Project title | Informed Consent between Theory and Practice in the North–Eastern Region of Romania Medical Research Field

Final Report | Ana Frunza | July 2016

The research was carried out at the LUMEN Research Center for Social and Humanistic Sciences, as part of the “Informed Consent between Theory and Practice in North – Eastern Region of Romania Medical Research Field”.

Research Project initiated within a Program supported by NIH Research Grant # 5R25TW007085 – funded by the Fogarty International Center, the National Institute of Environmental Health Sciences, the National Heart Lung and Blood Institute, and the National Institute on Drug Abuse.

Objectives|

• O1. Analysis of the content of IC in 10 medical institutions that are allowed to conduct medical research on human subjects in Iasi, Romania
• O2. The identification of meanings attributed to IC as an ethical tool by health professionals who are or have been involved in medical research from medical research institutions in Iasi.
• O3. Validation of the model obtained from O2 and its generalization within the entire North – Eastern Romanian region.

Data collection |

• Objective 1

Based on a list of medical institutions that are allowed to conduct medical research on human subjects, we sent emails to request example IC forms used in medical practice, where such documents were not identified on the official website of a particular institution. Following the responses received, we followed up with phone calls and we continued with visits to medical institutions to request specific form of IC.

The obtaining of IC form was facilitated by Romanian legislation concerning the free access to information of public interest.

11 IC forms were collected, transcribed and analyzed based on a grid of analysis and on a model developed based on the approach of Beauchamp and Childress (1994) on the IC obtaining process.

Objective 2

Data collection for O2 was conducted through individual interviews with representatives of selected medical institutions.We made a list with 10 medical institutions accredited to conduct research on human subjects, after we made online researches on the web page of the National Agency for Scientific Research and Innovation (ANCSI) – the Romanian regulatory body of scientific research. Each medical institution from Iasi, identified online, was checked on the national database of ANCSI – the Potential Contractors Register, in order to see if is accredited to conduct research in Romania. After identification of the institutions, we made phone calls to establish meetings. We used the “snowball” method, starting from contacts obtained by phone. As specific criteria of inclusion we considered if the potential respondent had published scientific research results from medical research conducted within the selected institution in the last five years. We identified medical staff other than physicians – for example, nurses, psychologists, management representatives, EC directors etc. and we included them in the sample.

The interviewes were conducted based on the interview guide (previously approved by IRB). If more clarification was needed, additional questions were asked to respondents. The interviews were conducted in Romanian language and audio recorded.

Note: We refer to physicians that had position of head of the clinic or director of hospital as managers. In the Romanian health system most of the management positions are occupied by physicians who also have training in health management and/or public health. We referred to the following thematic axes: the awareness the necessity of IC, the difference between IC in medical research and IC in therapeutic intervention, the process of obtaining IC, and the understanding of IC.The interview guide was approved by IRB of Clarkson University.  See Progress report Annex 3 – Interview guide and IC form approved by IRB

• Objective 3

O’3 data collection is done through a short online questionnaire addressed to medical staff of research institutions from counties from the North-Eastern region of Romania.

The online questionnaire was sent by email, using Google forms, to hospitals, research institutes and other centres that are allowed to conduct medical research.

Final results |

Results related to O1 will be presented into a draft article, with the title “Obtaining Broad Therapeutic Informed Consent – ethical acceptability of secondary use of data and biological samples in medical research”, authored by Ana Frunza and Antonio Sandu.

Results from O2 |

Results related both to O1 & O2 are partially presented within the draft article with title: “Is Informed Consent Well Understood in the Romanian Healthcare System?” , authored by ana Frunza and Antonio Sandu.

Please see the Annex 2F with the draft article and the Annex 3F with the data interpretation in GT, in Romanian language.

Results related to O3 |

Online questionnaire was applied as mentioned in research methodology, but because of the Romanian health care system context described bellow and following the suggestion of the project mentors regarding the possible lack of relevance of the data collected via questionnaire, the objective was not completed.

So far, I sent the questionnaire to 60 contacts form health care system, and I received only 6 answers; that shos a very hight reluctance in answering to this wuestionnaire.

The healthcare system is currently under numerous investigations aimed at Romanian hospital hygiene, threatened by the diluted disinfectants provided by the largest company of its kind in Romania – Hexi Pharma. It was identified that for the last 10 years active substances needed to hygenize the hospitals were diluted and documents were falsified in order to cover this up. Data were released in the media that showed that more than 40,000 ill persons became ill because of nosocomial infections, cases which could have been avoided if the concentration of the cleaning substances had been correct. Due to this particular situation new information will be difficult to obtain. Health care system representatives are very reluctant to provide any information because investigations are publicized. https://www.opendemocracy.net/can-europe-make-it/stephen-mcgrath/healthcare-horror-show-is-shaking-romania

References:

• *** (2002). Department of Human Services Victoria Genetics Advisory Committee, Submission G089, 24 January 2002.
• Alexander, L. (1996). ”The Moral Magic of Consent (II),” Legal Theory 2, 165
• Appelbaum, P.S., Roth, L.H., Lidz, C.W. et al. (1987). “False hopes and best data: consent to research and the therapeutic misconception”, Hastings Cent Rep, (17)20–24.
• Arnason, V. (2004). “Coding and Consent: Moral Challenges of the Database Project in Iceland”, Bioethics,(18):27-49.
• Ballantyne, A., (2016). “It’s mine: owenership and control of health data”, in S61: Symposium: Consent for Secondary Use of Clinical Data for Research, PN: 353 Holm S, Ballantyne A, Wilson J, Borgerson K, IAB2016.
• Beauchamp, T.L., Childress, J.F. (1994). Principles of biomedical ethics (4th ed.).New York: Oxford University Press.
• Bulger, R.E., (2002). “Research with Human Beings”. In Bulger, R.E., Heitman, I., & Reiser, J. (Ed.), The Ethical Dimensions of the Biological and Health Sciences (pp. 117-125). New York: Cambridge University Press.
• Cambon-Thomsen, A. (2004). “The Social and Ethical Issues of Post-Genomic Human Biobanks”, Nature Review Genetics, (5)6–13.
• Faden, R. R., Beauchamp, T.L., (1986). A History and Theory of Informed Consent. New York: Oxford University Press.
• Grady, C., (2015). “Enduring and Emerging Challenges of Informed Consent”, New England Journal of Medicine, 855-862, 37 9 doi:10.1056/NEJMra141125025714163
• Hansson, M.G., Dillner, J., Bartram, C.R., Carlson, J.A., Helgesson, G. (2006).“Should donors be allowed to give broad consent to future biobank research?”Lancet Oncol, (7):266-9.
• Helgesson, G., (2012). “In defense of Broad Consent”, Camb Q Healthc Ethics, (21):40-50.
• Hofmann, B., (2009). “Broadening consent – and diluting ethics?”, J Med Ethics, (35):125-9, http://www.nejm.org/doi/full/10.1056/NEJMra1411250
• Hofmann, B., Solbakk, J.H., Holm, S., (2009). “Consent to biobank research: one size fits all?”  In: Solbakk, D.J.H., Holm, D.S., Hofmann, D.B., eds. The ethics of research biobanking. Springer US: 3-23.
• Karlsen, J. R., Solbakk, J.H., Holm, S., (2011). “Ethical endgames: broad consent for narrow interests; open consent for closed minds”,Camb Q Healthc Ethics, (20):572-83.
• Law no. 46/2003 on patient’s rights law (updated in 2015).
• Law Nr. 95/2006 on healthcare reform
• Lederer, S. E., (1995). Subjected to Science: Human Experimentation in America Before World War II, Baltimore: Johns Hopkins University Press, 1–192.
• Maclean, A., (2009). Autonomy, Informed Consent and Medical Law: A Relational Challenge, Cambridge University Press.
• O’Neill, O.,(2003). “Symposium On Consent And Confidentiality, Some limits of informed consent”, Journal of Mdecial Ethics, (29): 4-7
• Otlowski, M.F.A., (2009). “Developing an appropriate consent model for biobanks: in defence of “broad” consent”. In: Kaye J, Stranger M, eds. Principles and practice in biobank governance. Ashgate Publishing,79-92.
• Petrini, C., (2010). “Broad consent, exceptions to consent and the question of using biological samples for research purposes different from the initial collection purpose”, Soc Sci Med, (70):217–20.
• Scott, Y. H., Kim, M.D., Miller, F., (2014). “Informed Consent for Pragmatic Trials — The Integrated Consent Model”, N Engl J Med,  (370)769-772, February 20, 2014, DOI: 10.1056/NEJMhle1312508
• Sheehan, M., (2011). “Can Broad Consent be Informed Consent?” Public Health Ethics, (4)3:226–235
• https://www.opendemocracy.net/can-europe-make-it/stephen-mcgrath/healthcare-horror-show-is-shaking-romania

Valorisation of results |

Please see the partial results disemnination mentioned in the first progress report.

The final results:

• A draft article “Obtaining Broad Therapeutic Informed Consent – ethical acceptability of secondary use of data and biological samples in medical research”, authored by Ana Frunza and Antonio Sandu.  

• A draft article “Is Informed Consent Well Understood in the Romanian Healthcare System?”, authored by Ana Frunza and Antonio Sandu.

Acknowledgement | Research reported in this publication was supported by the Fogarty International Center of the National Institutes of Health under Award Number R25TW007085. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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Project initiated within Program supported by NIH Research Grant # 5R25TW007085 – funded by the Fogarty International Center, the National Institute of Environmental Health Sciences, the National Heart Lung and Blood Institute, and the National Institute on Drug Abuse