2020 – Institutional Review Board (IRB)

November 12, 2020dsomerville No Comments

Instructions for locating and submitting forms required for amendment or renewal of approved studies in IRBManager

You have submitted and received approval for your IRB application (yay!). Now you have to submit another form to make changes to your original study (amendment), acknowledge a reliance agreement with another institution, request a continuation for your study (renewal/termination form) or terminate your study (renewal/termination form).

All subsequent forms submitted have to be processed through the study page of the initial submission. The initial application established a study page with your study number. Your study number should be connected to every form that is submitted for that particular study thereafter.

You access your study page by clicking on the hyperlinked study number on your home page. Once you click on your study number, that will take you to a page that looks like this.

Notice that your study number is at the top of the page. When you look on the side column, you will notice the “start x form” in the side toolbar (circled below). Push “start x form” on your study page and that will take you to the next screen.

You will see all of the forms you can use in relationship to your study number. From here, you should be able to submit your form.

If for some reason you are not able to access your study page, please contact the IRB Office.

Here is a short video that provides instructions.

November 12, 2020dsomerville No Comments

Not sure if your form was submitted properly? Here is how you can be absolutely sure.

If it’s been weeks since you’ve submitted your IRB form and you are wondering why you haven’t heard back yet, there is a likely chance that you haven’t completed the submission process.

Each form requires two steps for submission: sign and submit. If you have seen a screen that asks for you to enter your username and password, then you haven’t signed off on your form. If you haven’t seen a submit screen, then you haven’t actually submitted your form.

Here is what you should look for.

After you enter your information in the form, push “next” at the bottom of your form. On the next screen you will see a page that asks for you to sign off on your form. Push “sign” and this will take you to a screen that asks for your username and password, same as when you log on to IRBManager. Once you complete that step, you should see this screen.

This screen verifies that you have actually signed your form. You will need to push next again to go to the next screen.

When you push “submit” your form will be sent to the next level of review. If you are a student, your faculty advisor will receive the form. If you are a faculty or staff researcher, your form will go to the IRB Office.

Once you see the above screen, your form has been submitted.

If you have completed these steps and you require your faculty advisor to sign off on the form, please make sure that your faculty advisor has done so. Once they have signed off on the form and you still haven’t heard back in two weeks, then please reach out to the IRB Office to make sure that your form has been reviewed.

August 19, 2020dsomerville No Comments

Planning to use crowdsourcing for your research study? Here are a few tips.

You’ve decided that you are going to recruit your participants using crowdsourcing. As a student, you may not know much about it, but you figure that it shouldn’t really be difficult to pull off. You’ve considered using Amazon MTurk, but wonder if there are other sources to consider. You have a (limited) budget and want to use it to pay eligible participants for your study. Your faculty advisor isn’t familiar with it, or has little to no knowledge about how it works. You feel this will be the best and easiest way to go about this process, and time is passing each day you delay. What do you do?

Where do I start?

Speak with your advisor about your interest and options. The IRB has found that when student researchers include their faculty advisors and mentors in their plans and gauge their level of knowledge or interest in their plans, the student has a much better chance to carry out those plans successfully. if your faculty advisor is not knowledgeable about crowdsourcing, there are other faculty who are. Reach out to them with your faculty advisor, so that you both learn about the process together. The IRB can refer you to faculty who have used this recruitment process numerous times. If for some reason you are unable to speak with your faculty advisor in earnest about this, then consider another person to fill that role. If you wait too long for them to get back to you, then you risk putting yourself in a situation that can be avoided by working with a more responsive faculty advisor.
Take the time to read more about it to make sure that this is what you really want to do. Here is an article that can jumpstart your research. A beginner’s guide to crowdsourcing (1) includes some useful information, links and references.

How do I fill out your IRB application?

Once you click on the link to IRBManager, the online submission system, use the information provided in the area of this blog titled, “application checklist”.
When discussing your plans to recruit your participants in your IRB application, keep in mind that the IRB is concerned about what the recruitment process will look like from the perspective of your participants. The IRB wants to know how you will reach them, what they will learn about the project and whether they will be compensated for their participation. The IRB will flag any studies that don’t clarify these three points. The IRB needs make sure that your study provides everyone the same opportunity to participate (unless you have some reason to exclude people based on your research aims). that no one is unduly influenced by your study, and that compensation is reasonable in relationship to their time and effort contributed to the study.
1. If you are are planning to recruit participants using crowdsourcing, state this outright.
2. Once you’ve established that crowdsourcing will be used, explain which tool will be used (Amazon MTurk, Prolific, Qualtrics, SONA). Each tool has very different processes for how end users are selected and engaged in your study. Know the differences and be prepared to discuss the relevant choice to the IRB. Will they be paid an estimated amount based on the anticipated time it will take to fill out the survey? Are there specific guidelines specified by the crowdsourcing platform that inform your decision? If so, what are they? What is the form of compensation? Will they have to complete the survey to receive payment?
3. DO NOT use a third party system different from the crowdsourcing platform to carry out any part of the study. Keep the consent form, study materials and any additional information relevant to participants within the crowdsourcing platform. To make a different choice will cause problems that may compromise the anonymity of your study and complicate the process for participants, which can show up as harm depending on what occurs. And finally, this will cause problems for you and delay the time it takes for you to complete your research.

Have additional questions? Contact the IRB Office at x2449 or research@roosevelt.edu.

August 5, 2020dsomerville No Comments

Why haven’t I heard back from the IRB about my study yet? It’s been a while…

You submitted your IRB application, Renewal or Termination and may not be sure sure why you haven’t heard back from the IRB. Here are a few reasons why this may be the case:

You are a student whose faculty advisor did not sign off on your study. This is the most common issue for why this happens. Every student study submitted to the IRB requires approval from your faculty advisor. If you haven’t been in touch with your faculty advisor, check in with them to find out if they actually reviewed your study after your submission to the IRB. Faculty advisors are now responsible for agreeing to providing proper oversight over student research that requires IRB approval and to provide a one-page plan on how they will monitor student research projects. Once a faculty advisor completes that process and actually pushes the “submit” button, then the project comes to the IRB for review. If your study is sent back to you during the pre-review, review, and post-review stage (if a full board study), then your faculty advisor is required to review and submit it again before the IRB reviews your changes. Keep in contact with your faculty advisor to make sure that they are actually responding to emails received from IRBManager.
You are a PI with a different submitter for your study. The IRB application has a place to indicate whether the person is the submitter and/or PI. If that person is one in the same, then the submission should move forward without an issue. If a student or staff person submits a study on behalf of someone else, then the system requires that the PI sign off on the study prior to IRB review. The IRB Office sees numerous studies at this stage all the time. Please be sure to check for emails from the IRB Office, or research@roosevelt.edu. You likely have been sent an email that requires your attention and response. Once you receive an email notification from the IRB, please go into your study, review it and push “submit” to complete the submission process.
You did not use your actual Roosevelt University email address to submit your study. All study information is tied to your Roosevelt profile. The system recognizes this information for everyone to have single sign-on access through Roosevelt and to access your CITI training information. Any submitter that uses a personal email address while accessing IRBManager or providing contact information for the IRB Office to process is creating a situation that confuses the system’s ability to recognize you as a submitter. Applications submitted with private contact information are not processed by the system and require the IRB Office to delete the second contact information and for the submitter to begin again with another form.
You didn’t actually complete the submission process by pushing “submit”. We have found that many submitters simply do not push “submit”. The submission will only be completed once this task is completed.
You received an email notification requesting changes to your application that you haven’t responded to. Please be sure to check your emails to make sure that you are being responsive to any feedback, questions, or required changes to your study.
If you have addressed any or all of the above concerns and you are still haven’t received a response in 5-10 business days following your submission, please check in IRBManager to see if there has been a status change to your submission. If it shows as “under review” please call or email the IRB Office to inquire about the status of your study for exempt or expedited studies. If your level of review is full board, please know that it will be reviewed at the next full board meeting. If your level of review is exempt or expedited, it will be reviewed by one or two IRB reviewers, which should not take as long. Please contact the IRB Office (dsomerville@roosevelt.edu) if the review time has been longer than 10 business days for your exempt or expedited study.

April 1, 2020lstanton04 No Comments

Cooperative Research and the New Common Rule

By LaVonneDowney, Ph.D.

So, what does the new common rule say about cooperative research? First of all, let’s define cooperative research which is research “involving more than one institution”. Previously, both institution’s IRB would review the research which extended and often duplicated the review process for all involved, especially researchers. The new Common Rule wants to avoid having to duplicate IRB reviews and make the process more cooperative. This can be done by having an IRB Authorization / Reliance Agreement. The simplicity of the solution a cooperative /authorizing agreement belies the potential complexity involved. This is in part, due to issues involving whose IRBis doing oversight. Each institution is still responsible for safeguarding the rights and welfare of human subjects and for complying with applicable laws and regulations. Thus, certain steps have to be outlined in any agreement.

These include the following :

Determining when other IRBs are involved, and whose guidelines are followed
Determining which IRB has the expertise to be the led for example a medical institution might have more experience and structures in place to oversee medical patient-based research than a non-medicine patient-based research university.
Determining the time frame of the agreements defining their respective responsibilities in connection with the research; such as where data is stored
Communicating as appropriate with the other involved IRBsNotifying investigators of any special expectations with regard to the conduct of multi-site research.
The University IRB should determine prior to the initiation of research how it will solicit and review reports of unanticipated problems involving risks to subjects or others thus, certain steps have to be outlined in any agreement.

Again, the good news is this can all be done through cooperative agreements, intra-institutional, reliance, and authorizing agreements. You can find the current IRB Reliance Agreement here under “Sample Consent Forms“. The neutral news is that this process is often like negotiating a contract, often between two entities with differing layers of requirements and procedures. Thus, the process of creating and moving towards an agreement should start as soon as possible with the understanding that it might take time for both parties( IRB ) to agree on all the details. The helpful news is that the research office can help you with the process. Please use these resources so both sites are working together with their respective strengths to ensure ethical research is being done.

April 1, 2020lstanton04 No Comments

COVID-19 Policy Update

All studies involving person-to-person contact are being reviewed based on whether protocols are well aligned with Roosevelt University, CDC and State of Illinois guidance
Any studies involving person-to-person contact on any Roosevelt University campus must include within the IRB application acknowledgement of Roosevelt University COVID-19 mandates for all vaccinated and unvaccinated participants and research personnel.
The IRB is committed to ensuring that all study protocols submitted for review reflect the most recent recommendations and mandates from the Roosevelt University COVID-19 Task Force. As the Task Force provides updates to the university community, so shall the IRB update and adapts its requirements for all protocols.

SUMMARY

Given federal, state, and university stay-at-home guidelines, the Roosevelt IRB is adopting additional precautionary measures to ensure the continued protection of researchers and research participants. Please stay in touch with the IRB if your study (whether ongoing or in development) may be impacted.

Stay safe and be well.