policy analysis research paper

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Article Contents

• THE ROLE OF POLICY ANALYSIS IN HEALTH PROMOTION
• ORIENTATIONS AND APPROACHES TO POLICY ANALYSIS
• ILLUSTRATIVE EXAMPLES OF RUDIMENTARY THEORY-BASED POLICY ANALYSIS
• AUTHORS’ CONTRIBUTIONS
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A guide to policy analysis as a research method

Jennifer Browne and Brian Coffey are Joint first authors.

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Jennifer Browne, Brian Coffey, Kay Cook, Sarah Meiklejohn, Claire Palermo, A guide to policy analysis as a research method, Health Promotion International , Volume 34, Issue 5, October 2019, Pages 1032–1044, https://doi.org/10.1093/heapro/day052

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Policy analysis provides a way for understanding how and why governments enact certain policies, and their effects. Public health policy research is limited and lacks theoretical underpinnings. This article aims to describe and critique different approaches to policy analysis thus providing direction for undertaking policy analysis in the field of health promotion. Through the use of an illustrative example in nutrition it aims to illustrate the different approaches. Three broad orientations to policy analysis are outlined: (i) Traditional approaches aim to identify the ‘best’ solution, through undertaking objective analyses of possible solutions. (ii) Mainstream approaches focus on the interaction of policy actors in policymaking. (iii) Interpretive approaches examine the framing and representation of problems and how policies reflect the social construction of ‘problems’. Policy analysis may assist understanding of how and why policies to improve nutrition are enacted (or rejected) and may inform practitioners in their advocacy. As such, policy analysis provides researchers with a powerful tool to understand the use of research evidence in policymaking and generate a heightened understanding of the values, interests and political contexts underpinning policy decisions. Such methods may enable more effective advocacy for policies that can lead to improvements in health.

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A guide to policy analysis as a research method

Affiliations.

• 1 Department of Public Health, School of Psychology and Public Health, Latrobe University, Bundoora, Victoria, Australia.
• 2 Department of Global, Urban and Social Studies, RMIT University, 124 La Trobe Street, Melbourne, Victoria, Australia.
• 3 Department of Social Sciences, Faculty of Health, Arts and Design, Swinburne University, 24 Wakefield Street, Hawthorn, Victoria, Australia.
• 4 Department of Nutrition Dietetics and Food, Monash University, Level 1, 264 Ferntree Gully Road, Notting Hill, Victoria, Australia.
• PMID: 30101276
• DOI: 10.1093/heapro/day052

Policy analysis provides a way for understanding how and why governments enact certain policies, and their effects. Public health policy research is limited and lacks theoretical underpinnings. This article aims to describe and critique different approaches to policy analysis thus providing direction for undertaking policy analysis in the field of health promotion. Through the use of an illustrative example in nutrition it aims to illustrate the different approaches. Three broad orientations to policy analysis are outlined: (i) Traditional approaches aim to identify the 'best' solution, through undertaking objective analyses of possible solutions. (ii) Mainstream approaches focus on the interaction of policy actors in policymaking. (iii) Interpretive approaches examine the framing and representation of problems and how policies reflect the social construction of 'problems'. Policy analysis may assist understanding of how and why policies to improve nutrition are enacted (or rejected) and may inform practitioners in their advocacy. As such, policy analysis provides researchers with a powerful tool to understand the use of research evidence in policymaking and generate a heightened understanding of the values, interests and political contexts underpinning policy decisions. Such methods may enable more effective advocacy for policies that can lead to improvements in health.

Keywords: interpretive policy analysis; mainstream policy analysis; nutrition; public health; sugar sweetened beverage tax.

© The Author(s) 2018. Published by Oxford University Press. All rights reserved. For permissions, please email: [email protected].

• Health Policy*
• Health Promotion
• Policy Making*
• Public Health / legislation & jurisprudence
• Public Health Administration
• Public Policy
• Research Design

How to Write a Policy Analysis Paper in 6 Easy Steps (+Examples)

Working on a policy analysis paper is both challenging and fulfilling. In this article, we'll guide you through the process, whether you're new to the field or experienced. Understanding how policies are made, evaluated, and recommended is crucial for making a difference in public discussions and decisions. We'll cover everything from defining your goals to researching thoroughly, analyzing data, and presenting persuasive arguments. By following these steps, you'll be able to communicate your ideas effectively, shape procedure debates, and contribute to positive changes in society. Should you need more hands-on aid with the assignment, hire a college essay writer for the maximum result.

What Is a Policy Analysis Paper

A policy analysis essay definition is a comprehensive examination and evaluation of a particular policy or set of policies within a given context. It involves analyzing the rationale behind the system, its objectives, implementation strategies, and its intended and unintended consequences. This type of paper aims to provide insights into the effectiveness, efficiency, equity, and feasibility of the approach, often considering various perspectives, stakeholders, and alternatives. Through rigorous research, data analysis, and critical reasoning, procedure analysis papers aim to inform decision-makers, scholars, and the public about the strengths and weaknesses of existing policies and propose recommendations for improvement or alternative courses of action.

Haven’t Written a Policy Analysis Paper Before?

Let expert writers guide you through the process!

Policy Analysis Paper Purpose

The purpose of a policy analysis paper is to critically assess a specific procedure or set of policies in order to provide valuable insights into its effectiveness, implications, and potential areas for improvement. By examining the underlying rationale, objectives, and outcomes of the implementation, this type of paper aims to inform decision-makers, stakeholders, and the public about its strengths, weaknesses, and impacts on society. 

Students are writing a policy analysis paper in college for several reasons. Firstly, it allows them to develop critical thinking and analytical skills by evaluating real-world policies and their implications. Additionally, it helps students understand the complexities of policy-making processes and how policies impact various stakeholders. Writing analysis papers also enhances research and writing skills, as students must gather and synthesize information from diverse sources to support their arguments effectively. Furthermore, engaging with procedure analysis fosters civic engagement and social responsibility, encouraging students to contribute to public discourse and advocate for evidence-based solutions. Are you dealing with multiple assignments all at the same time? If you’re about to address the audience, say, ‘ write a speech for me ,’ so our experts can relieve your workload.

Topic Ideas for Policy Analysis Paper

Here’s a collection of 50 thought-provoking policy analysis paper topics for your inspiration. In addition, we’d like to offer you informative essay topics for the purpose of learning and self-education.

• The viability of a universal healthcare system: An analysis.
• Plastic bag bans: Environmental implications examined.
• Tax credits for renewable energy adoption: Assessing effectiveness.
• Social security and raising the retirement age: Exploring implications.
• Implementing a four-day workweek: Feasibility assessment.
• Community policing strategies: Effectiveness in crime reduction.
• Increasing the minimum wage: Consequences evaluated.
• School voucher programs: Impact on educational equity.
• Congestion pricing for urban areas: Benefits and drawbacks analyzed.
• Government subsidies for electric vehicles: Effectiveness assessed.
• Zoning laws and affordable housing availability: An investigation.
• National carbon tax: Feasibility and impact explored.
• Mandatory voting laws: Consequences for political participation.
• Drug rehabilitation programs: Effectiveness in reducing recidivism.
• Legalizing marijuana: Public health implications examined.
• Immigration policies and cultural diversity: Assessing impact.
• Privatizing water utilities: Consequences analyzed.
• Anti-bullying policies in schools: Effectiveness evaluated.
• Free college tuition programs: Benefits and drawbacks assessed.
• Wealth tax implementation: Feasibility analysis.
• Ride-sharing services and traditional taxi industries: Impact assessment.
• Gender quotas in corporate leadership: Effectiveness examined.
• National gun registry: Implications and feasibility explored.
• Expanding nuclear energy production: Consequences evaluated.
• Mandatory parental leave policies: Effectiveness assessment.
• Charter school expansion: Impact on public education explored.
• Basic income implementation: Viability and consequences assessed.
• Affordable housing initiatives: Success factors examined.
• Internet privacy regulations: Impact on data security analyzed.
• Corporate tax breaks: Economic implications assessed.
• Universal preschool programs: Long-term benefits explored.
• Climate change adaptation policies: Effectiveness in resilience building.
• Universal voting by mail: Implications for voter turnout examined.
• Reducing military spending: Consequences and feasibility analyzed.
• Workplace diversity training: Effectiveness in promoting inclusivity.
• Renewable energy subsidies: Impact on energy independence assessed.
• Telecommuting incentives: Feasibility and impact on traffic analyzed.
• Carbon capture and storage initiatives: Viability and effectiveness.
• Local food sourcing policies: Benefits for communities examined.
• Police body camera mandates: Impact on accountability assessed.
• Community land trust programs: Success factors and limitations.
• Mental health parity laws: Effectiveness in improving access.
• Corporate social responsibility regulations: Impact on sustainability.
• Universal pre-kindergarten education: Social and economic benefits.
• Land value tax implementation: Impact on property markets assessed.
• Affordable childcare initiatives: Impact on workforce participation.
• Smart city technology investments: Benefits for urban development.
• Flexible work hour policies: Impact on productivity and well-being.
• Prescription drug pricing regulations: Consequences for affordability.
• Public-private partnerships for infrastructure development: Effectiveness and risks assessed.

If you need more ideas, you may want to consult our guide on argumentative essay topics , which will definitely help kickstart your creativity. 

How to Structure a Policy Analysis Paper

A policy analysis paper format demands organizing your content coherently and logically to effectively communicate your analysis and findings. Here's a typical structure you can follow:

Introduction

• Provide an overview of the issue or problem you're analyzing.
• Clearly state the purpose of your analysis.
• Introduce the policy or policies under review.
• Provide background information to contextualize the issue.
• State your thesis or research question.

Policy Context and Background

• Provide more in-depth background information on the issue.
• Describe the historical development of the policies.
• Discuss the context in which the procedure was implemented.
• Identify key stakeholders and their interests in the strategy.

Policy Analysis Framework

• Explain the framework or methodology you're using to analyze the policy.
• Define key concepts and terms relevant to your analysis.
• Discuss any theoretical frameworks or models guiding your analysis.
• Outline the criteria or criteria you will use to evaluate the procedure's effectiveness.

Policy Goals and Objectives

• Identify and discuss the stated goals and objectives of the policy.
• Evaluate the clarity and coherence of these goals.
• Discuss any potential conflicts or contradictions among the goals.

Policy Implementation

• Describe how the policy has been implemented in practice.
• Discuss any challenges or barriers to implementation.
• Evaluate the effectiveness of implementation strategies.

Policy Outcomes and Impacts

• Assess the outcomes and impacts of the policy.
• Evaluate the extent to which the procedure has achieved its intended goals.
• Discuss any unintended consequences or side effects of the approach.

Policy Alternatives

• Identify and discuss alternative policy options or approaches.
• Evaluate the strengths and weaknesses of each alternative.
• Discuss the potential trade-offs associated with each alternative.

Recommendations

• Based on your analysis, provide recommendations for policymakers.
• Discuss specific actions or changes that could improve the process.
• Justify your recommendations with evidence from your analysis.
• Summarize the main findings of your analysis.
• Restate your thesis or research question.
• Reflect on the broader implications of your analysis.
• Discuss any limitations or areas for further research.
• Provide a list of sources cited in your paper.
• Follow the appropriate citation style (e.g., APA, MLA, Chicago).

Need help with the assignment at this stage? Use our political science essay assistance to save time and secure optimal academic results.

How to Write a Policy Analysis Paper

In this section, we'll cover the basics of writing a policy analysis paper. This type of paper involves breaking down complicated policy issues, figuring out how well they're working, and suggesting ways to make them better. We'll walk you through the steps, like defining the goals of the implementation, looking at how it's being put into action, and checking what effects it's having. By the end, you'll have the skills to write a clear, well-reasoned paper that can help shape policies for the better. 

Understanding the Policy Issue

Start by thoroughly understanding the policy issue or problem you're analyzing. Research its background, context, and significance. Identify key stakeholders, relevant laws or regulations, and any existing policies addressing the issue.

Defining the Scope and Purpose

Clearly define the scope and purpose of your analysis. Determine what specific aspect of the approach you'll focus on and why it's important. Clarify the goals of your analysis and what you hope to achieve with your paper. Use an expert essay writing service to streamline your effort in producing a first-class paper. 

Gathering Data and Evidence

Collect relevant data and evidence to support your analysis. This may include statistical information, case studies, expert opinions, and academic research. Use credible sources and ensure your data is accurate and up-to-date.

Analyzing the Policy

A policy analysis paper evaluates the legislative program’s effectiveness, strengths, weaknesses, and implications. Use a structured approach, such as a SWOT analysis (Strengths, Weaknesses, Opportunities, Threats) or cost-benefit analysis, to assess the procedure from multiple perspectives. Consider its intended goals, implementation strategies, outcomes, and unintended consequences. If you need help with SWOT analysis, using our analytical essay writing service is highly recommended. 

Developing Recommendations

Based on your analysis, develop clear and actionable recommendations for policymakers or stakeholders. Identify specific changes or improvements that could enhance the system’s effectiveness or address its shortcomings. Support your recommendations with evidence and reasoning.

Writing and Communicating Your Analysis

Organize your analysis into a coherent and persuasive paper. Structure your paper with an introduction, background information, analysis, recommendations, and conclusion. Use clear and concise language, avoiding jargon or technical terms unless necessary. Provide citations for your sources and evidence. Finally, ensure your paper is well-written, logically organized, and effectively communicates your insights and recommendations.

Policy Analysis Paper Example

A policy analysis paper example serves as a valuable learning tool for students by providing a concrete model to follow and reference when undertaking their own analysis assignments. By studying an example paper, students can gain insights into the structure, content, and methodology of analysis, helping them understand how to effectively frame their analysis, support their arguments with evidence, and formulate actionable recommendations.

Example 1: “Implementing Universal Basic Income”

This policy analysis paper examines the feasibility and potential impacts of implementing a Universal Basic Income (UBI) program in the United States. It explores various options for UBI design, including cost and financing considerations, labor market effects, poverty reduction potential, and administrative feasibility. By reviewing existing evidence and debates surrounding UBI, the paper aims to provide a comprehensive understanding of the opportunities and challenges associated with adopting such a program, ultimately highlighting the need for careful analysis, experimentation, and stakeholder engagement in shaping effective UBI policies.

Example 2: “Addressing Climate Change through Carbon Pricing”

This policy analysis paper examines the role of carbon pricing policies in addressing climate change, evaluating their efficacy, implementation challenges, and potential impacts. Carbon pricing mechanisms, including carbon taxes and cap-and-trade systems, aim to internalize the external costs of carbon emissions and incentivize emission reductions. The paper discusses the economic efficiency of carbon pricing in promoting innovation and investment in clean technologies while also addressing equity considerations regarding its distributional impacts on low-income households and vulnerable communities.

Writing a policy analysis paper is super important for students because it helps them learn how to tackle tough societal problems and make smart decisions. You get to sharpen your thinking skills, learn how to research thoroughly and become better at expressing yourself clearly. Plus, writing these papers helps students practice effectively communicating their ideas, which is a skill they'll need in their future careers, whether they work in government, nonprofits, or elsewhere. By digging into real-world issues, students also get a better grip on how politics, economics, and society all fit together. If you’re not committed to handling this task yourself, instruct our experts, saying, ‘ write my essay ,’ and receive the most competent help within hours. 

How Short Is Your Deadline?

Use our writing service to submit an A-grade policy analysis paper on time.

What Is a Policy Analysis Paper Outline?

How to write a policy analysis paper, what is a policy analysis paper.

is an expert in nursing and healthcare, with a strong background in history, law, and literature. Holding advanced degrees in nursing and public health, his analytical approach and comprehensive knowledge help students navigate complex topics. On EssayPro blog, Adam provides insightful articles on everything from historical analysis to the intricacies of healthcare policies. In his downtime, he enjoys historical documentaries and volunteering at local clinics.

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• 15 April 2024
• Correction 22 April 2024

Revealed: the ten research papers that policy documents cite most

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When David Autor co-wrote a paper on how computerization affects job skill demands more than 20 years ago, a journal took 18 months to consider it — only to reject it after review. He went on to submit it to The Quarterly Journal of Economics , which eventually published the work 1 in November 2003.

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doi: https://doi.org/10.1038/d41586-024-00660-1

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Correction 22 April 2024 : The original version of this story credited Sage, rather than Overton, as the source of the policy papers’ citation data. Sage’s location has also been updated.

Autor, D. H., Levy, F. & Murnane, R. J. Q. J. Econ. 118 , 1279–1333 (2003).

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Costanza, R. et al. Nature 387 , 253–260 (1997).

Willett, W. et al. Lancet 393 , 447–492 (2019).

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Policy Analysis

You have clearly defined your problem and created a problem statement. Now it’s time to consider the policies that could address it. If you haven’t defined your problem, visit the Problem Identification page.

What is policy analysis?

Policy Analysis is the process of identifying potential policy options that could address your problem and then comparing those options to choose the most effective, efficient, and feasible one.

Why is policy analysis important?

Conducting a policy analysis ensures you have gone through a systematic process to choose the policy option that may be best for your situation.

Who should you involve in your policy analysis?

People who can provide and/or interpret information about the policy

Who they are:

• Subject matter experts
• Community Partners

How they can contribute:

• Provide and interpret information you need for your policy analysis

People affected by the policy

People whose jobs or lives might be affected by the policy

• Community members
• Community partners
• Local decision makers
• Provide contextual knowledge, such as potential social, educational, and cultural perspectives

People who administer resources related to the policy

• Public officials and administrators
• Include these stakeholders during the policy analysis process to help you understand the potential economic and/or budgetary impacts of the policy options being considered. They can also help you understand the legal landscape around the potential policies

You may want assistance from an economist or researcher when complex calculations are needed to determine some impacts.

How do you conduct a policy analysis?

1. Research and identify possible policy options.

You can do this by reviewing research literature, conducting an environmental scan, and surveying best practices to understand what other communities are doing.

2. Describe the possible policy options.

As you conduct your policy analysis, pay attention to the health impact, cost of implementation, and feasibility of each option. To describe these three factors, you can ask yourself and your stakeholders questions such as:

• What population(s) will be affected by each policy option? By how much? And when?
• What is the context around the possible policy options, including political history, environment, and policy debate?
• What are the costs and benefits associated with each policy option from a budgetary perspective?

When you are assessing feasibility, it is important to identify any barriers that could prevent a policy from being developed, enacted, or implemented. A policy might be more feasible in one city or at a certain time, but not others. You might find that as circumstances change, what is considered affordable or publicly acceptable may change with them.

3. Rank the possible policy options and pick the one you think is best.

Compare the policy options for health impact, economic and budgetary impact, and feasibility. Next, rank each one based on those criteria. Stakeholders can provide guidance on how to do this. Your rankings will always be partially subjective, so it helps to systematically document your rationale. In some cases, your review may reveal a clear winner—a policy that is a) feasible, b) has a strong, positive impact on public health, and c) is economically and fiscally viable. In other cases, ranking the options may be more complicated and involve assessing trade-offs.

For example, when considering policies for reducing smoking, there are trade-offs related to feasibility and impact between options. (Feasibility and impact depends on your context, like your location.) You may have to have choose between a more feasible policy (like an indoor smoking ban for restaurants) and one with more widespread impact (like raising prices on tobacco products in your state).

LITERATURE REVIEW: an examination of the current body of research about your policy problem (and can include possible policy options). This kind of review may help you identify what is already known about the policy options as well as any gaps in the current research.

ENVIRONMENTAL SCAN : a proactive, systematic collection of information about events, trends, and expectations of what you might encounter during the policy process.

Learn more – See CDC’s Policy Analysis Worksheet  for more examples of questions you can use in your policy analysis.

• You researched and identified possible policy options with a literature review, environmental scans, and surveys of best practices
• You described possible policy options, including each one’s health impact, cost of implementation, and feasibility
• You ranked each policy option based on health impact, economic and budgetary impact, and feasibility—and then chose the one you think is best for your situation

Policy Analysis: Key Questions : This worksheet provides questions that form a framework for your policy analysis.

Policy Analysis Table : This organizational table can help you assess each policy option against set criteria and then to compare policy options.

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How to Do a Policy Analysis Paper

25 jun 2018.

A policy analysis paper requires students to research in depth an issue of public concern. It can be an issue of ongoing political debate or an issue that has not yet gained the attention of policy makers. A policy analysis defines the problem or issue at hand, describes its background and provides a balanced assessment of options that policy makers could pursue to resolve the problem. The paper should conclude with a recommended course of action for policy makers.

Introduce the problem you wish to research and analyze. Whether the issue is universal health care, improved educational achievement or campaign-finance reform, you should identify a specific issue and articulate why it is important. Establish a set of criteria for resolving the problem in question. For example, an increase in the number of people covered by health insurance represents a criterion for resolving the issue of the uninsured. Improved scores on standardized academic assessments and higher graduation rates from high schools would be criteria for improved achievement in education.

Place the issue in historical context by describing how the problem arose and outlining previous efforts, if any, to address the problem. To detail the issue and any prior policy responses, you can use a range of sources, including books, articles from scholarly journals, previous policy analyses, government reports, legislative materials and news articles. Summarize the results of prior policy efforts and identify the major stakeholders. These are the individuals and groups likely to affect or be affected by new government policies taken in response to the issue under discussion.

Identify a set of policy options government might take to resolve the issue. Be sure the options involve substantive policy measures aimed at the issue in question. This is a policy analysis, not a manifesto outlining broader social, economic or political changes. Your research on the issue and past policy actions will help you identify policy proposals and create new approaches for addressing the identified problem.

Compare the policy alternatives outlined in the previous step, applying the specified criteria. This forms the main body of your policy analysis research paper. Discuss how each alternative would meet the criteria for issue resolution identified in your introduction. Depending on the specific issue and the available data, compare policy alternatives with qualitative and quantitative methods of analysis. Quantitative methods are especially effective in weighing the anticipated costs and benefits of a policy proposal. Consider political factors as well; describe how the stakeholders would be affected by the various policy alternatives.

Recommend a policy action, based on your analysis of a set of alternatives. Articulate reasons, supported by facts and evidence, why the policy proposal you have chosen would be the best avenue from addressing the issue in question.

• Consider a wide range of policy options before settling on a number of policy options to discuss and analyze.
• Brainstorming, research of other policy analyses and writing scenarios will help you locate and formulate policy options for resolving a particular issue.
• 1 University of Texas School of Innovation: Suggestions for Writing Policy Analysis
• 2 Purdue University: Organizing Your Analysis
• 3 University of North Carolina: Policy Brief

About the Author

Shane Hall is a writer and research analyst with more than 20 years of experience. His work has appeared in "Brookings Papers on Education Policy," "Population and Development" and various Texas newspapers. Hall has a Doctor of Philosophy in political economy and is a former college instructor of economics and political science.

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Policy decision-support for inland waterway transport in sustainable urban areas: an analysis of economic viability

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• Published: 16 May 2024

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• Anicia Jaegler   ORCID: orcid.org/0000-0002-3014-4561 1 ,
• Laingo M. Randrianarisoa 1 &
• Hiba Yahyaoui 1  

Many cities have initiated promoting inland waterway transport to serve parcel delivery in urban areas to achieve sustainable transportation. This research aims to identify the key components of an economically viable urban network distribution, where inland waterway transport is deployed as the main transport, and cargo bikes or electric vehicles are used for last-mile delivery. The analysis uses a decision-support framework based on a two-echelon city distribution scheme. Numerical experiments are conducted using near-practical instances in France and inputs from industry stakeholders. From the study, it was found that the economic viability of inland waterways as main transport depends on the number of parcels to be delivered, and the existing infrastructures. The city configurations, their accessibility, as well as their operating conditions are also of utmost importance. The lowest CO 2 equivalent emissions are obtained by combining inland waterways with electric bikes. This paper can be used as decision-making support and guidance for transport companies, industry stakeholders, and public authorities for an efficient and sustainable urban distribution network combining inland waterways and bikes/vans.

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Data availability

The data that support the findings of this study are available on request from the corresponding author, AJ. The data are not publicly available due to confidentiality.

Delay costs are the costs associated with the value of travel time lost relative to a free-flow situation, while the deadweight loss costs is the part of the delay costs that is regarded as a proper basis for transport pricing.

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In practices, the parcels can be sorted either on-board of the barge or at the departure port. In the present framework, we do not make any distinction between these alternatives and consider that the time spent to sort the parcels are the same wherever the sorting location. This allows us to focus on the main operations of IWT and last-mile delivery.

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Conceptualization: AJ, LR, HY; Data curation: HY; Formal analysis: AJ, HY; Funding acquisition: AJ; Investigation: AJ, LR, HY; Methodology: AJ, LR, HY; Project administration: AJ; Resources: AJ, LR, HY; Software: HY; Supervision: AJ, LR; Validation: AJ, LR; Visualization: AJ, LR, HY; Roles/Writing—original draft: AJ, LR, HY; and Writing—review & editing: AJ, LR.

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Jaegler, A., Randrianarisoa, L.M. & Yahyaoui, H. Policy decision-support for inland waterway transport in sustainable urban areas: an analysis of economic viability. Ann Oper Res (2024). https://doi.org/10.1007/s10479-024-06034-0

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Cultural Relativity and Acceptance of Embryonic Stem Cell Research

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There is a debate about the ethical implications of using human embryos in stem cell research, which can be influenced by cultural, moral, and social values. This paper argues for an adaptable framework to accommodate diverse cultural and religious perspectives. By using an adaptive ethics model, research protections can reflect various populations and foster growth in stem cell research possibilities.

INTRODUCTION

Stem cell research combines biology, medicine, and technology, promising to alter health care and the understanding of human development. Yet, ethical contention exists because of individuals’ perceptions of using human embryos based on their various cultural, moral, and social values. While these disagreements concerning policy, use, and general acceptance have prompted the development of an international ethics policy, such a uniform approach can overlook the nuanced ethical landscapes between cultures. With diverse viewpoints in public health, a single global policy, especially one reflecting Western ethics or the ethics prevalent in high-income countries, is impractical. This paper argues for a culturally sensitive, adaptable framework for the use of embryonic stem cells. Stem cell policy should accommodate varying ethical viewpoints and promote an effective global dialogue. With an extension of an ethics model that can adapt to various cultures, we recommend localized guidelines that reflect the moral views of the people those guidelines serve.

Stem cells, characterized by their unique ability to differentiate into various cell types, enable the repair or replacement of damaged tissues. Two primary types of stem cells are somatic stem cells (adult stem cells) and embryonic stem cells. Adult stem cells exist in developed tissues and maintain the body’s repair processes. [1] Embryonic stem cells (ESC) are remarkably pluripotent or versatile, making them valuable in research. [2] However, the use of ESCs has sparked ethics debates. Considering the potential of embryonic stem cells, research guidelines are essential. The International Society for Stem Cell Research (ISSCR) provides international stem cell research guidelines. They call for “public conversations touching on the scientific significance as well as the societal and ethical issues raised by ESC research.” [3] The ISSCR also publishes updates about culturing human embryos 14 days post fertilization, suggesting local policies and regulations should continue to evolve as ESC research develops. [4]  Like the ISSCR, which calls for local law and policy to adapt to developing stem cell research given cultural acceptance, this paper highlights the importance of local social factors such as religion and culture.

I.     Global Cultural Perspective of Embryonic Stem Cells

Views on ESCs vary throughout the world. Some countries readily embrace stem cell research and therapies, while others have stricter regulations due to ethical concerns surrounding embryonic stem cells and when an embryo becomes entitled to moral consideration. The philosophical issue of when the “someone” begins to be a human after fertilization, in the morally relevant sense, [5] impacts when an embryo becomes not just worthy of protection but morally entitled to it. The process of creating embryonic stem cell lines involves the destruction of the embryos for research. [6] Consequently, global engagement in ESC research depends on social-cultural acceptability.

a.     US and Rights-Based Cultures

In the United States, attitudes toward stem cell therapies are diverse. The ethics and social approaches, which value individualism, [7] trigger debates regarding the destruction of human embryos, creating a complex regulatory environment. For example, the 1996 Dickey-Wicker Amendment prohibited federal funding for the creation of embryos for research and the destruction of embryos for “more than allowed for research on fetuses in utero.” [8] Following suit, in 2001, the Bush Administration heavily restricted stem cell lines for research. However, the Stem Cell Research Enhancement Act of 2005 was proposed to help develop ESC research but was ultimately vetoed. [9] Under the Obama administration, in 2009, an executive order lifted restrictions allowing for more development in this field. [10] The flux of research capacity and funding parallels the different cultural perceptions of human dignity of the embryo and how it is socially presented within the country’s research culture. [11]

b.     Ubuntu and Collective Cultures

African bioethics differs from Western individualism because of the different traditions and values. African traditions, as described by individuals from South Africa and supported by some studies in other African countries, including Ghana and Kenya, follow the African moral philosophies of Ubuntu or Botho and Ukama , which “advocates for a form of wholeness that comes through one’s relationship and connectedness with other people in the society,” [12] making autonomy a socially collective concept. In this context, for the community to act autonomously, individuals would come together to decide what is best for the collective. Thus, stem cell research would require examining the value of the research to society as a whole and the use of the embryos as a collective societal resource. If society views the source as part of the collective whole, and opposes using stem cells, compromising the cultural values to pursue research may cause social detachment and stunt research growth. [13] Based on local culture and moral philosophy, the permissibility of stem cell research depends on how embryo, stem cell, and cell line therapies relate to the community as a whole. Ubuntu is the expression of humanness, with the person’s identity drawn from the “’I am because we are’” value. [14] The decision in a collectivistic culture becomes one born of cultural context, and individual decisions give deference to others in the society.

Consent differs in cultures where thought and moral philosophy are based on a collective paradigm. So, applying Western bioethical concepts is unrealistic. For one, Africa is a diverse continent with many countries with different belief systems, access to health care, and reliance on traditional or Western medicines. Where traditional medicine is the primary treatment, the “’restrictive focus on biomedically-related bioethics’” [is] problematic in African contexts because it neglects bioethical issues raised by traditional systems.” [15] No single approach applies in all areas or contexts. Rather than evaluating the permissibility of ESC research according to Western concepts such as the four principles approach, different ethics approaches should prevail.

Another consideration is the socio-economic standing of countries. In parts of South Africa, researchers have not focused heavily on contributing to the stem cell discourse, either because it is not considered health care or a health science priority or because resources are unavailable. [16] Each country’s priorities differ given different social, political, and economic factors. In South Africa, for instance, areas such as maternal mortality, non-communicable diseases, telemedicine, and the strength of health systems need improvement and require more focus [17] Stem cell research could benefit the population, but it also could divert resources from basic medical care. Researchers in South Africa adhere to the National Health Act and Medicines Control Act in South Africa and international guidelines; however, the Act is not strictly enforced, and there is no clear legislation for research conduct or ethical guidelines. [18]

Some parts of Africa condemn stem cell research. For example, 98.2 percent of the Tunisian population is Muslim. [19] Tunisia does not permit stem cell research because of moral conflict with a Fatwa. Religion heavily saturates the regulation and direction of research. [20] Stem cell use became permissible for reproductive purposes only recently, with tight restrictions preventing cells from being used in any research other than procedures concerning ART/IVF.  Their use is conditioned on consent, and available only to married couples. [21] The community's receptiveness to stem cell research depends on including communitarian African ethics.

c.     Asia

Some Asian countries also have a collective model of ethics and decision making. [22] In China, the ethics model promotes a sincere respect for life or human dignity, [23] based on protective medicine. This model, influenced by Traditional Chinese Medicine (TCM), [24] recognizes Qi as the vital energy delivered via the meridians of the body; it connects illness to body systems, the body’s entire constitution, and the universe for a holistic bond of nature, health, and quality of life. [25] Following a protective ethics model, and traditional customs of wholeness, investment in stem cell research is heavily desired for its applications in regenerative therapies, disease modeling, and protective medicines. In a survey of medical students and healthcare practitioners, 30.8 percent considered stem cell research morally unacceptable while 63.5 percent accepted medical research using human embryonic stem cells. Of these individuals, 89.9 percent supported increased funding for stem cell research. [26] The scientific community might not reflect the overall population. From 1997 to 2019, China spent a total of $576 million (USD) on stem cell research at 8,050 stem cell programs, increased published presence from 0.6 percent to 14.01 percent of total global stem cell publications as of 2014, and made significant strides in cell-based therapies for various medical conditions. [27] However, while China has made substantial investments in stem cell research and achieved notable progress in clinical applications, concerns linger regarding ethical oversight and transparency. [28] For example, the China Biosecurity Law, promoted by the National Health Commission and China Hospital Association, attempted to mitigate risks by introducing an institutional review board (IRB) in the regulatory bodies. 5800 IRBs registered with the Chinese Clinical Trial Registry since 2021. [29] However, issues still need to be addressed in implementing effective IRB review and approval procedures.

The substantial government funding and focus on scientific advancement have sometimes overshadowed considerations of regional cultures, ethnic minorities, and individual perspectives, particularly evident during the one-child policy era. As government policy adapts to promote public stability, such as the change from the one-child to the two-child policy, [30] research ethics should also adapt to ensure respect for the values of its represented peoples.

Japan is also relatively supportive of stem cell research and therapies. Japan has a more transparent regulatory framework, allowing for faster approval of regenerative medicine products, which has led to several advanced clinical trials and therapies. [31] South Korea is also actively engaged in stem cell research and has a history of breakthroughs in cloning and embryonic stem cells. [32] However, the field is controversial, and there are issues of scientific integrity. For example, the Korean FDA fast-tracked products for approval, [33] and in another instance, the oocyte source was unclear and possibly violated ethical standards. [34] Trust is important in research, as it builds collaborative foundations between colleagues, trial participant comfort, open-mindedness for complicated and sensitive discussions, and supports regulatory procedures for stakeholders. There is a need to respect the culture’s interest, engagement, and for research and clinical trials to be transparent and have ethical oversight to promote global research discourse and trust.

d.     Middle East

Countries in the Middle East have varying degrees of acceptance of or restrictions to policies related to using embryonic stem cells due to cultural and religious influences. Saudi Arabia has made significant contributions to stem cell research, and conducts research based on international guidelines for ethical conduct and under strict adherence to guidelines in accordance with Islamic principles. Specifically, the Saudi government and people require ESC research to adhere to Sharia law. In addition to umbilical and placental stem cells, [35] Saudi Arabia permits the use of embryonic stem cells as long as they come from miscarriages, therapeutic abortions permissible by Sharia law, or are left over from in vitro fertilization and donated to research. [36] Laws and ethical guidelines for stem cell research allow the development of research institutions such as the King Abdullah International Medical Research Center, which has a cord blood bank and a stem cell registry with nearly 10,000 donors. [37] Such volume and acceptance are due to the ethical ‘permissibility’ of the donor sources, which do not conflict with religious pillars. However, some researchers err on the side of caution, choosing not to use embryos or fetal tissue as they feel it is unethical to do so. [38]

Jordan has a positive research ethics culture. [39] However, there is a significant issue of lack of trust in researchers, with 45.23 percent (38.66 percent agreeing and 6.57 percent strongly agreeing) of Jordanians holding a low level of trust in researchers, compared to 81.34 percent of Jordanians agreeing that they feel safe to participate in a research trial. [40] Safety testifies to the feeling of confidence that adequate measures are in place to protect participants from harm, whereas trust in researchers could represent the confidence in researchers to act in the participants’ best interests, adhere to ethical guidelines, provide accurate information, and respect participants’ rights and dignity. One method to improve trust would be to address communication issues relevant to ESC. Legislation surrounding stem cell research has adopted specific language, especially concerning clarification “between ‘stem cells’ and ‘embryonic stem cells’” in translation. [41] Furthermore, legislation “mandates the creation of a national committee… laying out specific regulations for stem-cell banking in accordance with international standards.” [42] This broad regulation opens the door for future global engagement and maintains transparency. However, these regulations may also constrain the influence of research direction, pace, and accessibility of research outcomes.

e.     Europe

In the European Union (EU), ethics is also principle-based, but the principles of autonomy, dignity, integrity, and vulnerability are interconnected. [43] As such, the opportunity for cohesion and concessions between individuals’ thoughts and ideals allows for a more adaptable ethics model due to the flexible principles that relate to the human experience The EU has put forth a framework in its Convention for the Protection of Human Rights and Dignity of the Human Being allowing member states to take different approaches. Each European state applies these principles to its specific conventions, leading to or reflecting different acceptance levels of stem cell research. [44]

For example, in Germany, Lebenzusammenhang , or the coherence of life, references integrity in the unity of human culture. Namely, the personal sphere “should not be subject to external intervention.” [45]  Stem cell interventions could affect this concept of bodily completeness, leading to heavy restrictions. Under the Grundgesetz, human dignity and the right to life with physical integrity are paramount. [46] The Embryo Protection Act of 1991 made producing cell lines illegal. Cell lines can be imported if approved by the Central Ethics Commission for Stem Cell Research only if they were derived before May 2007. [47] Stem cell research respects the integrity of life for the embryo with heavy specifications and intense oversight. This is vastly different in Finland, where the regulatory bodies find research more permissible in IVF excess, but only up to 14 days after fertilization. [48] Spain’s approach differs still, with a comprehensive regulatory framework. [49] Thus, research regulation can be culture-specific due to variations in applied principles. Diverse cultures call for various approaches to ethical permissibility. [50] Only an adaptive-deliberative model can address the cultural constructions of self and achieve positive, culturally sensitive stem cell research practices. [51]

II.     Religious Perspectives on ESC

Embryonic stem cell sources are the main consideration within religious contexts. While individuals may not regard their own religious texts as authoritative or factual, religion can shape their foundations or perspectives.

The Qur'an states:

“And indeed We created man from a quintessence of clay. Then We placed within him a small quantity of nutfa (sperm to fertilize) in a safe place. Then We have fashioned the nutfa into an ‘alaqa (clinging clot or cell cluster), then We developed the ‘alaqa into mudgha (a lump of flesh), and We made mudgha into bones, and clothed the bones with flesh, then We brought it into being as a new creation. So Blessed is Allah, the Best of Creators.” [52]

Many scholars of Islam estimate the time of soul installment, marked by the angel breathing in the soul to bring the individual into creation, as 120 days from conception. [53] Personhood begins at this point, and the value of life would prohibit research or experimentation that could harm the individual. If the fetus is more than 120 days old, the time ensoulment is interpreted to occur according to Islamic law, abortion is no longer permissible. [54] There are a few opposing opinions about early embryos in Islamic traditions. According to some Islamic theologians, there is no ensoulment of the early embryo, which is the source of stem cells for ESC research. [55]

In Buddhism, the stance on stem cell research is not settled. The main tenets, the prohibition against harming or destroying others (ahimsa) and the pursuit of knowledge (prajña) and compassion (karuna), leave Buddhist scholars and communities divided. [56] Some scholars argue stem cell research is in accordance with the Buddhist tenet of seeking knowledge and ending human suffering. Others feel it violates the principle of not harming others. Finding the balance between these two points relies on the karmic burden of Buddhist morality. In trying to prevent ahimsa towards the embryo, Buddhist scholars suggest that to comply with Buddhist tenets, research cannot be done as the embryo has personhood at the moment of conception and would reincarnate immediately, harming the individual's ability to build their karmic burden. [57] On the other hand, the Bodhisattvas, those considered to be on the path to enlightenment or Nirvana, have given organs and flesh to others to help alleviate grieving and to benefit all. [58] Acceptance varies on applied beliefs and interpretations.

Catholicism does not support embryonic stem cell research, as it entails creation or destruction of human embryos. This destruction conflicts with the belief in the sanctity of life. For example, in the Old Testament, Genesis describes humanity as being created in God’s image and multiplying on the Earth, referencing the sacred rights to human conception and the purpose of development and life. In the Ten Commandments, the tenet that one should not kill has numerous interpretations where killing could mean murder or shedding of the sanctity of life, demonstrating the high value of human personhood. In other books, the theological conception of when life begins is interpreted as in utero, [59] highlighting the inviolability of life and its formation in vivo to make a religious point for accepting such research as relatively limited, if at all. [60] The Vatican has released ethical directives to help apply a theological basis to modern-day conflicts. The Magisterium of the Church states that “unless there is a moral certainty of not causing harm,” experimentation on fetuses, fertilized cells, stem cells, or embryos constitutes a crime. [61] Such procedures would not respect the human person who exists at these stages, according to Catholicism. Damages to the embryo are considered gravely immoral and illicit. [62] Although the Catholic Church officially opposes abortion, surveys demonstrate that many Catholic people hold pro-choice views, whether due to the context of conception, stage of pregnancy, threat to the mother’s life, or for other reasons, demonstrating that practicing members can also accept some but not all tenets. [63]

Some major Jewish denominations, such as the Reform, Conservative, and Reconstructionist movements, are open to supporting ESC use or research as long as it is for saving a life. [64] Within Judaism, the Talmud, or study, gives personhood to the child at birth and emphasizes that life does not begin at conception: [65]

“If she is found pregnant, until the fortieth day it is mere fluid,” [66]

Whereas most religions prioritize the status of human embryos, the Halakah (Jewish religious law) states that to save one life, most other religious laws can be ignored because it is in pursuit of preservation. [67] Stem cell research is accepted due to application of these religious laws.

We recognize that all religions contain subsets and sects. The variety of environmental and cultural differences within religious groups requires further analysis to respect the flexibility of religious thoughts and practices. We make no presumptions that all cultures require notions of autonomy or morality as under the common morality theory , which asserts a set of universal moral norms that all individuals share provides moral reasoning and guides ethical decisions. [68] We only wish to show that the interaction with morality varies between cultures and countries.

III.     A Flexible Ethical Approach

The plurality of different moral approaches described above demonstrates that there can be no universally acceptable uniform law for ESC on a global scale. Instead of developing one standard, flexible ethical applications must be continued. We recommend local guidelines that incorporate important cultural and ethical priorities.

While the Declaration of Helsinki is more relevant to people in clinical trials receiving ESC products, in keeping with the tradition of protections for research subjects, consent of the donor is an ethical requirement for ESC donation in many jurisdictions including the US, Canada, and Europe. [69] The Declaration of Helsinki provides a reference point for regulatory standards and could potentially be used as a universal baseline for obtaining consent prior to gamete or embryo donation.

For instance, in Columbia University’s egg donor program for stem cell research, donors followed standard screening protocols and “underwent counseling sessions that included information as to the purpose of oocyte donation for research, what the oocytes would be used for, the risks and benefits of donation, and process of oocyte stimulation” to ensure transparency for consent. [70] The program helped advance stem cell research and provided clear and safe research methods with paid participants. Though paid participation or covering costs of incidental expenses may not be socially acceptable in every culture or context, [71] and creating embryos for ESC research is illegal in many jurisdictions, Columbia’s program was effective because of the clear and honest communications with donors, IRBs, and related stakeholders.  This example demonstrates that cultural acceptance of scientific research and of the idea that an egg or embryo does not have personhood is likely behind societal acceptance of donating eggs for ESC research. As noted, many countries do not permit the creation of embryos for research.

Proper communication and education regarding the process and purpose of stem cell research may bolster comprehension and garner more acceptance. “Given the sensitive subject material, a complete consent process can support voluntary participation through trust, understanding, and ethical norms from the cultures and morals participants value. This can be hard for researchers entering countries of different socioeconomic stability, with different languages and different societal values. [72]

An adequate moral foundation in medical ethics is derived from the cultural and religious basis that informs knowledge and actions. [73] Understanding local cultural and religious values and their impact on research could help researchers develop humility and promote inclusion.

IV.     Concerns

Some may argue that if researchers all adhere to one ethics standard, protection will be satisfied across all borders, and the global public will trust researchers. However, defining what needs to be protected and how to define such research standards is very specific to the people to which standards are applied. We suggest that applying one uniform guide cannot accurately protect each individual because we all possess our own perceptions and interpretations of social values. [74] Therefore, the issue of not adjusting to the moral pluralism between peoples in applying one standard of ethics can be resolved by building out ethics models that can be adapted to different cultures and religions.

Other concerns include medical tourism, which may promote health inequities. [75] Some countries may develop and approve products derived from ESC research before others, compromising research ethics or drug approval processes. There are also concerns about the sale of unauthorized stem cell treatments, for example, those without FDA approval in the United States. Countries with robust research infrastructures may be tempted to attract medical tourists, and some customers will have false hopes based on aggressive publicity of unproven treatments. [76]

For example, in China, stem cell clinics can market to foreign clients who are not protected under the regulatory regimes. Companies employ a marketing strategy of “ethically friendly” therapies. Specifically, in the case of Beike, China’s leading stem cell tourism company and sprouting network, ethical oversight of administrators or health bureaus at one site has “the unintended consequence of shifting questionable activities to another node in Beike's diffuse network.” [77] In contrast, Jordan is aware of stem cell research’s potential abuse and its own status as a “health-care hub.” Jordan’s expanded regulations include preserving the interests of individuals in clinical trials and banning private companies from ESC research to preserve transparency and the integrity of research practices. [78]

The social priorities of the community are also a concern. The ISSCR explicitly states that guidelines “should be periodically revised to accommodate scientific advances, new challenges, and evolving social priorities.” [79] The adaptable ethics model extends this consideration further by addressing whether research is warranted given the varying degrees of socioeconomic conditions, political stability, and healthcare accessibilities and limitations. An ethical approach would require discussion about resource allocation and appropriate distribution of funds. [80]

While some religions emphasize the sanctity of life from conception, which may lead to public opposition to ESC research, others encourage ESC research due to its potential for healing and alleviating human pain. Many countries have special regulations that balance local views on embryonic personhood, the benefits of research as individual or societal goods, and the protection of human research subjects. To foster understanding and constructive dialogue, global policy frameworks should prioritize the protection of universal human rights, transparency, and informed consent. In addition to these foundational global policies, we recommend tailoring local guidelines to reflect the diverse cultural and religious perspectives of the populations they govern. Ethics models should be adapted to local populations to effectively establish research protections, growth, and possibilities of stem cell research.

For example, in countries with strong beliefs in the moral sanctity of embryos or heavy religious restrictions, an adaptive model can allow for discussion instead of immediate rejection. In countries with limited individual rights and voice in science policy, an adaptive model ensures cultural, moral, and religious views are taken into consideration, thereby building social inclusion. While this ethical consideration by the government may not give a complete voice to every individual, it will help balance policies and maintain the diverse perspectives of those it affects. Embracing an adaptive ethics model of ESC research promotes open-minded dialogue and respect for the importance of human belief and tradition. By actively engaging with cultural and religious values, researchers can better handle disagreements and promote ethical research practices that benefit each society.

This brief exploration of the religious and cultural differences that impact ESC research reveals the nuances of relative ethics and highlights a need for local policymakers to apply a more intense adaptive model.

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[5] Concerning the moral philosophies of stem cell research, our paper does not posit a personal moral stance nor delve into the “when” of human life begins. To read further about the philosophical debate, consider the following sources:

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[7] Socially, at its core, the Western approach to ethics is widely principle-based, autonomy being one of the key factors to ensure a fundamental respect for persons within research. For information regarding autonomy in research, see: Department of Health, Education, and Welfare, & National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1978). The Belmont Report. Ethical principles and guidelines for the protection of human subjects of research.; For a more in-depth review of autonomy within the US, see: Beauchamp, T. L., & Childress, J. F. (1994). Principles of Biomedical Ethics . Oxford University Press.

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[9] Stem Cell Research Enhancement Act of 2005, H. R. 810, 109 th Cong. (2001). https://www.govtrack.us/congress/bills/109/hr810/text ; Bush, G. W. (2006, July 19). Message to the House of Representatives . National Archives and Records Administration. https://georgewbush-whitehouse.archives.gov/news/releases/2006/07/20060719-5.html

[10] National Archives and Records Administration. (2009, March 9). Executive order 13505 -- removing barriers to responsible scientific research involving human stem cells . National Archives and Records Administration. https://obamawhitehouse.archives.gov/the-press-office/removing-barriers-responsible-scientific-research-involving-human-stem-cells

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[13] Source for further reading: Tangwa G. B. (2007). Moral status of embryonic stem cells: perspective of an African villager. Bioethics , 21(8), 449–457. https://doi.org/10.1111/j.1467-8519.2007.00582.x , see also Mnisi, F. M. (2020). An African analysis based on ethics of Ubuntu - are human embryonic stem cell patents morally justifiable? African Insight , 49 (4).

[14] Jecker, N. S., & Atuire, C. (2021). Bioethics in Africa: A contextually enlightened analysis of three cases. Developing World Bioethics , 22 (2), 112–122. https://doi.org/10.1111/dewb.12324

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[18] Oosthuizen, H. (2013). Legal and Ethical Issues in Stem Cell Research in South Africa. In: Beran, R. (eds) Legal and Forensic Medicine. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-32338-6_80 , see also: Gaobotse G (2018) Stem Cell Research in Africa: Legislation and Challenges. J Regen Med 7:1. doi: 10.4172/2325-9620.1000142

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[21] Kooli, C. Review of assisted reproduction techniques, laws, and regulations in Muslim countries.  Middle East Fertil Soc J   24 , 8 (2020). https://doi.org/10.1186/s43043-019-0011-0 ; Gaobotse, G. (2018) Stem Cell Research in Africa: Legislation and Challenges. J Regen Med 7:1. doi: 10.4172/2325-9620.1000142

[22] Pang M. C. (1999). Protective truthfulness: the Chinese way of safeguarding patients in informed treatment decisions. Journal of medical ethics , 25(3), 247–253. https://doi.org/10.1136/jme.25.3.247

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[36] Association for the Advancement of Blood and Biotherapies.  https://www.aabb.org/regulatory-and-advocacy/regulatory-affairs/regulatory-for-cellular-therapies/international-competent-authorities/saudi-arabia

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Culturally, autonomy practices follow a relational autonomy approach based on a paternalistic deontological health care model. The adherence to strict international research policies and religious pillars within the regulatory environment is a great foundation for research ethics. However, there is a need to develop locally targeted ethics approaches for research (as called for in Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: interviews with researchers from Saudi Arabia. BMC medical ethics, 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6), this decision-making approach may help advise a research decision model. For more on the clinical cultural autonomy approaches, see: Alabdullah, Y. Y., Alzaid, E., Alsaad, S., Alamri, T., Alolayan, S. W., Bah, S., & Aljoudi, A. S. (2022). Autonomy and paternalism in Shared decision‐making in a Saudi Arabian tertiary hospital: A cross‐sectional study. Developing World Bioethics , 23 (3), 260–268. https://doi.org/10.1111/dewb.12355 ; Bukhari, A. A. (2017). Universal Principles of Bioethics and Patient Rights in Saudi Arabia (Doctoral dissertation, Duquesne University). https://dsc.duq.edu/etd/124; Ladha, S., Nakshawani, S. A., Alzaidy, A., & Tarab, B. (2023, October 26). Islam and Bioethics: What We All Need to Know . Columbia University School of Professional Studies. https://sps.columbia.edu/events/islam-and-bioethics-what-we-all-need-know

[39] Ababneh, M. A., Al-Azzam, S. I., Alzoubi, K., Rababa’h, A., & Al Demour, S. (2021). Understanding and attitudes of the Jordanian public about clinical research ethics.  Research Ethics ,  17 (2), 228-241.  https://doi.org/10.1177/1747016120966779

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[43] The EU’s definition of autonomy relates to the capacity for creating ideas, moral insight, decisions, and actions without constraint, personal responsibility, and informed consent. However, the EU views autonomy as not completely able to protect individuals and depends on other principles, such as dignity, which “expresses the intrinsic worth and fundamental equality of all human beings.” Rendtorff, J.D., Kemp, P. (2019). Four Ethical Principles in European Bioethics and Biolaw: Autonomy, Dignity, Integrity and Vulnerability. In: Valdés, E., Lecaros, J. (eds) Biolaw and Policy in the Twenty-First Century. International Library of Ethics, Law, and the New Medicine, vol 78. Springer, Cham. https://doi.org/10.1007/978-3-030-05903-3_3

[44] Council of Europe. Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (ETS No. 164) https://www.coe.int/en/web/conventions/full-list?module=treaty-detail&treatynum=164 (forbidding the creation of embryos for research purposes only, and suggests embryos in vitro have protections.); Also see Drabiak-Syed B. K. (2013). New President, New Human Embryonic Stem Cell Research Policy: Comparative International Perspectives and Embryonic Stem Cell Research Laws in France.  Biotechnology Law Report ,  32 (6), 349–356. https://doi.org/10.1089/blr.2013.9865

[45] Rendtorff, J.D., Kemp, P. (2019). Four Ethical Principles in European Bioethics and Biolaw: Autonomy, Dignity, Integrity and Vulnerability. In: Valdés, E., Lecaros, J. (eds) Biolaw and Policy in the Twenty-First Century. International Library of Ethics, Law, and the New Medicine, vol 78. Springer, Cham. https://doi.org/10.1007/978-3-030-05903-3_3

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[47] Regulation of Stem Cell Research in Germany . Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-germany

[48] Regulation of Stem Cell Research in Finland . Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-finland

[49] Regulation of Stem Cell Research in Spain . Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-spain

[50] Some sources to consider regarding ethics models or regulatory oversights of other cultures not covered:

Kara MA. Applicability of the principle of respect for autonomy: the perspective of Turkey. J Med Ethics. 2007 Nov;33(11):627-30. doi: 10.1136/jme.2006.017400. PMID: 17971462; PMCID: PMC2598110.

Ugarte, O. N., & Acioly, M. A. (2014). The principle of autonomy in Brazil: one needs to discuss it ...  Revista do Colegio Brasileiro de Cirurgioes ,  41 (5), 374–377. https://doi.org/10.1590/0100-69912014005013

Bharadwaj, A., & Glasner, P. E. (2012). Local cells, global science: The rise of embryonic stem cell research in India . Routledge.

For further research on specific European countries regarding ethical and regulatory framework, we recommend this database: Regulation of Stem Cell Research in Europe . Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-europe   

[51] Klitzman, R. (2006). Complications of culture in obtaining informed consent. The American Journal of Bioethics, 6(1), 20–21. https://doi.org/10.1080/15265160500394671 see also: Ekmekci, P. E., & Arda, B. (2017). Interculturalism and Informed Consent: Respecting Cultural Differences without Breaching Human Rights.  Cultura (Iasi, Romania) ,  14 (2), 159–172.; For why trust is important in research, see also: Gray, B., Hilder, J., Macdonald, L., Tester, R., Dowell, A., & Stubbe, M. (2017). Are research ethics guidelines culturally competent?  Research Ethics ,  13 (1), 23-41.  https://doi.org/10.1177/1747016116650235

[52] The Qur'an  (M. Khattab, Trans.). (1965). Al-Mu’minun, 23: 12-14. https://quran.com/23

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[54] Aksoy, S. (2005). Making regulations and drawing up legislation in Islamic countries under conditions of uncertainty, with special reference to embryonic stem cell research. Journal of Medical Ethics , 31: 399-403.; see also: Mahmoud, Azza. "Islamic Bioethics: National Regulations and Guidelines of Human Stem Cell Research in the Muslim World." Master's thesis, Chapman University, 2022. https://doi.org/10.36837/ chapman.000386

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[57] Jafari, M., Elahi, F., Ozyurt, S. & Wrigley, T. (2007). 4. Religious Perspectives on Embryonic Stem Cell Research. In K. Monroe, R. Miller & J. Tobis (Ed.),  Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical, and Political Issues  (pp. 79-94). Berkeley: University of California Press.  https://escholarship.org/content/qt9rj0k7s3/qt9rj0k7s3_noSplash_f9aca2e02c3777c7fb76ea768ba458f0.pdf https://doi.org/10.1525/9780520940994-005

[58] Lecso, P. A. (1991). The Bodhisattva Ideal and Organ Transplantation.  Journal of Religion and Health ,  30 (1), 35–41. http://www.jstor.org/stable/27510629 ; Bodhisattva, S. (n.d.). The Key of Becoming a Bodhisattva . A Guide to the Bodhisattva Way of Life. http://www.buddhism.org/Sutras/2/BodhisattvaWay.htm

[59] There is no explicit religious reference to when life begins or how to conduct research that interacts with the concept of life. However, these are relevant verses pertaining to how the fetus is viewed. (( King James Bible . (1999). Oxford University Press. (original work published 1769))

Jerimiah 1: 5 “Before I formed thee in the belly I knew thee; and before thou camest forth out of the womb I sanctified thee…”

In prophet Jerimiah’s insight, God set him apart as a person known before childbirth, a theme carried within the Psalm of David.

Psalm 139: 13-14 “…Thou hast covered me in my mother's womb. I will praise thee; for I am fearfully and wonderfully made…”

These verses demonstrate David’s respect for God as an entity that would know of all man’s thoughts and doings even before birth.

[60] It should be noted that abortion is not supported as well.

[61] The Vatican. (1987, February 22). Instruction on Respect for Human Life in Its Origin and on the Dignity of Procreation Replies to Certain Questions of the Day . Congregation For the Doctrine of the Faith. https://www.vatican.va/roman_curia/congregations/cfaith/documents/rc_con_cfaith_doc_19870222_respect-for-human-life_en.html

[62] The Vatican. (2000, August 25). Declaration On the Production and the Scientific and Therapeutic Use of Human Embryonic Stem Cells . Pontifical Academy for Life. https://www.vatican.va/roman_curia/pontifical_academies/acdlife/documents/rc_pa_acdlife_doc_20000824_cellule-staminali_en.html ; Ohara, N. (2003). Ethical Consideration of Experimentation Using Living Human Embryos: The Catholic Church’s Position on Human Embryonic Stem Cell Research and Human Cloning. Department of Obstetrics and Gynecology . Retrieved from https://article.imrpress.com/journal/CEOG/30/2-3/pii/2003018/77-81.pdf.

[63] Smith, G. A. (2022, May 23). Like Americans overall, Catholics vary in their abortion views, with regular mass attenders most opposed . Pew Research Center. https://www.pewresearch.org/short-reads/2022/05/23/like-americans-overall-catholics-vary-in-their-abortion-views-with-regular-mass-attenders-most-opposed/

[64] Rosner, F., & Reichman, E. (2002). Embryonic stem cell research in Jewish law. Journal of halacha and contemporary society , (43), 49–68.; Jafari, M., Elahi, F., Ozyurt, S. & Wrigley, T. (2007). 4. Religious Perspectives on Embryonic Stem Cell Research. In K. Monroe, R. Miller & J. Tobis (Ed.),  Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical, and Political Issues  (pp. 79-94). Berkeley: University of California Press.  https://escholarship.org/content/qt9rj0k7s3/qt9rj0k7s3_noSplash_f9aca2e02c3777c7fb76ea768ba458f0.pdf https://doi.org/10.1525/9780520940994-005

[65] Schenker J. G. (2008). The beginning of human life: status of embryo. Perspectives in Halakha (Jewish Religious Law).  Journal of assisted reproduction and genetics ,  25 (6), 271–276. https://doi.org/10.1007/s10815-008-9221-6

[66] Ruttenberg, D. (2020, May 5). The Torah of Abortion Justice (annotated source sheet) . Sefaria. https://www.sefaria.org/sheets/234926.7?lang=bi&with=all&lang2=en

[67] Jafari, M., Elahi, F., Ozyurt, S. & Wrigley, T. (2007). 4. Religious Perspectives on Embryonic Stem Cell Research. In K. Monroe, R. Miller & J. Tobis (Ed.),  Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical, and Political Issues  (pp. 79-94). Berkeley: University of California Press.  https://escholarship.org/content/qt9rj0k7s3/qt9rj0k7s3_noSplash_f9aca2e02c3777c7fb76ea768ba458f0.pdf https://doi.org/10.1525/9780520940994-005

[68] Gert, B. (2007). Common morality: Deciding what to do . Oxford Univ. Press.

[69] World Medical Association (2013). World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA , 310(20), 2191–2194. https://doi.org/10.1001/jama.2013.281053 Declaration of Helsinki – WMA – The World Medical Association .; see also: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979).  The Belmont report: Ethical principles and guidelines for the protection of human subjects of research . U.S. Department of Health and Human Services.  https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html

[70] Zakarin Safier, L., Gumer, A., Kline, M., Egli, D., & Sauer, M. V. (2018). Compensating human subjects providing oocytes for stem cell research: 9-year experience and outcomes.  Journal of assisted reproduction and genetics ,  35 (7), 1219–1225. https://doi.org/10.1007/s10815-018-1171-z https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6063839/ see also: Riordan, N. H., & Paz Rodríguez, J. (2021). Addressing concerns regarding associated costs, transparency, and integrity of research in recent stem cell trial. Stem Cells Translational Medicine , 10 (12), 1715–1716. https://doi.org/10.1002/sctm.21-0234

[71] Klitzman, R., & Sauer, M. V. (2009). Payment of egg donors in stem cell research in the USA.  Reproductive biomedicine online ,  18 (5), 603–608. https://doi.org/10.1016/s1472-6483(10)60002-8

[72] Krosin, M. T., Klitzman, R., Levin, B., Cheng, J., & Ranney, M. L. (2006). Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa.  Clinical trials (London, England) ,  3 (3), 306–313. https://doi.org/10.1191/1740774506cn150oa

[73] Veatch, Robert M.  Hippocratic, Religious, and Secular Medical Ethics: The Points of Conflict . Georgetown University Press, 2012.

[74] Msoroka, M. S., & Amundsen, D. (2018). One size fits not quite all: Universal research ethics with diversity.  Research Ethics ,  14 (3), 1-17.  https://doi.org/10.1177/1747016117739939

[75] Pirzada, N. (2022). The Expansion of Turkey’s Medical Tourism Industry.  Voices in Bioethics ,  8 . https://doi.org/10.52214/vib.v8i.9894

[76] Stem Cell Tourism: False Hope for Real Money . Harvard Stem Cell Institute (HSCI). (2023). https://hsci.harvard.edu/stem-cell-tourism , See also: Bissassar, M. (2017). Transnational Stem Cell Tourism: An ethical analysis.  Voices in Bioethics ,  3 . https://doi.org/10.7916/vib.v3i.6027

[77] Song, P. (2011) The proliferation of stem cell therapies in post-Mao China: problematizing ethical regulation,  New Genetics and Society , 30:2, 141-153, DOI:  10.1080/14636778.2011.574375

[78] Dajani, R. (2014). Jordan’s stem-cell law can guide the Middle East.  Nature  510, 189. https://doi.org/10.1038/510189a

[79] International Society for Stem Cell Research. (2024). Standards in stem cell research . International Society for Stem Cell Research. https://www.isscr.org/guidelines/5-standards-in-stem-cell-research

[80] Benjamin, R. (2013). People’s science bodies and rights on the Stem Cell Frontier . Stanford University Press.

Mifrah Hayath

SM Candidate Harvard Medical School, MS Biotechnology Johns Hopkins University

Olivia Bowers

MS Bioethics Columbia University (Disclosure: affiliated with Voices in Bioethics)

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