For Initial Applications: Ateneo Faculty, Graduate Students, Staff
Form 1 – Initial Ethics Clearance Application Use this form to apply for expedited (minimal risk) or full (greater than minimal risk) review of research involving human participants. Check Guideline 1 (on research that requires clearance and on exemptions from review) to determine whether your research is possibly exempt from ethics review. If possibly exempt, complete the Form 4 for Validation of Exemption and submit to the UREO to validate exempt status.
Form 2 – Submission Checklist Acknowledgement Use this form to guide you in submitting required documents for applications for ethics clearance. The UREO Office Staff acknowledges receipt of documents when complete and follows-up with applicant if not yet complete.
Form 4 – Validation of Exemption from Review Use this form to request UREO to validate your research as exempt from ethics review. Check Guideline 1 (on research that requires clearance and on exemptions from review) to see whether your research fits any of the categories exempt from ethics review. The exempt categories are also indicated in Form 4.
Form 12.5 – High School/Undergraduate Student Validation of Exemption Application Use this form to apply for validation of exemption from ethics clearance of research involving human participants at the Department level. Review Guideline 2 (on ethics review of student-initiated research such as theses or capstone projects)
Post-Approval Applications: Extensions and Amendments
Form 5 – Application for Ethics Clearance of Protocol Amendment Use this form to apply for ethics approval if your previously-approved protocol is to be modified, as modifications may change the evaluation of potential risks to human participants. The proponent is advised to submit this form and suspend or postpone research activities until the amendments have been cleared.
Form 6 – Continuing Ethics Clearance Application Use this form to apply for continuing ethics approval if data collection with human participants goes beyond the period of the initial or previous ethics approval (as indicated in the ethics clearance letter issued by UREO; typically 1 year). The proponent is advised to submit this form 45 days prior to the expiry date of the original approval.
Reporting Forms
Form 8 – Unanticipated Problem / Unanticipated Adverse Event Report Form Use this form to report unanticipated problems and/or unanticipated adverse events (refer to definition below). This report should be submitted to the UREO as promptly as possible, or within 2 weeks of the investigator becoming aware of the problem. Unanticipated problems that are serious adverse events should be reported within one week of the investigator becoming aware of the event. The AdMUREC will decide on the course of action (including possible termination of the study).
Unanticipated problems are defined as any incident that meets all of the following: a) it is unexpected (i.e. not anticipated or reported in initial application) in terms of nature, severity, or frequency; b) related or possibly related to participation in the research; and c) suggests that the research places subjects or others at a greater risk of harm than was previously known or recognized.
Adverse events refer to any unfavorable medical occurrence in a human participant, including any abnormal sign, 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. Serious adverse events are life-threatening or require hospitalization and treatment.
Form 9 – Progress Report Form Use this form to report on the interim progress on protocols that have been evaluated by AdMUREC as requiring monitoring. Whether you should submit a Progress Report is indicated in the ethics approval letter issued by the UREO. The report should be submitted to the UREO no later than 30 days from the specific date or within the time period indicated in the ethics approval letter.
Form 11 – Final Report Form Use this form to indicate to the UREO that the study has been completed. Completion indicates that there are no further data collection from human participants in the study, and that the data is being handled and/or stored in accordance with the AdMUREC-approved protocol. The final report, if deemed satisfactory by the UREC, signifies that the protocol is to be rendered inactive and archived. The final report should be submitted to the University Research Ethics Office within 30 days of completion of the study.
