Introduction: The National Institutes of Health (NIH), through the National Institute on Drug Abuse – Intramural Research Program (NIDA IRP), is seeking capability statements from BOTH Other than Small Business and Small Business organizations to provide the Government support for participant screening and remuneration at the NIDA IRP Clinical Program. This is a SOURCES SOUGHT NOTICE to determine the availability of BOTH Other than Small Business and Small Businesses (e.g., 8(a), Veteran-owned small businesses, service-disabled Veteran-owned small businesses, HUBZone small businesses, small disadvantaged businesses, and women-owned small businesses) with the capability to meet the objectives and requirements described below. 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 mission of NIDA IRP is to conduct state-of-the-art research on basic mechanisms that underlie substance use disorders (SUDs), and to develop new methods for the treatment of SUDs. Research is supported at the molecular, genetic, cellular, animal, and human clinical levels and is conceptually integrated and utilizes highly innovative strategies and techniques. The long-term goal of the research is to better understand the biological and behavioral factors contributing to initiation, maintenance, and elimination of SUDs (and associated diseases), and to translate this knowledge into improved strategies for prevention, treatment, and reduction of negative consequences for the individual and for society caused by substance use disorders. Using volunteer human participants, the NIDA IRP clinical program conducts residential and nonresidential research studies that interrelate with pre-clinical laboratory work. In general, these studies include assessment of drug-use patterns, investigation of underlying brain mechanisms, and testing of a variety of SUD behavioral or biomedical treatments. Purpose and Objectives: The purpose of this Sources Sought Notice and market research is to identify vendors with demonstrated experience and capabilities in providing services for screening and remuneration of eligible research participants for inclusion in human research studies conducted by the NIDA IRP as part of their ongoing mission. NIDA IRP enrolls a highly targeted and representative study population of unique research participants including those with active SUDs (e.g. nicotine, alcohol, cocaine, marijuana, opioids) who are not seeking treatment, those who are seeking treatment, people who use these substances occasionally and healthy controls who match the other populations with respect to characteristics such as age, gender, socio-economic status (SES), IQ, etc. The NIDA IRP is also conducting studies requiring HIV-positive populations. Special attention and consideration needs to be made to the sensitive nature of the data collected when working with these populations. General Requirements: A Capable Vendor must demonstrate its experience and ability to perform the following key requirements: Screening Conduct preliminary screening procedures by phone and online surveys that are compliant with a variety of criteria and protocols based on the designated recruitment initiative. Phone screeners must have experience working with patient or research populations and discussing sensitive topics such as SUD and/or HIV, etc., and be familiar with empathetic, supportive and non-stigmatizing methods of communication. Phone screeners must be familiar with each study and prepared to answer questions about the study such as purpose, timeline, procedures and payment. A capable vendor should demonstrate its experience in utilizing a structured computer-based screening process designed to capture relevant information from the aforementioned populations to assess basic inclusion/exclusion criteria and the candidate’s current research interests. Screening results must be interpreted in the context of the current epidemiology and natural history of drug use, misuse, use disorders and treatment for appropriate referral to research opportunities. Phone screening must accommodate after-hours callers (i.e. evenings/weekends) and have the flexibility to handle transient high call volume and include flexible timeframes to accommodate research candidate’s availability and call fluctuations based on new campaign launches. Phone screeners must work with various scheduling methods as requested by the Government (e.g. online calendars), to accommodate candidates who pre-schedule calls online in addition to answering calls in real-time. Phone screeners will need to schedule participants for in-person screening appointments. Conduct in-person screening procedures that are compliant with a variety of criteria and protocols based on the designated recruitment initiative. The in-person screening process is a very critical element of this contract and our research operations. All study candidates must undergo a thorough onsite screening process. A small number of the studies permit portions of the screening process to be completed via secure online methods (e.g. Skype, FaceTime) with participants who are offsite. All screening procedures must be streamlined to optimize efficiency and cost-effectiveness of the process. In-person screeners must be familiar with each study and be prepared to answer questions about the study such as purpose, timeline, procedures and payment. In-person screeners are required to obtain informed consent, conduct basic medical assessments (e.g. obtaining vital signs, drawing blood, performing echocardiograms (ECGs), urine pregnancy testing, CO monitoring, breathalyzer and urine testing for drugs of abuse). Capable vendors will also be required to supply the Clinical Laboratory Improvement Amendments (CLIA) waiver testing kits needed for pregnancy, HIV and urine testing for drugs of abuse, and other screening supplies as requested. At least one staff member would be required to be present at all times during onsite screening hours who is qualified to: assess the mental health of potential study participants to determine whether they can give informed consent, assess whether a potential volunteer meets The Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria for mental and substance use disorders, and intervene should psychological distress occur during screening. The screening process also includes assessment of SUDs via administering medical and psychiatric measures, and psychiatric interviewing. Screeners should be familiar with and qualified to administer psychiatric measures (e.g. Structured Clinical Interview for DSM Disorders (SCID), Substance Use Disorder Evaluation (DSM-5)) and be prepared to obtain measure-specific training as needed. Provide schedule coordination services for those candidates that are accepted through the screening process. Vendors should have the capability to provide or work with existing automated options (as requested by NIDA) for those respondents who click on digital ads/media and include digital (e.g. text) reminders and confirmations of scheduled appointment times. Digital (e.g. text) reminders and confirmations of scheduled appointment times must be offered to all candidates. Remuneration, Travel and Subsistence Provide remuneration services to participants as they complete sections of a protocol. Remuneration may be dispersed as cash, checks, gift cards, online payments or paying bills directly on behalf of the participant, as defined by the protocol. All expenses must be tracked in the participants’ electronic medical record in addition to overall record keeping of all funds distributed. Coordinate and track participant progress within each study, and account for all remuneration paid to participants through the various forms of compensation. Develop and document a clear chain of custody of all funds for remuneration. Manage security of and limit access to all funds. Confirm debits and credits via a tiered system to ensure accuracy. Provide and coordinate travel and subsistence for participants requiring transportation lodging and/or meals, as needed and as described in each protocol. This may include but not be limited to car services, taxi, train, bus, or plane, as well as local hotel accommodations when required (in accordance with NIH policies). Transportation shall be provided via a platform that provides safeguards and administrative controls for study teams to manage transportation. Features shall include ability to book in advance, book ad-hoc travel, ride price information (notifications and price caps), flexible rebooking, ride distance caps, and allowable vehicle types, to monitor expenses and prevent unauthorized costs. Transportation shall include text options and reminders and be user-friendly for staff booking the transportation and participants to receive notifications. Provide accurate accounting of all expenses for travel and accommodation, cancelations, confirmations and participant satisfaction. Provide and coordinate snacks, meals and drinks as needed to accommodate participants and as described in approved protocols. Snacks and meals must accommodate protocols or participants with strict dietary limitations or guidelines. Snacks and meals must be ordered and delivered according to protocol requirements and timelines. Adherence with respect to providing or restricting meals based on protocol requirements is also required (e.g. study may have a fasting blood draw or meal required before or after drug administration). Accommodations for these protocol specific needs is required and may change over time. Provide tracking of expenses, participant satisfaction and minimize waste of food and resources. Flexible Staffing Support the effective communication and coordination of all requirements through regular reporting and the implementation of an automated system to track and generate specific performance and accounting reports, as well as maintain close communication with study staff to determine and optimize participant needs for travel, meals and remuneration. Support the effective communication and coordination of all requirements through regular reporting and the implementation of an automated system to track and generate specific performance and accounting reports, as well as maintain close communication with study staff to determine and optimize how participants who are interested and eligible for multiple studies will proceed through the screening process and into a study. Provide cross-trained staffing solutions with flexible and adaptive hours, (including evenings and weekends) capable of conducting screening services online, over the phone, or in-person as well as remuneration, travel and subsistence services. Instructions: Interested organizations must demonstrate and document in the submitted capability statement extensive experience in the technical areas and requirements listed above. Furthermore, organizations should include relevant and specific information on each of the following qualifications: 1) Experience: An outline of previous similar projects, specifically the techniques employed in the areas described above. 2) Personnel: Name, professional qualifications of personnel with specific experience in the work requested and knowledge of, and experience in, the field of biomedical research. 3) Facilities: Availability and description of the facilities and equipment required to conduct this type of work. 4) Compliance with Requirements: Vendors must identify and demonstrate specifically how they will meet the requirements listed above. The Government will assess the appropriateness of professional and technical personnel classifications. The Government will consider any other specific and relevant information about this particular announcement that would improve our assessment of respondents. Organizations should demonstrate capability to administer and coordinate interrelated tasks in an effective and timely manner. Documentation may include, but is not limited to, contracts in which the organization performed equivalent tasks (Government and commercial); references, i.e., names, titles, telephone numbers and any other information serving to document the organizations capability; and awards or commendations. All capability statements also should include the following: 1) company name and address; 2) point of contact, 3) phone/fax/email; 4) NAICS Code(s), 5) business size and status; 6) capability information in response to the requirement and qualifications identified in this notice; and 7) type(s) of business, if applicable (e.g., Other than Small, Small, Veteran-owned, service-disabled Veteran-Owned, women-owned, 8(a), Small Disadvantaged Business (SDB), and Historically Underutilized Business Zone (HUBZone). THIS IS NOT A REQUEST FOR PROPOSAL : This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. The Government does not intend to award a contract based on responses under this announcement nor otherwise pay for the preparation of any information sent for the Government’s use. Any proprietary information should be so marked. 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 to provide feedback to respondents with respect to any information submitted. The information submitted must be in a clear and concise format that addresses each of the elements of the project requirement listed above. A cover page and an executive summary may be included but is not required. The response is limited to fifteen (15) pages not including a cover page or executive summary. Responses must include your technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. Additional marketing materials, pamphlets, and information not relevant to the requirements identified above should not be submitted with the capability statement. Any business concerns that believe they possess the capability necessary to successfully undertake the work described above must SUBMIT CAPABILITY STATEMENTS ELECTRONICALLY to the Contract Specialist, Josh Lazarus at
[email protected], NO LATER THAN 4:00 p.m. EST on Wednesday, February 26, 2020 . The Subject line for the submission should include this Sources Sought Number. NIDA will not accept paper or faxed capability statements.