Administrative staff, including principal investigators, administrative managers, and elected officials, have a crucial role in ensuring the ethical conduct of the clinical research that occurs in their organisations. However, only few studies have focused on their perspectives.
Aim
This study describes the ethical aspects of clinical research from the perspectives of the administrative staff at university hospitals in Finland.
Methods
Qualitative data were collected with semi-structured face-to-face interviews (n = 31), and subjected to content analysis.
Results
Four core perspectives emerged: human subject autonomy and its acknowledgement in clinical practice, increased tension between the regulations and practice of clinical research, concerns about a changing research environment, and factors that promote ethical research conduct in hospitals.
Conclusion
Ethics always extends beyond the law. Therefore it is important to strengthen researchers’ ethical sensitivity through education. Furthermore, we should reinforce elements such as organisational culture, cooperation, and a workable research infrastructure that support good research ethics in hospitals.
Pandi-PerumalSRAkhterSZiziF. Project stakeholder management in the clinical research environment: How to do it right. Front Psychiatry2015; 6: 1–18.
3.
ScottFIMcConnellRALewisME. Increasing complexity of clinical research in gastroenterology: Implications for the training of clinician-scientists. Am J Gastroenterol2012; 107: 496–500.
4.
ShamooAEResnikDB. Ethical issues for clinical research managers. Drug Inf J2006; 40: 371–383.
5.
Nurmi S-M, Pietilä A-M, Kangasniemi M, et al. Nurse leaders’ perceptions of the ethical recruitment of study subjects in clinical research. J Nurs Manag 2015; 23: 1020–1028.
6.
ChilengiR. An ethics perspective on responsibilities of investigators, sponsors and research participants. Acta Trop2009; 112: 53–62.
7.
SlowtherABoyntonPShawS. Research governance: Ethical issues. J R Soc Med2006; 99: 65–72.
8.
ShamooAResnikD. Responsible Conduct of Research, 2nd ed. New York, NY: Oxford University Press, 2009.
9.
Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for Biomedical Research Involving Human Subjects. Available at: http://www.cioms.ch/publications/layout_guide2002.pdf (2002, accessed 2 September 2015).
10.
Antonio-GarcíaMTLópez-NavarroIRey-RochaJ. Determinants of success for biomedical researchers: A perception-based study in a health science research environment. Scientometrics2014; 101: 1747–1779.
RickardCWilliamsGRay-BarruelG. Towards improved organisational support for nurses working in research role in clinical settings: A mixed methods investigation. Collegian2011; 18: 165–176.
13.
ResnikDB. The Ethics of Science an Introduction, UK: Taylor & Francis e-Library, 2005.
14.
BeauchampTLChildressJF. Principles of Biomedical Ethics, 6th ed. New York, NY: Oxford University Press, 2009.
15.
EmmanuelEJWendlerDGradyCAn ethical framework for biomedical research. In: EmanuelEJGradyCCrouchRA (eds). The Oxford Textbook of Clinical Research Ethics, New York, NY: Oxford University Press, 2008, pp. 123–135.
16.
HeimerCAPettyJ. Bureaucratic ethics: IRBs and the legal regulation of human subjects research. Annu Rev Law Soc Sci2010; 6: 601–626.
17.
VähäkangasK. Research ethics in the post-genomic era. Environ Mol Mutagen2013; 54: 599–610.
18.
DiltsDM. “Three-plus-one” evaluation model for clinical research management. Eval Prof2013; 36: 464–477.
19.
SharpRRTaylorHABoyleM. Research ethics consultation: Ethical and professional practice challenges and recommendations. Acad Med2015; 90: 615–620.
20.
BoeynaemsJ-MCanivetCChanA. A European approach to clinical investigator training. Front Pharmacol2013; 4: 1–5.
21.
BullockAMorrisZSAtwellC. Collaboration between health services managers and researchers: Making a difference?J Health Serv Res Policy2012; 17: 2–10.
22.
HalkoahoAVähäkangasKHäggman-LaitilaA. Views of midwives about the ethical aspects of participation in placenta perfusion studies. Midwifery2012; 28: 131–137.
23.
Al-Shahi SalmanRBellerEKaganJ. Increasing value and reducing waste in biomedical research regulation and management. Lancet2014; 383: 176–185.
24.
HemminkiE. Actors involved in the regulation of clinical research: Comparison of Finland to England, Canada, and the USA. Health Res Policy Syst2015; 13: 1–12.
BurnsNGroveSK. The Practice of Nursing Research. Conduct, Critique and Utilization, 5th ed. Philadelphia: Elsevier, 2009.
28.
SankarPJonesNLSemi-structured interviews in bioethics research. In: JacobyLSiminofL (eds). Empirical Methods for Bioethics: A Primer, UK: Elsevier, 2008, pp. 117–138.
29.
DiCicco-BloomBCrabtreeBF. The qualitative research interview. Med Educ2006; 40: 314–321.
30.
GraneheimUHLundmanB. Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurse Educ Today2004; 24: 105–112.
31.
PolitDBeckCT. Nursing Research. Generating and Assessing Evidence for Nursing Practice, 9th ed. Philadelphia: Lippincott Williams & Wilkins, 2012.
32.
JeffordMMooreR. Improvement of informed consent and the quality of consent documents. Lancet Oncol2008; 9: 485–493.
33.
BiggsHMarcheisiA. Information for consent: Too long and too hard to read. Res Ethics2015; 11: 133–141.
34.
NishimuraACareyJErwinPJ. Improving understanding in the research informed consent process: A systematic review of 54 interventions tested in randomized control trials. BMC Med Ethics2013; 14: 1–15.
35.
GellerGBoyceAFordDE. Beyond “compliance”: The role of institutional culture in promoting research integrity. Acad Med2010; 85: 1296–1302.
36.
CartwrightJCHickmanSENelsonCA. Investigators’ successful strategies for working with institutional review boards. Res Nurs Health2013; 36: 478–486.
37.
BowenAJModels of institutional review board function. In: EmanuelEJGradyCCrouchRA (eds). The Oxford Textbook of Clinical Research Ethics, New York, NY: Oxford University Press, 2008, pp. 552–559.
38.
KuusistoHVirkkiMWuolijokiE. Hospital training program increases awareness of Good Clinical Practice (GCP). Contemp Clin Trials2011; 32: 339–341.
39.
HalkoahoAMatveinenMLeinonenV. Education of research ethics for clinical investigators with Moodle tool. BMC Med Ethics2013; 14: 1–6.
40.
WeaverKMorseJMitchamC. Ethical sensitivity in professional practice: Concept analysis. J Adv Nurs2008; 62: 607–618.
41.
Luis González-de PazLKostovBSolans-JulianP. Do patients and health care professionals view the communication processes of clinical research differently? A Rasch analysis from a survey. J Eval Clin Pract2015; 21: 790–797.
MoherDGlasziouPChalmersI. Increasing value and reducing waste in biomedical research: Who’s listening?Lancet2016; 387: 1573–1586.
47.
DimondsEPGermainDNacpilLM. Creating a ‘‘culture of research’’ in a community hospital: Strategies and tools from the National Cancer Institute Community Cancer Centers Program. Clin Trials2015; 12: 246–256.
48.
HallowellNCookeSCrawfordG. Ethics and research governance: The views of researchers, health-care professionals and other stakeholders. Clin Ethics2008; 3: 85–90.
49.
HalkoahoAItkonenEVanninenE. Can lean thinking enhance research administration?J Hosp Admin2014; 3: 61–69.
