Emory IRB RenewalAnalyst/Reviewer Worksheet (paper studies)
Date:Reviewer: Analyst:
Emory IRB File # PI:
Do you have a conflict of interest with this project? Yes No Maybe (explain)
Mode of review now: Expedited or Full Board
If Expedited, check each applicable category from expeditable list:
F(1) clinical studies where IND or IDE is not required
F(2) blood draws < 550 ml/<3 sticks per week over 8 w for adults; < 50 ml or 3 ml/kg/same sticks/time for kids
F(3) prospective, noninvasive biological specimens for research purposes (e.g., buccal swab, sweat, skin swab)
F(4) data collection noninvasively, routinely used in clinical px (e.g., MRI, EKG, ultrasound, moderate exercise)
F(5) materials collected past or future for nonresearch purposes (medical records, labs)
F(6) data collection from voice, video, digital or image recordings made for research purposes
F(7) research on individual or group characteristics/behavior (e.g., surveys, focus groups, interviews)
F(8)a enrollment permanently closed; and all interventions complete; and open for long-termfollow-up only
F(8)b no subjects enrolled ever and no new risks identified
F(8)c data analysis only.
- If data are de-identified and all links destroyed, study may be eligible for close-out. Eligible? ______
F(9) Past full board documented min risk and no new risks;F(2) – (8) don’t apply; and no IND or IDE needed
Reviewer agrees with Analyst triaging: Yes No or not sure, explain:
Amendment with this Renewal: Yes No
Study Progress: Chart Review No participants enrolled yet Enrolling
Enrollment complete, subjects still undergoing intervention or follow up
Study complete; data analysis ongoing.
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Version 09/26/2008
Emory University IRB
Criteria for Reapproval (please add protocol-specific comments)1)The risks to subjects remain minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk. Yes No
2)The risks to subjects remain minimized whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes. Yes No
3)The risks to subjects remain reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. Yes No
4)The number of participants initially requested and approved has not been exceeded. Yes No
5)Subject selection remains equitable. Yes No
6)When some or all participants are likely to be vulnerable to coercion or undue influence, additional safeguards are included. Yes No
7)Specific additional protections are included for research involving pregnant women, fetuses, neonates, prisoners, or children as specified in the regulations. Yes No
8)Unless waived or altered, informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by the regulations. Yes No
- The investigator will obtain the legally effective informed consent of the participant or the participant’s LAR.
- The circumstances of consent minimize the possibility of coercion or undue influence.
- The information that will be given to the participant or the LAR will be in language understandable to the participant or the LAR.
- No information will be provided to the participant or the LAR that waives or appears to waive any of the participant’s legal rights, or that releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.
- All required and appropriate additional disclosures will be provided to the participant or the participant’s LAR. (See Elements of Informed Consent)
9)Unless waived, informed consent will be appropriately documented, in accordance with, and to the extent required by regulations. Yes No, waiver of documentation appropriate Other, explain:
10)The consent document remains accurate and complete based on your review of the progress of the research and reported events. Yes No, explain:
11)For research involving more than minimal risk to participants, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. Yes No N/A
12)There is evidence that the DSMP is being followed. Yes No N/A
13)Procedures protecting the subject’s privacy and confidentiality of data remain adequate.Yes No
If going to full board: is application ready to put on the agenda (likely to be approved or approved pending)?
Yes No, explain:
Risk at this time:
Minimal Moderate/Standard High due to Other (e.g., slightly more than minimal)
Device Risk at this time: Non-Significant Significant N/A
Pediatric Risk at this time: 46.404 46.405 46.406 46.407
Parent signature: One parent Both parents Parent signature waived Parental permission waived
Assent obtained: Yes No N/A
Assent waived: Yes No N/A
Reviewer Recommendation:
Approval / No changes needed; approve as is.Reapproval Period: 12 mo 6 mo Other _____
Expedite in the future
Pending Approval / Changes requested.
Refer to full board / Expedited reviewer cannot determine whether risk is minimal; or for another reason prefers full board to review (explain below)
Reviewer comments/changes requested:
IRB Staff use only. If deferral is likely, try to get deferrable issues resolved before placing on the agenda.
Comments:
Please make sure you have reviewed the following:
- The Continuing Review application and complete current protocol and ICF (See Elements of IC Worksheet)
- Any newly proposed consent document or amendment
- Any reported events and a summary of reported events for internal and external sites, if applicable.
- A summary of withdrawals and reasons for them
Reviewer SignatureDate
9/26/08
Emory University IRB