There are some questions that keep coming up. We have included a number of them here. If you don’t find the answer to your question in this section, you may contact the IRB at IRBMAIL@nyspi.columbia.edu, and someone will try to help you. The main headings and subheadings are listed below. Please scroll down to find your area of interest. For further guidance please see the Office for Human Research Protections (OHRP)
I. Getting Started
Do I need IRB approval before I submit my grant?
No, you do not. For NIH funded studies, approval by an Institutional Review Board (IRB) is no longer required before NIH peer review of the grant application. Since 2000, researchers are expected to submit their research for IRB review "Just in Time"—only after they have received their Summary Statement ("pink sheet") notification of priority score/percentile or otherwise learn that the grant is in the fundable range. That said, sometimes "Just in Time" is not enough time. For particularly complex, novel, high-risk or multi-site studies, please consult with us to determine how to time your IRB submission.
Who may be a principal investigator?
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; however, due to FDA requirements in regards to Investigator-held INDs, we have created a designation for PI and Contact PI. If you have questions about this, please contact us for further information.
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.
What are the qualifications for Research Chief who signs off on a new PSF prior to submitting to the NYPSI IRB?
A Research Chief must be a PhD or an MD with research experience and receive specific training in human subject protections (CITI training).
They are required to confirm that the protocol submitted has been prepared and reviewed by appropriately qualified members of the department's staff, and the investigators are appropriately qualified members to carry out the study.
They must confirm that they approve the use of departmental space and resources to carry out the study.
The Research Chief must confirm that they have reviewed and approved the protocol for submission to the IRB.
The Research Chief will be asked to attest to each of these items for each new protocol submitted by investigators within their division.
Do I need approval from an IRB in addition to the NYSPI IRB?
If your research at another facility or institution requires local IRB review, but that site does not have an IRB, the NYSPI IRB can consider serving as the IRB of record for that institution. See directions for how to request such an arrangement.
If your research includes other Office of Mental Health facilities, you may not need separate IRB approvals for each site. Learn more about OMH multi-site approvals.
What are the requirements for training in human subjects research?
All those who play a significant role in the design, conduct, or oversight of research that is reviewed by the NYSPI IRB are required to complete a web-based instruction course known as "CITI" (Collaborative IRB Training Initiative).
Does my research require review by the NYSPI IRB?
Yes, if the research...
is sponsored by (funded through) this institution (NYSPI or RFMH), or
is conducted by or under the direction of any employee or agent of this institution in connection with his or her institutional responsibilities, or
is conducted by or under the direction of any employee or agent of this institution using any property or facility of this institution, or
involves the use of this institution’s non-public information to identify or contact human subjects or prospective subjects.
Also, as per an amendment to a cooperative agreement with CUIMC, all research originating in the Department of Psychiatry at Columbia is reviewed by the New York State Psychiatric Institute IRB for CUIMC. Research submitted by a faculty member with a joint appointment in Psychiatry and another Columbia Department shall be reviewed by the NYSPI IRB when:
The research is in a field of Psychiatry or related disciplines or NYSPI or Research Foundation for Mental Hygiene ("RFMH") patients, personnel, records, space, or funding is involved.
In other circumstances, the Columbia Health Sciences IRBs conduct review of such research for Columbia and, when applicable, NYPH.
May I consent my own patients into a research study?
No. Clinicians/physicians may not consent their own patients. The Declaration of Helsinki, item #27 states: "When seeking informed consent for participation in a research study the physician must be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress. In such situations the informed consent must be sought by an appropriately qualified individual who is completely independent of this relationship."
Take some time to learn the ropes
You will save yourself and your colleagues time by becoming familiar with the IRB's policies and procedures and the federal regulations upon which our rules are based. Start with the CITI training, use the information on this website, ask questions of an IRB member who works in your division or field, and if your research group is interested in an in-service training about human subjects protection and NYSPI IRB procedures, we will gladly arrange one with you. Finally, consider sitting in on an IRB subcommittee meeting.
See one, do one, teach one
Learn from the expertise of others. Preparing and submitting research for human subjects review should be an important part of the training for all research staff. Devote time to it. Ask your colleagues to share their approved protocols and consent forms with you, ask them to comment on yours. Share your knowledge of the IRB process and what works and doesn't with others on your team and in your division. Learn to discuss consent with subjects by observing more senior researchers and observe and supervise your junior team members. See one, do one, teach one.
Consult with other investigators in your division
Why re-invent the wheel? Discuss your study with others who have approved studies using similar methodologies or populations. Review their approved studies. Many investigators have developed considerable expertise in navigating rocky shoals of IRB review. Use them, and if you don't know who they are, ask us.
The IRB protocol should not look like your grant
Grants and sponsor protocols tend to focus on methodology and procedures from the investigator's perspective, not the human subject point of view. When investigators cut and paste extensively from the grant or sponsor protocol, they tend to provide information not needed by the IRB (how to ship blood specimens, the feasibility of recruitment strategies) and omit information that is required (how long will someone be in the scanner, who will be involved in carrying out the study procedures). Write your protocol after you have thought through the study with human subjects and NYSPI IRB requirements in mind.
Never submit the sponsor consent form without revision
Never sounds strong, we know, but let's just say that consent forms written in-house at the major pharmaceutical companies aren't always written with the ideal of informed consent in mind. Most seem like liability documents, providing information to protect the sponsor, not facilitate a choice by a prospective research participant. In form and content, they require re-thinking and re-writing. For example:
- The alternatives section shouldn't be buried after nine pages of mind-numbing detail about each and every study visit. The presentation of ways to treat the condition outside of research participation should be presented clearly after the study purpose is introduced (in the form and in the process).
- There is no need to provide too much detail about each EKG and blood test and study visit. Summarize what the study visits will involve once.
- Revise the consent so it doesn't hide the fact that subjects will never learn what their treatment assignment or dose was in "pivotal" /FDA registration trials. Explain the impact that blinding will have on post-study treatment decisions.
- Carefully and simply explain what the treatment conditions are and what randomization involves.
- Revise the sponsor consent so the risks of delay to treatment and worsening as a result of treatment with ineffective treatments or placebo are described and discussed prominently.
- Describe the most serious risks and most frequent risks of the drug, and make sure subjects know how many people have been treated with the drug previously so you can help them put risks and adverse events in context (for example, don't provide assurance that the drug is well tolerated when only 6 people have been treated with it).
- Long lists of side effects don't provide information that is useful.
- Make sure it reads at the 8th grade level and is appropriate in length for the study population.
Please see the Consent section under Procedures for more information on everything from the principles of consent to sample language.
II. What is Considered 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 am 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 human subjects. The NYSPI IRB requires you to submit this research for review and we will determine if these conditions are met.
My study has no patients. Does 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 necessarily. 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 knowledge." However, whether informed consent is appropriate should be carefully considered. Also, see more under chart review.
If I evaluate a course I am teaching, is that research?
There are 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. As it turns out, the NYSPI IRB is not permitted, under a long-standing New York State regulatory arrangement, to exempt any human subjects research from IRB review. So even if you think your activity is exempt, it does require NSYPI IRB review at this time. To explain further, the federal regulations are the first regulatory requirement but state requirements may be more restrictive. In the case of New York State for OMH facilities, which NSYPI is considered, exempt categories of research are not recognized due to the vulnerability of the populations we serve. Again, thank you for looking into the federal regulations, but in this case, the state requirements need to be met.
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.
If I remove the identifiers from my data, do I need to submit a continuation application for data analysis every year?
If you remove all Protected Health Information from your data, you may submit a Close-Out form in PRISM to close out the study. You must attest that you will not re-identify the data. No further IRB review is required.
What are the 18 HIPAA Identifiers?
Geographic subdivisions smaller than a state (e.g., street address, city, county, etc.)
All elements of dates (except year) for any date directly related to an individual, including dates for birth, admission, discharge, and death, and all ages over 89
Electronic email addresses
Social Security number
Medical record numbers
Health plan beneficiary numbers
Vehicle identifiers (license plates and serial numbers)
Device identifiers and serial numbers
Biometric identifiers, including genetic information, finger, or voice prints
Full face photographic images and any comparable images
Internet Protocol (IP) address numbers
Any other unique identifying number, characteristic, or code that is derived from or related to the individual (e.g., initials, etc.)
III. Recruitment Materials
What needs to be reviewed by the IRB?
All direct public recruitment materials must be reviewed and approved by the IRB prior to the initiation of recruitment procedures. This includes websites, social media announcements, newspaper advertisements, postings and flyers used in the community and within the NYSPI-Columbia Presbyterian campus, brochures to be distributed in clinics, enrollment in web-based or other forms of referral services, etc. This material should be submitted to the IRB with the initial protocol submission if possible.
For more information, visit the Recruitment Materials page.
What materials do not need to be reviewed by the IRB?
IRB review is not required for general material regarding a study or clinic. This type of material is usually oriented towards the general public and includes articles, informational websites, and press releases. Material not requiring review by the IRB should be sent to Carla Cantor, Director of Communications, at Carla.Cantor@nyspi.columbia.edu.
To request a protocol exception (a one time change to inclusion/exclusion criteria, procedures, or any other element of the study), write to IRBmail.
What is the process for review and approval of recruitment materials?
All recruitment materials must be submitted to the IRB for review and approval before they are used and may be submitted via the FastTrack path in PRISM. When the IRB completes its review, it will issue a stamp on the approved material. The stamp will indicate the date on which the material was approved and the date on which IRB approval of the study is due to expire.
Copies of all recruitment material intended for use in the upcoming year should be included in the Application for Continuation of Research (ACAR). Only material with the NYSPI IRB Approval stamp may be used.
For more information, visit the Recruitment Materials page.
IV. Serious Adverse Events (SAE), Unanticipated Problems (UP), Protocol Violations (PV), and Other Reporting Requirements
How do I file an SAE/UP report?
All SAE and unanticipated problems (UP) reports are filed in PRISM under the tab titled "Start a Protocol Violation/Serious Adverse Event Form." SAE/UPs can only be submitted in PRISM under the login credentials of the study's Principal Investigator. No other member of the research team can submit an SAE/UP report through PRISM.
For SAE/UPs, the process begins with the SAE/UP worksheet. The SAE/UP worksheet questions are designed to help you decide if an adverse event requires reporting to the NYSPI IRB based upon the nature of the event, your assessment of its importance and the NYSPI IRB's responsibility for oversight of the research.
If the worksheet indicates "do not submit" or "do not proceed," you are not required to submit anything (not even the worksheet).
When does the NYSPI IRB have responsibility and when does it not?
If the CU or RFMH grants office funds research at the study site, we assume responsibility for the conduct of the study; therefore, all serious adverse events and unanticipated problems must be reported.
There are other circumstances where a NYSPI/CU investigator is assuming overall responsibility for a multi-site study, regardless of funding. Our responsibility is evidenced by the fact that the site is listed on the face page of the PSF, we approve enrollment at the off-site location, we require evidence of local IRB approval, and we approve their consent forms. If so, then all SAEs and unanticipated problems must be reported from the site. If a local IRB has reviewed and commented on the event, we ask that you include this information with your report. Supporting documents can be uploaded in PRISM with your SAE/UP report.
Do I need to submit something to the IRB when the sponsor sends me adverse event reports?
No, the distribution of unanalyzed adverse event reports from event site to sponsor to investigator to the NYSPI IRB doesn't assist the IRB with its responsibility to protect research participants. The NYSPI IRB requires reporting of adverse events from sites not under its jurisdiction only when the NYSPI Principal Investigator has reviewed the report and determined: a)the event is related to the study intervention, b) the event could impact the risk/benefit analysis of the study taking place at NYSPI, and c) the event would require changes to the consent form language.
- Example: You get many IND safety reports from the sponsor of your clinical trial since the drug is in widespread use in post-marketing studies. Those studies are usually unrelated to yours and your study population.
According to the worksheet, you must make a determination as to whether the event is related to your study intervention, if it impacts on your study's risk/benefit analysis, and if it requires changes to your consent form language. If the answer to all three is "yes", submit an SAE/UP report in PRISM. If the answer to any of the three is "no", do not submit a report.
- Example: You are the local PI of a clinical trial employing a medication marketed for a different indication. A series of adverse event reports are forwarded to you by the sponsor describing new evidence, from other performance sites of the same study, that the medication appears to be associated with a lowering of white blood cell counts. This appears to be an unanticipated problem related to the study intervention that changes the risk/benefit analysis for your study and requires changes to the consent form. Complete an SAE/UP report in PRISM.
How much information do you want in response to the following question on the SAE/UP report: Have any unexpected events, similar to the one you are reporting, previously occurred in this study or in any related studies?
Please use your judgment here. Review the adverse event history of the study or intervention and carefully consider if the current adverse event has more, or less, significance in the context of previous occurrences. While a single event may mean little, a series of events might be of importance.
It is certainly not helpful to submit an extensive outline of all events similar to the one you are reporting unless you are of the opinion that, in aggregate, the events potentially represent an unanticipated problem. However, we do think a brief summary statement in the comments section can address this question. If warranted, the IRB will request further information.
What happens in the IRB once I submit my SAE report?
All reports are reviewed by the IRB monitor, the IRB Chair or designee, or the Full Board, depending on the nature of the event and the perceived impact on study risks or benefits. The Full Board receives a periodic summary of all adverse event reports. This information is considered a central part of the continuing review process.
During initial review by the monitor or chairs, we will determine that:
- no further action on your part is indicated,
- additional information or analysis is required before a determination can be made, or
- review of the event by convened meeting of the IRB is required.
You will be notified of all determinations and actions.
How do I file a Protocol Violation report?
All Protocol Violation reports are filed in PRISM under the tab titled "Start a Protocol Violation/Serious Adverse Event Form". Protocol Violation reports can only be submitted in PRISM under the login credentials of the study's Principal Investigator. No other member of the research team can submit a PV report through PRISM.
Other Reporting Requirements
IRB leadership routinely discusses SAEs, UPs, and PVs with NYSPI administration and leadership in NYS OMH and RFMH Central Office.
Certain SAEs, UPs, and PVs require the institution to provide a report to the Office of Human Subjects Research, the funding agency (e.g., NIH), or the study sponsor. We will discuss this with you when necessary.
Principal Investigators are responsible for familiarizing themselves with other requirements. For example:
Local incident and adverse event reporting requirements at the research site.
NYSPI has a separate incident reporting policy when Office of Mental Health patients are participants. Contact the Office of Quality Management for information.
Requirements of the funding agency or study sponsor regarding adverse event reporting.
FDA reporting requirements for studies conducted under an IND or IDE.
Radiation safety committee requirements regarding adverse events related to radioactive compounds.
V. CITI Training in Human Subject Protections
What is CITI?
The Collaborative Institutional Training Initiative (CITI) program was founded in March 2000 as collaboration between the University of Miami and the Fred Hutchinson Cancer Research Center to develop a training program to promote the responsible conduct of research. It is a well-respected and widely used Web-based program designed around topic specific modules, each followed by a short quiz. The content is extensively reviewed, updated and maintained by a number of nationally known IRB professionals.
How does CITI work?
Each time you login to the CITI site, CITI's grade book will keep track of the modules and quizzes you have completed. The study modules may be completed in multiple sessions. CITI will also keep track of where within a module you are each time you logout. The required modules must be done in the listed order, but the optional modules can be completed in any order.
After completing all the modules (required and elective) for your learner group, CITI will provide you with a certificate of completion if your score is 90% or better. You may return to the quiz if a response is incorrect and re-take the quiz. The course provides correct answers and explanations.
The NYSPI IRB Office will be notified when you complete the training.
How do I access CITI?
To access CITI, go to https://www.citiprogram.org/default.asp. Select NEW USERS and register or Select ALREADY REGISTERED
How can I access CITI at home?
You can go to the website https://www.citiprogram.org/default.asp at home and click on "Register for the CITI course" and follow the instructions. You can access the CITI site from any internet connection.
What if I forget my CITI username or password?
Click on the box stating FORGOT LOGIN INFORMATION on the CITI “Welcome” Page. The system will send your user name and password to your e-mail address.
Who must take the CITI Training Program?
All researchers and key personnel who play a significant role in the design or implementation of the study, those who otherwise interact with human subjects, and those who work with identifiable human subject data who submit research for review by the New York State Psychiatric Institute IRB. IRB Members, IRB administrative staff, and other institutional officials involved in research oversight.
For studies reviewed by NYSPI where research is being conducted at another site under the jurisdiction of a local IRB, local site investigators must confirm human subject protection training in accordance with their local IRB's requirements. NYSPI and CU personnel must complete the NYSPI CITI requirements. Similarly, collaborators from other institutions will not be subject to the NYSPI requirements but must confirm human subject training in accordance with their home institution's requirements.
When must CITI training be completed?
All persons involved in research involving human subjects must complete the CITI training prior to participating in the design or conduct of the research. The training is valid for 3 years, and a "refresher" course is required every 3 years thereafter.
What happens if I don't complete the training?
Failure to do so can delay approval of an IRB submission.
When do I have to complete the Refresher Training?
The CITI training program sends an automatic email notification to those who completed CITI training for the New York State Psychiatric Institute. The email is sent 90 days in advance of the individual's expiration date. If you completed the NYSPI Basic Course, you should take the 3-Year Refresher Course. If you completed the Basic Course and the 3-Year Refresher Couse, you should take the 6-Year Refresher Courses. If you have any questions about which Refresher course to take, write to email@example.com.
If you completed CITI training for a different institution, then you will not receive an email notice for the New York State Psychiatric Institute. You will therefore need to logon to the CITI program and update your institutional affiliation to fulfill requirements for NSYPI by completing the Basic Course or the Refresher Course. For those key personnel, staff, IRB members and institutional officials who are new, the Basic Course must be completed.
I already completed CITI training for another institution. How do I transfer my completion certificate to NYSPI?
You can log onto the CITI site with your other affiliation. Once you log on, you will be directed to the Learner’s menu. Here you can choose to add New York State Psychiatric Institute from the dropdown menu as another affiliation. You may be required to complete additional modules to fulfill the NYSPI training requirements.
What if I’ve completed the CITI training for Columbia?
The training is not reciprocal. Although some of the modules are the same, the requirements are not the same. The modules you have completed may count toward the NYSPI requirement. If you are already registered in CITI, you do not need to create a new registration. You can login and click on “Affiliate With Another Institution ” and choose New York State Psychiatric Institute from the dropdown menu.
How do I know which Learner Group to select?
Select the “learner group” which is most applicable to you. Depending on your role in research, when you register, you will be asked a series of questions to be assigned to one of 4 learner groups: Biomedical Researchers and their Key Personnel, Social and Behavioral Researchers and their Key Personnel, IRB Staff/IRB members, Institutional Officials & Their Designee. You also can add a course or change your learner group.
Individuals who are both biomedical and social and behavioral researcher should select Biomedical Researcher.
Biomedical or Social and Behavioral Researchers who are also IRB members should select a Researcher group, but you are also be required to select the IRB member training module from the optional module list within the course.
Institutional Officials or Designees who are also researchers should select a Researcher learner group.
How do I know which modules to complete?
The Grade Book on the Learner's menu includes instructions for required modules and elective (optional modules). The required modules must be done in the listed order, but the elective modules can be completed in any order. You must complete all the required modules and a set number of elective modules, depending on your Learner group.
What is the CITI "Integrity Assurance Statement'?
This is a CITI requirement that all learners must read and complete indicating that they are taking the course for themselves. Learners cannot access any modules until the Integrity Assurance Statement has been completed.
How do I document that I have completed the CITI Training Program?
When you have completed the training requirements, CITI allows you to print out a certificate of completion. Please retain a copy for your records. You do not have to submit a copy to the IRB. The NYSPI IRB will be notified by email so you do not have to provide the certificate to the IRB Office.
With each new IRB submission and at the time of continuing review, each principal investigator is asked to attest to the fact that all study personnel required to complete the course have done so. PI's or department heads are expected to maintain documentation of staff certification. The IRB will conduct periodic audits of these study records.
Is the Good Clinical Practice Course required?
Effective January 1, 2017, all investigators and study staff engaged in the conduct, oversight or management of clinical trials are required to complete all fourteen elective modules of GCP Training, including investigators whose research does not involve drug or devices. The ID numbers of the required elective modules are as follows: 1350-1352, 1354-1364.
For investigators and staff not engaged in conducting clinical trials, GCP is optional training that will not count toward the NYSPI IRB requirement.
Who do I contact with questions?
If you have any additional questions about CITI requirements write to firstname.lastname@example.org. Technical questions regarding the CITI website should be directed to CITI's technical support: 888-529-5929 or email@example.com.
What is PRISM?
PRISM, the Psychiatric Research IRB Submission Module is designed to facilitate and manage all electronic submissions to the NYSPI IRB. PRISM has been expanded to include the Protocol Summary Form (PSF), as well as the Application for Continuation of Approval of Research (ACAR), Amendments and Fast Track submissions for recruitment materials. The IRB accepts new submissions through the PRISM system, using the PRISM PSF.
To register and receive a login to access PRISM for the first time, please click on the REGISTER link on the top of the NYSPI IRB website. For technical questions about the PRISM system, you may contact our IT team at IRBWEB.
For technical assistance: As was the case with the ACAR, we expect that the PRISM PSF will take some getting used to. You may contact the PRISM Help Desk at 646-774-6506 during business hours regarding technical questions or feedback or email us at IRBWEB.
To login to prism, click here.
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.
Having difficulty with file uploads?
If you experience any problems uploading files to your PSF or ACAR, please do the following.
Send a copy of the document and the text of the error message to IRBWEB.
Convert the document to a pdf. You can use this free software.
Review the pdf for any inconsistencies with the original, and if there are none, upload it to your form.
If you continue to have problems please contact us at 646-774-6530 or email us at IRBWEB.
PRISM Instructions Manuals
PRISM: 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 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.
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.
PRISM: 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’ 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') 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.
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.
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. You also have the option to create a new ACAR form from scratch and submit to the IRB.
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.
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.
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.
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.” Then 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.
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.
PRISM Form FAQs
How do I get to an existing form in 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 ‘view related forms’ to view all forms that have been created for that protocol. Click the ‘Menu’ icon of the form whose menu you need to go to.
How do I edit an existing form in 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 ‘view related forms’ to view all forms that have been created for that protocol. Click ‘Menu’ to go to the form menu. Click ‘’edit form’ to edit the form.
'I have completed this page’ does not work for me. What do I do?
Please make sure that you have completed and filled out every question on that page. You will see a red asterisk beside questions that have not been completed.
Cutting and pasting from a word document into the text area provided messes up the formatting. How do I fix that?
The text area that you cut and paste into is an editor. You can use the following tools, ‘Paste as plain text’ or ‘Paste from Word’ from the editor toolbar to clean up the formatting.
Where do I upload materials that need to be reviewed and stamped?
Both forms, the PSF as well as the ACAR have an 'Uploads' section catered only for uploading attachments that need to be reviewed and stamped. This would include copies of consent forms bolded and unbolded, recruitment material, MRI findings letters, anything that needs to be reviewed and/or stamped.
If your form is sent back by the IRB for revisions, please delete attachments that are not relevant under the 'Uploads' section, re-upload revised copies to the same section and re-submit.
***Please do not upload your memo in this section. You will be asked for the memo during the re-submission process.
I am unable to upload documents to the system. What do I do?
The PRISM system currently handles only PDF uploads. Please convert your document to a PDF before uploading it.
Where do I upload my memo?
A separate box will pop up prompting you to upload your cover memo during the submission process. Please do not upload your memo to the 'Uploads' page of the PSF and the ACAR.
Where do I view the PDF?
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 ‘view related forms’ to view all forms that have been created for that protocol. Click ‘Menu’ to go to the form menu. Click ‘view PDF of current version’ to view the PDF in it's current un-submitted form. Click 'View PDF of last submitted version' to view the PDF of a version that has been previously submitted to the IRB, if any.
Where do I find memos or other documents sent by the IRB?
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 ‘view related forms’ to view all forms that have been created for that protocol. Click ‘Menu’ to go to the form menu. Click ‘view form history’ to view all memos and additional files associated with the form.
PRISM Protocol FAQs
Where do I see all my studies?
You should be able to find all studies that you have access to, under the ‘My Studies’ tab.
Why can’t I see any studies after I log in?
You have to be added, given a role on any study that you need access to. This can be done by going to 'change personnel or modify title' under the protocol menu. The PI or anybody who is a part of the research team can add you.
Why can’t I find my name on the personnel drop down menu?
You should have had completed CITI training with NYSPI to find your name on the drop down list as it is filtered by investigator’s CITI credentials. Note, that CITI completed for NYSPI and Columbia differ, and the IRB requires the investigator to complete CITI for NYSPI.
How do I add or change staff members on my protocol?
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 ‘change personnel or modify title’ to make changes to the research team. Select names from the drop down list accordingly.
Note: Team members will not be able to add or remove anybody except research staff from the drop down menu after the protocol has been accepted by the IRB. Researchers will have to submit an amendment to the IRB to make that change.
How do I edit the title?
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 'change personnel or modify title’. Scroll all the way till the end of the page to edit the title.
How do I see all my forms?
There is a 'Forms' tab that is visible on the Home Page after you log into PRISM. The 'Forms' tab displays all forms that you have access to. Clicking each individual form will take you to the form menu of the respective form.
Who do I contact if I have any questions?
If you have any questions or comments, please email us at IRBMail.