23-008494

As part of its oversight responsibilities, the Office of Clinical Research (OCR) in the National Institute of Mental Health (NIMH) is seeking support in psychiatric clinical consultation for the review of safety in studies funded by the NIMH. This includes reviewing NIMH grant applications, clinical site study monitoring reports, research protocols, and other documents relevant to clinical research data and safety monitoring and the protection of participants in research.     

Independently, and not as an agent of the Government, the Contractor shall furnish all necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work below:

• Provide psychiatric consultation on clinical questions that arise during NIMH staff oversight activities. 
• Review NIMH grant applications to evaluate plans to ensure research participant safety and provide recommendations on their adequacy to NIMH staff.
• Review reportable event reports (e.g., reports of serious adverse events or unanticipated problems), research protocols, consent forms and other relevant documents, and provide recommendations to NIMH staff on the adequacy of safety plans and the steps taken to protect participants in NIMH funded research studies. 
• Provide clinical review and consultation on clinical data contained in data and safety monitoring reports of NIMH funded studies. 
• Review clinical research study audit reports and, when indicated, evaluate the adequacy of study team responses to findings.

Please note that the Contractor is expected to be available to meet with the Government Contracting Officer’s Representative (COR) and/or his or her designees for scheduled, as well as short-notice meetings for urgent situations. 

Specific Requirements:

1. Provide recommendations in response to psychiatric consultations on clinical questions presented to the Office of Clinical Research on NIMH-funded applications and research protocols.
2. Review NIMH grant applications and other relevant documents to evaluate plans to ensure research participant safety and provide NIMH staff recommendations on their adequacy. 

The contractor will review NIMH grants applications and evaluate the identified clinical risks to participants in the study, and the adequacy of the plans to mitigate those risks. Further, the contractor will highlight to NIMH staff any additional risks that may require additional discussion to ensure adequate plans to ensure the safety of participants in the research study. The contractor may be tasked to provide further review as directed by the NIMH Office of Clinical Research (OCR).

1. Review reportable event reports and other relevant documents of NIMH funded studies and provide NIMH staff recommendations on the adequacy of the safety plans and the steps taken to protect participants in NIMH funded studies. 
2. The contractor will review reportable event reports, study protocols and other relevant documents of NIMH funded studies and evaluate the adequacy of the steps taken to protect participants in the study. When indicated, the contractor will also evaluate the adequacy of the grantee-proposed corrective and preventive action plans (CAPA) relative to the reportable event. 
3. Provide clinical review and consultation on clinical data contained in data safety monitoring reports of NIMH funded studies. 

The contractor will review data safety monitoring reports of NIMH funded studies and provide consultation to NIMH staff on clinical questions that may arise from the data presented in the report.   

1. Review clinical research study audit reports and, when indicated, evaluate the adequacy of the study team’s response to findings. 

The contractor will review clinical research audit reports of NIMH funded studies and, when indicated, the adequacy of the grantee-proposed corrective and preventive action plans (CAPA) to address any findings outlined in the report. 

A. Personnel

The Contractor shall provide a psychiatrist with the appropriate training, expertise, experience, and capabilities to perform the duties outlines in the requirements outlined above: 

• Training and at least 5 years of experience in General Adult Psychiatry 
• Experience in data and safety monitoring of clinical trials and studies conducted in the United States. 
• Exceptional skills in professional scientific writing.
• Current knowledge of NIH policies, Federal Regulations for the Protection of Human Subjects, FDA regulations, and Good Clinical Practice (GCP).

1. Personnel Training and Oversight
   
   

The Contractor shall ensure that the psychiatrist working under this requirement is appropriately trained with the skills and abilities relevant to this requirement. Please note that HHS policy requires Contractors and Subcontractors to receive security training commensurate with their responsibilities for performing work under the terms and conditions of their contractual agreements. The Contractor will be responsible for assuring that each Contractor/Subcontractor employee has completed the NIH Computer Security Awareness Training prior to performing any contract work, and thereafter completing the NIH-specified fiscal year refresher course during the period of performance of the contract.  The successful offeror shall maintain a listing of all individuals who have completed this training and shall submit this listing to the COR. 

Contract Management

The Contractor shall provide sufficient project management support to ensure adequate management and coordination of all activities related to the statement of work. This effort shall include responsibility for technical and administrative, financial management, reporting and deliverables, and proper invoicing. The Contractor shall ensure that all contractor personnel safeguard intellectual property, the confidentiality of human subjects and other data, and other information provided by third parties or by the Government, as well as data generated through this contract. Contract management shall also oversee quality assurance and control. 

LEVEL OF EFFORT:

Psychiatrist reviewer: up to 100 hours per the period of performance

DELIVERY OR DELIVERABLES 

The Contractor shall provide the following deliverables and reports:
Provide response(s) to clinical consultations and recommendations. 

No later than 5 business days after the receipt of each clinical consultation, the contractor must provide a response to the clinical consult.

REPORTING REQUIREMENTS 

Ad-Hoc Meetings and Reports
At the request of the COR, the Contractor shall arrange teleconferences and/or meetings with the COR, other COR-designated NIMH Staff as necessary to discuss contractual matters, and other relevant Contractor Staff to discuss specific audit review assignments and work products. For each such meeting/teleconference, the Contractor shall be responsible for preparing and distributing the agenda and other materials, including recommendations for improvements or corrective actions at least three (3) calendar days in advance of the teleconference or in-person meeting.  The Contractor shall also prepare and distribute meeting minutes that include written summaries of the major decisions and action items resulting from these meetings and teleconferences and submit to the COR and other COR-designated NIMH staff within seven (7) calendar days of meeting/teleconference completion.

OTHER CONSIDERATIONS

In some instances, in agreement with the contractor, some travel may be indicated.

The Government will authorize expenses for travel and lodging for visits to NIMH funded clinical sites, as approved in advance by the Contracting Officer’s Representative (COR). All travel expenses must be in accordance with the Federal Travel Regulations. The amount of lodging will be determined based on the length of the visit to the site. Travel time may not be billed to the Government per the Federal Travel Regulation. Visits to clinical sites will take place in the United States.

The Contractor shall propose one (1) Psychiatrist reviewer as key personnel for this contract. 

The proposed Key Personnel will become subject to the provisions of Health and Human Services Acquisition Regulation (HHSAR) Clause HHSAR 352.237-75 Key Personnel as follows: 

The key personnel specified in this contract is considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract. If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty-day notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

NOTE: During the first ninety (90) days of the contract performance period no key personnel substitutions by the contractor will be made unless such substitutions are necessitated by an individual’s sudden illness, death or termination of employment.

Psychiatrist Reviewer Role Description: 

The Psychiatrist reviewer shall be the primary point of contact for all contract tasks, projects, reports, and invoices. This individual is responsible for the overall quality and performance of contractor, and for any subcontractor work performed under this contract. This individual is also responsible for overall customer relationship management and problem resolution. 

Psychiatrist Reviewer Mandatory Qualifications:

• Education: Graduation from an accredited medical school. Training: Board Certified or Board Eligible in Psychiatry having completed medical school (MD or DO). Successful completion of a residency program as applicable.         
• Licensure: Retains a current, active, valid, and unrestricted license in one of the 50 States, District of Columbia, or US Territory.                                                  
• Certifications: American Board Eligibility/Board Certification preferred.                                         
• Experience: Preferable experience specific to clinical trials and research studies for mental health and psychiatric disorders. 

This position requires expert communication skills and organizational abilities including the ability to track the multiple clinical consults received, reviewed, and finalized.