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Open Access
Pitfalls and Safeguards in Industry-Funded Research
Joseph L. Breault and Emily Knafl
Ochsner Journal March 2020, 20 (1) 104-110; DOI: https://doi.org/10.31486/toj.19.0093
Joseph L. Breault
1Former Chair, Institutional Review Board, and Senior Physician, Department of Family Medicine, Ochsner Clinic Foundation, New Orleans, LA
2The University of Queensland Faculty of Medicine, Ochsner Clinical School, New Orleans, LA
MD, ScDEmily Knafl
2The University of Queensland Faculty of Medicine, Ochsner Clinical School, New Orleans, LA
MDREFERENCES
- 1.↵
- 2.↵
- 3.↵
- 4.↵
- Whoriskey P
- 5.↵
- Knox R
- 6.↵
- Prakash S,
- Valentine V
- 7.↵
- 8.↵
- 9.↵Accelerating medicines partnership (AMP). National Institutes of Health. www.nih.gov/research-training/accelerating-medicines-partnership-amp. Accessed November 10, 2019.
- 10.↵NIH launches collaborative program with industry and researchers to spur therapeutic development [news release]. National Institutes of Health; May 3, 2012. www.nih.gov/news-events/news-releases/nih-launches-collaborative-program-industry-researchers-spur-therapeutic-development. Accessed November 10, 2019.
- 11.↵
- Lexchin J,
- Bero LA,
- Djulbegovic B,
- Clark O
- 12.↵
- Rochon PA,
- Gurwitz JH,
- Simms RW,
- et al.
- 13.↵
- McCarthy M
- 14.↵
- 15.↵
- 16.
- Psaty BM,
- Rennie D
- 17.↵
- Andersen M,
- Kragstrup J,
- Søndergaard J
- 18.↵OIG compliance program guidance for pharmaceutical manufacturers. Fed Regist. 2003;68(86):23731-23743. www.govinfo.gov/content/pkg/FR-2003-05-05/pdf/03-10949.pdf. Accessed March 9, 2020.
- 19.↵Exceptions. Program integrity–Medicare and state health care programs. 42 CFR §1001.952. US Department of Health and Human Services. www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=38617225b7a4d12f545f19f24ac59a5f&ty=HTML&h=L&mc=true&n=pt42.5.1001&r=PART#se42.5.1001_1952. Accessed November 30, 2019.
- 20.↵A roadmap for new physicians: fraud and abuse laws. Office of Inspector General. US Department of Health and Human Services. oig.hhs.gov/compliance/physician-education/01laws.asp. Accessed November 30, 2019.
- 21.↵Emory University to pay $1.5 million to settle False Claims Act investigation [news release]. US Attorney's Office Northern District of Georgia; August 28, 2013. www.justice.gov/usao-ndga/pr/emory-university-pay-15-million-settle-false-claims-act-investigation. Accessed November 30, 2019.
- 22.↵Health care fraud and abuse control program annual report for fiscal year 2016. US Department of Health and Human Services and US Department of Justice. oig.hhs.gov/publications/docs/hcfac/FY2016-hcfac.pdf. Published January 2017. Accessed November 30, 2019.
- 23.↵
- Pfadenhauer JB
- 24.↵
- Silverman E
- 25.↵Recruiting human subjects: pressures in industry-sponsored clinical research. US Office of Inspector General. Department of Health and Human Services. oig.hhs.gov/oei/reports/oei-01-97-00195.pdf. Published June 2000. Accessed September 12, 2019.
- 26.↵
- Tigas M,
- Jones RG,
- Ornstein C,
- Groeger L
- 27.↵
- Yaraghi N
- 28.↵
- Scutti S
- 29.↵
- Jonsen AR,
- Siegler M,
- Winslade WJ
- 30.↵
- 31.↵Conflicts of interest in research: code of medical ethics opinion 7.1.4. American Medical Association. www.ama-assn.org/delivering-care/ethics/conflicts-interest-research. Accessed September 12, 2019.
- 32.↵Conflicts of interest in patient care: code of medical ethics opinion 11.2.2. American Medical Association. www.ama-assn.org/delivering-care/ethics/conflicts-interest-patient-care. Accessed September 12, 2019.
- 33.↵Patient-physician relationships: code of medical ethics opinion 1.1.1. American Medical Association. www.ama-assn.org/delivering-care/ethics/patient-physician-relationships. Accessed September 12, 2019.
- 34.↵
- Sox HC,
- Rennie D
- 35.↵Tip sheet 10: financial conflict of interest for researchers and research staff. Association for the Accreditation of Human Research Protection Programs, Inc. admin.aahrpp.org/Website%20Documents/Tip%20Sheet%2010%20in%20pdf.pdf. Accessed September 12, 2019.
- 36.↵PhRMA Principles on conduct of clinical trials. Pharmaceutical Research and Manufacturers of America. www.phrma.org/en/Codes-and-guidelines/PhRMA-Principles-on-Conduct-of-Clinical-Trials. Revised December 2014. Accessed September 12, 2019.
- 37.↵
- 38.↵Conflicts of interest: bio-medical research. In: American Medical Association, ed. Code of Medical Ethics of the American Medical Association: Current Opinions With Annotations 2010-2011. Chicago, IL: American Medical Association; 2010:216-218.
- 39.↵
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Pitfalls and Safeguards in Industry-Funded Research
Joseph L. Breault, Emily Knafl
Ochsner Journal Mar 2020, 20 (1) 104-110; DOI: 10.31486/toj.19.0093
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