IRB Tips and New Information
Inquiries and Exempt Research
If you are not sure whether your project is one that must meet human subjects or research requirements, you should submit an inquiry. The new eIRB does not include an inquiry pathway, but we do have a new Inquiry Form, which can be found on our website and in the eIRB. The form will walk you through the determinations for engaged in research, human subjects, and research. The form must be uploaded as your protocol.
The Code of Federal Regulations defines Research as:
“A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” [45 CFR 46.102(d)]
and defines Human Subjects as:
” living individual(s) about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.” [45 CFR 46.102(f)(1-2)]
Exempt research is a category or type of human subjects research that does not require ongoing oversight by an IRB. The new eIRB does not have a separate pathway for exempt research, so you will have to fill out the full application.
The IRB must determine if a research project fits one of the six exempt research categories. Below is a summary of the most common exempt categories:
(1) Research conducted in established or commonly accepted educational settings, involving normal educational practices.
(2) Research involving the use of educational tests, survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified and (ii) any disclosure could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
(4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
For more information see HHS Regulations.
NIH Requirement for Single IRB Review
You may have heard that NIH released a policy to require single IRB review for many multi-site studies receiving NIH funding. This means that sites involved in the research will need to select a single IRB to serve as the IRB of record, and all other sites will cede review to that IRB. While this will help reduce duplicative IRB reviews, there is typically a fair amount of administrative work upfront to get a ceding agreement and review procedures in place with the reviewing IRB. Researchers planning to ask KPNW to cede to another IRB should work with the RSPO early in the process to ensure these administrative tasks are completed and do not delay study start-up. The policy takes effect for proposals submitted on or after May 25, 2017. Read more details here.
Final Report for Migrated Study
In some cases the final report may be the first submission after a study has been migrated to the new eIRB system. If that is the case, select the "Continuing Review" option on the first page of the Modification/CR form (do not also select "Modification"). You will not need to make any other updates to your study information.
Updating eIRB account information
Need to change your name or update other information in your eIRB account? Email ResCompTeam@kpchr.org.
Wondering if you need to keep a study open?
Check out the Winter 2016 newsletter article “When Can I Submit a Final Report to Close My Study?” for guidance about when you can close a study.
Naming Documents in the eIRB
When uploading a document in the eIRB system, please use the Name field to name the document in accordance with IRB requirements. This is the easiest way to name your document. The system will default to the file name if the Name field is left blank. You do not need to change the file name to conform with IRB naming requirements unless you wish to have it serve as the default name in the eIRB system.
For additional guidance, see the eIRB Help Center document “Naming Study Documents in the eIRB” or the Spring 2016 newsletter article “Naming Study Documents in the Upgraded System.”
Whom to notify when you comment in the eIRB
When you add a comment in the eIRB, you have the option of notifying the PI/proxy/primary contact, study team, or IRB coordinator. If you select PI/proxy/primary contact, emails will go to your PI and whomever is assigned as the primary contact on the project. The study team option will result in emails to the study team in its entirety. And of course, if you select IRB coordinator, a notification will go to the IRB team member assigned to the study. If an IRB coordinator is not yet assigned, all RSPO staff are notified of comments.
Please keep in mind that IRB coordinators do not need to be included on certain notifications. Most specifically, when a submission is ready for PI notification, the IRB coordinator should NOT be included in that email. IRB coordinators should only be cc’d on and notified of comments when you have a direct question or are documenting information such as responding to a question from the IRB coordinator or making a comment that the PI has accepted requested changes, etc. For internal notifications of the PI; however, the IRB coordinator should be left of this correspondence.
Full Board Review of Modifications
The RSPO sees many modification submissions at the beginning of each month. Some of these end up requiring review by the full board; however, most meet the criteria for minimal risk, expedited review. The first of the month is a busy time for RSPO staff because we are preparing for the IRB meeting. Thus, we encourage project teams to submit minimal risk modifications whenever they are ready. Please do not feel obligated to shoot for the deadline since it is likely the modification will not be taken before the board.
Also, it is important to keep in mind that if your study was originally reviewed and approved as minimal risk under an exemption or expedited criteria, it is likely that the modification will be reviewed under those same criteria. As a rule of thumb, the following types of modifications DO NOT need full board review:
- Minor edits to the consent form and study materials to correct spelling, update contact information, and revise formatting.
- Adding a new questionnaire or measure that is in keeping with the approved methodology of the study.
- Adding a new recruitment document such as a flier or phone script.
- Revising a process that is not more than minimal risk (such as requesting to contact subjects over the phone instead of via email).