IRB Application

Information on submitting research applications to committees other than the Institutional Review Board can be found on their respective committee pages. Investigators who are unsure about whether they will need to submit their research to other committees can make that determination by reviewing the information IRB Application Resources. These human subjects regulations decision charts may be helpful.

Information about submitting to internal versus external IRBs can be found in IRB Application Resources.

In order to begin the process of submitting the first application to the Institutional Review Board, the following steps will need to be complete:

  1. CITI training must be complete, more information is available in IRB Application Resources.
  2. Register in eResearch.
  3. Conflict of interest (COI) form. A COI form will be sent out electronically in the form of an email upon registration in eResearch. The investigator or staff member will need to complete the COI form electronically every year.

Once the above steps are complete, the application can be created and submitted in eResearch by following the instructions in IRB Application Resources.

It is important to keep in mind that there are other documents that must be provided along with the application.  

For more information, please contact hmhirb@hmhn.org or 201-880-3669.

Frequently asked questions can be found here.

A memo that includes common problems with eResearch applications can be found here.

IRB Application Resources

All study team members MUST complete CITI training before any research initiatives can be conducted at Hackensack Meridian Health. The training assigned will be determined based on your answers to a short series of questions that will be posed when you register initially. These questions will be about the types of research that you will be conducting.

To register, go to: https://www.citiprogram.org and click on “Register.” Select your Organization Affiliation by entering Hackensack Meridian Health.

If you have already completed the CITI training at another institution outside of Hackensack Meridian Health, you will need to go into your CITI account and select the option to “Affiliate with Another Institution” and select Hackensack Meridian Health, in order for your completed training courses to be shared with this institution. Once you do that, it will be determined whether the courses taken are sufficient or whether additional coursework is needed to meet the requirements at this institution.

Below are some of the most frequently asked questions about CITI:

Are all these modules necessary?

Research is highly regulated, and conducting it properly requires knowledge of the regulations and guidelines that govern the field. We have consulted with individuals from other organizations and with CITI and have been assured that our requirements are consistent with those of comparable institutions. Our suggestion is to start the training in advance, so that you are not overwhelmed by trying to complete it all in one day. We are continually reviewing our program to ensure that we are offering the most appropriate training.

What if I don’t fit into any of the categories mentioned on the enrollment questions?

If you don’t fit into any of the categories mentioned, choose the training that most closely represents your interests/work.

What if I have been assigned modules that are unrelated to my line of work?

It is possible that not every module will relate to you directly. It would be difficult to individualize the training much more than we have. However, if you believe that you may have selected the wrong options on the enrollment questions or have another type of specific concern, please reach out to us.

Have I been assigned modules that are redundant?

Some of the assigned modules may be similar in content. However, you should not be assigned modules identical to those that you have already completed (and are unexpired). If you believe that to be the case, please reach out to us or CITI (888-529-5929), and you can discuss your case individually. If you have completed CITI training at another institution, affiliate with Hackensack Meridian Health, so that the courses can go towards our institution’s requirements. There have been some cases where the courses haven’t been transferred even after affiliating. If you suspect that that is the case, call CITI to have them transfer the courses manually.

What is the difference between internal and external institutional review boards?

An internal, or local, Institutional Review Board (IRB) is the institution’s IRB, or the Hackensack Meridian Health IRB (HIRB). It is a system-wide institutional review board that only reviews research that is being conducted within the network. An external IRB is an institutional review board that is an outside entity. It is also referred to as a central or commercial IRB. These types of IRBs work with many research programs and institutions. Some examples of external IRBs include Western IRB (WIRB) or Central IRB (CIRB).

How is it determined whether a study will go to an external or internal IRB?

If the study is supported by a commercial sponsor/pharmaceutical company, they generally require a central/commercial IRB to review the study on behalf of all the sites involved. Additionally, due to the changes to the Common Rule (the federal regulations governing human subjects research), if a multi-site study receives federal funding, then a single IRB of Record is required. The Research Integrity Office has Master IRB Reliance Agreements (agreements detailing how one IRB can relinquish jurisdiction to another IRB) in place with several central/commercial IRBs.

How are the processes different? What does the PI have to do differently?

Initially, the process is the same regardless of which IRB serves as the IRB of record. In both cases, the PI will need to complete a new submission through the local IRB system. If the PI is utilizing an external IRB, the application through the local system will be abbreviated and will be in addition to the external application. The PI will need to provide the local IRB with the approval documents once received from the external IRB. In addition, it is necessary to utilize the IRB of record’s ICF and add in local content information such as injury language, local contact information, confidentiality language, and disclosure of financial conflict of interest.

Please note: Although a study can be opened by any member of the study team, ONLY the Principal Investigator (PI) can submit the complete application.

The submission process requires the following THREE steps:

STEP 1: Create And Complete The New Study Application

  1. On the left-hand side of the study workspace, under “Create” click on the “New Study”. Your study is now open and will be in “Pre-submission” until completed and submitted by the PI.
  2. Fill the applicable items in every page of the application and then click “Continue”.

The fields marked with an asterisk (*) are mandatory and you cannot move to the next page without providing the required information.

  1. Make sure your protocol is uploaded in section 2 (item 12) and all other supplementary material (collection tool, informed consent form etc.) are uploaded in section 8.1.
  2. The application is automatically saved every time you click on the “Continue” button UNLESS you have uploaded a document in which you will need to manually save the application. To do that, click the “Save” button located on the top banner.
  3. To make sure that you have not missed any required field, click on “Hide/Show Errors” also located on the top banner.
  4. For any section that is marked “MISSING REQUIRED FIELD”, click on the name of the section under “Jump To” (located on the top banner). The application page for that section will open so the appropriate answers can be supplied.
  5. In order for the study to be ready for submission, all missing required fields must be answered.
  6. If you choose to complete your application on a different time, click the “Save” and then the “Exit” button, both located on the top banner.
  7. Until you submit your application, you can return to it as many times as you need.

To access your application to go the “Edit Study’ Button located on the workspace on the left-hand side of the study.

STEP 2: All Co-Investigators Must Agree to Participate In the Study

  1. Co-investigators may indicate their agreement to participate in the study at any time. To do so, after logging into the eResearch system, they must click the “Agree to participate” button under My Activities in the study workspace found in the left-hand side.
  2. In the new window that opens up, they must select Yes or No to indicate their agreement, then click the “OK” button.
  3. If a co-investigator indicates that he/she does not agree to participate in the study, they must be removed from the application before the application can be submitted by the PI.

Please note: For a co-investigator to be able to agree to participate, he/she must have completed the required CITI training.

STEP 3: The Principal Investigator Must Submit The Application.

  1. Once the application is completed ONLY the PI will be able to submit the application. To do so, the PI will have a “Submit Study” button under My Activities (left-had side workspace).
  2. If the application is not complete, a list of missing fields will appear. The application must be complete before it can be submitted.
  3. Click the “Submit Study” listed under My Activities. IRB is the specific IRB the study is being submitted to.
  4. In the new window that opens up, read the Principal Investigator’s Assurance and indicate your agreement by checking the “I Agree” box. If you are a trainee or a student, also indicate your agreement to the Trainee/Student Investigator’s Assurance.
  5. Click the “OK” button.

Please note: The PI will not be allowed to submit the study until all co-investigators have agreed to participate.

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