IRB Manual
      3.6 Review By the Director, RFMH and Department
   

In addition to the approval of the IRB, a researcher must also obtain the approval of the facility Director, RFMH and the Department before a project may commence. OMH studies which involve investigational drugs must also be approved by the facility Pharmacy and Therapeutics Committee. (See section 3.6.3 for details of delegations of authority that have been made to NYSPI and NKI.)



3.6.1 Review by the Director
   


It is recommended that the Director of an institution conduct his/her review of a project after review by the IRB, so that the report of the IRB can be considered when making the decision. If a Director approves a study prior to IRB review, significant changes made to the study during IRB review must be reviewed and, when appropriate, approved by the Director.

The types of issues generally considered by the Director are: the appropriateness of the study for the institution; availability of staff and other necessary resources; scientific validity of the study; effects on patient/client care.

The Director may approve, disapprove or approve with conditions. However, the Director does not have the authority to overturn a disapproval by the IRB.  The Director may disapprove a study that has been approved by the IRB.

It is not uncommon for IRBs to identify issues of concern that are outside their jurisdiction e.g. possible disruption of activities for non-subject patients.  In this instance the IRB should base its decision on the factors within its jurisdiction, and submit a report to the Director on the issues that are outstanding.



3.6.2 Review by RFMH
   


Following approval by the IRB and the Director, except as provided in 3.6.3.1 below, the following documents should be submitted to RFMH:


 
(1)   
Disposition form with IRB and Director’s signature of approval
(see Section 9.1 Disposition Form)

 
(2)   
the approved protocol (including the consent form(s) and other supporting documentation);

 
(3)   
the minutes of the IRB meeting at which the study was approved or a certification of expedited approval (the minutes and/or the protocol should contain details of the monitoring process and the process for assessing capacity and obtaining informed consent, including the personswho will perform these functions).

 
(4)   
OMH facilities only: an assessment of the amount of state staff time involved in the study and the Director's approval of the use of that time. If the research is integrated with a treatment or other non-research component, separate the time needed for the research from the time that would be allocated to patient care etc. regardless of research participation;

 
(5)   
a copy of an approval of the study from other agencies involved in the study. For example, if an investigator from a university wants to involve patients/clients in a research project he/she must submit the approval of the university to conduct the study at the DMH facility. In most instances this approval should be an IRB approval. Administrative approvals may be accepted under limited circumstances;

 
(6)   
for investigational drug studies:  a copy of the IND or similar documentation;

 
(7)   
documentation of research team training in the protection of human subjects;

 
(8)   
any other information that RFMH and the appropriate agency: OMH, OPWDD or OASAS, may require to adequately review the study.
   

The local procedure manual should specifically assign the responsibility for submitting this documentation. In most instances facilities have chosen to give this responsibility to the IRB.

Review by RFMH will focus on the following: was the appropriate level of review conducted, i.e., convened (full board) or expedited; if by convened was a quorum present; did the review conform to established procedures and standards; does the study comply with the provisions of the Federal and State Regulations and agency policy and procedures for the protection of human subjects?

The decision of RFMH will be communicated to the IRB. If questions arise, the RFMH will ask the IRB to resolve the particular issue(s).  The IRB and investigator may, of course, present additional information or other justification for the item in question. Any changes made to the protocol or consent form as a result of questions raised by RFMH must be reviewed by the IRB and may only be implemented with the approval of the IRB.

Following approval by RFMH, protocols will be forwarded to the appropriate OMH or OPWDD officials for review. (OASAS does not require OASAS central office review).
The RFMH derives its authority to oversee the operation of the IRBs from the Federal Wide Assurance and established practice. This document, which is negotiated and approved by the Department, the RFMH and the Office for Human Research Protections, provides assurance that the regulations will be appropriately implemented.

3.6.3 Review by the Department
   

Review by the Department will cover many different aspects of the proposed research including, but not limited to: scientific merit; appropriateness to the goals of the agency; use of staff and facilities; qualifications of the investigator(s); patient/client safety; consent; and ethical considerations.

The requirements will be implemented as follows:

  OPWDD
   

Authority to approve research has been delegated by the Commissioner to the Director of the Institute for Basic Research in Developmental Disabilities for research conducted by or at that facility. (Note: this research must still be reviewed by the RFMH as described above).

Research  involving human subjects which is conducted by or at any other OPWDD facility will be forwarded to the Director of District Operations of OPWDD by RFMH.  The Director of District Operations will review protocols following procedures that are appropriate for the complexity and level of risk of the study and may convene an ad hoc Research Review Committee or consult specialists in the area under study when appropriate.


  OMH
   

Authority to approve research has been delegated to the Directors of the New York State Psychiatric Institute (NYSPI) and the Nathan Kline Institute for Psychiatric Research (NKI), for research conducted by or at those facilities. (However, studies conducted by NYSPI or NKI at OMH Psychiatric Centers will be reviewed by the Commissioner's Designee.) Protocols from all other facilities will automatically be forwarded to the Commissioner's Designee by RFMH. The Commissioner's Designee will include other offices of OMH in the review process when appropriate. A copy of the Commissioner's Designee approval will be forwarded to the IRB by the RFMH.

     
3.6.3.1 Oversight Procedures for NYSPI
     
   
    1. The detailed minutes of the NYSPI IRB provide a comprehensive list of studies involving human subjects proposed at NYSPI. Following each meeting, the IRB administrator will send a copy of the draft IRB minutes to RFMH and to the Commissioner's Designee.


    2. RFMH and the Commissioner's Designee will review the minutes. If issues or questions arise they will contact the Director of the Office of Research Protections at NYSPI or the IRB. If additional information is necessary in order to evaluate the appropriateness of a particular study, arrangements will be made for RFMH and/or the Commissioner's Designee to receive additional material and/or to discuss the study with the IRB chairperson, the investigator or the Director of NYSPI. RFMH and the Commissioner's Designee will also request sample protocols for review to provide oversight of the IRB review process.


    3. RFMH and the Commissioner's Designee may:
      • request a delay in implementation of a study to allow further time for review;
      •  require modifications to ensure compliance with applicable laws, regulations, policies, procedures and established standards;
      • recommend to the Director of NYSPI that a particular study should be modified or not conducted; or
      • refer a study to the Executive Deputy Commissioner of OMH for consideration


    4. All studies for which the Director of NYSPI or the Director of Research of NYSPI is a Principal Investigator will be submitted to, reviewed by, and require the approval of RFMH and the Commissioner's Designee because of the direct oversight and authority that the persons in these two positions have over the NYSPI IRB and the potential conflict of interest that this structure creates. A judgment sample 3 of studies for which these persons are named co-investigators will be made by RFMH, and these studies will also be reviewed by RFMH and the Commissioner's Designee. The review of Director of NYSPI or Director of Research of NYSPI studies will encompass the same criteria as described in sections 3.6.2 and 3.6.3 above for other studies within DMH/RFMH.


    5. “Principal Investigator” is defined as a person named on the IRB application Protocol Summary Form as the Principal Investigator, and is the person who will be  held accountable for the conduct of the study, including compliance with all regulatory requirements, by the IRB, NYSPI and RFMH.


    6. “Co-Investigator” is defined as a person named on the IRB application (Protocol Summary Form) as a co-investigator, and is typically a person who is involved in the study  design, subject recruitment, screening, consent, assessment of capacity to consent, or research interventions.
     
    3 The judgment sample will consider the type of study, including level and certainty of risk, subject population and study context.  It is anticipated that Phase I and II studies, international studies and studies funded by pharmaceutical companies will typically be selected for review.
   


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