Institutional Review Board and the Local Review Research Committee
Important Notice Regarding COVID-19
Dear Sheppard Pratt research investigators,
The COVID national emergency may affect your research studies at Sheppard Pratt. The Sheppard Pratt IRB requests that you inform us about any intentional changes in research projects due to this epidemic. If you are pausing recruitment, that alone does not require reporting to the IRB. What would need to be reported is any intentional change in the study procedures.
The changes to procedures may be guided by the potential benefit of the study to participants, the location of recruitment, the risk level of the participant population in terms of age and medical comorbidities, and the risk benefit ratio of continuing to provide the study treatment. Procedural changes may include the location/format of study visits and or drug dispensation.
To communicate with the IRB about any procedural changes, please send a letter or memo on IRBNet as a “new package” to the existing study. Please note that any changes that are undertaken to reduce patient risk do not need to be reported in advance of their being instituted but within a 5-day time period.
Please don’t hesitate to be in touch with any questions or concerns.
Thank you,
Faith Dickerson, IRB Chair (fdickerson@sheppardpratt.org)
Jen Sklar, IRB Vice Chair (jsklar@sheppardpratt.org)
The Sheppard Pratt Institutional Review Board (IRB) has purview over all research activities conducted in the Sheppard Pratt Health System and all programs and agencies that are within the Sheppard and Enoch Pratt Foundation unless the Sheppard Pratt IRB formally defers the study to another IRB. The Sheppard Pratt IRB must first approve any research activity proposed to be performed at Sheppard Pratt. The Sheppard Pratt Local Research Review committee must approve studies that are being deferred by Sheppard Pratt to another IRB.
The Sheppard Pratt IRB and Local Research Review committee meets on a regular basis, the third Wednesday of each month, to review research applications. All materials to be reviewed at the monthly meeting must be submitted on IRBNet by 5:00 p.m. on the second Wednesday of the month.
An employee of Sheppard Pratt, the Sheppard Pratt Physicians Practice Association, or one of the Sheppard Pratt Community agencies may submit a research application. Sheppard Pratt contractors and courtesy staff or investigators who are in a student role may have their projects considered as long as there is a designated Sheppard Pratt supervisor who will oversee the study.
The Sheppard Pratt IRB is registered with the Department of Health and Human Services and the IRB registration number is 0000 4510. The IRB also has a federal-wide assurance (FWA), FWA00008407.
All investigators are required to have documented completion of a course in human subjects research protection. Sheppard Pratt has an account for staff who need this training through the Collaborative Institutional Training Initiative or CITI program. You may access the training through this link.
Click here to review the policies and procedures of the Sheppard Pratt Institutional Review Board.
IRB FAQs
What is the first step before I submit a proposal to the Sheppard Pratt IRB or Local Research Review Committee?
All proposals must be pre-approved by Sheppard Pratt prior to submission on IRBNet. For questions relating to this process, please contact the Sheppard Pratt IRB Administrator, Jennifer Sklar (jsklar@sheppardpratt.org or 410-938-3136).
How do I submit a proposal to the Sheppard Pratt IRB or Local Research Review Committee?
To submit forms on IRBNet, you must be individually registered on IRBNet. To access the IRBNet website, go to www.irbnet.org.
How can I receive more training about how to use IRBNet?
Click here to access training resources including short, helpful videos.
You will need to use the following log-on to access these trainings.
User Name: sheppardpratt
Password: training
What forms and resources are available?
For purposes of your application to the Sheppard Pratt IRB, the research institution will appear as “the Sheppard and Enoch Pratt Foundation.” Do not list your home institution.
I am not sure if my project is a “research” study that requires review by the Sheppard Pratt IRB. What should I do?
Contact Jennifer Sklar at jsklar@sheppardpratt.org. Sometimes it is not clear if a project is an evaluation study which may not need to be reviewed by the IRB or if it is a “research” study which does need IRB review. This determination can be made by discussion about the proposed study with Jennifer Sklar.
When I am submitting a project to IRBNet for the first time, with whom do I need to “share” the project and who needs to “sign” the project in IRBNet?
The project must be signed electronically on IRBNet by the PI. For outside researchers, the project must also be shared with and signed electronically on IRBNet by the Sheppard Pratt co-investigator and the Sheppard Pratt site director or designee.
How do I submit a modification, renewal report, or other official document about a study which has already been submitted?
You must submit a new “package” within the same IRB project. To do so, go to the initial project, click on “Project History” then “Create New Package.” Please also refer to the “Library” in IRBNet for forms and additional resources.
How do I attach an education certificate such as a completion of a human subjects’ protection course?
Certificates should be attached to the individual’s “profile” on IRBNet. To do so, go to “User Profile” for the individual on the top bar of the IRBNet screen and then go to the bottom of screen in the section entitled “Training and Credentials.”
My protocol has been reviewed by the IRB of another institution. Do I still need to have the study reviewed by the Sheppard Pratt IRB in order to perform the study at a Sheppard Pratt site?
Your study will still need to be reviewed at Sheppard Pratt, but may not need to be formally reviewed by the Sheppard Pratt IRB. Please contact Jennifer Sklar, who will determine the review process that will need to take place at Sheppard Pratt.
How long does it take for a Sheppard Pratt IRB review? What if I need to start my study before then?
Once the Sheppard Pratt IRB receives the final protocol and all of the necessary materials, the initial review process can usually be completed in less than one month. If modifications are required by the IRB, the initial review may take longer. The IRB meets on the third Wednesday of the month. Materials must be submitted by 5:00pm ET on the second Wednesday of the month to be reviewed that month. Investigators are prohibited from starting a study before it receives approval by the Sheppard Pratt IRB or is officially deferred to and approved by another IRB.
Is it necessary for research that takes place at Sheppard Pratt Community Programs (e.g. a psychiatric rehabilitation program) to be reviewed by the Sheppard Pratt IRB?
Yes. The Sheppard Pratt IRB has purview over research conducted at all Sheppard Pratt sites and sites affiliated with the Sheppard and Enoch Pratt Foundation. This includes the psychiatric rehabilitation programs and school programs that are affiliated with Sheppard Pratt.
Is it necessary for research that takes place at Sheppard Pratt affiliates (e.g. a psychiatric rehabilitation program) to be reviewed by the Sheppard Pratt IRB?
Yes. The Sheppard Pratt IRB has purview over research conducted at all Sheppard Pratt sites and sites affiliated with the Sheppard and Enoch Pratt Foundation. This includes the psychiatric rehabilitation programs and school programs that are affiliated with Sheppard Pratt.
In what format should I submit my protocol document(s)?
This information is covered in the resources available in the “Library” in IRBNet.
If my protocol has been reviewed by another IRB, can I submit the existing protocol or does Sheppard Pratt have a required format for the protocol?
Sheppard Pratt does not require a specific format if the protocol was reviewed/approved by another IRB. However, the protocol should include any specific information, procedures, or risks that apply to participants at Sheppard Pratt sites. Refer to the “Library” on IRBNet for a protocol template.
In what format should I submit my informed consent document(s)?
The information is covered in the Requirements and Policies document available in the “Library” in IRBNet. An informed consent template can also be found in the IRBNet “Library.”
If my protocol has been reviewed by another IRB, can I submit the existing approved consent form or does SP require that I have a second separate consent form?
Sheppard Pratt does not necessarily require a separate consent form. However, the consent form should include any specific information that applies to participants from Sheppard Pratt sites. At a minimum, this typically includes the following:
- Reference to the Sheppard sites generally found in a procedures section. For example, a consent that includes the statement, “The research will be conducted at the following locations: Location X, Location Y, and Location Z,” should include the Sheppard Pratt location(s) in the list.
- For multisite studies or studies that would require additional travel or coordination of care for participants from Sheppard Pratt sites, any special procedures or risks that apply to participants from the Sheppard Pratt sites.
- If the Sheppard Pratt IRB is the IRB of record, the contact information is generally found in the rights section. For example, “If you have questions regarding your rights as a research participant, you may contact Dr. Faith Dickerson of the Sheppard Pratt IRB at 410-938-3000.” For multi-site studies, you may need to direct the statement to participants from Sheppard Pratt. For example, “If you are a participant from Sheppard Pratt and have questions regarding your rights as a research participant, you may contact Dr. Faith Dickerson of the Sheppard Pratt IRB at 410-938-3000.”
I would like to review medical records at Sheppard Pratt for a research project. Do I still need to submit to the IRB?
Yes. Studies based on record reviews do require review by the IRB.
How do I know when my study is due for continuing review?
The approval letter will indicate the approval/expiration date. In addition, IRBNet will send reminder emails at 60 and 45 days prior to the study expiration at Sheppard Pratt, which is typically one year after the previous approval. It is the investigator’s responsibility to submit materials for continuing review in a timely manner.
What is “HIPAA” and how does it apply to research studies?
HIPAA refers to privacy laws that have been enacted by the federal government for clinical practice and which also pertain to research studies. Under the terms of the HIPAA regulations, persons participating in a research study must be informed about the privacy of the health information that is being collected in the study. A parallel act (FERPA) applies to school settings. Refer to the “Library” in IRBNet for the Privacy Waiver application form, if needed, and additional guidance on consent language and privacy requirements.
Who can I talk to at Sheppard Pratt about my study and the research review process?
Your first step is to talk with the Sheppard Pratt IRB Administrator, Jennifer Sklar (jsklar@sheppardpratt.org or 410-938-3136). If you need further assistance, you may contact the IRB chair, Dr. Faith Dickerson at fdickerson@sheppardpratt.org.