Practice-Based Clinical Research and Ethical Decision Making-Part II: Deciding Whether to Host a Particular Research Study in Your Practice

ABSTRACT

Due to the growth and expansion of clinical research, particularly research conducted in practice-based settings, all practicing physicians should have a fundamental understanding of clinical research and the differences between clinical care and clinical research. Physicians considering adding clinical research to their everyday practice of medicine should carefully assess the practical and ethical dimensions of this decision on their practice. We discuss a framework that can help physicians assess a study they are considering hosting in their practice for seven requirements for ethical clinical research. Such an assessment can help them determine whether they are comfortable that the study is ethical and whether they can adhere to the requirements of the protocol in an ethically appropriate manner to maintain the ethics of the study. Together with the systems-informed professionalism framework presented in the preceding article, using the seven requirements of ethical clinical research framework can help practicing physicians with ethical decision making regarding incorporating practice-based research into their everyday practice of medicine.

KEYWORDS

Practice-based research - research networks - research ethics - informed consent

REFERENCES

• 1 Primary Care Practice-Based Research Networks .Fact Sheet, June 2001. AHRQ Publication No. 01-P020. Rockville, MD; Agency for Healthcare Research and Quality http://Available at: www.ahrq.gov/research/pbrnfact.htm Accessed December 19, 2005
• 2 NIH Roadmap Initiative: Re-engineering the Clinical Research Enterprise .Available at: http://nihroadmap.nih.gov/clinicalresearchtheme Accessed December 19, 2005
• 3 NINDS .Proceedings of the Stroke Disparities Advisory Panel Meeting. Bethesda, MD; November 7-8, 2002 http://Available at: www.ninds.nih.gov/news_and_events/proceedings/stroke_report_nov_2002.htm Accessed December 19, 2005
• 4 NINDS .NINDS Clinical Research Collaboration Workshop. Bethesda, MD; October 7-8, 2002 http://Available at: www.ninds.nih.gov/news_and_events/proceedings/2002_clinical_research_workshop.htm Accessed December 19, 2005
• 5 NINDS .Report of the Stroke Progress Review Group. Bethesda, MD; April 2002 http://Available at: www.ninds.nih.gov/find_people/groups/stroke_prg/04_2002_stroke_prg_report.htm Accessed December 19, 2005
• 6 Bodenheimer T. Uneasy alliance: clinical investigators and the pharmaceutical industry.  N Engl J Med. 2000;  342 1539-1544
• 7 Lightfoot G D, Sanford S M, Shefrin A. Can investigator certification improve the quality of clinical research?.  Qual Manag Health Care. 1999;  7 31-36
• 8 Eichenwald K, Kolata G. Drug trials hide conflicts for doctors. New York Times (print) 1999: 1, 34
• 9 Chen D T, Worrall B B. Practice-based clinical research and ethical decision making-part I: deciding whether to incorporate practice-based research into your clinical practice.  Semin Neurol. 2006;  26 , In press
• 10 Beecher H K. Ethics and clinical research.  N Engl J Med. 1966;  274 1354-1360
• 11 Wolf L E, Walden J F, Lo B. Human subject's issues and IRB review in practice-based research.  Ann Fam Med. 2005;  3(suppl 1) S30-S37
• 12 Wolf L E, Croughan M, Lo B. The challenges of IRB review and human subjects protections in practice-based research.  Med Care. 2002;  40 521-529
• 13 Pace W D, Staton E W, Holcomb S. Practice-based research network studies in the age of HIPAA.  Ann Fam Med. 2005;  3(suppl 1) S38-S45
• 14 Lader E W, Cannon C P, Ohman E M et al.. The clinician as investigator: participating in clinical trials in the practice setting.  Circulation. 2004;  109 2672-2679
• 15 Beach J E. Clinical trials integrity: a CRO perspective.  Account Res. 2001;  8 245-260
• 16 Green L A, White L L, Barry H C, Nease Jr D E, Hudson B L. Infrastructure requirements for practice-based research networks.  Ann Fam Med. 2005;  3(suppl 1) S5-S11
• 17 Emanuel E J, Wendler D, Grady C. What makes clinical research ethical?.  JAMA. 2000;  283 2701-2711
• 18 Smedley B D, Stith A Y, Nelson A R. Institute of Medicine (U.S.) .Committee on Understanding and Eliminating Racial and Ethnic Disparities in Health Care. Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care. Washington, DC; National Academy Press 2003
• 19 DHHS .NCMHD Community Participation in Health Disparities Intervention Research RFA-MD-05-002. Available at: http://grants1.nih.gov/grants/guide/rfa-files/RFA-MD-05-002.html Accessed December 19, 2005
• 20 Corbie-Smith G, Moody-Ayers S, Thrasher A D. Closing the circle between minority inclusion in research and health disparities.  Arch Intern Med. 2004;  164 1362-1364
• 21 Taylor A L, Ziesche S, Yancy C et al.. Combination of isosorbide dinitrate and hydralazine in blacks with heart failure.  N Engl J Med. 2004;  351 2049-2057
• 22 Corbie-Smith G, Miller W C, Ransohoff D F. Interpretations of “appropriate” minority inclusion in clinical research.  Am J Med. 2004;  116 249-252
• 23 Weijer C, Goldsand G, Emanuel E J. Protecting communities in research: current guidelines and limits of extrapolation.  Nat Genet. 1999;  23 275-280
• 24 Weijer C, Emanuel E J. Ethics: protecting communities in biomedical research.  Science. 2000;  289 1142-1144
• 25 Grimes D A, Schulz K F. Uses and abuses of screening tests.  Lancet. 2002;  359 881-884
• 26 Levine R J, Lasagna L. Demystifying central review boards: current options and future directions.  IRB. 2000;  22 1-9
• 27 American Society of Clinical Oncology . American Society of Clinical Oncology policy statement: oversight of clinical research.  J Clin Oncol. 2003;  21 2377-2386
• 28 Chen D T, Miller F G, Rosenstein D L. Enrolling decisionally impaired adults in clinical research.  Med Care. 2002;  40 V20-V29
• 29 World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.  JAMA. 2000;  284 3043-3045
• 30 Morin K, Rakatansky H, Riddick Jr F A et al.. Managing conflicts of interest in the conduct of clinical trials.  JAMA. 2002;  287 78-84
• 31 Harris Interactive .New survey shows public perception of opportunity to participate in clinical trials has decreased slightly from last year. Harris Interactive Healthcare News 2005;5:1-14. http://Available at: www.harrisinteractive.com/news/newsletters/healthnews/HI_HealthCareNews2005Vol5_Iss06.pdf Accessed December 19, 2005
• 32 Chen D T, Miller F G, Rosenstein D L. Clinical research and the physician-patient relationship.  Ann Intern Med. 2003;  138 669-672
• 33 Werhane P, Doering J. Conflicts of interest and conflicts of commitment.  Prof Ethics. 1995;  4 47-81
• 34 Wolf L E, Lo B. Association of Professors of Medicine. Ethical issues in clinical research: an issue for all internists.  Am J Med. 2000;  109 82-85
• 35 Miller F G, Rosenstein D L, DeRenzo E G. Professional integrity in clinical research.  JAMA. 1998;  280 1449-1454
• 36 Klein J E, Fleischman A R. The private practicing physician-investigator: ethical implications of clinical research in the office setting.  Hastings Cent Rep. 2002;  32 22-26
• 37 DHHS .Code of Federal Regulations, 45CFR46.116. Revised November 13 2001
• 38 Lo B, Groman M. Oversight of quality improvement: focusing on benefits and risks.  Arch Intern Med. 2003;  163 1481-1486
• 39 Pantell R H, Newman T B, Bernzweig J et al.. Management and outcomes of care of fever in early infancy.  JAMA. 2004;  291 1203-1212
• 40 Babaev A, Frederick P D, Pasta D J et al.. Trends in management and outcomes of patients with acute myocardial infarction complicated by cardiogenic shock.  JAMA. 2005;  294 448-454
• 41 Neale A V, Schwartz K L. A primer of the HIPAA Privacy Rule for practice-based researchers.  J Am Board Fam Pract. 2004;  17 461-465
• 42 Ingelfinger J R, Drazen J M. Registry research and medical privacy.  N Engl J Med. 2004;  350 1452-1453
• 43 Richardson L D. The ethics of research without consent in emergency situations.  Mt Sinai J Med. 2005;  72 242-249