SOURCES SOUGHT
R -- NIDA IRP Clinical Protocol Participant Recruitment Support
- Notice Date
- 10/2/2014
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SSSA-SBSS-15-004
- Archive Date
- 10/31/2014
- Point of Contact
- Lauren M. Phelps, Phone: 3015942490
- E-Mail Address
-
lauren.phelps@nih.gov
(lauren.phelps@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Contracting Office Address: Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, MD 20892, UNITED STATES. Introduction: This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources, (2) whether they are small businesses; HUBZone small businesses, service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. Background: The Intramural Research Program (IRP) of the National Institute on Drug Abuse (NIDA) is located on the campus of Johns Hopkins Bayview Medical Center (JHBMC) in Baltimore, Maryland. Using volunteer human participants, the IRP clinical program conducts multidisciplinary research involving residential and nonresidential clinical studies. In general, these studies evaluate the nature of drug use disorders and addiction by assessing the abuse potential of drugs, investigating their underlying mechanisms, and assessing treatment modalities for these disorders. As many IRP clinical protocols investigate addictive or potentially addictive drugs, they require research participants who are active drug users, clients of drug abuse treatment programs, individuals seeking treatment for drug abuse or persons with a documented history of drug use or addiction. Purpose and Objectives for the Procurement: The purpose of this potential procurement is to obtain contractor support services for the recruitment of eligible research participants for inclusion in clinical research studies conducted by NIDA IRP as part of their ongoing mission. Participants will be active licit and illicit drug users, and persons with drug use disorders as well as healthy research study participants. Drug user populations to be recruited may include former users, those currently seeking treatment for their disorders and active users not currently seeking treatment. All clinical research performed by the IRP is reviewed and approved by appropriate Institutional Review Boards or by exemption from the OHSR. The objectives of this potential requirement are to provide the NIDA IRP with: 1. Advertisement strategy development 2. Development and placement of ads in various media outlets 3. Community Outreach 4. Online and Telephone Screening 5. In-person Screening 6. Participants Scheduling 7. Participant Remuneration 8. Report production Project Requirements: The Contractor shall provide the following services: 1. Advertisement Responsibilities: The contractor shall establish and maintain relationships with multi-media services and community services and organizations, including but not limited to local medical associations, public and private colleges and school systems, community organizations, etc. for the purpose of recruiting participants into various NIDA IRP protocols. The contractor shall be capable of timely creation of protocol and/or population specific advertisements by working with the study team to design and implement specific advertisements prior to enrollment of the first participant. Institutional Review Board (IRB) approval must be obtained before implementation of proposed advertising strategies may begin in full compliance with Addiction Institutional Review Board, the IRP Clinical Director and the NIDA Public Information and Liaison Board. Each Principal Investigator (PI) may elect to use a different contract (set up independently by the PI) for advertising. Any ads developed by the Contractor shall belong to NIDA IRP and may be used by the PIs at their discretion, i.e. using a different contract to set up advertisement strategies or placement. 2. Recruitment Responsibilities : The contractor shall establish effective marketing plans to reach target populations specific to individual protocol and/or population eligibility requirements and study timelines. The contractor shall collaborate and coordinate advertisement production with principal investigators (PIs) and research teams in full compliance with the Addictions Institutional Review Board, the IRP Clinical Director and the NIDA Public Information and Liaison Branch. The contractor shall remain knowledgeable on the eligibility requirements of all protocols for effective and efficient use of resources. The contractor shall track recruitment success and remain flexible to change recruitment strategies to optimize success. 3. Community Outreach Responsibilities : The contractor shall participate in community resource groups to raise awareness of NIDA research opportunities and participate in community outreach when indicated. 4. Telephone Screening Responsibilities: The contractor shall be proficient in performing structured telephone interview to determine eligibility and/or acceptability of participants in research protocols. Additionally the contractor shall be proficient in accurate and timely electronic data entry of pertinent information into electronic medical record system. The contractor shall be capable of communicating effectively with drug abuse/user populations while assessing their histories and needs, interpreting the data in the context of the current epidemiology and natural history of drug use, misuse, addiction and treatment for appropriate referral to research opportunities. The contractor shall schedule participant history/physicals, laboratory testing, ECGs and specialized testing. 5. In-person Screening Responsibilities: The contractor shall be proficient in performing in-person screening in coordination with NIDA research staff including but not limited to Physician Assistants, Nurse Practitioners and Physicians. The contractor shall obtain informed participant consent for screening protocol and procedures including completion of appropriate screening instruments. The Contractor will provide the staffing necessary for basic medical assessments including obtaining vital signs, drawing blood, performing ECGs, urine pregnancy tests, CO monitoring, breathalyzer and testing urine for drugs of abuse. The contractor shall have strong interpersonal skills to ensure appropriate explanations of the current research protocols for which the participant may be eligible in the most professional manner. The contractor shall have knowledge of drug use disorders, medical and psychiatric measures and psychiatric interviewing. The contractor shall coordinate repeat testing and follow up evaluations, as needed with study participants under the guidance from research team members. The contractor shall perform exit interviews with individuals screened for research participation by the IRP. The contractor shall possess strong interpersonal skills to collaborate effectively with inter-disciplinary teams for proper placement of participants. 6. Participant Remuneration Responsibilities: The contractor shall prepare and deliver payment to all study participants in full compliance with the NIDA Remuneration Policy and study timelines. The contractor shall maintain record of all accounting records per protocol and per participant with daily tracking of each PIs' use of their remuneration allowances. It is the responsibility of the Contractor to notify the PI and Clinical Director (CD) prior to the depletion each PI's remuneration allowance. The contractor shall produce and distribute monthly and annual reports on all participant remuneration per protocol to Project Officer, PI and Clinical Director. 7. Miscellaneous Responsibilities: The contractor shall maintain full compliance for all necessary training and/or clearances as required working with special populations (OPM/FBI) including children and adolescents. The contractor shall ensure proper use of all approved (by OCD, Clinical investigators and/or IRB) forms developed by the NIDA IRP specific to the recruitment, screening and remuneration process and generally located in the electronic medical records systems or paper versions. The contractor shall work in full compliance to established Good Clinical Practices (GCP). This shall include quality assurance for all clinical procedures and record keeping. All personnel working with human subjects are required to undergo necessary training and orientation regarding federal regulations, NIH regulations, and specific NIDA IRP clinical policies and procedures. As part of its capabilities statement the Contractor should demonstrate its familiarity with these or similar standards. 8. Project Reporting Requirements: The contractor shall provide periodic reporting on a monthly, annual, an ad hoc basis regarding status, progress, etc. to the Contracting Officer's Representative. Anticipated Period of Performance: The anticipated period of performance is one base year and four (4) option years. Contract periods may be divided into six month intervals. Capability Statement: Contractors that believe they possess the ability to provide the required services should submit documentation of their ability to meet each of the project requirements to the Contract Specialist. The capability statement must include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the above outlined requirements, 3) an outline of previous participant recruitment projects in which the contractor has participated, and 4) any other information considered relevant to this program. Contractors must also provide their Company Name, DUNS number, Physical Address, and Point of Contact Information. Contractors also should provide a list of IDIQ or GWAC contracts currently maintained that may be of relevance to this potential requirement. Interested organizations are required to identify their type of business, applicable North American Industry Classification System Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. All capability statements sent in response to this Sources Sought Notice must be submitted electronically (via email) to Lauren Phelps, Contract Specialist, at Lauren.Phelps@nih.gov in MS Word format before the closing date and time of this announcement. All responses must be received by the specified due date and time in order to be considered. Note: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After review of the responses received, pre-solicitation and solicitation notices may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. The solicitation release date is pending. The Government anticipates negotiation of a cost-reimbursement contract
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-2/HHS-NIH-NIDA-SSSA-SBSS-15-004/listing.html)
- Place of Performance
- Address: Baltimore, Maryland, 21224, United States
- Zip Code: 21224
- Zip Code: 21224
- Record
- SN03541316-W 20141004/141002235210-a388ea8cdf4069a983f711ac01441948 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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