The purpose of this required form is to document IRB determinations. Complete the “Reviewer Worksheet” in addition to this form.
Instructions: / Complete the required sections.
Sections marked with an asterisk ( * ) are required.
Sections marked with a double asterisk ( ** ) are required if applicable.
/
1805 Sigma Chi NE | Tel: (505) 277-2644
Website: irb.unm.edu | Email:
V01.17.18
To be completed by OIRB Staff:
Project Identification* IRB reference number
& IRBNet ID with package: / * Project title:
* Principal Investigator: / ** Student Investigator:
* Submission type: / Choose one:New ProjectAmendmentContinuing ReviewAnomaly / * Reviewer name: / * Agenda date:
IRB Pre-Review
* OIRB Staff: / Enter Staff name / * Project Status: / - Pending
- Active
- Active – Open to Enrollment
- Active – Closed to Enrollment
- Active – Data Analysis Only
- Active – Long-Term Follow-Up Only
- Closed
- Closed – Expired
- Deferred – Information Required
- Deferred – Modifications Required
- Exempt
- Not Research
- Research – Not Engaged
- Research – Not Human Subjects Research
- Withdrawn
Comments: / This [faculty/student] project designed to [study [a problem] OR test/evaluate [something] OR analyze [something], etc…] by using [surveys/questionnaires, interviews, focus groups, devices/technology, etc…with/aboutadults, students, children, pregnant women, prisoners, etc…].
The IRB has previously reviewed and approved this project and has made the following determinations:
- Review type is [Exempt (#) or Expedited (#) or Full Board]
- Informed Consent is [n/a or required or altered or waived] and documentation of informed consent is [required or waived]
- Subpart Determinations = C [n/a or #]; D [n/a or 404]
- Justifications for waivers/alteration/subparts are [acceptable or needed]
- Include information onLAR, HIPAA, FERPA, etc.
This is a continuing review submission. The project is currently [open or closed] to enrollment. # out of a total of # are enrolled to date; # during the recent review period. Last signed consent [n/a or reviewed and [no issues or issues noted]. No reportable amendments, protocol deviations, unanticipated problems, adverse events, nor withdrawals.
This is an amendment submission. The project is currently [open or closed] to enrollment. The researcher has revised the [document] with [describe type of changes].
Funding: / None / Federal / Agency: / Other
To be completed by the IRB Reviewer:
Conflict of Interest Disclosure* Do you have a conflict of interest (significant personal or financial interest) associated with the review of this project? / Yes.
Do not review. Advise OIRB as soon as possible to reassign.
No.Complete review.
IRB Review Recommendations
* Based on the information and documents provided in this package, my recommendation is: / Select only one response
Approve
Exempt (federally funded research only)
Modifications Required
Refer to Full Board
Modifications and Additional Information are:
Not Requested.
Requested:
In the field below, indicate what changes or additional information is to be requested from the researchers. Make sure to write your requests as you want the researcher to read them.
Notes:
N/A.
– OR –
In the field below, include comments that are for the OIRB and not to be seen by the researchers. This may include questions or comments for the analyst or may include information that you want in the minutes but do not want the researchers to see.
** Based on the information provided in the protocol, I recommend:
Continuing Review:
Continuing Review (CR) is defined as a re-review of the criteria for approval and is no longer required for non-federally funded minimal risk projects, but can be required at the decision of the reviewer. The interval of CR would be decided by the reviewer (can be longer than 1 year). Projects that may be appropriate for CR include ones that involve: Subparts/vulnerable populations; criminal behavior; substance use/mental health data; external sites; complex research procedures; use of devices; or other issues, which must be detailed in the justification.
CR is NOT required for this project (Exempt and NFF MR projects).
CR is required for this project and should occur:
annually
every years
every months
Administrative Check-in:
Administrative check-in at the anticipated end date is an option for projects that do not require CR. Mark NOT recommended if this project is receiving a CR.
Administrative check-in is NOT recommended for this project.
Administrative check-in is recommended for this project.
Post Approval Monitoring:
PAM activities will be conducted on projects reviewed by the IRB. Please make a recommendation of the most appropriate PAM activity for this project. This recommendation will help guidethe conduct of PAM activities.
None
Full on-site assessment
Self-assessment
Consent document review
Consent process review (conducted by the researcher)
Consent process observation (conductedby OIRB staff)
Project team review (for projects with many team members or that require specialized training)
Informed Consent:
must be obtained and documentation of informed consent is required.
must be obtained and documentation of informed consent has been waived.
has been altered and documentation of informed consent is required.
has been altered and documentation of informed consent has been waived for this project.
has been waived.
is not applicable.
Protocol specific justification is required for alterations or waivers:
Justification:
HIPAA Authorization:
is not applicable.
is required for this project and all elements of the authorization are included.
is waived for all aspects of this project and the justification for waiver provided by the PI is adequate.
is waived for recruitment purposes only and the justification for waiver provided by the PI is adequate.
FERPA:
is not applicable.
applies to the project and signed permission is required.
FERPA exception has been granted.
Legally Authorized Representative:
is not applicable.
is required for this project and must be employed in the consent process; LAR signature is required.
Subpart C:
is not applicable.
is applicable AND the protocol meets the required conditions to enroll prisoners under Subpart C 306(a)(2)(i)(ii)(iii)(iv).
Protocol specific justification is required forenrollment of prisoners:
Justification:
Subpart D:
is not applicable.
is applicable AND the protocol meets the required conditions to enroll children under Subpart D 404 and one parent/guardian signature is:
requiredwaived
Protocol specific justification is required for enrollment of children and waiver of parental permission:
Justification:
Assent:
is not applicable.
must be obtained and documentation of assent is required.
must be obtained and documentation of assent has been waived.
has been altered and documentation of assent is required.
has been altered and documentation of assent has been waived.
has been waived.
Protocol specific justification is required for alterations or waivers:
Justification:
Device Risk Determination:
is not applicable.
Device is a Non-significant Risk Device.
Device is a Significant Risk Device.