Designing a National Charter for Fetal Rights in Iran: A Mixed-Methods Policy Study Protocol

Designing a National Charter for Fetal Rights in Iran: A Mixed-Methods Policy Study Protocol | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Study protocol Designing a National Charter for Fetal Rights in Iran: A Mixed-Methods Policy Study Protocol Sepideh Panjalipour Kakrodi, Shirin Shahbazi Sighaldeh, Mohamad Ali Mosadeghrad, and 1 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7092827/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background: While fetal rights in Iran have primarily been addressed through criminal law perspectives, their health dimensions remain significantly overlooked. Current research indicates no comprehensive charter exists to safeguard these rights systematically. This study aims to bridge this gap by developing Iran’s first national fetal rights charter, integrating health and legal frameworks. "The study received ethical approval from Tehran University of Medical Sciences (IR.TUMS.FNM.REC.1403.014) Methods: Employing a mixed-methods design, the study unfolds across four phases: Qualitative interviews with policymakers, healthcare providers, and legal experts to explore contextual perspectives on fetal rights. Scoping review of international fetal rights frameworks to identify transferable policies and gaps. Charter drafting synthesizing findings from Phases 1–2, followed by validation via Delphi consensus (3 rounds). Policy translation through a stakeholder-oriented brief to guide implementation. Discussion: The study will critically examine: Phase 1–2 findings on Iran’s fetal rights landscape and global benchmarks. How the synthesized charter addresses Iran’s unique sociolegal context. Practical implications for healthcare and legal systems, alongside future research priorities. Fetal rights Health policy Charter development Mixed-methods research Iran Figures Figure 1 Figure 2 Introduction In recent years, fetal rights have become a topic of great interest in the world (1). According to existing texts, the rights of the fetus are divided into the right to life, the right to health, and rights related to the fetal and childbirth period (2). The right to life and the right to health are the most fundamental human rights and the natural rights of every human being (3). Natural rights are rights that are not bound by the laws and customs of any particular culture or government and are undeniable (4). Every human being, regardless of their location, whether in the womb or outside, deserves the basic right to life, including the right to life and freedom (1). Among the important behaviors caused by the lack of attention to fetal rights are induced abortions (5). On average, 121 million unintended pregnancies occur annually in the world, of which 73 million (61%) lead to induced abortion (6). 45% of induced abortions occur under unsafe conditions, 97% of which occur in developing countries (7). According to Article 56 of the Family and Youth Protection Law of Iran (2021), induced therapeutic abortion is allowed up to 19 weeks’ gestation when continuing the pregnancy is life-threatening for the mother or in cases of fetal disease, including retardation or imperfection of the fetus. However, other cases such as maternal addiction, pregnancy resulting from incest (8), or fetal injuries caused by negligence or domestic violence (9) are not included. While some developed countries criminalize fetal injury and punish perpetrators (10), Iran’s laws address fetal rights in other ways, such as delaying sentencing of pregnant mothers, exempting them from fasting (11), and invalidating divorce decrees during pregnancy (12). Additionally, Iranian law grants the fetus material and spiritual rights, including inheritance, will, alimony, physical and mental health, and the right to a healthy family (13). Another fetal right aligned with the right to health is the right to mental health, which depends on the mother’s mental well-being (14). The fetus also has the right to independent but parallel medical care, granting it equal standing with parents in cases of medical malpractice (15). Principle 20 of the Iranian Constitution recognizes fetal rights as human rights, emphasizing the preservation of fetal dignity. One key aspect is ensuring a natural childbirth process without unnecessary intervention, as undue medical actions may harm the fetus (11). Violations of fetal dignity include elective cesarean sections performed without medical necessity, a practice prevalent in some developing countries like Iran (16, 17). Such interventions infringe on fetal rights (18). The medicalization of childbirth in countries like Iran has also led to unnecessary cesarean sections and episiotomies, constituting violence against the mother and fetus (19). Verbal violence during childbirth further undermines their dignity (20). A major contributing factor is the lack of awareness among healthcare providers about fetal and maternal rights (21). In developed countries, fetal rights are well-established in civil law, whereas developing countries often lack clear regulations, leading to preventable fetal harm (2). Health policymakers can safeguard fetal health by establishing a legal charter, advancing fetal dignity and societal well-being. Since no existing charter for fetal rights was found in international databases at the time of this study, this research aims to formulate one using Mosadeghrad’s integrated model of health policy analysis (22). Research Goal and Objectives This study aims to analyze and contribute to the policy development process for establishing Iran's first comprehensive fetal rights charter. The research will pursue the following specific objectives: To examine the current status and conceptualization of fetal rights within Iran's legal and healthcare systems To systematically identify and evaluate fetal rights provisions in both international literature and Iranian scholarly discourse To develop and validate through expert consensus a culturally-appropriate fetal rights charter for Iran To translate research findings into actionable policy recommendations through a targeted policy brief Methods Study Design This mixed-methods study will be conducted in five sequential phases: i) Qualitative Study The first phase employs qualitative methods to explore fetal rights policy development using Mosadeghrad's integrated health policy and analysis model (2022). This model, applicable to both policy-making and analysis in developing countries, consists of four stages(Fig. 1 ) : Policy formulation preparation Policy formulation Policy implementation Policy validation The diagram illustrates the four-stage policy cycle used in this study, adapted from Mosadeghrad's integrated model (2022). These stages encompass ten operational steps (Fig. 2 ), making the model particularly suitable for health policy development. Data collection will involve in-depth, semi-structured interviews using a guide with two sections: Demographic information (age, gender, education, position, organization, professional background) Semi-structured questions aligned with study objectives and Mosadeghrad's model (Appendix 1) Participants will include Iranian couples, healthcare providers (midwives, obstetricians), medical ethicists, forensic experts, lawyers, clergy, and policymakers. Using purposeful sampling with maximum variation, recruitment will continue until data saturation is achieved, supplemented by snowball sampling. Interview procedures will include: Audio recording with simultaneous note-taking Researcher introduction and study explanation Confidentiality assurance and oral consent Participant-determined timing and location Progressive questioning from general to specific Probing questions as needed (e.g., "Could you elaborate?") Flexible addition of new questions during analysis Data will be analyzed using conventional qualitative content analysis with MAXQDA2020 software for coding and categorization. ii) Scoping Review Following Arksey and O'Malley's 6-step framework (23), this phase will: Identify research questions regarding: Definition and specification of fetal rights nationally/internationally Current fetal rights protections Search multiple sources including: Academic databases International organization websites Gray literature (parliamentary research, ministry reports, UN documents) Manual journal searches Use comprehensive search terms covering: Fetal/maternal rights Religious perspectives (Islam, Christianity, Judaism) Clinical contexts (cesarean, labor interventions) Policy and legal frameworks 4. Charting the data; 5. Collating, summarizing, and reporting the results, and 6. Consultation. Extracted data will be categorized, visualized graphically, and analyzed qualitatively to identify policy options for subsequent phases. iii) Policy Development Combining findings from Phases I and II, we will: Draft an initial fetal rights charter Complete the policy formulation stage of Mosadeghrad's model Prepare the charter for content validation iv) Charter Validation Using Delphi technique (24,25), we will: Convene an expert panel (10–15 specialists in relevant fields) Conduct iterative survey rounds until consensus is reached Finalize the charter based on expert feedback v) Policy Brief Development The study will culminate in a policy brief presenting the validated charter and implementation recommendations. Discussion Fetal rights encompass three fundamental domains: the right to life, the right to health, and rights pertaining to the gestational and childbirth periods (2). Both public and medical professionals' lack of awareness regarding these rights may lead to significant harm affecting families and society at large (11). Beyond the immediate physical and psychological consequences for fetuses, insufficient recognition of these rights by health authorities can result in broader demographic consequences, including increased rates of elective abortions, medically unnecessary labor induction, non-indicated cesarean deliveries, and preventable fetal harm (2). Existing research highlights a critical policy gap in Iran's healthcare system: while fetal rights have been primarily addressed through criminal law frameworks, their health dimensions remain substantially overlooked, with no comprehensive charter currently existing to protect these rights (26). Given the unique nature of healthcare policymaking, developing a specialized legal charter for fetal rights could serve dual purposes - safeguarding fetal dignity and health while supporting national childbearing policies. This study represents the first systematic effort toward this goal. Utilizing Mosadeghrad's integrated health policy analysis model (22), this research will examine the policy development process for Iran's fetal rights charter. The resulting document aims to: Serve as a reference for healthcare providers Enhance professional competencies in maternal-fetal health Support cost-effective interventions in reproductive healthcare By establishing clear guidelines, the charter may help bridge the current gap between legal protections and healthcare practice, ultimately promoting fetal wellbeing from the earliest stages of development Declarations Acknowledgements The authors would like to thank Tehran University of Medical Sciences for funding and supporting this study and all participants who helped us in exploring the valuable experiences and perspectives of Iranian people about fetal rights. Authors’ contributions SSS, MAMR and MM participated in conceptualization and methodology. SPK participated in investigation and writing-original draft preparation. SSS, MAMR and MM participated in writing-review and editing. All authors read and approved the final manuscript. Funding Current study was funded and supported by Tehran University of Medical Sciences (Grant no.IR.TUMS.FNM.REC.1403.014). Availability of data and materials No datasets were generated or analyzed during the current study. Ethical approval and consent to participate The protocol for this study received approval from the Ethics Committee of Tehran University of Medical Sciences, Tehran, Iran (reference number IR.TUMS.FNM.REC.1403.014). Prior to their participation, all individuals involved will receive comprehensive information about the research objectives and procedures, and their written informed consent will be obtained. Strict confidentiality measures will be implemented to safeguard the privacy and anonymity of the gathered information. Participants will be well-informed about their right to withdraw from the study at any phase without facing any adverse consequences. No financial burden will be imposed on participants, as all services provided will be free of charge. The data collected during the study will be completely dissociated from any personally identifiable information. Personal identifiers will not be used for data storage, and confidentiality will be maintained throughout all phases of data management to ensure the privacy and anonymity of participants. Access to the data collected during the project will be restricted to authorized members of the research team only. Consent for publication Not applicable Funding Statement This study was funded by Tehran University of Medical Sciences (Grant no. IR.TUMS.FNM.REC.1403.014)." Competing interests The authors declare no competing interests. References Paulsen MSJOSL. The Plausibility of Personhood. 2013;74:13. Fathi Najafi T, Najafi Fathi M, Dashti S, Farnoosh EJJoPM. Comparative study of the Fetal Rights in National and International laws: a narrative Review Paper. 2022;9(3):292-301. Abbasi M, Kalhornia Golkar MJCRJ. Dimensions of Legal Liability in Malapropos Cesarean in the Light of the Fundamental Rights of the Fetus. 2019;1(2):155-69. Finnis J. Natural law and natural rights: Oxford University Press; 2011. Abhary MN, Shaghaghi F, Safinejad H, Asadi L, Mohebbi-Dehnavi ZJJoM, Health R. The Effects of Unsafe Abortion on the Health System from a Socio-economic Perspective: A Narrative Review. 2023;11(4). Cioffi A, Cioffi F, Rinaldi RJC, coletiva s. Reflections about abortion limitation. 2021;26:3787-90. Kang L, Liu J, Ma Q, Jing W, Wu Y, Zhang S, et al. Prevalence of induced abortion among Chinese women aged 18–49 years: Findings from three cross-sectional studies. 2022;10:926246. Meshkat MJJoCLR. The comparative study of fetal abuse in the criminal system of Iran and United States. 2018;7(24):37-65. ZAHEDI F. ETHICAL CONSIDERATIONS OF GAMETE AND EMBRYO DONATION. 2007. Niţă AM, Goga CIJRJoM, Embryology. A research on abortion: ethics, legislation and socio-medical outcomes. Case study: Romania. 2020;61(1):283. Asadī M, Nuzarī Firdusīyih MJJ-lsow, family. Fetal civil rights in the family system. 2020;2(4):113-39. Pezeshki S, Hosseini SA, Nazemi AMH. Review of legal regulations related to the fetus based on the issues of his physical and mental health in the family center. 2021. Mashayekhi J, Derakhshan Z, Parsapoor AJIJoME, Medicine Ho. A review of the basis of fetal dignity in some contemporary medical ethics theories. 2019;12:127-39. Zampas C, Amin A, O’Hanlon L, Bjerregaard A, Mehrtash H, Khosla RJH, et al. Operationalizing a human rights-based approach to address mistreatment against women during childbirth. 2020;22(1):251. Wellman CJL, Phil. The concept of fetal rights. 2002;21:65. Gamble JA, Creedy DKJB. Women's request for a cesarean section: a critique of the literature. 2000;27(4):256-63. Black M, Bhattacharya SJPM. Cesarean section in China, Taiwan, and Hong Kong—A safe choice for women and clinicians? 2018;15(10):e1002676. Jenabi E, Khazaei S, Bashirian S, Aghababaei S, Matinnia NJTJoM-F, Medicine N. Reasons for elective cesarean section on maternal request: a systematic review. 2020;33(22):3867-72. Molla W, Wudneh A, Tilahun RJBp, childbirth. Obstetric violence and associated factors among women during facility based childbirth at Gedeo Zone, South Ethiopia. 2022;22(1):565. Vedam S, Stoll K, Taiwo TK, Rubashkin N, Cheyney M, Strauss N, et al. The Giving Voice to Mothers study: inequity and mistreatment during pregnancy and childbirth in the United States. 2019;16:1-18. Perrotte V, Chaudhary A, Goodman AJOJoO, Gynecology. “At least your baby is healthy” obstetric violence or disrespect and abuse in childbirth occurrence worldwide: A literature review. 2020;10(11):1544. Mosadeghrad AMJP. A practical model for health policy making and analysis. 2022;21(1):7-24. Arksey H, O'Malley LJIjosrm. Scoping studies: towards a methodological framework. 2005;8(1):19-32. Pelletier D, Duffield C, Adams A, Mitten-Lewis S, Nagy S, Crisp JJCNS. The cardiac nurse's role: an Australian Delphi study perspective. 1997;11(6):255-63. Trevelyan EG, Robinson NJEJoIM. Delphi methodology in health research: how to do it? 2015;7(4):423-8. Doshmangir L, Ravaghi HJHJ. Theories and models of policymaking for doing health policy analysis. 2015;18(1):68-82. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7092827","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Study protocol","associatedPublications":[],"authors":[{"id":502023734,"identity":"1e0875ef-64cd-4845-b504-8f8a8f3d1a40","order_by":0,"name":"Sepideh Panjalipour Kakrodi","email":"","orcid":"","institution":"Tehran University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Sepideh","middleName":"Panjalipour","lastName":"Kakrodi","suffix":""},{"id":502023735,"identity":"028cd63c-3d90-4182-8e79-3bdf1077adc1","order_by":1,"name":"Shirin Shahbazi Sighaldeh","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA8ElEQVRIiWNgGAWjYDACCQY2ZiDFwyDB2MCQwGADEiFNSxrxWmAqDxPWIj+7+dnjgpo6GSCj7cPDHecT+2c3H3zAUGMTjUuLwZ1j5sYzjrHxGNw52Dwj8cztxBl3jiUbMBxLy23ApUUiwUyah42Hx0AisZkhse12YsONHDOgvw7j1CI/I/2bNM8/CR75GWAt5xLnE9LCAFQgzdtmwMNwA6zlQOIGQloMbuSUSc/sS+AxgGhJNt54Iy3ZIAGPX4AO2yZd8K3OHsh4zPizzU523o3kgw8+1Njgdhg6cASrTCBWOQjYk6J4FIyCUTAKRgYAAKesWpjjOdkzAAAAAElFTkSuQmCC","orcid":"","institution":"Tehran University of Medical Sciences","correspondingAuthor":true,"prefix":"","firstName":"Shirin","middleName":"Shahbazi","lastName":"Sighaldeh","suffix":""},{"id":502023736,"identity":"5091af41-9bc3-4c52-826d-10f90c8cd617","order_by":2,"name":"Mohamad Ali Mosadeghrad","email":"","orcid":"","institution":"Tehran University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Mohamad","middleName":"Ali","lastName":"Mosadeghrad","suffix":""},{"id":502023737,"identity":"382059e3-d6f2-4fd9-983a-8d93d2217ffe","order_by":3,"name":"Mahmoud Abbassi","email":"","orcid":"","institution":"Shahid Beheshti University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Mahmoud","middleName":"","lastName":"Abbassi","suffix":""}],"badges":[],"createdAt":"2025-07-10 12:08:14","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-7092827/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7092827/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":89355421,"identity":"8f9b5e8b-750f-4d18-8d34-15d4d991d06c","added_by":"auto","created_at":"2025-08-19 07:18:23","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":35359,"visible":true,"origin":"","legend":"\u003cp\u003eHealth policy cycle\u003c/p\u003e\n\u003cp\u003eThe diagram illustrates the four-stage policy cycle used in this study, adapted from Mosadeghrad's integrated model (2022).\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-7092827/v1/6c8ceb8bce8b8a5b3da7c3c1.png"},{"id":89356428,"identity":"825ba180-f094-4628-b9d3-16554e8e4b68","added_by":"auto","created_at":"2025-08-19 07:26:23","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":69114,"visible":true,"origin":"","legend":"\u003cp\u003eStages of the integrated model for health policy making and analysis. This figure depicts the ten operational steps of Mosadeghrad's model, combining garbage and rationality approaches in policy making. In the preparation stage for policy formulation, the policymaking secretariat is formed so that the problem, problem solving solutions, key people and the right opportunity for policymaking are put together in a purposeful and systematic manner and the preparations and background for policymaking are provided (garbage approach). Then, the issue is placed on the policy maker's agenda, final analyses are performed, policy options are reviewed, evaluated and selected, and a policy document is written and approved. Also, by using the analysis of the stakeholders and using the appropriate strategies, the necessary advocacy for the policy is done. Then the policy is announced for implementation, an operational plan is written at the level of organizations to implement it; the necessary resources are provided and finally, the policy plan is implemented. The outputs and results of the implementation of the policy are continuously monitored and evaluated, and the degree of achievement of the policy goals is measured in order to solve the problem, and the necessary corrective measures are applied (rationality approach)(22).\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-7092827/v1/bf0b80f6a6e07a9260b8a5ad.png"},{"id":103050315,"identity":"82d8a5ea-34c7-4355-b02b-f11bf000cce5","added_by":"auto","created_at":"2026-02-20 07:49:24","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":560361,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7092827/v1/03c7d7fa-6986-4462-a24b-97e31e9bcf43.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Designing a National Charter for Fetal Rights in Iran: A Mixed-Methods Policy Study Protocol","fulltext":[{"header":"Introduction","content":"\u003cp\u003eIn recent years, fetal rights have become a topic of great interest in the world (1). According to existing texts, the rights of the fetus are divided into the right to life, the right to health, and rights related to the fetal and childbirth period (2). The right to life and the right to health are the most fundamental human rights and the natural rights of every human being (3). Natural rights are rights that are not bound by the laws and customs of any particular culture or government and are undeniable (4). Every human being, regardless of their location, whether in the womb or outside, deserves the basic right to life, including the right to life and freedom (1).\u003c/p\u003e\u003cp\u003eAmong the important behaviors caused by the lack of attention to fetal rights are induced abortions (5). On average, 121\u0026nbsp;million unintended pregnancies occur annually in the world, of which 73\u0026nbsp;million (61%) lead to induced abortion (6). 45% of induced abortions occur under unsafe conditions, 97% of which occur in developing countries (7).\u003c/p\u003e\u003cp\u003eAccording to Article 56 of the Family and Youth Protection Law of Iran (2021), induced therapeutic abortion is allowed up to 19 weeks’ gestation when continuing the pregnancy is life-threatening for the mother or in cases of fetal disease, including retardation or imperfection of the fetus. However, other cases such as maternal addiction, pregnancy resulting from incest (8), or fetal injuries caused by negligence or domestic violence (9) are not included. While some developed countries criminalize fetal injury and punish perpetrators (10), Iran’s laws address fetal rights in other ways, such as delaying sentencing of pregnant mothers, exempting them from fasting (11), and invalidating divorce decrees during pregnancy (12). Additionally, Iranian law grants the fetus material and spiritual rights, including inheritance, will, alimony, physical and mental health, and the right to a healthy family (13).\u003c/p\u003e\u003cp\u003eAnother fetal right aligned with the right to health is the right to mental health, which depends on the mother’s mental well-being (14). The fetus also has the right to independent but parallel medical care, granting it equal standing with parents in cases of medical malpractice (15). Principle 20 of the Iranian Constitution recognizes fetal rights as human rights, emphasizing the preservation of fetal dignity. One key aspect is ensuring a natural childbirth process without unnecessary intervention, as undue medical actions may harm the fetus (11).\u003c/p\u003e\u003cp\u003eViolations of fetal dignity include elective cesarean sections performed without medical necessity, a practice prevalent in some developing countries like Iran (16, 17). Such interventions infringe on fetal rights (18). The medicalization of childbirth in countries like Iran has also led to unnecessary cesarean sections and episiotomies, constituting violence against the mother and fetus (19). Verbal violence during childbirth further undermines their dignity (20). A major contributing factor is the lack of awareness among healthcare providers about fetal and maternal rights (21).\u003c/p\u003e\u003cp\u003eIn developed countries, fetal rights are well-established in civil law, whereas developing countries often lack clear regulations, leading to preventable fetal harm (2). Health policymakers can safeguard fetal health by establishing a legal charter, advancing fetal dignity and societal well-being. Since no existing charter for fetal rights was found in international databases at the time of this study, this research aims to formulate one using Mosadeghrad’s integrated model of health policy analysis (22).\u003c/p\u003e\u003cp\u003e\u003cb\u003eResearch Goal and Objectives\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThis study aims to analyze and contribute to the policy development process for establishing Iran's first comprehensive fetal rights charter. The research will pursue the following specific objectives:\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003col\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003eTo examine the current status and conceptualization of fetal rights within Iran's legal and healthcare systems\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003eTo systematically identify and evaluate fetal rights provisions in both international literature and Iranian scholarly discourse\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003eTo develop and validate through expert consensus a culturally-appropriate fetal rights charter for Iran\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003eTo translate research findings into actionable policy recommendations through a targeted policy brief\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003c/ol\u003e\u003cp\u003e\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003e\u003cb\u003eStudy Design\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThis mixed-methods study will be conducted in five sequential phases:\u003c/p\u003e\u003cp\u003e\u003cb\u003ei) Qualitative Study\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThe first phase employs qualitative methods to explore fetal rights policy development using Mosadeghrad's integrated health policy and analysis model (2022). This model, applicable to both policy-making and analysis in developing countries, consists of four stages(Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e1\u003c/span\u003e\u003cb\u003e)\u003c/b\u003e:\u003c/p\u003e\u003col\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003ePolicy formulation preparation\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003ePolicy formulation\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003ePolicy implementation\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003ePolicy validation\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003c/ol\u003e\u003cp\u003eThe diagram illustrates the four-stage policy cycle used in this study, adapted from Mosadeghrad's integrated model (2022).\u003c/p\u003e\u003cp\u003eThese stages encompass ten operational steps (Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e2\u003c/span\u003e), making the model particularly suitable for health policy development. Data collection will involve in-depth, semi-structured interviews using a guide with two sections:\u003c/p\u003e\u003cul\u003e\u003cli\u003e\u003cp\u003eDemographic information (age, gender, education, position, organization, professional background)\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eSemi-structured questions aligned with study objectives and Mosadeghrad's model (Appendix 1)\u003c/p\u003e\u003c/li\u003e\u003c/ul\u003e\u003cp\u003eParticipants will include Iranian couples, healthcare providers (midwives, obstetricians), medical ethicists, forensic experts, lawyers, clergy, and policymakers. Using purposeful sampling with maximum variation, recruitment will continue until data saturation is achieved, supplemented by snowball sampling.\u003c/p\u003e\u003cp\u003eInterview procedures will include:\u003c/p\u003e\u003cul\u003e\u003cli\u003e\u003cp\u003eAudio recording with simultaneous note-taking\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eResearcher introduction and study explanation\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eConfidentiality assurance and oral consent\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eParticipant-determined timing and location\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eProgressive questioning from general to specific\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eProbing questions as needed (e.g., \"Could you elaborate?\")\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eFlexible addition of new questions during analysis\u003c/p\u003e\u003c/li\u003e\u003c/ul\u003e\u003cp\u003eData will be analyzed using conventional qualitative content analysis with MAXQDA2020 software for coding and categorization.\u003c/p\u003e\u003cp\u003e\u003cb\u003e ii) Scoping Review\u003c/b\u003e\u003c/p\u003e\u003cp\u003eFollowing Arksey and O'Malley's 6-step framework (23), this phase will:\u003c/p\u003e\u003col\u003e\n \u003cli\u003eIdentify research questions regarding:\u003cul\u003e\n \u003cli\u003eDefinition and specification of fetal rights nationally/internationally\u003c/li\u003e\n \u003cli\u003eCurrent fetal rights protections\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/li\u003e\n \u003cli\u003eSearch multiple sources including:\u003cul\u003e\n \u003cli\u003eAcademic databases\u003c/li\u003e\n \u003cli\u003eInternational organization websites\u003c/li\u003e\n \u003cli\u003eGray literature (parliamentary research, ministry reports, UN documents)\u003c/li\u003e\n \u003cli\u003eManual journal searches\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/li\u003e\n \u003cli\u003eUse comprehensive search terms covering:\u003cul\u003e\n \u003cli\u003eFetal/maternal rights\u003c/li\u003e\n \u003cli\u003eReligious perspectives (Islam, Christianity, Judaism)\u003c/li\u003e\n \u003cli\u003eClinical contexts (cesarean, labor interventions)\u003c/li\u003e\n \u003cli\u003ePolicy and legal frameworks\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/li\u003e\n\u003c/ol\u003e\u003cp\u003e4. Charting the data; 5. Collating, summarizing, and reporting the results, and 6. Consultation.\u003c/p\u003e\u003cp\u003eExtracted data will be categorized, visualized graphically, and analyzed qualitatively to identify policy options for subsequent phases.\u003c/p\u003e\u003cp\u003e\u003cb\u003eiii) Policy Development\u003c/b\u003e\u003c/p\u003e\u003cp\u003eCombining findings from Phases I and II, we will:\u003c/p\u003e\u003cul\u003e\u003cli\u003e\u003cp\u003eDraft an initial fetal rights charter\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eComplete the policy formulation stage of Mosadeghrad's model\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003ePrepare the charter for content validation\u003c/p\u003e\u003c/li\u003e\u003c/ul\u003e\u003cp\u003e\u003cb\u003eiv) Charter Validation\u003c/b\u003e\u003c/p\u003e\u003cp\u003eUsing Delphi technique (24,25), we will:\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cul\u003e\u003cli\u003e\u003cp\u003eConvene an expert panel (10–15 specialists in relevant fields)\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eConduct iterative survey rounds until consensus is reached\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eFinalize the charter based on expert feedback\u003c/p\u003e\u003c/li\u003e\u003c/ul\u003e\u003cp\u003e\u003cb\u003ev) Policy Brief Development\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThe study will culminate in a policy brief presenting the validated charter and implementation recommendations.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eFetal rights encompass three fundamental domains: the right to life, the right to health, and rights pertaining to the gestational and childbirth periods (2). Both public and medical professionals' lack of awareness regarding these rights may lead to significant harm affecting families and society at large (11). Beyond the immediate physical and psychological consequences for fetuses, insufficient recognition of these rights by health authorities can result in broader demographic consequences, including increased rates of elective abortions, medically unnecessary labor induction, non-indicated cesarean deliveries, and preventable fetal harm (2).\u003c/p\u003e\u003cp\u003eExisting research highlights a critical policy gap in Iran's healthcare system: while fetal rights have been primarily addressed through criminal law frameworks, their health dimensions remain substantially overlooked, with no comprehensive charter currently existing to protect these rights (26). Given the unique nature of healthcare policymaking, developing a specialized legal charter for fetal rights could serve dual purposes - safeguarding fetal dignity and health while supporting national childbearing policies. This study represents the first systematic effort toward this goal.\u003c/p\u003e\u003cp\u003eUtilizing Mosadeghrad's integrated health policy analysis model (22), this research will examine the policy development process for Iran's fetal rights charter. The resulting document aims to:\u003c/p\u003e\u003cp\u003e\u003cul\u003e\u003cli\u003e\u003cp\u003eServe as a reference for healthcare providers\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eEnhance professional competencies in maternal-fetal health\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eSupport cost-effective interventions in reproductive healthcare\u003c/p\u003e\u003c/li\u003e\u003c/ul\u003e\u003c/p\u003e\u003cp\u003e By establishing clear guidelines, the charter may help bridge the current gap between legal protections and healthcare practice, ultimately promoting fetal wellbeing from the earliest stages of development\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors would like to thank Tehran University of Medical Sciences for funding and supporting this study and all participants who helped us in exploring the valuable experiences and perspectives of Iranian people about fetal rights.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;SSS, MAMR and MM participated in conceptualization and methodology. SPK participated in investigation and writing-original draft preparation. SSS, MAMR and MM participated in writing-review and editing. All authors read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eCurrent study was funded and supported by Tehran University of Medical Sciences\u0026nbsp;(Grant no.IR.TUMS.FNM.REC.1403.014).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNo datasets were generated or analyzed during the current study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthical approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe protocol for this study received approval from the Ethics Committee\u0026nbsp;of Tehran University of\u0026nbsp;Medical Sciences, Tehran, Iran (reference number\u0026nbsp;IR.TUMS.FNM.REC.1403.014). Prior to their participation, all individuals involved\u0026nbsp;will receive comprehensive information about the research objectives and\u0026nbsp;procedures, and their written informed consent will be obtained. Strict\u003c/p\u003e\n\u003cp\u003econfidentiality measures will be implemented to safeguard the privacy and\u0026nbsp;anonymity of the\u0026nbsp;gathered information. Participants will be well-informed\u0026nbsp;about their right to withdraw from the study at any phase without facing any\u0026nbsp;adverse consequences. No financial burden will be imposed on participants,\u0026nbsp;as all services provided will be free of charge. The data collected during the\u0026nbsp;study will be completely dissociated from any personally identifiable information. Personal identifiers will not be used for data storage, and confidentiality\u0026nbsp;will be maintained throughout all phases of data management to ensure the\u0026nbsp;privacy and anonymity of participants. Access to the data collected during the\u0026nbsp;project will be restricted to authorized members of the research team only.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding Statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was funded by Tehran University of Medical Sciences (Grant no. IR.TUMS.FNM.REC.1403.014).\u0026quot;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare no competing interests.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003ePaulsen MSJOSL. The Plausibility of Personhood. 2013;74:13.\u003c/li\u003e\n\u003cli\u003eFathi Najafi T, Najafi Fathi M, Dashti S, Farnoosh EJJoPM. Comparative study of the Fetal Rights in National and International laws: a narrative Review Paper. 2022;9(3):292-301.\u003c/li\u003e\n\u003cli\u003eAbbasi M, Kalhornia Golkar MJCRJ. Dimensions of Legal Liability in Malapropos Cesarean in the Light of the Fundamental Rights of the Fetus. 2019;1(2):155-69.\u003c/li\u003e\n\u003cli\u003eFinnis J. Natural law and natural rights: Oxford University Press; 2011.\u003c/li\u003e\n\u003cli\u003eAbhary MN, Shaghaghi F, Safinejad H, Asadi L, Mohebbi-Dehnavi ZJJoM, Health R. The Effects of Unsafe Abortion on the Health System from a Socio-economic Perspective: A Narrative Review. 2023;11(4).\u003c/li\u003e\n\u003cli\u003eCioffi A, Cioffi F, Rinaldi RJC, coletiva s. Reflections about abortion limitation. 2021;26:3787-90.\u003c/li\u003e\n\u003cli\u003eKang L, Liu J, Ma Q, Jing W, Wu Y, Zhang S, et al. Prevalence of induced abortion among Chinese women aged 18\u0026ndash;49 years: Findings from three cross-sectional studies. 2022;10:926246.\u003c/li\u003e\n\u003cli\u003eMeshkat MJJoCLR. The comparative study of fetal abuse in the criminal system of Iran and United States. 2018;7(24):37-65.\u003c/li\u003e\n\u003cli\u003eZAHEDI F. ETHICAL CONSIDERATIONS OF GAMETE AND EMBRYO DONATION. 2007.\u003c/li\u003e\n\u003cli\u003eNiţă AM, Goga CIJRJoM, Embryology. A research on abortion: ethics, legislation and socio-medical outcomes. Case study: Romania. 2020;61(1):283.\u003c/li\u003e\n\u003cli\u003eAsadī M, Nuzarī Firdusīyih MJJ-lsow, family. Fetal civil rights in the family system. 2020;2(4):113-39.\u003c/li\u003e\n\u003cli\u003ePezeshki S, Hosseini SA, Nazemi AMH. Review of legal regulations related to the fetus based on the issues of his physical and mental health in the family center. 2021.\u003c/li\u003e\n\u003cli\u003eMashayekhi J, Derakhshan Z, Parsapoor AJIJoME, Medicine Ho. A review of the basis of fetal dignity in some contemporary medical ethics theories. 2019;12:127-39.\u003c/li\u003e\n\u003cli\u003eZampas C, Amin A, O\u0026rsquo;Hanlon L, Bjerregaard A, Mehrtash H, Khosla RJH, et al. Operationalizing a human rights-based approach to address mistreatment against women during childbirth. 2020;22(1):251.\u003c/li\u003e\n\u003cli\u003eWellman CJL, Phil. The concept of fetal rights. 2002;21:65.\u003c/li\u003e\n\u003cli\u003eGamble JA, Creedy DKJB. Women\u0026apos;s request for a cesarean section: a critique of the literature. 2000;27(4):256-63.\u003c/li\u003e\n\u003cli\u003eBlack M, Bhattacharya SJPM. Cesarean section in China, Taiwan, and Hong Kong\u0026mdash;A safe choice for women and clinicians? 2018;15(10):e1002676.\u003c/li\u003e\n\u003cli\u003eJenabi E, Khazaei S, Bashirian S, Aghababaei S, Matinnia NJTJoM-F, Medicine N. Reasons for elective cesarean section on maternal request: a systematic review. 2020;33(22):3867-72.\u003c/li\u003e\n\u003cli\u003eMolla W, Wudneh A, Tilahun RJBp, childbirth. Obstetric violence and associated factors among women during facility based childbirth at Gedeo Zone, South Ethiopia. 2022;22(1):565.\u003c/li\u003e\n\u003cli\u003eVedam S, Stoll K, Taiwo TK, Rubashkin N, Cheyney M, Strauss N, et al. The Giving Voice to Mothers study: inequity and mistreatment during pregnancy and childbirth in the United States. 2019;16:1-18.\u003c/li\u003e\n\u003cli\u003ePerrotte V, Chaudhary A, Goodman AJOJoO, Gynecology. \u0026ldquo;At least your baby is healthy\u0026rdquo; obstetric violence or disrespect and abuse in childbirth occurrence worldwide: A literature review. 2020;10(11):1544.\u003c/li\u003e\n\u003cli\u003eMosadeghrad AMJP. A practical model for health policy making and analysis. 2022;21(1):7-24.\u003c/li\u003e\n\u003cli\u003eArksey H, O\u0026apos;Malley LJIjosrm. Scoping studies: towards a methodological framework. 2005;8(1):19-32.\u003c/li\u003e\n\u003cli\u003ePelletier D, Duffield C, Adams A, Mitten-Lewis S, Nagy S, Crisp JJCNS. The cardiac nurse\u0026apos;s role: an Australian Delphi study perspective. 1997;11(6):255-63.\u003c/li\u003e\n\u003cli\u003eTrevelyan EG, Robinson NJEJoIM. Delphi methodology in health research: how to do it? 2015;7(4):423-8.\u003c/li\u003e\n\u003cli\u003eDoshmangir L, Ravaghi HJHJ. Theories and models of policymaking for doing health policy analysis. 2015;18(1):68-82.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Fetal rights, Health policy, Charter development, Mixed-methods research, Iran","lastPublishedDoi":"10.21203/rs.3.rs-7092827/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7092827/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground:\u003c/strong\u003e While fetal rights in Iran have primarily been addressed through criminal law perspectives, their health dimensions remain significantly overlooked. Current research indicates no comprehensive charter exists to safeguard these rights systematically. This study aims to bridge this gap by developing Iran’s first national fetal rights charter, integrating health and legal frameworks.\u003cem\u003e \"The study received ethical approval from Tehran University of Medical Sciences (IR.TUMS.FNM.REC.1403.014)\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods:\u003c/strong\u003e Employing a mixed-methods design, the study unfolds across four phases:\u003c/p\u003e\n\u003col\u003e\n \u003cli\u003e\u003cstrong\u003eQualitative interviews\u003c/strong\u003e with policymakers, healthcare providers,\u0026nbsp;and legal experts to explore contextual perspectives on fetal rights.\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003eScoping review\u003c/strong\u003e of international fetal rights frameworks to identify transferable policies and gaps.\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003eCharter drafting\u003c/strong\u003e synthesizing findings from Phases 1–2, followed by validation via Delphi consensus (3 rounds).\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003ePolicy translation\u003c/strong\u003e through a stakeholder-oriented brief to guide implementation.\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003e\u003cstrong\u003eDiscussion:\u003c/strong\u003e The study will critically examine:\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003ePhase 1–2 findings on Iran’s fetal rights landscape and global benchmarks.\u003c/li\u003e\n \u003cli\u003eHow the synthesized charter addresses Iran’s unique sociolegal context.\u003c/li\u003e\n \u003cli\u003ePractical\u0026nbsp;implications for healthcare and legal systems, alongside future research priorities.\u003c/li\u003e\n\u003c/ul\u003e","manuscriptTitle":"Designing a National Charter for Fetal Rights in Iran: A Mixed-Methods Policy Study Protocol","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-08-19 07:18:18","doi":"10.21203/rs.3.rs-7092827/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"0e8c42aa-8f7e-44bd-893e-c417eee998b1","owner":[],"postedDate":"August 19th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2026-02-19T21:38:56+00:00","versionOfRecord":[],"versionCreatedAt":"2025-08-19 07:18:18","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7092827","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7092827","identity":"rs-7092827","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}