QR codes and international databases: promoting transparency in IRB approvals for medical research

KEYWORDS:

• Approval integrity
• clinical transparency
• compliance
• digital verification
• ethical oversight
• participant safety
• research ethics
• violation

1. Introduction

With over 10,000 articles retracted in 2023, research misconduct once again set a grim record [1]. The causes are manifold, but those tied to ‘ethical violations’ such as falsifying institutional review board (IRB) approvals, account for 2% [2]. These transgressions are particularly severe as they jeopardize the credibility and reliability of scientific discoveries [3–5], potentially exposing participants to harm from unauthorized interventions [3–5]. The consequences of falsifying IRB documents go beyond the scientific field, involving potential retractions of published works, damaged reputations for researchers and organizations, and possibly legal repercussions [3–7]. In light of the increasing number of retracted manuscripts due to research misconduct and ethical violations, there is a growing recognition of the need to address various gaps in scholarly understanding [8]. The gaps include a lack of comprehensive strategies to detect and prevent IRB approval falsification, insufficient awareness and training on research ethics among researchers, and the absence of robust systems to verify the authenticity of IRB approvals [8].

This editorial aimed to address the aforementioned gaps and advance scholarly understanding by examining the underlying causes, and potential solutions for IRB approval falsification in medical research.

2. Exploring IRB falsification and its root causes

IRB falsifications typically involve the intentional fabrication of false IRB approvals, often manifesting as the creation of counterfeit acceptance codes without providing requisite documentation or ethical oversight [4]. Additionally, misconduct may entail the unauthorized use of a single IRB approval for multiple studies [4,5].

To address the issue of unethical research conduct, we used an approach based on the “precede-proceed” planning model commonly used in public health and other fields to guide the development, implementation, and evaluation of health promotion and other intervention programs [9]. The first is the “precede” phase, which focuses on assessing factors that influence behaviors and identifying the predisposing, enabling, and reinforcing factors. The second is the “proceed” phase, which involves planning, implementing, and evaluating interventions based on the findings from the “precede” phase.

2.1. Social and epidemiological assessment (“precede” phase)

Although falsification of IRB approvals is less prevalent than some other types of ethical misconduct, such as data fabrication and plagiarism, it still poses significant risks to the integrity of scientific research [10]. As we stated before, the current state of awareness and understanding of research ethics among researchers, reviewers, and IRB members may reflect enlarging deviations. The existing discrepancies in training programs and resources available acting like barriers or facilitators to effective education and empowerment in research ethics, could afford intervention targets.

2.2. Behavioral and environmental assessment (“precede” phase)

2.2.1. Predisposing factors

The pervasive pressure of the ‘publish-or-perish culture’ prevalent in academic environments, may encourage unethical behaviour. Despite the pressure to publish ‘positive’ results, intense competition for funding, and potential career anxieties, researchers must adhere to the highest ethical standards to ensure the integrity and credibility of their work. It is crucial to foster an environment that supports ethical research practices and prioritizes the quality and honesty of scientific findings over the mere quantity of publications.

While insufficient awareness and education concerning research ethics and its legal ramifications can exacerbate some forms of ethical misconduct, it should be noted that falsification of IRB approval is typically a deliberate act and not merely a result of inadequate education or awareness [4,11].

2.2.2. Enabling factors

These include the inadequate oversight and accountability within IRB committees, stemming from resource constraints, limited communication with researchers, and a lack of clear consensus-driven guidelines [4,11].

2.2.3. Reinforcing factors

These include social norms, motivations, and consequences that either encourage or discourage ethical behavior in research.

3. Proposing solutions for policy, community, and education

Although focusing on predisposing and positive enabling factors is preferable, there are instances where repressive measures might need to be employed. This could involve implementing short-term, efficient measures to promptly modify behaviour while simultaneously working on long-term solutions that target predisposing factors.

3.1. Administrative and policy assessment (“proceed” phase): quick-response (QR) codes for IRB approvals

QR codes, two-dimensional barcodes accessible to all and easily scanned by smartphones or tablets, offer a universally recognized and user-friendly tool [12]. We propose the implementation of unique QR codes for all IRB-approved research studies. These QR codes would be prominently displayed on consent forms and other pertinent study documents. Participants and stakeholders could simply scan the code to access a secure website or online portal housing the complete IRB-approved protocol, including any amendments or modifications.

This system offers numerous advantages. Firstly, it would significantly enhance the transparency of the IRB review process by providing easy access to comprehensive information about the study, including the IRB’s assessment of its risks and benefits. Secondly, it would serve as a powerful preventive measure against falsifying IRB approvals. Any attempt at falsification would be swiftly exposed, as the QR code would link directly to the authentic IRB-approved protocol, leaving no room for cheating. Implementing QR codes for IRB approvals represents a practical and effective step toward ensuring the integrity and credibility of medical research.

3.2. Community interventions: international IRB database proposal

Drawing parallels to the successes of international databases such as ClinicalTrials.gov (https://clinicaltrials.gov) and PROSPERO (https://www.crd.york.ac.uk/prospero/) in fostering transparency within clinical trials and systematic reviews, an international IRB database would serve as a centralized hub for researchers, participants, and regulatory bodies to access vital information regarding IRB-approved research studies. This platform would empower researchers to identify reputable IRBs, enable participants to make informed decisions about study participation, and allow regulatory bodies to monitor IRB activities more efficiently.

For instance, imagine a researcher planning a clinical trial in a developing nation. By utilizing the international IRB database, they could pinpoint a trustworthy IRB within that country, possessing expertise in the relevant research domain. This would ensure that the study undergoes review by a qualified and experienced IRB, thereby elevating the ethical and scientific standards of the research. Similarly, prospective participants expecting involvement in a clinical trial could use the database to gather insights into the study and the endorsing IRB. Equipped with this knowledge, individuals can make informed choices about their involvement, based on the IRB’s assessment of the study’s possible risks and benefits.

Moreover, the international IRB database would facilitate the exchange of best practices and the standardization of IRB review procedures across different nations. The database has the potential to improve the quality and uniformity of IRB evaluations worldwide through offering a platform for IRBs to exchange their ideas and experience.

This collective effort would eventually benefit researchers, participants, and the broader public by ensuring that research adheres to the highest ethical principles and standards.

The implementation of QR codes for IRB approvals and the establishment of an international IRB database would generate numerous practical implications (Table 1).

Table 1. Practical implications of quick-response (QR) codes and institutional review board (IRB) database.

Implication	Description
Increased transparency	Participants and stakeholders would have effortless access to information regarding IRB-approved research studies.
Reduced risk of falsified approvals	The QR code links directly to the authentic IRB-approved protocol, thus unveiling any attempts at falsification.
Improved accountability	IRBs would be held more accountable for their decisions. Researchers could easily search for IRB-approved studies within their field of research. Participants and stakeholders could search for studies they are considering participating in.
Increased efficiency	Researchers could utilize the database to identify reputable IRB institutions with a proven track record of approving high-quality research studies.
Approved scientific Integrity	Ensuring the safeguarding of research participants and upholding the integrity of scientific inquiry is of the highest priority, as it directly translates to safeguarding the confidence and reliance of the general public.

3.3. Education and empowerment

In contrast to the preceding phase, which tended towards immediate punitive actions, this strategy targeting predisposing factors, emphasises the importance of exploration and recognizes that outcomes may require a significant passage of time. These initiatives aim to do more than just providing information; they are about empowering stakeholders by giving them the practical tools and understanding required to effectively tackle ethical challenges.

3.4. Implementation and evaluation

Key measures include utilizing solutions drawn from the “precede” framework and engaging researchers, academic institutions, financial resources, and professional organizations in the implementation process. The evaluation phase is designed to gauge the influence of these initiatives and to analyse the effectiveness of interventions in the reduction of unethical practices and cultivating a climate of research integrity. Overall, this strategy places a premium on sustained investment in educational purposes and cultural transformation, with the objective of achieving enduring enhancements in research ethics.

4. Future research directions on QR codes and international databases: enhancing transparency in IRB approvals for medical research

Future research must address several crucial areas to enhance the transparency of IRB approvals using QR codes and international databases.

4.1. Potential impediments to QR code implementation

One of the primary research areas is to explore the potential barriers to the implementation of QR codes in medical research. This includes understanding technological, logistical, and regulatory challenges. Additionally, it is important to consider whether academic journals can play a significant role in facilitating the adoption of QR codes, thereby ensuring that IRB approvals are easily accessible and verifiable.

4.2. Possible resistance to an international database of IRB approvals

Another critical area of focus is the potential resistance to establishing an international database of IRB approvals. Researchers must investigate the reasons behind any reluctance, whether it be due to privacy concerns, data security issues, or administrative burdens. Understanding these factors is essential to developing strategies that can address and mitigate such resistance.

4.3. Alternative approaches to verifying IRB approvals

Besides QR codes, exploring other methods to verify the authenticity of IRB approvals is paramount. One promising approach could be the use of digital signatures with certificates issued by authorized certificate authorities. This method ensures the authenticity of IRB approvals without requiring reviewers or journal staff to access detailed IRB documentation. It can offers a cost-effective solution that requires minimal training for research entities and imposes no additional burden on editors or reviewers. This approach aligns with the manuscript’s objective of finding potential solutions for IRB approval falsification.

By addressing these key areas, future research can contribute to developing robust mechanisms that enhance transparency and integrity in medical research, ensuring that IRB approvals are genuine and verifiable.

5. Conclusion

Confronted with the challenge of IRB falsification, it is our responsibility as researchers to hunt solutions that uphold scientific integrity. We firmly advocate for the adoption of QR codes for IRB approvals and the creation of an international IRB database as crucial measures to fortify the integrity of the IRB review process.

Authors’ contributions

LBE, ID, and HBS: initiated the drafting of the manuscript.

LBE, ID, MG, EE, MB, and HBS: played key roles in critically revising the content for significant intellectual substance.

All the authors approved the final form of this manuscript.

Declaration

In order to correct and improve the academic writing of some sentences of this editorial, we have used the language model ChatGPT 4.0 [13].

Disclosure statement

No potential conflict of interest was reported by the author(s).

Data availability statement

The data that support the findings of this study are openly available upon request from the corresponding author.

Additional information

Funding

The author(s) reported there is no funding associated with the work featured in this article.