- Any unanticipated problems involving risks to subjects or others in any human subject research, (Adverse Event Form)
- Adhere to the approved protocol
- Ensure Informed and Voluntary participation (Informed Consent Form)
- Submit any proposed protocol changes with an Amendment form to the IRB for approval
- Submit an Annual Renewal form for projects lasting more than 12 mos.
- Submit a Final Report Form at the completion of the study
- Monitoring of Approved Protocols
- Investigations of Non-Compliance with IRB
- Reporting Suspensions or Termination of Research Projects
The IRB is charged with the responsibility of reviewing reported unanticipated problems involving risks to subjects and adverse events in accordance with federal policy. Investigators are responsible for informing the IRB of any adverse event and/or unanticipated problem involving risks to subjects in accordance with federal regulations.
A PI must report any adverse event or unanticipated problem resulting during research to the IRB as soon as they are aware of any problem. Contact the Research Compliance Coordinator, Jena Fioravanti Burkett, at (610) 660-1298 or firstname.lastname@example.org to begin the reporting process. This contact information should also be given to any participant who reports adverse reaction during the project.
An Adverse Event/Unanticipated Problem form must be submitted immediately after an Adverse Event is experienced. An additional attachment may be included, if necessary, to provide details of the unanticipated problem that has occurred.
This form should be used to report single adverse events. The PI should complete all information on the form in IRBNet. The PI should include an attachment which elaborates on the nature of the adverse event involving the conduct of the study or subject participation. These events may include problems with the recruitment and/or consent processes and any deviations from the approved protocol in a letter attached with this form.
The SJU IRB has the authority to suspend of terminate approval of research that is not being conducted in accordance with the IRB requirements or that has been associated with unexpected serious harm to subjects. Not reporting an Adverse Event to the IRB could result in suspension or termination of the IRB approval for your protocol. If the IRB decides to suspend or terminate approval of a project, the IRB shall report its decision promptly to the investigator, appropriate institutional officials and federal department or agency head (if federally funded). The IRB report must include a statement of the reasons for suspension or termination.
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Once a research protocol has been reviewed and approved by the SJU IRB, it is expected that the researcher is following the procedures and using the research instruments as they appeared in the proposal. With any project, there is always the possibility that changes will be necessary. Before any change may be implelmented in a research project, the researcher must submit an Amendment form to the IRB for review and approval. Only after the IRB has reviewed and approved this change can the new procedures of research instrument be used. The only exception to this rule is in the event that the change is necessary to prevent harm to subjects. If it is the case that the researhcer identifies an unforseen harm to participants during the conduct of the project, they should stop using the procedure causing the harm or discomfort. Before continuing with new participants, the PI should contact the IRB administrator about amending the procedure and the possiblity of filing an ADVERSE EVENT report if necessary. (Back to top)
It is the researchers responsibility to make sure that all participants are fully informed about the project and that they are volunteering to participate free of any coercive forces. This is achieved primarily with the Informed Consent Form. Along with the use of the Informed Consent document, researchers must be vigilant during their interactions with participants for any signs of discomfort that may arise while going through the procedures of the project. Researchers should remember that a signed Informed Consent form does not bind a participants to complete the project. Participants should be reminded that their participation is voluntary and that they may stop participating at any time. (Back to top)
Researchers must submit any proposed protocol changes with an Amendment form to the IRB for review and approval before implementing any changes to an approved protocol.(Back to top)
If your research project will last longer than 12 months from the approval date, you will need to submit an Annual Renewal form prior to the first anniversary of approval, to extend the renewal period for your project. (Back to top)
At the conclusion of any study, the Principal Investigator (PI) must submit a Final Report form to the IRB, including applicable data analysis and long-term follow-up, so that the study can be closed. The final report of study results should be received by the IRB no later than 90 days after the completion of the study. When a protocol is complete except for data analysis or long-term follow-up, the PI should indicate the status of the protocol on the Final Report form. (Back to top)
With projects involving protected subject groups or covering research topics considered above Minimal Risk, the IRB may ask the researcher to submit an Interim Report to allow the IRB assess the progress of the research. In order to help ensure compliance with federal regulations and local IRB policies regarding research with human subjects, and to ensure that human subjects are adequately protected, the IRB Administrator may conduct routine, targeted or random audits of approved research protocol files. In addition, the IRB may request monitoring of approved projects that may take the form of routine, targeted, or random audits. These activities may include, but are not limited to the following:
- Request progress reports from investigators at specified intervals;
- Collect signed Informed Consent Documents;
- Examine research records;
- Contact research subjects;
- Verify from sources other than investigators that no material changes in the study have occurred;
- Audit advertisements and other recruiting materials to confirm proper IRB approval;
- Review projects to verify from sources other than the investigator(s) that no material changes have occurred since previous IRB review; and/or
- Other monitoring or auditing activities deemed appropriate by the IRB.
The results of any audit by will be reported to the full IRB on the agenda of the next regularly scheduled meeting. However, if the information gained during the monitoring or auditing process indicates that human subjects may be exposed to unexpected serious harm, the IRB may suspend or terminate approval of the research prior to the next regularly scheduled IRB meeting. (Back to top)
Research investigators are the most frequent source of noncompliance with human subjects regulations. The most common lapses in investigator compliance include unreported changes in the IRB approved protocol or consent documents, misuse or non-use of the IRB approved informed consent documents, lapse in approval for continuing review, and failure to obtain IRB approval prior to starting research activities. When unapproved research is discovered, the IRB and the University will act promptly to halt the research, assure remedial action regarding compliance with federal, local, and institutional human subject protection requirements, and address the question of the investigator's fitness to conduct human subject research. Any serious or continuing noncompliance with Department of Health and Human Services (DHHS) human subjects regulations or the determinations of the IRB must be promptly reported to the Office for Human Research Protections (OHRP) and possibly the funding department or agency head. (Back to top)
As soon as possible, but no later than within 10 days of determination by the convened IRB, suspensions, terminations and/non-compliance findings will be reported in writing to the Institutional Official, Associate Provost, Dr. Paul Devito. The Institutional Official must also notify in writing the relevant Department Head, any applicable regulatory body and OHRP (for federally-funded research) of any suspensions, terminations, and/or serious or continuing non-compliance. (Back to top)