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FBO DAILY - FEDBIZOPPS ISSUE OF DECEMBER 18, 2014 FBO #4772
SOLICITATION NOTICE

R -- NIDA IRP Clinical Protocol Participant Recruitment Support

Notice Date
12/16/2014
 
Notice Type
Presolicitation
 
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-RFP-15-032
 
Archive Date
1/17/2015
 
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
SOLICITATION NUMBER: HHS-NIH-NIDA-SSSA-RFP-15-032 PRE-SOLICITATION NOTICE INFORMATION Title: NIDA IRP Clinical Protocol Participant Recruitment Support 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 Pre-Solicitation Notice of Intent. This is NOT a solicitation for proposals, proposal abstracts, or quotations. A solicitation will be issued on a later date. The purpose of this pre-solicitation is to notify potential offerors that the National Institute on Drug Abuse (NIDA) intends to solicit proposals for NIDA Intramural Research Program (IRP) Clinical Protocol Participant Recruitment Support from qualified contractors having the capability to perform the tasks identified in this pre-solicitation. This acquisition is a re-competition of the Participant Recruitment Support requirement of the NIDA IRP Clinical Research Program. The initial Participant Recruitment Support contract (HHSN271201100030C) was awarded in 2011 to Matthews Media Group, Inc. Requirement Background Information: 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 Requirement: The purpose of this 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 its ongoing mission. Project Tasks/Requirements: The NIDA IRP requires support in the following task areas: 1. Project Management It is the responsibility of the Contractor to ensure adequate staffing and any supervision of that staff. The Contractor will assure smooth daily operations of the Recruiting Department to include staffing the call center, providing for in-person screening and managing the flow of participants throughout the day. Reports will need to reflect effectiveness of various types of advertising as well as volume of phone screens, in person screens and participants sent for clearance to protocols and participants consented to protocols. The invoicing needs to include costs associated with the screening process such as participant transportation and meals if needed as well as the staffing hours, ads developed and run, and tracking of participant remuneration. Monthly reports to the Project Officer, OCD and participating PI will reflect the performance outcomes of each recruitment strategy. 2. Advertisement Support The advertising support will be in two main divisions; first is the steady state advertising common to all the Principal Investigators (PIs). This includes postings to Craigslist and maintaining the NIDA IRP Recruiting website. The second division will allow for the PIs (up to four) to opt-in and use the Contractor as their marketing team to develop ads, suggest ways to deploy the advertising as well as actually running the ads or outreach campaign. As the NIDA IRP is based in Baltimore, the overwhelming majority of advertising is in this market. Participants are only recruited from the local area. Common forms of advertising include local newspapers, bus ads, radio ads and some web advertising such as craigslist posting. Community outreach is another form of advertising that is frequently used. It may include posting fliers in businesses, public and private colleges and school systems and other places. The Contractor may be asked to attend local events as a means of raising awareness of NIDA research opportunities to community resource groups or arrange for in-services for specific research team members to appropriately target audiences in the community. Lastly, the Contractor may be asked to attend local activities that are primarily for entertainment for recruiting purposes. The Contractor will work with study teams to provide timely creation of protocol and/or population specific advertisements prior to enrollment of the first participant. Also, the Contractor will frequently re-assess the effectiveness of the marketing strategies used and suggest changes to improve the recruitment of specific target populations. 3. Participant Screening The screening of NIDA IRP participants occurs in two phases: telephone and in person. If the potential participant appears during telephone interviewing to fit the inclusion/exclusion criteria of a current protocol, they are invited to come to the BRC for an in-person screen. Generally, the in-person screen takes six to eight hours and is conducted in one day. Currently the NIDA IRP conducts 350 telephone screening interviews monthly. The Contractor will provide Bachelors level staff trained and proficient in performing structured telephone interview to determine eligibility and/or acceptability of participant in research protocols. The in-person screening process requires coordination with NIDA IRP staff including but not limited to Physician Assistants, Nurse Practitioners and Physicians. The Contractor will provide the staffing necessary for basic medical assessments including obtaining vital signs, drawing blood, performing ECGs, urine pregnancy testing, CO monitoring, breathalyzer and testing urine for drugs of abuse. The Contractor will also supply the CLIA waiver testing kits needed for pregnancy, HIV and urine testing for drugs of abuse. The staff conducting the in-person screening must have knowledge of drug use disorders, medical and psychiatric measures and psychiatric interviewing. The staff obtains informed consent from each participant for screening protocol and procedures including completion of appropriate screening instruments. Strong interpersonal skills will ensure appropriate explanations of the current research protocols for which the participant may be eligible in the most professional manner. As the records of NIDA IRP are electronic, computer proficiency is needed to ensure proper and accurate recording of participant clinical record. The staff will coordinate repeat testing and follow up evaluations, as needed with study participants under the guidance from research team members. Also, appropriate referrals to community providers for medical and drug treatment will be provided as needed during recruitment in coordination with the research team. The staff may perform exit interviews with individual screened for research participation by the IRP. 4. Participant Remuneration The Contractor will be responsible for the remuneration of all the NIDA IRP participants. In keeping with the NIDA Remuneration Policy, as participants complete sections of a protocol, it is indicated in the NIDA electronic medical records system, Human Research Information System (HuRIS). At pre-determined times within each protocol participants are allowed to collect funds. The funds may be checks, paying bills for the participant, gift cards or cash as defined by the protocol. The HuRIS records must then be married up to the Contractor records of funds. If PIs approach the allowable limit of their funds for remuneration, the PI and Clinical Director must be alerted in advance. 5. Training and Documenting Issues The Contractor will assure that all staff members comply with current and future requirements mandated for human subjects' protection, including but not limited to NIH/NIDA /IRP clinical, ethical, informed consent, good clinical practice (GCP), confidentiality, privacy and conflict of interest requirements. Likewise, any necessary training and/or clearances as required for working with special populations (OPM/FBI) including children and adolescents will be completed as required by NIDA IRP. The Contractor will make 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. All documents will be Section 508 compliant. The Contractor will maintain quality assurance procedures and records for all processes including but not limited to the phone screen, the various tasks of the in-person screen and the medical elements of screening (vital signs, ECG, CLIA waived testing). Set-Aside Status: It is anticipated that the services will be acquired through unrestricted full and open competitive procedures under NAICS Code 541990. Anticipated Period of Performance: The anticipated period of performance is one (1) six-month base period and nine (9) six-month option periods. Anticipated Contract Type: The NIDA anticipates the award of one (1) contract. It is anticipated that the contract type shall be cost-reimbursement. Request for Proposal Release Information: Request for Proposal (RFP) No. NIH-NIDA-SSSA-RFP-15-032 will be available electronically on or about January 8, 2015. The RFP shall be accessible through FedBizOpps at http://fedbizopps.gov. All information required for the submission of a proposal will be contained in or accessible through the RFP package. Responses to the RFP will be due on or about 30 days following RFP release. Offerors must submit a proposal for all Task Areas in order to be considered for award. WE ENCOURAGE ALL RESPONSIBLE SOURCES TO SUBMIT A PROPOSAL WHICH WILL BE CONSIDERED BY THE AGENCY. Notes: This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted. It is the Offeror's responsibility to monitor the above mentioned site for the release of the solicitation and any amendments.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-2/HHS-NIH-NIDA-SSSA-RFP-15-032/listing.html)
 
Place of Performance
Address: Baltimore, Maryland, 21224, United States
Zip Code: 21224
 
Record
SN03597171-W 20141218/141216234432-524b7b3cff0b5664b32c0d96310abc9f (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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