Indiana University Institutional Review Board (IRB)

ExpeditedReviewer Checklist –Renewal

IRB Study #: / Renewal #: / Expiration Date:
Principal Investigator: / Original Submission Date:
This form is for expedited review. If the IRB reviewer determines review by the convened IRB is necessary, please copy comments from the IRB Reviewer section below into the Full Board RVC on SharePoint or provide a copy of this form to the convened IRB assigned reviewer.
HSOStaff Pre-Reviewer:
Screener Initials:
1.Number of subjects currently approved:
Number of subjects enrolled on site:
2.Is this study FDA- or VA-regulated?
No. Study may be electronically signed.
Yes. Study may NOT be electronically signed.
Staff Comments:
IRB Reviewer:
Reviewer Initials:
  1. Based on the information provided by the investigator, do you believe the study meets the criteria for approval under 45 CFR 46.111 (see below)?
Yes.
No. Please explain:
For expedited studies: the study continues to meet the criteria for approval under Expedited Category as originally approved by the IRB.
  1. Check the appropriate level of risk (considering the current status of the study):
Minimal risk: The probability or magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Greater than minimal risk
  1. Based on the information provided by the investigator, the IRB should take the following action:
Approve. No changes needed to the research study. Investigator may proceed with the research.
Revisions needed. Renewal qualifies for expedited review, but further revisions are needed before investigator may proceed with the research. Requested revisions are described below.
Refer to convened IRB. Renewal does not appear to qualify for expedited review. Reviewer requests that the item be reviewed by the convened IRB. Requested revisions and/or reviewer concerns are described below.
  1. Renewal is required for this protocol, even though federal regulations and the IU HRPP Policy on IRB Review Process do notrequire it.
No.
Yes, based on the following rationale: .
N/A. Research is federally funded or regulated and therefore requires renewal.
Renewal interval:
One (1) year
Other:
Reviewer comments/revisions:
Section I: Items to Examine for Renewal
Please answer the questions below or indicate whether the following criteria have been met by choosing YES if the statement is true or NO if the statement is false. Please choose N/A if the statement does not apply. / YES / NO / N/A
  1. Is the number of subjects enrolled consistent with the number approved by the IRB?

  1. Are there any concerns arising from subject withdrawal or recruitment issues?
If yes, please note concerns in the IRB Reviewer section above.
  1. Were there any major unanticipated problems, complaints, or complications?
If yes, were these adequately addressed by the PI?
If not adequately addressed by the PI, please explain in the IRB Reviewer section above.
  1. Is additional verification from sources other than the PI needed to ensure that no material changes have occurred since the last IRB review?
Consider the following criteria:
  • Is this a complex project involving unusual levels or types of risks to subjects?
  • Is this project conducted by investigators who previously have failed to comply with the requirements of the HHS regulations or the requirements or determinations of the IRB?
  • Does this project raise concern about possible material changes occurring without IRB approval based upon information provided in renewal reports or from other sources?

  1. Are the researchers following the established data safety monitoring plan?

  1. Does any of the information provided affect the risk/benefit ratio?
If yes, please explain in the IRB Reviewer section above.
  1. Are there significant new findings which need to be provided to subjects?
    If yes, please explain in the IRB Reviewer section above.

  1. If a conflict of interest management plan has been attached, the management plan is appropriate and no additional information or action is required.
If no, please explain in the IRB Reviewer section above.
Section II: Informed Consent Requirements
Informed consent has been waived for this study.
NOTE: Informed consent requirements should be considered even for studies now closed to enrollment. For studies which are closed to enrollment, please review the last-approved consent document while considering the questions below.
Please indicate whether the following criteria have been met by choosing YES if the statement is true or NO if the statement is false. Please choose N/A if the statement does not apply to this study. / YES / NO / N/A
  1. Is the informed consent still accurate and complete?
If no, please explain in the IRB Reviewer section above.
  1. Does the current informed consent adequately reflect the risk/benefit ratio?
If no, please explain in the IRB Reviewer section above.
  1. Do subjects need to be informed of significant new findings or risks which may relate to their willingness to continue participating?
If yes, please explain in the IRB Reviewer section above.

Criteria for approval under 45 CFR 46.111:

  1. Risks to subjects are minimized: (i) By using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
  2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
  3. Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
  4. 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 §46.116.
  5. Informed consent will be appropriately documented, in accordance with, and to the extent required by §46.117.
  6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
  7. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

END of IRB Reviewer portion. Thank you!

Section III: HSO Staff Pre-Review
Please indicate whether the following criteria have been met by choosing YES if the statement is true or NO if the statement is false. Please choose N/A if the statement does not apply to this study. / YES / NO / N/A
  1. The subject enrollment numbers reported in KCIRB are consistent with the numbers reported on the last Renewal or an explanation of any inconsistencies is provided.

  1. No changes have been made to the last-approved versions without an approved amendment or, if an amendment issubmitted with the Renewal, all changes are described in the Amendment questionnaire and noted via track changes as appropriate.

  1. Unless the study is in Data Analysis Only, all key personnelhave a conflict of interest disclosure form on file.

  1. Unless the study is in Data Analysis Only, all key personnel and non-key, interacting personnelhave completed the required human subjects CITI modules.

  1. For interventional clinical trials:PI, co-PI, and Site-Specific PI have completed the CITI GCP course.

  1. If any investigators have a financial interest in the research, the financial interest statement has been included in the informed consent and the management plan has been provided for the reviewer.

Section IV: Administrative Updates
Please indicate whether the following criteria have been met by choosing YES if the statement is true or NO if the statement is false. Please choose N/A if the statement does not apply to this study. / YES / NO / N/A
  1. For Closed to Enrollment and Data Analysis Only renewals, base protocol has been updated to the correctstudy status.

  1. All unnecessary documents have been deleted from the Notes & Attachments tab and Reviewer folder.

  1. For open to enrollment NIH-funded studies commenced or ongoing on or after December 13, 2016: A Certificate of Confidentiality (CoC) has been granted. Adescription of the CoC and its protections has been added to the informed consent document – see informed consent templates for suggested language.

Section V: VA Updates (For VA Studies ONLY)
Please indicate whether the following criteria have been met by choosing YES if the statement is true or NO if the statement is false. Please choose N/A if the statement does not apply to this study. / YES / NO / N/A
  1. For multicenter research studies, the progress report includes the number of local subjects and the number of national subjects, if available.

END of HSOStaff portion. Thank you!

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