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FBO DAILY ISSUE OF JULY 12, 2009 FBO #2785
DOCUMENT

R -- Conslultant(s) for Evaluation of the NIH Human Subjects Protection Program to acquire Accreditation from the Association of Human Research Protection Program (AAHRPP) - AAHRPP RFP

Notice Date

7/10/2009
 

Notice Type

AAHRPP RFP
 

NAICS

541690 — Other Scientific and Technical Consulting Services
 

Contracting Office

Department of Health and Human Services, National Institutes of Health, Office of Administration, 6011 Executive Blvd, 5th Floor, Rockville, Maryland, 20852-3804, United States
 

ZIP Code

20852-3804
 

Solicitation Number

NIHOD2009132
 

Point of Contact

Timothy Johnson, Phone: 301402-5450, Danielle L. Sweeney, Phone: (301) 402-3065
 

E-Mail Address

johnsontim@mail.nih.gov, sweeneyd@od.nih.gov
(johnsontim@mail.nih.gov, sweeneyd@od.nih.gov)
 

Small Business Set-Aside

N/A
 

Description

AAHRPP STATEMENT OF WORK AAHRPP TECHNICAL EVALUATION Evaluation Instrument for Accreditation NIH is in the process of evaluating its human research protection program (HRPP) using standards established by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). This organization is the recognized world leader in evaluating and accrediting HRPPs. NIH’s goal is to obtain full accreditation from AAHRPP by 2010. Achieving this goal requires an evaluation of current human subjects’ protection policies and practices to determine if NIH policies meet accreditation standards, if modifications are needed, or, if additional policies must be created. The policies include standard operating procedures for the NIH IRBs, the NIH Manual Chapter for the NIH HRPP, MAS policies, OHSR Information sheets, memos, delegations of authority, and possibly the Intramural Research Program Conflict of Interest policy (COI). This evaluation will be used for the accreditation process, as well as administrative management assessment of the HRPP. This evaluation process is a trans-NIH initiative involving the NIH Office of Human Subjects Research (OHSR); NIH institutes and centers with clinical programs (Clinical Directors, Principal Investigators) to include the: Deputy Director for Intramural Research, Human Subjects Research Advisory Committee, the 12 NIH IRBs, the Clinical Center, Medical Executive Board, as well as committees established specifically for the purpose of AAHRPP accreditation activities. All of these organizational units/scientists are stakeholders in the evaluation process. NIH requires expertise and additional personnel support in this work. The final product of this evaluation will be an NIH application for AAHRPP accreditation that clearly states the policies and procedures of the NIH for human subject’s research and meets the standards set by AAHRPP for accreditation. This work product will include any new policies and procedures that are developed during the evaluation. An additional work product will be findings and recommendations for strategic management planning for the NIH HRPP. The most significant deliverable will be an NIH Application for AAHRPP Accreditation, consistent with regulatory requirements, NIH policies, and AAHRP standards. However this work involves significant evaluation activities in order to prepare such an application. The evaluation will collect and analyze data from document reviews of policies and procedures of the HRPP, IRBs, OHSR, the ICs clinical programs, Medical Administrative Service (MAS), and the Medical Executive Committee (MEC). OHSR will work with the various units to modify current policies and procedures or establish new policies and procedures to obtain accreditation and maintain the high standards of the NIH HRPP. All work under this SOW will be monitored by the Project Officer. The Office of Human Subject Research (OHSR) NIH proposes to select a vendor in accordance with the procedures for acquiring commercial items authorized in FAR Part 12. This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-26 and local clauses of the Department of Health and Human Services and the National Institutes of Health. The acquisition will be made pursuant to the authority in FAR 13.5 to use simplified procedures for commercial requirements. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation is attached. In accordance with FAR 52.216-1, the Government contemplates the award of a Firm Fixed Price contracts from this solicitation. The North American Industry Classification System (NAICS) code is 541690 and the business size standard is $7,000,000.00, however, this requirement is not set-aside for small businesses. In order to be considered for award offerors must be registered in the Central Contractor Registration (CCR) at www.ccr.gov. Description of Requirements: This is a combined synopsis/solicitation for Commercial Items, prepared in accordance with the format in FAR 12.6, as supplemented with additional information included in this notice. 1. The contractor shall review and provide written assessment of existing policies, procedures and supporting documents for the NIH Human subjects Protection Program (NIH HRPP), and shall provide written assessment where existing policies procedures and supporting documents do not fulfill the requirements in content and comprehensiveness, articulated by all elements of the latest Association for the Accreditation of Human Research Protection Programs (AAHRPP) self evaluation tool. 2. The contractor shall review and provide written assessment of self-evaluation processes and review mechanisms for standard operating procedure (SOP) review and development as they currently exist. 3. The contractor shall analyze findings of reviews and make written recommendations for further evaluation and review in a Strategic Management Plan. 4. The contractor shall create new policies, procedures and supporting documents for the NIH HRPP when existing policies, procedures and supporting documents are found lacking, for example quality assurance for the NIH HRPP, collaborative and contracted research, and FDA regulated research. 5. The contractor shall develop new or amend existing HRPP checklists once gaps are identified in the existing policies and procedures based on existing policy reviews. The contractor shall review existing NIH IRB checklists, review SOPs to see where checklists and templates are referenced, identify areas where checklists are needed, including but not limited to initial review checklist (version for Principle Investigator (PI) and Institutional Review Board (IRB) Administrative staff), CR checklist (versions for PI and IRB administrative staff, amendment checklist (versions for PI and IRB administrative staff, research and vulnerable populations. The contractor shall develop and submit checklists for NIH Office of Human Subject Research (OHSR) review. 6. The contractor shall provide written project updates of OHSR evaluating progress to the NIH Project Officer on a weekly basis. 7. The contractor shall provide a written summary of project expenditures to the NIH Project Officer on a monthly basis. 8. The contractor shall provide all deliverables in e-mail format and at the option of the NIH Project Officer, hard copy. 9. The contractor shall update accreditation advisory committees and NIH leadership when required by the NIH Project Officer. 10. The contractor shall perform the following 3 evaluation related tasks within the first 30 days of initiation of the contract. (a)The contractor shall evaluate self-evaluation processes and review mechanisms for SOP review and development as they currently exist. (b)The contractor shall review existing HRPP policies and procedures. (c) The contractor shall complete revisions to HRPP SOPs, checklists and attachments completed for the following domains: oversight of the NIH HRPP system; policy development for the NIH HRPP system: conduct of the IRB meetings; initial review procedures; continuing review procedures. 11. The contractor shall perform the following 2 revision related tasks within the first 60 days of initiation of the contract. (a)The contractor shall provide written revisions to HRPP SOPs, checklists and attachments completed for the following domains: IRB membership and structure; management and administrative operations of the IRB; amendments to approved protocols; research with children; adverse event reporting; data and safety monitoring and (b) Provide 10-page summary of the HRPP to accompany the application. 12. The contractor shall perform the following 2 revision related tasks within the first 90 days of initiation of the contract. (a) The contractor shall perform revisions to HRPP SOPs, checklists and attachments completed for the following domains: policy pertaining to non-compliance, informed consent, vulnerable subjects, suspensions and terminations, selection and recruitment of subjects. (b) The contractor shall attend meetings of relevant NIH committees (HSRAC SOP, pre-review subcommittee, IPAC SOP pre-review subcommittee, HSRAC) to present revisions to policies and solicit feedback. 13. The contractor shall perform the following 2 revision related tasks within the first 120 days of initiation of the contract. (a)The contractor shall perform revisions to HRPP SOP, checklists and attachments completed for the following domains; collaborative research; confidentiality and privacy; FDA regulated research; investigator responsibilities; managing conflicts of interest; quality assurance and quality improvement for the HRPP; create glossary; final editorial review for chapter order, format, consistency. (b)The contractor shall attend meetings of relevant NIH committees (HSRAC SOP pre-review subcommittee, IPAC SOP pre-review subcommittee, HSRAC) to present revisions to policies and solicit feedback. 14. The contractor shall perform the following revision related task listed within the first 180 days of initiation of the contract. (a) The contractor shall create additional HRPP SOPs as identified in the initial assessment as necessary for AAHRPP accreditation that have not otherwise been created by OHSR for the HRPP. (b)The contractor shall perform revisions to HRPP SOPs, checklists and attachments completed for the following domains: QA reviews to assure that each of the AAHRPP standards is addressed in the SOPs and supporting materials for the element by element index before submitting the AAHRPP Application; create the AAHRPP Element by Element Index to supporting documents (Section C of AAHRPP Application); compile Section D of the AAHRPP application with all supporting documents to application, including SOPs; submit application and supporting written materials to AAHRPP after review by the NIH Project Officer; final evaluation report. Given the nature of the contract, the vendor shall possess the following skills and qualifications: 15. The contractor shall possess expertise in the AAHRPP accreditation standards and the AAHRPP accreditation process as evidenced at a minimum by: 1) Documentation that they are from an AAHRPP accredited institution and that they participated in that accrediting process or 2) Documentation that they have provided AAHRPP accreditation consultation for at least one successful AAHRPP accreditation process. 16. The contractor shall possess extensive experience in evaluating policies and procedures of a complex human subjects program with respect to AAHRPP standards. 17. The contractor shall possess experience writing and editing human research protection policies. 18. The contractor shall possess experience in management of a large evaluation project. 19. The contractor shall possess skill and experience in evaluation methods for program assessment, reviewing documents, conducting individual and group interviews, attending meetings and making observations as a means of data collection, to analyze, summarize, and interpret the data into findings and based on these findings, make recommendations. 20. The contractor shall possess skill and experience in evaluation methods for program assessment, reviewing documents, conducting individual and group interviews, attending meetings and making observations as a means of data collection, to analyze, summarize, and interpret the data into findings and based on these findings, make recommendations. Deliverables: 1.Written assessment(s) where existing policies procedures and supporting documents do not fulfill the requirements in content and comprehensiveness, articulated by all elements of the latest Association for the Accreditation of Human Research Protection Programs (AAHRPP) self evaluation tool. 2.Written assessment(s) of self-evaluation processes and review mechanisms for standard operating procedure (SOP) review and development as they currently exist. 3.Written recommendations for further evaluation and review in a Strategic Management Plan. 4.Develop and deliver new or amend existing HRPP checklists. 5.Written project updates of OHSR evaluating progress to the NIH Project Officer 6.Provide a written summary of project expenditures. 7.Update accreditation advisory committees and NIH leadership when required by the NIH Project Officer. The period of performance shall be for 6 months from the date of award. The provision at FAR 52.212-2, Evaluation of Commercial Items applies. The Government will award one Firm Fixed Price contracts resulting from this RFQ to the most responsive, responsible offerors whose offer represents the best value in terms of price and the following factors (all factors being equal to price): Experience, Comprehension of the Requirement and Key Personnel Experience. The solicitation incorporates the provisions at FAR 52.212-1, INSTRUCTIONS TO OFFERORS - COMMERCIAL ITEMS - DEVIATION FOR SIMPLIFIED ACQUISITIONS, and at FAR 52.212-3, OFFEROR REPRESENTATIONS AND CERTIFICATIONS - COMMERCIAL ITEMS - WITH DUNS NUMBER ADDENDUM. The resulting contract will incorporate the requirements of the clause at FAR 52.212-4, CONTRACT TERMS AND CONDITIONS - COMMERCIAL ITEMS, and the requirements contained in paragraphs (a) and (d) of the clause at FAR 52.212-5, CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS - COMMERCIAL ITEMS - DEVIATION FOR SIMPLIFIED ACQUISITIONS. The following FAR provision is applicable: FAR 52.252-1, Solicitation Provisions Included by Reference. The following FAR clauses are applicable: FAR 52.252-2, Clauses Included by Reference; FAR 52.212-4, Contract Terms and Conditions Commercial Items, with addendum; FAR 52.212-5, Contract Terms and Conditions Required to Implement Statues or Executive Orders Commercial Items (Nov 2007), applies to this acquisition, and specifically the following FAR clauses under paragraph (b) are applicable: 52.219-6, Total Small Business Set-Aside (June 2003); 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Aug 2007); 52.222-21, Prohibition of Segregated Facilities (Feb 1999); 52.222-26 - Equal Opportunity (Mar 2007); 52.222-35 - Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sep 2006); 52.222-36 - Affirmative Action for Workers With Disabilities (Jun 1998); 52.222-37 - Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sep 2006); 52.223-9 ? Estimate of Percentage of Recovered Material Content for EPA-Designated Products (Aug 2007); 52.225-13 -Restrictions on Certain Foreign Purchases (Feb 2006); and 52.232-33 - Payment by Electronic Funds Transfer--Central Contractor (Oct 2003). FAR Clauses and provisions incorporated by reference may be viewed in full text via the Internet at http://farsite.hill.af.mil/ or http://www.arnet.gov/far/. The technical portion of quotations will receive paramount consideration in selecting a vendor. Cost/price will also be a significant factor in the event that two or more vendors are determined to be essentially equal following the evaluation of technical factors. Please refer to the attached Statement of Work and technical evaluation criteria to be used in evaluating offers. The Government reserves the right to enter into an agreement with other than the lowest offeror. The Government intends to enter into an agreement without discussions, nevertheless, the government may communicate with an offeror in order to clarify or verify information submitted in its offer. Offerors must submit representations and certifications in accordance with the provision at FAR 52.212-3, Offeror Representation and Certifications Commercial, with its offer and FAR 52.204-8, Annual Representations and Certifications, or certification that these have been completed online via Online Representations and Certifications Applications (ORCA) at https://orca.bpn.gov/. FAR 52.212-3 can be downloaded from the internet: http://farsite.hill.af.mil/. Offerors that fail to furnish the required representation information, or reject the terms and conditions of the solicitation, may be excluded from consideration. Submission of Proposals Submission of proposals on SF 1449 forms are not required however shall include a signed statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation. Offers that fail to furnish required representations or information, or reject the terms and conditions of the solicitation may be excluded from consideration. Due to time constraints proposals must be received no later than 4:00pm local time, 27 July 2009; in accordance with FAR part 12.603 (a) (b) and request for extension of the deadline date will not be entertained. Proposals can be mailed or delivered via courier to National Institutes of Health, Office of Acquisitions, and ATTN: Timothy Johnson, 6011 Executive Blvd., Suite 529W, Rockville, MD 20852 - Ph (301) 402-5450, email – johnsontim@od.nih.gov. The point of contact for information regarding this solicitation is as mentioned above. Interested parties shall submit the following documents in response to this RFP: Technical approach/proposal, Prices/Costs proposal, Offeror Representations and Certifications, Past Performance Information, signed acceptance to all terms and conditions listed herein. Past Performance Information: Interested parties/bidders shall provide three (3) customer references for the same or similar work as follows: Description; contract number; date of award; name and telephone contact. Attachments: 1. Statement of Work. 2. Technical Evaluation Criteria.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/OoA/NIHOD2009132/listing.html)
 

Document(s)

AAHRPP RFP
 

File Name: AAHRPP OFFICIAL WEBSITE (http://www.aahrpp.org)

Link: http://www.aahrpp.org

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: Bldg. 31, C2, Bethesda Main Campus, Claude P. Pepper Building, 31 Center Drive, 2nd Floor, Wing C, Bethesda, Maryland, 20814, United States

Zip Code: 20814
 

Record

SN01871193-W 20090712/090710235301-480136f75abf7943e89f4c7803d2d835 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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