IRB Manual - Section 1.1
  1.1 Scope of the IRB's Authority
     
   

Research conducted by or at OMH, OPWDD and OASAS operated facilities is subject to the provisions of a federally approved "Federal Wide Assurance" (FWA). The currently approved FWA  is number 00006105. IRBs derive much of their authority and responsibilities from this Assurance. IRB members and investigators must be familiar with this document. Under the provisions of the federal research regulations and the FWA all IRBs under our Assurance have been formally registered with the federal Office of Human Research Protections (OHRP): http://www.hhs.gov/ohrp/assurances/

DMH/RFMH research must comply with all applicable federal, state and local laws and regulations. In addition, research must comply with  policies and procedures of the applicable DMH agency and RFMH and the ethical principles contained in the Belmont Report: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html


1.1.1  General
         
   
The IRB is responsible for the initial and ongoing review of all research which involves human subjects, (patients, staff, control groups, volunteers, etc.) regardless of the source of funding (if any), if:
     
  (i)   the research is sponsored by the institution 1; or
  (ii)   the research is conducted by, or under the direction of any employee or agent of  the institution in connection with his or her institutional responsibilities and/or using any patients, staff or facilities of the institution; or
  (iii)   the research involves the use of the institution's non-public information to identify or contact human research subjects or prospective subjects; or
  (iv)   the research involves the use of the institution's patients or facilities.
     
   

The IRB may approve, require modification in, or disapprove research and amendments to previously approved research. The IRB may also require modifications to, or revoke approval of previously approved protocols, typically when new information affecting the risk/benefit analysis becomes available or if there is serious or continuing non-compliance with the approved protocol. The Director of the institution may disapprove research which has been approved by the IRB, but may not approve research which has been disapproved by the IRB.

IRBs also have the authority to suspend approval of an entire study or certain activities within a study, e.g., recruitment of new subjects, if new information becomes available, there is reason to believe that non-compliance with IRB requirements may have occurred, or the IRB has some other reason, particularly safety concerns, for re-evaluating all or part of a study.

IRBs must review protocols at intervals appropriate to the degree of risk, but not less than once per year (“continuing review”). ALL PROTOCOLS INVOLVING HUMAN SUBJECTS MUST MAINTAIN A CURRENT IRB APPROVAL. See Section 3.3 for details of monitoring and continuing review requirements. If a continuing review has not been completed prior to the expiration of IRB approval, the human subjects component of the study must stop until the updated approval has been obtained unless the IRB finds that it is in the best interests of individual subjects to continue participating in the research interventions or interactions. Enrollment of new subjects cannot occur after the expiration of IRB approval.

Research involving cadavers or specimens removed during an autopsy does not require IRB review. However, facility directors have the authority to extend the IRB's jurisdiction to include this research. Please note: the use of identifiable patient/client records in association with cadaver/autopsy specimens for research purposes, does require IRB review and approval.

1 Institution = OMH, OPWDD, OASAS and/or RFMH

     
1.1.2  Research Involving More Than One Institution
     
   

Many research projects involve more than one institution and therefore potentially require review by more than one IRB. All entities that are ‘engaged in research’ that is funded by DHHS are required to file a Federal Wide Assurance (FWA) and obtain IRB review (DMH/RFMH research is covered by an existing FWA).  

Consult the OHRP website for additional information about FWA’s.
http://www.hhs.gov/ohrp/assurances/assurances_index.html

In order to avoid duplication of effort, both the Food and Drug Administration (FDA) (21 CFR) and the Common Rule, including Department of Health and Human Services (DHHS) regulations (45 CFR 46), allow institutions to use joint review, reliance upon the review of another qualified IRB or similar arrangements. Within the OMH system the Multi Site IRB Process should be followed (see Section 1.1.3).

DMH/RFMH does not generally rely on the review of outside IRBs. However, exceptions may be made on a case by case basis. If a collaborating site requests to use a DMH/RFMH IRB, please consult with RFMH about required procedures, including those related to a Federal Wide Assurance.
 
Department of Health and Human Services (DHHS) regulations specify that when a DHHS sponsored study involves cooperating institutions the grantee or prime contractor remains responsible to the DHHS for safeguarding the rights and welfare of the human subjects. When the cooperating institutions conduct some or all of the research involving human subjects each of the cooperating institutions must comply with the provisions of the human subjects regulations.

When an investigator from a non-DMH facility submits an application to a DMH IRB and facility for approval to conduct research which involves DMH patients, staff or facilities, he/she must provide documentation of the approval of his/her own institution. The approval must reference the DMH facility as a performance site.
     
1.1.3  Procedures for IRB Review of Multi Site Studies Within OMH
     
   

Studies involving more than one OMH facility may be reviewed and overseen by a single (“Designated”) OMH IRB.  The Designated IRB will be chosen from OMH’s facility and central office IRBs and will vary by study. The Designated IRB will be responsible for all required IRB functions including initial, continuing, amendment and adverse event reviews.  Facility Directors are encouraged to permit the use of a Designated IRB, particularly for studies involving no more than minimal risk. 

The following procedures will be followed for IRB review of multi (OMH) site studies.


   
    1. The Principal Investigator (PI) of the study will consult with the IRB at the facility at which he/she is employed and prepare a recommendation regarding which IRB is most appropriate to conduct the Designated IRB review. If the PI is not an OMH employee, or if the OMH facility at which the PI is employed does not have its own IRB, the PI should consult with the Deputy Managing Director of the Research Foundation for Mental Hygiene, Inc. (RFMH).   The recommendation shall be based on the guidelines in section 4 below.

    2. The recommendation of the PI shall be provided to the Deputy Managing Director of RFMH, together with sufficient information about the study to identify:
      1. the OMH sites involved;
      2. the role and responsibilities of each site, including staff involvement and the nature of the activities that will be conducted;  and the OMH or outside institutional affiliations of the PI and key staff.

    3. The Deputy Managing Director of RFMH will review the recommendation in light of  the guidelines in section 4 below and the specific study circumstances and, if she agrees with the recommendation, will  request that the  director of the chosen facility (or the Commissioner's Designee, as the case may be) consent to the designation.  In the event that the director does not consent, the Deputy Managing Director of RFMH will confer with the PI to select an alternative IRB as the Designated IRB, subject to the consent of that facility’s director.

    4. Guidelines for choosing the Designated IRB:
      1. Generally, if the study involves NYPI or NKI the IRB at that Institute will conduct the Designated IRB review.
      2. Other factors that influence the choice of the Designated IRB include the locations of the PI and the various groups of research subjects, as well as the relative expertise of the IRBs in relation to the particular study.

    5. The PI submits an application for the study to the Designated IRB.

      The Designated IRB and the local IRB for any facility that elects to conduct its own IRB review will use the New York State Psychiatric Institute (NYPI) application forms for initial and continuing reviews. This will eliminate the need for investigators to provide information in multiple formats. Copies of the NYPI forms can be obtained by contacting:
      irbmail@pi.cpmc.columbia.edu

    6. The PI submits a copy of that application together with a copy of the attached Multi-Site Study IRB Agreement (Agreement) to the Director of each involved OMH facility (Commissioner's Designee for Central Office) who may approve or disapprove the study at the local site.  He/she may also agree to rely on the Designated IRB or may require local IRB review. The form requires Facility Directors to identify the person who will be the contact person for the Designated IRB. This person will provide information to the Designated IRB about the site and will receive a copy of the IRB approved protocol and consent form(s) if any, and copies of approved continuing reviews and amendments. The form also requires Facility Directors to identify the person who will be responsible for ensuring that IRB required monitoring (and any additional monitoring that the facility requires) is conducted and for reporting the results of the monitoring to the Designated IRB. Note:  Facility Directors may want to consult with their own IRB chairperson, IRB member or other facility personnel before approving the study and use of a Designated IRB.  Facility Directors retain the ability to suspend or terminate a study at their facility at any time. 

    7. The completed Agreement is returned to the Designated IRB

    8. The Designated IRB submits the approved protocol, including copies of each Agreement  to RFMH for RFMH and OMH review.

    9. RFMH will communicate any concerns about the study to the Designated IRB for any necessary follow-up with the PI.  When approved, RFMH will issue an approval to the Designated IRB which will be responsible for notifying the PI.  The PI provides a copy of the IRB approval and the IRB approved protocol and consent forms (if any) to the contact person designated on the attached form by each Facility Director.

    10. The PI is responsible for submitting all amendments, continuing review applications, reports of unanticipated adverse events involving risks to subjects or others, FDA mandated adverse event reports (when applicable) and all other information and materials required by the IRB to the Designated IRB (and to the IRB for any site that elects to conduct its own IRB review).  Adverse event reports must also be provided to the local facility in accordance with facility and OMH requirements.

    11. The PI is responsible for providing the named contact person at each facility with copies of all IRB approved amendments and continuing reviews.  Amendments may not be implemented at a site until the contact person at that site (or designee) has received copies of the amendment and documentation of IRB approval of that amendment.

    12. At the conclusion of the study the PI is responsible for providing the contact person at each site with a copy of the final report submitted to the Designated IRB, together with the Designated IRB’s approval of the study closure.

     
   


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