Human Subjects In Research

 

Overview of Human Subjects

Institutional Information

  • SBU operates under Federalwide Assurance #00000125, expiration date December 17, 2024.
  • Our human research protection program has been accredited by the Association for Accreditation of Human Research Protection Programs, Inc. (AAHRPP) since September 2010.

Federal Regulations

Stony Brook Standard Operating Procedures

In order to ensure ethical research performance on human subjects, Stony Brook issues this Human Subjects Standard Operating Procedures Manual and expects researchers to be familiar with its policies.

Principles and Guidance

Which Institutional Review Board (IRB)?

Stony Brook IRBs

The University’s on-site Institutional Review Board (IRB) is used for all reviews except for studies as defined below as being reviewed by Advarra or National Cancer Institute’s Central IRB Adult and Pediatrics Initiative.

Non-Stony Brook (External) IRBs

​In addition to our partnership with Advarra and the NCI CIRBs (as described below), Stony Brook abides by the NIH ‘Policy on the Use of a Single Institutional Review Board for Multi-Site Research’, and encourages such single IRB review for non-NIH funded multi-center studies as well. In general, SBU will only cede IRB review to an external entity if that entity is AAHRPP accredited.

Note that Stony Brook is a participating institution in the SMART IRB National IRB Reliance Initiative. All participating sites have signed the SMART IRB agreement that enables them to accept each other's IRB as the IRB of record for a multi-site study, if so desired. Investigators are encouraged to review http://smartirb.org to see if their other collaborating sites are participating too.

Advarra

SBU investigators wishing to conduct industry-funded, industry-initiated biomedical research studies must use the IRB services provided by our associate, Advarra. All other studies (e.g. investigator-initiated, etc.) must be reviewed by the local SBU IRB. There is one exception to this requirement. If the following criteria is met, review will need to be conducted by our local IRB:  when the industry sponsor will not accept direct invoicing from Advarra and/or allow direct payments to Advarra. 

National Cancer Institute’s Central IRB Adult and Pediatrics Initiative

Stony Brook University is a participant in the National Cancer Institute’s Central Institutional Review Board (CIRB) Initiative. Local investigators who wish to enroll patients onto CIRB-approved protocols are encouraged to utilize this service. Such investigators should first contact Ms. Lu-Ann Kozlowski so that she may complete paperwork to secure a username and password for the PI and study coordinator. NCI requires that investigators wishing to do so must first submit CIRB review materials (along with minimal local paperwork) to their local IRB for a facilitated review (similar to our expedited review process), to confirm the acceptability of CIRB as the IRB of record for that particular study.

myResearch IRB

Regarding studies already approved or submitted in IRBNet as of February 26, 2019: All submissions related to these studies will continue to be reviewed in IRBNet until the time of continuing review. From the time of continuing review and onward, these studies will be reviewed in myResearch. 

All studies with an expiration date after February 27, 2019 will be imported into myResearch and available to the Principal Investigator and study team members in their myResearch Inbox. These studies will be imported as a “shell,” which means that some but not all of the study data will be transferred into the myResearch application. The Principal Investigator and study team members are responsible for reviewing all automatically imported information for accuracy and completing the remainder of the application prior to submission for continuing review.  In order to submit a continuing review application for a study imported into myResearch, see the continuing review submission instructions below. 

As of February 2019, no new studies will be accepted in IRBNet. All new studies must be submitted for review in myResearch IRB.

Note: Please refer to the first page of the continuing review manual below for instructions if you are unable to locate one of your studies in myResearch.

 

Instructions for myResearch IRB - How To:

Create a submission

Create a continuing review submission

Create an external IRB submission

Submit modification

Close a study

Complete/submit an ancillary review

In lieu of the electronic signature requirement as in IRBNet, departmental representatives (e.g. Department Chairs/designated signatories, University Hospital administrators, etc) complete ancillary reviews in myResearch. Ancillary reviewers must complete a brief form prior to submitting the review certifying approval or disapproval of the proposed submission. 

Checklists for myResearch IRB

New Study Submission Requirements Checklist

Continuing Review Submission Requirements Checklist

Modification Submission Requirements Checklist

 

Submission Guidelines for External (non-SBU) IRBs

Chesapeake Research Review, Inc.

Complete Your CRRI Application at the CRRI CIRBI™ Website

Satisfy SBU Application Requirements for CRRI Studies (Using IRBNet)

What Are SBU Responsibilities Re: CRRI-Reviewed Protocols

PI Responsibilities post-CRRI approval

National Cancer Institute’s Central IRB Adult and Pediatrics Initiative

Submission

When your Protocol has been Approved for CIRB Oversight

External IRBs (not covered above)

1. Contact the Office of Research Compliance when you are first considering using an IRB that is not one of SBU's internal committees. If acceptable, an agreement (or individual reliance arrangement, if part of the SMART IRB Initiative) between the Institutions will be necessary.

2. Satisfy SBU Application Requirements for other External IRBs

IRB Submission Deadlines

Deadline for Materials Meeting Date Deadline for Materials Meeting Date
12/31/2019 1/09/2020 6/8/2020 6/25/2020
1/6/2020 1/15/2020 6/15/2020 7/1/2020
1/13/2020 1/23/2020 6/22/2020 7/9/2020
1/20/2020 2/5/2020 6/29/2020 7/15/2020
1/27/2020 2/13/2020 7/6/2020 7/23/2020
2/3/2020 2/19/2020 7/20/2020 8/5/2020
2/10/2020 2/27/2020 7/27/2020 8/13/2020
2/17/2020 3/4/2020 8/3/2020 8/19/2020
2/24/2020 3/12/2020 8/10/2020 8/27/2020
3/2/2020 3/18/2020 8/17/2020 9/2/2020
3/9/2020 3/26/2020 8/24/2020 9/10/2020
3/16/2020 4/1/2020 8/31/2020 9/16/2020
3/23/2020 4/9/2020 9/7/2020 9/24/2020
3/30/2020 4/15/2020 9/21/2020 10/7/2020
4/6/2020 4/23/2020 10/5/2020 10/22/2020
4/20/2020 5/6/2020 10/19/2020 11/4/2020
4/27/2020 5/14/2020 10/26/2020 11/12/2020
5/4/2020 5/20/2020 11/2/2020 11/18/2020
5/11/2020 5/28/2020 11/16/2020 12/2/2020
5/18/2020 6/3/2020 11/23/2020 12/10/2020
5/25/2020 6/11/2020 11/30/2020 12/16/2020
6/1/2020 6/17/2020 12/21/2020 1/6/2021

For a list of Committee Members, please click here

Human Subjects Training

Human Subjects Training

In order for you to be certified to conduct research involving human subjects, you must satisfy the following training requirement (along with obtaining IRB approval for the activity):

Training in Human Subjects Protection, see Section 12.4 for training instructions

Training is completed through the CITI web-based courses in Human Research Protections (either biomedical or social behavioral).  In order to see your training in myResearch, please make sure to link your CITI program account to your netID.  To find more information on how to link your account, please click here.

For those who must certify training to the NIH, the this template is acceptable for your Certification of Completion of Human Subjects Training letter.

Note: HIPAA Training must be satisfied within the CITI curriculum.

Questions

Email questions to ORC_HS_Training_Documents@stonybrook.edu.

Linking your SBU NetID to CITI

Stony Brook NetID Single Sign On (SSO) has recently been enabled for CITI Program training. However, existing CITI Program accounts were not automatically matched to Stony Brook NetID credentials.

To link your Stony Brook NetID and NetID password to your existing CITI Program account:

  • navigate to www.citiprogram.org/?pageID=668
  • click Log In Through My Institution
  • select SUNY - University at Stony Brook
  • log in using your NetID and NetID password

 

You should receive the following message:

 

You will then be asked if you have an existing CITI Program account:

Please select the first option, I already have a CITI Program account.  You will then be asked for your CITI Program username and password:

Once this step is complete, your CITI account should be linked to your Stony Brook credentials.

 

If you have any questions regarding this process, please contact University Information Systems/Research at ovpr-it@stonybrook.edu.

 

Human Subjects Standard Operating Procedures

In order to ensure ethical research performance on human subjects, Stony Brook issues this Human Subjects Standard Operating Procedures Manual and expects researchers to be familiar with its policies.

Learn about existing protection programs, review boards and processes, informed consent, and other governing regulations in order to allow research to be conducted as smoothly as possible.

Human Subject Guidance on Covid-19

Question:

Is the Institutional Review Board at Stony Brook University operating as usual?

Answer:

The Stony Brook IRB continues to meet as scheduled via videoconference. All email addresses will continue to be monitored with the same frequency as typically provided. The main office number is being monitored regularly and any messages left on the main line will be returned.

 

Question:

What is the effect on the review of new studies?

Answer:

The Human Research Protection Program will continue to receive and review new studies. For studies that are approvable, but involve in-person interactions with study subjects and do not have the potential for direct benefit, the IRB will approve the study but with a stipulation that the study cannot begin enrollment until official guidance (e.g., government) states that social distancing is no longer necessary.

 

Question:

Which human subject studies should be placed on hold during the outbreak of the COVID-19?

Answer:

For studies in which there is no direct benefit to subjects or where there is subjects travel for research purposes (and no direct benefit), studies must be paused, effective immediately or as soon as can be implemented. Procedures such as telephone contact or monitoring or remote data collection, if part of such studies, may continue. 

Studies in which there is direct benefit to subjects may continue. If possible, these studies should be performed remotely. This would include the collection of safety data (based on the ability to detect potential adverse events). It is suggested that laboratory tests or imaging needed for safety monitoring occur at local laboratories or clinics.

 

Question:
Do I need to contact the industry sponsor if my research activities are placed on hold?
Answer:
Yes. If it is determined that your study will be placed on hold. However,  trials with investigational treatments, including drugs and devices, that provide the potential for direct benefit should continue.

 

Question:
What do I need to do to place my study on hold?
Answer:
Submit an amendment indicating which study components should be placed on hold and which will remain open. Provide a short statement of the risks and benefits in light of the COVID-19 epidemic.  The IRB will review each response and make a determination.

 

Question:
Can I continue to collect data and follow-up information from subjects by telephone when in-person data collection has been placed on hold?
Answer:
Yes. Once the amendment is approved for the change in data collection (through an IRB amendment) you can continue to collect information from subjects. NOTE: You do not need to modify your protocol in order to hold visits remotely or to change the schedule if the study is exempt or if the IRB protocol does not specifically describe whether the visit would be in person or remote, or give specifics about visit schedule.

 

Question:
Can I continue to collect data from home visits?
Answer:
If there is no benefit to the subjects, you should not collect data from a home visit. If there is another way for the subject to participate in the study, pursue those avenues (i.e., phone visits, email)

 

Question:
Do I need IRB approval to let my study subjects know that the study has been placed on hold?
Answer:
No. An amendment is not needed for this activity.

 

Question:
How do subjects need to be notified of visit cancellations and changes?
Answer:
When a study visit needs to be cancelled or changed to a phone call or on-line encounter, the subject should be told the reason and that they will be contacted again when the in-person visit can be rescheduled. These messages to subjects do not require IRB approval.

 

Question:
Will the IRB provide language that we can use in contacting our subjects?
Answer:
“Due to the potential or perceived risks of COVID-19, Stony Brook University has to place this study on hold. This study will continue to contact you and regular data collection activities may resume when the risk of COVID-19 has passed.”

 

Question:
Do I need to register modifications with ClinicalTrials.gov?
Answer:
Some studies registered at the federal site ClinicalTrials.gov are modifying their research procedures to include testing for SARS-CoV-2 and/or assessment of COVID-19 symptoms. The ClinicalTrials.gov information for the study should be updated to include these new procedures, if they are done for research purposes. If they are being added as public health surveillance activities in coordination with public health authorities, the registration information does not need to be modified.
The federal requirement about modifications is that any research-related changes that are communicated to the subjects (past, ongoing, future) must be added to the study’s ClinicalTrials.gov registration with 30 days after IRB approval of the modification.

 

Question:
I am conducting an FDA-regulated study. I hold the IND or IDE. Do I need to notify the FDA if I place my study on hold?
Answer:
Yes. The FDA will need to be notified.

 

Question:
Is the Institutional Review Board at Stony Brook University operating as usual?
Answer:
The Stony Brook IRB continues to meet as scheduled via videoconference. All email addresses will continue to be monitored with the same frequency as typically provided.  The main office number is being monitored regularly and any messages left on the main line will be returned.

 

Question:
What is the effect on the review of new studies?
Answer:
The Human Research Protection Program will continue to receive and review new studies. For studies that are approvable, but involve in-person interactions with study subjects and do not have the potential for direct benefit, the IRB will approve the study but with a stipulation that the study cannot begin enrollment until official guidance (e.g., government) states that social distancing is no longer necessary.

 

Question:
Which human subject studies should be placed on hold during the outbreak of the COVID-19?
Answer:
For studies in which there is no direct benefit to subjects or where there is subjects travel for research purposes (and no direct benefit), studies must be paused, effective immediately or as soon as can be implemented. Procedures such as telephone contact or monitoring or remote data collection, if part of such studies, may continue. Studies in which there is direct benefit to subjects may continue. If possible, these studies should be performed remotely. This would include the collection of safety data (based on the ability to detect potential adverse events). It is suggested that laboratory tests or imaging needed for safety monitoring occur at local laboratories or clinics.

Question:
When do I need to report protocol deviations to the Institutional Review Board (IRB)?
Answer:
Protocol deviations do not need to be reported to the IRB unless they impose an increase risk of harm to participants or adversely affect the integrity of the data. As a reminder, a protocol deviation is something that applies to one individual.
·        Example: A subject is not able to travel for an in-person visit because of self-quarantine. This is a minor deviation and does not need to be reported to the IRB unless it impacts the risk to the participant.
·        Example: A subject has self-reported or documented symptoms compatible with COVID-19 infection 24 hours prior to dosing or at the time of dosing. The Principal Investigator will determine whether or not the subject will not receive the study drug. This situation is considered a protocol deviation as it could impact subject risk. This deviation needs to be reported to the IRB.
·        Example: A subjects’ insurance does not cover monthly laboratory testing, subjects with normal laboratory values skip the laboratory testing at the discretion of the Principal Investigator, in order to limit contact. This is a protocol deviation as it could impact subject safety and data integrity and is reportable to the IRB.
·        Example: In order to minimize contact between study staff and subjects at the time of home visits, body measurements and vitals are not be documented. This will not be considered a deviation as it does not impact subject safety or data integrity and does not need to be reported to the IRB.
·        Example: Final diagnostic testing (e.g., MRI, biopsies, etc.) is postponed based on COVID-19 precautions. This is a protocol deviation as it impacts subject safety and is reportable to the IRB.

 

 

 

 

 

 

   

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