.
Possible outcomes or corrective actions by the IRB may include:
  • education requirements for the investigator and research staff engaged in the research;
  • temporary or permanent suspension of the research and/or the investigator;
  • random audits of the research or investigator;
  • disallowance of research use of data collected; or
  • other actions deemed appropriate by the IRB and communicated in writing to the investigator in a final notification.
The inquiry process of the IRB will include the following stages:
  1. The Complaint or Concern: Review by the IRB Chair to determine seriousness and validity.
  2. Initial Inquiry: Administrative review by the IRB Chair or a Subcommittee with notification to investigator of complaint or concerns. May result in minor corrective actions for resolution, or referral to full IRB at a convened meeting.
  3. IRB Investigation: Audit of protocol by IRB Chair or IRB Subcommittee with a report of findings at a convened meeting with notification to investigator. May result in major correction actions, suspension, or termination of study.
  4. Appeal Hearing: Investigator responds in writing and/or in person at an IRB convened meeting.
  5. Final IRB Determination: Report of full IRB meeting with any corrective actions, resolutions or stipulations regarding the future of the research study or its termination if warranted.