When writing minutes, keep the following in mind: 

• The audience for minutes includes IRB staff and members as well as external auditors. Minutes are subject to open records requests. 
• Descriptions should be succinct but detailed enough to enable readers to identify what the IRB determined and why the IRB made the decision 
• Add to and edit template language as needed for accuracy and clarity 
• For controversial discussions or cases where an external report is likely, you may seek advice from a supervisor, IRB chair, or legal counsel  
• Minimize abbreviations and define them when they first appear (e.g., PI, RE) 
• If reviewing minutes and you notice an error, please send Office Admin an email with the mtg date, study # and section heading that needs correction and corrections needed.  Corrections will be made to edit document and ARROW minutes

This section briefly states the IRB’s motion for the submission and whether the criteria for IRB approval are met (45 CFR 46.111, 21 CFR 56.111, or 38 CFR 16.111). IRB motions are the following: Approved, Approved with Administrative Hold, Modifications Requested, Deferred, and Disapproved.

This section summarizes the actual discussion that occurred at the IRB meeting. It does not need to be lengthy and should focus on any controverted issues as well as the resolution to those issues. Unless it was discussed at the meeting, do not include specific regulatory findings in this section (e.g., waivers of consent or HIPAA authorization).

This section should briefly state whether the risk/benefit ratio was found to be acceptable and whether risks are adequately minimized and are reasonable in relation to the potential benefits. The risk level of a study should be clearly documented. If the study is determined to constitute minimal risk, that regulatory finding must be cited in this section. If the study is determined to constitute more than minimal risk, that finding must be noted in this section along with a rationale for why the study constitutes more than minimal risk. 

For changes of protocol:

Briefly state whether the risk/benefit ratio was altered by the change of protocol and if it is still found to be acceptable as a result of the change. If the study has been determined previously to constitute minimal risk or more than minimal risk and this level of risk changes, this finding should be cited in this section.

This section addresses the selection of subjects, recruitment, consent process(es), and document(s) for the study, and the minutes should note whether the board found the investigator’s plan and document(s), if applicable, approvable. This section should describe any special consent processes required if the study enrolls vulnerable subjects (e.g., children, subjects with impaired decision-making capacity, who are non-English or limited English speakers, illiterate subjects). The inclusion of potentially vulnerable subject populations or subjects likely to be susceptible to coercion or undue influence should be further addressed in the Special Populations section below. 

This section should also include whether the study involves waivers of informed consent/assent, waivers of documentation of informed consent, or consent alterations. The templated minutes language for the waivers and alterations includes references to the appropriate checklist(s) where the justification for the waivers, alterations will be described. Justification that is already included in the checklists should not be duplicated here.  

For changes of protocol:

This section addresses any changes to subject selection, recruitment or consent processes, or consent documents. If a change in consent process requires waiver of informed consent, waiver of documentation of informed consent, and/or alteration of elements of informed consent, it should be noted here, and the minutes should reference the appropriate checklist. Caveats related to waiver requirements should be addressed if the study falls under the pre-2018 Common Rule. 

If new or revised consent documents were submitted as part of the change of protocol, the minutes should describe whether the documents were approved as submitted, or if modifications were requested. The minutes should address whether re-consent will be required and if yes, when reconsent will occur. 

NOTE FOR VA STUDIES:The minutes should document that, unless waived, all elements of informed consent, including any applicable consent form language required by VA, are included in the consent form.

This section addresses whether the study will enroll any potentially vulnerable populations or subjects likely to be susceptible to coercion or undue influence and whether the IRB determined that the subject population is appropriate for this study. This section also must address whether the IRB found the study provides adequate safeguards to protect the proposed subject population, or required additional safeguards be put in place. Minutes template language includes references to checklists for vulnerable subjects where the specific regulatory language and justification is be included. Regulatory citations and justification should not be repeated here.  

This section also must document whether any special representative (e.g., prisoner, DHS) was present for the IRB discussion and vote on the submission. 

For changes of protocol:

This section addresses whether the change adds or alters any potentially vulnerable populations or subjects likely to be susceptible to coercion or undue influence. If no changes to the subject population are made as a result of the change of protocol, this should be stated.

This section addresses any concerns or issues related to the protection of subject privacy and confidentiality (including data security) as well as how HIPAA Privacy Rule requirements will be met for this study (e.g., obtaining authorization), or why HIPAA Privacy Rule regulations do not apply to the study (e.g., the researchers are not part of the health care component or affiliated covered entity, data will be recorded in a de-identified manner, no protected health information will be collected as part of the study). 

This section must document if the study is covered by a Certificate of Confidentiality, whether as a result of NIH funding or because the investigators have or will apply for the certificate. 

If HIPAA Privacy Rule regulations apply to the study and a waiver or alteration is being granted, this must be noted this section. If a waiver of authorization or an alteration of authorization is granted, the minutes should document whether the waiver or alteration is for all or part of the study. Template minutes language references the HIPAA waiver/alteration checklist where the regulatory citation and criteria are provided. This regulatory information should not be repeated here. 

For changes of protocol:

his section should address any changes that affect the protection of subject privacy and confidentiality and any applicable HIPAA requirements. If HIPAA regulations apply to the study and a nw waiver or alteration is being granted, this must be noted and whether the waiver applies to part or all of the study. Template minutes language references the HIPAA waiver/alteration checklist where the regulatory citation and criteria are provided. This regulatory information should not be repeated here. 

NOTE FOR VA STUDIES: 

In the case of VA research, a partial waiver of authorization must be granted for review of medical records to identify potential subjects.  

If a study involves the use of Social Security Numbers (SSNs), scrambled SSNs, or the last four digits of SSNs, the IRB must specifically document its approval of their use. 

VA regulations clarify that the role of the IRB is to ensure that authorization forms, if required, are consistent with the consent forms. Thus, this section of the minutes should note whether any revisions to the HIPAA form are needed to bring it in line with the consent form or that the authorization and consent documents are consistent.

This section addresses whether any study team member has a potential financial conflict of interest related to the submission. This section must state either that no financial COIs exist for the study team related to the research or explain how a COI will be managed (e.g., the study is minimal risk and the IRB considered compliance with the management plan adequate to protect participants). If the IRB determines that the conflict should not be disclosed in the consent form, explain why this is the case.

This section identifies any IRB member attending the IRB meeting who had a COI with the submission, explains the nature of the conflict, and confirms that the conflicted IRB member was not present for the final discussion and vote. 

This section describes the funding for the study or if the study does not receive any funding. 

For changes of protocol:

This section should describe any changes to funding or state there are no changes.

This section addresses any IRB oversight issues regarding study sites or personnel external to the UW-Madison/UW Health/Madison VA, if any. This includes stating whether an IRB authorization agreement (IAA) or individual (a.k.a. independent) investigator agreement (IIA) will be needed or is in place and whether there are any outstanding issues related to serving as an IRB for an external site or individuals.

This section must state whether the study is FDA regulated or not. If FDA regulations apply to the submission, all relevant FDA regulatory citations regarding the submission must be noted in this section, such as significant risk and non-significant risk (NSR) findings for devices or whether the study will be conducted under an IND, for example. If applicable, the minutes should reference the NSR checklist. 

For changes of protocol:

This section must state that the study is not FDA regulated, that the change does not alter previous FDA determinations, or describe new determinations regarding FDA regulations, such as significant risk or non-significant risk findings for devices. The NSR checklist should be referenced, if a new non-significant risk device was added with the change or if revisions to the previous NSR determinations were made, for example.

This section addresses whether VA regulations apply to the submission. The VA Research and Development Committee’s endorsement should be noted. 

If the study includes non-veterans, the minutes should document a justification for their inclusion. 

For changes of protocol this section should note whether any changes impacted any VA regulatory requirements.

This section addresses any regulatory issues not otherwise noted in the minutes such as state law requirements or federal agency requirements other than the VA (e.g., Department of Defense). State law requirements include: 

• Research involving individuals a) receiving protective services, voluntarily or involuntarily, because of aging infirmities, chronic mental illness, developmental disabilities or like incapacities, or b) receiving inpatient or outpatient treatment for mental illness, development disabilities or substance and alcohol dependency in Wisconsin 
• Research that may uncover elder or child abuse (e.g., studies involving home visits) 
• Release of HIV tests and birth defect records for research purposes 

For changes of protocol:

This section should address any regulatory issues not otherwise noted in the minutes (e.g., state law requirements) that must be made as a result of the change.

This section will state whether the IRB requested modifications from the study team. If modifications were requested, the minutes should state whether the response will be reviewed as either simple concurrence or under expedited review procedures. 

This section addresses whether a study can be excused from continuing review based on applicable policy (i.e., institutional) and regulations (e.g., FDA, Common Rule). If a study is federally funded and could be excused under federal regulations from undergoing continuing review, this section must document the rationale for requiring continuing review. 

If the study requires continuing review, this section describes the period of time (in months) for which the study has been approved by the IRB before continuing review is required. The most common review period is 12 months. If the IRB assigned a review period shorter than 12 months, the reason should be documented here. 

If a study is excused from continuing review because it meets expedited review criteria, the specific expedited categories under which it qualifies should be listed. 

For changes of protocol:

This section should note whether the review period has been altered as a result of the change of protocol and the rationale for the change, if not previously noted.