SOLICITATION NOTICE
R -- Office of Research Integrity - Research Misconduct
- Notice Date
- 6/6/2005
- Notice Type
- Solicitation Notice
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Program Support Center, Division of Acquisition Management, Parklawn Building Room 5-101 5600 Fishers Lane, Rockville, MD, 20857
- ZIP Code
- 20857
- Solicitation Number
- Reference-Number-05t675008
- Response Due
- 6/20/2005
- Archive Date
- 7/5/2005
- Small Business Set-Aside
- Total Small Business
- Description
- SIMPLIFIED ACQUISITION PROCEDURES DATE: JUNE 6, 2005 REQUISITION NO: 05T675008 INTENDED SOURCE: DR. PETER H. ABBRECHT PERIOD OF PERFORMANCE: DATE OF AWARD THROUGH TWELVE MONTHS PURPOSE: THE DEPARTMENT OF HEALTH AND HUMAN SERVICES, OFFICE OF RESEARCH INTEGRITY, THROUGH THE PROGRAM SUPPORT CENTER, PLANS TO AWARD A SOLE SOURCE SIMPLIFIED ACQUISITION TO DR. PETER H. ABBRECHT . CLOSING DATE IS JUNE 20, 2005. THE SPECIFIC OBJECTIVE OF THIS PROCUREMENT IS TO: PERIOD OF PERFORMANCE: THE PERIOD OF PERFORMANCE FROM COMMENCEMENT OF THE CONTRACT IS 12 MONTHS. THE CONTRACT WILL NOT EXCEED 1,000 HOURS PER YEAR. BACKGROUND: THE OFFICE OF RESEARCH INTEGRITY (ORI), OFFICE OF PUBLIC HEALTH AND SCIENCE, HAS GENERAL RESPONSIBILITY FOR THE RESEARCH INTEGRITY AND RESEARCH MISCONDUCT ACTIVITIES OF THE PUBLIC HEALTH SERVICE. THIS INCLUDES IMPLEMENTING REGULATIONS AND DEVELOPING AND ISSUING GUIDELINES ON HANDLING ALLEGATIONS OF RESEARCH MISCONDUCT, OFFERING TECHNICAL ASSISTANCE TO INSTITUTIONS, AND PROVIDING INFORMATION TO INSTITUTIONAL OFFICIALS, SCIENTISTS, AND THE GENERAL PUBLIC ON CASES INVOLVING HUMAN SUBJECTS, INCLUDING PATIENTS IN CLINICAL RESEARCH TRIALS. THE DIVISION OF INVESTIGATIVE OVERSIGHT (DIO), ORI, IS RESPONSIBLE FOR THE ADVISING ON AND CONDUCT OVERSIGHT OVER INVESTIGATIONS OF ALLEGATIONS OF RESEARCH MISCONDUCT. ALL CASES MUST BE DEVELOPED TO MEET THE STANDARDS OF FEDERAL INVESTIGATIONS; THE EVIDENCE DEVELOPED IN INDIVIDUAL CASES MAY RESULT IN AN ADMINISTRATIVE HEARING BY THE DEPARTMENT OF HEALTH AND HUMAN SERVICES, OR, IF APPROPRIATE, MAY BE USED IN CIVIL OR CRIMINAL CASES BY THE DEPARTMENT OF JUSTICE. THUS, THE EVIDENCE DEVELOPED BY DIO INVESTIGATORS MUST CONFORM TO THIS HIGH STANDARD. OVER ONE-THIRD OF ORI?S CASES OF RESEARCH MISCONDUCT INVOLVE HUMAN SUBJECTS IN RESEARCH, RANGING FROM SOCIAL SCIENCE INTERVIEWS OF VOLUNTEERS OR PATIENTS, TO PREVENTION AND TREATMENT TRIALS IN CLINICAL RESEARCH ON PATIENTS WITH CANCER, DIABETES, ASTHMA, AND OTHER DEBILITATING DISEASES. AN ESSENTIAL PART OF SUCH INVESTIGATIONAL CASES IS THE ANALYSIS OF CLINICAL RECORDS, INCLUDING PATIENT CHARTS, PHYSICIAN NOTES, TRIAL PROTOCOLS, PHARMACY RECORDS, CONSENT FORMS, AND RELATED DOCUMENTS, TO DETERMINE THEIR RELIABILITY AND VALIDITY AND THE SIGNIFICANCE OF ANY RESULTS REPORTED THEREIN. FORENSIC STATISTICAL TECHNIQUES ARE USED TO CHECK DATA FOR AUTHENTICITY AND ARE ESSENTIAL TO DETERMINING WHETHER DATA HAVE BEEN FALSIFIED OR FABRICATED. SUCH ANALYSES IN CLINICAL CASES ALSO INCLUDE A REVIEW OF THE MEDICAL LITERATURE AND A DETERMINATION OF THE IMPORTANCE OF THE QUESTIONED FINDINGS TO HUMAN HEALTH AND THEIR POTENTIAL DAMAGE TO HUMAN BEINGS IF FALSE. PURPOSE: THE OFFICE OF RESEARCH INTEGRITY (ORI) HAS AN ONGOING CRITICAL NEED FOR A MEDICAL EXPERT CONSULTANT, THE CONTRACTOR IS THE ONLY PERSON WITH THE NECESSARY QUALIFICATIONS, SKILLS, EXPERTISE AND PRIOR EXPERIENCE WHO IS CURRENTLY AVAILABLE AND HAS DEMONSTRATED COMPETENCY IN ANALYZING AND RESOLVING CASES OF RESESARCH MISCONDUCT. ABOUT 30 TO 40% OF ORI'S CASES OF RESEARCH MISCONDUCT INVOLVE ISSUES OF CLINICAL RESEARCH AND FUNDAMENTAL MEDICINE, WITH PATIENTS AND OTHER HUMAN SUBJECTS. A CONTRACT FOR A MEDICAL EXPERT CONSULTANT IS DESPERATELY NEEDED TO CONTINUE THIS WORK, ADVISING THE DIO AND ORI DIRECTORS, AS WELL AS THE RESEARCH INTEGRITY BRANCH (RIB) OF THE OFFICE OF GENERAL COUNSEL (OGC), ON THESE IMPORATANT CASES TO ORI. STATEMENT OF WORK: 1. PROVIDE EXPERTISE IN DESCRIBING FOR ORI THE NATURE OF THE DISEASES AND NORMAL MEDICAL CONDITION, THE TYPES OF RECORDS THAT SHOULD EXIST, AND AN ANALYSIS OF DISCREPANCIES IN THESE RECORDS, FROM A VIEWPOINT THAT RECOGNIZES THEIR MEDICAL AND SCIENTIFIC SIGNIFICANCE. IN PERFORMING THIS ROLE, THE CONTRACTOR SHALL WRITE DRAFT AND FINAL INVESTIGATIONAL SUMMARY REPORTS FOR CLINICAL CASES INVOLVING ORI FINDINGS OF RESEARCH MISCONDUCT AND PROVIDE ADVICE FOR THE ORI AND THE OFFICE OF GENERAL COUNSEL ON SUCH CASES UNDER NEGOTIATION FOR VOLUNTARY AGREEMENTS. THE CONTRACTOR SHALL ALSO DEVELOP DRAFT AND FINAL OVERSIGHT REPORTS FOR CLINICAL CASES THAT DO NOT LEAD TO ORI FINDINGS OF RESEARCH MISCONDUCT. THE CONTRACTOR SHALL ALSO ATTEND AND PARTICIPATE IN WEEKLY MEETINGS OF THE ORI CASE EVALUATION COUNCIL, PROVIDING COMMENTS BASED ON THE CONTRACTOR?S EXPERTISE IN OTHER PENDING ORI CASES. 2. DRAFT A GUIDANCE DOCUMENT FOR INSTITUTIONS ON BEST PRACTICES IN HANDLING ALLEGATIONS AND INVESTIGATIONS OF RESEARCH MISCONDUCT IN CLINICAL TRIALS AND RESEARCH INVOLVING PATIENT RECORDS. IN DEVELOPING THIS DOCUMENT, THE CONTRACTOR SHALL MEET WITH ORI STAFF TO DISCUSS RELEVANT ISSUES IN THE BROAD RANGE OF CLINICAL AND HUMAN SUBJECT CASES. THE CONTRACTOR WILL CONTINUE TO REVISE THE DRAFT DOCUMENT UNTIL ALL MAJOR ISSUES ARE RESOLVED AND ORI HAS APPROVED IT FOR POSTING ON THE ORI WEBSITE AND DISTRIBUTION TO MEDICAL INSTITUTIONS. 3. CONDUCT HISTORICAL ANALYSES OF ORI?S CLINICAL CASES 4. PREPARE PRESENTATIONS AND MANUSCRIPTS FOR PUBLICATION ON THIS RESEARCH. SOLE SOURCE DETERMINATION IS BASED UPON THE FOLLOWING: THE CONTRACTOR IS AN EXPERT IN MEDICINE, WHO IS STILL INVOLVED IN TEACHING MEDICAL STUDENTS AND MAINTAINS AN ACTIVE LICENSE TO PRACTICE MEDICINE. THE RETIREMENT OF THE ONLY FULL-TIME M.D. EVER ON THE ORI STAFF IN ITS 13 YEARS OF EXISTENCE, HAS LEFT ORI UNABLE TO FIND A QUALIFIED FULL-TIME REPLACEMENT. HOWEVER, THE CONTRACTOR, WHO HAD RETIRED FROM THE UNIFORMED SERVICES UNIVERSITY OF THE HEALTH SCIENCES IN BETHESDA AND FROM ACTIVE SERVICE AT THE WALTER REED ARMY HOSPITAL, BECAME AVAILABLE FOR PART-TIME EMPLOYMENT WITH ORI. THE CONTRACTOR HAS MAINTAINED HIS MEDICAL LICENSE.PART-TIME ASSISTANCE IS A COST-EFFECTIVE STRATEGY FOR ORI TO OBTAIN THE REQUIRED MEDICAL EXPERTISE AND CLINICAL RESERACH MISCONDUCT EXPERIENCE NEEDED IN ORI. IN ADDITION, THE CONTRACTOR HAS ADMINISTRATIVELY CLOSED 6 MAJOR CASEFILES INVOLVING CLINICAL RESEARCH, IN WHICH HE CONDUCTED EXPERT ANALYSES AND HE DETERMINED THAT THERE WAS INSUFFICIENT EVIDENCE OF SCIENTIFIC MISCONDUCT WITHIN ORI OR THE INSTITUTION TO PURSUE THE MATTERS FURTHER. THE CONTRACTOR HAS ALSO GIVEN NUMEROUS TALKS FOR ORI AS MEDICAL EXPERT, AT BOTH ORI CONFERENCES AND AT HOSPITAL AND MEDICAL ASSOCIATION WORKSHOPS ON HIS HANDLING OF RESEARCH MISCONDUCT CASES. HE HAS PROVIDED CRITICAL EXPERT ADVICE TO OPHS, ORI, AND THE OFFICE OF GENERAL COUNSEL ON THESE MATTERS. THE PROPOSED CONTRACT WILL PROVIDE EXPERT MEDICAL CONSULTATION DURING ORI OVERSIGHT, GUIDELINE DEVELOPMENT, AND ADVICE PROVISION TO RESEARCH INSTITUTIONS, HOSPITALS, AND MEDICAL ADMINISTRATORS WITHIN THE FEDERAL GOVERNMENT AND OUTSIDE, ASSISTING ORI IN DETERMINING WHETHER RESEARCH MISCONDUCT MAY HAVE OCCURRED OR WHETHER THE ACCUSED SCIENTIST SHOULD BE EXONERATED. IT WILL ALSO PROVIDE MATERIALS AND ASSISTANCE TO OTHERS TO DO SOME OF SUCH ANALYSES THEMSELVES. THERE IS A COMPELLING NEED FOR THIS CONTRACT. FABRICATION AND FALSIFICATION OF DATA AND MEDICAL RECORDS IS A MAJOR COMPONENT OF THE ALLEGATIONS OF RESEARCH MISCONDUCT ROUTINELY REVIEWED BY ORI. EXPERT ANALYSIS IS CRITICAL TO THE ABILITY OF ORI TO ADEQUATELY ASSESS ALLEGATIONS AND INVESTIGATION REPORTS AND, IF MISCONDUCT IS FOUND, DEFEND THOSE FINDINGS IN APPEALS HEARINGS AND/OR IN CIVIL/CRIMINAL LITIGATION IN THE FEDERAL COURTS. THE CONTRACT WILL PROVIDE THIS ANALYSIS FOR INDIVIDUAL CLINICAL CASES AND DEVELOP GUIDANCE. THE TYPE OF MEDICAL EXPERT IN RESEARCH MISCONDUCT CASE EXPERTISE REQUIRED BY ORI IS UNIQUE AND NOT AVAILABLE ELSEWHERE, ORI HAS NOT BEEN ABLE TO IDENTIFY ANY OTHER SOURCES IN THE WASHINGTON, D.C. AREA. THE PROPOSED SIMPLIFIED ACQUISITION IS FOR SERVICES FOR WHICH THE GOVERNMENT INTENDS TO SOLICIT AND NEGOTIATE WITH ONLY ONE SOURCE (FAR 6.302-1). A DETERMINATION BY THE GOVERNMENT NOT TO COMPETE THIS PROPOSED SIMPLIFIED ACQUISITION BASED UPON RESPONSES TO THIS NOTICE IS SOLELY WITHIN THE DISCRETION OF THE GOVERNMENT. CONTRACTORS MAY FORWARD CAPABILITY STATEMENTS TO THE REFERENCED ADDRESS. INFORMATION RECEIVED WILL NORMALLY BE CONSIDERED SOLELY FOR THE PURPOSES OF DETERMINING WHETHER TO CONDUCT A COMPETITIVE PROCUREMENT. FOR FURTHER INFORMATION, PLEASE CONTACT DARREN JANSEN, IN ROOM 5C-13, PARKLAWN BLDG., 5600 FISHERS LANE, ROCKVILLE, MD 20857 OR ON 301-443-1857.
- Record
- SN00823259-W 20050608/050606211754 (fbodaily.com)
- Source
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