Is it research

The principal investigator (PI) is the individual responsible for all aspects of the design and conduct of the study.

• A PI must have relevant research and/or clinical experience to serve in this role,

• A PI must receive specific training in human subjects protections.

• Each study may have only one PI.

The following are minimal institutional criteria for the study PI at the NYS Psychiatric Institute (NYSPI)/Columbia University Department of Psychiatry (CUDP). The PI must have an appointment in the CUDP, RFMH or NYSPI as follows:

• NYSPI research psychiatrists and those designated as psychiatrist II or III, or

• OMH or RFMH Research Scientist V or above, or

• Those who hold the rank of Assistant Professor or higher.

• Do I need approval from an IRB in addition to the NYSPI IRB?

• What are the requirements for human subjects research?

• Does my research require review by the NYSPI IRB?

• Helpful Hints – learn the ropes; see one, do one, teach one; Consult with other investigators in your divisions; an IRB protocol should not look like your grant; do not submit a sponsor consent form without revisions.

Is it research?

• How is research defined?

• I’m just analyzing data. Do I need IRB approval?

• My study has no patients. Do that mean I don’t need IRB review?

• Do I always need IRB approval if I plan to publish?

• Do I have to get IRB approval to write a case report?

• If I evaluate a course I’m teaching, is that research?

• You said I need IRB review, but the regulations say my activity is exempt.

• Does chart review require IRB review?

 

PSF, ACAR, FastTrack, and Close-Out Details

- What is a Protocol Summary Form (PSF) in PRISM?

- What is an Application for Continuing Review of Research (ACAR) in PRISM?

- What is a Fast Track Form?

- What is a Study Close-Out Form in PRISM?

 

How to Submit

- How do I submit any form to the IRB?

- How do I create and submit new protocols in PRISM?

- How does the Research Chief approve and submit new protocols in PRISM?

- How do I submit an amendment through PRISM?

- How do I submit an annual renewal/continuation?

- Is the 5 year renewal submission process through PRISM different from an annual review?

- How do I submit a close-out memo?

- How do I submit a Fast Track Form?

- How do I submit the new Uploaded Protocol Summary Form?

- How do I register to receive a login and gain access to PRISM?

 

Re-Submit Forms to the IRB

- How do I proceed after the IRB sends my form back for revisions?

- Do consent forms, recruitment material, etc that have been uploaded to a form during initial submission need to be uploaded again while re-submitting for review/approval after revisions?

 

Is it research?

• How is research defined?

According to the federal regulations...Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

• I’m just analyzing data. Do I need IRB approval?

Secondary analysis of data collected originally with IRB approval and appropriate consent does not require IRB approval when the data is truly anonymous,  publicly available, or otherwise does not involve participants.  The PI IRB requires you to submit this research for review and we will determine if these conditions are met.

• My study has no patients. Do that mean I don’t need IRB review?

Research and the regulations which govern it are concerned about subjects, participants, or volunteers who may or may not be patients.  If you are doing research and it involves individuals who fulfill  the federal definition of "human subject," then IRB review is required.

• Do I always need IRB approval if I plan to publish?

Not at all. While usually the plan to publish suggests your intent is to create "generalizable knowledge," the activity itself must fulfill the entire definition of human subjects research to require IRB approval. Not sure? Email us.

• Do I have to get IRB approval to write a case report?

A typical case report, retrospective, descriptive, based on a single or small series of cases managed clinically by the author, generally does not qualify as "a systematic investigation designed to create generalizable knowlege." However, whether informed consent is appropriate should be carefully considered. Also, see more under chart review.

• If I evaluate a course I’m teaching, is that research?

There are no fine lines between human subjects research and program evaluation/quality assurance activities.  Sometimes this work is considered research which requires IRB review.  It depends on how and why you are doing it.  Is what you are evaluating a research intervention?  Is the intent or methods of  the evaluation consistent with the definition of research (does it involve human subjects, is the aim to create generalizable knowledge)?  If yes, you need IRB review.  If unsure, send us a query.

• You said I need IRB review, but the regulations say my activity is exempt.

Glad you took the time to read the regulations, but in this case, a little bit of knowledge.... As it turns out, the PI IRB is not permitted, under a longstanding State regulatory arrangement, to exempt any human subjects research from IRB review. We think it's a drag too.

• Does chart review require IRB review?

A chart review involves human subjects under the federal regulations when private and identifiable (or coded) information is accessed.  If the aims of the review are research (" a systematic investigation...), then IRB review is required.  In most cases, a waiver of informed consent can be justified when the conditions specified in 45cfr46.116(d) are met.

 

PSF, ACAR, FastTrack, and Close-Out Details

- What is a Protocol Summary Form (PSF) in PRISM?

The Protocol Summary Form (PSF) is a form in PRISM that gets generated when you submit a new protocol or a 5 year continuation to the IRB

- What is an Application for Continuing Review of Research (ACAR) in PRISM?

Federal regulations and OHRP guidance are quite clear about the requirements for continuing review: all studies need to be reviewed for approval at least annually. The Application for Continuing Review of Research (ACAR) is a form in PRISM that lets you submit your annual renewal online. 

NYSPI requires all studies to be reviewed as if new after five years. You do not have to submit an ACAR for a five-year renewal. When submitting a five-year renewal through PRISM, you will have to click on "Start a new draft protocol or 5 year continuation" after you log into PRISM and create a new draft protocol.

- What is a Fast Track Form?

A Fast Track form can be filled out and submitted when the investigator needs to make revisions to material that does not require a change to the Protocol Summary Form (PSF). The IRB is currently accepting Fast Track forms only for recruitment material.

- What is a Study Close-Out Form in PRISM?

A Study Close-Out form has to be filled out when the study has been completed. It has to be submitted when subjects have completed participation including all follow-up activities AND data analysis is complete.

 

How to Submit

- How do I submit any form to the IRB?

Log into PRISM and click on the ‘My Studies’ tab. Search for the protocol by protocol name or IRB #. Click on the protocol to go to the protocol menu. Click ‘view related forms’ to view all forms that have been created for that protocol. Click the ‘Menu’ icon of the form that has to be submitted. Click ‘send form’ under the form menu and select the most appropriate option from the list of choices provided.

Alternately, while editing the form, a ‘send form’ button pops up on the page that will allow you to submit your form after the page is completed and saved.

- How do I create and submit new protocols in PRISM?

After you log into PRISM, click ‘Start a draft protocol or 5 year continuation’ to create a new study. Fill out the information on that page and then click on ‘Open protocol’ to view the protocol summary form. Fill out all the sections in the form and hit the workflow options/send form button to submit it. Choose ‘Forward to Research Chief for initial approval (ALL NEW PROTOCOLS & 5 YEAR RENEWALS)’ to send it across for Research Chief Approval. The Research Chief will be notified of your submission by email and he/she will send your submission across to the IRB after approval.

***A 5 year continuation is treated as a new protocol in PRISM and will have to be submitted as a new protocol. It will be assigned a new IRB #. For more information on 5 year continuations, please click here.

- How does the Research Chief approve and submit new protocols in PRISM?

The Research Chief will receive a notification by the PI via email when a new submission is sent for approval. After the Research Chief logs into PRISM, he/she will see a tab on the left hand side of the page that will say 'Research Chief'. On clicking it, he/she will be able to view Protocol Summary forms that require review.

- How do I submit an amendment through PRISM?

Log into PRISM and click on the ‘My Studies’ tab. Search for the protocol by protocol name or IRB #. Click the protocol title to go to the protocol menu. Click ‘start a new amendment only’ under the protocol menu. You will be directed to a page that will display all the PSFs that are there in the system for that protocol. Select one to make a copy, make revisions to this editable version and hit the 'send form' button to submit it. Choose ‘Submit directly to IRB’ to send it across to the IRB.

Note: If the system does not contain any PSFs for the specified protocol, you will be given the option to create a brand new PSF form from scratch. You also have the option to submit a hard copy.

- How do I submit an annual renewal/continuation?

Log into PRISM and click on the ‘My Studies’ tab. Search for the protocol by protocol name or IRB #. Click the protocol title to go to the protocol menu. Click ‘start an annual continuation with or w/o an amendment’ under the protocol menu. You will be directed to a page that will display all the PSFs that are there in the system for that protocol. Select one to make a copy, make revisions to this editable version and hit the 'send form' button to submit it. Choose ‘Submit directly to IRB’ to send it across to the IRB..

Note: If the system does not contain any PSFs for the specified protocol, you will be given the option to create a brand new PSF form from scratch. You also have the option to create a new ACAR form from scratch and submit to the IRB.

- Is the 5 year renewal submission process through PRISM different from an annual renewal?

Yes, the submission process is different for a 5 year renewal study. The IRB treats a 5 year renewal study as a new study and at 5 years, IRB protocols are assigned a new number with an “R” suffix. When submitting a five-year renewal through PRISM, you will have to click on "Start a new draft protocol or a 5 year renewal" after you log into PRISM and create a new draft protocol rather than creating a new PSF under your existing protocol number. 

An investigator may request a waiver of this 5 year review when the study is closed to new enrollment.

- How do I submit a close-out memo?

Log into PRISM and click the ‘My Studies’ tab. Search for the protocol that you wish to terminate by protocol name or IRB #. Click the protocol title to go to the protocol menu. Click ‘Start a new IRB form’ to create a close-out memo (CloseOut).

- How do I submit a Fast track Form?

Log into PRISM and click the ‘My Studies’ tab. Search for the protocol that you wish to create a FastTrack for by protocol name or IRB #. Click the protocol title to go to the protocol menu. Click ‘Start a new IRB form’ to create a Fast Track Form (FastTrack).

- How do I submit the new Uploaded Protocol Summary Form?

In this section you have the option of uploading a portion of your Protocol Summary Form in PDF format.  This functionality will significantly reduce the amount of time required to enter the protocol information in the PRISM system.  If you choose to upload your Protocol Summary Form, you must use the word template found on the NYSPI Institutional Review Board website.  You are not required to use this option and may continue entering the required PRISM information to submit your protocol.  To use this option, select “Yes” for the first question and follow the directions below.

  1. Obtain the Protocol Summary Form Word template from the IRB website. This template is found on the ‘Forms’ tab, under the PRISM section. This template is protected and only the highlighted areas may be changed.

  2. Complete the protocol information on the template.  Depending on the type of protocol being submitted, not all of the sections within the template may be required.  Please be sure to verify which sections are required for your protocol.  Any sections not complete will result in your submission being returned to you. 

  3. When you are complete, save this document as a PDF.  Word allows the user to select options when choosing this format.  Be sure to select the option “Create Bookmarks Using.”  The  select “Headings” to create bookmarks in the saved PDF.   These bookmarks will be used in the final Unified PSF.

This PDF can be uploaded at this time.

- How do I register to receive a login and gain access to PRISM?

Click on the REGISTER link on the top right of the NYSPI IRB website to request a login and access to the PRISM.

 

Re-Submit Forms to the IRB

- How do I proceed after the IRB sends my form back for revisions?

You will receive an email from the IRB through PRISM that your form has been released for editing. You can view the IRB memo, edit and re-submit the form by following the links sent out in the email.

Alternately, under the form menu, click 'edit form' to make revisions to your form. Please indicate changes in bold, delete old attachments if not required from the 'Uploads' section of the form and re-upload revised bolded and unbolded copies for review and stamping. Do not delete forms that continue to be part of the protocol, just because those particular forms do not require revision.Click 'send form' from within the form or the 'send form' icon from the form menu to re-submit. You will be asked to complete a couple of steps during this process. The submission is completed when your form status changes to 'Submitted to IRB'.

- Do consent forms, recruitment material, etc that have been uploaded to a form during initial submission need to be uploaded again while re-submitting for review/approval after    revisions?

Any material requiring review has to be uploaded to the 'Uploads' section of the form. During every submission of your form to the IRB, the Uploads page should include all of the parts of the complete document as you intend for the IRB to review it. If documents have been revised, you will have to delete the old ones and re-upload bolded and unbolded copies of revised documents. Do not delete attachments or sections, previous to submission, unless you do not wish for them to be reviewed, approved and/or stamped.

Everything that gets uploaded to the Uploads page of the form are final documents that will be considered for approval and will be stamped accordingly.