Review Basics

This section provides information related to reviews that span across all review types.

   

Sending Studies Back to Pre-Submission

Send to IRB Member Activity during Pre-Review

Protocol Review

When reviewing protocol-based applications, analysts should use HRP-308 Worksheet: Pre-Review to evaluate whether the protocol includes the required information. “Missing/Inappropriately Answered should be interpreted as:

  • Missing information,
  • Incorrect / wrong information, or
  • Information that significantly diverges from regulations/institutional policy

Study teams are encouraged but not required to use the IRB’s protocol templates. Note that poorly prepared protocols may be sent back to pre-submission if there are significant deficiencies: Sending Studies Back to Pre-submission

HS IR Submissions – Post First Round Review Email

After the first round of IRB pre-review, HS staff send the application back to the study team in ARROW. At that time, staff should also email the PI and primary point of contact for the study to highlight any issues that may need further clarification and to give the study team an indication, if possible, of when the application could be scheduled for a board meeting. Please copy the IRBDirector@hsirb.wisc.edu email on the message. See the example email text below.

Dear PI and Primary Point of Contact,

I am the IRB staff analyst assigned to your submission. You should have received automatic notification from ARROW that I returned your study with questions and requests for clarification. I thought it might be helpful to provide a brief overview of these to help you in responding to the issues. 

(Elaborate on concerns.)

The HS IRB meets 6 times each month and you can see the meeting dates through the end of the year on the IRB web site. Each board meeting has a scheduling deadline of one week prior to that meeting, and I will likely need a few days to review your response to these comments before it can be scheduled. (Add an estimated meeting date and when you would need the response back.)

I am available by phone or email if you have any questions.

Completing HRP-401

See Completing HRP-401 for information on how to complete the Pre-Review Checklist.

Completing Other Checklists at Initial Review

NOTES: 

  1. Where protocol specific findings are requested, analysts should provide text in the protocol, rather than reference the section or page in the protocol where the information is provided.
  2. If the submission will be reviewed by the full board, analysts should select “Checklist prepared”, if the study will be approved under expedited review, analysts should select “Checklist completed” when ready to approve the submission. The exception to this is the HIPAA waiver checklist.  See below.   
  3. If a checklist is completed in error (e.g., waiver of informed consent instead of waiver of consent documentation) or if a checklist is no longer relevant to the study (e.g., study team decides they will no longer enroll children), add a private comment stating that the checklist was completed in error or the reason that the checklist no longer applies to the study.

HRP-411 Waiver of Written Documentation of Consent

Analysts select the appropriate set of criteria. If the item requires full board review, include any outstanding questions that may require board discussion in HRP-401 Notes.

HRP-410 Waiver or Alteration of the Consent Process
HRP-412 Pregnant Participants
HRP-413 Non-viable neonates
HRP-414 Neonates of Uncertain Viability
HRP-415 Prisoners
HRP-417 Adults with Impaired Decision-Making Capacity

Analysts select the appropriate set of criteria and provide protocol specific findings where appropriate.  If the item requires full board review, include any outstanding questions that may require board discussion in the relevant protocol-specific findings section or in HRP-401 Notes.

HRP-416 Children

Analysts select the appropriate set of criteria and provide protocol specific findings where appropriate. Additional sections regarding parental consent and assent, or waivers, when appropriate will need to be completed. If the item requires full board review, include any outstanding questions that may require board discussion in the relevant protocol-specific findings section or in HRP-401 Notes.

HRP-418 Non-significant Risk Device

Analysts use the justification provided in the study team’s protocol to complete this checklist. If the item requires full board review, include any outstanding questions that may require board discussion in HRP-401 Notes.

HRP-419 Waiver of Consent Process for Emergency Research

All criteria must be selected, and protocol specific findings provided, where appropriate. Any outstanding questions that may require board discussion in the relevant protocol-specific findings section or in HRP-401 Notes.

HRP-441 HIPAA Waiver of Authorization

This checklist is completed after the IRB meeting or at the time of expedited approval.  See Post Meeting Processing for details on completion of this checklist for full board review items.

Ancillary Committee Reviews

As part of the pre-review process, analysts will assess whether any ancillary committee reviews required prior to IRB pre-review are missing or must be completed prior to board review and/or approval.  Analysts should consult HRP-309 Worksheet: Ancillary Review Matrix to determine the need for ancillary committee reviews and ensure the study team is aware of their responsibilities. 

Funding Considerations

Analysts conducting review should be aware of additional criteria that apply to studies funded by the Department of Justice (DOJ)*, Department of Energy (DOE), and the Department of Defense (DOD). Refer to HRP-318 for additional criteria.

One type of federal grant occasionally uploaded in the IRB application, called the T32 which denotes a training grant, cannot be claimed as federal support for a research study unless the grant specifies the specific research supported. A T32 grant typically supports a person or program rather than a specific research protocol.

Studies that are fully industry funded and are not initiated by a UW investigator are typically reviewed by a commercial IRB. Those that are investigator initiated are reviewed by the UW IRB. Contact IRB RELIANT with questions.

*The DOJ is not a signatory of the Revised Common Rule. Therefore, the DOJ regulations regarding human subjects protections, 28 CFR Part 46, remain in effect for DOJ research awards; the provisions of the Revised Common Rule do not apply. Thus, the exemption categories listed in 45 CFR Part 46 of the Revised Common Rule cannot be accepted for DOJ funded research. Instead, the study can only qualify for an exemption if it meets one or more of the exemption categories outlined in 28 CFR Part 46. Otherwise, the study will require expedited or Full review (and continuing review).

When the application is ready for approval, see Completing HRP-401 on how to complete the pre-review checklist to account for the DOJ funding. If the study is non-exempt, proceed with filling out HRP-402 as normal. If the study is exempt, in section 2 of HRP-402, select Exempt and choose the “Other” category from the list of categories. In the text box, indicate the exemption category from 28 CFR Part 46 that applies.

The approval letter to DOJ awardees must reflect 28 CFR Part 46 citations and cannot be accepted using 45 CFR part 46 references. Therefore, the letter must be edited to remove the 45 CFR Part 46 citation and replace it with the 28 CFR Part 46 citation.

Reviewing Financial Conflicts of Interest

Visit Reviewing Financial Conflicts of Interest for information on how to review COIs.

Reliance Considerations

Visit Reliance Considerations for information on how to address reliance issues during pre-review.

Registries and Repositories

Visit Registries & Repositories for information on how to review registries and repositories.

Data and Specimen Sharing

Visit Data & Specimen Sharing for information on data and specimen sharing considerations.

Genomic Data Sharing

Data and Safety Monitoring

Studies that are more than minimal risk or are clinical investigations involving a drug/biologic or device regardless of risk, should include data and safety monitoring.

  • Data and Safety Monitoring Plans (DSMP): A DSMP as outlined in HRP-335 is usually sufficient.
    • Clinical site monitoring (an aspect of the DSMP) may be completed by ICTR’s Central Monitoring Service (CMS). For minimal risk studies (e.g., using NSR devices with no other risks greater than minimal), the IRB does not need to review the details of the clinical site monitoring; it is enough for the protocol to refer to a separate monitoring plan approved by the PI.
  • Data and Safety Monitoring Committees or Boards (DSMC): DSMCs are not required for every trial but are generally recommended for any controlled trial of any size that will compare rates of mortality or major morbidity. In this case, the IRB should review information about its scope and composition. See HRP-335 for additional DSMC considerations.

Certificates of Confidentiality (CoC)

The Investigator Manual describes automatic CoC coverage for NIH funded studies, and how investigators may obtain a CoC for studies funded by other agencies. Study teams are advised to consult HRP-333 Certificates of Confidentiality to assist them in determining whether a CoC is required or appropriate.

The IRB usually requires studies not funded by NIH to obtain a CoC when sensitive information is created or collected for research purposes. This could include but is not limited to the following: creating new genetic information (not obtaining genetic information already in a participant’s medical record); collecting information on psychological well-being which could be used to diagnose psychiatric conditions; collecting information on participants' sexual attitudes, preferences or practices; collecting data on specific substance abuse or other illegal risk behaviors (e.g., definitive responses about what substances were used); studies where participants may be involved in litigation related to exposures under study (e.g., breast implants, environmental or occupational exposures). 

If staff are unsure whether to require researchers to obtain a CoC (expedited reviews) or to suggest that the convened board consider making this request (full reviews) for a specific study, they should discuss this with their Team Lead.

VA Considerations

Visit VA Considerations for information on VA research.

FDA Considerations

Visit Reviewing studies involving drugs, biologics, devices for information on FDA regulated research.

Prisoners

Visit Prisoners for information on research involving prisoners.

AI/Machine Learning Technologies Research

See AI/Machine Learning Technologies Research for information on AI/machine learning considerations.

International Research

See International Research for information on international research considerations.

Expanded Access Submission

See Expanded Access Submissions for information on expanded access processes and considerations.

Hospitals and Clinics Under the Purview of UW

HIPAA Considerations

See HIPAA for resources regarding HIPAA requirements.

Part 2 Considerations

See Records Covered by HIPAA and Part 2 for information regarding Part 2 requirements.

Reconsent Considerations

See the reconsent guidance in the IM pertaining to when and how participants should be informed of new information during the course of a study.

If participants will be reconsented, the process and documents must meet all regulatory criteria for documentation of informed consent, or waiver of documentation of consent or alteration.

If participants will be informed in some other manner, such as through a consent addendum, information sheet, or an oral process, this does not need to constitute legal informed consent, all elements of consent may not be necessary, and no waivers or alterations need to be approved. Scripts or written documents still require IRB review and must still provide enough information for participants to evaluate the new information and determine willingness to continue their participation.

IRB Noncompliance

See IRB Noncompliance for information regarding how to address incidents of IRB noncompliance.

Other Considerations

See Additional Review Considerations for other considerations regarding research with:

  • fetal tissue
  • stem cells
  • neonates
  • data retention

Return to Staff Manual



Keywords:
pre-review, worksheet, checklist, HIPAA, VA, FDA, sharing, ancillary, funding, pre-submission 
Doc ID:
118770
Owned by:
Monica E. in Health Sciences Institutional Review Boards
Created:
2022-06-01
Updated:
2025-06-24
Sites:
HSIRBs-internal