***THIS IS A NOTIFICATION ONLY, NOT A SOLICITATION***
Consistent with Section 144 of State Economic Development Law, the New York State Office of Mental Health (OMH) is seeking an exemption for advertising in the New York State Contract Reporter (NYSCR) to enter into a sole source contract with the Research Foundation for Mental Hygiene (RFMH) to support the salary costs associated with RFMH staff working at the New York State Psychiatric Institute (NYSPI) on Human Research projects as well as the costs for ongoing legal, audit & consultant services required as part of the corrective actions taken by NYSPI to resume work under their Human Subjects Research program. This is a request for a new $19.675M 15-month contract, effective November 1, 2024 through January 31, 2026.
This contract will provide support for the ongoing legal, audit, and consultant costs incurred by RFMH because of a suspension in human subjects research that was implemented in June 2023, including resources to establish a temporary independent governance board for enhanced oversight, an external Internal Review Board (IRB) process, , external compliance monitoring, and RFMH salary costs associated with participating in training on human subjects best practices and navigating the new IRB procedures, as well as updating the various research study protocols & submitting for IRB approval. Additional RFMH resources are required to support the NYS response to the National Institute of Health's (NIH) audit of NYSPl's federal funded human subject research studies and the Administrative Agreement with the US Department of Health & Human Services. OMH already expended $5.2M on RFMH costs associated with the NIH audit through October 31, 2023 on the prior Supporting Sciences Contract #C101156 pursuant to a zero-dollar scope of work amendment, and $11.9M of the current Supporting Sciences contract #C102100 for this purpose for support through October 31, 2024. Division of Budget (DOB) and OMH have agreed on a quarterly review of the funding for this contract and have agreed that funds may be approved in quarterly increments for the duration of the contract. OMH will only be encumbering funds for this contract based on the prior approval of funds by DOB. OMH is seeking to enter into this new sole source contract rather than continuing to seek amendments to the Supporting Sciences instrument, which is a tool used for multiple OMH projects and initiatives. This will allow OMH and RFMH to complete the required work & implement the plan to reopen all human subject research at NYSPI. Partnering with RFMH is a critical measure given that OMH directs research efforts under the NYSPI umbrella. It is the mission of RFMH to assist and enhance the research and training objectives of OMH and the other Department of Mental Hygiene agencies. They provide an organizational bridge between State researchers and sponsors of research by providing OMH and their scientists with the independence and administrative flexibility to respond quickly to the demands of sponsored programs in a manner that facilitates their specific or technical execution. Specifically, RFMH supports the administration of $106M in grants associated with NYSPI.
RFMH funds are supporting consultants engaged in the following activities related to NYSPl's Administrative Agreement and Corrective Action Plan recently executed with HHS:
• Advise, supervise, and train NYSPI Human Research Protections Program (HRPP) directors and HRPP Advisory Committee members• Advise NSYPI regarding NYSPI IRB reorganization and training activities required to meet specific corrective action commitments• Non-NYSPI and consultant IRBs are overseeing all NYSPI research studies until further notice (at least through 2025) pending reorganization and retraining of the NYSPI IRB• Review, advise, and evaluate implementation of corrective action items related to reconfiguration of the NYSPI HRPP• Review and determine when individual research studies can be recommended for resumption of paused activities• Conduct investigator site initiation monitoring visits for all research studies coming off pause• Conduct post-approval monitoring of research participant records for all studies coming off pause• Prepare monthly reports of all research compliance activities at NYSPI
RFMH's unique relationship to OMH is analogous to the relationship between SUNY Research Foundation and SUNY and the relationship between HRI, Inc. and the Department of Health. The legislature has repeatedly recognized the unique relationship between RFMH and OMH by 1) defining RFMH as a state agency for certain purposes (e.g. in State Finance Law Section 53-A, where it is one of several membership corporations closely affiliated with specific state agencies ... whose purposes are essentially to support, supplement or extend the functions and programs of such state agencies ... ; 2) extending the State Code of Conduct in Public Officers Law Section 74 to RFMH employees, creating a heightened ethical obligation for RFMH employees which cannot be replicated with other parties through contract (and which is of particular note here due to the sensitive nature of the information involved); and, 3) annually appropriating overhead recovery funds collected by RFMH in respect of State overhead on sponsored research back to RFMH for the same type of activities as are proposed in this contract. RFMH has a long history of working with OMH to respond to time-sensitive research, training and information needs. Successful collaborations have included evaluation studies of service programs, needs assessment and epidemiological studies and the development of clinical and administrative computerized systems. For these reasons, OMH strongly believes that no other entity could provide these services without a significant adverse impact on those individuals who reap the benefit resulting from work done on this contract. Looking to any other vendor at this juncture would be a devastating and costly setback.
The 15-month period will allow OMH and RFMH to maintain support of the services and action of the temporary independent governance board and external IRBs for the anticipated life of the project from the end of coverage under the Supporting Sciences contract (October 2024) until January 31, 2025.
This period will allow the services to move out of the Support Sciences contract, as previously requested by OSC, and be maintained as its own contract vehicle through the remainder of the term. At the conclusion of this 15 month term, OMH will no longer need to provide funding due to the resumption of funding flow from grants. As a result, there is no future competitive procurement anticipated.
Outside of the decades long relationship between the OMH and RFMH, significant taxpayer dollars have funded the pivotal development of an infrastructure heavily utilized throughout New York State in the research, training, implementation, delivery, and evaluation of a multitude of mental health program services and practices. Infrastructure that has been developed over many years with RFMH provides OMH with a nationally recognized, established, expert administration with personnel that have achieved a high degree of collaboration and coordination with and within the agency. RFMH developed the tools and training and these tools and training protocols have been enhanced over decades. One of RFMH's oversight roles is to collect data for performance measurement and evaluation. The RFMH supports a multitude of OMH initiatives and is a key partner in the advancement and delivery of OMH services through its participation, collaboration, contribution to research, administration, evaluation and data collection, and development and delivery of training that has demonstrated to improve patient outcomes for individuals. The loss of continued RFMH participation, integration, expertise, and support for OMH programming would be devastating not only to New Yorkers, but, also to Mental Health Institutes/Providers nationwide. The RFMH provides OMH with a nationally recognized, established, expert administration with personnel that have achieved a high degree of collaboration and coordination with the agency. Additionally, total staff costs are lower compared to State items and lead times for projects are reduced when existing infrastructure is utilized. The RFMH can provide these services at a significantly lower overhead rate than the rate offered by most academic institutions. With a consistently minimal 10% overhead rate and fringe benefit rates (31 %) well below NYS fringe benefit rate of 67.05%. Finally, the RFMH title structure supports more of the research titles the OMH utilizes. Reason for advertising exemption: Single Source Award recipient: Research Foundation for Mental Hygiene Any questions or comments regarding this notice of sole-source, single-source, or procurement otherwise exempt from advertising in the NYS Contract Reporter should be directed to the contact person listed for the contracting agency or public authority.
Ad end date:09/17/2025
Contract term: 15 Months
County(ies): All NYS counties
Location: OMH Central Office
