Mentor IRB is the hub of all our IRB traffic—from new protocol submissions to consent form templates. A part of my job includes helping researchers navigate the administrative side of Mentor. Below is a snapshot of the structure I use to guide researchers through Mentor.
“What’s, What?” – There’s probably a template for it.
We understand that every research project is unique. However, we also understand that researchers sometimes need a boost to get started. As such, we created templates for researchers. For example, we have an informed consent form (parental permission and student assent) template. The template is color-coded in three ways:
- BLUE text is suggestions from IRB and can be freely edited out (e.g., “List specific inclusion criteria”).
- RED text is editable and should be tailored for each researcher’s individual study (e.g., “You will be given a pseudonym/de-identified code in order to keep your identity confidential.”).
- BLACK text is standard and must be kept in the final consent form copy (e.g., “participants rights”).
We also have a template for requesting permission from a recruitment site. This template includes prompts for researchers to include information about the duration of the study and what is requested from the site (e.g., Space to conduct the study or access to break rooms to post recruitment flyers, etc.).
Lastly, we have a template for researchers to use if they request specific data from an outside source. This template includes guides for researchers to explain the purpose of their research, how the data will be stored, and how they will maintain participant confidentiality.
“What’s in a Name?” – Standardize file names.
In Mentor, researchers can submit different file types for review including a protocol description, consent forms, individual or focus group protocols, recruitment materials, study instruments and measurements, site permission forms, and/or translated documents (e.g., flyer in English and Spanish). Each type of file has a label so that they are easily identified on the protocol record.
We ask that files be uploaded onto Mentor using specific formats (e.g., .doc, .docx, .pdf, or .rtf) and that file names match their assigned category. For example, if a researcher is submitting an interview protocol, they should name the .doc or .docx file in this way; ML_interview protocol, with the researchers first and last initials and the file name clearly marking the appropriate category. They would upload this file under the “Interview/Survey Instrument” file type so that it is easily identifiable to our IRB reviewers, members and staff.
We remind researchers that Mentor is their IRB hub, so anything that pertains to the protocol from initial submission, to amendments, continuing reviews, adverse events, protocol deviations, and protocol terminations are all reported within Mentor (see Figure 1 and 2 for examples of how to submit a new protocol in Mentor and Figure 3 for creating a new Amendment to an existing IRB protocol).
“How and Where do I Upload That?” – Click and ye shall find.
We also offer “where to click” guides for researchers to help them understand how to navigate through Mentor and what each icon in Mentor means (see Figure 4 and Figure 5).
“What’s This?” – Message the IRB administrator.
We encourage researchers to explore the Mentor portal. We want them to feel comfortable with the interface and what resources are available to them.
However, we also caution researchers that not every template or resource is applicable for their every need because each research project is unique.
In most cases we have either a template or an answer behind their mouse click.
However, in the event that a researcher cannot find an answer to their question, they can always use “Messages” in Mentor to ask any IRB administrator for help (see Figure 6).
Messages are sent by email and saved on the protocol Messages page. Replies to those emails are also sent back to Mentor and archived on the protocol Messages page and then sent out to the original recipients and sender. This way, each protocol has a complete archive of all messages that have been sent back and forth between reviewers, administrators and the PIs.
Figure 6. Cannot find an immediate answer to a question in Mentor? “Message” the IRB Administrator for help.
“What if I Make a Mistake in Mentor?” – Select “replace” or “edit.”
Sometimes new researchers accidentally select the wrong file to upload onto Mentor or make some other clerical error. Mentor has some options for users to replace or edit a protocol file prior to submission for IRB review (see Figure 7).
When “Replace” is used, the original file(s) are saved in version control. This way there is a complete record of all materials submitted to the IRB.
“When is the IRB Protocol Ready to Submit?” – For students, check with your faculty sponsor. For faculty, whenever you are ready.
We require that student researchers seek approval from their faculty sponsor for each protocol where they are listed as the primary investigator. A students’ protocol will be saved in Mentor but not formally “submitted” until their faculty sponsor has accepted that role on the protocol. Once the faculty sponsor accepts that role, by clicking the “accept” option in Mentor, the students’ protocol is put in queue for IRB review (and an email notification is sent to the administrator). We encourage students to clearly communicate with their faculty sponsor before submitting a new IRB protocol into Mentor. We also encourage the faculty sponsor’s to review all submitted materials.
For faculty members, they can submit a protocol for review at any time.
In both cases, the researchers must upload the necessary documents and click, “Submit Protocol for Review.” (see Figure 8).
In summary, Mentor is the hub for all IRB traffic. Navigating through Mentor is relatively simple if you are aware of these few guiding tips:
- There’s probably a template for most of your IRB protocol submission needs.
- Try searching Mentor for resources on how to submit a new protocol, you’ll likely find what you need.
- Keep in mind that not every resource on Mentor will fit your exact needs because every research project is unique. Use “Messages” in Mentor to ask your IRB administrator questions.
- Be sure to standardize file names on the documents you submit.
- Use the replace or edit features in Mentor if you make a clerical error.
- For students, check with your faculty sponsor prior to your final protocol submission.
- For faculty members submit a new protocol whenever you are ready.