Getting to an and d th through rough the IRB Mary R. Lynn (Mary_Lynn@unc.edu) Professor, School of Nursing Previously - Assistant Director Office of Human Research Ethics University of North Carolina at Chapel Hill
Your IRB experience or thoughts …
Which studies are reviewed by IRB? Those studies classified as human subjects research (HSR).
Which studies are HSR? 1. Human Subject(s) 2. Research Neither may be what you think!
What is a Human Subject? First must be alive Then information must be ABOUT them (not just FROM them) Interviews of “key stakeholders” ABOUT something is generally not human subject research “Interaction with“ and “identifiable data” are considerations HSR includes when data about someone are collected through interaction OR is identifiable The question always is … Is there someone to protect ?
What is research? Systematic investigation, including research development, testing and evaluation Designed to develop or contribute to generalizable knowledge Interaction with individual (or their data) Many examples of “research - like” activities that are not QI/QA Case Studies Program evaluation Etc.
The part that matters (HSR) Is the activity a systematic Activity is research investigation designed involving human to contribute to subjects generalizable knowledge YES YES Activity is research Does the research Does the research YES involve intervention or involved obtaining interaction with the information about individuals? living individuals?
So if my study is HSR? If you will be interacting (directly or indirectly) with a living human being (or their identifiable data) for any activity related to research (which includes those aspects some call “preparatory to research”) you need to either submit an application to the IRB for approval before the interaction or clarify with the IRB in advance if an IRB application is required.
Examples of NHSR Secondary analysis of de-identified data from a local business about the unpaid invoices from the last year Interviews of university administrators about the cost of college athletics Examining soap consumption when different signs are used to remind employees about hand washing These are all likely research but are also NHSR!
Who decides? The IRB makes determination not the researcher (or for students … not a student or their advisor). The online application will screen for “NHSR” for all studies. If it is “NHSR” the application will be very short.
How to succeed Follow the directions Inconsistencies across various parts of the application is one of the biggest issues in having the “opportunity” to address concerns after the IRB has reviewed it.
And where are the directions? irb.unc.edu One website for all of the campus IRBs (one entry place as well)
What will you find there? Application (submission instructions) Regulatory documents and other information for researchers Deadlines & meeting dates (Only matter if you have a “full board” study which few students have) Lots of additional information
Where do you start? Start with the online application … answer any and all questions you are offered. It is a “smart application” and should tailor what is asked to the kind of study you are proposing Ask your advisor for help with the application Your consent form will be “ templated ” as you complete the application. Once the application is done fill out the “individualized” aspects of the template.
Where do you start? (cont) Call the IRB if you still have questions: 966- 3113. Can make an appointment with an “IRB Analyst” if have more questions.
It all starts here, logging in using your onyen and password
Do students have additional requirements? Students must have their materials reviewed and “co - signed” (by certifying when the application is routed) by their faculty advisor who is assuming responsibility with/for the student
Routing of IRB Submissions PI’s Home Oncology Certification PI and/or Department PRC or by PI Administering Study Staff (Chair or CTSA- Department (if IRB (and Faculty Drafts Dept CTRC any) Advisor if Application Review Student PI)* (if relevant ) Committee) Non-IRB Issues (if any) *Note that student research will follow same routing process as any project
Speaking of proposals All relevant proposals (1 copy) if one exists must be submitted with the IRB application. This applies to all researchers, whether students or faculty.
Anything Else? Complete the required IRB education at https://about.citiprogram.org/en/series/human- subjects-research-hsr/. Advise – do it in a few sessions rather than one; it will take you several hours to do! Be sure to print a copy of your certificate you get at the end of the program for safekeeping in case the automatic “transfer” of your completion record does not work right away. The training database will verify that you have done the required education when you submit your application Be sure your advisor (at a minimum) has also done the required education
Data Security Levels Subject Sensitive Security Requirements* IDs Questions Level --- --- I Password protection YES --- II Level I plus secure network --- YES II Level I plus secure network YES YES III Level II plus encryption, vulnerability scans, security audits * Note: There is an IT person designated for this role in the School of Nursing it is Jan Blue, email address is: jhblue@email.unc.edu
Risk dictates LEVEL of review Full Board Minimal Risk Expedited “ Exempt ” RISK NHSR
Types of Review Are reviewed by IRB Exempt staff/Chairs and do not go to Expedited the full committee Convened Committee (“Full Board”)
Are all applications handled in the same time frame? No Exempt and expedited - submit ANYTIME (there are no deadlines that apply), expect feedback in ~ 7 business days Full board* – submit at least 2 weeks before a scheduled meeting (check deadlines), expect feedback within 3 days after the meeting * These are rare for researchers outside the biomedical realm
Feedback? Indeed Rare is the application that makes it through the first time with no issues to be resolved The purpose of the feedback is either to get clarification or the submission has not exactly conformed to the requirements (remember, follow the directions!)
What do I do with the feedback? Whine and moan All interactions are online but you can, of course, call with any questions about the feedback Address the issues and resubmit what is asked for in the feedback you receive
Within a few days of the resubmission . . . You will usually receive an approval memo which includes information related to the IRB and it’s ongoing role with you and your research study
With your approval you’ll also have access to . . . Consent forms, flyers, recruitment materials, etc. Note if you have been involved with IRB previously: All materials that remain with a submission have been reviewed Materials from “wherever” you might be
Modification Modification – any change in the study requires IRB review and approval before being implemented Submitting a modification will allow you access to your application to alter it in line with the proposed changes
Continuing review (aka “renewal”) At least annually Includes the addition of questions about what occurred since the last review and what will occur during the next period.
How will I know when to renew? Your approval (or renewal) will include the date for renewal. The IRB will notify you at least two months in advance of the renewal date and again 30 days before the expiration date. But it is ultimately your responsibility to have the study renewed on time --- make a note of the renewal date and plan ahead for it.
And after I submit the renewal? If it’s “full board” it is reviewed by the whole committee at the next meeting, after which you’ll receive feedback – changes may be needed so be sure to plan time before your approval expires If it’s expedited, you should hear about the renewal in a few days after it is submitted
How long must studies stay “active”? The general rule is as long as there are human subjects to protect. Once a study is in data analysis only and there is no chance you will re-contact the subjects, it is possible to close the study.
If I close it, can it be reopened? Not really You’ll likely need to submit a new application, which is easy in the online system … you can clone studies.
What about student’s studies? Students should close their studies online before they graduate. If they do not do so the faculty advisor will be responsible for the closure. Exempt studies are never really “opened” since the IRB doesn’t maintain contact with those projects. However, an email to the IRB when the study has ended helps the IRB with record keeping.
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