Avoiding & Responding to the Most Common IRB Application Stipulations
May 2019 Issue
Submitting to the IRB can be a daunting prospect for both novice and experienced researchers. While each study is different, study teams often encounter similar issues with their submissions. This article highlights key takeaways from the recent monthly CRRO seminar given by the BMC/BU Medical Campus IRB Analysts on May 8, 2019 on some tips and tricks on how to avoid the most common pitfalls with your next IRB application. This article is based on a “typical” study and may not apply to studies that you’re currently working on. To dig deeper into these issues, you can watch our presentation or view our presentation slides.
Two common sources of stipulations are inconsistency and missing information.
Study procedures are often not consistently described across the application, attached protocol, consents and other study materials.
Key information that the IRB needs to make study determinations is often not provided in full; for example: textboxes in the application are incomplete, or referenced documents are not attached to the submission.
Proofreading the submission for consistency and completeness before submitting can help to avoid a significant number of stipulations.
During initial submission reviews, analysts frequently encounter errors related to the Department Chair/Section Chief role. The Principal Investigator’s superior is the most appropriate person to fill this role. When the PI is a Department Chair/Section Chief, then this role would still need to be filled by the PI’s superior. Often, this person is the Dean or Provost.
BMC and BU Medical Campus require that all researchers engaged in human research (i.e., having contact with subjects or their identifiable data) complete formal training prior to starting any research activities. Depending on the type of research, there are several levels of required training. Please see our website for more information on training requirements. Applications will not be approved until all required training has been completed.
Internal Study Personnel are personnel who are primarily affiliated with BMC or BU Medical Campus and should be added using the Internal Personnel Change Request Form through INSPIR. External Study Personnel are defined as personnel from institutions other than BMC or BU Medical Campus. If external personnel are engaged in human subjects research, then they must be added through an authorization agreement. Please contact IRB Coordinator, Roz Schomer at email@example.com for study-specific questions about authorization or reliance agreements.
The Navigation Menu contains branching logic that generates certain sections based on responses to specific questions. For instance, selecting a separate protocol, or an investigational drug or device, populate some sections while hiding others.
An affirmative answer to the separate protocol question collapses the application to avoid duplication of information. The sections of the application that follow must be completed in full--it is not acceptable to refer to the attached protocol in these instances. If you choose to attach a separate protocol when it is not needed, then the IRB may still request that the entire application be completed if the protocol is incomplete.
In the Subjects section, you need to make a distinction between the “will be recruited” and the “will be targeted” groupings. “Will be recruited” applies if even one member of that group (e.g., minors, pregnant women, prisoners) is anticipated to be a subject. “Will be targeted” is for populations that are the principal focus of your research (e.g., students, homeless, individuals with psychiatric disorders, terminally ill patients). You can incidentally enroll an individual in one of these “will be targeted” groups without prior approval. However, if you know that you will be targeting these individuals, you must indicate so in your application. For both types of groups, you must describe how you will comply with the requirements for additional protections.
The two most common issues the IRB encounters in this section are (1) insufficient detail and (2) copying-and-pasting from a grant submission. This section should be plainly written and provide the IRB with enough detail to understand exactly what will happen during your study. You need to focus on providing sufficient information to answer the questions in the application, but also avoid confusing and unnecessary detail. Do not copy and paste from the grant application; otherwise, the submission will be returned to you for revision.
In this section, list the risks, how they will be mitigated, what the benefits of the study are, and how risks to subjects are reasonable in relation to anticipated benefits. All studies have risks, even chart reviews where there is a risk of loss of confidentiality. It is important to distinguish between direct and indirect benefits. Direct benefits are those experienced by the individual subjects, while indirect benefits are those to science or society at large. Compensation is not considered a study benefit.
Explaining how you will recruit subjects is one of the more detailed sections of the application. By far, the most common issue here is that recruitment strategy lacks sufficient information. For instance, “We’re going to recruit from our own patients in the XXX clinic” is not acceptable. An excellent mantra for both the recruitment and consent sections is: “who, where, when and how”. If you need to access medical records or the daily schedule to identify potentially eligible subjects, then make sure the HIPAA section is completed (see the presentation slides for detailed guidance).Recruitment materials need to be submitted as final versions and comply with all requirements, such as making it clear that your study involves research and not treatment and not overemphasizing study payment by using big and bolded text.
If your study team is interacting with potential subjects before consent in order to confirm eligibility, then you need to describe your screening process. If you are interacting with potential subjects in person or by phone, you must use a screening agreement (oral or written brief consent script). Here, one of the most common stipulations involves an incomplete screening section; so, take care to read and respond to all the questions and prompts in the sub-sections.
Arguably one of the most important mechanisms to minimize research-related risk, this section regularly contains four easy-to-rectify mistakes:
If you have questions about appropriate data storage methods, please refer to this CRRO presentation by the Privacy and Security officers of BMC and BMU or contact the presenters directly.
It is important to always use the latest version of the IRB-approved consent templates unless there is a sponsor-provided consent available.
The IRB may still ask your team to revise some of the sponsor language if it does not align with BMC/BU Medical Campus IRB policy. The following points should be kept in mind:
There are specific Data and Safety Monitoring requirements depending on the risk level of the study. For minimal risk studies, simply complete the relevant section in the application, stating that Unanticipated Problems, Adverse Events, and protocol deviations will be reported to the IRB as required by IRB policies. For greater than minimal risk studies, a Data Safety Monitoring Plan is required, which is usually part of the separate protocol.
Any payment for participation or reimbursement of travel costs is not considered a benefit. It is important to carefully consider the payment amount, method and timing in research because the payment scheme (depending on the research) may potentially represent undue influence to participate. Cost refers to costs that the subject may be responsible for covering, such as parking or co-pays for clinical procedures.
All study documents need to be submitted as “clean” versions because the IRB cannot approve documents with tracked changes. If possible, please submit all documents in Word formatting. PDF versions are acceptable if you do not have a Word version available (i.e., sponsor-created protocol).
For amendments, updated documents must be attached as a revision to the current approved document. This is especially true for consent forms. Attaching modified documents as revisions helps the IRB to compare documents to see changes more clearly. Also, revisions help to keep track of study changes over time.
This article conveys the most common stipulations encountered in typical submissions. You can also consult the IRB website for templates and detailed instructions. While these tips and tricks may not apply to your particular study, we hope that it provides basic information that can be used in most studies. Keep in mind that the IRB applies its interpretation of regulations and institutional policies on a study-by-study basis, which means that our guidance and suggestions may also vary from study to study.
Navigating the submission process can be challenging, but remember that we are here to help! Feel free to reach out to us via phone at 617-358-5372, via email (firstname.lastname@example.org) or in-person at IRB drop-in hours.