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TF-E Toolkit

Toolkit with a list of topics and articles related to Ethics in Laboratory Medicine 

Dear Colleagues:

I'm happy to present the “Toolkit”, prepared by the TF-E in order to help and facilitate access to bibliography referred to Ethics in Laboratory Medicine.

You will find relevant articles, documents, guides, codes, regulations and chapters of books referred to Ethics applied to Laboratory practice into separate folders, as per below list, currently uploaded on the IFCC website.

  • References are written following the Vancouver recommendations for citing articles.
  • Some articles could be placed under more than one topic so in case you do not find an article, you can search under other different topics.
  • Under Item 8, referred to Education, some chapter of books for teaching purposes are included.
  • Under Item 9 some of current compiled bibliography will be re-ordered in the next future, as more references will be included.

Dr Nilda Fink
TF-E Chair

 

IMPORTANT NOTICE:
Documents that haven't obtained permission for publication or permission is pending, are not downloadable.

 

CONTENT

  1. Ethics committees
  2. Documents, guides, regulations, codes
  3. Ethics within laboratory medicine
  4. Conflict of Interest (COI)
  5. Informed consent
  6. Ethics in scientific publications
  7. Ethics in work with other animals
  8. Ethics and education in laboratory medicine
  9. Miscellaneous

1- Ethics committees

  1. Bhatt A. Managing conflict of interest in Ethics Committee. Perspect. Clin Res. 2018;9(1):37-39.
  2. British Medical Association (BMA). Medical Ethics Committee. 
    https://www.bma.org.uk/collective-voice/committees/medical-ethics-committee
  1. Burnett L, McQueen MJ, Jonsson JJ, Torricelli F; IFCC Taskforce on Ethics. IFCC position paper: report of the IFCC taskforce on ethics: introduction and framework. Clin Chem Lab Med. 2007;45(8):1098-1104.
  2. Das NK, Sil A. Evolution of Ethics in Clinical Research and Ethics Committee. Indian J Dermatol. 2017;62(4):373-379.
  3. Hajibabaee F, Joolaee S, Cheraghi MA, Salari P, Rodney P. Hospital/clinical ethics committees' notion: an overview. J Med Ethics Hist Med. 2016;9:17.
  4. University of Oslo. Institute of Health and Society. Manual for working in a Clinical Ethics Committee in secondary health services. 2012. https://www.med.uio.no/helsam/tjenester/kunnskap/etikk-helsetjenesten/praksis/systematisk-etikkarbeid/english-cec-manual.pdf
  1. Magelssen M, Miljeteig I, Pedersen R, Førde R. Roles and responsibilities of clinical ethics committees in priority setting. BMC Med Ethics. 2017;18(1):68.
  2. McLean SA. What and who are clinical ethics committees for? J Med Ethics. 2007;33 (9):497-500.
  3. Montgomery J. The Virtues of National Ethics Committees. Hastings Cent Rep. 2017; 47 Suppl 1:S24-S27.
  4. Petrini C, Ricciardi W. Clinical ethics and the role of clinical ethics committees: proposals for a revival. Commentary. Ann Ist Super Sanita. 2017;53(3):183-184.
  5. Pich J, Carné X, Arnaiz JA, Gómez B, Trilla A, Rodés J. Role of a research ethics committee in follow-up and publication of results. Lancet. 2003;361(9362):1015-6.
  6. Seay JD. On forming an institutional ethics committee: the dilemmas' dilemma. Bull N Y Acad Med. 1985; 61(9):842-52.
  7. Slowther A, Hope T, Ashcroft R. Clinical Ethics Committees: a worldwide development. Journal of Medical Ethics. 2001; 27:1-1

2- Documents, guides, regulations, codes

  1. American Association for Clinical Chemistry (AACC). Ethics guidelines. 2018. https://www.aacc.org/membership/ethic-guidelines
  1. Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for Health-related Research Involving Humans. 2017. https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf
  1. Committee on Publication Ethics (COPE). What to do if you suspect redundant (duplicate) publication. 2006. https://publicationethics.org/files/redundant%20publication%20A_0.pdf  
  1. Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for biomedical research involving human subjects. 2002. https://cioms.ch/wp-content/uploads/2016/08/International_Ethical_Guidelines_for_Biomedical_Research_Involving_Human_Subjects.pdf
  1. International Organization for Standardization ISO 15189:2012. Medical Laboratories  - Requirements for quality and competence. Annex C  Ethics in laboratory medicine. https://www.iso.org/standard/56115.html  
  1. National Health and Medical Research Council [of Australia] (NHMRC). National Statement on Ethical Conduct in Research Involving Humans (2007) Updated 2018.  https://nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018  
  2. Elżbieta P, Waldemar G, Barbara MC. Polish Code of Ethics of a Medical Laboratory Specialist. EJIFCC. 2014;25(2):199-206
  3. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research [USA]. The Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects of Research. 1979. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html
  1. Wager E, Kleinert S. Cooperation between research institutions and journals on research integrity cases: guidance from the Committee on Publication Ethics (COPE). Acta Inform Med. 2012;20 :136-40.
  2. World Medical Association (WMA). Medical Ethics Manual. 2015 https://www.wma.net/what-we-do/education/medical-ethics-manual/
  1. World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. 2008 https://www.wma.net/wp-content/uploads/2018/07/DoH-Oct2008.pdf
  1. World Medical Association (WMA). International Code of Medical Ethics. https://www.wma.net/policies-post/wma-international-code-of-medical-ethics/  
  1. World Medical Association (WMA). Declaration on Medical Ethics and Advanced Medical Technology. https://www.wma.net/policies-post/wma-declaration-on-medical-ethics-and-advanced-medical-technology/
  1. World Health Organization (WHO). WHO guidelines on ethical issues in public health surveillance. 2017. http://apps.who.int/iris/bitstream/handle/10665/255721/9789241512657-eng.pdf?sequence=1
  1. World Medical Association (WMA). Declaration of Geneva. 2006. https://www.wma.net/wp-content/uploads/2018/07/Decl-of-Geneva-v2006-1.pdf
  1. The Nuremberg Code (1947). BMJ 1996; 313(7070):1448. http://www.cirp.org/library/ethics/nuremberg/
  1. United Nations Educational, Scientific and Cultural Organization (UNESCO). Universal Declaration on Bioethics and Human Rights. In UNESCO. The Records of the 33rd session of the General Conference. 2005. Pp 74-80. https://unesdoc.unesco.org/in/documentViewer.xhtml?id=p::usmarc
  1. Australian Government Department of Health. The Requirement for Medical Pathology Services (Second Edition). 2018. https://www.health.gov.au/internet/main/publishing.nsf/content/21B7F24866EF1DEECA257C2A001EC403/$File/20180608%20-%20Final%20-%20RMPS.pdf
  1. European Society of Human Genetics. Statement of the ESHG on direct-to-consumer genetic testing for health-related purposes. Eur J Hum Genet. 2010;18(12):1271-1273.
  2. The Croatian chamber of medical biochemists. Code of ethics.
  3. International Federation of Biomedical Laboratory Science (IFBLS). Code of Ethics for Biomedical Laboratory Scientists. 2010. http://www.ifbls.org/index.php/statements/code-of-ethics

3- Ethics within laboratory medicine

  1. Allen MJ, Powers MLE, Gronowski KS, Gronowski AM. Human tissue ownership and use in research: What laboratories and researchers should know. Clin Chem 2010;56(11):1675-1682.
  2. Charo RA. Body of research--ownership and use of human tissue. N Eng J Med 2006;355(15):1517-19.
  3. vanDiest PJ. No consent should be needed for using leftover body material for scientific purposes. BMJ 2002;325 (7365):648-651.
  4. Bathe OF, McGuire AL. The ethical use of existing samples for genome research. Genet Med. 2009;11(10):712-715.
  5. Barlow-Stewartand K, Burnett L. Ethical considerations in the use of DNA for the diagnosis of diseases. Clin Biochem Review 2006;27(1):53-61.
  6. El-Nageh MM, Linehan B, Cordner S, Wells D, McKelvie H. World Health Organization Regional Office for Eastern Mediterranean. Ethical practice in Laboratory Medicine and Forensic Pathology. 1999. http://applications.emro.who.int/dsaf/dsa38.pdf
  1. Sekadde-Kigondu CB, Higgins T, Bruns DE, Gronowski AM. Ethical Considerations in Clinical Chemistry and Laboratory Medicine. 2016. In IFCC's Essentials of Clinical Laboratory Management in Developing Regions Published by IFCC. http://www.ifcc.org/media/446882/IFCC_TF_Ethics_in_Lab_Medicine.pdf
  1. McQueen MJ. Ethics and Laboratory Medicine. Clin Chem 1990;36:1404-1407.
  2. Nyrhinen T, Leino-Kilpi H. Ethics in the laboratory examination of patients, J Med Ethics 2000;26:54-60.
  3. Wijeratne N, Benatar SR. Ethical issues in laboratory medicine, J Clin Pathol 2010;63:97-98.
  4. Gronowski AM, Scott R, Caplan A, Nelson A. The Ethical Implications of Preimplantation Genetic Diagnosis (Q&A) Clin Chem 2014;60:25-29.

4- Conflict of Interest (COI)

  1. Abramson J, Redberg R. Conflicts of Interest. N Engl J Med 2015; 373(8):778.
  2. Annals of Blood (AOB). Conflicts of Interest. http://aob.amegroups.com/pages/view/conflict-of-interest
  1. American Society of Hematology (ASH). Conflict of Interest. http://www.hematology.org/About/Governance/380.aspx
  1. Besley JC, Zahry NR, McCright A, Elliott KC, Kaminski NE, Martin JD. Conflict of Interest Mitigation Procedures May Have Little Influence on the Perceived Procedural Fairness of Risk-Related Research. Risk Anal. 2018  DOI: 10.1111/risa.13182
  2. Breimer LH, Nilsson TK, Breimer ME. Declarations of conflict of interest are still inadequate. Indian J Med Ethics. 2018; 3 (3):256-257.
  3. Chew M, Brizzell C, Abbasi K, Godlee F. Medical journals and industry ties. BMJ. 2014; 349: g7197.
  4. Committee on Publication Ethics (COPE). COPE consultation/guidance document on handling competing interests. 2015. https://publicationethics.org/resources/discussion-documents/cope-forum-9-december-2015-cope-consultationguidance-document
  1. Dowden J. Conflict of interest in medical journals. Aust Prescr. 2015; 38(1):2-3.
  2. Elsevier. Authorship & Conflicts of Interest Statement.  https://www.elsevier.com/__data/promis_misc/asjsur_ascoi.pdf
  1. Elsevier. Ethics in Research & Publication. https://www.elsevier.com/__data/assets/pdf_file/0008/653885/Ethics-in-research-and-publication-brochure.pdf
  1. Fontanarosa P, Bauchner H. Conflict of Interest and Medical Journals. JAMA 2017;317(17):1768-1771.
  2. Haque W, Minhajuddin A, Gupta A, Agrawal D. Conflicts of interest of editors of medical journals. PLoS One. 2018; 13(5): e0197141.
  3. International Committee of Medical Journal Editors (ICMJE). ICMJE Form for Disclosure of Potential Conflicts of Interest. http://www.icmje.org/about-icmje/faqs/conflict-of-interest-disclosure-forms/
  1. Ioannidis JZ. Conflict of Interest. Laboratory Medicine 2000; 31(6):303.
  2. James A, Horton R. The Lancet’s policy on conflicts of interest. Lancet 2003; 361(9351):8-9.
  3. James A, Horton R, Collingridge D, McConnell J, Butcher J. The Lancet’s policy on conflicts of interest—2004. Lancet 2004; 363(9402):2-3.
  4. Johson C. Conflict of interest in scientific publications: a historical review and update. J Manipulative Physiol Ther. 2010; 33(2):81-86.
  5. Journal of Epidemiology and Global Health. Conflict of Interest Declaration and Author Agreement Form.  https://www.elsevier.com/__data/promis_misc/JEGH_dec.pdf  
  1. Journal of Health & Productivity. Conflict-of-Interest Statement. https://www.ihpm.org/pdf/Conflict-of-InterestStatement.pdf
  1. Journal of Laboratory and Precision Medicine. Conflict of Interest. http://jlpm.amegroups.com/pages/view/conflict-of-interest  
  1. Jornal of the International Clinical Dental Research Organization. Conflict of interest statement. http://www.jicdro.org/contributors.asp
  1. Kesselheim A, Wang B, Studdert DM, Avorn J. Conflict of Interest Reporting by Authors Involved in Promotion of Off-Label Drug Use: An Analysis of Journal Disclosures. PLoS Med. 2012; 9(8): e1001280.
  2. Lu Y, Jones DJ, Sharara N, Kaltenbach T, Laine L, McQuaid K, et al. Transparency ethics in practice: Revisiting financial conflicts of interest disclosure forms in clinical practice guidelines. PLoS One. 2017;12(8):e0182856.
  3. Mahajan RP. Conflicts of interest in medical journals. Rev. Colomb. Anestesiol. 2013; 41(3):179–181.
  4. McCoy MS, Carniol M, Chockley K, Urwin JW, Emanuel EJ, Schmidt H. Conflicts of Interest for Patient-Advocacy Organizations. N Engl J Med 2017;376(9):880-885.
  5. Nature – Laboratory investigation. Conflict of Interest. https://www.nature.com/labinvest/
  1. Rohwer A, Young T, Wager E, Garner P. Authorship, plagiarism and conflict of interest: views and practices from low/middle-income country health researchers. BMJ Open. 2017; 7(11): e018467.
  2. Ruff K. Scientific journals and conflict of interest disclosure: what progress has been made? Environ Health. 2015; 14:45.
  3. Salem DN, Boumil MM. Conflict of Interest in Open-Access Publishing. N Engl J Med 2013; 369(5):491.
  4. Springer Ethik in der Medizin. Compliance with Ethics Guidelines. https://www.springer.com/medicine/journal/481?print_view=true&detailsPage=pltci_2251693  
  1. The International Society for Laboratory Hematology (ISLH). Conflict of Interest Policy. 2017. http://www.islh.org/web/2017COIPolicy.pdf
  1. Topol E. Conflict-of-Interest Policies. N Engl J Med 2001; 344(13):1017-1024.
  2. World Medical Association (WMA). WMA STATEMENT ON CONFLICT OF INTEREST. 2015. https://www.wma.net/policies-post/wma-statement-on-conflict-of-interest/
  3. Ziai K, Pigazzi A, Smith BR, Nouri-Nikbakht R, Nepomuceno H, Carmichael JC, et al. Association of Compensation From the Surgical and Medical Device Industry to Physicians and Self-declared Conflict of Interest. JAMA Surg. 2018;153(11):997–1002.

5- Informed consent

  1. Anderson AJ, Cummings BJ. Achieving Informed Consent for Cellular Therapies: A Preclinical Translational Research Perspective on Regulations versus a Dose of Reality. J Law Med Ethics. 2016;44(3):394-401.
  2. Bester J, Cole CM, Kodish E. The Limits of Informed Consent for an Overwhelmed Patient: Clinicians' Role in Protecting Patients and Preventing Overwhelm. AMA J Ethics. 2016;18(9):869-886.
  3. Bossert S, Kahrass H, Heinemeyer U, Prokein J, Strech D. Participatory improvement of a template for informed consent documents in biobank research - study results and methodological reflections. BMC Med Ethics. 2017;18(1):78.
  4. Dal-Ré R, Carcas AJ, Carné X, Wendler D. Patients' beliefs regarding informed consent for low-risk pragmatic trials. BMC Med Res Methodol. 2017;17(1):145.
  5. Kane EI 3rd, Gallo JJ. Perspectives of IRB Chairs on the Informed Consent Process. AJOB Empir Bioeth. 2017;8(2): 137–143.
  6. Fawcett J, AbuFannouneh AM. Thoughts About Population Health Nursing Research Methods: Questions About Participants and Informed Consent. Nurs Sci Q.. 2017;30(4):353-355.
  7. Kalkman S, Kim SYH, van Thiel GJMW, Grobbee DE, van Delden JJM. Ethics of Informed Consent for Pragmatic Trials with New Interventions. Value Health. 2017;20(7):902-908.
  8. Kraft SA , Constantine M, Magnus D, Porter KM, Lee SS, Green M, et al. A randomized study of multimedia informational aids for research on medical practices: Implications for informed consent. Clin Trials. 2017; 14(1):94-102.
  9. McCormack DJ, Gulati A, Mangwani J. Informed consent: a global perspective. Bone Joint J 2018;100-B(6):687–692.
  10. Merz JF. The Nuremberg Code and Informed Consent for Research. JAMA. 2018; 319(1):85-86.
  11. Moreno JD, Schmidt U, Joffe S. The Nuremberg Code and Informed Consent for Research-Reply. JAMA. 2018;319(1):86.
  12. Niemiec E, Borry P, Pinxten W, Howard HC. Content Analysis of Informed Consent for Whole Genome Sequencing Offered by Direct-to-Consumer Genetic Testing Companies. Hum Mutat. 2016; 37(12):1248-1256.
  13. Osuji PI. Relational autonomy in informed consent (RAIC) as an ethics of care approach to the concept of informed consent. Med Health Care Philos. 2018; 21(1):101-111.
  14. Patryn R, Sak J. Analysis of the concept of informed consent concerning the use of genetic material according to the European Convention on Bioethics and in other solutions - Propositions for broad consent for future genetic research from the point of view of the activity of the Biobank. Ann Agric Environ Med. 2017; 24(3):383-386.
  15. Vollmann J, Winau R. Informed consent in human experimentation before the Nuremberg code. BMJ. 1996;313(7070):1445-9.
  16. Grady C. Enduring and emerging challenges of informed consent. N Eng J Med 2015;372:855-862.
  17. Warner EA, Walker RM, Friedmann PD. Should informed consent be required for laboratory testing for drugs of abuse in medical settings? Am J Med 2003;115:54-57.
  18. Borovecki A, Mlinaric A, Horvat M, Supak Smolcic V. Informed consent and ethics committee approval in laboratory medicine. Biochem Med (Zagreb). 2018;28(3):030201.

6- Ethics in scientific publications

  1. Belinchón I, Ramos JM, Bellver V. Scientific production in bioethics in Spain through MEDLINE. Gac Sanit. 2007;21(5):408-411.
  2. Mandal J, Parija SC. Ethics of authorship in scientific publications. Trop Parasitol. 2013;3(2):104-5.
  3. McCullough LB, Chervenak FA, Brent RL, Hippen B. A case study in unethical transgressive bioethics: "Letter of concern from bioethicists" about the prenatal administration of dexamethasone. Am J Bioeth. 2010;10(9):35-45.
  4. McCullough LB, Chervenak FA, Brent RL, Hippen B. The intellectual and moral integrity of bioethics: response to commentaries on "A case study in unethical transgressive bioethics: 'Letter of concern from bioethicists' about the prenatal administration of dexamethasone". Am J Bioeth. 2010; 10(9): W3-5.
  5. Miziara ID. Ethics in scientific publications: the double copyright problem. Braz J Otorhinolaryngol. 2010;76(5):543.
  6. Morovati M, Ejraei A, Hadi Z, Atefi M, Morovati MJ. Scientific publications on medical ethics in thomson reuters database, 1990-2010. Iran J Med Sci. 2012; 37(4):277-278.
  7. Paul G. Will the real author please stand up! J Maxillofac Oral Surg. 2011; 10(1):2-3.

7- Ethics in work with other animals

  1. Baker D, Lidster K, Sottomayor A, Amor S. Two Years Later: Journals Are Not Yet Enforcing the ARRIVE Guidelines on Reporting Standards for Pre-Clinical Animal Studies. PLOS Biology 2014;12(1): e1001756.
  2. de Montera B. Genomics and ethics: the case of cloned and/or transgenic animals. Comp Funct Genom 2003;4(1):26–30.
  3. Festing S, Wilkinson R. The ethics of animal research. Talking Point on the use of animals in scientific research. EMBO Rep. 2007;8(6):526-30.
  4. Robert JS. The science and ethics of making part-human animals in stem cell biology. FASEB J. 2006;20(7):838-45.
  5. Kilkenny C, Browne WJ, Cuthill IC, Emerson M, Altman DG. Improving Bioscience Research Reporting: The ARRIVE Guidelines for Reporting Animal Research. PLoS Biol 2010;8(6):e1000412.
  6. Mandal J, Parija SC. Ethics of involving animals in research. Trop Parasitol. 2013; 3(1): 4–6.
  7. Rollin BE. An ethicist's commentary on the ethics of killing healthy animals. Can Vet J 2001; 42(12):908-909.
  8. Sideris L, McCarthy CR, Smith DH. Roots of Concern with Nonhuman Animals in Biomedical Ethics. ILAR J 1999; 40(1):3-14.
  9. Svendsen O. Ethics and Animal Welfare Related to in vivo Pharmacology and Toxicology in Laboratory Animals. Basic Clin Pharmacol Toxicol. 2005; 97(4):197–199.
  10. VandeWoude S, Rollin BE. Practical Considerations in Regenerative Medicine Research: IACUCs, Ethics, and the Use of Animals in Stem Cell Studies. ILAR J 2009; 51(1):82-84.
  11. Verschuere B, Autissier C, Degryse AD, Gallix P, Gotti B, Laurent J, et al. Ethics committee recommendations for laboratory animals in private research in France. Lab Anim. 2000;34(3):236-243.
  12. Watanabe M, da Fonseca CD, Vattimo Mde F. Instrumental and ethical aspects of experimental research with animal models. Rev Esc Enferm USP 2014; 48(1):177-183.

8- Ethics and education in laboratory medicine

  1. Bruns DE, Burtis CA, Gronowski AM, McQueen MJ, Newman A, Jonsson JJ. Variability of ethics education in laboratory medicine training programs: results of an international survey. Clin Chim Acta 2015;442:115-118.
  2. Beauchamp TL, Childress JF. Principles of biomedical ethics. 7th Ed. New York: Oxford University Press;2013:480 p.
  3. Bruns DE, Ashwood ER, Burtis CA. Clinical Chemistry, Molecular Diagnsotics and Laboratory Medicine. In: Burtis CA, Ashwood ER, Bruns DE, editors. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 5th Edition. St. Louis (MO): Elsevier Saunders;2013. p 4-6.
  4. Linehan, BJ, El-Nagen, MN, Corder S, Richter A. Ethics in Laboratory Medicine. In: McClatchey KD, editor. Clinical Laboratory Medicine. 2nd Ed. Philadelphia (PA): Lippincott Williams and Wilkins; 2002. p. 134-142.

9- Miscellaneous

  1. Keränen T, Halkoaho A, Itkonen E, Pietilä AM. Placebo-controlled clinical trials: how trial documents justify the use of randomisation and placebo. BMC Med Ethics. 2015; 16:2.
  2. Papavasiliou E, Payne S, Brearley S, Brown J, Seymour J. Continuous sedation (CS) until death: mapping the iterature by bibliometric analysis. J Pain Symptom Manage. 2013; 45(6):1073-1082.
  3. Relevant materials compiled for different countries (Lithuania, USA, Australia, United Kingdom, Canada, Philippines)
 
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