Project title | Informed Consent between Theory and Practice in the North–Eastern Region of Romania Medical Research Field
Progress 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.
This empirical research is based on personal experience as a patient in the Romanian medical system. In the moment of hospitalization into a recovery public clinical hospital at the department of Otorhinolaryngology (ORL), I noticed that the hospitalization forms included a few informative paragraphs intended to facilitate Informed Consent (IC). In addition to IC for therapeutic intervention, an agreement request for participation as a human subject in further medical research was also included. I reflected that the formulation of such paragraphs could involve serious issues in the understanding of this ethical instrument from those who apply it, especially because the patients who are faced with signing such statements could in fact become participants in future research on human subjects whose purpose and specific benefits or risks are not made known to them. This kind of consent is taken too generally, for any kind of research without the patient knowing what kind of research the data provided by him/her will be used in, or in what kind of actions he/she could be enrolled. I was concerned that the wording and the positioning of IC for research participation in the forms for hospitalization, could be a form of abuse, as they positioning medical research interventions as being naturally requested and exploited: the patient becomes the object of scientific research, just by agreeing that “harvesting biological material (blood, tissues, organs) for diagnosis “can be examined also for the “purposes of scientific research (including DNA analysis), instruction, can be photographed and published without further express authorization from [the patient], maintaining confidentiality ” (excerpt from an IC form).
We don’t know if there exists a practice of using of collected data and samples grounded in this broad IC, this gap in knowledge creating the necessity for this research.
The research in itself is initial research on the ethical use of IC in medical practice and medical research in the field of Romanian research ethics and aims to identify how ethics is applied in medical research practice. Specifically, it investigates how IC of research participants is understood by professionals as an ethical instrument, how it is applied and what the ethical implications of using it are, starting from the 4 bioethical principles.
This research aims to identify how IC of research participants is understood by professionals as an ethical instrument in medical research, how it is applied and what the ethical implications of using it are, starting from bioethical principles.
We were interested to identify if the medical staff that apply the IC as an ethical instrument have knowledge of the bioethical principles which should be the basis of adopting and implementing such an instrument. We would like to explore if the IC is understood by medical staff as a means to respect patients’ autonomy or as a protective measure for health care staff in the event of a potential future medical negligence and/or of claims from patients about treatment performed or not, and to changes in their health after medical intervention. We are interested if a broad formulation of IC, such as the one quoted above, is used to allowing the conducting of studies and further publication of the resulting data (including when we are facing rare cases or rare genetic mutations etc.) or whether these are just conjectural forms introduced in the content of IC without prior reflection on possible significance.
Romanian background |
In the Romanian legislative framework we identified references to IC used in both medical practice and medical research. Rules of Good Clinical Practice defining the procedure by which IC is obtained were first adopted in 1998. Currently through the Romanian Minister of Public Health’s Orders 903 and 904 from 2006, Romanian legislation is transposing the Directives of the EP and the EC on the approximation of the laws, regulations and administrative provisions of Member States on the principles and detailed guidelines for good clinical practice in the conduct of clinical trials on medicinal products for human use. The EP and EC Directives (2001/20/EC) are the manifestation of effects of the WMA Declaration from Helsinki. The Romanian legislation that requires the IC of patients is: Law Nr. 95/2006 on healthcare reform: and Law no. 46/2003 on patient’s rights.
- 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.
Research is based on a mixed methodology, including both qualitative (content analysis and Grounded Theory) and quantitative (online surveys) methods.
No stress, physical, psychological, social or economic harm may be incurred by participation in this research.
The subjects could have been concerned at the fact that they should spend time answering the questions, and we ensured that this did not happen by ensuring participants understood that they could withdraw at any moment in the interview.The data to be collected did not relate to illegal activities.
The transcription of the interviews did not contain any identification data of the subjects. The subjects were informed about the confidentiality of the data. If the subject mentioned data that could lead to his/her identification or of an institutional affiliation, these were anonymized at the data transcription stage.
The records from voice recorders were deleted at the end of the project.
- Benefits for improving knowledge in the field: knowledge of Romanian customization of IC use as an ethical instrument in medical practice and medical research on human subjects;
- Benefits for public policy: Formulation of institutional and public ethics policies suggestions aimed at the consensus between the significance offered by practitioners and international significance from literature of the IC;
- Benefits for participants in research: They can be invited to future ethics training.
Interview: 10 (minimum) until the saturation of the sample| between 28- 60 years| M & F
Survey: 30- 40 (minimum)| between 28- 60 years| M & F
Recruitment population and inclusion/exclusion criteria:
For the qualitative analysis we proceeded with the identification of a minimum 2 representatives of each medical institution for the interview, by using the “snowball” method, starting from contacts obtained by phone or by email. As specific criteria of inclusion we considered whether the potential respondent had published scientific research results from a medical research conducted within the selected institution in the last five years. We identified medical staff other than physicians – for example, nurses, psychologists etc. – and we included them in the sample. We included at least two hospital directors in the sample.
For the survey we applied a short online questionnaire addressed to medical staff of research institutions from counties from the North-Eastern region of Romania. We expected 30-40 questionnaires to be filled in. The online questionnaire was sent by email, using Google doc forms, to hospitals, research institutes and other centres that are allowed to conduct medical research. In this way we constructed a data base of such units from the research region and established contacts by email or by phone in order to increase the chances of getting the questionnaires completed.
Informed Consent or authorization to use/release information |
An informed consent form was provided to respondents prior to the start of data collection.
Ethical Approval of the LUMEN Research Center (Romania)/ IRB Clarkson University (USA)
The LUMEN Research Center approved the research protocol on 29 January 2016, through a decision of the President of Research Ethics and the Publication Ethics Committee of LUMEN.
The Certificate of Exemption from full IRB review and approval for research development from Clarkson University was obtained on 23 March 2016 (16-27E)
Evaluation (How to determine if the goals and objectives of the project have been accomplished) |
- Providing a partial report on the analysis of institutional policy regarding the IC; (O1)
- A partial report on the model of regarding the IC; (O2)
- A final report of the results
- The dissemination of results within a national or international scientific conference in bioethics.
- A submitted draft of a scientific article proposed to be evaluated by peer review.
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.
The interpretative grid which helped us in the content analysis was focused on the following items:
- The structural coherence of the document (the existence or non-existence of the contradictions between paragraphs);
- The preponderance of therapeutic issues over research activity;
- Whether the formulation of IC offers real liberty of choice regarding participation in research or not;
- If there are other elements to allow the patient to notify those who developed the IC form of concerns regarding dignity, welfare, non-injury, beneficence;
- If confidentiality and anonymization of data are mentioned.
The references to IC forms in this document will be achieved by abbreviations as follows: IC1 – IC patient consent to chemotherapy; IC2 – IC patient consent to surgical intervention; IC3 – IC fragments in hospitalization, recovery clinic forms; IC4 – IC to surgery/treatment, hospital emergency; IC5 – IC form (clinical trials); IC6 – IC form for treatment/surgery; IC7 – IC of patient for investigations and therapeutic procedures, and for participation in the medical educational process (psychiatry); IC8 – IC for performing procedures/medical interventions (psychiatry); IC9 – written consent of the patient – hepatitis (gastroenterology); IC10 – consent/agreement of the patient to diagnostic methods, treatment, anesthesia, and surgery (emergency); IC11 – IC on investigations, therapeutic procedures, for participation in the medical educational process and internal compliance inpatient (hospital emergency). See Annex 2 (Examples of IC forms used in analysis)
- 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 interviews 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.
- 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.
Partial results |
Partial results related to O1 will be exposed through a series of respondents selected for analysis of content of the forms of IC. Examples of IC collected and analyzed forms are attached as an Annex in Romanian language; from the contents of IC forms we selected those respondents who answered our interpretation grid and I translated for the report.
Conclusions from O1:
- Analysis of the IC forms showed that analyzed medical institutions approach the issue of obtaing of IC as purely administrative;
- Ethical reflection on the significance of IC in the construction of patient autonomy is missing or reduced to a mostly formal aspect. These can be formal aspects such as attention to the expression of patient understanding, the fact that he/she was informed and consents.
- All forms analyzed require the patient to a lesser or greater extent to have absolute trust in the professionalism of the medical team and give almost total freedom in the choice of therapy and intervention deemed necessary, allowing passage beyond the IC given by the patient, even in situations modifying the therapeutic approach that may involve risk of death.
- IC transformation in insurance against malpractice processes by transferring the patient’s absolute risk of all.
- The forms analyzed contain references to the implicit consent of the patient to participate in didactic activities or unspecified research.
- Broad consent elements are introduced, in our view illegitimately, in the content of the IC forms, in order to allow secondary use of data collected during patient diagnosis and therapy, especially after tissue sampling. The right to use research data obtained during diagnostic or therapeutic interventions can turn the therapeutic act into an illegitimate clinical trial.
- Using images obtained during diagnosis or treatment for the purpose of research and education, though less serious from the ethical standpoint, can lead to vulnerability of the patient, who does not know if he/she is used for purposes which in another context, they would not agree to.
- Both consent to participate in research activities and participation in medical education should be requested separately, making them the subject of another informed consent. In offering these types of IC, it should be explained clearly to the patient that refusal to participate in research or medical education does not endanger access to proper treatment.
Partial Results from O2 |
Partial results related to O2 include 9 interviews with representatives (doctors, managers, chairs of ECs) of Romanian medical institutions (Iasi city) who are allowed to conduct medical research on human subjects.
Following data collection we built preliminary conceptual categories, specific to the Grounded Theory analysis:
Open coding stage | Examples of Categories
- Category “The operational definition of IC”
- Category “Role of IC”
- Category “The process of IC obtaining”
- Category “Voluntarity of the patient for participation in medical research”
- Category “The medical staff’sneed for ethics”
- Category “The co-responsibility in doctor–patient relationship;
- Category “Values in medical practice. Doctor-patient relationship and ethical grounding of the profession “
- Category “IC and respect for patient’s rights”
- Category “Types of IC”
The overall analysis of the interview data collected thus far is intended to generate the discursive frame of the research and the theoretical corpus, including models with the value of hypotheses, in order to generate further research into the ethical conformity of care practices, or the need for ethical training in the field.
The partial findings show that the obtaining IC in medical practice is thought of rather as an administrative practice, mediated by the IC form provided by the institution, without reflecting on the ethical usefulness of the process itself.
The statements by interviewed Staff are confusing: they do not specify clearly the role of obtaining IC and references to the protective nature of IC form signing by the patient are very frequent.
The specifics of IC are also difficult to identify from the perspective of doctors, since either one cannot find any difference between IC for diagnostic work and therapeutic intervention and IC for medical research, or they identify the difference between them based on the size of the forms, without reference to ethical considerations. Transcription and analysis of this data is ongoing.After the construction of categories a theoretical model will be generated based on the GT analysis of the data. We concur with the suggestion of Strauss and Corbin (1990) that saturation is a “matter of degree”, and that saturation should be more concerned with reaching the point where it becomes “counter-productive” and that “the new” which is discovered does not necessarily add anything to the overall story, model, theory or framework (Strauss and Corbin, 1990:136; Mason, 2010). If the data will not be saturated from the interviews already taken, more interviews will be conducted.
Partial results related to O3 |
Online questionnaire was applied as mentioned in research methodology, but there are a number of issues that pose difficulty in meeting the objective related to the current Romanian healthcare context. 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
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Valorisation of partial results |
Partial results were exploited by their dissemination at the following important national and international scientific events:
- 11th National Conference in Bioethics 2015, 5-7 November 2015, “Consimțământul informat între teorie și practică”, Ana FRUNZĂ & Antonio SANDU – oral presentation
- World LUMEN Congress 2016 | Iasi & Suceava, Romania | April 12-17, 2016 | 221 Informed Consent between Theory and Practice, Ana FRUNZĂ & Antonio SANDU
- IAB2016, 14- 17 June 2016, 56 – Ethical Values of Broad Informed Consent. Individual vs Institutional Protection, Ana Frunza & Antonio Sandu
- IAB2016, 14- 17 June 2016, 57 – What Type of Respect is the Respect for Autonomy?, Ana Frunza – poster presentation
- IAB2016, 14- 17 June 2016, 58 – On understanding the Informed Consent Process in medical care services, Ana Frunza & Antonio Sandu -poster presentation- see appendix
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.
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
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