Barriers and Facilitators for Implementing a National Guideline to Foster the Responsible Use of Residual Biospecimens and Data in Health Research

Abstract

Residual biospecimens that are stored in hospitals' diagnostic specimen archives can be used for scientific research under strict legal and ethical regulations. In the Netherlands, a Code of Conduct governs responsible secondary use of residual biospecimens. However, implementation of this Code seems to be challenging. This study aims to explore the most important factors that facilitate or hinder the implementation of the Code. In addition, it investigates what is needed to further foster the responsible use of residual biospecimens. A mixed-methods design was used. Questionnaires were sent out to pathologists, patient information centers, physicians, researchers, data protection officers (DPOs), members of research ethics committees, and members of the boards of directors of all hospitals in the Netherlands (81 hospitals). To further investigate the barriers and facilitators, interviews were conducted with pathologists, patient information centers, physician-researchers, DPOs, review boards, research coordinators, and quality managers of pathology departments. In total, 246 respondents filled out the questionnaire and 36 interviews were conducted. Major barriers for implementing were a lack of resources (time, money), a lack of attention for responsible use, and a lack of practical knowledge (knowing what to do, where to go with questions). In contrast, the perception that implementing the Code was necessary, either by the respondent or by colleagues, was considered “a driver” for implementation. Practical instruments such as checklists and roadmaps were considered necessary to foster implementation; however, the creation of such instruments was hindered by a lack of clear-cut answers regarding legal aspects. Therefore, more clarity and harmonization on how to interpret both the Code and legislation regarding secondary use were considered necessary.

Introduction

Residual human biospecimens, collected from patients for diagnostic and treatment purposes, are stored for possible future use.^1,2 They have great research potential, illustrated by important discoveries for prevention, diagnosis, and treatment of diseases such as cancer.³ The increased use of residual biospecimens and related data for progress in science and health care emphasizes the importance of the responsible use of these biospecimens.^4–6

Currently, in the Netherlands, only some aspects of biospecimen use are explicitly regulated by law, for example in the Medical Treatment Contracts Act.⁷ This Act states that there has to be an opt-out procedure for the use of anonymous biospecimens. The Act does not discuss (directly or indirectly) identifiable biospecimens; however, it does discuss identifiable data. The Act states that informed consent is the standard consent procedure, although an opt-out procedure is considered sufficient when consent cannot reasonably be requested or when asking consent is not reasonably possible (and when certain requirements are met, for instance with respect to data protection). In practice, this leaves room for interpretation: when do we consider it unreasonable to request consent for identifiable biospecimens, and which data protection measures provide sufficient guarantees? To meet the need for additional regulation and explanation, the first version of the “Human Tissue and Medical Research: Code of Conduct for responsible use” (hereafter: Code) was published in 2002 by COREON^* and updated in 2011. The Code was endorsed by the participants of COREON, consisting of 35 scientific institutes/societies, representing most academic hospitals and other major scientific institutes. The main aim of the Code is to explain legislation, for example, the Medical Treatment Contracts Act and the Dutch Personal Data Protection Act (no longer in force with the enforcement of the General Data Protection Regulation [GDPR]). These legislations provide a general framework, and the self-regulatory Code provides a more detailed interpretation of how to apply legislation for observational biomedical research with human biospecimens and data.

This Code covers the whole chain of residual biospecimen use, from patient information and consent, to governance of the biobank, review of the biospecimen chain and study protocols, issuing of samples, research, transparency and involvement of patient representatives.

The Code describes which conditions must be met. Regarding the consent procedure, it states that an opt-out procedure is considered sufficient for most research with residual tissue, provided that several conditions are met, for example, transparency and sufficient information provision. Privacy should be well protected (e.g., by using pseudonymized data), and research should be reviewed by an ethics committee. Patients should be able to decide whether they allow researchers to use their biospecimens.

The Code also specifies who is responsible for meeting which conditions, for example, by stating that the pathologist should ensure that sufficient biospecimens are left for patient care. In addition, guidelines are provided for several other topics, including consent procedures for minors, how to report which incidental findings, review criteria for study protocols, and the expertise that should be available in an Institutional Review Board. Commercial use is out of scope of the Code.⁸

There is no compliance or monitoring procedure, and adherence is voluntary. In the Netherlands, it is not yet legally mandatory to review observational research, it is only mandatory to review invasive research or trials. Therefore, not every hospital established a review committee for observational research.

Implementation of the Code has been challenging, leading to a suboptimal use of residual biospecimens for research. The consent procedure and information provision regarding secondary use are parts that are often subject to debate, and seem the most challenging to implement in a harmonized way.

The Code provides much room for the use of the exception as formulated in the Medical Treatment Contracts Act (stating that an opt-out procedure is considered sufficient when consent cannot reasonably be requested). This became a frequently used consent procedure for research with residual biospecimen, also when using indirectly identifiable biospecimens and data.^8–11 However, previous research showed that with an opt-out procedure, only 30% of hospital patients are aware of biospecimen storage and potential further use.¹¹ This indicates that the information provision is insufficient, and therefore that the Code is not fully implemented. This is highly problematic as patients' interests are not fully protected, and patients' trust in the health care system and science may erode.^7,12 However, most hospitals seem willing to fulfill this ethical obligation, and are increasingly forced to do so by medical journals, (research) project financers, and changes in both European and Dutch laws.

A major legislative change is the General Data Protection Regulation. This European regulation, enforced starting in 2018, aims to protect personal (pseudonymized and identifiable) data. Since biospecimens are often accompanied by data when used for research, and because data can be derived from biospecimens, the GDPR is important for research with residual biospecimens.

The GDPR states that processing sensitive data, such as health data, is generally prohibited, but there are some exceptions. Most relevant exceptions here are processing for which explicit consent has been given, and scientific research, if this has been based on national legislation.¹³ Many other requirements of the GDPR, such as technical and organizational safeguards and data minimization, are similar to those in the Code. Yet, to fully integrate new requirements of the GDPR, a new version of the Code of Conduct is being drafted. The new version will undergo the approval procedure by the supervisory authority under article 40 of the GDPR.

It is not known what factors are hindering or facilitating Dutch hospitals in implementing the Code (or similar requirements in the GDPR). Better understanding of these factors may provide insight into hospitals' needs. This is essential to effectively assist the hospitals in the responsible use of biospecimens for research, balancing patient protection with research progress. Our study was therefore aimed at investigating the barriers and facilitators by looking into the experiences and vision of hospital employees with relevant roles.

Although an update of the Code of Conduct is currently being developed, results of this study will be useful for implementing the updated Code of Conduct as well, because the new edition will cover similar topics, such as consent, information provision, data protection, ethics review, and transparency regarding results of research. Barriers and facilitators of implementing the new version are likely to be similar.

Methods

A mixed-methods design with questionnaires and interviews was used. See Supplementary Data S1 and S2 for more details.

Questionnaires

Questionnaires were sent out to employees of all hospitals (81) in the Netherlands with relevant roles. The Code clearly designates certain responsibilities regarding secondary use toward hospital employees with specific roles. For example, health care professionals involved in the excision of human tissue should register opt-outs clearly; researchers should explicitly describe how they protect the patients' privacy; and ethics committees should review whether the interests of research participants are disproportionately harmed.

Therefore, we selected employees with those roles for the questionnaires and interviews. In one case, the role was described on a slightly more general level, namely for “biobank managers.” In practice, reuse of biospecimens is most common at pathology departments. Therefore, the questionnaires and interviews were also aimed at pathologists. Further, since data protection officers (DPOs) are responsible for the data protection measures in a hospital, we included them in our selection.

Between November 2017 and January 2018, online questionnaires were sent out to pathologists, patient information centers, physicians, researchers, DPOs, members of research ethics committees, and members of boards of directors. Each group only received questions relevant for their role. Together with some participants not answering all questions, this resulted in varying sample sizes per question. The quantitative results were summarized using frequencies and percentages (based on sample size for that question) using SPSS (version 25).

Interviews

A topic guide was used. A pilot interview was conducted in an academic hospital in the Netherlands. Hospitals in which at least three employees filled in the questionnaire were ranked; of those scoring the lowest, four hospitals were randomly selected; and of those scoring the highest, two academic hospitals and two nonacademic hospitals were randomly selected (stratified purposeful sampling method¹⁴).

Employees with relevant roles (see above) of these hospitals were approached by email to be interviewed. During interviews, participants were asked whether there were other employees who play a role in implementing the Code in their hospital. In some hospitals, the pathology department quality manager or research coordinator was indicated to be responsible for implementing or executing responsible procedures, therefore, they were approached as well. Interviews were conducted between May and October 2018, shortly after the GDPR was enforced. Verbal consent from the participant was requested in advance.

Ethics

Following Dutch regulations, there was no explicit ethical review for this noninvasive questionnaire study.¹⁵ All participants were informed about the study aims and volunteered to participate. Data were handled in accordance with privacy regulations^16,17 and stored in a pseudonymized way.

Results

Sample characteristics and response rate

In total, 247 respondents started the questionnaire, and one respondent was excluded from analysis for not being affiliated with a hospital. Response rates ranged from 10% to 100% per role. Of the 246 respondents, 76% (187 respondents) completed the questionnaire (response rates ranged from 7% to 91% per role, Table 1). Of 246 respondents, 89.8% worked in a hospital (of which 62% were nonacademic, 33.5% academic, and 4.5% unknown), 6.1% worked for an independent pathology laboratory, and 1.2% for an independent Medical Ethics Review Committee. For 2.8% of the respondents, it is unknown in what type of organization they worked, but since they indicated familiarity with the Code, it was assumed that they were involved in the reuse of human biospecimen or patient data. Members of boards of directors did not want to participate, indicating that they had limited time and/or in-depth knowledge of the subject.

Table 1.

Characteristics and Response Rate of Questionnaire Respondents

Position	Invited (n)	Started (n)	Response rate started (%)	Completed (n)	Response rate completed (%)
Pathologist	45	42	93	32	71
Physicians	379	61	16	52	14
Data protection officers	68	36	53	21	31
Patient information center	81	35	43	25	31
Medical ethics review boards	22	22	100	20	91
Researcher	151	27	18	20	13
Members of the boards of directors	81	8	10	6	7
Research coordinator	—^a	11	—	11	—
Unknown	—	4	—	0	—
Total	827	246		187

Research coordinators were not directly invited but received questionnaires through their colleagues.

Interviews were conducted with 36 participants; 24 interviews were conducted in six nonacademic hospitals and 12 interviews were conducted in three academic hospitals (Supplementary Table S1). Not all of those interviewed had participated in the questionnaire study.

General barriers and facilitators

Two levels of barriers and facilitators were identified in this study: general factors influencing implementation of the Code as a whole and specific factors influencing a certain aspect of residual biospecimen use.

In the questionnaire, 24% of the respondents answered that they did not know the guidelines or had not implemented them, and 48% indicated that none of the general barriers listed in the questionnaire applied to them (Table 2). A variety of explanations were given, ranging from “not my responsibility,” to “we already work according to the Code for many years,” and “we don't conduct scientific research.” One person indicated that not having enough knowledge played a role.

Table 2.

What Factors Hindered or Stimulated You to Implement the Code of Conduct? (n = 136 Respondents, Multiple Responses Possible)

Barriers	n	%	Facilitators	n	%
I do not know the guidelines or have not implemented them	32	24	I do not know the guidelines or have not implemented them	30	22
I did not have time to do it	18	13	I thought it is necessary	57	42
The guidelines do not provide clarity	10	7	I thought it is important	45	33
I did not have enough manpower	10	7	The guidelines provide clarity	37	27
It was not clear to me what to do	9	7	My colleagues thought it is necessary	29	21
I did not know where to go with questions	9	7	My colleagues thought it is important	21	15
I did not have relevant policy documents at my disposal	6	4	Colleagues contributed to the implementation	16	12
The departments involved did not work well together on implementation	6	4	I saw advantages for my work	13	10
I saw disadvantages for my work	5	4	The Board of Directors had given instructions	13	10
My colleagues thought it is not important	3	2	My supervisor(s) paid attention to the implementation	12	9
The Board of Directors had not given instructions	3	2	I wanted to do it	11	8
I did not have enough budget	3	2	I was able to do it	11	8
Colleagues did not contribute to or hindered the implementation	3	2	It was clear to me what to do	10	7
My hospital did not have the necessary technological applications	3	2	I had relevant policy documents at my disposal	10	7
My colleagues thought it is not necessary	2	1	I thought that implementation is feasible	10	7
I was not able to do it	2	1	The departments involved work well together on implementation	9	7
My supervisor(s) was/were not involved in the implementation	2	1	I had time to do it	8	6
I thought it is not necessary	1	1	I knew where to go with questions	8	6
There were no evaluation moments	1	1	There were evaluation moments	7	5
My supervisor(s) did not pay attention to the implementation	1	1	My hospital had the necessary technological applications	7	5
I thought it is not important	0	0	My supervisor(s) was/were involved in the implementation	6	4
I did not want to do it	0	0	I had enough manpower	4	3
I thought that implementation is not feasible	0	0	I had enough budget	3	2
None of the above	65	48	None of the above	26	19

Sixty-one of the 246 respondents reported that they were “very familiar” with the Code (Table 3), suggesting that unfamiliarity is an important barrier. Receiving sufficient information was considered most important for improving implementation (Supplementary Table S2). Other most frequently indicated barriers were a lack of resources (time, manpower) and practical knowledge (knowing what to do, where to go with questions). The most indicated facilitators were that the implementation of the Code was considered necessary or important, by the respondent or by colleagues. Thinking the guidelines provided clarity was considered to stimulate implementation by 27% of the respondents, while 7% of the respondents indicated “The guidelines do not provide clarity” as a barrier. During interviews, it became clear that although the Code provides guidelines for a number of topics, it was sometimes still unclear how to organize this in practice.

Table 3.

To What Extent Are You Familiar with the Contents of the Code of Conduct? (n = 246)

	Very familiar	A little familiar	Not at all familiar	Total
Pathologists	20	21	1	42
Physicians	5	27	29	61
Data protection officers	6	12	18	36
Patient information centers	0	11	24	35
Medical ethics review boards	15	5	2	22
Researchers	9	16	2	27
Members of the boards of directors	1	6	1	8
Research coordinators	5	4	2	11
Total	61	106	79	246

During interviews, three general barriers and facilitators were mentioned. One of the most important barriers was the lack of resources. Participant 31 (research coordinator): “Well, there is just too much work to do in too little time.” Prioritizing by the board of directors was found to help with this barrier, as did explicitly assigning staff to implement the Code.

A second barrier was lack of attention for responsible use of residual biospecimens. Participants sometimes felt unheard by their organization. Participant 26 (pathologist): “It is often speaking to an empty room.” Participants also felt patients did not show much interest in the topic. Participant 22 (physician-researcher): “People come in [our hospital] with a completely different focus. They think: I have a problem and I want to get rid of it.”

A third barrier was not knowing how to interpret the GDPR. Although the GDPR was mentioned as facilitating by creating attention for privacy, information provision, and transparency, participants indicated that they did not know how to translate the GDPR in daily practice and what was still allowed now the GDPR had come into force. Participant 10, pathologist: “It is overwhelming to me. I kind of feel like I can't quite grasp it right now.” Therefore, practical tools such as roadmaps or checklists were considered necessary. Because of the GDPR, privacy protection measures were intensifying, leading to resistance. Participant 19, pathologist: “It's so cumbersome! It really blocks everything.”

Both this haziness and resistance can be reduced with communication, workshops, and presentations. Participant 14, DPO: “I have organized meetings and I have often been invited to all kinds of departments where research can take place, to explain things.” In addition, ongoing guidance was considered useful for disseminating knowledge on how to interpret the GDPR. Participant 4, policy advisor: “They guide people in the run-up to […] submitting to the ethics review committee. So they check: do you have everything? Is your protocol OK?.”

Barriers and facilitators for specific aspects of residual biospecimen use

Consent procedures and information provision

An important part of responsible use of biospecimens is patient information and consent procedures. Half of the respondents indicated that their hospital provided patients with written information regarding use of residual biospecimens (49%), and 38% thought that this information was easy to find for patients (Supplementary Table S3). Interviewees all indicated that their hospital provided an opt-out procedure for residual biospecimen use, although some voiced the desire to implement a broad opt-in procedure in the future.

Interviews elucidated two barriers. First, hospitals struggled with registering the opt-outs and lacked the technical ability to connect registration systems. Furthermore, having to check opt-outs for a large cohort manually took a lot of time. Participant 1 (pathologist): “Well, some tend to just say, with such a long list, after 2 patients: checked. So not really actively checking [all the patients].” A centralized opt-out with the technical ability to automatically check opt-outs was considered to facilitate responsible consent procedures. If such a tool would be realized, issuing biospecimens from those patients who have opted out could reliably be avoided.

Second, hospitals struggled with patient information. Participant 2 (pathologist): “How to explain this properly and how to ensure that the patient is not overloaded with all kinds of documents? All those brochures are nice, but actually, no one reads those.” Hospitals struggled with both content (what topics to address, how to create understandable but legally sound information) and logistics (keeping information up to date and easy to find for both patients and staff) of information. Learning from other hospitals' experiences and templates, and assigning responsibility for updating the information to one party, was considered to be facilitating.

Research and ethics review

The Code states that the use of biospecimens for scientific research should be reviewed by an ethics committee. Since review of observational research is not (yet) legally mandatory in the Netherlands, some hospitals, especially those that do not conduct much research, did not establish an ethics review committee.

The reviewers that were interviewed for this study (mostly legal experts or research coordinators who played a role in the review of study protocols) indicated that they insisted on compliance with the Code. Yet, they indicated struggling with the same barriers as other hospital employees in implementing the Code. Participants pointed out that ethics review procedures were expanding and that an increased workload caused resistance in researchers. On top of this, multicenter studies ran into a burdensome chain of review procedures, for instance because of a diversity of GDPR interpretations.

Participants indicated that the creation of an interactive submission form with questions that pop up only if necessary improved ethics review procedures. Participant 20, DPO: “Then you make sure that people don't have to answer six questions with ‘n/a’ and then think: pfff.” Participant 14, DPO: “And if you don't do anything alarming, so you stay within the lines, […] you just get a kind of automatic approval and you can continue.” Providing researchers examples of approved submissions, and using preapproved “standard” protocols so that only deviating components need to go through review were expected to facilitate compliance.

Issuing biospecimens

In the questionnaire, 72% of the respondents answered that their hospital checked whether the patient opted out before they issued residual biospecimens for research, and 26% indicated that they did not know whether this happened (Supplementary Table S4).

During interviews, it became clear that some pathologists were reluctant to issue biospecimens for research, for instance because researchers never returned the samples or because biospecimens were used up. Participants indicated that Material Transfer Agreement help to curb this. Some pathologists (in nonacademic setting) felt that they did not receive enough credit, for example, a coauthorship, or financial reimbursement. “Honor where credit is due” (participant 19, pathologist).

Transparency regarding results of research with residual biospecimens

Participants mentioned several ways to improve transparency regarding research with residual biospecimens: sharing results with participants on a public platform (website, report, information meeting), sharing publication lists in annual reports, and sharing examples of scientific breakthroughs on a national or European level.

Most hospitals enrolled in this study did not actively provide research results on a hospital-wide level. Reasons were mostly the lack of time or considering providing transparency not to be their task. Returning results only to the participants of that specific study was considered problematic, because patients were sometimes not aware (anymore) of the use of their biospecimens, and because of pseudonymization. Participant 25 (pathologist): “It is often anonymized, so to trace it back to a patient, like: ‘your tissue was used in research, and […] these are the results', yes, that's almost impossible.”

However, improving transparency regarding research has advantages, both for patients and for researchers. Participant 2 (pathologist): “You don't have to do those experiments anymore because they have already been done and those were the results. But […] IT-wise it is a challenge to do it well.”

Discussion

This article is the first to describe barriers and facilitators for implementing the Dutch Code of Conduct for responsible use of residual biospecimens. Although the study was focused on a Dutch Code in the Dutch setting, the general principles^9,11,18,19 and challenges^20,21 are expected to be largely similar in other (especially European) countries, making the conclusions relevant in a broader setting.

Using the framework of Fischer et al.,²² we allocated the barriers in three categories (knowledge- and attitude-related barriers, guideline-related barriers, and external barriers) and discussed corresponding interventions. We focus on the general barriers (lack of resources, lack of attention, lack of knowing how to interpret the Code), since the specific barriers (technical issues, not sufficiently checking opt-outs, etc.) flow from the general barriers.

Knowledge- and attitude-related barriers (personal factors)

Not knowing how to interpret the Code and legislation and how to translate these in daily practice has been found to be a major barrier, in both our study and others.²³ This barrier may even be greater than that indicated by participants, because participants were possibly not aware of information and tools that already existed.

Provision of practical instruments and education of staff are strategies to develop more knowledge.²² The creation of such instruments is hindered by a lack of consensus or a lack of clear-cut answers regarding legal aspects.²⁴ Therefore, ongoing discussions are necessary to stimulate consensus and to create widely supported practical tools that are kept up to date.²⁵ This requires collaboration of multiple parties: researchers, research coordinators, and review boards for input regarding what instruments are necessary and to ensure practical usefulness, DPOs and legal experts for legal input, and the government and financers for resources.

Barriers related to attitude, such as lack of agreement with the guidelines, lack of skills, or lack of motivation, were often not voiced regarding the implementation of the Code, but were mentioned as barriers for implementing the GDPR. However, this was not because the requirements were substantially different, but because the enforcement of the GDPR led to more awareness of the requirements. Therefore, these barriers are important for the Code as well.

Active learning from experts as opinion leaders, for example, by attending their workshops, is a possible intervention.²² These interactive educational strategies were mentioned by participants, and are considered effective.^26,27 We consider it the responsibility of the hospital to enable employees (with relevant knowledge) to provide guidance. We consider it the responsibility of researchers to reach out for guidance in an early stage of research.

Guideline-related barriers

Most guideline-related barriers, such as complexity or lack of clear goals, were not directly specified as barriers during our study. Struggles to translate the Code in daily practice could (besides, e.g., lack of knowledge, consensus, and resources) however be caused by Code-related barriers. Simplicity, short and user-friendly (easy-to-read) versions of the Code and checklists are interventions to overcome this barrier.^22,27 Therefore, even though we found no direct proof that there were Code-related barriers that played a role in implementation problems, we recommend the writers of the currently updated Code of Conduct to ensure the new Code is user-friendly.

External barriers

Many of the barriers indicated in this study stem from a lack of resources. One of the corresponding interventions is establishing clear responsibilities.²² Our study indicated that an effective way to do so is for hospitals (boards of directors) to explicitly assign staff to implement (parts of) the Code. We expect it to be helpful if the new Code (which is currently being written) also defines clear responsibilities where possible, structured in an easy-to-read format. Moreover, approval of the new Code by the Dutch supervisory authority might help in this respect. Another barrier indicated during this study is the diversity of guideline and legislation interpretation. A strategy to solve this, mentioned during this and other studies, is cooperation with other hospitals,²² and consultation with experts and stakeholder groups.²⁰

Previous research showed several barriers that were not voiced during our study, such as sample availability, awareness of biobanks among researchers and biobank networks.^23,28,29 A possible explanation for the absence of these barriers in this study are the Dutch PALGA system and the Dutch National Tissuebank Portal, a nationwide network and registry, which researchers can use to locate, request, and collect tissue samples from all Dutch hospitals.³⁰ Finally, previous research showed that multifaceted interventions are more effective than single-faceted interventions, stressing the importance of a combination of strategies.^27,31

Way forward

This study showed that most of the barriers for implementing the Code do not stem from the Codes' content, but from a lack of active (help with) implementation. Implementation of the Code is a process that does not happen automatically but requires several interventions after publication of the Code. Therefore, to ensure implementation of the new Code that is currently being written, national initiatives are needed that stimulate the aforementioned interventions.

For example, changing the contents of the new Code does not help in diminishing researchers' resistance toward an expanding workload caused by (unharmonized) ethics review of study protocols, because the current Code already describes basic principles for ethics review of observational health research. Rather, the government, research financers, and cooperating hospitals may play a role in providing the resources for stimulating national interventions (e.g., discussions, workshops, working groups).

These interventions should lead to practical documents (e.g., flowcharts, checklists, examples of approved protocols), and harmonized review criteria, to actively help hospitals to implement the Code in a harmonized way. The writers of the Code should be involved to ensure that these national interventions lead to practical translations that are in line with the Code.

Limitations and strengths

In our study, hospitals that do not prioritize responsible use of residual biospecimens in research might be under-represented. However, considering the high number of respondents who indicated in the questionnaire that they did not have the knowledge or were not responsible for implementation, we think that we do have sufficient input from this group.

Second, the GDPR came into force during this study, creating awareness of and attention for topics that are considered important by the Code as well (consent, information provision, data protection). The GDPR was therefore considered as a facilitator, as mentioned in the results. Interview respondents sometimes framed barriers as being related to the implementation of the GDPR. However, the barriers and facilitators that they framed as being relevant for implementing the GDPR were often also relevant for implementing the Code, since the topics investigated by this study are similar. Therefore, it is unlikely that this was the main influence for the barriers and facilitators that were mentioned.

Moreover, a broad range of stakeholders were involved in this study. Both academic and nonacademic hospitals contributed, and employees with diverse roles, all involved in a different part of the chain of residual biospecimen use, participated.

Conclusion

In this article, barriers and facilitators for implementing the Dutch Code of Conduct for responsible use of residual biospecimens have been identified. This Code is currently revised, and this study provides grounds for appropriate interventions to foster implementation of the new Code.

This study showed that implementation of the Code is a process that does not happen automatically but requires several interventions after publication of the Code. The government, research financers, and cooperating hospitals should facilitate and stimulate national initiatives to foster harmonization, hospitals (e.g., their review boards, research coordinators, researchers, and DPOs) should participate in these initiatives, create accessible and practical instruments such as checklists and roadmaps, and boards of directors should prioritize responsible use by providing manpower and financial means. The writers of the Code should be involved to ensure that these national interventions lead to a practical translation that is still in line with the Code.

Footnotes

Acknowledgment

The authors thank the questionnaire respondents and interview participants for their contribution.

Author Disclosure Statement

No conflicting financial interests exist.

Funding Information

This study was funded by ZonMw, project no. 20-22600-98-026.

Supplementary Material

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