Human Subjects In Research

Overview of Human Subjects

Research conducted on human subjects needs to be done so in accordance with ethical principles and policies. This topic offers instruction as to what policies exist and how to adhere to them.

Stony Brook IRBs

Institutional Review Boards

The University's On-site Institutional Review Boards

  1. Committees on Research Involving Human Subjects (CORIHS) a
  2. Committees on Research Involving Human Subjects (CORIHS) b

Members | Meeting Dates

    Chesapeake Research Review, INC. IRB Services

    Effective April 1, 2013, SBU investigators wishing to conduct industry-funded, industry-initiated biomedical research studies must use the IRB services provided by our associate, Chesapeake Research Review Inc. (CRRI).  All other studies (e.g. investigator-initiated, etc.) must be reviewed by the local SBU IRB's (CORIHS).  There are two exceptions to this requirement. If one of the following criteria are met, review will need to be conducted by our local IRB's (CORIHS):

    • when the study in question is part of the SUNY-REACH initiative, or
    • when the industry sponsor will not accept direct invoicing from CRRI and/or allow direct payments to CRRI.    

    Directions for use of CRRI are as follows:

    1. Complete Your CRRI Application At The CRRI CIRBI™ Website

    The Center for IRB Intelligence (CIRBI) is Chesapeake IRB's web-based electronic platform, which supports the entire IRB process, from initial submission and review to study close-out.

    All users must register prior to accessing the CIRBI system. To register, go to www.cirbi.net and click on "Sign Up". A temporary password will be sent to the e-mail account specified at the time of registration. Users are required to change their password when logging into CIRBI for the first time.

    All study-related contacts must also be registered in the CIRBI system prior to completion of an online protocol application. Therefore, it is recommended that any individual who intends to use CIRBI immediately register in order to facilitate future research submissions.

    To submit a research proposal follow the directions/prompts found within CIRBI and the Smart Form: CIRBI uses Smart Form technology, which directs users to complete only those sections of the application that are directly applicable to the research study. Users will be prompted to upload all required study documents into the Smart Form. The Smart Form may be completed in one session or multiple sessions by saving the form and accessing it at a later date.

    First-time CIRBI users are highly encouraged to contact our CRRI Project Coordinator, Rick Cruise, for assistance. Rick can be reached at 443-283-1624 or via rcruise@irbinfo.com. Additional CRRI contact information can be found below.

    NOTE #1: At the time of your initial protocol submission to CRRI, please include the Sponsor's template Informed Consent Form. CRRI will then convert the Sponsor's Consent Document into the CRRI/SBU approved ICF.

    NOTE #2: In assessing CRRI deadlines and meeting dates (available on CRRI's website at www.chesapeakeirb.com, the investigator must factor in two working days for ORC review/processing. ORC does not assume responsibility for making a particular CRRI review deadline.

    2. Satisfy SBU Application Requirements For CRRI Studies (Using IRBNet)

    If you are not already registered and/or if you have not yet created a study on IRBNet, please follow the directions available on our website.

    Create a study, complete initial fields, and when it's time to download, complete, and upload documents back into your study designer, do so with the following documents from the forms and documents library of IRBNet:

    1. Registration Form for Expedited or Full CORIHS Review: This is a short ‘smart’ or ‘wizard’ form that quickly captures critical, searchable data pertaining to your study. To access this document:

      • Go to your project’s Designer
      • Select ‘Add New Document’
      • In the lower shaded ‘On-Line Document’ box, select ‘Registration Form for Expedited or Full Committee Review’, then hit the ‘Add’ button
      • Begin completing the Registration Form. You do not need to complete the whole form in one sitting; you can ‘save and exit’, and then go back and update the document by clicking the pencil icon next to the document listed in the designer.
      • When you are done completing the registration form, click “Preview” to see what the completed form looks like, and confirm that all the information provided is accurate. Once you are satisfied in this regard, Click "Save and Exit", and then continue constructing your project package to completion:
    2. SBU IRB/Institutional Fee Invoice Authorization Form
    3. SBU Scientific Merit Review Form: The application materials must be endorsed as scientifically meritorious by either the department chair or departmental review committee of all departments impacted by the proposed activity.
    4. SBU University Hospital Form: This form is necessary to assess impact of the proposed activity on UH patients, services and facilities.
    5. The Study Protocol

    Make sure you share, and obtain e-signatures from all appropriate parties, as detailed in sections V and VI of the IRBNet link above.

    3. Contact The Office Of Research Compliance

    Send an e-mail to Judy.Matuk@Stonybrook.edu with the subject heading: CRRI study submitted on CIRBI [Insert PI name here]

    4. What Are SBU Responsibilities Re: CRRI-Reviewed Protocols

    • SBU Responsibilities Prior to Protocol Submission to CRRI

    When the e-mail referenced in Step 3 is received:

    1. Eligibility to use CRRI, and proper fee authorization will be certified,
    2. Departmental chair/committee scientific merit assessment will be confirmed
    3. Institutional processes for financial disclosure/ COI management requirements, budget review and contract negotiation will be confirmed as initiated, in process or completed with notification to appropriate University officials for tracking and compliance purposes.

    Once 1, 2 and 3 are reviewed and determined to be satisfied, CRRI will be notified to commence review of the submitted protocol. Concurrent with this notification may be reminders of special considerations for local context that should be considered during IRB review.

    • SBU Responsibilities Concurrent with Protocol Review by CRRI

    Concurrent with CRRI IRB review will be ORC's review of local compliance and administrative local requirements. Often, CRRI, SBU and the sponsor will need to negotiate together to confirm compliance with federal regulations and SBU best practices.

    SBU University Policy P209, including the investigator disclosure form process, and following thresholds for determining significant financial interest in a pharmaceutical company are applicable to investigators submitting to CRRI for IRB review. Where there is human subject involvement in a sponsored activity, recommendations of the SBU COI Committee will be forwarded to ORC, who will retain responsibility for forwarding the management plan (as applicable) to CRRI.

    • SBU Responsibilities: Post CRRI IRB Approval

    SBU's ORC retains on-site monitoring responsibility for all studies, reviewed locally or by CRRI. Reports of site monitoring activities which have any finding that potentially impact human subject protections will be shared with CRRI.

    Similarly, the ORC will be provided with any reports of CRRI's on-site monitoring activities.

    5. Report Unanticipated Problems To Both, SBU Office Of Research Compliance And CRRI

    Investigators approved through CRRI's IRB must still report Unanticipated Problems to the SBU Office of Research Compliance, in addition to CRRI reporting requirements

    The policy is available here

    The form is available in the IRBNet project designer of your study.

    NCI'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. Judy Matuk 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 (CORIHS) 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.

    INSTRUCTIONS FOR USE OF NCI CIRB

    1. Upload the following into IRBNet and submit the project package to the CORIHS Office. Be sure to obtain signatures of PI and Chair, and 'share' your IRBNet project with all applicable individuals as you would if you were applying to CORIHS (e.g., William Greene, Wayne Patterson, Rhona Vainder and others as required. For details concerning use of IRBNet, please follow the directions available on our website:
      • SBU Application for Facilitated CORIHS Review of NCI Central IRB (CIRB) Approved Studies
      • Stony Brook University Hospital Facilities and Pharmacy Approval Form
      • CIRB application, protocol, notification letters, SAE reports and amendments, downloaded from the CIRB website
      • CIRB-approved consent form, modified in accordance with our local boilerplate language, HIPAA section, and contact information. NOTE:
        • What you (and CORIHS) can’t do to the CIRB-approved consent form:
          • - You cannot delete any information from the document.
        • What you (and CORIHS)can do to the CIRB-approved consent form:
          • - You can make minor word substitutions or additions to the consent form, to conform to, e.g., our institution’s requirements or IRB policies, or to simply or clarify statements, as long as the changes don’t alter the meaning of the CIRB-approved contents.
          • - You can add additional risks as you deem necessary.

      From www.ncicirb.org :
      “…Revisions/changes to the local consent form other than those described above require full board review at the local level, facilitated review may not be used, and the CIRB cannot serve as the IRB of record for the protocol at the local site."

    2. CORIHS staff will download the remaining CIRB documentation, i.e., CIRB reviews, minutes etc., relevant to the study being submitted locally for review.
    3. Designated CORIHS member(s) will conduct a facilitated review of the downloaded documents. There are three possible outcomes:
      1. Approved (for CIRB Oversight): The CIRB will be designated as the IRB of record. You will receive an acceptance letter, a copy of the confirmation e-mail from the CIRB, and a hard copy of the local consent document(s).
      2. Modifications Required (in order to secure approval for CIRB Oversight) : Specific stipulations must be addressed before the CIRB can be designated as the IRB of record. See consent form issue above, and:

        From www.ncicirb.org:
        “…the local IRB may add stipulations or local requirements to protocols, particularly to increase subjects' safety, to clarify procedures, etc, but may not delete or contradict any protocol contents…”

      3. Protocol Not Accepted (for CIRB Oversight): Local IRB oversight is required. You must complete a local IRB application and submit materials to the IRB office via the standard application process. The CIRB will not be permitted to oversee the protocol.

    WHEN YOUR PROTOCOL HAS BEEN APPROVED FOR CIRB OVERSIGHT

    Once the CIRB is designated as the IRB of record for your study, your interaction with CORIHS will be minimal, but very important.

    • Consent Form Revisions: The CIRB will notify the PI and coordinator (by e-mail) when changes to the consent have been made and posted on the CIRB website. Make all changes on the local consent, update the header to match the CIRB approved consent and submit one copy to CORIHS for our records. No approval letter will be issued by CORIHS.
    • Continuing Reviews: Continuing review will be conducted by the CIRB. The PI and the coordinator will receive e-mail notification of these reviews from CIRB. Submit one copy of CIRB’s review for the study, the updated local consent form, and SBU’s Continuing Review Application for NCI CIRB Studies. No approval letter will be issued by CORIHS.
    • Unanticipated Problems (including Serious Adverse Events (SAEs): You must submit all Unanticipated Problems occurring in subjects enrolled through SBU (“local UP’s”) to CORIHS, in accordance with CORIHS policy.

      From www.ncicirb.org:
      “Your local IRB is still responsible for reviewing SAE's that occur at your site; for all others, the CIRB does the review. Investigators continue using their routine reporting procedures. There is no need for the investigator to report SAE's to the CIRB. SAE's are reported using the customary mechanisms on CTEP-sponsored phase III protocols (Cooperative Group and others); the CIRB will be able to access SAE reports directly from NCI, to review SAEs and to report back to participating local IRBs via a confidential web site.”

    • Local Alterations (e.g., Personnel, Advertisements etc.) Submit any local personnel changes, local advertisements etc. to CORIHS for review and approval. Notification from CORIHS regarding review outcome (approval, modifications required etc) will be sent to you.
    • Study Closure: To close a CIRB study at this site, submit a “Termination Request Form” to the CORIHS, who will, in turn, notify the CIRB.
    • Protocol Amendments (NOT TO BE SENT TO CORIHS): Whenever the Cooperative Group makes protocol amendments; you must use only the CIRB approved version. These can be downloaded from the CIRB website through the investigator log-in access.

    Human Subjects IRBNet

    IRBNet is SBU's electronic system for the administration and management of IRB records for investigators and CORIHS.

    If you have any questions, or would like to schedule in-person training, please contact the Office of Research Compliance, at 631-632-9036.

    CORIHS Submission Deadlines

    CORIHS A CORIHS B
    Deadline for Materials Meeting Date Deadline for Materials Meeting Date
    9/22/2014 10/9/2014 10/6/2014 10/23/2014
    10/20/2014 11/6/2014* 11/3/2014 11/20/2014*
    11/17/2014 12/11/2014 12/1/2014 12/18/2014*
    12/23/2014 1/8/2015 1/6/2015 1/22/2015
    1/20/2015 2/12/2015 2/10/2015 2/26/2015
    2/23/2015 3/12/2015 3/10/2015 3/26/2015
    3/23/2015 4/9/2015 4/6/2015 4/23/2015
    4/20/2015 5/14/2015 5/12/2015 5/28/2015
    5/26/2015 6/11/2015 6/8/2015 6/25/2015
    6/22/2015 7/9/2015 7/7/2015 7/23/2015
    7/20/2015 8/13/2015 8/10/2015 8/27/2015
    8/24/2015 9/10/2015 9/8/2015 9/24/2015
    9/21/2015 10/8/2015 10/5/2015 10/22/2015
    10/19/2015 11/5/2015* 11/2/2015 11/19/2015*
    11/16/2015 12/3/2015* 11/30/2015 12/17/2015*
    * Exceptions to the 2nd and 4th Thursday rule due to Holidays

    CORIHS Members

    CORIHS A CORIHS B
    Dr. Harold Carlson, Medicine, Chair Dr. Michael Pearl, Gynecologic Oncology,  Chair
    Dr. Rishimani Adsumelli, Anesthesiology Dr. Philip Bao, Surgery
    Ms. Elizabeth Baron, IRB Administrator Dr. Patricia Eckardt, Nursing
    Dr. Marijean Buhse, Nursing Ms. Gail Frankel, Community Member
    Mr. James Farrell, Community Member Mr. Omar Gould, Community Member
    Dr. Kathleen Gambino, Nursing Dr. Luis Gruberg, Cardiology
    Dr. Donald Harrington, Radiology Dr. Marie Marino, Nursing
    Dr. Andrzej Kudelka, Medical Oncology Dr. Robert Marmo,  Prisoner Advocate
    Ms. Aimee Minton, IRB/COI Administrator Dr. Margaret McNurlan, Surgery
    Dr. Richard Morgan, Social Welfare Dr. Susan O'Leary, Psychology
    Ms. Stephanie Musso, UH Privacy Officer Mr. Abdool Samad, IRB Administrator
    Ms. Lynn Perry, Community Member Dr. Marie Varela, PharmD, Pharmacy
    Dr. Jila Sharif, MD, Neonatology Dr. Stephen Vitkun, Anesthesiology
      Mr. Michael Wade, IRB Assistant
    ALTERNATE MEMBERS ALTERNATE MEMBERS
    Dr. Michael Pearl, Gyn. Onc. (Alternate for Chair) Dr. Harold Carlson, Medicine (Alternate for Chair)
    Ms. Lu-Ann Kozlowski (Alternate for Ms. Baron) Ms. Elizabeth Baron (Alternate for Mr. Samad)
    Mr. Abdool Samad (Alternate for Ms. Baron) Ms. Lu-Ann Kozlowski (Alternate for Mr. Samad)
    Mr. Michael Wade (Alternate for Ms. Minton) Ms. Aimee Minton (Alternate for Mr. Wade)
    Updated October 4, 2012

    Federal Regulations

    Department of Health and Human Services (DHHS)/Office for Human Research Protections (OHRP)
    Website: http://www.hhs.gov/ohrp/ 
    Regulations: DHHS: 45 CFR Part 46 DHHS -- Protection of Human Subjects
    Guidance: http://www.hhs.gov/ohrp/policy/index.html#topics

    Food and Drug Administration (FDA)
    Website: http://www.fda.gov/
    Regulations:​

    Office of Civil Rights (HIPAA: Privacy Law)
    Website: http://www.hhs.gov/ocr/hipaa/ 
    Regulationhttp://www.hhs.gov/ocr/hipaa/finalreg.html 
     

     

    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 Subjects Training

    In order for you to be certified to conduct research involving human subjects, you must:

    1. Be registered in IRBNet. Directions on how to register on IRBNet are available here. 
    2. And then satisfy the following TWO training requirements (along with obtaining IRB approval for the activity):

    1. TRAINING IN HUMAN SUBJECT PROTECTIONS
    Click here to read Section 12.4 for training instructions

    • Training can be completed through 1 of 2 options:
      • For individuals, training can be completed through CITI OR
      • For groups of 20 or more, 'Live' training lectures for new or recertifying researchers can be scheduled. Contact Judy Matuk, 631-632-9036 if you are interested in this training option.

    For those who must certify training to the NIH, the following template is acceptable for your Certification of Completion of Human Subjects Training letter.
    Click here to download Word Template

    2. HIPAA IN RESEARCH TRAINING

    1. Review the SBU Policy and Procedure on Research Subjects' Right to Privacy at Section 16 of the Standard Operating Procedures
    2. Review the University Hospital's general HIPAA awareness training materials.
    3. Satisfy this HIPAA training requirement by sending an e-mail to ORC_HS_Training_Documents@stonybrook.edu.
    • the subject reading: HIPAA RESEARCH TRAINING COMPLETED and the
    • body of the text reading: "I have read and understood the HIPAA awareness training materials and agree to comply with the SBU Policy and Procedures on Research Subjects' Right to Privacy."

       

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