Perception of Polish patients with cancer of the ethical and legal issues related to biobank research

Abstract

Background

Although biobanks have become fundamental to many research centers and contribute to medical development, they generate many ethical and legal issues that may discourage patients from donating.

Materials and Methods

To understand patients’ perception of ethical and legal issues related to biobanks we conducted a survey among 548 Polish patients with cancer.

Results

While 93.1% of patients with cancer declared themselves willing to donate biospecimens left over after a medical procedure to a biobank, most opted for one-time consent or study-specific consent, blanket consent being less frequently preferred. Many patients believed that future use of previously collected tissues require second contact. Most patients preferred pseudonymization over anonymization of the data, and supported donors’ right to withdraw informed consent at any given moment. Finally, while personal health information was the most expected form of compensation for donation, most patients suggested that all parties, including the biobank concerned, the sponsors of the research, and the donors, should own the rights to cancer tissues donated and profit from the biobank research. Patients’ opinions on the ethical and legal issues related to biobank research were associated with age, sex, religiosity, education level, and place of residence.

Conclusions

Since biobanks generate ethical and legal issues related to informed consent, data protection and storage, as well as the sharing of biosamples, tissue ownership, and profit sharing, that may discourage patients from donation, when asking a patient for a donation, healthcare professionals should communicate in a donor-centered manner and address patients’ ethical and moral concerns related to donation and offer resources to help manage these concerns.

This article reports results of a survey conducted to better understand cancer patients’ perception of ethical and legal issues related to biobanks.

Implications for Practice.

Since there are numerous ethical and legal challenges related to biobanks, prospective biomedical research cannot be conducted without considering patients’ perspective. To increase public trust and support for donation biobanks should address patients’ ethical and legal concerns and strengthen communication with the donors. Tissue and organ donor coordinators should be trained on the ethical and legal framework for donation, (non-verbal) communication and active listening skills, and the role of religious and cultural belief systems in tissue and organ donation. This research suggests that patients with cancer prefer one-time consent or study-specific consent over blanket consent.

Introduction

Cancer is a complex condition that causes a major threat to human health. Even though over the years advances in cancer research have improved the diagnosis, treatment, and prognosis of patients, cancer remains the second leading cause of death in all OECD countries, following cardiovascular disease, as in 2019 in the European Union (EU) alone more than 1.2 million people died of cancer, accounting for more than 1 in 4 (26%) of all deaths.¹ Similarly, although Poland has implemented a variety of policies to improve cancer diagnosis and treatment through the National Oncology Network, and national population-based screening programs for several cancers have been launched (ie, breast and cervical cancer), with 283 cancer deaths per 100 000 population cancer mortality in Poland is still 15% above the EU average, and is among the highest in the European region.² Cancer risk factors (smoking, alcohol consumption, obesity, and air pollution) are also much higher in Poland than in other EU countries.² While during past 2 decades, the number of new cancer cases in Poland has doubled, more than 43 000 new cases of rare cancers are expected in Poland each year, which equates to 22% of all new cases. For that reason, early prevention, detection, and the treatment of cancer have become a public health priority.

Simultaneously, since many forms of cancer are caused by inherited genetic changes, it is equally important to develop cancer-related genetic research that might help to develop new options for diagnosis and treatment. Since the advancement of cancer-related research requires a large number of high-quality samples and well-annotated patient clinical and pathological data, associated with demographic, socio-economic, genealogical, lifestyle, and environmental data, biobanks play a crucial role in modern large-scale research in the field of cancer.^3-8 Since cancer biobanks facilitate the collection, storage, and study of human biospecimens, they are pivotal in cancer-related research and create a unique opportunity to investigate the mechanisms of the cause of cancer, as well as resistance and response to treatment. While they have the potential to develop more accurate diagnoses, better treatment selection, and novel therapies, cancer biobanks may revolutionize the personalized or precision medicine,^9-11 which has been defined by the Precision Medicine Initiative as “an approach to disease treatment and prevention that seeks to maximize effectiveness by taking into account individual variability in genes, the environment and lifestyle.”¹²

As cancer biobanks have become fundamental in many medico-research centers and since they represent a great opportunity for large-scale networking at national and international level, public and medical opinion of research biobanks is largely encouraging and favors the discussion on the (medical) benefits of biobanking over risks.¹³ Resent advances in the field of biobanking, however, and related genomic research generates many ethical, legal, and social issues (ELSI) related to the collection, storage, and sharing of biosamples donated for biobank research that may discourage patients from donating.^14-22

While some research on patients with cancer willingness and motivations for (non)participation in cancer research biobank exists,^23-34 previous Polish studies on the ethical and legal issues related to biobank research have been conducted on the general population.^35–40 Little empirical data exists, however, on Polish cancer patients’ perception of biobanking of human biological material for research purposes. This study therefore seeks to assess their views on the ethical and legal issues related to donation for research biobanking. This is important since research has demonstrated that, although many patients are willing to share their biospecimens left over after medical procedures for research purposes, ethical concerns related to biomedical research, including fear over privacy and confidentiality of data, are among the most common reasons for not consenting.^{23,29,31,33,34,41–43} Understanding patients’ perceptions of these issues may help to improve recruitment campaigns and effectively recruit patients and their families to participate in research projects. Given that Poland still maintains a relatively homogeneous population, it serves as an ideal pool for conducting genetic studies within populations.

Materials and methods

Study design

This study was designed to assess the views of patients with cancer on the ethical and legal issues related to research biobanks. It includes data from an anonymous, self-administered paper-pencil questionnaire conducted among Polish patients with cancer. After a thorough analysis of literature, a questionnaire was developed to assess the perception of Polish patients with cancer on the ethical and legal issues related to biobanking of human biological material for research purposes.

Ethical issues

This project was granted approval by the Poznan University of Medical Sciences Bioethics Committee (KB—1035/22, granted December 14, 2022). The survey was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki (revised in 2000).⁴⁴ Before answering any questions, all eligible participants signed the informed consent form to participate which explained the purpose of the study and methods used, voluntary, anonymous, and confidential character of the survey, and the possibility of withdrawing from the study at any time without any implications.

Participants and setting

The survey was conducted over a 5 month period, between February 1, 2023 and June 30^, 2023 among patients with cancer at the Institute of Oncology of the University Clinical Hospital in Poznań and the Gynecological and Obstetrics Clinical Hospital of Poznan University of Medical Sciences.

Respondents were eligible to participate if they were aged over 18, had been diagnosed with cancer, were willing to participate in the survey, and provided informed consent.

Research tool

The questionnaire used in this project was developed in accordance with the recommendations of the European Statistical System.⁴⁵ After a literature search, a preliminary questionnaire was designed. The questionnaire was then evaluated by a panel of experts (a public health specialist, a sociologist, and an ethicist) and revised based on their comments. It was then evaluated by an oncologist who provided additional comments which led to the reformulation of 5 questions. After a standardized questionnaire was developed, it was pre-tested with 20 patients with cancer. This in turn, led to the rephrasing of 3 questions. The questionnaire was finally re-evaluated by 4 additional external specialists: an oncologist, a public health specialist, a sociologist, and an ethicist. It was approved by the Poznan University of Medical Sciences Bioethics Committee.

The questionnaire itself was designed to explore questions on the assessment of the perception of patients with cancer on the ethical and legal issues related to research biobanking. The first part included questions about the preferences of patients’ with cancer for the type of consent and withdrawing consent, control over data sharing, data protection, tissue ownership and profit sharing, and their opinion on the preferred compensation for sharing their samples. The second part of the survey concerned patients with cancer demographic characteristics, such as sex and age, education, place of residence (number of inhabitants), and religiosity (determined by patients’ declaration on “What role does religion play in your life?”), the type of tumor and the stage of disease. All items in the questionnaire were designed as close-ended questions and patients were asked to choose from a limited range of pre-defined options. The questionnaire used close-ended questions with a 5-Likert scale ranging from 1 (strong dissatisfaction or disagreement) to 5 (high satisfaction or agreement).

At the same time, since research shows that people’s awareness of biobanks in Poland is low,^35–40 before completing the survey all respondents were provided with a definition of a research biobank (“A biobank is a collection of human biological samples, ie, bodily fluid, DNA or tissues, and associated information (ie, demographic, socio-economic, genealogical, lifestyle, and environmental data) collected from patients and healthy persons, organized systematically to help researchers study the way genes, the environment, and lifestyle might affect a person’s health”). All the questions asked were formulated in simple language using descriptive definitions without technical jargon to facilitate the completion of the survey.

Data collection

After permission to distribute a questionnaire was obtained from the directors of the Institute of Oncology and the Gynecological and Obstetrics Clinical Hospital, the survey was distributed to patients with cancer in 5 clinical wards in Poznan: the Oncology Ward, the Gynaecological Oncology Ward, the Surgical Oncology Ward, the Clinical and Experimental Oncology Ward, and the Chemotherapy Ward at the Institute of Oncology of the University Clinical Hospital in Poznań and the Outpatient Clinic and the Division of Gynecological Oncology at the Gynecological and Obstetrics Clinical Hospital of the Poznan University of Medical Sciences.

The study included patients with cancer of both sexes who were willing to participate. A convenience sampling approach was used. The data were collected using a self-administered paper-and-pencil questionnaire with the assistance of a member of a research team (JC). Questionnaires were given out to the patients after the study’s purpose and methods used were explained, and patients were apprized of the voluntary, anonymous, and confidential character of the survey. The respondents had the opportunity to ask questions during the data collection process or cancel their participation and withdraw from the study at any point without any implications before the questionnaires were collected. Study participants received neither monetary nor non-monetary compensation for completing the survey. It took approximately between 15 and 20 minutes to complete the survey.

Data Analysis

The data acquired from the administered questionnaires underwent meticulous scrutiny to ensure accuracy, consistency, and comprehensiveness. Descriptive statistics were used to summarize the socio-demographic characteristics of the study participants, including sex, age, education, place of residence, and religiosity. Based on the patients’ declarations regarding the role religion plays in their lives, participants were divided into 2 groups: religious (religion defined as significant or rather significant) and nonreligious (religion defined as of little or no significance). To assess the impact of the respondent’s age, we categorized the study population into 2 groups: those above and those below the median age.

The results were presented as counts and percentages for categorical variables and measures such as the median, mean, interquartile range (IQR), and SD for continuous variables. Odds ratios (ORs), along with their associated 95% confidence intervals (CIs), were calculated to assess the strength of associations between different variables. The CI provides a range within which the true OR is likely to fall with a specified level of confidence. Chi-square tests were conducted to evaluate associations between preferences and demographic characteristics. All calculations were performed using JASP (Version 0.17.2.1), while maintaining a statistical significance level of P < .05.

Results

Out of all 621 patients approached 595 participated by completing the survey, providing a response rate of 95.8%. Of those 55 (9.1%) questionnaires were invalid due to non-responses or incorrect answers. All in all, a total of 548 questionnaires were included in the study.

The participants were predominantly women (85.2%), and were an average of 52 years old (SD = 13.37; rage: 19-84) (Table 1). The majority of participants declared university level education (52.2%), followed by secondary education (33%), and vocational school (13.6%). Most participants lived in towns with more than 500 000 inhabitants (26.6%) or in towns with less than 100 000 inhabitants (27.2%). A total of 53% of patients declared that religion was significant for them and that it influenced their life decisions and choices, and 47% declared that it is irrelevant in their lives. While the predominant cancer stages were III (26.5%) and II (26.3%), the most prevalent cancer types included breast cancer (44.9%), ovarian cancer (17.2%), and colon cancer (10.4%).

Table 1.

Patients’ with cancer socio-demographic characteristics.

Characteristics	N (%)
Sex
Woman	467 (85.2)
Man	81 (14.8)
Patient’s age
Range	19-84
Median	52
IQR (1-3)	43-63
Mean (95%CI)	52.46 (51.34-53.58)
SD (95%CI)	13.37 (12.69-14.00)
Education
Primary school	7 (1.3)
Vocational school	74 (13.6)
High school	170 (33)
University	286 (52.2)
Medical university	9 (1.6)
Missing	2 (0.3)
Place of residence
Up to 10 000 inhabitants	149 (27.2)
10-50 000 inhabitants	108 (19.7)
51-100 000 inhabitants	60 (11)
101-500 000 inhabitants	85 (15.5)
Above 500 000 inhabitants	146 (26.6)
What role does religion play in your life?
Significant	123 (22.5)
Rather significant	167 (30.5)
Little	146 (26.6)
None	112 (20.4)
Stage of cancer
Stage I: non-invasive cancer	59 (10.8)
Stage II: early stage	144 (26.3)
Stage III: intermediate cancer	145 (26.5)
Stage IV: advanced cancer	134 (24.4)
Stage V: very advanced cancer	66 (12)
Type of tumor
Breast cancer	246 (44.9)
Ovarian cancer	94 (17.2)
Colon cancer	57 (10.4)
Skin cancer	21 (3.8)
Other type of cancer	130(23.7)

Within our research cohort, 93.1% of patients declared their willingness to share cancer tissues left over after a medical procedure to a biobank for research purposes, while only 4% refused. When asked about the preferred type of consent, most patients with cancer enrolled in this study opted either for one-off consent, in which a person is asked to consent to take part in the research project only once with additional consent for biobanking (26.3%) or study-specific consent (21.2%) (Table 2). On the other hand, 17.1% of participants would consent only for cancer research and 17.7% declared their support for blanket consent. At the same time, 44.9% of participants believed that in sharing their cancer tissue with a biobank the patient should rather specify the types of research for which their specimens may be used rather than those to which they refuse consent (21.9%).

Table 2.

Patients’ with cancer preferences for informed consent.

	N (%)
Would you donate your cancer tissues left over after a medical procedure to a biobank for research purposes?
Yes	510 (93.1)
No	22 (4)
I do not know	16 (2.9)
What type of consent would you prefer when sharing your cancer tissue samples to a biobank for research purposes?
Consent for only one research project with a well-defined aim for which the tissue was taken and additional consent for biobanking	144 (26.3)
Consent only to cancer research	94 (17.1)
Tiered consent (individually selected categories of research or research uses, eg, only research on somatic diseases)	19 (3.5)
Study-specific consent (before every research project that involves my samples)	116 (21.2)
Blanket consent (open-ended permission with no limitations and no need to renewed consent)	97 (17.7)
Consent delegated to a bioethical committee	32 (5.8)
I do not know	45 (8.2)
Missing	1 (0.2)
When sharing their cancer tissue with a biobank patients should:
Specify the types of research for which their specimens may be used	246 (44.9)
Specify the types of research for which their specimens may not be used	120 (21.9)
I do not know	182 (33.2)
Samples collected from patients should be
Pseudonymized (reversibly coding, ie, in case a disease is detected)	350 (63.9)
Anonymized (irreversibly coded, so patients’ data cannot be determined)	36 (6.6)
I do not know	162 (29.5)
Should patients have the right to withdraw informed consent at any given moment?
Definitely yes	220 (40.1)
Rather yes	191 (34.9)
I do not know	56 (10.2)
Rather no	56 (10.2)
Definitely no	22 (4)
Missing	3 (0.6)
When patients want to withdraw informed consent their samples should be:
Anonymised (irreversible coded) but available for further research	114 (20.8)
Their further reuse should be prohibited	80 (14.6)
Destroyed	231 (42.1)
I do not know	122 (22.3)
Missing	1 (0.2)

A substantial percentage 63.9% of patients declared that biosamples collected from patients should be pseudonymized, ie, reversibly coded, so that in a case when a disease is detected in a patient, the patient might be informed about it, rather than anonymized, ie, irreversibly coded, so that patient’s data cannot be determined (6.6%). Almost one-third of participants, however, had no opinion on that matter (29.5%).

While 75% of patients supported patients’ right to withdraw informed consent at any given moment, 14.2.% were against it. At the same time, 42.1% declared that in such cases biosamples should be destroyed, while 20.8% opted for their anonymization.

Participants were also asked about their preferences regarding the moment a biobank should ask for permission to use their cancer tissue for research purposes (Table 3). While 66% of the study’s participants believed that a biobank need not ask for patients’ consent if they agreed, 69.1% expected such a request if a new research were to differ from the original project and 51.3% wanted to be asked before every research project. Significantly, 75.2% wanted to be asked again if the samples donated were going to be used by researchers from other research institutions and 71.9% if it was going to be used by foreign researchers.

Table 3.

Patients’ with cancer preferences on when the biobank should ask the patient for permission to use their cancer tissue.

	1. Definitely not n (%N)	2. Rather not n (%N)	3. I do not know n (%N)	4. Rather yes n (%N)	5. Definitely yes n (%N)	Missing n (%N)
When should the biobank ask patients for permission to use their samples?
does not have to ask if the patient gave consent while sampling	71 (13)	80 (14.6)	35 (6.4)	114 (20.8)	248 (45.2)	0 (0)
before every new research project	84 (15.3)	148 (27)	34 (6.2)	131 (23.9)	150 (27.4)	1 (0.2)
if a new research project differs from the original project	39 (7.1)	94 (17.1)	37 (6.7)	177 (32.3)	201 (36.8)	0 (0)
if it is going to be used by researchers from other research institutions than the one patient donated to	42 (7.6)	57 (10.4)	35 (6.4)	144 (26.3)	268 (48.9)	2 (0.4)
if it is going to be used by researchers from other foreign research institutions	45 (8.2)	65 (11.9)	42 (7.6)	134 (24.5)	260 (47.4)	2 (0.4)

When asked about their expectations regarding compensation for sharing their biomaterial for cancer research, 52.6% of patients opted for personal health information, and 11.3% preferred research results (Table 4). At the same time, 20.8% expected nothing. More than half of the participants believed that patients should receive no financial compensation for sharing their cancer tissue for research purposes (55.1%).

Table 4.

Patients’ with cancer opinions on tissue ownership and profit sharing.

What would you expect in exchange for donating samples of your cancer tissues with a cancer biobank?
Acknowledgment	24 (4.4)
Personal health information (detection of disease or genetic predispositions)	288 (52.6)
Results	62 (11.3)
Financial remuneration	3 (0.5)
Medical examinations free of charge	16 (2.9)
Preferential treatment in terms of waiting lists for examination	40 (7.3)
Nothing	114 (20.8)
Missing	1 (0.2)
Should patients receive financial compensation for sharing their cancer tissue for research purposes?
Definitely yes	20 (3.7)
Rather yes	51 (9.3)
I do not know	175 (31.9)
Rather no	178 (32.5)
Definitely no	124 (22.6)
Who should own the rights to cancer tissue donated to the biobank for research purposes?
Biobank	206 (37.6)
Patient	169 (30.8)
Sponsor of the research	4 (0.7)
Patient, biobank, and sponsor of the research	82 (15)
I do not know	87 (15.9)
Who should profit from the biobank research?
Sponsor of the research	33 (6)
Biobank owner	81 (14.8)
Patients	67 (12.2)
Patient, biobank, and sponsor of the research	129 (23.6)
I do not know	238 (43.4)

While 37.6% of patients declared that the biobank should own the rights to cancer tissues donated to a biobank, 30.8% believed that it belongs to patients and 15% declared that such a right should be granted to all parties involved in biobanking. On the other hand, even though 43.4% had no opinion regarding who should profit from biobank research, 23.6% believed that such profit should be shared among the patient, the biobank, and the sponsor of the research, while 14.8% indicated the biobank and 12.2% the patients.

The findings indicate that the majority of patients with cancer maintain consistent perspectives on crucial ethical and legal aspects associated with research biobanking, irrespective of factors such as sex, age, religious beliefs, place of residence and educational background, and the type of tumor and the stage of disease (Table 5). A noteworthy distinction arises, however, concerning the use of samples by researchers from different institutions within the same country. In this context, patients expressed a stronger inclination for the biobank to seek their permission. Within our research group, it was observed that men and individuals from smaller towns were more inclined to provide such consent. These insights offer valuable understanding of the way demographic characteristics may influence patient preferences in the domain of biobank research ethics.

Table 5.

Comparison of cancer patients’ views on the ethical and legal issues related to research biobanking based on different demographic characteristics.

		Men vs women	Older group vs younger group	Non-religious vs religious respondents	Those living in towns with fewer than 100 000 inhabitants vs those living in cities with more than 100 000	Respondents with university education vs others
When should the biobank ask patients for permission to use their samples?
Need not ask if the patient gave consent while sampling	OR
	95% CI
	P	ns	ns	ns	ns	ns
Before every new research project	OR
	95% CI
	P	ns	ns	ns	ns	ns
if a new research project differs from the original project	OR
	95% CI
	P	ns	ns	ns	ns	ns
if it is going to be used by researchers from a different research institution from the one patient donated to	OR	1.79			1.70
	95% CI	1.078-2.969			1.129-2.560
	P	P < .05	ns	ns	P < .01	ns
if it is going to be used by researchers other foreign in research institutions	OR
	95% CI
	P	ns	ns	ns	ns	ns
Should the patient have the right to withdraw informed consent at any given moment?	OR
	95% CI
	P	ns	ns	ns	ns	ns
Should patients receive financial compensation for sharing their cancer tissue for research purposes?	OR
	95% CI
	P	ns	ns	ns	ns	ns

Patients with cancer preferences regarding the preferred type of consent for sharing their cancer tissue with a biobank for research purposes varied. While no statistically significant differences were found in relation to the type of tumor or the stage of disease, we observed, however, the influence of age, religiosity, and education on these preferences (Table 6). Across all demographic groups, the majority of patients prefer to specify the types of research for which their specimens may be used. Statistically significant differences in preferences were noted between religious and non-religious respondents, women and men, and among different education groups. Irrespective of their demographic characteristics, patients predominantly favored pseudonymized samples, with consistent preferences across the various demographic groups. No statistically significant differences were found in patients’ preferences for acknowledgment, personal health information, results, financial compensation, or medical examination among different demographic groups. The majority of patients, regardless of demographic characteristics, lean toward the biobank owning the rights to cancer tissues, with no statistically significant differences in preferences among different demographic groups. Patients tended to express a preference for shared profits among the patient, biobank, and the sponsor of the research. A statistically significant difference was, however, observed between the older and younger groups, as well as between respondents with and without a university education.

Table 6.

Comparison of cancer patients’ opinions on consent issues based on different demographic characteristics.

	Women	Men	Older group	Younger group	Religious respondents	Non-religious respondents	Living in towns with fewer than 100 000 inhabitants	Living in cities with more than 100 000 inhabitants	Respondents without university education	Respondents with university education
What type of consent would you prefer when donating your cancer tissue samples to a biobank for research purposes?
Consent for only one research with well-defined aim that involves tissue that was taken for	121 (26)	23 (28.4)	85 (31.1)	59 (21.5)	81 (27.9)	63 (24.5)	91 (28.8)	53 (22.9)	76 (30.4)	67 (22.7)
Consent only to cancer research	78 (16.7)	16 (19.8)	63 (23.1)	31 (11.3)	60 (20.7)	34 (13.2)	58 (18.4)	36 (15.6)	49 (19.6)	44 (14.9)
Tiered consent (individually selected categories of research or research uses eg, only research on somatic diseases)	17 (3.7)	2 (2.5)	6 (2.2)	13 (4.7)	6 (2.1)	13 (5)	8 (2.5)	11 (4.8)	10 (4)	9 (3.1)
Study-specific consent (before every research project that involves my samples)	103 (22.1)	13 (16)	38 (13.9)	78 (28.5)	66 (22.8)	50 (19.5)	60 (19)	56 (24.2)	38 (15.2)	78 (26.5)
Blanket (open-ended permission without any limitations and the need to renewed consent)	85 (18.2)	12 (14.8)	43 (15.8)	54 (19.7)	40 (13.8)	57 (22.2)	53 (16.8)	44 (19.1)	37 (14.8)	60 (20.3)
Consent delegated to bioethical committee	25 (5.4)	7 (8.6)	14 (5.1)	18 (6.6)	11 (3.8)	21 (8.2)	14 (4.4)	18 (7.8)	13 (5.2)	19 (6.4)
I do not know	37 (7.9)	8 (9.8)	24 (8.8)	21 (7.7)	26 (9)	19 (7.4)	32 (10.1)	13 (5.6)	27 (10.8)	18 (6.1)
Chi-square test	χ2 = 4.026, ns		χ2 = 33.906, P < .001		χ2 = 19.501, P < .01		χ2 = 12.233, ns		χ2 = 19.477, P < .01
When donating their cancer tissue to a biobank patient should
Specify the types of research for which their specimens may be used	209 (44.7)	37 (45.7)	122 (44.7)	124 (45.1)	147 (50.7)	99 (38.4)	144 (45.4)	102 (44.1)	119 (47.4)	125 (42.4)
Specify the types of research for which their specimens may not be used	111 (23.8)	9 (11.1)	44 (16.1)	76 (27.6)	50 (17.2)	70 (27.1)	63 (19.9)	57 (24.7)	30 (12)	90 (30.5)
I do not know	147 (31.5)	35 (43.2)	107 (39.2)	75 (27.3)	93 (32.1)	89 (34.5)	110 (34.7)	72 (31.2)	102 (40.6)	80 (27.1)
Chi-square test	χ2 = 7.924, P < .05		χ2 = 14.169, P < .001		χ2 = 10.956, P < .01		χ2 = 1.957, ns		χ2 = 29.452, P < .001
Samples collected from patients should be
Pseudonymized (reversibly coded, ie, in case a disease is detected)	299 (64)	51 (62.9)	142 (52)	208 (75.6)	172 (59.3)	178 (69)	192 (60.6)	158 (68.4)	142 (56.6)	207 (70.2)
anonymized (irreversibly coded, so that patient’s data cannot be determined)	31 (6.7)	5 (6.2)	24 (8.8)	12 (4.4)	22 (7.6)	14 (5.4)	25 (7.9)	11 (4.8)	15 (6)	20 (6.8)
I do not know	137 (29.3)	25 (30.9)	107 (39.2)	55 (20)	96 (33.1)	66 (25.6)	100 (31.5)	62 (26.8)	94 (37.5)	68 (23)
Chi-square test	χ2 = 0.089, ns		χ2 = 33.130, P < .001		χ2 = 5.587, ns		χ2 = 4.270, ns		χ2 = 13.535, P = .001
When a patient wants to withdraw informed consent their samples should be
Anonymized (irreversible coded) but available for further research	93 (20)	21 (25.9)	59 (21.7)	55 (20)	62 (21.4)	52 (21.2)	67 (21.2)	47 (20.3)	41 (16.4)	73 (24.7)
Their further reuse should be prohibited	71 (15.2)	9 (11.1)	33 (12.1)	47 (17.1)	48 (16.5)	32 (12.5)	45 (14.2)	35 (15.2)	39 (15.6)	40 (13.6)
Destroyed	198 (42.5)	33 (40.7)	118 (43.4)	113 (41.1)	113 (39)	118 (45.9)	132 (41.8)	99 (42.9)	107 (42.8)	123 (41.7)
I do not know	104 (22.3)	18 (22.2)	62 (22.8)	60 (21.8)	67 (23.1)	55 (21.4)	72 (22.8)	50 (21.6)	63 (25.2)	59 (20)
Chi-square test	χ2 = 2.033, ns		χ2 = 2.715, ns		χ2 = 3.387, ns		χ2 = 0.238, ns		χ2 = 6.568, ns
What would you expect in exchange of donating samples of your cancer tissues to a cancer biobank?
Acknowledgment	20 (4.3)	4 (4.9)	15 (5.5)	9 (3.3)	14 (4.8)	10 (3.9)	13 (4.1)	11 (4.8)	17 (6.8)	7 (2.4)
Personal health information (detection of disease or genetic predisposition)	242 (51.9)	46 (56.8)	138 (50.8)	150 (54.6)	146 (50.5)	142 (55)	163 (51.4)	125 (54.4)	134 (53.6)	152 (51.5)
Results	56 (12)	6 (7.4)	27 (9.9)	35 (12.7)	36 (12.4)	26 (10.1)	35 (11.1)	27 (11.7)	27 (10.8)	35 (11.9)
Financial remuneration	3 (0.6)	0 (0)	1 (0.4)	2 (0.7)	2 (0.7)	1 (0.4)	2 (0.6)	1 (0.4)	1 (0.4)	2 (0.7)
Medical examination free of charge	14 (3)	2 (2.5)	9 (3.3)	7 (2.5)	12 (4.2)	4 (1.6)	11 (3.5)	5 (2.2)	6 (2.4)	10 (3.4)
Preferential treatment in terms of waiting lists for examination	33 (7.1)	7 (8.6)	15 (5.5)	25 (9.1)	19 (6.6)	21 (8.1)	26 (8.2)	14 (6.1)	13 (5.2)	27 (9.1)
Nothing	98 (21)	16 (19.8)	67 (24.6)	47 (17.1)	60 (20.8)	54 (20.9)	67 (21.1)	47 (20.4)	52 (20.8)	62 (21)
Chi-square test	χ2 = 2.542, ns		χ2 = 9.608, ns		χ2 = 5.345, ns		χ2 = 2.121, ns		χ2 = 9.793, ns
Who should own the rights to cancer tissue donated to a biobank for research purposes?
Biobank	174 (37.3)	32 (39.5)	110 (40.3)	96 (34.9)	110 (37.9)	96 (37.2)	121 (38.2)	85 (36.8)	100 (39.8)	105 (35.6)
Patient	146 (31.3)	23 (28.4)	85 (31.1)	84 (30.5)	90 (31)	79 (30.6)	100 (31.5)	69 (29.9)	68 (27.1)	100 (33.9)
Sponsor of the research	3 (0.6)	1 (1.2)	3 (1.1)	1 (0.4)	4 (1.4)	0 (0)	3 (0.9)	1 (0.4)	3 (1.2)	1 (0.3)
Patient, biobank, and sponsor of the research	69 (14.8)	13 (16.1)	32 (11.7)	50 (18.2)	37 (12.8)	45 (17.5)	42 (13.3)	40 (17.3)	33 (13.2)	49 (16.6)
I do not know	75 (16)	12 (14.8)	43 (15.8)	44 (16)	49 (16.9)	38 (14.7)	51 (16.1)	36 (15.6)	47 (18.7)	40 (13.6)
Chi-square test	χ2 = 0.751, ns		χ2 = 5.913, ns		χ2 = 5.991, ns		χ2 = 2.170, ns		χ2 = 7.405, ns
Who should profit from the biobank research?
Sponsor of the research	29 (6.2)	4 (4.9)	21 (7.7)	12 (4.4)	18 (6.2)	15 (5.8)	21 (6.6)	12 (5.2)	18 (7.2)	15 (5.1)
Biobank owner	70 (15)	11 (13.6)	49 (17.9)	32 (11.6)	45 (15.5)	36 (14)	50 (15.8)	31 (13.4)	36 (14.3)	44 (14.9)
Patients	60 (12.8)	7 (8.7)	42 (15.4)	25 (9.1)	40 (13.8)	27 (10.5)	41 (12.9)	26 (11.3)	37 (14.7)	30 (10.2)
Patient, biobank, and sponsor of the research	102 (21.9)	27 (33.3)	47 (17.2)	82 (29.8)	58 (20)	71 (27.5)	67 (21.2)	62 (26.8)	40 (16)	89 (30.2)
I do not know	206 (44.1)	32 (39.5)	114 (41.8)	124 (45.1)	129 (44.5)	109 (42.2)	138 (43.5)	100 (43.3)	120 (47.8)	117 (39.6)
Chi-square test	χ2 = 5.486, ns		χ2 = 20.245, P < .001		χ2 = 4.934, ns		χ2 = 3.111, ns		χ2 = 17.019, P < .01

Discussion

Although lay involvement in biobank research and effective collaboration between the public and research community should be standard practice,^46-48 our findings confirm that from patients with cancer perspective participation in biobank research raises serious ethical and legal challenges related to the protection of autonomy and confidentiality, control of information, intellectual property, and profit sharing.^14-22 In this respect this study yielded several important findings.

Most importantly, while some studies suggest that broad consent is widely acknowledged,^34,41 our study shows that most patients with cancer enrolled in this study prefer one-time or study-specific consent, and blanket consent had less support than that. Most Polish patients also expected that future research using previously collected tissues should require re-contact and the donors should be required actively to give consent for their data to be shared in future projects rather than explicitly refuse some types of research. A study conducted in Canada also showed that most patients with leukemia opted for one-time consent (59.6%) and tiered consent (30.3%).²⁴ Similarly, Lhousni et al found that, although 80.7% of patients in Eastern Morocco declared a willingness to donate to biobank research, their preference for one-time consent (75%) was associated with a lack of trust in biomedical research and concerns about privacy.⁴³

In contrast, Pentz et al reported that in an ethnically diverse community, 95% of patients with cancer were eager to donate for future research and the majority favored one-time broad consent obviating re-contact.²³ In the Netherlands only 3% of patients with colon or breast cancer wished to be asked for consent for each new research project, while 71% opted for broad and opt-out consent.⁴⁹ Similar results were found among patients with cancer in Hawaii, where only 10% would ask for re-consent every time a researcher wanted to include their tissue in a study, and 77% opted for blanket consent.²⁵ Finally, 71% of oncology outpatients in Australia preferred a blanket consent and wished that their samples be linked to medical records (62%).²⁶ Some research also suggests that patients’ preference for broad consent is associated with their belief that the consent processes put up many unnecessary financial and administrative barriers that might hinder cancer research and they perceived consent as unnecessary.³² 58% of Canadian patients, for example, were of the opinion that re-consenting was a waste of time and money.²⁴

Another important finding is that as in other countries, many patients with cancer desire some form of control as exemplified by participants’ preference for the method of data protection. This study also confirms that allowing participants to withdraw consent at any given moment is desirable among cancer patients. This is in line with previous research that showed as many as 60.8% of French cancer patients opted for signed consent.⁵⁰ Similarly, while 55.8% of patients with leukemia in Canada declared that patients should have the right to decide what is done with their samples, 54.6% opted for anonymization of samples and 45.4% wished to be de-identified. While 62.6% of patients expected the right to withdraw either their sample or health information from a biobank.²⁴

Our results also confirm that personal health information is the most expected form of compensation for participation in biobank research. This should come as no surprise, since it was shown that, although most patients with cancer support biobanks, declare a willingness to donate their blood or cancer tissue for future research and are driven by altruistic motives, ie, they hope it might contribute to cancer research, provide a greater understanding of cancer etiology and help in the discovery of new diagnostic techniques and therapeutic options, and thus benefit others, including the health of future patients, their families and society at large,^{23,29,30,32–34,41,51} many still perceive donation as an act of reciprocity and expect personal benefits largely in the form of increased knowledge about their own health.^26,27,51 While 75% of patients in London, for example, expected research results, more than half expected that it assured them of the best treatment available (51%), or that they would be monitored more closely (33%).²⁹ Similarly, more than 88% of Chinese patients⁴¹ and 79% of Australian oncology outpatients²⁷ expressed a desire to obtain the research results.

At the same time, while some suggest that patients expect neither fee nor a share in profits made, and perceive such benefits as unnecessary or undesirable,⁵⁰ this study shows that, even though only 0.5% of participants expected financial remuneration for donation, most patients with cancer enrolled in the survey declared that all parties, including biobanks, sponsors of the research and patients themselves should own the rights to cancer tissues donated to a biobank and profit from the biobank research. This is in line with observations made by Mancini et al that very few (6.4%) patients believe that they would be the main beneficiaries of research.⁵⁰ Similarly, while only 19.4% of patients in Canada were of the opinion that research participants own their samples, 62.2% believed it to be the research institution that owned the samples, and 16.3% that it is the researcher, and 2% that it is the sponsor of the research.²⁴

Finally, this study shows that patients’ opinions on ethical and legal issues related to biobank research were associated with their socio-demographic characteristics, since male patients and those living in smaller communities expected to be asked for permission for researchers from other institutions to use their samples. Patients’ sex, age, religiosity, and education also influenced their preferences for the type of consent. This supports previous findings indicating that patients’ willingness to donate is associated with their level of education and their history of blood donation.^23,28,41 Lee et al, for example, demonstrated that older women with a college education, previous breast biopsies, family histories of breast cancer, or comorbidities were more likely to donate.⁵² In another study patients with a higher education level were more likely to donate, while female patients and older patients were less willing to donate leftover biospecimens or additional blood samples or even clinical data for research.³⁰

All in all, while previous findings showing higher support for broad consent among patients with cancer and less of a preference for re-consenting may result from their personal interest in the development of cancer research^23,34,41,51 and the high degree of trust in science and doctors resulting from frequent interaction with the healthcare system,²⁴ our study shows that the greater preference for one-time consent and study-specific consent, the wish to control the use of donated samples and to the right to withdraw the consent may be due to lower awareness regarding biomedical research and biobanks in particular. In fact, even though many people in Poland expect biotechnology to deliver benefits, previous research demonstrated that one of key factors in determining social acceptance is the knowledge of scientific data, since both Polish medical students^38,39 and the general population^35–37,40 who are unaware of biobanks, possess limited knowledge on biobanking or confuse donation for biobank research with medical examination.

Limitations

Although to the best of our knowledge, this is the first empirical study of the perception of patients with cancer of the ethical and legal issues related to biobanking for cancer-related research in Poland, it has some limitations. First, although the response rate was high, patients with cancer from only one Polish city were enrolled in the study. Since this study had a local dimension, it would therefore be desirable to compare findings from other parts of the country. Additionally, since this study was designed as an explanatory study it was conducted in 2 hospital centers only and future research should include more healthcare facilities that would enhance the generalizability of the findings. Secondly, this study may be biased due to non-probabilistic convenience sampling which is not fully representative of the population being studied and lacks clear generalizability. Third, since women were over-represented, the results of this survey under-represent the opinions of male patients, whose perspectives may be different. Fourth, because not all patients approached responded and completed the survey, it is possible that those who did may have more positive views of research in general and be more likely to participate in new research than patients who did not volunteer. Fifth, although in developing the questionnaire for this survey we consulted several specialists in the fields of oncology, medical sociology, public health, and, bioethics, and the questions used were formulated in simple language, there remains the risk of misunderstanding some terms or questions. Sixth, while we did not set any particular inclusion criteria in terms of type of tumor, stage, and phase of the disease patients with some types of cancer were represented more than others. Consequently, this study may carry out a bias in data collection due to underrepresentation of some groups of patients. At the same time, it seems that neither the type nor the stage of disease influenced patients opinions on the biobanking as no statistically significant differences were found. Finally, since our study was based on the quantitative method only, to yield a better understanding of patients perspectives, more in-depth studies using qualitative methods is recommended. These limitations should be considerations for future prospective studies.

Apart from these limitations, since our survey is one of only a few that examines perceptions of Polish patients with cancer biobank research it identified the main ethical and legal issues related to biobanking and provides an important contribution to a broader understanding of patients concerns surrounding biobanking. While it fills the gap in the research on the topic, it also has relevance for the development of research policy on biobanking.

Conclusions

Although research shows that many patients with cancer are generally well disposed to donating their biospecimens left over after medical procedures for the purpose of future research, this survey confirms that there are numerous ethical and legal issues related to informed consent, data protection and storage, and sharing of biosamples, as well as tissue ownership and profit sharing, any of which may discourage patients from donation.

Unsurprisingly, biobanks understand that biomedical research cannot be conducted without considering patients’ points of view. Since most biobanks recognize that patients are more than just donors, they actively seek the involvement of patients’ organizations and local communities in the planning and control of biobank activity.^48,53,54

This study yielded 7 major findings. First, most patients with cancer enrolled in this study opted for one-time consent or study-specific consent, while blanket consent had less support. Second, participants expected that future studies using previously collected tissue would require re-contact. Third, most participants suggested that the donors should actively give consent for their data to be shared in future projects rather than explicitly refuse some types of research. Fourth, there was a preference for pseudonymization over anonymization of the data. The majority of cancer patients also supported donors’ right to withdraw informed consent at any given moment. Personal health information was the form of compensation most commonly expected in return for participation in biobank research. Finally, patients with cancer declared that all parties, including biobanks, sponsors of the research and patients, should own the rights to cancer tissues donated to a biobank and profit likewise from the biobank research. While most patients with cancer declared a willingness to donate, their opinions on ethical and legal issues related to biobanks were linked with some socio-demographic factors, including age, sex, religiosity, and level of education.

This research therefore confirms that although the public discourse highlights numerous benefits of biobanking,¹³ patients express various concerns related to ethical, legal, and social issues related to biobank research. Consequently, apart from establishing the standards of biobanking best practice (ie, the principles for responsible custodianship, construction of appropriate informed consent, privacy and confidentiality, international coordination and the sharing of biospecimens and intellectual property, and resource sharing), it is equally important to inform the public that biobanks meet the required standards. Thus, while planning a cancer biorepository, it is crucial to improve mutual communication with the donors and explain them these ethical and legal issues, as it warrants a culture of trust toward biobanks and ensures the success of the recruitment process.^54–57 In order to persuade patients to participate in research projects the following guidelines should also be implemented:

1. While every donor should have a chance to express one’s ethical and moral concerns related to donation and biomedical research, they should also receive information (leaflets) on how biobanks manage these issues.

2. To increase public trust in and support for donation to biomedical research the role of ethics committees in the organization, management, and supervision of biobanks should be strengthened.

3. Tissue and organ donor coordinators should be trained not only in the physical and psychological requirements of donation but also in the ethical and legal framework for donation, (non-verbal) communication and active listening skills and the role of religious and cultural belief systems on tissue and organ donation.

4. When asking a patient for donations for biobank purposes, healthcare professionals should communicate in a donor-centered manner and address patients’ ethical and moral concerns related to donation and biomedical research and offer resources to help manage these patient concerns.

Author contributions

Conception/design: All authors. Provision of study material or patients: Jan Domaradzki, Justyna Czekajewska. Collection and/or assembly of data: Jan Domaradzki, Justyna Czekajewska. Data analysis and interpretation: Jan Domaradzki, Dariusz Walkowiak. Manuscript writing: Jan Domaradzki, Dariusz Walkowiak. Final approval of manuscript: All authors. Study supervision: Jan Domaradzki

Conflict of interest

The authors declare that they have no conflict of interest.

Funding

The authors declare no funding.

Ethics approval and consent to participate

This study was performed in line with the principles of the Declaration of Helsinki. This project was granted approval by the Poznan University of Medical Sciences Bioethics Committee (KB—1035/22, granted December 14, 2022.

Data availability

The datasets generated during the study are available from the corresponding author on reasonable request.

Consent for publication

Not applicable.