Modifications

Request for Modification

Per federal regulations, once a human participant study has received IRB approval, any subsequent changes to the study or IRB approved documents must be reviewed and approved by the IRB prior to implementation. To request approval of a proposed modification, complete and submit a Request for Modification form.

Note: If the proposed modification changes any IRB approved documents (e.g., the protocol narrative, the informed consent form, study information sheet etc.), the investigator must submit an updated version of each document for IRB review. Provide two (2) versions of the revised documents with the Modification request:

  • a clean copy of each revised document (changes not highlighted), and
  • a highlighted copy of each revised document (all changes highlighted).

Approval Notification

Approval of electronically submitted modification requests are documented in an approval letter to the Principal Investigator (PI), and copied to the Faculty Advisor (if the PI is a student). Approved modifications are appended to the protocol in the official IRB file.

Note: Approved modifications do not extend the approval period of the protocol.

Protocol Extensions/Close-outs

Continuing Review

Except for research studies approved through Minimal Review, federal regulations requires the IRB to continually review ongoing research at intervals appropriate to the potential risk to participants, but at least annually. To request a Continuing Review of a research study involving human subjects, complete a Continuing Review form and submit to the Office of Research Compliance (ORC). While initial Expedited or Full IRB review is based on the researcher’s best assessment of the anticipated benefits, risk, and procedures, the continuing review process is important because it is based on the conduct of the study; actual risk can be evaluated and preliminary results used to assess the risk/benefit ratio. In addition, the risk/benefit ratio may change not only because of unexpected results and effects of the research intervention itself, but because new knowledge resulting from related research may affect the balance.

Suggested Timeline for Approval

Investigators must plan ahead to meet required continuing review dates. If an investigator fails to submit an electronic Continuing Protocol Application (CPA) to the IRB or the IRB does not approve continuation of the research before the date of expiration, the research must stop. It is strongly recommended that investigators submit their CPA and the required hard copy documentation to ORC at least 30 days prior to expiration.

Approval Notification

Approval of electronically submitted Continuing Review requests are documented in an approval letter to the Principal Investigator (PI), and copied to the Faculty Advisor (if the PI is a student).

Unanticipated Events

Federal regulations require that UTD have written procedures for ensuring prompt reporting of unanticipated problems involving risk to subjects or others to the IRB. The IRB will review the unanticipated or adverse event report in a timely manner and determine whether the reported event is an unanticipated problem involving risk to participants or others (hereinafter referred to as unanticipated problems). Items described below can be reported to the IRB by completing the Adverse Events Report form.

Reportable Items

Unexpected Adverse Event

Unexpected adverse events are untoward or undesirable experiences associated with research, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research. A reportable item is an adverse event occurring in one or more subjects in a research protocol, the nature, severity, or frequency of which is not consistent with either:

  • the known or foreseeable risk of adverse events associated with the procedures involved in the research that are described in (a) the IRB-approved documents (e.g., applicable investigator brochure, current protocol narrative, current informed consent document), and (b) other relevant sources of information, such as product labeling and package inserts; or
  • the expected natural progression of any underlying disease, disorder, or condition of the subject(s) experiencing the adverse event and the subject’s predisposing risk factor profile for the adverse event.

Serious Adverse Event

Serious adverse event is any adverse event temporally associated with the subject’s participation in research that meets any of the following criteria:

  • results in death
  • is life-threatening situation
  • requires inpatient hospitalization or prolongation of existing hospitalization
  • results in persistent or significant disability/incapacity
  • results in a congenital anomaly/birth defect
  • any other adverse events based upon the Researcher’s medical judgment, that may jeopardize the subject’s health and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition

Protocol Deviation

Protocol Deviation: Accidental or unintentional changes to, or non-compliance with the research protocol that does not increase risk or decrease benefit or; does not have a significant effect on the subject’s rights, safety or welfare; and/or on the integrity of the data. Deviations may result from the action of the subject, researcher, or research staff. It is the responsibility of the Principal Investigator to ensure all research staff involved in the conduct of the research follows the IRB-approved research protocol. When modifications are necessary, a request for modification should be submitted to the IRB for review and approval prior to implementation of the changes.

Closing a IRB Approved Protocol

A study may be closed when all of the following apply:

  • All subject recruitment and enrollment is complete (i.e., no new subject recruitment or enrollment are ongoing).
  • All subject specimens, records, data have been obtained (i.e., no further collection of data/information from or about living individuals will be obtained).
  • No further contact with subjects is necessary (i.e., all interactions or interventions are complete and no further contact with enrolled subjects is necessary).
  • Analysis of subject identifiable data, records, specimens are complete (i.e., use or access to subject identifiable data is no longer necessary. Note: this includes review of source documents by study sponsors, if appropriate.

In order to close an IRB protocol officially, submission of a Final Report Form is required. Once the closing report has been received by the IRB, a confirming e-mail will be sent to the Principal Investigator and the Faculty Sponsor (if applicable), to document protocol closure.

Post Approval Monitoring

The University of Texas at Dallas is committed to the protection of human subjects involved in research studies. In pursuit of this commitment and to satisfy federal regulatory agencies, a Human Research Subject Post Monitoring Program was initiated in 2005. The purpose of this program is to assess the research activities conducted under the University’s Federal Wide Assurance Agreement with the Office of Human Research Protections (OHRP). This program assures human subject safety in research, provides education to research professionals, and identifies strengths and areas for improvement in research practice at The University of Texas at Dallas.

The purpose of the program is to provide internal oversight on compliance issues relating to the performance of human research trials. The emphasis of the program is:

  • To ensure the rights and well-being of research subjects and the quality and integrity of the research.
  • To identify educational and research support needs.
  • To ensure compliance with federal, state, local and institutional regulations and guidelines.
  • To identify areas of strength and needs of improvement in research policies and practice.

Scheduling a Monitoring Session

Notification of a post approval monitoring visit is sent by the IRB via email to the Principal Investigator (PI) and Faculty Sponsor (if the PI is a student). IRB staff will work with the PI to establish a monitoring visit usually within 30 days of notification.