| Revision Date | ||
| Exempt New Study Application Checklist | 04/23/2009 | |
| Expedited New Study Application Checklist | 04/23/2009 | |
| Full Committee New Study Application Checklist | 04/23/2009 |
| Revision Date | ||
| Exempt Application | 04/23/2009 | |
| Expedited Application | 04/23/2009 | |
| Full Committee Application | 04/23/2009 | |
|
Protocol Document Guidelines |
07/21/2008 |
| Revision Date | ||
| Department Review Form Note: Law students should have the Dean complete this form. | 10/10/2008 | |
| 1. Additional Investigator List | 10/10/2008 | |
| 2. Studies Involving Minors | 10/10/2008 | |
| 4. Studies Involving Biological Specimens | 10/10/2008 | |
| 8. Request for Waiver of Informed Consent | 10/10/2008 | |
| 10. Studies Involving Prisoners | 10/10/2008 |
Each Investigator listed on Attachment 1 should complete a COI form. This includes the Responsible Faculty if applicable. |
||
| Revision Date | ||
| Conflict of Interest form - UNM Employee or Student | 07/10/2000 | |
| Conflict of Interest form - Non-UNM Personnel | 05/17/2006 | |
| Revision Date | ||
| UNM Consent Form | 08/05/2009 | |
| Minors Assent Form | 10/20/2008 | |
| Survey Research Consent Form | 06/09/2009 | |
| Combined Consent/HIPAA (minimal risk study) | 10/20/2008 | |
| Parent of Minor Student Survey Consent Form | 10/20/2008 | |
| Spanish Version Short Consent Form | 10/20/2008 | |
| Guidelines for obtaining and documenting Informed Consent for Non-English Speaking Subjects (HHS Website) | ||
| Revision Date | ||
| Continuation (Progress) Report | 10/06/2008 | |
| Closure of Research | 06/08/2009 | |
| Reactivation of Research | 05/29/2009 | |
| Change/Addition of Investigator | 10/27/2009 | |
| Amendment Request Form (Major change: change of PI; change in study design, etc) | 10/27/2009 | |
| Change Request form (Minor change: administrative changes) | 10/27/2009 | |
| Unanticipated events that meet the 3 criteria below must be reported to the IRB. Other events including protocol violations, incorrect consent procedures, etc. may be reportable to the IRB, please submit an event form, or contact the IRB at 272-1129 if you have questions. | ||
When an unexpected event occurs during a research study that is: |
||
| 1. Unanticipated ; 2 Caused Harm or Increase of Risk AND | ||
| 3. More than likely related to the research; Then the event should be submitted to the IRB | ||
| Investigators must report events to the IRB as soon as possible, but no later than 5 days from the event date or "site awareness date" | ||
| Revision Date | ||
| Event Form | 04/04/2006 | |
| Revision Date | ||
| UNM HIPAA Authorization Addendum | 10/20/2008 | |
| UNM HIPAA Authorization -Spanish | 10/20/2008 | |
| HIPAA Authorization Waiver Request (Attachment 8) | 10/10/2008 | |
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